International Patient Summary

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This document contains: Standard for Trial Use International Patient Summary (1.86). The text materials belong to category cdaips.

CDAR2_INTLPATSUMMARY_STU_R1_2018OCT

HL7 CDA® R2 Implementation Guide
International Patient Summary
STU Release 1 (Universal Realm)

International Patient Summary

Standard for Trial Use

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HL7 CDA® R2 Implementation Guide: International Patient Summary, STU Release 1

October 2018 – ©2018 Health Level Seven International. All rights reserved.

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Following is a non-exhaustive list of third-party terminologies that may require a separate license:

Terminology	Owner/Contact
Current Procedures Terminology (CPT) code set	American Medical Association https://www.ama-assn.org/practice-management/cpt-licensing
SNOMED CT©	SNOMED International http://www.snomed.org/snomed-ct/get-snomed-ct or info@ihtsdo.org
Logical Observation Identifiers Names & Codes (LOINC©)	Regenstrief Institute, Inc.
International Classification of Diseases (ICD) codes	World Health Organization (WHO)
NUCC Health Care Provider Taxonomy code set	American Medical Association. Please see www.nucc.org. AMA licensing contact: 312-464-5022 (AMA IP services)

Primary Editor	Giorgio Cangioli, PhD Consultant, HL7 Italy giorgio.cangioli@gmail.com
Primary Editor	Rob Hausam Hausam Consulting LLC rob@hausamconsulting.com
Primary Editor	Dr Kai U. Heitmann Heitmann Consulting and Services, HL7 Germany, ART-DECOR Open Tools GmbH info@kheitmann.de
Primary Editor	François Macary Phast francois.macary@phast.fr
Contributor	Dr Philip Scott HL7 UK philip.scott@uwtsd.ac.uk
Contributor	Dr Christof Geßner Gematik christof.gessner@gematik.de
Contributor	Dr Stefan Sabutsch ELGA, HL7 Austria stefan.sabutsch@elga.gv.at
Contributor	Gary Dickinson CentriHealth gary.dickinson@ehr-standards.com
Contributor	Catherine Chronaki HL7 International Foundation chronaki@gmail.com
Contributor	Dr Stephen Chu HL7 Australia chuscmi88@gmail.com
Contributor	Didi Davis The Sequoia Project ddavis@sequoiaproject.org
Other Contributors	Alexander Berler (a.berler@gnomon.com.gr) ; Carina Seerainer (carina.seerainer@elga.gv.at); John Roberts (John.A.Roberts@tn.gov); Julie James (julie_james@bluewaveinformatics.co.uk); Mark Shafarman (mark.shafarman@earthlink.net); Fernando Portilla (fportila@gmail.com); Ed Hammond (william.hammond@duke.edu); Steve Kay (s.kay@histandards.net)

Introduction

An International Patient Summary (IPS) document is an electronic health record extract containing essential healthcare information intended for use in the unscheduled, cross-border care scenario, comprising at least the required elements of the IPS dataset. The IPS dataset is a minimal and non-exhaustive patient summary dataset, specialty-agnostic, condition-independent, but readily usable by clinicians for the cross-border unscheduled care of a patient.

Purpose

The goal of this Implementation Guide is to identify the required clinical data, vocabulary and value sets for an international patient summary. The international patient summary is specified as a templated document using HL7 CDA R2. The primary use case is to provide support for cross-border or cross-juridictional emergency and unplanned care.

This specification aims to support:

• Cross-jurisdictional patient summaries (through adaptation/extension for multi-language and realm scenarios, including translation).
• Emergency and unplanned care in any country, regardless of language.
• Value sets based on international vocabularies that are usable and understandable in any country.
• Data and metadata for document-level provenance.

Project Background

This Implementation Guide has drawn upon the results of multiple previous projects on patient summaries (including but not limited to epSOS , ONC S&I, Trillium Bridge, Sequoia eHealth Exchange ), rules and recommendations for vocabularies and value sets (in multilingual settings) and templates for the implementation of international patient summary documents.

The idea of the International Patient Summary has been one of the main results of the 2010 EU/US Memorandum of Understanding through its two operational arms: the European project Trillium Bridge and the Interoperability of EHR work group formed under the ONC Standards and Interoperability Framework (ONC S&I) EU/US eHealth Cooperation Initiative. These initiatives identified the need for common templates and vocabularies for the patient summary.

The Joint Initiative Council (JIC) on SDO Global Health Informatics Standardization has initiated the standard sets project with patient summary as its pilot ; and the IPS became one of the main subjects of the new EU / US roadmap , having as a declared goal “to enable a standardized international patient summary (IPS) to be in use by 2020”.

The first standardization activity concerning the IPS was initially promoted in April 2014 by ONC within HL7 International. The project was called “INTernational PAtient Summary (INTERPAS)”. In May 2016, the European Commission granted an Agreement with CEN/ TC 251, recognizing the need to effectively support the leadership and active participation in IPS standardization activities. Thanks to the new boost from the European Commission (EC) and ONC a revision of the HL7 project was started in May 2016, as well as the standardization activities in CEN/TC 251 for the European standards on Patient Summaries. Since the beginning of this new phase, the initiatives were envisaged as a single common IPS project supported by different organizations; where the CEN/TC 251 and the HL7 teams worked together, taking in account the inputs of the JIC Standard Sets initiative on Patient Summary, with the common intent of developing coherent set of standards to support the International Patient Summary concept.

To expedite progress it was also agreed to set up an informal collaboration, promoting a continuous alignment process between the two SDO-specific projects, thanks also to a cross-participation in the project teams. Overlaps have thus been minimized: the CEN/TC 251 activities have been focused on the IPS dataset, formalized by the CEN/TC 251 Draft European standard (prEN) 17269:2018: The Patient Summary for Unscheduled, Cross-border Care" (the CEN/TC 251 prEN 17269:2018 PS in ); the HL7 ones initially on its implementation based on HL7 CDA R2 - this guide - and next on FHIR (the HL7 IPS IGs in ). The figure shows how the products of these standardization activities are placed in the HL7 SAIF Interoperability Matrix.

IPS Standards in the HL7 SAIF Interoperability Matrix

A formal agreement between HL7 International and CEN/TC 251 has been finally signed in April 2017 in which these organizations established “in order to further the care for citizens across the globe <…> to collaborate on a single, common International Patient Summary (IPS) specification”; and that “the IPS specification shall focus on a minimal and non-exhaustive Patient Summary dataset, which is specialty-agnostic and condition-independent, but still clinically relevant.”.

Scope

As expressed in the introduction, the International Patient Summary is

• a minimal and non-exhaustive patient summary,
• specialty-agnostic,
• condition-independent,
• but readily usable by clinicians for cross-border unscheduled care of a patient.

In this context, minimal and non-exhaustive means that an IPS is not intended to reproduce (the entire) content of an Electronic Health Record (EHR).

Specialty-agnostic means that an IPS is not filtered for a specialty. As an example, allergies are not filtered to the specialty of internal medicine, thus may also include food allergies, if considered to be relevant for, e.g. unplanned care.

Condition-independent means that an IPS is not specific to particular conditions, and focuses on the patient current condition(s).

Furthermore the scope of the IPS is global. Although this is a major challenge, this implementation guide takes various experiences and newer developments into account to address global feasibility as far as possible.

General Principles for this Specification

With the formal agreement signed on April 2017, HL7 International and CEN/TC 251 expressed their intent to collaborate under the following principles for the IPS:

The IPS Principles

1. The standards specification for the IPS will be implementable
   • Promote (the evolution and convergence of) existing standards
   • Rely on solutions that are already implemented or ready for implementation
   • Consider new or additional solutions as they become available
2. The standards specification for the IPS will be applicable for global use
   • Strive for global accessibility of standards for use at no cost
   • Strive for a core set of globally accessible and usable terminologies and value sets
   • Include free text in addition to the structured codes as needed
   • Do not include local solutions in the core specification that are not available in other jurisdictions
3. The standards specification will be extensible and open to future use cases and solutions
   • The IPS provides common content that can be extended and specialized for other use cases, or localized for specific jurisdictional needs
   • The IPS is open to emerging solutions for unresolved issues or improvements
4. The standards specification and their implementation must be sustainable through:
   • A robust maintenance and update process for the IPS
   • A process to ensure clinical validity of the IPS, meeting:
     • clinical requirements (including workflow)
     • clinical documentation requirements
     • information quality requirements

Moreover HL7 International and CEN/TC 251 will manage the expectations of the IPS standards specification among stakeholders, by

• stipulating the role of the IPS as a foundation for others to extend
• justifying the inclusion of items in the IPS within the limited context of cross-border or cross-jurisdiction unscheduled care.

The more relevant consequences of these principles in the template design are:

• The adoption of a meet in the middle approach in the templates design to balance the need of maximizing the reuse of existing implemented templates (epSOS, C-CDA CCD; IHE PCC…) and facilitate implementation with the need of optimizing the fitness for purpose within the IPS scope. This approach aims to avoid a pure technical exercise of templates harmonization or an academic exercise that does not take in account what is already implemented.

The IPS meet-in-the-middle approach

• Cooperate with the HL7 Terminology Authority and the organizations that own the used code systems (e.g. SNOMED International) to make the IPS value sets available for global use at no cost for implementation of the IPS.
• When global identifiers are not (or not yet) available, as in the case of the medicinal products, enhance the model proposed for that element with relevant identifying and descriptive attributes that could help with the global identification of that element.
• Select a set of global reference terminologies, with provision for the inclusion of locally used terminologies.
• Avoid solutions (e.g. identifiers, terminologies, standards) that are not yet available for actual global use (even those that are otherwise promising for resolution of well-known issues, such as medicinal product identification). However, the IPS has been already designed, where possible, to be ready to adopt these solutions when they are made available for real use (e.g. the IDMP identifiers) and to already support parts of those solutions that can be used today.
• Within the scope of the IPS and of the “implementable” principle, attempt to be sufficiently generic in the design of the templates so that the IPS templates are extensible for supporting new scenarios, specific specialties or conditions through template specialization or adaptation mechanisms.

Structuring Choices

The International Patient Summary is specified as a templated document using HL7 CDA R2. The expressiveness of SNOMED CT and other primary terminologies enables this specification to represent the two general categories “condition/activity unknown” and “condition/activity known absent” in a style which is more independent of the underlying syntax (CDA R2 or FHIR), as explained in detail in section 4.2.

To be universally exchangeable and understood, a patient summary must rely as much as possible on structured data and multilingual international reference terminologies that are licensed at no cost for global use in the International Patient Summary. In the case of SNOMED CT, it is envisioned that SNOMED International could embrace the idea of a globally accessible open and free specification for the International Patient Summary that references a core set of globally accessible and usable value sets licensed at no-cost with the aim to serve the public good. In this spirit, this version of the International Patient Summary defines SNOMED CT as a primary terminology (the meaning of "primary terminology" is explained in section 4.1) and it is used in many of the value sets. To allow, however, a global and free implementation of the IPS this guide does not impose the usage of these SNOMED CT-based value sets. This choice may be revised in future versions. Other primary terminologies used in this specification are LOINC for observations (e.g., laboratory tests) and document sections, UCUM for units of measure, and EDQM Standard Terms for dose forms and routes. Looking at the availability of other globally usable reference terminologies and toward alignment with a future FHIR version of the IPS, in some selected cases FHIR-defined terminologies are recommended.

This specification adopts ART-DECOR® as the specification platform for this Implementation Guide and uses the HL7 template exchange format. This tool and format are increasingly used by several regions, including European countries, and have been adopted by the EU eHealth Digital Service Infrastructure (eHDSI) project for the operational deployment of the EU cross-borders patient summary and ePrescription services. Users of the specification can visit the IPS project page in ART-DECOR® to browse the specifications and review examples. Users may also use the tool to validate their IPS instances.

Ballot Status of the Document

This Implementation Guide is STU with the intention to go normative.

Audience

The audience for this Implementation Guide includes:

Public

• Citizens who want to carry or access their healthcare data for emergency or unplanned care purposes.

Regulatory

• Policy makers such as healthcare payers or government agencies.
• Healthcare information governance authorities and regulatory bodies.

Clinical

• Healthcare providers that offer unscheduled and emergency care.
• Healthcare providers that populate regional and national patient summaries.

Technical

• Vendors of EHR systems for unplanned care management, personal health records and mobile health data applications.
• System integrators.
• Organizations that manage regional and national patient summaries.

Relationships with other projects and guidelines

This guide is one of the products of the International Patient Summary project (see the Project Background section for details). This project relates to other projects and products as:

• The European Commission CEN/TC 251 Grant Agreement “The International Patient Summary Standards Project” (SA/CEN/GROW/EFTA/000/2015-16).
  This project has as one of its goal “to participate in the creation of an International Patient Summary specification, at a global level, and turn this into a European standard, in line with the Guidelines on Minimum/Nonexhaustive Patient Summary Dataset for Electronic Exchange as adopted by the European eHealth Network"
  Under this project two other standard work items have been promoted under CEN/TC 251:
  • The CEN/TC 251 “prEN 17269: The Patient Summary for Unscheduled, Cross-border Care”.
    Its goal is to “formalise the dataset required to share information about the medical background and history of a patient …. It uses the European guidelines (version 2, November 2016) as an official source for the requirements….”
    Even if it is a European standard it is designed to be applicable in a wider global context.
  • The CEN/TC 251 “prTS 17288: The International Patient Summary: Guidance for European Implementation Technical Specification.
    Its goal is to “provide implementation guidance to support the use of the International Patient Summary dataset in a European context”
    This document is focused on the European cross-country services.

The European Commission CEN/TC 251 Grant Agreement

• The European eHealth Network Guideline on the electronic exchange of health data under Cross-Border Directive 2011/24/EU. Release 2. This Guideline, together with the general guidelines for the electronic exchange of health data under Cross-Border Directive 2011/24/EU, documents the clauses agreed among the European Countries to support the exchange of Patient Summary data for unscheduled care.

The relationships among these standards are shown in Figure 14 included in the section Conformance clause.

Listed below are other related initiatives:

• The HL7 Consolidated CDA (C-CDA) implementation guide was developed and produced through the joint efforts of HL7, two Sub-Work Groups of the Office of the National Coordinator (ONC) Standards and Interoperability (S&I) Framework — Longitudinal Care Plan (LCP) and Long-Term Post-Acute Care (LTPAC) Transition) — and through the SMART C-CDA Collaborative hosted by ONC and Harvard Medical School. It provides a library of CDA templates for implementing a set of CDA documents.
  This is one of the primary sources for this Implementation Guide.
• The IHE Patient Care Coordination (PCC) Cross-Enterprise Sharing of Medical Summaries (XDS-MS) – “defines a mechanisms to automate the sharing process between care providers of Medical Summaries, a class of clinical documents that contain the most relevant portions of information about the patient intended for a specific provider or a broad range of potential providers in different settings.” .
  This is one of the primary sources for this Implementation Guide.
• eHealth Digital Service Infrastructure (eHDSI) Patient Summary Service .This European initiative operationalizes the work done by the epSOS and EXPAND projects for the implementation of European Cross-border services for the exchange of patient summaries and ePrescriptions. This is one of the primary sources for this Implementation Guide.
• The Joint Initiative on SDO Global Health Informatics Standardization (JIC) Patient Summary Standards Set is a set of health informatics standards and related artifacts that can be used to support the implementation of a Patient Summary . The definition of the Patient Summary given by this initiative is a little broader than that adopted by the HL7 and CEN/TC 251 projects, being ““the minimum set of information needed to assure healthcare coordination and the continuity of care” .
• The Data Provenance is an ONC S&I initiative addressing the “source data” challenge so that trust in the authenticity of the data can help inform decision making. The HL7 CDA® Release 2 Implementation Guide: Data Provenance, Release 1 is one of the products resulting from the joint efforts of Health Level Seven (HL7) and the Office of the National Coordinator (ONC) Standards and Interoperability Standards and Interoperability Framework-Data Provenance Initiative.

Reading Publication Artifacts

A reading guide is available that explains the formalism used to express the publication artifacts, i.e. template meta data and template design. For convenience the guide is included in the appendix. (see section 12 How to read the table view for templates)

Technical Background

What is a CDA

CDA R2 is "… a document markup standard that specifies the structure and semantics of clinical documents for the purpose of exchange” [CDA R2, Section 1.1]. Clinical documents, according to CDA, have the following characteristics:

• Persistence
• Stewardship
• Potential for authentication
• Context
• Wholeness
• Human readability

CDA defines a header for classification and management and a document body that carries the clinical record. While the header metadata are prescriptive and designed for consistency across all instances, the body is highly generic, leaving the designation of semantic requirements to implementation.

Templated CDA

CDA R2 can be constrained by mechanisms defined in the “Refinement and Localization” section of the HL7 Version 3 Interoperability Standards. The mechanism most commonly used to constrain CDA is referred to as “templated CDA”. This specification created a set of artifacts containing modular CDA templates (and associated value sets) for the purpose of the International Patient Summary, and the templates can be reused across any number of CDA document types.

There are different kinds of templates that might be created. Among them, the most common ones are:

• CDA Document Level Templates constrain fields in the Clinical Document Architecture (CDA) header, and define containment relationships to CDA sections.
  For example, a History-and-Physical document-level template might require that the patient’s name be present, and that the document contain a Physical Exam section.
• CDA Header Level Templates constrain fields for parts of the CDA header, like the patient (record target), the author, participations or the service event.
• CDA Section Level Templates constrain fields in the CDA section, and define containment relationships to CDA entries.
  For example, a Physical-exam section-level template might require that the section/code be fixed to a particular LOINC code, and that the section contain a Systolic Blood Pressure observation.
• CDA Entry Level Templates constrain the CDA clinical statement model in accordance with real world observations and acts.
  For example, a Systolic-blood-pressure entry-level template defines how the CDA Observation class is constrained (how to populate observation/code, how to populate observation/value, etc.) to represent the notion of a systolic blood pressure.

Open and Closed Templates

Open templates permit anything to be done in the underlying standard that is not explicitly prohibited. This allows templates to be built up over time that extend and go beyond the original use cases for which they were originally designed.

Closed templates only permit what has been defined in the template, and do not permit anything beyond that. There are good reasons to use closed templates, sometimes having to do with local policy. For example, in communicating information from a healthcare provider to an insurance company, some information may need to be omitted to ensure patient privacy laws are followed. Most templates developed for CDA are of the open sort.

Template versioning

Template versioning is needed to enable template designs to evolve over time.

Template versioning enables template designers to control and shape the conformance statements that make up a template’s design over time tailoring the design to fit the template’s intended purpose.

Each template version is associated with a particular template. The template – as a whole – has a mandatory globally unique, non-semantic, identifier. The identifier serves as the identifier of the original intent of the template and as the identifier of the set of versions that represent the template over time.

Template versions have a mandatory timestamp (date and optional time), called the “effective date”. The date can be seen as the point in time when the template version “came into being”, i.e. was recognized as existent by the governance group. Use of the template prior to this date would be considered an invalid use of the template.

For further information on Templates, Template Versions and related topics refer to the HL7 Templates Standard.

Conformance Verbs

The conformance verb keywords SHALL, SHOULD, MAY and SHALL NOT in this document are to be interpreted as described in the HL7 Version 3 Publishing Facilitator's Guide.

• SHALL: an absolute requirement
• SHALL NOT: an absolute prohibition against inclusion
• SHOULD: best practice or recommendation. There may be valid reasons to ignore an item, but the full implications must be understood and carefully weighed before choosing a different course
• MAY: truly optional; can be included or omitted as the author decides with no implications

Identifiers for Templates and Value Sets

This specification uses the following OIDs for the artifacts that are registered at the HL7 OID registry.

• The root OID for templates is 2.16.840.1.113883.10.22
  • Document Level Templates are sub branch .1, e.g. 2.16.840.1.113883.10.22.1.1 International Patient Summary
  • Header Level Templates are summarized under 2.16.840.1.113883.10.22.2, e.g. 2.16.840.1.113883.10.22.2.1 IPS CDA recordTarget
  • Section Level Templates are summarized under 2.16.840.1.113883.10.22.3, e.g. 2.16.840.1.113883.10.22.3.1 IPS Medication Summary Section
  • Entry Level templates are summarized under 2.16.840.1.113883.10.22.4, e.g. 2.16.840.1.113883.10.22.4.19 IPS Certainty Observation
  • “other” assistance templates are summarized under 2.16.840.1.113883.10.22.9, e.g. 2.16.840.1.113883.10.22.9.2 IPS CDA Device
• The root OID for Value Sets is 2.16.840.1.113883.11

The sub branches for templates follow the recommendations of HL7 International and ISO 13582

Terminologies

Note: Much of the description provided in this section is copied and adapted from the §4.2.8 Vocabulary Conformance section of the C-CDA DSTU R2.1 Implementation Guide Volume 1.

The templates in this document use terms from several code systems. These vocabularies are defined in various supporting specifications and may be maintained by other bodies, as is the case for the LOINC® and SNOMED CT® vocabularies. The primary terminologies identified for this specification are listed in section 4.1.

Note that value set identifiers (e.g., ValueSet 2.16.840.1.113883.1.11.78 Observation Interpretation (DYNAMIC)) used in the binding definitions of template conformance statements do not appear in the XML instance of a CDA document. The definition of the template must be referenced to determine or validate the vocabulary conformance requirements of the template.

Value set bindings adhere to HL7 Vocabulary Working Group best practices, and include both an indication of stability and of coding strength for the binding. Value set bindings can be STATIC, meaning that they bind to a specified version of a value set, or DYNAMIC, meaning that they bind to the most current version of the value set. If a STATIC binding is specified, a date SHALL be included to indicate the value set version. If a DYNAMIC binding is specified, the value set authority and link to the base definition of the value set SHALL be included, if available, so implementers can access the current version of the value set. When a vocabulary binding binds to a single code, the stability of the binding is implicitly STATIC.

For example, to convey @code=11450-4, the code’s displayName 'Problem List', the OID of the codeSystem from which the code is drawn '2.16.840.1.113883.6.1', and the codeSystemName 'LOINC', the tabular view used in this guide is presented as shown below.

hl7:code		1 … 1	M
@code	CONF	1 … 1	F	11450-4
@codeSystem		1 … 1	F	2.16.840.1.113883.6.1 (LOINC)
@displayName		1 … 1	F	Problem List

Binding to a Single Code (tabular view)

HL7 Data Types Release 1 requires the codeSystem attribute unless the underlying data type is “Coded Simple” or “CS”, in which case it is prohibited. The displayName and the codeSystemName are optional, but recommended, in all cases.

The above example would be properly expressed as follows.

<code code="11450-4" codeSystem="2.16.840.1.113883.6.1"/>

<!-- or -->

<code code="11450-4" codeSystem="2.16.840.1.113883.6.1" 
  displayName="Problem List" codeSystemName=”LOINC”/>

XML Expression of a Single-Code Binding

A full discussion of the representation of vocabulary is outside the scope of this document; for more information, see the HL7 V3 Normative Edition 2010 sections on Abstract Data Types and XML Data Types R1.

There is a discrepancy between the HL7 R1 Data Types and this guide in the implementation of translation code versus the original code. The R1 data type requires the original code in the root. The convention agreed upon for this implementation guide is that a code from the required value set is used in the element and other codes not included in the value set are to be represented in a translation for the element. Note: This discrepancy is resolved in HL7 Data Types R2, but that is not available for use in CDA R2.

In the next example, the conformant code is SNOMED CT code 206525008.

<code code="206525008" codeSystem="2.16.840.1.113883.6.96"
  displayName="neonatal necrotizing enterocolitis" codeSystemName="SNOMED CT">
  <translation code="NEC-1" codeSystem="2.16.840.1.113883.19"
    displayName="necrotizing enterocolitis"/>
</code>

Translation Code Example

Value set tables are present below a template, or are referenced if they occur elsewhere in the specification, when there are value set bindings in the template. The value set table provides the value set identifier, a description, and a link to the source of the value set when possible. Ellipses in the last row indicate the value set members shown are examples and the true source must be accessed to see all members.

If a value set binding has a DYNAMIC stability, implementers creating a CDA document must go to the location in the URL to check for the most current version of the value set expansion.

Note: Much of the description provided in the following three sections on value set definitions and expansions and extending value sets is adapted from Core Principles and Properties of HL7 Version 3 Models.

Value Set Definitions

Two approaches can be used to define the contents of a Value Set:

• Extensional Definition: Explicitly enumerating each of the Value Set concepts.
  • An Extensional Definition is an enumeration of all of the concepts within the Value Set. A Value Set defined by extension is composed of explicitly enumerated sets of concept representations (with the Code System in which they are valid). The simplest case is when the Value Set consists of only one concept.
• Intensional Definition: Defining an algorithm that, when executed by a machine (or interpreted by a human being), yields an enumeration of all of the concepts within the Value Set, which is called a Value Set Expansion.
  • An Intensional Definition is a set of rules that can be expanded (ideally computationally) to an exact set of concept representations at a particular point in time.

Many of the value sets used in the IPS specification are defined intensionally. The source of truth for these value sets and their definitions for IPS is ART-DECOR®.

Intensional value set definition.

Value Set Expansions

To obtain a list of enumerated concepts, Value Sets must be expanded. This means that the Value Set Definition must be converted to a list of concept representations at a point in time. This normally is a list of codes that may be used in populating or validating communicated model instances (but it may alternatively be a list of designations). While this is straightforward for extensional Value Set Definitions, an intensional Value Set Definition must be resolved to a Value Set Expansion by processing the rules contained in the Value Set Definition. Value Set Expansion can be done as early as the point of Value Set definition or as late as run time. For intensional Value Sets, the set of concepts contained in the expansion will generally change when the definition is changed (a new version of the Value Set Definition), but also may change with the identical version of the definition if the underlying code systems change, and the changes are part of the Value Set Expansion. This can be controlled if the definition statement refers to specific code system versions, thereby prohibiting the expansion from changing when the code system changes with a new version release. See Core Principles and Properties of HL7 Version 3 Models for additional details.

In order to implement the IPS specification, the intensionally defined value sets must be expanded (as noted above). ART-DECOR® is expected to provide capabilities for generating the required value set expansions. Other terminology servers are also expected to provide this service.

How to extend Value Sets

For elements with a binding to a value set that allows extensibility (Extensible/CWE), it may at times be necessary to extend the value set in order to support implementation needs. Coded With Extensibility (Extensible/CWE) means that the set of codes resulting from processing the Value Set Definition is not necessarily complete for its intended use-case. There may be some concepts that need to be communicated that cannot be represented within the expansion of the specified value set. In these cases, implementers therefore have permission to send local codes or original text within the coded element if an appropriate code cannot be found within the value set and its current expansion. When this does occur, however, there is an expectation that implementers should feed back these "missing concepts" to the maintainers of the Value Sets or referenced Code System(s) to have the necessary concept added, and then to transition to the new "official" code when one is subsequently added to the value set.

Functional requirements and high-level use cases

Several use cases may be identified for the International Patient Summary within its scope (“specialty-agnostic, condition-independent, but readily usable by clinicians for the cross-border unscheduled care”). Section Examples provide a subset of some real world user stories for the cross-border care developed by the Trillium Bridge Project and by the S&I EU-US eHealth Cooperation Initiative in the scope of the EU/US Roadmap initiative.

The cross-border care is not however the only expected usage scenario for the IPS. Some European countries have already manifested their interest on the IPS work for their future national Patient Summary for unscheduled care. Patient summary initiatives are currently in various stages of development in other parts of the world.

As shown by the user stories there are several possible options in terms of creation, sharing and usage of an IPS. For example:

1. An IPS can be created when requested and used before, during, or after a care episode; or can be asynchronously generated and made available for future usage (e.g. store and retrieve).
2. The IPS can be retrieved using a document exchange infrastructure; transported by the patient; or shared using cloud-services.
3. The IPS may be subject of a transformation process that may include syntactical conversions, coded concept mappings and coded concept designation or free text translations. This transformation process may be performed in the creation phase, during the transmission, or after the IPS has been received, possibly using an external service.
4. Finally, the received CDA may be used in different ways. For example, displayed using a common CDA stylesheet; display the extracted relevant information; incorporated into the receiver’s EHR. Alternatively, a specialized viewer may be adopted to enable the display of the translated content.

Moreover for cross-jurisdiction exchange, the IPS could be used as:

1. shared format among jurisdictions (case A), where jurisdictions originate and use IPS conforming documents unaltered.
2. pivot document among existing summaries / data formats (case B). For example, the IPS is used as intermediate format between the US C-CDA CCD (please note that the CCD scope differs from that of the IPS) and the European eHDSI Patient Summary for a Transatlantic Patient Summary exchange.
3. mixed mode (Case C), where either the originator or the consumer is expected to use an IPS conforming document.

Examples of IPS usage

Considering all those possible combinations and additional business requirements agreed by jurisdictions, there are several technical infrastructures and services that may be designed to support these requirements.

It is out of scope of this standard to provide any indication about solutions and strategies for the IPS creation, sharing, syntactical and semantic mapping, translation, and use.

That said, an International Patient Summary may:

1. be the result of automatic assembly (assembled IPS) or of a human summarization act (human curated IPS)
2. have one or more EHR sources
3. document information from a single or multiple jurisdictions/organizations
4. aggregate input from a single or multiple encounters.

A clear determination of such contextual information raises the trustworthiness of the received IPS and helps the appropriate usage of its content by the receiver . Most of these aspects are related to data provenance introduced in section 1.8 and further detailed in section 4.11.

Even if many jurisdictions require that only one active Patient Summary for unscheduled care be made available, this guide does not impose such constraints and leaves them to jurisdictional implementations.

Moreover it is also out of scope of this guide to:

• provide guidance on how to determine the relevance of data for their inclusion in a IPS;
• define selection or composition rules for facing potential inconsistencies from multiple sources in case of automatic collection.

Code mappings and multilingual support

The capability of managing locally used coded concepts and reference terminologies, and that of providing receiving providers with human readable information in a language that can be understood by them, are critical aspects to be taken in account in the cross-border sharing of documents. This section summarizes some of the requirements related to these aspects, including also additional needs derived from the European cross-border services and some lessons learned by the EU/US Trillium Bridge Project.

The European cross-border services (eHDSI) use a business to business exchange infrastructure based on a network of country gateways that mediate access to the national infrastructures. The eHDSI Patient Summary (eHDSI PS) is used as a “pivot” document for the cross-border exchange. Local PS using data/document formats are in fact remapped into the eHDSI PS. The document exchanged is processed each time it passes through one of these gateway applying the needed syntactical transformation, code mappings. and translation of the code designations. Finally, in the current practice the received PSs are displayed using specialized display tools that build a human readable representation of the PS in the target language using the translated designations reported in the coded entries.

The adoption of translated narratives in the received document has been one of the indications received by the Trillium Bridge Project. This in fact allows extending multilingual support for the cross-border patient summaries to a wider set of potential consumers (EHR-or PHR systems), without requiring specialized viewers as applied in the eHDSI services.

Concept code mapping

In several real world use cases the records used as source for the Patient Summaries may use locally adopted terminologies, which are mapped to the reference value sets when possible, or otherwise used directly to provide uncoded information. This leads to a series of requirements listed below and detailed further in section 4 Design conventions and principles.

• When the original coded concept is mapped to one of the coded concepts included in the reference value sets (called hereafter reference code/coded concept), both the original and the reference codes SHALL be reported in the IPS instance.
• When the original coded concept is not mapped to one of the coded concepts included in the reference value sets, the original code SHALL be reported in the IPS instance as well as the indication that mapping was not successful.
• When the original record, for a specific coded element, is not able to provide coded but only textual information, this information SHALL be reported in the IPS instance.

This guide also accommodates these situations:

• The original record may support multi-coding. The IPS instance should make clear whether the additional codes belong to the original content or are the result of post hoc concept code mapping.
• The original record may include references to the pieces of text the coding was derived from. If present, the IPS instance should preserve this link between the original code and the referred text.
• Distinct original and reference coded concepts may belong to the same code system. This may be the result of a different level of granularity between the original and the reference value sets, or the result of format transformation - e.g. CCD document is used as input for generating an IPS. The requirement of recording both coded concepts applies also to these cases.

Multilingual support

Multilingual support by IPS can be split in two categories of action:

1. The translation of coded concept designations (displayName)
2. The translation of the narrative.

These actions may deal with various choices:

• Translation to the language of the receiving care provider: a foreign provider retrieves a translated copy of the IPS from the patient's country of affiliation…
• Translation to a commonly agreed language: an English version of the IPS is prepared.
• Predefined set of translations included in the shared IPS.

This guide does not favor any of these solutions. All of them are supported.

Translation of Designations

The European Cross-border services requires that for “safety and liability reasons” all of the original coded terms (designations, displayName) shall be recorded in the exchanged documents together with at least the English and the receiving country language terms (designations, displayName) associated with the reference codes. The designations translated in the receiving country language are used to generate the human readable content shown to the receiving provider. No free text translation is applied in this case. In order to accomplish this objective, the IPS should have the capability to record one or more designations, possibly indicating the language used. The solution chosen to fulfill this requirement is specified in section 4.6.

Narrative Translation

Narrative translation covers two kinds of operations:

• Translation of the original narrative text, which can be automated (e.g. using translation services) and/or human curated.
• Creation of new narrative for the target language, based on the coded entries.

The level of quality and liability obtained depends on the solution adopted and on the quality of the translation service used. It is out of the scope of this guide to suggest any of these solutions. In all cases, however:

• the language of the narrative should be identifiable
• the original and the translated narrative should be clearly distinguished
• the translation methodology applied (e.g. derived from the coded entries; translated by a generic service;..) should be noted

Design conventions and principles

How to use terminologies (preferred binding)

As stated in section 1.5, to be universally exchangeable the International Patient Summary must rely on international multilingual reference terminologies. To that effect, each codeable element of the international patient summary template is bound to a Value Set built upon an international reference terminology, such as SNOMED CT, LOINC, UCUM or EDQM Standard Terms. In some selected cases, in consideration of the availability of other globally usable reference terminologies and for alignment with a future FHIR version of the IPS, FHIR-defined terminologies have been specified. These terminologies have been selected to provide the preferred bindings for the codeable elements of the patient summary. They are the primary terminologies of this specification.

Nevertheless, it is anticipated that in some situations a system producing an instance of patient summary might not support one or the other of these primary terminologies, supporting only a local interface terminology instead. Similarly, it is also anticipated that the receiving system might in some cases not be able to use a code in a patient summary, either because this code belongs to a primary terminology that the receiving system does not support or because this code belongs to an interface terminology specific to the country of the producing system.

In order to maximize the international scope and usability of patient summaries, and also to accommodate the exceptional situations listed above, this specification makes these requirements:

• The Primary Code of a codeable element SHOULD be populated.
• If populated, the Primary Code of a codeable element SHALL be chosen from the primary terminology assigned to the value set bound to this element; unless exceptions have been agreed.
• The 'displayName' of the Primary Code SHALL be populated with a term representing this same code in the terminology used, in the language chosen for the current instance of the patient summary.
• When the primary 'code' element is not populated, an appropriate 'nullFlavor' value SHALL be used along with the 'originalText' element (referencing a textual expression in the narrative representing the meaning for the producer) and/or one or more coded 'translation' elements.
• One or more Alternate Codes from a local interface terminology MAY be provided, each with its associated 'displayName'.
• In case the primary code is derived from an alternate terminology the alternate code SHOULD be provided in the translation element.

Primary Code

In the data type for codeable elements (CD constrained by the CD.IPS template), the Primary Code is represented by the attributes @code, @displayName, @codeSystem, @codeSystemName, @codeSystemVersion.

Alternate Code

In the data type for codeable elements (CD constrained by the CD.IPS template), an Alternate Code is carried in a 'translation' sub-element.

Original Text

In the data type for codeable elements (CD constrained by the CD.IPS template), the Original Text is provided in the 'originalText' sub-element.

Representing "known absent" and "not known"

In line with the properties of minimalism and non-exhaustiveness for the IPS (see the IPS definition above), and benefiting from the experience acquired with the European cross-border services, this guide explicitly addresses two general situations:

1. condition or activity unknown
2. condition or activity known absent.

Other kinds of negations such as: (a) the negation of an allergy to a specific agent; (b) the absence of a particular disease; or (c) the fact that a specific vaccination has not been performed, have been considered beyond the set of essential data for an IPS.

This specification represents this core set of negations (“general condition/activity unknown” and “general condition/activity/known absent” ) using explicit coded elements rather than relying on specific mechanisms of HL7 CDA such as nullFlavor and negationInd attributes or human readable text (possibly not understood by the foreign country receiver).

In contrast to the practice to use negationInd or nullFlavor attributes on a section itself, we prohibit the use of these attributes on section level to express “unknown” or “no information” situations. A section holds the categorized (coded) narrative part of the documented activity and will never carry negationInd or nullFlavor attributes. Instead, we enforce by design, that “unknown” or “no information” expressions always go to the coded entry with a corresponding act code.

The main reasons for this choice are:

• @negationInd in CDA has been superseded in V3 later by two other negation indicators: @actNegationInd and @valueNegationInd.
• To make clinical content representation less dependent on a particular format or syntax, enabling a more practical path to transforming and exchanging data from one standard format (e.g. CDA R2) to another (e.g. FHIR).
• to provide one single method to express the presence or absence of a particular condition (e.g. an allergy) or activity (e.g. an immunization), or the lack of knowledge regarding this kind of condition or activity, resulting in a more robust and easily implementable specification.

For the other kinds of negations, not explicitly mentioned in this guide, it is suggested to apply – where possible – the same approach. Future versions of this guide may extend the number of cases covered and include new coded concepts for supporting them.

When needed, more specific statements such as the absence of a specific condition or activity, although considered as beyond the set of essential data for IPS, can still be expressed by using the native negationInd attribute of CDA R2.

Uncoded information

An IPS originator may not be able to value a coded element with an appropriate coded concept, but only with textual information. This may happen for two reasons:

1. the originator is not able to express the concept in the reference value sets
2. the originator is not able to express the concept in any known terminology.

The first case, assuming that the coding strength is Required (aka CNE, coded, no extensions), is represented in this guide with the following assertion:

<code codeSystem="2.16.840.1.113883.6.96" nullFlavor="OTH">
  <originalText>
    <reference value="#ref1"/>
  </originalText>
</code>

That is expressing that there are no codes applicable in the referred code system (in the example, SNOMED CT). Please note that according to this guide the text is documented in the section narrative and only referenced by the coded element.

Note: Data Types R1 doesn't allow specifying that there are no codes applicable in the referred value set, as instead is possible with Data Types R2. Future versions of this guide may consider extending the data type to better support this situation.

The second case, that applies both to Required (aka CNE, coded no extensions) and Extensible (CWE, coded with extensions) coding strengths, is instead here represented valuing the coded element with the most generic nullFlavor “NI” (No Information) and pointing the text in the section narrative:

<value xsi:type="CD" nullFlavor="NI">
  <originalText>
    <reference value="#ref1"/>
  </originalText>
</value>

Note: The most proper NullFlavor code to be used here would be "UNC" (Uncoded). This code is available in the current and other recent versions of the HL7 RIM, but it is not present in version 2.07 of the RIM on which the CDA R2 standard is based. In the absence of "UNC", the most appropriate NullFlavor code to use for representing that the data is unable to be coded is "NI".

Unmapped Coded Concepts

In several real world situations the records used as source for the Patient Summaries may use locally adopted terminologies mapped into the reference value sets. When the original coded concept cannot be mapped in one of the coded concepts included in the reference value sets, it is recommended to populate the original code in the IPS instance (in a 'translation' sub-element), with a nullFlavor indicating that the mapping didn’t occur. (See also the Concept code mapping in the functional requirements section.). The nullFlavor value depends upon the coding strength of the binding.

Two circumstances are considered here: the case in which the coding strength is Required (CNE) and when it is Extensible (CWE).

In the case of coding strength Required (CNE), use nullFlavor "OTH":

<value xsi:type="CD" codeSystem="2.16.840.1.113883.6.96" nullFlavor="OTH"> 
  [
    <originalText>
      <reference value="#ref1"/>
    </originalText>
  ] 
  <translation code="A02.9" codeSystem="2.16.840.1.113883.6.3"
    displayName="Infezioni da Salmonella non specificate"/>
</value>

The square brackets [ ] are used to indicate that the originalText element may or may not be present

Note: It may happen that a mapping would be possible in the target code system, but not in the target value set; Data Types R1 does not allow the specification of this difference, that there are no codes applicable in the reference value set, which is possible with Data Types R2.

Future versions of this guide may consider extending the data type to better support this situation.

In the case of Extensible (CWE) coding strength, this guide recommends representing the original code in the <translation> sub-element and using a nullFlavor for the primary code. This highlights the fact that a mapping to the reference value set was attempted, but no suitable target codes were identified.

<value xsi:type="CD" codeSystem="2.16.840.1.113883.6.96" nullFlavor="NI"> 
  [
    <originalText>
      <reference value="#ref1"/>
    </originalText>
  ] 
  <translation code="A02.9" codeSystem="2.16.840.1.113883.6.3" 
    displayName="Infezioni da Salmonella non specificate"/>
</value>

The square brackets [ ] are used to indicate that the originalText element may or may not be present.

Mapped coded concepts

As mentioned above, in several circumstances an original coded concept is mapped into the reference value set. When this occurs, both the original and the reference codes should be reported in the IPS instance.

Functional requirements exposed in section 3.1 (multi-coding, link to original text, mapping between codes of the same code system) are also detailed below.

Case 1: Single local code mapped to primary code from the reference value set.

<value xsi:type="CD" code="42338000" codeSystem="2.16.840.1.113883.6.96"
  displayName="Salmonella gastroenteritis">
  [
    <originalText>
      <reference value="#ref1"/>
    </originalText>
  ] 
  <translation code="003.0" codeSystem="2.16.840.1.113883.6.103"
    displayName="Gastroenterite da Salmonella"/>
</value>

The square brackets [ ] are used to indicate that the originalText element may or may not be present

Case 2: Multiple local codes mapped together using nested 'translation' elements, and mapped to the primary code from the reference value set.

<value xsi:type="CD" code="422479008" codeSystem="2.16.840.1.113883.6.96"
  codeSystemName="SNOMED CT"
  displayName="FEMALE BREAST INFILTRATING DUCTAL CARCINOMA, STAGE 2">
  [
    <originalText>
       <reference value="#problem4name"/>
    </originalText>
  ]
  <translation code="code-example" codeSystem="1.999.999"
    codeSystemName="this is only an example"
    displayName="FEMALE BREAST INFILTRATING DUCTAL CARCINOMA, STAGE 2">
    <translation code="174.9" codeSystem="2.16.840.1.113883.6.103"
      codeSystemName="ICD-9CM"
      displayName="Malignant neoplasm of breast (female), unspecified"/>
    <translation code="C50.919" codeSystem="2.16.840.1.113883.6.90"
      codeSystemName="ICD-10-CM"
      displayName="Malignant neoplasm of unspecified site of unspecified female breast"/>
 </translation>
</value>

Case 3: Original and the reference coded concepts belong to the same code system (distinct codes). This may be the result of a different level of granularity between the original term and the reference value sets.

<code code="60591-5" codeSystem="2.16.840.1.113883.6.1"
  codeSystemName="LOINC" displayName="Patient Summary">
  <translation code="60592-3" codeSystem="2.16.840.1.113883.6.1"
    displayName="Patient summary unexpected contact"/>
</code>

Note: The R1 data type definition identifies the <translation> as “a set of other concept descriptors that translate this concept descriptor into other code systems." There is however a common understanding that it may be more than one representation in a single code system where code systems allow multiple representations, such as SNOMED CT. Data Types R2 extended the possibility to provide translations also in the same code system.

Translation of designations

The capability of recording one or more designations, in different languages, for the exchanged Patent Summary is one of the functional requirements requested for “safety and liability reasons” by the European Cross-border services (see Designations’ Translation under the Functional requirements and high-level use cases for more details).

Given that the base CDA R2 standard which uses datatypes R1 does not offer a native way to convey the language translation of 'displayName', this guide introduces an optional 'ips:designation' extension to the CD datatype for that purpose.

Below are examples of usage of this extension.

No code mapping

<code code="60591-5" codeSystem="2.16.840.1.113883.6.1"
  codeSystemName="LOINC" displayName="Patient Summary">
  <ips:designation language="it-IT">Profilo Sanitario Sintetico</ips:designation>
  <ips:designation language="fr-FR">Patient Summary</ips:designation>
  <ips:designation language="en">Patient Summary</ips:designation>
</code>

Including code mapping

<value xsi:type="CD" code="42338000" codeSystem="2.16.840.1.113883.6.96"
  displayName="Salmonella-gastroenterit">
  <ips:designation language="da-DK">Salmonella-gastroenterit</ips:designation>
  <ips:designation language="en">Salmonella gastroenteritis (disorder)</ips:designation> 
  [
    <originalText>
      <reference value="#ref1"/>
    </originalText>
  ]
  <translation code="003.0" codeSystem="2.16.840.1.113883.6.103"
    displayName="Gastroenterite da Salmonella"/>
</value>

Narrative Translations

“Narrative translation” means both the translation of the original narrative text, that can be human curated or automatically performed, and the generation of a translated narrative based on the coded entries.

The functional requirements associated with this process are described in the Designations’ Translation section under Functional requirements and high-level use cases, and can be summarized in two main points : (a) language identification and (b) distinguishable original and translated narratives. Moreover, the methodology applied for the narrative translation (e.g. derived from the coded entries; translated by a generic service;..) should be noted.

Regarding the translation of section narrative <text>, this guide recommends providing this translation on purely textual subordinate sections (one per translation) as specified in the IPS Translation Section (2.16.840.1.113883.10.22.3.15) template.

An example of this is:

<section>
  <templateId root="2.16.840.1.113883.3.1937.777.13.10.5"/>
   <id root="..." extension="..."/>
   <code code="48765-2" codeSystem="2.16.840.1.113883.6.1"
      displayName="Allergies and adverse reactions"/>
   <title>Allergies and Intolerances</title>
   <text>No known Allergies</text>
   <!-- omissions -->
   <component>
      <section>
        <!--  subordinate section carrying a translation of the parent section -->
        <title>Allergie ed Intolleranze</title>
        <text>Nessuna Allergia Nota</text>
        <languageCode code="it-IT"/>
      </section>
    </component>
</section>

Determining the Status of Clinical Statement

Note: Most of the description provided in this section is copied from the § 3.3 Determining the Status of Clinical Statement of the C-CDA DSTU R2.1 Implementation Guide Volume 1.

A recipient must be able to determine whether the status of an entry — which can include a problem, a medication administration, etc. — is active, completed, or in some other state. Determination of the exact status is dependent on the interplay between an act’s various components (such as statusCode and effectiveTime). The following principles apply when representing or interpreting the status of a clinical statement.

• The Act.statusCode of the clinical statement specifies the state of the entry: Per the RIM, the statusCode “reflects the state of the activity. In the case of an Observation, this is the status of the activity of observing, not the status of what is being observed.”
• Act.statusCode and Act.moodCode are inter-related: Generally, an act in EVN (event) mood is a discrete event (a user looks, listens, measures, and records what was done or observed), so generally an act in EVN mood will have a statusCode of “completed.” A prolonged period of observation is an exception, in which a user would potentially have an observation in EVN mood that is “active.” For an Observation in RQO (request) mood, the statusCode generally remains “active” until the request is complete, at which time the statusCode changes to “completed.” For an Observation in GOL (goal) mood, the statusCode generally remains “active” as long as the observation in question is still an active goal for the patient.
• Act.statusCode and Act.effectiveTime are interrelated: Per the RIM, the effectiveTime, also referred to as the “biologically relevant time,” is the time at which the act holds for the patient. So, whereas the effectiveTime is the biologically relevant time, the statusCode is the state of the activity. For a provider seeing a patient in a clinic and observing a history of heart attack that occurred 5 years ago, the status of the observation is completed, and the effectiveTime is five years ago.

The IPS Problem Concern Entry and the IPS Allergy and Intolerance Concern templates reflect an ongoing concern on behalf of the provider that placed the concern (e.g. a disease, an allergy, or other conditions) on a patient’s problem or allergy list. The purpose of the concern act is that of supporting the tracking of a problem or a condition (e.g. an allergy). A concern act can contain one or more discrete observations related to this concern. Each of them reflects the change in the clinical understanding of a condition over time. For instance, a Concern may initially contain a symptom of “chest pain”, later identified as consequence of a gastroesophageal reflux. The later problem observation will have a more recent author time stamp.

There are different kinds of status that could be of clinical interest for a condition:

• The status of the concern (active, inactive,..)
• The status of the condition (e.g. active, inactive, resolved,..)
• The confirmation status [verification status, certainty] (e.g. confirmed, provisional, refuted,…)

Not all of them can be represented in a CDA using the statusCode elements of the concern (ACT) and observation (condition).

Status of the concern and related times

The statusCode of the Problem Concern Act is the definitive indication of the status of the concern. So long as the provider has an ongoing concern — meaning that the provider is monitoring the condition, whether it includes problems that have been resolved or not — the statusCode of the Concern Act is “active.” When the underlying conditions are no longer an active concern, the statusCode of the Problem Concern Act is set to “completed.”

The Concern Act effectiveTime reflects the time that the underlying condition was considered a concern. It may or may not correspond to the effectiveTime of the condition (e.g., even five years later, the clinician may remain concerned about a prior heart attack). The effectiveTime/low of the Concern Act asserts when the concern became active. This equates to the time the concern was authored in the patient's chart. (i.e. it should be equal to the earliest author time stamp) The effectiveTime/high asserts when the concern became inactive, and it is present if the statusCode of the concern act is "completed". If this date is not known, then effectiveTime/high will be present with a nullFlavor of "UNK".

Status of the condition and related times

Each Observation contained by a Concern Act is a discrete observation of a condition. Its statusCode is always “completed” since it is the “status of the activity of observing, not the status of what is being observed”. The clinical status of a condition (e.g. a disease, an allergy,..) is instead recorded by specialized subordinated observations (IPS Allergy Status Observation; IPS Problem Status Observation), documenting whether it is active, in remission, resolved, et cetera. The effectiveTime, also referred to as the "biologically relevant time", is the time at which the observation holds for the patient. For a provider seeing a patient in the clinic today, observing a history of penicillin allergy that developed six months ago, the effectiveTime is six months ago. The effectiveTime of the Observation gives an indication of whether or not the underlying condition is resolved, but the current status is documented by a subordinated observation. The effectiveTime/low (a.k.a. "onset date") asserts when the allergy/intolerance became biologically active. The effectiveTime/high (a.k.a. "resolution date") asserts when the allergy/intolerance was biologically resolved. If the date of resolution is not known, then effectiveTime/high will be present with a nullFlavor of "UNK".

Problem Concern Act (from C-CDA IG DTSU R2.1)

Confirmation status

The confirmation status, also noted as verification status or certainty, indicates the certainty associated with a condition (e.g. confirmed, provisional, refuted,…) providing information about the potential risk, for example, of a reaction to the identified substance. The confirmation status of a condition (e.g. a disease, an allergy,..) is recorded by a specialized subordinated observation (IPS certainty Observation), documenting whether the condition is confirmed, unconfirmed, provisional, refuted, et cetera.

The use of medication statements in the summary

A medication list may strongly vary depending on the context of use (e.g. support for prescription or dispensation, drug reconciliation, etc. ) and on the type of information reported (e.g. patient-reported medication, prescribed, dispensed or administered medications, active or past medications, etc.).

This is still true also for the medication summary in a Patient Summary. It could be, for instance, a list of "Relevant prescribed medicines whose period of time indicated for the treatment has not yet expired whether it has been dispensed or not" (European guidelines on Patient Summary ); a list of actually dispensed medications; a list of relevant medications for the patient (IHE PCC ); or conversely, it could be a complete history including the full patient's prescription and dispensation history and information about intended drug monitoring (C-CDA ).

Moreover, for the scope of the International Patient Summary, it is important to know what medications are being taken by or have been given to a patient; without necessarily providing all the details about the medication order, supply, administration or monitoring. This information need, in line with the IPS principle of minimum non exhaustive data, is well expressed by the concept of Medication Statement (see https://www.hl7.org/fhir/medicationstatement.html).

The IPS medication summary is therefore a list of relevant medication statements, possibly built from either a prescription list or a dispensation list. In fact, in many practical cases data included in a Patient Summary are derived from the list of the medicines prescribed by a GP and recorded in its EHR-S; or extracted from a in regional/national prescribing and/or dispensation systems. In these cases, data obtained from actual dispensation and/or prescription records can be still recorded in the IPS as statements and the original request, supply or administration records referred by the statement if really needed.

Medicinal Product Identification

The identification of medicinal products is quite easily solved within a single jurisdiction relying on local drug databases. In contrast, it is one of the major open issues for eHealth services across jurisdictions.

The set of ISO standards called IDMP - designed initially for the regulatory scope, but hopefully extensible to other domains - are the most promising solution for solving this known issue, as also highlighted by the European project OpenMedicine . The completion of the IDMP implementation guides, the deployment of the needed supporting services, and the development of some companion standards that will allow the seamless flow of the IDMP identifiers and attributes from the regulatory space to the clinical world (and back) are however still in progress. Additional time is needed before these identifiers and attributes will be available in full for practical use.

Following therefore the IPS principles of “implementability”, “openness" and "extensibility”, the solution proposed here does not rely on IDMP identifiers. Nonetheless, it takes into account, however, relevant IDMP identifiers and attributes which are already usable in the IPS, namely the Pharmaceutical Product Identifiers (PhPIDs), the Medicinal Product Identifier (MPID), and the Medicinal Product Package Identifier (PCID).

Note: IDMP Medicinal Product (MPID) and Medicinal Product Package (PCID) identifiers depend on the market authorization. The “same” product might therefore have different IDs if different authorizations have been received in different countries, while the PhPID should be the same. For the purpose of the IPS, future standards and implementation guides should define global product identifiers that do not depend on the drug registration process (as the Virtual Medicinal Product in SNOMED CT) and relate to IDMP identifiers.

Thus, in the absence of a global identification system for medicinal products, the solution proposed here is based on the approach initially adopted by the European cross-border services (epSOS and currently by the eHDSI project), reused by the IHE Pharmacy templates and more recently adopted (for specific cases) by the HL7 Pharmacy Medication statement templates. The main idea is to integrate local drug identifiers (e.g. product codes) with all the relevant identifying and descriptive attributes that may help the receiver to understand the type of product the sender is referring to, e.g.: active ingredients, administrative dose forms, strength, route of administration and package description.

Medication data is usually represented in the CDA Templates using the manufacturedMaterial class, which includes a code and a name to describe any level of the product: packaged product, medicinal product, classes or clusters or products, and so on. This information is not however sufficient for covering the requirements of the IPS.

Representation of medicines in CDA

Hence, in order to describe these attributes the CDA model has been extended enhancing the Manufactured Material class with attributes and relationships derived from the latest published version of the R_Medication CMET (see HL7 V3 Normative Edition 2017) based on the HL7 Common Product Model (“The common product model is used to improve the alignment between the different representations of products used within the body of HL7 Version 3 models. One goal of this effort is to make it possible to have a single representation, which could then be used as a common message element type (CMET) across those models.”) .

shows how the CDA model has been enhanced with the R_Medication CMET.

Extension of the CDA model from the content of the R_Medication CMET.

Provenance

In the development of this Implementation Guide, consideration was given to the HL7 CDA® Release 2 Implementation Guide: Data Provenance, Release 1 - US Realm Draft Standard for Trial Use (December 2015). That guide provides a matrix offering a thorough and systematic analysis of provenance characteristics of electronic health records. Given the agreed scope principle that the IPS be minimal and implementable, and the variable maturity and operational methods of existing national patient summaries, the proposal is that this first version should not attempt to require the full detail of that provenance specification.

The approach proposed for this version of the IPS is to:

• Allow optional documentation of section-level provenance.
• Require document-level provenance.
• Define IPS document provenance as one of two types: human-curated or software-assembled, based on the authors recorded in the header.
  • The classification is based on whether the IPS document is constructed by a human or an automated process, regardless of whether the IPS contains some content of both kinds.
• Require the IPS source system to identify the IPS provenance type and author.
  • The author shall be a human, if the IPS provenance type is "human-curated", or a device or system if the IPS provenance type is "software-assembled".
  • In the case of a software-assembled IPS that is then verified by a human, the document provenance type shall be "software-assembled" and the author shall be the device or system that constructed the IPS document, but an additional verifier identity shall name the human who performed this check. For the avoidance of doubt, verifier is not the same as legalAuthenticator (the verifier is represented as a participant with typeCode "VRF"). However, in cases where the verifying person intentionally wishes to sign the document, this shall be recorded as a legalAuthenticator.
• Allow optional section level author, provenance type, verifier, and informant identification, for IPS source systems that can support this.
• Not attempt to implement the US Realm CDA data provenance templates.

Note: Discussions with the EHR work group suggest that a possible future project should be an IPS functional profile, once there is greater clarity and operational experience of using the IPS.

Representation of Names

This specification requires that any Person Name is represented including at least the given and family components and therefore is never documented as a single string.

Even though it is recognized that there is not in all cultures the same concept of “family name”, no evidence has been collected in analyzing the international context (e.g. Japan, Korea; China) that justifies the retirement of this requirement.

Moreover, due to the global scope of the International Patient Summary, the case of non-alphabetic representations of the names has also been considered.

In this case, to facilitate the global use of the IPS, at least one alphabetic representation of the name SHALL be provided.

Conformance clause

This section references the requirements, criteria, or conditions to be satisfied in order that a product (tangible) or a service may claim conformance to this guide, and how other artifacts may claim compliance with it. (Note: The concept of conformance and compliance are used coherently with the HL7 Service-Aware Interoperability Framework: Canonical Definition Specification, Release 2. The fulfilment of these clauses indirectly assures that a product that is the subject of a “conformity assessment” satisfies the business or the design requirements this specification complies to. It should, however, be clear that compliance with the specified business or design requirements, for example in the future with the CEN prEN 17269 IPS, does not imply that the compliant implementations are technically interoperable. A “conformity assessment” is a process that assesses that any proposition that is true in a given specification is also true in the service or product that implements it. In most real-world cases conformance testing objects are used to technically validate the products. These objects provide a great help in the validation of the instances, even if they are most often not sufficient to guarantee the functional/ semantic conformity: many real-life examples can be made about instances that are technically valid, but not clinically meaningful or correct.

below depicts how this concept applies to the business requirements, the current and hopefully future IPS projects standards (CEN/TC 251 and HL7) and other related artifacts involved in this assessment chain. (see section Relationships with other projects and guidelines for a description of the standards developed by the CEN/TC 251 IPS project )

The IPS World

The "rules" and processes for refining the standard through constraint and extension, including which standard artifacts are subject to constraint or extension; the definition of constraint and localization profiles; the criteria for establishing a conformance statement; and the principles guiding who may define extensions to the standards and under what circumstances they apply to the CDA standards are defined in §1.3 CDA Conformance of the CDA and detailed in the HL7 V3 Refinement, Constraint and Localization section (see the CDA R2 Standard).

This guide does not provide additional requirements regarding the Recipient and the Originator Responsibilities.

The formal representation used in this implementation guide for expressing the conformance statement is described in chapter "How to read the table view for templates" of this guide and makes use of a tabular representation that may include also computable or textual constraints. The template rules are formalized using the computable format defined by the HL7 Templates Standard: Specification and Use of Reusable Information Constraint Templates, Release 1 in order to facilitate also the automatic generation of consistent testing and validation capabilities.

The HL7 Templates Standard: "Specification and Use of Reusable Information Constraint Templates, Release 1" defines also how derived templates may relate to the templates defined in this guide for example:

• Specialization: “A specialized template is a narrower, more explicit, more constrained template based on a “parent” template.
• Adaptation: “The adapted template is “based on” the original template which means it can be an extension or a specialization (restriction) of the original template design.”
• Equivalency: “two templates have the same purpose and the same design; however, their governance and/or metadata and/or details of their design may be different.”

Based on this the following way to use this guide may be considered :

• IPS as a document: the conformance is asserted at the document level. All the rules defined by this guide, or by a specialized IPS document level template, are fulfilled. Implementers may take advantage of the template openness to better support specific cases - “extended” parts, however, may not be interoperable among them.
• IPS as a library: the conformance is asserted at the section or the entry level. The templates are used as a library to build, for example, new cross-border documents. For example the immunization section may be used to build an electronic implementation of the WHO yellow card for vaccinations; or the IPS section templates are used to communicate to the country of affiliation minimal and non-exhaustive information about the encounter in which the Patient Summary has been used (cross-border encounter report ). Implementers may take advantage of the template openness to better support specific cases - "extended” parts, however, may not be interoperable among them.
• IPS as a reference: the implementation is conformant with templates that are an adaptation of or equivalent to those defined by this guide. In this case some of the rules defined by this guide are not fulfilled and the conformance cannot be asserted. However, differences may be limited and the effort required to achieve the harmonization may not be not large. Typical examples are templates in which alternatives vocabularies are used.

Jurisdictions may also decide to impose the closure of the template in order to limit the implementation optionality. This should be carefully evaluated in terms of the flexibility of the solution.

CDA Document Level Templates

International Patient Summary

Id	2.16.840.1.113883.10.22.1.1	Effective Date	2020‑07‑14 16:08:21 Other versions this id: HL7-IPS as of 2020‑05‑08 12:30:59 HL7-IPS as of 2017‑04‑11
Status	Draft	Version Label	2021
Name	HL7-IPS	Display Name	International Patient Summary
Description The International Patient Summary is a "Minimal and non-exhaustive Patient Summary, specialty-agnostic, condition-independent, but readily usable by all clinicians for the unscheduled (cross-border) care of a patient." The IPS templates aim to: Serve for both cross-jurisdictional (through adaptation/extension for multi-language and realm scenarios, including translation) and national (through localization) patient summaries. Support emergency care and unplanned care in any country (home and foreign), regardless of language Define value sets based on international vocabularies that are usable and understandable in any country
Context	Pathname /
Classification	CDA Document Level Template
Open/Closed	Open (other than defined elements are allowed)
Uses	Uses 21 templates Used by as Name Version hl7ips-transaction-2 Transaction IPS Created 2017‑04‑07 11:10:54 Uses as Name Version 2.16.840.1.113883.10.22.2.1 Include IPS CDA recordTarget (2021) DYNAMIC 2.16.840.1.113883.10.22.2.2 Include IPS CDA author (STU1) DYNAMIC 2.16.840.1.113883.10.22.2.3 Include IPS CDA custodian (2021) DYNAMIC 2.16.840.1.113883.10.22.2.4 Include IPS CDA legalAuthenticator (STU1) DYNAMIC 2.16.840.1.113883.10.22.2.5 Include IPS Patient Contacts (STU1) DYNAMIC 2.16.840.1.113883.10.22.2.6 Include IPS CDA documentationOf (STU1) DYNAMIC 2.16.840.1.113883.10.22.2.7 Include IPS CDA relatedDocument (STU1) DYNAMIC 2.16.840.1.113883.10.22.3.1 Containment IPS Medication Summary Section (STU1) DYNAMIC 2.16.840.1.113883.10.22.3.2 Containment IPS Allergies and Intolerances Section (STU1) DYNAMIC 2.16.840.1.113883.10.22.3.3 Containment IPS Problems Section (STU1) DYNAMIC 2.16.840.1.113883.10.22.3.4 Containment IPS History of Procedures Section (STU1) DYNAMIC 2.16.840.1.113883.10.22.3.5 Containment IPS Immunizations Section (STU1) DYNAMIC 2.16.840.1.113883.10.22.3.6 Containment IPS Medical Devices Section (2021) DYNAMIC 2.16.840.1.113883.10.22.3.14 Containment IPS Results Section (STU1) DYNAMIC 1.3.6.1.4.1.19376.1.5.3.1.1.5.3.2 Containment IHE Coded Vital Signs Section (2014) DYNAMIC 2.16.840.1.113883.10.22.3.7 Containment IPS History of Past Illness Section (STU1) DYNAMIC 2.16.840.1.113883.10.22.3.8 Containment IPS Functional Status Section (TI-2020) DYNAMIC 2.16.840.1.113883.10.22.3.9 Containment IPS Plan of Care Section (TI-2020) DYNAMIC 2.16.840.1.113883.10.22.3.10 Containment IPS Social History Section (TI-2020) DYNAMIC 2.16.840.1.113883.10.22.3.11 Containment IPS History of Pregnancy Section (TI-2020) DYNAMIC 2.16.840.1.113883.10.22.3.12 Containment IPS Advance Directives Section (TI-2020) DYNAMIC
Relationship	Version: template 2.16.840.1.113883.10.22.1.1 International Patient Summary (2020‑05‑08 12:30:59) Version: template 2.16.840.1.113883.10.22.1.1 International Patient Summary (2017‑04‑11) Adaptation: template 1.3.6.1.4.1.12559.11.10.1.3.1.1.3 epSOS-Patient Summary (2013‑12‑20) ref epsos- Adaptation: template 2.16.840.1.113883.10.12.1 CDA ClinicalDocument (2005‑09‑07) ref ad1bbr-
Example	Example <ClinicalDocument>   <realmCode code="ES"/>  <typeId extension="POCD_HD000040" root="2.16.840.1.113883.1.3"/>  <templateId root="2.16.840.1.113883.10.22.1.1"/>  <id root="2.16.724.4.8.10.200.10" extension="PSCTD0160f274530a031"/>  <code displayName="Patient Summary" code="60591-5" codeSystem="2.16.840.1.113883.6.1"/>  <title>Patient Summary</title>  <effectiveTime value="20111113125600+0200"/>  <confidentialityCode code="N" displayName="normal" codeSystem="2.16.840.1.113883.5.25"/>  <languageCode code="es-ES"/>  <setId root="2.16.724.4.8.10.200.10" extension="PSCTD0160f274530a031S"/>  <versionNumber value="2"/>  <!-- include template 2.16.840.1.113883.10.22.2.1 'IPS CDA recordTarget' (dynamic) 1..1 M -->   <!-- include template 2.16.840.1.113883.10.22.2.2 'IPS CDA author' (dynamic) 1..* M -->   <!-- include template 2.16.840.1.113883.10.22.2.3 'IPS CDA custodian' (dynamic) 1..1 M -->   <!-- include template 2.16.840.1.113883.10.22.2.4 'IPS CDA legalAuthenticator' (dynamic) 0..1 R -->   <!-- include template 2.16.840.1.113883.10.22.2.5 'IPS Patient Contacts' (dynamic) 0..* O -->   <!-- include template 2.16.840.1.113883.10.22.2.6 'IPS CDA documentationOf ' (dynamic) 1..1 M -->   <!-- include template 2.16.840.1.113883.10.22.2.7 'IPS CDA relatedDocument' (dynamic) 0..* R -->   <component>     <structuredBody classCode="DOCBODY">       <component>         <!-- template 2.16.840.1.113883.10.22.3.1 'IPS Medication Summary Section' (dynamic) -->       </component>      <component>         <!-- template 2.16.840.1.113883.10.22.3.2 'IPS Allergies and Intolerances Section' (dynamic) -->       </component>      <component>         <!-- template 2.16.840.1.113883.10.22.3.3 'IPS Problems Section' (dynamic) -->       </component>      <component>         <!-- template 2.16.840.1.113883.10.22.3.4 'IPS History of Procedures Section' (dynamic) -->       </component>      <component>         <!-- template 2.16.840.1.113883.10.22.3.5 'IPS Immunizations Section' (dynamic) -->       </component>      <component>         <!-- template 2.16.840.1.113883.10.22.3.6 'IPS Medical Devices Section' (dynamic) -->       </component>      <component>         <!-- template 2.16.840.1.113883.10.22.3.7 'IPS History of Past Illness Section' (dynamic) -->       </component>      <component>         <!-- template 2.16.840.1.113883.10.22.3.14 'IPS Results Section' (dynamic) -->       </component>      <component>         <!-- template 2.16.840.1.113883.10.22.3.8 'IPS Functional Status Section' (dynamic) -->       </component>      <component>         <!-- template 2.16.840.1.113883.10.22.3.9 'IPS Plan of Treatment Section' (dynamic) -->       </component>      <component>         <!-- template 2.16.840.1.113883.10.22.3.10 'IPS Social History Section' (dynamic) -->       </component>      <component>         <!-- template 2.16.840.1.113883.10.22.3.11 'IPS History of Pregnancy Section' (dynamic) -->       </component>      <component>         <!-- template 2.16.840.1.113883.10.22.3.12 'IPS Advance Directives Section' (dynamic) -->       </component>    </structuredBody>  </component></ClinicalDocument>
Item DT Card Conf Description Label hl7:ClinicalDocument R CDA header (HL7-IPS) hl7:realmCode CS 0 … 1 R (HL7-IPS) hl7:typeId II 1 … 1 M The clinical document typeId identifies the constraints imposed by CDA R2 on the content, essentially acting as a version identifier. (HL7-IPS) @root uid 1 … 1 F 2.16.840.1.113883.1.3 @extension st 1 … 1 F POCD_HD000040   Example <typeId extension="POCD_HD000040" root="2.16.840.1.113883.1.3"/> hl7:templateId II 1 … 1 M (HL7-IPS) @root uid 1 … 1 F 2.16.840.1.113883.10.22.1.1 hl7:id II 1 … 1 M Unique identifier of this instance of the Patient Summary. (HL7-IPS) hl7:code CE.IPS 1 … 1 M Determines the document type that is the "Patient Summary" document (HL7-IPS) @displayName 1 … 1 R @code CONF 1 … 1 F 60591-5 @codeSystem 1 … 1 F 2.16.840.1.113883.6.1 (LOINC)   Example <code code="60591-5" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Patient Summary"/> hl7:translation CD.IPS 0 … * R This element can be here used either to provide the originally used document code if this IPS is the result of a transformation. (HL7-IPS) hl7:title ST 1 … 1 M ClinicalDocument/title is used for display purposes. (HL7-IPS)   Example <title>Patient Summary</title>   Example <title>Profilo Sanitario Sintetico</title> hl7:effectiveTime TS.IPS.TZ 1 … 1 M Time of creation of the Patient Summary (HL7-IPS)   Example <effectiveTime value="20111113125600+0200"/> hl7:confidentialityCode CE.IPS 1 … 1 R (HL7-IPS)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.16926 HL7 BasicConfidentialityKind (DYNAMIC)   Example <confidentialityCode code="N" codeSystem="2.16.840.1.113883.5.25" displayName="normal"/> hl7:language​Code CS 1 … 1 M Document Language Code (HL7-IPS)   Constraint The two characters form SHALL be used when available; otherwise the three characters representation SHALL be adopted   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.4.642.3.21 All Languages (DYNAMIC)   Example <languageCode code="en-GB"/>   Example <languageCode code="fil-PH"/>   Schematron assert role  error     test matches(@code,'[a-z]{2,3}-[A-Z]{2,3}')     Message The language code SHALL be in the form nn-CC or nnn-CCC, in accordance with BCP 47 (e.g. nn is the ISO language code; CC is ISO country code)   hl7:setId II 0 … 1 R This attribute “represents an identifier that is common across all document revisions”. In the case the IPS instance is generated as result of one or more transformations (translation/transcoding) the setId is supposed to remain unchanged across all those transformations. Implementers are recommended to use this attribute. (HL7-IPS) hl7:versionNumber 0 … 1 R (HL7-IPS) Included 1 … 1 M from 2.16.840.1.113883.10.22.2.1 IPS CDA recordTarget (DYNAMIC) hl7:recordTarget 1 … 1 M (HL7-IPS) @typeCode cs 0 … 1 F RCT @context​Control​Code cs 0 … 1 F OP   Example <recordTarget typeCode="RCT" contextControlCode="OP">   <patientRole classCode="PAT">     <id root="1.2.3.999" extension="__example only__"/>    <addr>       <streetAddressLine>HSE M CASSAR STR</streetAddressLine>      <city>ISLA</city>      <country>MT</country>    </addr>    <telecom use="HP" value="tel:+356124567891"/>    <telecom use="WP" value="mailto:elif@foo.too.mt"/>    <patient>       <name>         <family>BORG</family>        <given>TANIA</given>      </name>      <administrativeGenderCode code="F" codeSystem="2.16.840.1.113883.5.1" displayName="Female"/>      <birthTime value="19430130"/>      <!-- Optional guardian information ; see example below-->       <!-- Optional languageCommunication information see example below -->     </patient>  </patientRole></recordTarget> hl7:patientRole 1 … 1 M (HL7-IPS)   hl7ips-data​element-2.1  Patient Attributes  CEN/TC 251 prEN 17269 @classCode cs 0 … 1 F PAT hl7:id II 1 … * R Patient Identifiers: Primary Patient Identifier (Regional/National Health Id), Secondary Patient Identifier (Social/Insurance Number) (HL7-IPS)   hl7ips-data​element-202  Healthcare related Identifiers  CEN/TC 251 prEN 17269 hl7ips-data​element-7  Insurance identifier  CEN/TC 251 prEN 17269 hl7:addr AD.IPS 1 … * R The patient address. (HL7-IPS)   hl7ips-data​element-162  Address  CEN/TC 251 prEN 17269   Constraint When used for cross-border exchange the country address part has to be provided. Included from 2.16.840.1.113883.10.22.11 IPS Address (DYNAMIC) @use set_cs 0 … 1     CONF The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.10637 PostalAddressUse (2005‑05‑01) @nullFlavor cs 0 … 1 F NI   Constraint SHALL NOT have mixed content except for white space If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present.   Schematron assert role  error     test @nullFlavor or hl7:*     Message If addr is not nullflavored at least one sub element has to be provided   hl7:streetAddressLine ADXP 0 … * C Subject's or Organization's Street Address Line (HL7-IPS)   Schematron assert role  error     test hl7:streetAddressLine and (hl7:city or hl7:postalCode)     Message If the address line is included either the city or the zip code has to be provided   hl7:city ADXP 0 … 1 C Subject's or Organization's City (HL7-IPS) hl7:postalCode ADXP 0 … 1 C Subject's or Organization's Postal Code (HL7-IPS) hl7:state ADXP 0 … 1 C Subject's or Organization's State or Province (HL7-IPS) hl7:country ADXP 0 … 1 C Subject's Country. (HL7-IPS)   Constraint The content of this element SHALL be selected EITHER from ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300  DYNAMIC OR MAY be selected from ISO Country Alpha-3 2.16.840.1.113883.1.11.171 DYNAMIC, IF the country is not specified in ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300. hl7:telecom TEL 1 … * R Patient’s telecom information : e.g. telephone number, e-mail address.  (HL7-IPS)   hl7ips-data​element-100  Telecoms  CEN/TC 251 prEN 17269 @use set_cs 0 … 1     CONF The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.201 TelecommunicationAddressUse (DYNAMIC) @nullFlavor cs 0 … 1 F NI   Constraint If there is no information, the nullFlavor attribute shall have a value of 'NI' and the "value" and "use" attributes shall be omitted, otherwise the nullFlavor attribute shall not be present, and the "value" and "use" attributes shall be present.   Example <telecom use="HP" value="tel:+356124567891"/>   Example <telecom use="WP" value="mailto:elif@foo.too.mt"/>   Example <telecom nullFlavor="NI"/> hl7:patient 1 … 1 M (HL7-IPS) @classCode cs 0 … 1 F PSN @determiner​Code cs 0 … 1 F INSTANCE   Example Japanese example (Person Name) <patient>   <name use="IDE">     <family>木村</family>    <given>通男</given>  </name>  <name use="SYL">     <family>きむら</family>    <given>みちお</given>  </name>  <name use="ABC">     <family>KIMURA</family>    <given>MICHIO</given>  </name>  <administrativeGenderCode code="M" codeSystem="2.16.840.1.113883.5.1" displayName="Male"/>  <birthTime nullFlavor="UNK"/></patient> hl7:name PN 1 … * M Patient Name (HL7-IPS)   hl7ips-data​element-3  Patient's name  CEN/TC 251 prEN 17269   Constraint The Alphabetic representation of the name SHALL be always provided hl7:family 1 … * R Patient's Family Name/Surname (HL7-IPS) hl7:given 1 … * R Patient's Given Name (HL7-IPS) hl7:administrative​Gender​Code CE.IPS 1 … 1 R Patient's Gender (HL7-IPS)   hl7ips-data​element-4  Administrative gender  CEN/TC 251 prEN 17269 @nullFlavor cs 0 … 1 F UNK   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.1 Administrative Gender (HL7 V3) (DYNAMIC)   Example <administrativeGenderCode code="F" codeSystem="2.16.840.1.113883.5.1" displayName="Female">   <translation code="2" codeSystem="2.16.840.1.113883.3.129.1.2.21" codeSystemName="Cinsiyet" displayName="Kadın"/></administrativeGenderCode> hl7:birthTime TS 1 … 1 R Patient's Date of Birth. The patient date of birth may be a partial date such as only the year. (HL7-IPS)   hl7ips-data​element-5  Date of birth  CEN/TC 251 prEN 17269 hl7:guardian 0 … * R The guardians of a patient. Other patient contacts are described using the /ClinicalDocument/participant structure. The <associatedEntity> element defines the type of contact. (HL7-IPS) @classCode cs 1 … 1 F GUARD   Example <guardian classCode="GUARD">   <code code="AUNT" displayName="tante" codeSystem="2.16.840.1.113883.5.111"/>  <addr nullFlavor="NI"/>  <telecom use="MC" value="tel:+33-12345678"/>  <guardianPerson>     <name>       <family>Curie</family>      <given>Marie</given>    </name>  </guardianPerson></guardian> hl7:code CD.IPS 0 … 1 R The relationship between the patient and the guardian or other contact may be recorded in the element.  (HL7-IPS)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.19563 PersonalRelationshipRoleType (DYNAMIC) hl7:addr AD.IPS 1 … * R (HL7-IPS)   Constraint If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present. Included from 2.16.840.1.113883.10.22.11 IPS Address (DYNAMIC) @use set_cs 0 … 1     CONF The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.10637 PostalAddressUse (2005‑05‑01) @nullFlavor cs 0 … 1 F NI   Constraint SHALL NOT have mixed content except for white space If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present.   Schematron assert role  error     test @nullFlavor or hl7:*     Message If addr is not nullflavored at least one sub element has to be provided   hl7:streetAddressLine ADXP 0 … * C Subject's or Organization's Street Address Line (HL7-IPS)   Schematron assert role  error     test hl7:streetAddressLine and (hl7:city or hl7:postalCode)     Message If the address line is included either the city or the zip code has to be provided   hl7:city ADXP 0 … 1 C Subject's or Organization's City (HL7-IPS) hl7:postalCode ADXP 0 … 1 C Subject's or Organization's Postal Code (HL7-IPS) hl7:state ADXP 0 … 1 C Subject's or Organization's State or Province (HL7-IPS) hl7:country ADXP 0 … 1 C Subject's Country. (HL7-IPS)   Constraint The content of this element SHALL be selected EITHER from ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300  DYNAMIC OR MAY be selected from ISO Country Alpha-3 2.16.840.1.113883.1.11.171 DYNAMIC, IF the country is not specified in ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300. hl7:telecom TEL 1 … * R Guardian’s telecom information: e.g. telephone number; e-mail address.  (HL7-IPS) @use set_cs 0 … 1     CONF The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.201 TelecommunicationAddressUse (DYNAMIC) @nullFlavor cs 0 … 1 F NI   Constraint If there is no information, the nullFlavor attribute shall have a value of 'NI' and the "value" and "use" attributes shall be omitted, otherwise the nullFlavor attribute shall not be present, and the "value" and "use" attributes shall be present. hl7:guardian​Person 1 … 1 R (HL7-IPS) hl7:name PN 1 … * R Patient Guardian's Name (HL7-IPS) hl7:family ENXP 1 … * R Patient Guardian's Family Name/Surname (HL7-IPS) hl7:given ENXP 1 … * R Patient Guardian's Given Name (HL7-IPS) hl7:language​Communication 0 … * R (HL7-IPS) hl7:language​Code CS 1 … 1 R Patient’s language (HL7-IPS)   hl7ips-data​element-135  Patient’s preferred language  CEN/TC 251 prEN 17269   Constraint The two characters form SHALL be used when available; otherwise the three characters representation SHALL be adopted   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.4.642.3.21 All Languages (DYNAMIC)   Example British English <languageCode code="en-GB"/>   Example Amurdak (Australia) <languageCode code="amg-AU"/>   Schematron assert role  error     test matches(@code,'[a-z]{2,3}-[A-Z]{2,3}')     Message The language code SHALL be in the form nn-CC or nnn-CCC, in accordance with BCP 47 (e.g. nn is the ISO language code; CC is ISO country code)   Included 1 … * M from 2.16.840.1.113883.10.22.2.2 IPS CDA author (DYNAMIC) hl7:author 1 … * M (HL7-IPS) @typeCode cs 0 … 1 F AUT @context​Control​Code cs 0 … 1 F OP   Example <author>   <time value="201212290600+0100"/>  <assignedAuthor>     <id root="2.16.840.1.113883.2.9.4.3.2" extension="RSSMRA00A01F205F" assigningAuthorityName="Ministero Economia e Finanze"/>    <addr use="WP">       <streetAddressLine>Viale della Cristallina 3</streetAddressLine>      <city>Bologna</city>      <state>BO</state>      <postalCode>40121</postalCode>      <country>IT</country>    </addr>    <telecom use="WP" value="tel:+39-051-34343434"/>    <assignedPerson>       <name>         <given>Paolo</given>        <family>Rossi</family>      </name>    </assignedPerson>  </assignedAuthor>  <representedOrganization>     <!-- template 'IPS CDA Organization' (dynamic) -->   </representedOrganization></author> hl7:functionCode CE.IPS 0 … 1 R (HL7-IPS) hl7:time TS.IPS.TZ 1 … 1 R The author/time element represents the start time of the author’s participation in the creation of the clinical document.  (HL7-IPS)   Example <time value="201212290600+0100"/> hl7:assignedAuthor 1 … 1 R (HL7-IPS) @classCode cs 0 … 1 F ASSIGNED hl7:id II 1 … * R Author Identifier(s) (HL7-IPS) @nullFlavor cs 0 … 1   hl7:code CE.IPS (extensible) 0 … 1 R A code, which identifies the profession/competence/specialty of the author when it is a person. (HL7-IPS)   CONF The value of @code should be drawn from value set 2.16.840.1.113883.11.22.53 IPS Healthcare Professional Roles (DYNAMIC)   Example <code code="221" codeSystem="2.16.840.1.113883.2.9.6.2.7" codeSystemName="ISCO" displayName="Medical doctors"/> hl7:addr AD.IPS 1 … * R (HL7-IPS)   Example <addr use="WP">   <streetAddressLine>Viale della Cristallina 3</streetAddressLine>  <city>Bologna</city>  <state>BO</state>  <postalCode>40121</postalCode>  <country>IT</country></addr> hl7:telecom TEL.IPS 1 … * R (HL7-IPS) @use set_cs 0 … 1     CONF The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.201 TelecommunicationAddressUse (DYNAMIC) @value st 0 … 1     Example <telecom use="WP" value="tel:+39-051-34343434"/>   Example <telecom nullFlavor="NI"/> Choice 1 … 1 Elements to choose from: hl7:assigned​Person hl7:assigned​Authoring​Device containing template 2.16.840.1.113883.10.22.9.2 IPS CDA Device (DYNAMIC) hl7:assigned​Person 0 … 1 C (HL7-IPS) @classCode cs 0 … 1 F PSN @determiner​Code cs 0 … 1 F INSTANCE hl7:name PN 1 … * R Name of the person (e.g. the Healthcare Professional)  authoring this document (HL7-IPS)   Example <name>   <given>John</given>  <family>Español Smith</family></name> hl7:family 1 … * R (HL7-IPS) hl7:given 1 … * R (HL7-IPS) hl7:assigned​Authoring​Device 0 … 1 C Contains 2.16.840.1.113883.10.22.9.2 IPS CDA Device (DYNAMIC) (HL7-IPS)   Example <assignedAuthoringDevice classCode="DEV" determinerCode="INSTANCE">   <softwareName displayName="Turriano"/></assignedAuthoringDevice> hl7:represented​Organization 0 … 1 R Contains 2.16.840.1.113883.10.22.9.1 IPS CDA Organization (DYNAMIC) (HL7-IPS) Included 1 … 1 M from 2.16.840.1.113883.10.22.2.3 IPS CDA custodian (DYNAMIC) hl7:custodian 1 … 1 M (HL7-IPS) @typeCode cs 0 … 1 F CST   Example <custodian typeCode="CST">   <assignedCustodian classCode="ASSIGNED">     <representedCustodianOrganization classCode="ORG" determinerCode="INSTANCE">       <!-- template 'IPS CDA Organization' (dynamic) -->     </representedCustodianOrganization>  </assignedCustodian></custodian> hl7:assignedCustodian 1 … 1 R (HL7-IPS) @classCode cs 0 … 1 F ASSIGNED hl7:represented​Custodian​Organization 1 … 1 R (HL7-IPS) @classCode cs 0 … 1 F ORG @determiner​Code cs 0 … 1 F INSTANCE hl7:id II 1 … * R (HL7-IPS) @nullFlavor cs 0 … 1   hl7:name ON 1 … 1 R (HL7-IPS) @nullFlavor cs 0 … 1   hl7:telecom TEL 1 … 1 R (HL7-IPS) @use set_cs 1 … 1 R   CONF The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.201 TelecommunicationAddressUse (DYNAMIC) @nullFlavor cs 0 … 1     Constraint If there is no information, the nullFlavor attribute shall have a value of 'NI' and the "value" and "use" attributes shall be omitted, otherwise the nullFlavor attribute shall not be present, and the "value" and "use" attributes shall be present. hl7:addr AD.IPS 1 … 1 R (HL7-IPS) Included from 2.16.840.1.113883.10.22.11 IPS Address (DYNAMIC) @use set_cs 0 … 1     CONF The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.10637 PostalAddressUse (2005‑05‑01) @nullFlavor cs 0 … 1 F NI   Constraint SHALL NOT have mixed content except for white space If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present.   Schematron assert role  error     test @nullFlavor or hl7:*     Message If addr is not nullflavored at least one sub element has to be provided   hl7:streetAddressLine ADXP 0 … * C Subject's or Organization's Street Address Line (HL7-IPS)   Schematron assert role  error     test hl7:streetAddressLine and (hl7:city or hl7:postalCode)     Message If the address line is included either the city or the zip code has to be provided   hl7:city ADXP 0 … 1 C Subject's or Organization's City (HL7-IPS) hl7:postalCode ADXP 0 … 1 C Subject's or Organization's Postal Code (HL7-IPS) hl7:state ADXP 0 … 1 C Subject's or Organization's State or Province (HL7-IPS) hl7:country ADXP 0 … 1 C Subject's Country. (HL7-IPS)   Constraint The content of this element SHALL be selected EITHER from ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300  DYNAMIC OR MAY be selected from ISO Country Alpha-3 2.16.840.1.113883.1.11.171 DYNAMIC, IF the country is not specified in ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300. Included 0 … 1 R from 2.16.840.1.113883.10.22.2.4 IPS CDA legalAuthenticator (DYNAMIC) hl7:legalAuthenticator 0 … 1 R (HL7-IPS)   Example <legalAuthenticator>   <time value="20111013150937-0800"/>  <signatureCode code="S"/>  <assignedEntity>     <id extension="admin" root="2.16.17.710.780.1000.903.1.1.3.3"/>    <assignedPerson>       <name>         <given>John</given>        <family>Español Smith</family>      </name>    </assignedPerson>    <representedOrganization>       <name>Healthcare Facility's name</name>      <addr>         <country>NL</country>        <streetName>Duinweg</streetName>        <houseNumber>23</houseNumber>        <postalCode>7364 RX</postalCode>        <city>Amsterdam</city>      </addr>    </representedOrganization>  </assignedEntity></legalAuthenticator> hl7:time TS.IPS.TZ 1 … 1 M Time of signing the document (HL7-IPS) hl7:signatureCode CS 0 … 1 R Signature code (HL7-IPS) @code CONF 0 … 1 F S hl7:assignedEntity 0 … 1 R The entity that is responsible for the legal authentication of the CDA document (HL7-IPS) hl7:id 1 … * R Unique identification of legal authenticator (HL7-IPS) hl7:addr AD.IPS 1 … * R (HL7-IPS) hl7:telecom TEL.IPS 1 … * R (HL7-IPS) hl7:assigned​Person 1 … 1 R (HL7-IPS) @classCode cs 0 … 1 F PSN @determiner​Code cs 0 … 1 F INSTANCE hl7:name PN 1 … * R Name of the legal authenticator (HL7-IPS)   Example <name>   <given>John</given>  <family>Español Smith</family></name> hl7:family 1 … * R HP Family Name/Surname (HL7-IPS) hl7:given 1 … * R HP Given Name (HL7-IPS) hl7:represented​Organization 1 … 1 M Organization the legal authenticator is acting for Contains 2.16.840.1.113883.10.22.9.1 IPS CDA Organization (DYNAMIC) (HL7-IPS) Included 0 … * from 2.16.840.1.113883.10.22.2.5 IPS Patient Contacts (DYNAMIC) hl7:participant 0 … * R Patient contacts or the Preferred Health Professional to contact in case of emergency. (HL7-IPS) where [hl7:templateId/@root='2.16.840.1.113883.10.22.2.5']   hl7ips-data​element-154  Patient’s Address Book  CEN/TC 251 prEN 17269 hl7ips-data​element-163  Preferred Healthcare providers  CEN/TC 251 prEN 17269 @typeCode cs 1 … 1 F IND   Example <participant typeCode="IND">   <templateId root="2.16.840.1.113883.10.22.2.5"/>  <associatedEntity classCode="NOK">     <addr>       <streetAddressLine>Promenade des Anglais 111</streetAddressLine>      <city>Lyon</city>      <postalCode>69001</postalCode>      <country>FR</country>    </addr>    <telecom value="tel:(+33)555-20036" use="WP"/>    <associatedPerson>       <name>         <given>Martha</given>        <family>Mum</family>      </name>    </associatedPerson>  </associatedEntity></participant> hl7:templateId II 1 … 1 M (HL7-IPS) @root uid 1 … 1 F 2.16.840.1.113883.10.22.2.5 hl7:functionCode 0 … 1 C The  <functionCode> element may be used to indicate that this participant is the preferred Health Professional to contact in case of emergency.</functionCode> (HL7-IPS) @code CONF 0 … 1 F PCP @codeSystem 0 … 1 F 2.16.840.1.113883.5.88 (Participation Function) hl7:associated​Entity R The <associatedEntity> element identifies the type of contact. </associatedEntity> (HL7-IPS) @classCode cs 1 … 1 R   CONF The value of @classCode shall be drawn from value set 2.16.840.1.113883.11.20.9.33 INDRoleclassCodes (DYNAMIC)   Example <associatedEntity classCode="ECON">   <addr>     <streetAddressLine>Karl Strasse</streetAddressLine>    <city>Freiberg</city>    <postalCode>09599</postalCode>    <country>DE</country>  </addr>  <telecom value="tel:+49-761-11110000" use="WP"/>  <associatedPerson>     <name>       <given>Arzt</given>      <family>Guter</family>    </name>  </associatedPerson></associatedEntity> hl7:code CV.IPS 0 … 1 R This element indicates the relationship between the patient and this participant. (HL7-IPS)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.54 IPS Personal Relationship (DYNAMIC) or The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.53 IPS Healthcare Professional Roles (DYNAMIC)   Example <code code="AUNT" displayName="θεία" codeSystem="2.16.840.1.113883.5.111"/> hl7:addr AD.IPS 1 … * R Patient Contact's / Preferred HP's Address (HL7-IPS)   Schematron assert role  error     test @nullFlavor or hl7:*     Message If addr is not nullflavored at least one sub element has to be provided   Included from 2.16.840.1.113883.10.22.11 IPS Address (DYNAMIC) @use set_cs 0 … 1     CONF The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.10637 PostalAddressUse (2005‑05‑01) @nullFlavor cs 0 … 1 F NI   Constraint SHALL NOT have mixed content except for white space If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present.   Schematron assert role  error     test @nullFlavor or hl7:*     Message If addr is not nullflavored at least one sub element has to be provided   hl7:streetAddressLine ADXP 0 … * C Subject's or Organization's Street Address Line (HL7-IPS)   Schematron assert role  error     test hl7:streetAddressLine and (hl7:city or hl7:postalCode)     Message If the address line is included either the city or the zip code has to be provided   hl7:city ADXP 0 … 1 C Subject's or Organization's City (HL7-IPS) hl7:postalCode ADXP 0 … 1 C Subject's or Organization's Postal Code (HL7-IPS) hl7:state ADXP 0 … 1 C Subject's or Organization's State or Province (HL7-IPS) hl7:country ADXP 0 … 1 C Subject's Country. (HL7-IPS)   Constraint The content of this element SHALL be selected EITHER from ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300  DYNAMIC OR MAY be selected from ISO Country Alpha-3 2.16.840.1.113883.1.11.171 DYNAMIC, IF the country is not specified in ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300. hl7:telecom TEL 1 … * R Patient Contact's / Preferred HP's/Legal Organization telephone or e-mail <telecom> element is required.</telecom> (HL7-IPS)   hl7ips-data​element-169  Telecoms  CEN/TC 251 prEN 17269 hl7ips-data​element-174  Telecoms  CEN/TC 251 prEN 17269 @use set_cs 0 … 1     CONF The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.201 TelecommunicationAddressUse (DYNAMIC) @nullFlavor cs 0 … 1 F NI   Constraint If there is no information, the nullFlavor attribute shall have a value of 'NI' and the "value" and "use" attributes shall be omitted, otherwise the nullFlavor attribute shall not be present, and the "value" and "use" attributes shall be present   Example <telecom use="WP" value="tel:+45 20 7025 6161"/><telecom use="HP" value="mailto:jsmith@myprovider.co.uk"/> Choice 1 … 2 Elements to choose from: hl7:associated​Person hl7:scoping​Organization hl7:associated​Person 0 … 1 C Or the associatedPerson, or the scopingOrganization, or both elements shall be provided (HL7-IPS)   hl7ips-data​element-165  Healthcare Provider (person)  CEN/TC 251 prEN 17269 hl7:name PN 1 … * R Patient Contact's Name / Preferred HP's Name (HL7-IPS)   hl7ips-data​element-121  Name  CEN/TC 251 prEN 17269   Example <name>   <given>John</given>  <family>Español Smith</family></name> hl7:family 1 … * R Patient Contact's Family Name/Surname / Preferred HP's Family Name/Surname (HL7-IPS) hl7:given 1 … * R Patient Contact's Given Name / Preferred HP's Given Name (HL7-IPS) hl7:scoping​Organization 0 … 1 C Or the associatedPerson, or the scopingOrganization, or both elements shall be provided (HL7-IPS)   hl7ips-data​element-166  Healthcare Provider (organisation)  CEN/TC 251 prEN 17269 hl7:name ON 1 … * R Organization's Name (HL7-IPS)   hl7ips-data​element-172  Organisation’s Name  CEN/TC 251 prEN 17269 Included 1 … 1 M from 2.16.840.1.113883.10.22.2.6 IPS CDA documentationOf (DYNAMIC) hl7:documentationOf 1 … 1 M The documentationOf relationship in an International Patient Summary contains the representation of providers who are wholly or partially responsible for the safety and well-being of a subject of care. (HL7-IPS) @typeCode cs 0 … 1 F DOC   Example <documentationOf>   <serviceEvent classCode="PCPR">     <effectiveTime>       <low nullFlavor="NI"/>      <high value="20110308"/>    </effectiveTime>    <performer typeCode="PRF">       <!-- See example below -->     </performer>  </serviceEvent></documentationOf> hl7:serviceEvent 1 … 1 R The main activity being described by a IPS is the provision of healthcare over a period of time. This is shown by setting the value of serviceEvent/@classCode to “PCPR” (care provision) and indicating the duration over which care was provided in serviceEvent/effectiveTime. Additional data from outside this duration may also be included if it is relevant to care provided during that time range (e.g., reviewed during the stated time range). For example if the IPS is generated by a GP based on information recorded in his/her EHR-S, then the low value should represent the date when the treatment relationship between the patient and the GP started; and the high value the date of the latest care event. (HL7-IPS) @classCode cs 1 … 1 F PCPR @moodCode cs 1 … 1 F EVN hl7:id II 0 … * R (HL7-IPS) hl7:effectiveTime IVL_TS 1 … 1 R (HL7-IPS) hl7:low TS 1 … 1 R (HL7-IPS) hl7:high TS 1 … 1 R (HL7-IPS) hl7:performer 0 … * R It represents the healthcare providers involved in the current or pertinent historical care of the patient. Preferably, the patient’s key healthcare providers would be listed, particularly their primary physician and any active consulting physicians, therapists, and counselors (HL7-IPS) @typeCode cs 1 … 1 R   CONF The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19601 x_ServiceEventPerformer (DYNAMIC)   Example <performer typeCode="PRF">   <assignedEntity>     <id assigningAuthorityName="MEF" displayable="false" extension="DVLMMG57R07F205G" root="2.16.840.1.113883.2.9.4.3.2"/>    <code code="221" codeSystem="2.16.840.1.113883.2.9.6.2.7" codeSystemName="ISCO" displayName="Medical doctors">       <translation codeSystem="2.16.840.1.113883.2.9.5.1.111" code="MMG" displayName="Medico di Medicina Generale"/>    </code>    <addr nullFlavor="NI"/>    <telecom nullFlavor="NI"/>    <assignedPerson>       <name>         <family>DVALUNO</family>        <given>MMG</given>      </name>    </assignedPerson>    <representedOrganization>       <id assigningAuthorityName="A.S.L. DELLA PROVINCIA DI LECCO" extension="030305" root="2.16.840.1.113883.2.9.4.1.1"/>      <name>A.S.L. DELLA PROVINCIA DI LECCO</name>      <telecom nullFlavor="NI"/>      <addr>         <state>LECCO</state>        <city>LECCO</city>        <country>IT</country>        <postalCode>23900</postalCode>        <streetAddressLine>CORSO CARLO ALBERTO,120</streetAddressLine>      </addr>    </representedOrganization>  </assignedEntity></performer> hl7:functionCode CE.IPS 0 … 1 R (HL7-IPS) hl7:time IVL_TS.IPS.TZ 0 … 1 R (HL7-IPS) hl7:assignedEntity 1 … 1 M (HL7-IPS) hl7:id II 1 … * R Healthcare provider ID number (HL7-IPS) hl7:code CE.IPS (extensible) 0 … 1 R It describes the professional role of the healthcare provider involved in the current or pertinent historical care of the patient. (HL7-IPS)   CONF The value of @code should be drawn from value set 2.16.840.1.113883.11.22.53 IPS Healthcare Professional Roles (DYNAMIC) hl7:addr AD.IPS 1 … * R (HL7-IPS) hl7:telecom TEL.IPS 1 … * R (HL7-IPS) hl7:assigned​Person 0 … 1 Contains 2.16.840.1.113883.10.22.9.3 IPS CDA Person (DYNAMIC) (HL7-IPS) hl7:represented​Organization 0 … 1 Contains 2.16.840.1.113883.10.22.9.1 IPS CDA Organization (DYNAMIC) (HL7-IPS) Included 0 … 2 R from 2.16.840.1.113883.10.22.2.7 IPS CDA relatedDocument (DYNAMIC)   Constraint A conformant CDA document can have: a single relatedDocument with typeCode "APND"; OR a single relatedDocument with typeCode "RPLC"; OR a single relatedDocument with typeCode "XFRM";  OR a combination of two relatedDocuments with typeCodes "XFRM" and "RPLC"; OR a combination of two relatedDocuments with typeCodes "XFRM" and "APND".  No other combinations are allowed.  hl7:relatedDocument 0 … 2 R (HL7-IPS) @typeCode cs 1 … 1 R   CONF The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.11610 x_ActRelationshipDocument (DYNAMIC) hl7:parentDocument 1 … 1 R (HL7-IPS) @classCode cs 0 … 1 F DOCCLIN @moodCode cs 0 … 1 F EVN hl7:id II 1 … * R (HL7-IPS) hl7:code CD.IPS 0 … 1 R (HL7-IPS) @codeSystem CONF 0 … 1 F 2.16.840.1.113883.6.1 (LOINC) hl7:text ED 0 … 1 R (HL7-IPS) hl7:setId II 0 … 1 R (HL7-IPS) hl7:versionNumber INT 0 … 1 R (HL7-IPS) hl7:component 1 … 1 M (HL7-IPS) hl7:structuredBody 1 … 1 M Note: the proposed order of the sections hereafter indicated is not mandatory (HL7-IPS) @classCode cs 0 … 1 F DOCBODY hl7:component 1 … 1 M Contains 2.16.840.1.113883.10.22.3.1 IPS Medication Summary Section (DYNAMIC) (HL7-IPS) hl7:component 1 … 1 M Contains 2.16.840.1.113883.10.22.3.2 IPS Allergies and Intolerances Section (DYNAMIC) (HL7-IPS) hl7:component 1 … 1 M Contains 2.16.840.1.113883.10.22.3.3 IPS Problems Section (DYNAMIC) (HL7-IPS) hl7:component 0 … 1 R Contains 2.16.840.1.113883.10.22.3.4 IPS History of Procedures Section (DYNAMIC) (HL7-IPS) hl7:component 0 … 1 R Contains 2.16.840.1.113883.10.22.3.5 IPS Immunizations Section (DYNAMIC) (HL7-IPS) hl7:component 0 … 1 R Contains 2.16.840.1.113883.10.22.3.6 IPS Medical Devices Section (DYNAMIC) (HL7-IPS) hl7:component 0 … 1 R Contains 2.16.840.1.113883.10.22.3.14 IPS Results Section (DYNAMIC) (HL7-IPS) hl7:component 0 … 1 R Contains 1.3.6.1.4.1.19376.1.5.3.1.1.5.3.2 IHE Coded Vital Signs Section (DYNAMIC) (HL7-IPS) hl7:component 0 … 1 Contains 2.16.840.1.113883.10.22.3.7 IPS History of Past Illness Section (DYNAMIC) (HL7-IPS) hl7:component 0 … 1 Contains 2.16.840.1.113883.10.22.3.8 IPS Functional Status Section (DYNAMIC) (HL7-IPS) hl7:component 0 … 1 Contains 2.16.840.1.113883.10.22.3.9 IPS Plan of Care Section (DYNAMIC) (HL7-IPS) hl7:component 0 … 1 Contains 2.16.840.1.113883.10.22.3.10 IPS Social History Section (DYNAMIC) (HL7-IPS) hl7:component 0 … 1 Contains 2.16.840.1.113883.10.22.3.11 IPS History of Pregnancy Section (DYNAMIC) (HL7-IPS) hl7:component 0 … 1 Contains 2.16.840.1.113883.10.22.3.12 IPS Advance Directives Section (DYNAMIC) (HL7-IPS)

CDA Header Level Templates

IPS CDA author

Id	2.16.840.1.113883.10.22.2.2	Effective Date	2017‑04‑11
Status	Under pre-publication review	Version Label	STU1
Name	IPSCDAauthor	Display Name	IPS CDA author
Description A CDA document shall have at least one author. Authors could be either human (ClinicalDocument/author/assignedAuthor/assignedPerson) either devices (ClinicalDocument/author/assignedAuthor/assignedAuthoringDevice). For definition “The author element represents the creator of the clinical document. If the role of the actor is the entry of information from his or her own knowledge or application of skills, that actor is the author. If one actor provides information to another actor who filters, reasons, or algorithmically creates new information, then that second actor is also an author, having created information from his or her own knowledge or skills.” [From Implementation Guide for CDA Release 2: Imaging Integration – UV Realm, March 2009]. According to this definition, not any device that generates the electronic document has to be considered as an author: a spider collecting and filtering information from different repositories, according to defined rules and policies, for the scope of creating a Patient Summary is definitely a document author (and in some cases the only one ); an application that transforms a Patient Summary record into this CDA format may not be an author; For cross-border exchange purposes, a device, which modifies the concepts conveyed (e.g. applying code system mappings), should appear as one of the authors. In this case (document generated through a transformation process) the authors of the parent (original) patient summary should appear as authors as well. Further to this, authorship can give information about the nature of Patient Summary : if there is a person author only, then the Patient Summary is the result of a practitioner clinical act; if there are device authors only, the summary was automatically generated according to well defined rules defined by the responsible organization. The CDA standard allows to provide detailed information about what was authored by whom in the Patient Summary, allowing the specification of authorship at the whole document level, at the section level and also at the entry level. In any case it is not required to repeat this information for each of the mentioned levels, taking advantage of the context conduction propriety. In fact “context that is specified on an outer tag holds true for all nested tags, unless overridden on a nested tag. Context specified on a tag within the CDA body always overrides context propagated from an outer tag. For instance, the specification of authorship at a document section level overrides all authorship propagated from outer tags.” (HL7 CDA R2 Standard).
Classification	CDA Header Level Template
Open/Closed	Open (other than defined elements are allowed)
Uses	Uses 2 templates Uses as Name Version 2.16.840.1.113883.10.22.9.2 Containment IPS CDA Device (STU1) DYNAMIC 2.16.840.1.113883.10.22.9.1 Containment IPS CDA Organization (STU1) DYNAMIC
Relationship	Adaptation: template 2.16.840.1.113883.10.12.102 CDA author (2005‑09‑07) ref ad1bbr-
Example	Human Author <author>   <time value="201212290600+0100"/>  <assignedAuthor>     <id root="2.16.840.1.113883.2.9.4.3.2" extension="RSSMRA00A01F205F" assigningAuthorityName="Ministero Economia e Finanze"/>    <code code="221" codeSystem="2.16.840.1.113883.2.9.6.2.7" codeSystemName="ISCO" displayName="Medico"/>    <addr use="WP">       <streetAddressLine>Viale della Cristallina 3</streetAddressLine>      <city>Bologna</city>      <state>BO</state>      <postalCode>40121</postalCode>      <country>IT</country>    </addr>    <telecom use="WP" value="tel:+39-051-34343434"/>    <assignedPerson>       <name>         <given>Paolo</given>        <family>Rossi</family>      </name>    </assignedPerson>    <representedOrganization>       <!-- template 'IPS CDA Organization' (dynamic) -->     </representedOrganization>  </assignedAuthor></author>
Example	Device Author <author>   <time value="201212290600+0100"/>  <assignedAuthor>     <id root="1.2.3.999" extension="__example only__"/>    <addr use="WP">       <state>Castilla-La Mancha</state>      <city>Toledo</city>      <precinct>Toledo</precinct>      <country>ES</country>      <postalCode>45071</postalCode>      <streetAddressLine>Av. Río Guadiana, 4</streetAddressLine>    </addr>    <telecom nullFlavor="NI"/>    <assignedAuthoringDevice classCode="DEV" determinerCode="INSTANCE">       <softwareName displayName="Turriano"/>    </assignedAuthoringDevice>    <representedOrganization classCode="ORG" determinerCode="INSTANCE">       <id root="1.2.3.999" extension="__example only__"/>      <name>SESCAM</name>      <telecom use="WP" value="tel:+34925274100"/>      <addr use="WP">         <state>Castilla-La Mancha</state>        <city>Toledo</city>        <precinct>Toledo</precinct>        <country>ES</country>        <postalCode>45071</postalCode>        <streetAddressLine>Av. Río Guadiana, 4</streetAddressLine>      </addr>    </representedOrganization>  </assignedAuthor></author>
Item DT Card Conf Description Label hl7:author 1 … * R (IPS...hor) @typeCode cs 0 … 1 F AUT @context​Control​Code cs 0 … 1 F OP   Example <author>   <time value="201212290600+0100"/>  <assignedAuthor>     <id root="2.16.840.1.113883.2.9.4.3.2" extension="RSSMRA00A01F205F" assigningAuthorityName="Ministero Economia e Finanze"/>    <addr use="WP">       <streetAddressLine>Viale della Cristallina 3</streetAddressLine>      <city>Bologna</city>      <state>BO</state>      <postalCode>40121</postalCode>      <country>IT</country>    </addr>    <telecom use="WP" value="tel:+39-051-34343434"/>    <assignedPerson>       <name>         <given>Paolo</given>        <family>Rossi</family>      </name>    </assignedPerson>  </assignedAuthor>  <representedOrganization>     <!-- template 'IPS CDA Organization' (dynamic) -->   </representedOrganization></author> hl7:functionCode CE.IPS 0 … 1 R (IPS...hor) hl7:time TS.IPS.TZ 1 … 1 R The author/time element represents the start time of the author’s participation in the creation of the clinical document.  (IPS...hor)   Example <time value="201212290600+0100"/> hl7:assignedAuthor 1 … 1 R (IPS...hor) @classCode cs 0 … 1 F ASSIGNED hl7:id II 1 … * R Author Identifier(s) (IPS...hor) @nullFlavor cs 0 … 1   hl7:code CE.IPS (extensible) 0 … 1 R A code, which identifies the profession/competence/specialty of the author when it is a person. (IPS...hor)   CONF The value of @code should be drawn from value set 2.16.840.1.113883.11.22.53 IPS Healthcare Professional Roles (DYNAMIC)   Example <code code="221" codeSystem="2.16.840.1.113883.2.9.6.2.7" codeSystemName="ISCO" displayName="Medical doctors"/> hl7:addr AD.IPS 1 … * R (IPS...hor)   Example <addr use="WP">   <streetAddressLine>Viale della Cristallina 3</streetAddressLine>  <city>Bologna</city>  <state>BO</state>  <postalCode>40121</postalCode>  <country>IT</country></addr> hl7:telecom TEL.IPS 1 … * R (IPS...hor) @use set_cs 0 … 1     CONF The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.201 TelecommunicationAddressUse (DYNAMIC) @value st 0 … 1     Example <telecom use="WP" value="tel:+39-051-34343434"/>   Example <telecom nullFlavor="NI"/> Choice 1 … 1 Elements to choose from: hl7:assigned​Person hl7:assigned​Authoring​Device containing template 2.16.840.1.113883.10.22.9.2 IPS CDA Device (DYNAMIC) hl7:assigned​Person 0 … 1 C (IPS...hor) @classCode cs 0 … 1 F PSN @determiner​Code cs 0 … 1 F INSTANCE hl7:name PN 1 … * R Name of the person (e.g. the Healthcare Professional)  authoring this document (IPS...hor)   Example <name>   <given>John</given>  <family>Español Smith</family></name> hl7:family 1 … * R (IPS...hor) hl7:given 1 … * R (IPS...hor) hl7:assigned​Authoring​Device 0 … 1 C Contains 2.16.840.1.113883.10.22.9.2 IPS CDA Device (DYNAMIC) (IPS...hor)   Example <assignedAuthoringDevice classCode="DEV" determinerCode="INSTANCE">   <softwareName displayName="Turriano"/></assignedAuthoringDevice> hl7:represented​Organization 0 … 1 R Contains 2.16.840.1.113883.10.22.9.1 IPS CDA Organization (DYNAMIC) (IPS...hor)

IPS CDA custodian

Id	2.16.840.1.113883.10.22.2.3	Effective Date	2021‑08‑04 12:13:07 Other versions this id: IPSCDAcustodian as of 2017‑04‑11
Status	Draft	Version Label	2021
Name	IPSCDAcustodian	Display Name	IPS CDA custodian
Description The custodian element represents the organization that is in charge of maintaining and is entrusted with the care of the document. This information is required by the CDA R2 standard and shall be recorded in the ClinicalDocument/custodian/assignedCustodian/ representedCustodianOrganization element. There is only one custodian per CDA document. Allowing that a CDA document may not represent the original form of the authenticated document, the custodian represents the steward of the original source document. The custodian may be the document originator, a health information exchange, or other responsible party.
Classification	CDA Header Level Template
Open/Closed	Open (other than defined elements are allowed)
Uses	Uses 1 template Uses as Name Version 2.16.840.1.113883.10.22.11 Include IPS Address (STU1) DYNAMIC
Relationship	Version: template 2.16.840.1.113883.10.22.2.3 IPS CDA custodian (2017‑04‑11) Adaptation: template 2.16.840.1.113883.10.12.104 CDA custodian (2005‑09‑07) ref ad1bbr-
Example	Example <custodian typeCode="CST">   <assignedCustodian classCode="ASSIGNED">     <representedCustodianOrganization classCode="ORG" determinerCode="INSTANCE">       <!-- template 'IPS CDA Organization' (dynamic) -->     </representedCustodianOrganization>  </assignedCustodian></custodian>
Item DT Card Conf Description Label hl7:custodian 1 … 1 R (IPS...ian) @typeCode cs 0 … 1 F CST   Example <custodian typeCode="CST">   <assignedCustodian classCode="ASSIGNED">     <representedCustodianOrganization classCode="ORG" determinerCode="INSTANCE">       <!-- template 'IPS CDA Organization' (dynamic) -->     </representedCustodianOrganization>  </assignedCustodian></custodian> hl7:assignedCustodian 1 … 1 R (IPS...ian) @classCode cs 0 … 1 F ASSIGNED hl7:represented​Custodian​Organization 1 … 1 R (IPS...ian) @classCode cs 0 … 1 F ORG @determiner​Code cs 0 … 1 F INSTANCE hl7:id II 1 … * R (IPS...ian) @nullFlavor cs 0 … 1   hl7:name ON 1 … 1 R (IPS...ian) @nullFlavor cs 0 … 1   hl7:telecom TEL 1 … 1 R (IPS...ian) @use set_cs 1 … 1 R   CONF The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.201 TelecommunicationAddressUse (DYNAMIC) @nullFlavor cs 0 … 1     Constraint If there is no information, the nullFlavor attribute shall have a value of 'NI' and the "value" and "use" attributes shall be omitted, otherwise the nullFlavor attribute shall not be present, and the "value" and "use" attributes shall be present. hl7:addr AD.IPS 1 … 1 R (IPS...ian) Included from 2.16.840.1.113883.10.22.11 IPS Address (DYNAMIC) @use set_cs 0 … 1     CONF The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.10637 PostalAddressUse (2005‑05‑01) @nullFlavor cs 0 … 1 F NI   Constraint SHALL NOT have mixed content except for white space If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present.   Schematron assert role  error     test @nullFlavor or hl7:*     Message If addr is not nullflavored at least one sub element has to be provided   hl7:streetAddressLine ADXP 0 … * C Subject's or Organization's Street Address Line (IPS...ian)   Schematron assert role  error     test hl7:streetAddressLine and (hl7:city or hl7:postalCode)     Message If the address line is included either the city or the zip code has to be provided   hl7:city ADXP 0 … 1 C Subject's or Organization's City (IPS...ian) hl7:postalCode ADXP 0 … 1 C Subject's or Organization's Postal Code (IPS...ian) hl7:state ADXP 0 … 1 C Subject's or Organization's State or Province (IPS...ian) hl7:country ADXP 0 … 1 C Subject's Country. (IPS...ian)   Constraint The content of this element SHALL be selected EITHER from ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300  DYNAMIC OR MAY be selected from ISO Country Alpha-3 2.16.840.1.113883.1.11.171 DYNAMIC, IF the country is not specified in ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300.

IPS CDA documentationOf

Id	2.16.840.1.113883.10.22.2.6	Effective Date	2017‑04‑12
Status	Under pre-publication review	Version Label	STU1
Name	IPSdocumentationOfPCPR	Display Name	IPS CDA documentationOf
Description The documentationOf relationship in an International Patient Summary contains the representation of providers who are wholly or partially responsible for the safety and well-being of a subject of care. The main activity being described by a IPS is the provision of healthcare over a period of time. This is shown by setting the value of serviceEvent/@classCode to “PCPR” (care provision) and indicating the duration over which care was provided in serviceEvent/effectiveTime. Additional data from outside this duration may also be included if it is relevant to care provided during that time range (e.g., reviewed during the stated time range). For example if the IPS is generated by a GP based on information recorded in his/her EHR-S, then the low value should represent the date when the treatment relationship between the patient and the GP started; and the high value the date of the latest care event.
Classification	CDA Header Level Template
Open/Closed	Open (other than defined elements are allowed)
Uses	Uses 2 templates Uses as Name Version 2.16.840.1.113883.10.22.9.3 Containment IPS CDA Person (STU1) DYNAMIC 2.16.840.1.113883.10.22.9.1 Containment IPS CDA Organization (STU1) DYNAMIC
Relationship	Adaptation: template 2.16.840.1.113883.10.12.110 CDA documentationOf (2005‑09‑07) ref ad1bbr-
Example	Example <documentationOf typeCode="DOC">   <serviceEvent classCode="PCPR" moodCode="EVN">     <id root="1.2.3.999" extension="__example only__"/>    <effectiveTime>       <low nullFlavor="UNK"/>      <high value="20170613124706"/>    </effectiveTime>    <performer typeCode="PRF">       <assignedEntity>         <id root="1.2.3.999" extension="__example only__"/>        <code code="22" displayName="Health professionals" codeSystem="2.16.840.1.113883.2.9.6.2.7"/>        <addr nullFlavor="NI"/>        <telecom nullFlavor="NI"/>        <assignedPerson>           <!-- template 'IPS CDA Person' (dynamic) -->         </assignedPerson>        <representedOrganization>           <!-- template 'IPS CDA Organization' (dynamic) -->         </representedOrganization>      </assignedEntity>    </performer>  </serviceEvent></documentationOf>
Item DT Card Conf Description Label hl7:documentationOf 0 … * R The documentationOf relationship in an International Patient Summary contains the representation of providers who are wholly or partially responsible for the safety and well-being of a subject of care. (IPS...CPR) @typeCode cs 0 … 1 F DOC   Example <documentationOf>   <serviceEvent classCode="PCPR">     <effectiveTime>       <low nullFlavor="NI"/>      <high value="20110308"/>    </effectiveTime>    <performer typeCode="PRF">       <!-- See example below -->     </performer>  </serviceEvent></documentationOf> hl7:serviceEvent 1 … 1 R The main activity being described by a IPS is the provision of healthcare over a period of time. This is shown by setting the value of serviceEvent/@classCode to “PCPR” (care provision) and indicating the duration over which care was provided in serviceEvent/effectiveTime. Additional data from outside this duration may also be included if it is relevant to care provided during that time range (e.g., reviewed during the stated time range). For example if the IPS is generated by a GP based on information recorded in his/her EHR-S, then the low value should represent the date when the treatment relationship between the patient and the GP started; and the high value the date of the latest care event. (IPS...CPR) @classCode cs 1 … 1 F PCPR @moodCode cs 1 … 1 F EVN hl7:id II 0 … * R (IPS...CPR) hl7:effectiveTime IVL_TS 1 … 1 R (IPS...CPR) hl7:low TS 1 … 1 R (IPS...CPR) hl7:high TS 1 … 1 R (IPS...CPR) hl7:performer 0 … * R It represents the healthcare providers involved in the current or pertinent historical care of the patient. Preferably, the patient’s key healthcare providers would be listed, particularly their primary physician and any active consulting physicians, therapists, and counselors (IPS...CPR) @typeCode cs 1 … 1 R   CONF The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19601 x_ServiceEventPerformer (DYNAMIC)   Example <performer typeCode="PRF">   <assignedEntity>     <id assigningAuthorityName="MEF" displayable="false" extension="DVLMMG57R07F205G" root="2.16.840.1.113883.2.9.4.3.2"/>    <code code="221" codeSystem="2.16.840.1.113883.2.9.6.2.7" codeSystemName="ISCO" displayName="Medical doctors">       <translation codeSystem="2.16.840.1.113883.2.9.5.1.111" code="MMG" displayName="Medico di Medicina Generale"/>    </code>    <addr nullFlavor="NI"/>    <telecom nullFlavor="NI"/>    <assignedPerson>       <name>         <family>DVALUNO</family>        <given>MMG</given>      </name>    </assignedPerson>    <representedOrganization>       <id assigningAuthorityName="A.S.L. DELLA PROVINCIA DI LECCO" extension="030305" root="2.16.840.1.113883.2.9.4.1.1"/>      <name>A.S.L. DELLA PROVINCIA DI LECCO</name>      <telecom nullFlavor="NI"/>      <addr>         <state>LECCO</state>        <city>LECCO</city>        <country>IT</country>        <postalCode>23900</postalCode>        <streetAddressLine>CORSO CARLO ALBERTO,120</streetAddressLine>      </addr>    </representedOrganization>  </assignedEntity></performer> hl7:functionCode CE.IPS 0 … 1 R (IPS...CPR) hl7:time IVL_TS.IPS.TZ 0 … 1 R (IPS...CPR) hl7:assignedEntity 1 … 1 M (IPS...CPR) hl7:id II 1 … * R Healthcare provider ID number (IPS...CPR) hl7:code CE.IPS (extensible) 0 … 1 R It describes the professional role of the healthcare provider involved in the current or pertinent historical care of the patient. (IPS...CPR)   CONF The value of @code should be drawn from value set 2.16.840.1.113883.11.22.53 IPS Healthcare Professional Roles (DYNAMIC) hl7:addr AD.IPS 1 … * R (IPS...CPR) hl7:telecom TEL.IPS 1 … * R (IPS...CPR) hl7:assigned​Person 0 … 1 Contains 2.16.840.1.113883.10.22.9.3 IPS CDA Person (DYNAMIC) (IPS...CPR) hl7:represented​Organization 0 … 1 Contains 2.16.840.1.113883.10.22.9.1 IPS CDA Organization (DYNAMIC) (IPS...CPR)

IPS CDA legalAuthenticator

Id	2.16.840.1.113883.10.22.2.4	Effective Date	2017‑04‑11
Status	Under pre-publication review	Version Label	STU1
Name	IPSCDAlegalAuthenticator	Display Name	IPS CDA legalAuthenticator
Description The legalAuthenticator identifies the single person legally responsible for the document and must be present if the document has been legally authenticated. A clinical document that does not contain this element has not been legally authenticated. The act of legal authentication requires a certain privilege be granted to the legal authenticator depending upon local policy. Based on local practice, clinical documents may be released before legal authentication. All clinical documents have the potential for legal authentication, given the appropriate credentials. Local policies MAY choose to delegate the function of legal authentication to a device or system that generates the clinical document. In these cases, the legal authenticator is a person accepting responsibility for the document, not the generating device or system. Note that the legal authenticator, if present, must be a person.
Classification	CDA Header Level Template
Open/Closed	Open (other than defined elements are allowed)
Uses	Uses 1 template Uses as Name Version 2.16.840.1.113883.10.22.9.1 Containment IPS CDA Organization (STU1) DYNAMIC
Relationship	Adaptation: template 2.16.840.1.113883.10.12.106 CDA legalAuthenticator (2005‑09‑07) ref ad1bbr-
Example	Example <legalAuthenticator>   <time value="20111013150937-0800"/>  <signatureCode code="S"/>  <assignedEntity>     <id extension="admin" root="2.16.17.710.780.1000.903.1.1.3.3"/>    <assignedPerson>       <name>         <given>John</given>        <family>Español Smith</family>      </name>    </assignedPerson>    <representedOrganization>       <name>Healthcare Facility's name</name>      <addr>         <country>NL</country>        <streetName>Duinweg</streetName>        <houseNumber>23</houseNumber>        <postalCode>7364 RX</postalCode>        <city>Amsterdam</city>      </addr>    </representedOrganization>  </assignedEntity></legalAuthenticator>
Item DT Card Conf Description Label hl7:legalAuthenticator R (IPS...tor)   Example <legalAuthenticator>   <time value="20111013150937-0800"/>  <signatureCode code="S"/>  <assignedEntity>     <id extension="admin" root="2.16.17.710.780.1000.903.1.1.3.3"/>    <assignedPerson>       <name>         <given>John</given>        <family>Español Smith</family>      </name>    </assignedPerson>    <representedOrganization>       <name>Healthcare Facility's name</name>      <addr>         <country>NL</country>        <streetName>Duinweg</streetName>        <houseNumber>23</houseNumber>        <postalCode>7364 RX</postalCode>        <city>Amsterdam</city>      </addr>    </representedOrganization>  </assignedEntity></legalAuthenticator> hl7:time TS.IPS.TZ 1 … 1 M Time of signing the document (IPS...tor) hl7:signatureCode CS 0 … 1 R Signature code (IPS...tor) @code CONF 0 … 1 F S hl7:assignedEntity 0 … 1 R The entity that is responsible for the legal authentication of the CDA document (IPS...tor) hl7:id 1 … * R Unique identification of legal authenticator (IPS...tor) hl7:addr AD.IPS 1 … * R (IPS...tor) hl7:telecom TEL.IPS 1 … * R (IPS...tor) hl7:assigned​Person 1 … 1 R (IPS...tor) @classCode cs 0 … 1 F PSN @determiner​Code cs 0 … 1 F INSTANCE hl7:name PN 1 … * R Name of the legal authenticator (IPS...tor)   Example <name>   <given>John</given>  <family>Español Smith</family></name> hl7:family 1 … * R HP Family Name/Surname (IPS...tor) hl7:given 1 … * R HP Given Name (IPS...tor) hl7:represented​Organization 1 … 1 M Organization the legal authenticator is acting for Contains 2.16.840.1.113883.10.22.9.1 IPS CDA Organization (DYNAMIC) (IPS...tor)

IPS CDA Organization

Id	2.16.840.1.113883.10.22.9.1	Effective Date	2017‑04‑11
Status	Under pre-publication review	Version Label	STU1
Name	IPSCDAOrganization	Display Name	IPS CDA Organization
Description	This is a reusable template providing essential information for describing / identifying an organization.
Classification	CDA Header Level Template
Open/Closed	Open (other than defined elements are allowed)
Uses	Uses 1 template Uses as Name Version 2.16.840.1.113883.10.22.11 Include IPS Address (STU1) DYNAMIC
Relationship	Adaptation: template 2.16.840.1.113883.3.1937.777.11.10.111 epSOS CDA Organization (2013‑12‑20) ref epsos-
Example	Example <id root="1.2.3.999" extension="__example only__"/><name>name</name><name>SESCAM</name><telecom use="WP" value="tel:+34925274100"/><telecom use="WP" value="mailto:best.organization@foo.too.es"/><addr use="WP">   <state>Castilla-La Mancha</state>  <city>Toledo</city>  <precinct>Toledo</precinct>  <country>ES</country>  <postalCode>45071</postalCode>  <streetAddressLine>Av. Río Guadiana, 4</streetAddressLine></addr>
Item DT Card Conf Description Label @classCode cs 1 … 1 F ORG @determiner​Code cs 1 … 1 F INSTANCE hl7:id II 1 … * R (IPS...ion) @nullFlavor cs 0 … 1   hl7:name ON 1 … 1 R (IPS...ion) @nullFlavor cs 0 … 1   hl7:telecom TEL 1 … * R (IPS...ion) @use set_cs 1 … 1 R   CONF The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.201 TelecommunicationAddressUse (DYNAMIC) @nullFlavor cs 0 … 1     Constraint If there is no information, the nullFlavor attribute shall have a value of 'NI' and the "value" and "use" attributes shall be omitted, otherwise the nullFlavor attribute shall not be present, and the "value" and "use" attributes shall be present. hl7:addr AD.IPS 1 … 1 R (IPS...ion) Included from 2.16.840.1.113883.10.22.11 IPS Address (DYNAMIC) @use set_cs 0 … 1     CONF The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.10637 PostalAddressUse (2005‑05‑01) @nullFlavor cs 0 … 1 F NI   Constraint SHALL NOT have mixed content except for white space If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present.   Schematron assert role  error     test @nullFlavor or hl7:*     Message If addr is not nullflavored at least one sub element has to be provided   hl7:streetAddressLine ADXP 0 … * C Subject's or Organization's Street Address Line (IPS...ion)   Schematron assert role  error     test hl7:streetAddressLine and (hl7:city or hl7:postalCode)     Message If the address line is included either the city or the zip code has to be provided   hl7:city ADXP 0 … 1 C Subject's or Organization's City (IPS...ion) hl7:postalCode ADXP 0 … 1 C Subject's or Organization's Postal Code (IPS...ion) hl7:state ADXP 0 … 1 C Subject's or Organization's State or Province (IPS...ion) hl7:country ADXP 0 … 1 C Subject's Country. (IPS...ion)   Constraint The content of this element SHALL be selected EITHER from ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300  DYNAMIC OR MAY be selected from ISO Country Alpha-3 2.16.840.1.113883.1.11.171 DYNAMIC, IF the country is not specified in ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300.

IPS CDA Person

Id	2.16.840.1.113883.10.22.9.3	Effective Date	2017‑04‑12
Status	Under pre-publication review	Version Label	STU1
Name	IPSCDAPerson	Display Name	IPS CDA Person
Description	Person name
Classification	CDA Header Level Template
Open/Closed	Open (other than defined elements are allowed)
Relationship	Adaptation: template 2.16.840.1.113883.10.12.152 CDA Person (2005‑09‑07) ref ad1bbr-
Item DT Card Conf Description Label @classCode cs 0 … 1 F PSN @determiner​Code cs 0 … 1 F INSTANCE hl7:name PN 1 … * R (IPS...son)

IPS CDA recordTarget

Id	2.16.840.1.113883.10.22.2.1	Effective Date	2021‑09‑02 12:10:24 Other versions this id: IPSCDArecordTarget as of 2020‑07‑14 16:56:08 IPSCDArecordTarget as of 2017‑04‑11
Status	Draft	Version Label	2021
Name	IPSCDArecordTarget	Display Name	IPS CDA recordTarget
Description The recordTarget records the administrative and demographic data of the patient whose health information is described by the clinical document; each recordTarget must contain at least one patientRole element.
Classification	CDA Header Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 9 concepts Id Name Data Set hl7ips-data​element-100  Telecoms  CEN/TC 251 prEN 17269 hl7ips-data​element-135  Patient’s preferred language  CEN/TC 251 prEN 17269 hl7ips-data​element-162  Address  CEN/TC 251 prEN 17269 hl7ips-data​element-2.1  Patient Attributes  CEN/TC 251 prEN 17269 hl7ips-data​element-202  Healthcare related Identifiers  CEN/TC 251 prEN 17269 hl7ips-data​element-3  Patient's name  CEN/TC 251 prEN 17269 hl7ips-data​element-4  Administrative gender  CEN/TC 251 prEN 17269 hl7ips-data​element-5  Date of birth  CEN/TC 251 prEN 17269 hl7ips-data​element-7  Insurance identifier  CEN/TC 251 prEN 17269
Uses	Uses 1 template Uses as Name Version 2.16.840.1.113883.10.22.11 Include IPS Address (STU1) DYNAMIC
Relationship	Version: template 2.16.840.1.113883.10.22.2.1 IPS CDA recordTarget (2020‑07‑14 16:56:08) Adaptation: template 2.16.840.1.113883.3.1937.777.11.10.100 epSOS CDA recordTarget (2013‑12‑20) ref epsos- Adaptation: template 2.16.840.1.113883.10.12.101 CDA recordTarget (2005‑09‑07) ref ad1bbr-
Example	Example <recordTarget typeCode="RCT" contextControlCode="OP">   <patientRole classCode="PAT">     <id root="1.2.3.999" extension="__example only__"/>    <addr>       <streetAddressLine>HSE M CASSAR STR</streetAddressLine>      <city>ISLA</city>      <country>MT</country>    </addr>    <telecom use="HP" value="tel:+356124567891"/>    <telecom use="WP" value="mailto:elif@foo.too.mt"/>    <patient>       <name>         <family>BORG</family>        <given>TANIA</given>      </name>      <administrativeGenderCode code="F" codeSystem="2.16.840.1.113883.5.1" displayName="Female"/>      <birthTime value="19430130"/>      <!-- Optional guardian information ; see example below-->       <!-- Optional languageCommunication information see example below -->     </patient>  </patientRole></recordTarget>
Item DT Card Conf Description Label hl7:recordTarget 1 … * R (IPS...get) @typeCode cs 0 … 1 F RCT @context​Control​Code cs 0 … 1 F OP   Example <recordTarget typeCode="RCT" contextControlCode="OP">   <patientRole classCode="PAT">     <id root="1.2.3.999" extension="__example only__"/>    <addr>       <streetAddressLine>HSE M CASSAR STR</streetAddressLine>      <city>ISLA</city>      <country>MT</country>    </addr>    <telecom use="HP" value="tel:+356124567891"/>    <telecom use="WP" value="mailto:elif@foo.too.mt"/>    <patient>       <name>         <family>BORG</family>        <given>TANIA</given>      </name>      <administrativeGenderCode code="F" codeSystem="2.16.840.1.113883.5.1" displayName="Female"/>      <birthTime value="19430130"/>      <!-- Optional guardian information ; see example below-->       <!-- Optional languageCommunication information see example below -->     </patient>  </patientRole></recordTarget> hl7:patientRole 1 … 1 M (IPS...get)   hl7ips-data​element-2.1  Patient Attributes  CEN/TC 251 prEN 17269 @classCode cs 0 … 1 F PAT hl7:id II 1 … * R Patient Identifiers: Primary Patient Identifier (Regional/National Health Id), Secondary Patient Identifier (Social/Insurance Number) (IPS...get)   hl7ips-data​element-202  Healthcare related Identifiers  CEN/TC 251 prEN 17269 hl7ips-data​element-7  Insurance identifier  CEN/TC 251 prEN 17269 hl7:addr AD.IPS 1 … * R The patient address. (IPS...get)   hl7ips-data​element-162  Address  CEN/TC 251 prEN 17269   Constraint When used for cross-border exchange the country address part has to be provided. Included from 2.16.840.1.113883.10.22.11 IPS Address (DYNAMIC) @use set_cs 0 … 1     CONF The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.10637 PostalAddressUse (2005‑05‑01) @nullFlavor cs 0 … 1 F NI   Constraint SHALL NOT have mixed content except for white space If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present.   Schematron assert role  error     test @nullFlavor or hl7:*     Message If addr is not nullflavored at least one sub element has to be provided   hl7:streetAddressLine ADXP 0 … * C Subject's or Organization's Street Address Line (IPS...get)   Schematron assert role  error     test hl7:streetAddressLine and (hl7:city or hl7:postalCode)     Message If the address line is included either the city or the zip code has to be provided   hl7:city ADXP 0 … 1 C Subject's or Organization's City (IPS...get) hl7:postalCode ADXP 0 … 1 C Subject's or Organization's Postal Code (IPS...get) hl7:state ADXP 0 … 1 C Subject's or Organization's State or Province (IPS...get) hl7:country ADXP 0 … 1 C Subject's Country. (IPS...get)   Constraint The content of this element SHALL be selected EITHER from ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300  DYNAMIC OR MAY be selected from ISO Country Alpha-3 2.16.840.1.113883.1.11.171 DYNAMIC, IF the country is not specified in ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300. hl7:telecom TEL 1 … * R Patient’s telecom information : e.g. telephone number, e-mail address.  (IPS...get)   hl7ips-data​element-100  Telecoms  CEN/TC 251 prEN 17269 @use set_cs 0 … 1     CONF The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.201 TelecommunicationAddressUse (DYNAMIC) @nullFlavor cs 0 … 1 F NI   Constraint If there is no information, the nullFlavor attribute shall have a value of 'NI' and the "value" and "use" attributes shall be omitted, otherwise the nullFlavor attribute shall not be present, and the "value" and "use" attributes shall be present.   Example <telecom use="HP" value="tel:+356124567891"/>   Example <telecom use="WP" value="mailto:elif@foo.too.mt"/>   Example <telecom nullFlavor="NI"/> hl7:patient 1 … 1 M (IPS...get) @classCode cs 0 … 1 F PSN @determiner​Code cs 0 … 1 F INSTANCE   Example Japanese example (Person Name) <patient>   <name use="IDE">     <family>木村</family>    <given>通男</given>  </name>  <name use="SYL">     <family>きむら</family>    <given>みちお</given>  </name>  <name use="ABC">     <family>KIMURA</family>    <given>MICHIO</given>  </name>  <administrativeGenderCode code="M" codeSystem="2.16.840.1.113883.5.1" displayName="Male"/>  <birthTime nullFlavor="UNK"/></patient> hl7:name PN 1 … * M Patient Name (IPS...get)   hl7ips-data​element-3  Patient's name  CEN/TC 251 prEN 17269   Constraint The Alphabetic representation of the name SHALL be always provided hl7:family 1 … * R Patient's Family Name/Surname (IPS...get) hl7:given 1 … * R Patient's Given Name (IPS...get) hl7:administrative​Gender​Code CE.IPS 1 … 1 R Patient's Gender (IPS...get)   hl7ips-data​element-4  Administrative gender  CEN/TC 251 prEN 17269 @nullFlavor cs 0 … 1 F UNK   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.1 Administrative Gender (HL7 V3) (DYNAMIC)   Example <administrativeGenderCode code="F" codeSystem="2.16.840.1.113883.5.1" displayName="Female">   <translation code="2" codeSystem="2.16.840.1.113883.3.129.1.2.21" codeSystemName="Cinsiyet" displayName="Kadın"/></administrativeGenderCode> hl7:birthTime TS 1 … 1 R Patient's Date of Birth. The patient date of birth may be a partial date such as only the year. (IPS...get)   hl7ips-data​element-5  Date of birth  CEN/TC 251 prEN 17269 hl7:guardian 0 … * R The guardians of a patient. Other patient contacts are described using the /ClinicalDocument/participant structure. The <associatedEntity> element defines the type of contact. (IPS...get) @classCode cs 1 … 1 F GUARD   Example <guardian classCode="GUARD">   <code code="AUNT" displayName="tante" codeSystem="2.16.840.1.113883.5.111"/>  <addr nullFlavor="NI"/>  <telecom use="MC" value="tel:+33-12345678"/>  <guardianPerson>     <name>       <family>Curie</family>      <given>Marie</given>    </name>  </guardianPerson></guardian> hl7:code CD.IPS 0 … 1 R The relationship between the patient and the guardian or other contact may be recorded in the element.  (IPS...get)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.19563 PersonalRelationshipRoleType (DYNAMIC) hl7:addr AD.IPS 1 … * R (IPS...get)   Constraint If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present. Included from 2.16.840.1.113883.10.22.11 IPS Address (DYNAMIC) @use set_cs 0 … 1     CONF The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.10637 PostalAddressUse (2005‑05‑01) @nullFlavor cs 0 … 1 F NI   Constraint SHALL NOT have mixed content except for white space If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present.   Schematron assert role  error     test @nullFlavor or hl7:*     Message If addr is not nullflavored at least one sub element has to be provided   hl7:streetAddressLine ADXP 0 … * C Subject's or Organization's Street Address Line (IPS...get)   Schematron assert role  error     test hl7:streetAddressLine and (hl7:city or hl7:postalCode)     Message If the address line is included either the city or the zip code has to be provided   hl7:city ADXP 0 … 1 C Subject's or Organization's City (IPS...get) hl7:postalCode ADXP 0 … 1 C Subject's or Organization's Postal Code (IPS...get) hl7:state ADXP 0 … 1 C Subject's or Organization's State or Province (IPS...get) hl7:country ADXP 0 … 1 C Subject's Country. (IPS...get)   Constraint The content of this element SHALL be selected EITHER from ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300  DYNAMIC OR MAY be selected from ISO Country Alpha-3 2.16.840.1.113883.1.11.171 DYNAMIC, IF the country is not specified in ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300. hl7:telecom TEL 1 … * R Guardian’s telecom information: e.g. telephone number; e-mail address.  (IPS...get) @use set_cs 0 … 1     CONF The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.201 TelecommunicationAddressUse (DYNAMIC) @nullFlavor cs 0 … 1 F NI   Constraint If there is no information, the nullFlavor attribute shall have a value of 'NI' and the "value" and "use" attributes shall be omitted, otherwise the nullFlavor attribute shall not be present, and the "value" and "use" attributes shall be present. hl7:guardian​Person 1 … 1 R (IPS...get) hl7:name PN 1 … * R Patient Guardian's Name (IPS...get) hl7:family ENXP 1 … * R Patient Guardian's Family Name/Surname (IPS...get) hl7:given ENXP 1 … * R Patient Guardian's Given Name (IPS...get) hl7:language​Communication 0 … * R (IPS...get) hl7:language​Code CS 1 … 1 R Patient’s language (IPS...get)   hl7ips-data​element-135  Patient’s preferred language  CEN/TC 251 prEN 17269   Constraint The two characters form SHALL be used when available; otherwise the three characters representation SHALL be adopted   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.4.642.3.21 All Languages (DYNAMIC)   Example British English <languageCode code="en-GB"/>   Example Amurdak (Australia) <languageCode code="amg-AU"/>   Schematron assert role  error     test matches(@code,'[a-z]{2,3}-[A-Z]{2,3}')     Message The language code SHALL be in the form nn-CC or nnn-CCC, in accordance with BCP 47 (e.g. nn is the ISO language code; CC is ISO country code)

IPS CDA relatedDocument

Id	2.16.840.1.113883.10.22.2.7	Effective Date	2017‑04‑12
Status	Under pre-publication review	Version Label	STU1
Name	IPSCDArelatedDocument	Display Name	IPS CDA relatedDocument
Description An IPS may have three types of parent document: A superseded version that the present instance of the document wholly replaces (typeCode = RPLC).  A source document from which the present document is transformed (typeCode = XFRM). An IPS may be created by transformation from an already existing local Patient Summary or an IPS document. An example of this case is the creation of a derived instance in which translations are appended in order to facilitate the cross-border usage of this document; or the case in which a local patient summary is transformed to originate a new IPS instance. An original version that the present document integrates (typeCode = APND). Some cross-border legal agreements (e.g.  the European Digital Service Infrastructure for eHealth) require the patient summary to be accompanied by  a printable representation of the original national data / document this IPS comes from. The relationship between the IPS and this content may be tracked using this relationship.  Note 1: even for countries not dealing with real documents in their National Infrastructures (e.g. data collected from local databases), this mechanism could be useful to identify the collection of data used for generating the epSOS CDAs, facilitating the information backtracking. In that case the ID might be that of the epSOS friendly document or of any other kind of intermediate document used for generating the NCP document input. Note 2: even if none of the allowable relationships defined by the CDA standard (XFRM, RPLC, APND) fits perfectly with the described case; the APND relationship seems to be the one that fits the better. In fact “An addendum is a separate document that references the parent document, and may extend or alter the observations in the prior document. The parent document remains a current component of the patient record, and the addendum and its parent are both read by report recipients.”
Classification	CDA Header Level Template
Open/Closed	Open (other than defined elements are allowed)
Relationship	Adaptation: template 2.16.840.1.113883.10.12.111 CDA relatedDocument (2005‑09‑07) ref ad1bbr-
Example	Example of national document identified by its ID <relatedDocument typeCode="XFRM">   <!-- the IPS is obtained as trasformation of the "aa-bb-cc" document -->   <parentDocument>     <id root="aa-bb-cc"/>  </parentDocument></relatedDocument>
Example	Reference to the local PS and to supporting documentation <!-- the example starts here --> <relatedDocument typeCode="XFRM">   <!-- the IPS is obtained as trasformation of the "aa-bb-cc" Local Patient Summary -->   <parentDocument>     <id root="aa-bb-cc"/>  </parentDocument></relatedDocument><relatedDocument typeCode="APND">   <!-- the IPS is integrated by the information provided by the "aa1-bb1-cc1" document -->   <parentDocument>     <id root="aa1-bb1-cc1"/>  </parentDocument></relatedDocument><!-- the example ends here -->
Item DT Card Conf Description Label hl7:relatedDocument 0 … * R (IPS...ent) @typeCode cs 1 … 1 R   CONF The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.11610 x_ActRelationshipDocument (DYNAMIC) hl7:parentDocument 1 … 1 R (IPS...ent) @classCode cs 0 … 1 F DOCCLIN @moodCode cs 0 … 1 F EVN hl7:id II 1 … * R (IPS...ent) hl7:code CD.IPS 0 … 1 R (IPS...ent) @codeSystem CONF 0 … 1 F 2.16.840.1.113883.6.1 (LOINC) hl7:text ED 0 … 1 R (IPS...ent) hl7:setId II 0 … 1 R (IPS...ent) hl7:versionNumber INT 0 … 1 R (IPS...ent)

IPS Patient Contacts

Id	2.16.840.1.113883.10.22.2.5	Effective Date	2017‑04‑12
Status	Under pre-publication review	Version Label	STU1
Name	IPSCDAContacts	Display Name	IPS Patient Contacts
Description The IPS may record several kinds of patient contacts, including parents, relatives, caregivers, and others related in some way to the patient. A patient contact may be an individual or an organization with a relationship to the patient, including health provider (person or organization) to be contacted in case of emergency.
Classification	CDA Header Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 8 concepts Id Name Data Set hl7ips-data​element-121  Name  CEN/TC 251 prEN 17269 hl7ips-data​element-154  Patient’s Address Book  CEN/TC 251 prEN 17269 hl7ips-data​element-163  Preferred Healthcare providers  CEN/TC 251 prEN 17269 hl7ips-data​element-165  Healthcare Provider (person)  CEN/TC 251 prEN 17269 hl7ips-data​element-166  Healthcare Provider (organisation)  CEN/TC 251 prEN 17269 hl7ips-data​element-169  Telecoms  CEN/TC 251 prEN 17269 hl7ips-data​element-172  Organisation’s Name  CEN/TC 251 prEN 17269 hl7ips-data​element-174  Telecoms  CEN/TC 251 prEN 17269
Uses	Uses 1 template Uses as Name Version 2.16.840.1.113883.10.22.11 Include IPS Address (STU1) DYNAMIC
Relationship	Adaptation: template 2.16.840.1.113883.10.12.108 CDA participant (DYNAMIC) ref ad1bbr- Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.2.4 IHE Patient Contacts (DYNAMIC) ref IHE-PCC-
Example	Contact person <participant typeCode="IND">   <templateId root="2.16.840.1.113883.10.22.2.5"/>  <associatedEntity classCode="NOK">     <addr>       <streetAddressLine>Promenade des Anglais 111</streetAddressLine>      <city>Lyon</city>      <postalCode>69001</postalCode>      <country>FR</country>    </addr>    <telecom value="tel:(+33)555-20036" use="WP"/>    <associatedPerson>       <name>         <given>Martha</given>        <family>Mum</family>      </name>    </associatedPerson>  </associatedEntity></participant>
Example	Preferred Health Professional for emergency contact <participant typeCode="IND">   <templateId root="2.16.840.1.113883.10.22.2.5"/>  <functionCode code="PCP" codeSystem="2.16.840.1.113883.5.88"/>  <time value="20070213"/>  <associatedEntity classCode="ECON">     <addr>       <streetAddressLine>Karl Strasse</streetAddressLine>      <city>Freiberg</city>      <postalCode>09599</postalCode>      <country>DE</country>    </addr>    <telecom value="tel:(+49)761-11110000" use="WP"/>    <associatedPerson>       <name>         <given>Arzt</given>        <family>Guter</family>      </name>    </associatedPerson>  </associatedEntity></participant>
Item DT Card Conf Description Label hl7:participant R Patient contacts or the Preferred Health Professional to contact in case of emergency. (IPS...cts) where [hl7:templateId/@root='2.16.840.1.113883.10.22.2.5']   hl7ips-data​element-154  Patient’s Address Book  CEN/TC 251 prEN 17269 hl7ips-data​element-163  Preferred Healthcare providers  CEN/TC 251 prEN 17269 @typeCode cs 1 … 1 F IND   Example <participant typeCode="IND">   <templateId root="2.16.840.1.113883.10.22.2.5"/>  <associatedEntity classCode="NOK">     <addr>       <streetAddressLine>Promenade des Anglais 111</streetAddressLine>      <city>Lyon</city>      <postalCode>69001</postalCode>      <country>FR</country>    </addr>    <telecom value="tel:(+33)555-20036" use="WP"/>    <associatedPerson>       <name>         <given>Martha</given>        <family>Mum</family>      </name>    </associatedPerson>  </associatedEntity></participant> hl7:templateId II 1 … 1 M (IPS...cts) @root uid 1 … 1 F 2.16.840.1.113883.10.22.2.5 hl7:functionCode 0 … 1 C The  <functionCode> element may be used to indicate that this participant is the preferred Health Professional to contact in case of emergency.</functionCode> (IPS...cts) @code CONF 0 … 1 F PCP @codeSystem 0 … 1 F 2.16.840.1.113883.5.88 (Participation Function) hl7:associated​Entity R The <associatedEntity> element identifies the type of contact. </associatedEntity> (IPS...cts) @classCode cs 1 … 1 R   CONF The value of @classCode shall be drawn from value set 2.16.840.1.113883.11.20.9.33 INDRoleclassCodes (DYNAMIC)   Example <associatedEntity classCode="ECON">   <addr>     <streetAddressLine>Karl Strasse</streetAddressLine>    <city>Freiberg</city>    <postalCode>09599</postalCode>    <country>DE</country>  </addr>  <telecom value="tel:+49-761-11110000" use="WP"/>  <associatedPerson>     <name>       <given>Arzt</given>      <family>Guter</family>    </name>  </associatedPerson></associatedEntity> hl7:code CV.IPS 0 … 1 R This element indicates the relationship between the patient and this participant. (IPS...cts)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.54 IPS Personal Relationship (DYNAMIC) or The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.53 IPS Healthcare Professional Roles (DYNAMIC)   Example <code code="AUNT" displayName="θεία" codeSystem="2.16.840.1.113883.5.111"/> hl7:addr AD.IPS 1 … * R Patient Contact's / Preferred HP's Address (IPS...cts)   Schematron assert role  error     test @nullFlavor or hl7:*     Message If addr is not nullflavored at least one sub element has to be provided   Included from 2.16.840.1.113883.10.22.11 IPS Address (DYNAMIC) @use set_cs 0 … 1     CONF The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.10637 PostalAddressUse (2005‑05‑01) @nullFlavor cs 0 … 1 F NI   Constraint SHALL NOT have mixed content except for white space If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present.   Schematron assert role  error     test @nullFlavor or hl7:*     Message If addr is not nullflavored at least one sub element has to be provided   hl7:streetAddressLine ADXP 0 … * C Subject's or Organization's Street Address Line (IPS...cts)   Schematron assert role  error     test hl7:streetAddressLine and (hl7:city or hl7:postalCode)     Message If the address line is included either the city or the zip code has to be provided   hl7:city ADXP 0 … 1 C Subject's or Organization's City (IPS...cts) hl7:postalCode ADXP 0 … 1 C Subject's or Organization's Postal Code (IPS...cts) hl7:state ADXP 0 … 1 C Subject's or Organization's State or Province (IPS...cts) hl7:country ADXP 0 … 1 C Subject's Country. (IPS...cts)   Constraint The content of this element SHALL be selected EITHER from ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300  DYNAMIC OR MAY be selected from ISO Country Alpha-3 2.16.840.1.113883.1.11.171 DYNAMIC, IF the country is not specified in ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300. hl7:telecom TEL 1 … * R Patient Contact's / Preferred HP's/Legal Organization telephone or e-mail <telecom> element is required.</telecom> (IPS...cts)   hl7ips-data​element-169  Telecoms  CEN/TC 251 prEN 17269 hl7ips-data​element-174  Telecoms  CEN/TC 251 prEN 17269 @use set_cs 0 … 1     CONF The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.201 TelecommunicationAddressUse (DYNAMIC) @nullFlavor cs 0 … 1 F NI   Constraint If there is no information, the nullFlavor attribute shall have a value of 'NI' and the "value" and "use" attributes shall be omitted, otherwise the nullFlavor attribute shall not be present, and the "value" and "use" attributes shall be present   Example <telecom use="WP" value="tel:+45 20 7025 6161"/><telecom use="HP" value="mailto:jsmith@myprovider.co.uk"/> Choice 1 … 2 Elements to choose from: hl7:associated​Person hl7:scoping​Organization hl7:associated​Person 0 … 1 C Or the associatedPerson, or the scopingOrganization, or both elements shall be provided (IPS...cts)   hl7ips-data​element-165  Healthcare Provider (person)  CEN/TC 251 prEN 17269 hl7:name PN 1 … * R Patient Contact's Name / Preferred HP's Name (IPS...cts)   hl7ips-data​element-121  Name  CEN/TC 251 prEN 17269   Example <name>   <given>John</given>  <family>Español Smith</family></name> hl7:family 1 … * R Patient Contact's Family Name/Surname / Preferred HP's Family Name/Surname (IPS...cts) hl7:given 1 … * R Patient Contact's Given Name / Preferred HP's Given Name (IPS...cts) hl7:scoping​Organization 0 … 1 C Or the associatedPerson, or the scopingOrganization, or both elements shall be provided (IPS...cts)   hl7ips-data​element-166  Healthcare Provider (organisation)  CEN/TC 251 prEN 17269 hl7:name ON 1 … * R Organization's Name (IPS...cts)   hl7ips-data​element-172  Organisation’s Name  CEN/TC 251 prEN 17269

CDA Section Level Templates

IPS Advance Directives Section

Id	2.16.840.1.113883.10.22.3.12	Effective Date	2020‑05‑08 16:38:49 Other versions this id: IPSAdvanceDirectivesSection as of 2017‑04‑13
Status	Under pre-publication review	Version Label	TI-2020
Name	IPSAdvanceDirectivesSection	Display Name	IPS Advance Directives Section
Description The advance directive section shall contain a narrative description of patient's advance directive. The optional author and informant elements are used when necessary to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header. Entries for references to consent and advance directive documents when known will be specified by future versions of this template.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.3.12
Classification	CDA Section Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 2 concepts Id Name Data Set hl7ips-data​element-26  Description  CEN/TC 251 prEN 17269 hl7ips-data​element-8  Advance Directives  CEN/TC 251 prEN 17269
Uses	Uses 4 templates Uses as Name Version 2.16.840.1.113883.10.22.4.14 Containment IPS Body Author (STU1) DYNAMIC 2.16.840.1.113883.10.12.319 Containment CDA Informant (Body) DYNAMIC 2.16.840.1.113883.10.22.4.46 Containment IPS Advance Directive Organizer (TI-2020) DYNAMIC 2.16.840.1.113883.10.22.3.15 Containment IPS Translation Section (2021) DYNAMIC
Relationship	Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.3.35 IHE Coded Advance directives section (DYNAMIC) ref IHE-PCC- Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.3.34 IHE Advance directives section (DYNAMIC) ref IHE-PCC- Adaptation: template 2.16.840.1.113883.10.20.22.2.17 Social History Section (V3) (DYNAMIC) ref bccdapilot-
Example	Example <hl7:section classCode="DOCSECT">   <hl7:templateId root="2.16.840.1.113883.10.22.3.12"/>  <hl7:id root="1.2.3.999" extension="--example only--"/>  <hl7:code code="42348-3" codeSystem="2.16.840.1.113883.6.1"/>  <hl7:title>title</hl7:title>  <hl7:text/>  <hl7:author>     <!-- template 2.16.840.1.113883.10.22.4.14 'IPS Body Author' (2017-03-02T00:00:00) -->   </hl7:author>  <hl7:informant>     <!-- template 2.16.840.1.113883.10.12.319 'CDA Informant (Body)' (2005-09-07T00:00:00) -->   </hl7:informant>  <hl7:entry typeCode="COMP" contextConductionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.46 'IPS Advance Directive Organizer' (2020-05-08T16:11:48) -->   </hl7:entry>  <hl7:component>     <!-- template 2.16.840.1.113883.10.22.3.15 'IPS Translation Section' (2017-07-12T00:00:00) -->   </hl7:component></hl7:section>
Item DT Card Conf Description Label hl7:section 1 … 1 M (IPS...ion)   hl7ips-data​element-8  Advance Directives  CEN/TC 251 prEN 17269 @classCode cs 0 … 1 F DOCSECT hl7:templateId II 1 … 1 M (IPS...ion) @root uid 1 … 1 F 2.16.840.1.113883.10.22.3.12 hl7:id II 0 … * R (IPS...ion) hl7:code CE.IPS 1 … 1 M (IPS...ion) @code CONF 1 … 1 F 42348-3 @codeSystem 1 … 1 F 2.16.840.1.113883.6.1 (LOINC) hl7:title ST 1 … 1 M Advance directives (IPS...ion) hl7:text SD.TEXT 1 … 1 M (IPS...ion)   hl7ips-data​element-26  Description  CEN/TC 251 prEN 17269 hl7:author 0 … * Contains 2.16.840.1.113883.10.22.4.14 IPS Body Author (DYNAMIC) (IPS...ion) hl7:informant 0 … * Contains 2.16.840.1.113883.10.12.319 CDA Informant (Body) (DYNAMIC) (IPS...ion) hl7:entry 0 … * Contains 2.16.840.1.113883.10.22.4.46 IPS Advance Directive Organizer (DYNAMIC) (IPS...ion) @typeCode cs 1 … 1 R   CONF The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19446 x_ActRelationshipEntry (DYNAMIC) @context​Conduction​Ind bl 0 … 1 F true hl7:component 0 … * Contains 2.16.840.1.113883.10.22.3.15 IPS Translation Section (DYNAMIC) (IPS...ion)

IPS Allergies and Intolerances Section

Id	2.16.840.1.113883.10.22.3.2	Effective Date	2016‑11‑11
Status	Under pre-publication review	Version Label	STU1
Name	IPSSectionAllergiesOrIntolerances	Display Name	IPS Allergies and Intolerances Section
Description This section documents the relevant allergies or intolerances (conditions) for that patient, describing the kind of reaction (e.g. rash, anaphylaxis,..); preferably the agents that cause it; and optionally the criticality and the certainty of the allergy.  At a minimum, it should list currently active and any relevant historical allergies and adverse reactions. If no information about allergies is available, or if no allergies are known this should be clearly documented in the section. The optional author and informant elements are used when necessary to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.3.2
Classification	CDA Section Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 3 concepts Id Name Data Set hl7ips-data​element-183  Description  CEN/TC 251 prEN 17269 hl7ips-data​element-28  Allergy or Intolerance list  CEN/TC 251 prEN 17269 hl7ips-data​element-9  Allergies and Intolerances  CEN/TC 251 prEN 17269
Uses	Uses 4 templates Uses as Name Version 2.16.840.1.113883.10.22.4.14 Containment IPS Body Author (STU1) DYNAMIC 2.16.840.1.113883.10.12.319 Containment CDA Informant (Body) DYNAMIC 2.16.840.1.113883.10.22.4.5 Containment IPS Allergy and Intolerance Concern (STU1) DYNAMIC 2.16.840.1.113883.10.22.3.15 Containment IPS Translation Section (2021) DYNAMIC
Relationship	Adaptation: template 2.16.840.1.113883.10.12.201 CDA Section (2005‑09‑07) ref ad1bbr- Adaptation: template 2.16.840.1.113883.10.20.1.2 Alerts section (DYNAMIC) ref ccd1-
Example	Example <section classCode="DOCSECT">   <templateId root="2.16.840.1.113883.10.22.3.2"/>  <id root="1.2.3.999" extension="__example only__"/>  <code code="48765-2" codeSystem="2.16.840.1.113883.6.1" displayName="Allergies and adverse reactions"/>  <title>Allergies and Intolerances</title>  <text>     <!-- Textual description of the Allergies and Intolerances -->   </text>  <author>     <!-- template 2.16.840.1.113883.10.22.4.14 'IPS Body Author' (dynamic) -->   </author>  <informant>     <!-- template 2.16.840.1.113883.10.12.319 'CDA Informant (Body)' (dynamic) -->   </informant>  <entry typeCode="COMP" contextConductionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.5 'IPS Allergy and Intolerance Concern' (dynamic) -->   </entry>  <component>     <!-- template 2.16.840.1.113883.10.22.3.15 'IPS Translation Section' (dynamic) -->   </component></section>
Example	No information available <cda:section>   <cda:templateId root="2.16.840.1.113883.10.22.3.2"/>  <cda:id root="1.2.3.999" extension="--example only--"/>  <cda:code code="48765-2" codeSystem="2.16.840.1.113883.6.1" displayName="Allergies and adverse reactions"/>  <cda:title>Allergies and Intolerances</cda:title>  <cda:text>     <!-- Textual description of the Allergies and Intolerances -->   </cda:text>  <cda:entry>     <cda:act classCode="ACT" moodCode="EVN">       <cda:templateId root="2.16.840.1.113883.10.22.4.5"/>      <cda:id root="1.2.3.999" extension="__example only__"/>      <cda:code code="CONC" codeSystem="2.16.840.1.113883.5.6"/>      <cda:statusCode code="active"/>      <cda:effectiveTime>         <cda:low nullFlavor="NA"/>      </cda:effectiveTime>      <cda:entryRelationship typeCode="SUBJ" inversionInd="false">         <cda:observation classCode="OBS" moodCode="EVN">           <cda:templateId root="2.16.840.1.113883.10.22.4.1"/>          <cda:code code="OINT" displayName="Allergy or Intolerance" codeSystem="2.16.840.1.113883.5.4"/>          <cda:statusCode code="completed"/>          <cda:effectiveTime>             <cda:low nullFlavor="NA"/>          </cda:effectiveTime>          <cda:value code="no-allergy-info" displayName="No information about allergies" codeSystem="2.16.840.1.113883.5.1150.1"/>        </cda:observation>      </cda:entryRelationship>    </cda:act>  </cda:entry></cda:section>
Item DT Card Conf Description Label hl7:section 1 … 1 R (IPS...ces)   hl7ips-data​element-9  Allergies and Intolerances  CEN/TC 251 prEN 17269 @classCode cs 0 … 1 F DOCSECT hl7:templateId II 1 … 1 M (IPS...ces) @root uid 1 … 1 F 2.16.840.1.113883.10.22.3.2 hl7:id II 0 … * R (IPS...ces) hl7:code CE.IPS 1 … 1 M (IPS...ces) @code CONF 1 … 1 F 48765-2 @codeSystem 1 … 1 F 2.16.840.1.113883.6.1 (LOINC) hl7:title ST 1 … 1 M (IPS...ces) hl7:text SD.TEXT 1 … 1 M Section text (IPS...ces)   hl7ips-data​element-183  Description  CEN/TC 251 prEN 17269 hl7:author 0 … * Contains 2.16.840.1.113883.10.22.4.14 IPS Body Author (DYNAMIC) (IPS...ces) hl7:informant 0 … * Contains 2.16.840.1.113883.10.12.319 CDA Informant (Body) (DYNAMIC) (IPS...ces) hl7:entry 1 … * M Contains 2.16.840.1.113883.10.22.4.5 IPS Allergy and Intolerance Concern (DYNAMIC) (IPS...ces)   hl7ips-data​element-28  Allergy or Intolerance list  CEN/TC 251 prEN 17269 @typeCode cs 1 … 1 R   CONF The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19446 x_ActRelationshipEntry (DYNAMIC) @context​Conduction​Ind bl 0 … 1 F true hl7:component 0 … * Contains 2.16.840.1.113883.10.22.3.15 IPS Translation Section (DYNAMIC) (IPS...ces)

IPS Functional Status Section

Id	2.16.840.1.113883.10.22.3.8	Effective Date	2020‑05‑08 19:17:37 Other versions this id: IPSFunctionalStatusSection as of 2017‑04‑13
Status	Under pre-publication review	Version Label	TI-2020
Name	IPSFunctionalStatusSection	Display Name	IPS Functional Status Section
Description The functional status section shall contain a narrative description of capability of the patient to perform acts of daily living, including possible needs of the patient to be continuously assessed by third parties. The invalidity status may in fact influence decisions about how to administer treatments. Coded clinical statements will be specified by future versions of this template. The optional author and informant elements are used when necessary to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.3.8
Classification	CDA Section Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 3 concepts Id Name Data Set hl7ips-data​element-10  Functional Status  CEN/TC 251 prEN 17269 hl7ips-data​element-137  Description  CEN/TC 251 prEN 17269 hl7ips-data​element-197  Description  CEN/TC 251 prEN 17269
Uses	Uses 4 templates Uses as Name Version 2.16.840.1.113883.10.22.4.14 Containment IPS Body Author (STU1) DYNAMIC 2.16.840.1.113883.10.12.319 Containment CDA Informant (Body) DYNAMIC 2.16.840.1.113883.10.22.4.42 Containment IPS Survey Panel (TI-2020) DYNAMIC 2.16.840.1.113883.10.22.3.15 Containment IPS Translation Section (2021) DYNAMIC
Relationship	Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.3.17 eHDSI Functional Status (DYNAMIC) ref epsos- Adaptation: template 2.16.840.1.113883.10.20.1.5 Functional status section (DYNAMIC) ref ccd1-
Example	Example <hl7:section classCode="DOCSECT">   <hl7:templateId root="2.16.840.1.113883.10.22.3.8"/>  <hl7:id root="1.2.3.999" extension="--example only--"/>  <hl7:code code="47420-5" codeSystem="2.16.840.1.113883.6.1"/>  <hl7:title>title</hl7:title>  <hl7:text/>  <hl7:author>     <!-- template 2.16.840.1.113883.10.22.4.14 'IPS Body Author' (2017-03-02T00:00:00) -->   </hl7:author>  <hl7:informant>     <!-- template 2.16.840.1.113883.10.12.319 'CDA Informant (Body)' (2005-09-07T00:00:00) -->   </hl7:informant>  <hl7:entry typeCode="COMP" contextConductionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.42 'IPS Survey Panel' (2020-05-08T19:02:26) -->   </hl7:entry>  <hl7:component>     <!-- template 2.16.840.1.113883.10.22.3.15 'IPS Translation Section' (2017-07-12T00:00:00) -->   </hl7:component></hl7:section>
Item DT Card Conf Description Label hl7:section 1 … 1 M (IPS...ion)   hl7ips-data​element-10  Functional Status  CEN/TC 251 prEN 17269 @classCode cs 0 … 1 F DOCSECT hl7:templateId II 1 … 1 M (IPS...ion) @root uid 1 … 1 F 2.16.840.1.113883.10.22.3.8 hl7:id II 0 … * R (IPS...ion) hl7:code CE.IPS 1 … 1 M (IPS...ion) @code CONF 1 … 1 F 47420-5 @codeSystem 1 … 1 F 2.16.840.1.113883.6.1 (LOINC) hl7:title ST 1 … 1 M Functional Status Assessment (IPS...ion) hl7:text SD.TEXT 1 … 1 M (IPS...ion)   hl7ips-data​element-137  Description  CEN/TC 251 prEN 17269 hl7ips-data​element-197  Description  CEN/TC 251 prEN 17269 hl7:author 0 … * Contains 2.16.840.1.113883.10.22.4.14 IPS Body Author (DYNAMIC) (IPS...ion) hl7:informant 0 … * Contains 2.16.840.1.113883.10.12.319 CDA Informant (Body) (DYNAMIC) (IPS...ion) hl7:entry 0 … * Contains 2.16.840.1.113883.10.22.4.42 IPS Survey Panel (DYNAMIC) (IPS...ion) @typeCode cs 1 … 1 R   CONF The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19446 x_ActRelationshipEntry (DYNAMIC) @context​Conduction​Ind bl 0 … 1 F true hl7:component 0 … * Contains 2.16.840.1.113883.10.22.3.15 IPS Translation Section (DYNAMIC) (IPS...ion)

IPS History of Past Illness Section

Id	2.16.840.1.113883.10.22.3.7	Effective Date	2017‑04‑12
Status	Under pre-publication review	Version Label	STU1
Name	IPSHistoryOfPastIllnessSection	Display Name	IPS History of Past Illness Section
Description The History of Past Illness section contains a narrative description and coded entries of the conditions the patient suffered in the past.  The optional author and informant elements are used when necessary to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.3.7
Classification	CDA Section Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 3 concepts Id Name Data Set hl7ips-data​element-11  History of Past Illness  CEN/TC 251 prEN 17269 hl7ips-data​element-31  Past health conditions and problems list  CEN/TC 251 prEN 17269 hl7ips-data​element-35  Description  CEN/TC 251 prEN 17269
Uses	Uses 4 templates Uses as Name Version 2.16.840.1.113883.10.22.4.14 Containment IPS Body Author (STU1) DYNAMIC 2.16.840.1.113883.10.12.319 Containment CDA Informant (Body) DYNAMIC 2.16.840.1.113883.10.22.4.7 Containment IPS Problem Concern Entry (2021) DYNAMIC 2.16.840.1.113883.10.22.3.15 Containment IPS Translation Section (2021) DYNAMIC
Relationship	Adaptation: template 2.16.840.1.113883.10.12.201 CDA Section (2005‑09‑07) ref ad1bbr- Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.3.8 IHE History of Past Illness Section (2013‑12‑20) ref IHE-PCC- Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.5.1 IHE Concern Entry (DYNAMIC) ref IHE-PCC-
Example	Example <section classCode="DOCSECT">   <templateId root="2.16.840.1.113883.10.22.3.7"/>  <id root="1.2.3.999" extension="__example only__"/>  <code code="11348-0" codeSystem="2.16.840.1.113883.6.1" displayName="History of Past illness"/>  <title>...</title>  <text>...</text>  <author>     <!-- template 2.16.840.1.113883.10.22.4.14 'IPS Body Author' (dynamic) -->   </author>  <informant>     <!-- template 2.16.840.1.113883.10.12.319 'CDA Informant (Body)' (dynamic) -->   </informant>  <entry typeCode="COMP" contextConductionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.7 'IPS Problem Concern Entry' (dynamic) -->   </entry>  <component>     <!-- template 2.16.840.1.113883.10.22.3.15 'IPS Translation Section' (dynamic) -->   </component></section>
Item DT Card Conf Description Label hl7:section 1 … 1 M (IPS...ion)   hl7ips-data​element-11  History of Past Illness  CEN/TC 251 prEN 17269 @classCode cs 0 … 1 F DOCSECT hl7:templateId II 1 … 1 M (IPS...ion) @root uid 1 … 1 F 2.16.840.1.113883.10.22.3.7 hl7:id II 0 … * R (IPS...ion) hl7:code CE.IPS 1 … 1 M (IPS...ion) @code CONF 1 … 1 F 11348-0 @codeSystem 1 … 1 F 2.16.840.1.113883.6.1 (LOINC) hl7:title ST 1 … 1 M History of Past Illness (IPS...ion) hl7:text SD.TEXT 1 … 1 M (IPS...ion)   hl7ips-data​element-35  Description  CEN/TC 251 prEN 17269 hl7:author 0 … * Contains 2.16.840.1.113883.10.22.4.14 IPS Body Author (DYNAMIC) (IPS...ion) hl7:informant 0 … * Contains 2.16.840.1.113883.10.12.319 CDA Informant (Body) (DYNAMIC) (IPS...ion) hl7:entry 1 … * R Contains 2.16.840.1.113883.10.22.4.7 IPS Problem Concern Entry (DYNAMIC) (IPS...ion)   hl7ips-data​element-31  Past health conditions and problems list  CEN/TC 251 prEN 17269 @typeCode cs 0 … 1 F COMP @context​Conduction​Ind bl 0 … 1 F true hl7:component 0 … * Contains 2.16.840.1.113883.10.22.3.15 IPS Translation Section (DYNAMIC) (IPS...ion)

IPS History of Pregnancy Section

Id	2.16.840.1.113883.10.22.3.11	Effective Date	2020‑05‑07 18:46:08 Other versions this id: IPSHistoryofpregnancysection as of 2018‑09‑06 09:46:57 IPSHistoryofpregnancysection as of 2017‑04‑13
Status	Under pre-publication review	Version Label	TI-2020
Name	IPSHistoryofpregnancysection	Display Name	IPS History of Pregnancy Section
Description The history of pregnancy section shall contain information about whether the patient is currently pregnant (optional with the Expected Delivery Date) or not. It may contain addition summarizing information about the outcome of earlier pregnancies. The optional author and informant elements are used when necessary to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.3.11
Classification	CDA Section Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 5 concepts Id Name Data Set hl7ips-data​element-12  History of Pregnancy  CEN/TC 251 prEN 17269 hl7ips-data​element-225  Pregnancy Description  CEN/TC 251 prEN 17269 hl7ips-data​element-37  Status of pregnancy  CEN/TC 251 prEN 17269 hl7ips-data​element-38  Previous Pregnancies  CEN/TC 251 prEN 17269 hl7ips-data​element-39  Previous Pregnancies Description  CEN/TC 251 prEN 17269
Uses	Uses 6 templates Uses as Name Version 2.16.840.1.113883.10.22.4.14 Containment IPS Body Author (STU1) DYNAMIC 2.16.840.1.113883.10.12.319 Containment CDA Informant (Body) DYNAMIC 2.16.840.1.113883.10.22.4.27 Containment IPS Pregnancy Status Observation (2021) DYNAMIC 2.16.840.1.113883.10.22.4.28 Containment IPS Pregnancy Outcome Observation (STU1) DYNAMIC 2.16.840.1.113883.10.22.4.36 Containment IPS Pregnancy Observation (TI-2020) DYNAMIC 2.16.840.1.113883.10.22.3.15 Containment IPS Translation Section (2021) DYNAMIC
Relationship	Version: template 2.16.840.1.113883.10.22.3.11 IPS History of Pregnancy Section (2018‑09‑06 09:46:57) Adaptation: template 2.16.840.1.113883.10.12.201 CDA Section (2005‑09‑07) ref ad1bbr- Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.1.5.3.4 eHDSI Pregnancy History (DYNAMIC) ref epsos-
Example	Example <hl7:section classCode="DOCSECT">   <hl7:templateId root="2.16.840.1.113883.10.22.3.11"/>  <hl7:id root="1.2.3.999" extension="--example only--"/>  <hl7:code code="10162-6" codeSystem="2.16.840.1.113883.6.1"/>  <hl7:title>title</hl7:title>  <hl7:text/>  <hl7:author>     <!-- template 2.16.840.1.113883.10.22.4.14 'IPS Body Author' (2017-03-02T00:00:00) -->   </hl7:author>  <hl7:informant>     <!-- template 2.16.840.1.113883.10.12.319 'CDA Informant (Body)' (2005-09-07T00:00:00) -->   </hl7:informant>  <hl7:entry typeCode="COMP" contextConductionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.27 'IPS Pregnancy Status Observation' (2020-05-07T19:22:01) -->   </hl7:entry>  <hl7:entry typeCode="COMP" contextConductionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.28 'IPS Pregnancy Outcome Observation' (2017-04-13T00:00:00) -->   </hl7:entry>  <hl7:entry typeCode="COMP" contextConductionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.36 'IPS Pregnancy Observation' (2020-05-07T18:36:37) -->   </hl7:entry>  <hl7:component>     <!-- template 2.16.840.1.113883.10.22.3.15 'IPS Translation Section' (2017-07-12T00:00:00) -->   </hl7:component></hl7:section>
Item DT Card Conf Description Label hl7:section 1 … 1 M (IPS...ion)   hl7ips-data​element-12  History of Pregnancy  CEN/TC 251 prEN 17269 @classCode cs 0 … 1 F DOCSECT hl7:templateId II 1 … 1 M (IPS...ion) @root uid 1 … 1 F 2.16.840.1.113883.10.22.3.11 hl7:id II 0 … * R (IPS...ion) hl7:code CE.IPS 1 … 1 M (IPS...ion) @code CONF 1 … 1 F 10162-6 @codeSystem 1 … 1 F 2.16.840.1.113883.6.1 (LOINC) hl7:title ST 1 … 1 M History of pregnancies (IPS...ion) hl7:text SD.TEXT 1 … 1 M (IPS...ion)   hl7ips-data​element-225  Pregnancy Description  CEN/TC 251 prEN 17269 hl7ips-data​element-39  Previous Pregnancies Description  CEN/TC 251 prEN 17269 hl7:author 0 … * Contains 2.16.840.1.113883.10.22.4.14 IPS Body Author (DYNAMIC) (IPS...ion) hl7:informant 0 … * Contains 2.16.840.1.113883.10.12.319 CDA Informant (Body) (DYNAMIC) (IPS...ion) hl7:entry 0 … 1 R Contains 2.16.840.1.113883.10.22.4.27 IPS Pregnancy Status Observation (DYNAMIC) (IPS...ion)   hl7ips-data​element-37  Status of pregnancy  CEN/TC 251 prEN 17269 @typeCode cs 1 … 1 R   CONF The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19446 x_ActRelationshipEntry (DYNAMIC) @context​Conduction​Ind bl 0 … 1 F true hl7:entry 0 … * R Contains 2.16.840.1.113883.10.22.4.28 IPS Pregnancy Outcome Observation (DYNAMIC) (IPS...ion)   hl7ips-data​element-38  Previous Pregnancies  CEN/TC 251 prEN 17269 @typeCode cs 1 … 1 R   CONF The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19446 x_ActRelationshipEntry (DYNAMIC) @context​Conduction​Ind bl 0 … 1 F true hl7:entry 0 … * Contains 2.16.840.1.113883.10.22.4.36 IPS Pregnancy Observation (DYNAMIC) (IPS...ion) @typeCode cs 1 … 1 R   CONF The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19446 x_ActRelationshipEntry (DYNAMIC) @context​Conduction​Ind bl 0 … 1 F true hl7:component 0 … * Contains 2.16.840.1.113883.10.22.3.15 IPS Translation Section (DYNAMIC) (IPS...ion)

IPS History of Procedures Section

Id	2.16.840.1.113883.10.22.3.4	Effective Date	2017‑03‑27
Status	Under pre-publication review	Version Label	STU1
Name	IPSHistoryofProceduresSection	Display Name	IPS History of Procedures Section
Description The History of Procedures Section contains a description of the  patient past procedures that are pertinent to the scope of this document. Procedures may refer for example to: Invasive Diagnostic procedure:e.g. Cardiac catheterization; (the results of these procedure are documented in the results section) Therapeutic procedure: e.g. dialysis;  Surgical procedure: e.g. appendectomy All those are represented in this template as procedures. The optional author and informant elements are used when necessary to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.3.4
Classification	CDA Section Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 3 concepts Id Name Data Set hl7ips-data​element-13  History of Procedures  CEN/TC 251 prEN 17269 hl7ips-data​element-43  Procedure list  CEN/TC 251 prEN 17269 hl7ips-data​element-51  Procedure description  CEN/TC 251 prEN 17269
Uses	Uses 4 templates Uses as Name Version 2.16.840.1.113883.10.22.4.14 Containment IPS Body Author (STU1) DYNAMIC 2.16.840.1.113883.10.12.319 Containment CDA Informant (Body) DYNAMIC 2.16.840.1.113883.10.22.4.17 Containment IPS Procedure Entry (2021) DYNAMIC 2.16.840.1.113883.10.22.3.15 Containment IPS Translation Section (2021) DYNAMIC
Relationship	Adaptation: template 2.16.840.1.113883.10.12.201 CDA Section (2005‑09‑07) ref ad1bbr- Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.1.16.2.2 IHE History of Surgical Procedures Section (2017‑03‑24 14:43:08) ref IHE-PCC-
Example	Example <section>   <templateId root="2.16.840.1.113883.10.22.3.4"/>  <id root="1.2.3.999" extension="__example only__"/>  <code code="47519-4" codeSystem="2.16.840.1.113883.6.1" displayName="History of procedures"/>  <title>History of procedures</title>  <text>...</text>  <author>     <!-- template 2.16.840.1.113883.10.22.4.14 'IPS Body Author' (dynamic) -->   </author>  <informant>     <!-- template 2.16.840.1.113883.10.12.319 'CDA Informant (Body)' (dynamic) -->   </informant>  <entry typeCode="COMP" contextConductionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.17 'IPS Procedure Entry' (dynamic) -->   </entry>  <component>     <!-- template 2.16.840.1.113883.10.22.3.15 'IPS Translation Section' (dynamic) -->   </component></section>
Item DT Card Conf Description Label hl7:section (IPS...ion)   hl7ips-data​element-13  History of Procedures  CEN/TC 251 prEN 17269 hl7:templateId II 1 … 1 M (IPS...ion) @root uid 1 … 1 F 2.16.840.1.113883.10.22.3.4 hl7:id II 0 … * R (IPS...ion) hl7:code CE.IPS 1 … 1 M (IPS...ion) @code CONF 1 … 1 F 47519-4 @codeSystem 1 … 1 F 2.16.840.1.113883.6.1 (LOINC) hl7:title ST 1 … 1 M History of procedures (IPS...ion) hl7:text SD.TEXT 1 … 1 R (IPS...ion)   hl7ips-data​element-51  Procedure description  CEN/TC 251 prEN 17269 hl7:author 0 … * Contains 2.16.840.1.113883.10.22.4.14 IPS Body Author (DYNAMIC) (IPS...ion) hl7:informant 0 … * Contains 2.16.840.1.113883.10.12.319 CDA Informant (Body) (DYNAMIC) (IPS...ion) hl7:entry 1 … * R Contains 2.16.840.1.113883.10.22.4.17 IPS Procedure Entry (DYNAMIC) (IPS...ion)   hl7ips-data​element-43  Procedure list  CEN/TC 251 prEN 17269 @typeCode cs 1 … 1 R   CONF The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19446 x_ActRelationshipEntry (DYNAMIC) @context​Conduction​Ind bl 0 … 1 F true hl7:component 0 … * Contains 2.16.840.1.113883.10.22.3.15 IPS Translation Section (DYNAMIC) (IPS...ion)

IPS Immunizations Section

Id	2.16.840.1.113883.10.22.3.5	Effective Date	2017‑04‑05
Status	Under pre-publication review	Version Label	STU1
Name	IPSImmunizationsSection	Display Name	IPS Immunizations Section
Description The Immunizations Section defines a patient's current immunization status and pertinent immunization history. The primary use case for the Immunization Section is to enable communication of a patient's immunization status. The section includes current immunization status, and may contain the entire immunization history that is relevant to the period of time being summarized. The optional author and informant elements are used when necessary to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.3.5
Classification	CDA Section Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 2 concepts Id Name Data Set hl7ips-data​element-14  Immunizations  CEN/TC 251 prEN 17269 hl7ips-data​element-50  Immunizations list  CEN/TC 251 prEN 17269
Uses	Uses 4 templates Uses as Name Version 2.16.840.1.113883.10.22.4.14 Containment IPS Body Author (STU1) DYNAMIC 2.16.840.1.113883.10.12.319 Containment CDA Informant (Body) DYNAMIC 2.16.840.1.113883.10.22.4.15 Containment IPS Immunization (STU1) DYNAMIC 2.16.840.1.113883.10.22.3.15 Containment IPS Translation Section (2021) DYNAMIC
Relationship	Adaptation: template 2.16.840.1.113883.10.12.201 CDA Section (2005‑09‑07) ref ad1bbr- Adaptation: template 2.16.840.1.113883.10.20.22.2.2.1 Immunizations Section (entries required) (V3) (2015‑08‑01) ref ccda- Adaptation: template 2.16.840.1.113883.10.12.201 CDA Section (2005‑09‑07) ref ad1bbr-
Example	Example <section classCode="DOCSECT">   <templateId root="2.16.840.1.113883.10.22.3.5"/>  <code code="11369-6" codeSystem="2.16.840.1.113883.6.1" disaplayName="History of Immunization"/>  <title>History of Immunization</title>  <text>...</text>  <author>     <!-- template 2.16.840.1.113883.10.22.4.14 'IPS Body Author' (dynamic) -->   </author>  <informant>     <!-- template 2.16.840.1.113883.10.12.319 'CDA Informant (Body)' (dynamic) -->   </informant>  <entry typeCode="COMP" contextConductionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.15 'IPS Immunization' (dynamic) -->   </entry>  <component>     <!-- template 2.16.840.1.113883.10.22.3.15 'IPS Translation Section' (dynamic) -->   </component></section>
Item DT Card Conf Description Label hl7:section (IPS...ion)   hl7ips-data​element-14  Immunizations  CEN/TC 251 prEN 17269 @classCode cs 0 … 1 F DOCSECT hl7:templateId II 1 … 1 M (IPS...ion) @root uid 1 … 1 F 2.16.840.1.113883.10.22.3.5 hl7:id II 0 … * R (IPS...ion) hl7:code CE.IPS 1 … 1 M (IPS...ion) @code CONF 1 … 1 F 11369-6 @codeSystem 1 … 1 F 2.16.840.1.113883.6.1 (LOINC) hl7:title ST 1 … 1 M (IPS...ion) hl7:text SD.TEXT 1 … 1 M (IPS...ion) hl7:author 0 … * Contains 2.16.840.1.113883.10.22.4.14 IPS Body Author (DYNAMIC) (IPS...ion) hl7:informant 0 … * Contains 2.16.840.1.113883.10.12.319 CDA Informant (Body) (DYNAMIC) (IPS...ion) hl7:entry 1 … * M Contains 2.16.840.1.113883.10.22.4.15 IPS Immunization (DYNAMIC) (IPS...ion)   hl7ips-data​element-50  Immunizations list  CEN/TC 251 prEN 17269 @typeCode cs 1 … 1 R   CONF The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19446 x_ActRelationshipEntry (DYNAMIC) @context​Conduction​Ind bl 0 … 1 F true hl7:component 0 … * Contains 2.16.840.1.113883.10.22.3.15 IPS Translation Section (DYNAMIC) (IPS...ion)

IPS Medical Devices Section

Id	2.16.840.1.113883.10.22.3.6	Effective Date	2021‑10‑20 17:11:42 Other versions this id: IPSMedicalDevicesSection as of 2017‑04‑11
Status	Draft	Version Label	2021
Name	IPSMedicalDevicesSection	Display Name	IPS Medical Devices Section
Description The medical devices section contains narrative text and coded entries describing the patient history of medical device use. Medical devices include, but are not limited to, implanted devices and devices for nutrition.  The optional author and informant elements are used when necessary to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.3.6
Classification	CDA Section Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 2 concepts Id Name Data Set hl7ips-data​element-15  Medical Devices  CEN/TC 251 prEN 17269 hl7ips-data​element-219  Device List  CEN/TC 251 prEN 17269
Uses	Uses 5 templates Uses as Name Version 2.16.840.1.113883.10.22.4.14 Containment IPS Body Author (STU1) DYNAMIC 2.16.840.1.113883.10.12.319 Containment CDA Informant (Body) DYNAMIC 2.16.840.1.113883.10.22.4.26 Containment IPS Medical Device (STU1) DYNAMIC 2.16.840.1.113883.10.22.4.17 Containment IPS Procedure Entry (2021) DYNAMIC 2.16.840.1.113883.10.22.3.15 Containment IPS Translation Section (2021) DYNAMIC
Relationship	Version: template 2.16.840.1.113883.10.22.3.6 IPS Medical Devices Section (2017‑04‑11) Adaptation: template 2.16.840.1.113883.10.12.201 CDA Section (2005‑09‑07) ref ad1bbr- Adaptation: template 1.3.6.1.4.1.12559.11.10.1.3.1.2.4 Section Medical Devices Coded (2013‑12‑20) ref epsos- Adaptation: template 2.16.840.1.113883.10.20.1.7 Medical equipment section (DYNAMIC) ref ccd1- Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.1.5.3.5 IHE Medical Devices Section (DYNAMIC) ref IHE-PCC-
Example	Example <section classCode="DOCSECT">   <templateId root="2.16.840.1.113883.10.22.3.6"/>  <id root="1.2.3.999" extension="__example only__"/>  <code code="46264-8" codeSystem="2.16.840.1.113883.6.1" displayName="History of medical device use"/>  <title>History of medical device use</title>  <text>...</text>  <author>     <!-- template 2.16.840.1.113883.10.22.4.14 'IPS Body Author' (dynamic) -->   </author>  <informant>     <!-- template 2.16.840.1.113883.10.12.319 'CDA Informant (Body)' (dynamic) -->   </informant>  <entry typeCode="COMP" contextConductionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.26 'IPS Medical Device' (dynamic) -->   </entry>  <component>     <!-- template 2.16.840.1.113883.10.22.3.15 'IPS Translation Section' (dynamic) -->   </component></section>
Item DT Card Conf Description Label hl7:section 1 … 1 M (IPS...ion)   hl7ips-data​element-15  Medical Devices  CEN/TC 251 prEN 17269 @classCode cs 0 … 1 F DOCSECT hl7:templateId II 1 … 1 M (IPS...ion) @root uid 1 … 1 F 2.16.840.1.113883.10.22.3.6 hl7:id II 0 … * R (IPS...ion) hl7:code CE.IPS 1 … 1 M (IPS...ion) @code CONF 1 … 1 F 46264-8 @codeSystem 1 … 1 F 2.16.840.1.113883.6.1 (LOINC) hl7:title ST 1 … 1 M Medical Devices (IPS...ion) hl7:text SD.TEXT 1 … 1 M (IPS...ion) hl7:author 0 … * Contains 2.16.840.1.113883.10.22.4.14 IPS Body Author (DYNAMIC) (IPS...ion) hl7:informant 0 … * Contains 2.16.840.1.113883.10.12.319 CDA Informant (Body) (DYNAMIC) (IPS...ion) hl7:entry 1 … * R Contains 2.16.840.1.113883.10.22.4.26 IPS Medical Device (DYNAMIC) (IPS...ion)   hl7ips-data​element-219  Device List  CEN/TC 251 prEN 17269 @typeCode cs 1 … 1 R   CONF The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19446 x_ActRelationshipEntry (DYNAMIC) @context​Conduction​Ind bl 0 … 1 F true hl7:entry 0 … * Contains 2.16.840.1.113883.10.22.4.17 IPS Procedure Entry (DYNAMIC) (IPS...ion) @typeCode cs 1 … 1 R   CONF The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19446 x_ActRelationshipEntry (DYNAMIC) @context​Conduction​Ind bl 0 … 1 F true hl7:component 0 … * Contains 2.16.840.1.113883.10.22.3.15 IPS Translation Section (DYNAMIC) (IPS...ion)

IPS Medication Summary Section

Id	2.16.840.1.113883.10.22.3.1	Effective Date	2016‑11‑11
Status	Under pre-publication review	Version Label	STU1
Name	IPSMedicationSummarySection	Display Name	IPS Medication Summary Section
Description The medication summary section contains a description of the patient's medications relevant for the scope of the patient summary. The actual content could depend on the jurisdiction, it could report: the currently active medications;  the current and past medications considered relevant by the authoring GP;  the patient prescriptions or dispensations automatically extracted by a regional or a national EHR. In all those cases however medications are documented in the Patient Summary as medication statements. This section requires either an entry indicating the subject is known not to be on any medications; either an entry indicating that no information is available about medications; or entries summarizing the subject's medications. The optional author and informant elements are used when necessary to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.3.1
Classification	CDA Section Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 2 concepts Id Name Data Set hl7ips-data​element-16  Medication Summary  CEN/TC 251 prEN 17269 hl7ips-data​element-61  List of medication  CEN/TC 251 prEN 17269
Uses	Uses 4 templates Uses as Name Version 2.16.840.1.113883.10.22.4.14 Containment IPS Body Author (STU1) DYNAMIC 2.16.840.1.113883.10.12.319 Containment CDA Informant (Body) DYNAMIC 2.16.840.1.113883.10.22.4.4 Containment IPS Medication Statement (2021) DYNAMIC 2.16.840.1.113883.10.22.3.15 Containment IPS Translation Section (2021) DYNAMIC
Relationship	Adaptation: template 2.16.840.1.113883.10.12.201 CDA Section (2005‑09‑07) ref ad1bbr- Adaptation: template 2.16.840.1.113883.10.20.1.8 Medication section (DYNAMIC) ref ccd1- Adaptation: template 1.3.6.1.4.1.12559.11.10.1.3.1.2.3 Section Medication Summary (2013‑12‑20) ref epsos-
Example	Example <section classCode="DOCSECT">   <templateId root="2.16.840.1.113883.10.22.3.1"/>  <id root="1.2.3.999" extension="__example only__"/>  <code code="10160-0" codeSystem="2.16.840.1.113883.6.1" displayName="Terapie farmacologiche"/>  <title>Terapie farmacologiche</title>  <text>...</text>  <author>     <!-- template 2.16.840.1.113883.10.22.4.14 'IPS Body Author' (dynamic) -->   </author>  <informant>     <!-- template 2.16.840.1.113883.10.12.319 'CDA Informant (Body)' (dynamic) -->   </informant>  <entry typeCode="COMP" contextConductionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.4 'IPS Medication Entry' (dynamic) -->   </entry>  <component>     <!-- template 2.16.840.1.113883.10.22.3.15 'IPS Translation Section' (dynamic) -->   </component></section>
Item DT Card Conf Description Label hl7:section 1 … 1 M (IPS...ion)   hl7ips-data​element-16  Medication Summary  CEN/TC 251 prEN 17269 @classCode cs 0 … 1 F DOCSECT hl7:templateId II 1 … 1 M (IPS...ion) @root uid 1 … 1 F 2.16.840.1.113883.10.22.3.1 hl7:id II 0 … * (IPS...ion) hl7:code CE.IPS 1 … 1 M History of medication use (IPS...ion) @code CONF 1 … 1 F 10160-0 @codeSystem 1 … 1 F 2.16.840.1.113883.6.1 (LOINC) hl7:title ST 1 … 1 M Medication Summary (IPS...ion) hl7:text SD.TEXT 1 … 1 M Section text (IPS...ion) hl7:author 0 … * Contains 2.16.840.1.113883.10.22.4.14 IPS Body Author (DYNAMIC) (IPS...ion) hl7:informant 0 … * Contains 2.16.840.1.113883.10.12.319 CDA Informant (Body) (DYNAMIC) (IPS...ion) hl7:entry 1 … * R Contains 2.16.840.1.113883.10.22.4.4 IPS Medication Statement (DYNAMIC) (IPS...ion)   hl7ips-data​element-61  List of medication  CEN/TC 251 prEN 17269 @typeCode cs 1 … 1 R   CONF The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19446 x_ActRelationshipEntry (DYNAMIC) @context​Conduction​Ind bl 0 … 1 F true hl7:component 0 … * Contains 2.16.840.1.113883.10.22.3.15 IPS Translation Section (DYNAMIC) (IPS...ion)

IPS Plan of Care Section

Id	2.16.840.1.113883.10.22.3.9	Effective Date	2020‑05‑08 18:28:38 Other versions this id: IPSPlanofCareSection as of 2017‑04‑13
Status	Under pre-publication review	Version Label	TI-2020
Name	IPSPlanofCareSection	Display Name	IPS Plan of Care Section
Description The care plan section contains a narrative description of the expectations for care including proposals, goals, and order requests for monitoring, tracking, or improving the condition of the patient. The optional author and informant elements are used when necessary to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.3.9
Classification	CDA Section Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 2 concepts Id Name Data Set hl7ips-data​element-110  Plan Description  CEN/TC 251 prEN 17269 hl7ips-data​element-17  Plan Of Care  CEN/TC 251 prEN 17269
Uses	Uses 8 templates Uses as Name Version 2.16.840.1.113883.10.22.4.14 Containment IPS Body Author (STU1) DYNAMIC 2.16.840.1.113883.10.12.319 Containment CDA Informant (Body) DYNAMIC 2.16.840.1.113883.10.22.4.41 Containment IPS Planned Observation (TI-2020) DYNAMIC 2.16.840.1.113883.10.22.4.38 Containment IPS Planned Procedure (TI-2020) DYNAMIC 2.16.840.1.113883.10.22.4.40 Containment IPS Planned Encounter (TI-2020) DYNAMIC 2.16.840.1.113883.10.22.4.47 Containment IPS Planned Immunization (TI-2020) DYNAMIC 2.16.840.1.113883.10.22.4.39 Containment IPS Planned Act (2022) DYNAMIC 2.16.840.1.113883.10.22.3.15 Containment IPS Translation Section (2021) DYNAMIC
Relationship	Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.3.31 IHE Care Plan Section (DYNAMIC) ref IHE-PCC- Adaptation: template 2.16.840.1.113883.10.20.1.10 Plan of care section (DYNAMIC) ref ccd1- Adaptation: template 2.16.840.1.113883.10.20.22.2.10 Plan of Treatment Section (V2) (DYNAMIC) ref bccdapilot-
Example	Example <hl7:section classCode="DOCSECT">   <hl7:templateId root="2.16.840.1.113883.10.22.3.9"/>  <hl7:id root="1.2.3.999" extension="--example only--"/>  <hl7:code code="18776-5" codeSystem="2.16.840.1.113883.6.1"/>  <hl7:title>title</hl7:title>  <hl7:text/>  <hl7:author>     <!-- template 2.16.840.1.113883.10.22.4.14 'IPS Body Author' (2017-03-02T00:00:00) -->   </hl7:author>  <hl7:informant>     <!-- template 2.16.840.1.113883.10.12.319 'CDA Informant (Body)' (2005-09-07T00:00:00) -->   </hl7:informant>  <hl7:entry typeCode="COMP" contextConductionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.41 'IPS Planned Observation' (2020-05-08T18:34:42) -->   </hl7:entry>  <hl7:entry typeCode="COMP" contextConductionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.38 'IPS Planned Procedure' (2020-05-08T17:38:48) -->   </hl7:entry>  <hl7:entry typeCode="COMP" contextConductionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.40 'IPS Planned Encounter' (2020-05-08T18:18:38) -->   </hl7:entry>  <hl7:entry typeCode="COMP" contextConductionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.47 'IPS Planned Immunization' (2020-05-08T17:29:18) -->   </hl7:entry>  <hl7:entry typeCode="COMP" contextConductionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.39 'IPS Planned Act' (2020-05-08T18:08:52) -->   </hl7:entry>  <hl7:component>     <!-- template 2.16.840.1.113883.10.22.3.15 'IPS Translation Section' (2017-07-12T00:00:00) -->   </hl7:component></hl7:section>
Item DT Card Conf Description Label hl7:section 1 … 1 M (IPS...ion)   hl7ips-data​element-17  Plan Of Care  CEN/TC 251 prEN 17269 @classCode cs 0 … 1 F DOCSECT hl7:templateId II 1 … 1 M (IPS...ion) @root uid 1 … 1 F 2.16.840.1.113883.10.22.3.9 hl7:id II 0 … * R (IPS...ion) hl7:code CE.IPS 1 … 1 M (IPS...ion) @code CONF 1 … 1 F 18776-5 @codeSystem 1 … 1 F 2.16.840.1.113883.6.1 (LOINC) hl7:title ST 1 … 1 M Plan of Care (IPS...ion) hl7:text SD.TEXT 1 … 1 M (IPS...ion)   hl7ips-data​element-110  Plan Description  CEN/TC 251 prEN 17269 hl7:author 0 … * Contains 2.16.840.1.113883.10.22.4.14 IPS Body Author (DYNAMIC) (IPS...ion) hl7:informant 0 … * Contains 2.16.840.1.113883.10.12.319 CDA Informant (Body) (DYNAMIC) (IPS...ion) hl7:entry 0 … * Contains 2.16.840.1.113883.10.22.4.41 IPS Planned Observation (DYNAMIC) (IPS...ion) @typeCode cs 1 … 1 R   CONF The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19446 x_ActRelationshipEntry (DYNAMIC) @context​Conduction​Ind bl 0 … 1 F true hl7:entry 0 … * Contains 2.16.840.1.113883.10.22.4.38 IPS Planned Procedure (DYNAMIC) (IPS...ion) @typeCode cs 1 … 1 R   CONF The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19446 x_ActRelationshipEntry (DYNAMIC) @context​Conduction​Ind bl 0 … 1 F true hl7:entry 0 … * Contains 2.16.840.1.113883.10.22.4.40 IPS Planned Encounter (DYNAMIC) (IPS...ion) @typeCode cs 1 … 1 R   CONF The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19446 x_ActRelationshipEntry (DYNAMIC) @context​Conduction​Ind bl 0 … 1 F true hl7:entry 0 … * Contains 2.16.840.1.113883.10.22.4.47 IPS Planned Immunization (DYNAMIC) (IPS...ion) @typeCode cs 1 … 1 R   CONF The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19446 x_ActRelationshipEntry (DYNAMIC) @context​Conduction​Ind bl 0 … 1 F true hl7:entry 0 … * Contains 2.16.840.1.113883.10.22.4.39 IPS Planned Act (DYNAMIC) (IPS...ion) @typeCode cs 1 … 1 R   CONF The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19446 x_ActRelationshipEntry (DYNAMIC) @context​Conduction​Ind bl 0 … 1 F true hl7:component 0 … * Contains 2.16.840.1.113883.10.22.3.15 IPS Translation Section (DYNAMIC) (IPS...ion)

IPS Problems Section

Id	2.16.840.1.113883.10.22.3.3	Effective Date	2017‑02‑15
Status	Under pre-publication review	Version Label	STU1
Name	IPSProblemList	Display Name	IPS Problems Section
Description The IPS problem section lists and describes clinical problems or conditions currently being monitored for the patient. This section can record different kinds of  problems as, but not limited to,  chronic diseases (e.g. COPD, diabetes, hypertension); contagious diseases; nutritional problems (e.g. metabolic diseases); and so on.The optional author and informant elements are used, when necessary, to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.3.3
Classification	CDA Section Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 3 concepts Id Name Data Set hl7ips-data​element-130  Description  CEN/TC 251 prEN 17269 hl7ips-data​element-139  Problem list  CEN/TC 251 prEN 17269 hl7ips-data​element-18  Problems  CEN/TC 251 prEN 17269
Uses	Uses 4 templates Uses as Name Version 2.16.840.1.113883.10.22.4.14 Containment IPS Body Author (STU1) DYNAMIC 2.16.840.1.113883.10.12.319 Containment CDA Informant (Body) DYNAMIC 2.16.840.1.113883.10.22.4.7 Containment IPS Problem Concern Entry (2021) DYNAMIC 2.16.840.1.113883.10.22.3.15 Containment IPS Translation Section (2021) DYNAMIC
Relationship	Specialization: template 2.16.840.1.113883.10.12.201 CDA Section (2005‑09‑07) ref ad1bbr- Adaptation: template 2.16.840.1.113883.10.20.1.11 Problem section (DYNAMIC) ref ccd1- Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.3.6 Section Active Problems (2013‑12‑20) ref epsos-
Example	Example <section classCode="DOCSECT">   <templateId root="2.16.840.1.113883.10.22.3.3"/>  <id root="1.2.3.999" extension="__example only__"/>  <code code="11450-4" codeSystem="2.16.840.1.113883.6.1" displayName="Problem List"/>  <title>Active Problems</title>  <text>Narrative text of the Problem List sections</text>  <author>     <!-- template 2.16.840.1.113883.10.22.4.14 'IPS Body Author' (dynamic) -->   </author>  <informant>     <!-- template 2.16.840.1.113883.10.12.319 'CDA Informant (Body)' (dynamic) -->   </informant>  <entry typeCode="COMP" contextConductionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.7 'IPS Problem Concern Entry' (dynamic) -->   </entry>  <component>     <!-- template 2.16.840.1.113883.10.22.3.15 'IPS Translation Section' (dynamic) -->   </component></section>
Item DT Card Conf Description Label hl7:section 1 … 1 M (IPS...ist)   hl7ips-data​element-18  Problems  CEN/TC 251 prEN 17269 @classCode cs 0 … 1 F DOCSECT hl7:templateId II 1 … 1 M (IPS...ist) @root uid 1 … 1 F 2.16.840.1.113883.10.22.3.3 hl7:id II 0 … * R (IPS...ist) hl7:code CE.IPS 1 … 1 M (IPS...ist) @code CONF 1 … 1 F 11450-4 @codeSystem 1 … 1 F 2.16.840.1.113883.6.1 (LOINC) hl7:title ST 1 … 1 M (IPS...ist) hl7:text SD.TEXT 1 … 1 M Section text (IPS...ist)   hl7ips-data​element-130  Description  CEN/TC 251 prEN 17269 hl7:author 0 … * Contains 2.16.840.1.113883.10.22.4.14 IPS Body Author (DYNAMIC) (IPS...ist) hl7:informant 0 … * Contains 2.16.840.1.113883.10.12.319 CDA Informant (Body) (DYNAMIC) (IPS...ist) hl7:entry 1 … * R Contains 2.16.840.1.113883.10.22.4.7 IPS Problem Concern Entry (DYNAMIC) (IPS...ist)   hl7ips-data​element-139  Problem list  CEN/TC 251 prEN 17269 @typeCode cs 1 … 1 R   CONF The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19446 x_ActRelationshipEntry (DYNAMIC) @context​Conduction​Ind bl 0 … 1 F true hl7:component 0 … * Contains 2.16.840.1.113883.10.22.3.15 IPS Translation Section (DYNAMIC) (IPS...ist)

IPS Results Section

Id	2.16.840.1.113883.10.22.3.14	Effective Date	2017‑04‑30
Status	Under pre-publication review	Version Label	STU1
Name	IPSResultsSection	Display Name	IPS Results Section
Description This section assembles relevant observation results collected on the patient or produced on in-vitro biologic specimens collected from the patient. Some of these results may be laboratory results, others may be anatomic pathology results, others, radiology results, and others, clinical results. The structured, machine-processable content of this section is sorted out between as many Result Organizer entries as needed. One Result Organizer entry groups results, which have a common context of production: common specialty (imaging, bacteriology, serology, chemistry,  surgical pathology, clinical, radiology ...),  common overall interpretation, (which interprets the set of results of the Organizer), common biologic specimen for in vitro diagnostic observations,  common associated illustrative image. The optional author and informant elements of the section are used when necessary to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header. In case this section assembles results from multiple authors (e.g.; results authored by a clinical laboratory, and results produced by a radiology center), the authors are listed in the section, and each Result Organizer of the section indicates its own author(s).
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.3.14
Classification	CDA Section Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 3 concepts Id Name Data Set hl7ips-data​element-126  Observations results list  CEN/TC 251 prEN 17269 hl7ips-data​element-142  Result Description  CEN/TC 251 prEN 17269 hl7ips-data​element-19  Results  CEN/TC 251 prEN 17269
Uses	Uses 4 templates Uses as Name Version 2.16.840.1.113883.10.22.4.14 Containment IPS Body Author (STU1) DYNAMIC 2.16.840.1.113883.10.12.319 Containment CDA Informant (Body) DYNAMIC 2.16.840.1.113883.10.22.4.9 Containment IPS Result Organizer (STU1) DYNAMIC 2.16.840.1.113883.10.22.3.15 Containment IPS Translation Section (2021) DYNAMIC
Relationship	Adaptation: template 2.16.840.1.113883.10.12.201 CDA Section (2005‑09‑07) ref ad1bbr-
Example	Example <section classCode="DOCSECT" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.3.14"/>  <id root="1.2.3.999" extension="__example only__"/>  <code code="30954-2" codeSystem="2.16.840.1.113883.6.1" displayName="Relevant diagnostic tests/laboratory data Narrative"/>  <title>MOST SIGNIFICANT RESULTS</title>  <text>     <!-- some clinical laboratory results and some surgical pathology results presented to the human reader -->   </text>  <author>     <!-- template 2.16.840.1.113883.10.12.318 'CDA Author (Body)' - 1st author: a clinical lab director -->   </author>  <author>     <!-- template 2.16.840.1.113883.10.12.318 'CDA Author (Body)' - 2nd author: a pathologist -->   </author>  <entry typeCode="COMP" contextConductionInd="true">     <!--- 1st Organizer: chemistry observations on blood serum specimen produced and interpreted by a clinical laboratory -->     <organizer classCode="BATTERY" moodCode="EVN">       <templateId root="2.16.840.1.113883.10.22.4.9"/>      <code code="18719-5" displayName="Chemistry studies (set)" codeSystemName="LOINC" codeSystem="2.16.840.1.113883.6.1"/>      <satusCode code="completed"/>      <author>         <!-- template 2.16.840.1.113883.10.12.318 'CDA Author (Body)' - 1st author: a clinical lab director -->       </author>      <component>         <!-- template 2.16.840.1.113883.10.22.4.13 'IPS Laboratory Result Observation' -->       </component>      <component>         <!-- template 2.16.840.1.113883.10.22.4.13 'IPS Laboratory Result Observation' -->       </component>      <component>         <!-- template 2.16.840.1.113883.10.22.4.30 'IPS Specimen Collection' - common blood serum specimen -->       </component>      <component>         <!-- template 2.16.840.1.113883.10.22.4.22 'IPS Comment Activity' - interpretation of chemistry results -->       </component>    </organizer>  </entry>  <entry>     <organizer classCode="BATTERY" moodCode="EVN">       <templateId root="2.16.840.1.113883.10.22.4.9"/>      <code code="18723-7" displayName="Hematology studies (set)" codeSystemName="LOINC" codeSystem="2.16.840.1.113883.6.1"/>      <satusCode code="completed"/>      <author>         <!-- template 2.16.840.1.113883.10.12.318 'CDA Author (Body)' - 1st author: a clinical lab director -->       </author>      <component>         <!-- template 2.16.840.1.113883.10.22.4.13 'IPS Laboratory Result Observation' -->       </component>      <component>         <!-- template 2.16.840.1.113883.10.22.4.13 'IPS Laboratory Result Observation' -->       </component>      <component>         <!-- template 2.16.840.1.113883.10.22.4.30 'IPS Specimen Collection' - venous blood total specimen -->       </component>      <component>         <!-- template 2.16.840.1.113883.10.22.4.22 'IPS Comment Activity' - interpretation of hematology results -->       </component>    </organizer>  </entry>  <entry>     <organizer classCode="BATTERY" moodCode="EVN">       <templateId root="2.16.840.1.113883.10.22.4.9"/>      <code code="11529-5" displayName="Surgical pathology studies (set)" codeSystemName="LOINC" codeSystem="2.16.840.1.113883.6.1"/>      <satusCode code="completed"/>      <author>         <!-- template 2.16.840.1.113883.10.12.318 'CDA Author (Body)' - 2nd author: a pathologist -->       </author>      <component>         <!-- template 2.16.840.1.113883.10.22.4.11 'IPS Pathology Result Observation' -->       </component>      <component>         <!-- template 2.16.840.1.113883.10.22.4.30 'IPS Specimen Collection' - excised tissue specimen -->       </component>      <component>         <!-- template 2.16.840.1.113883.10.22.4.22 'IPS Comment Activity' - pathologist's interpretation -->       </component>      <component>         <!-- template 2.16.840.1.113883.10.22.4.23 'IPS ObservationMedia' - an illustrative slide image -->       </component>    </organizer>  </entry></section>
Item DT Card Conf Description Label hl7:section (IPS...ion)   hl7ips-data​element-19  Results  CEN/TC 251 prEN 17269 @classCode cs 0 … 1 F DOCSECT @moodCode cs 0 … 1 F EVN hl7:templateId II 1 … 1 R (IPS...ion) @root uid 1 … 1 F 2.16.840.1.113883.10.22.3.14 hl7:id II 0 … * R (IPS...ion) hl7:code CE.IPS 1 … 1 M (IPS...ion) @code CONF 1 … 1 F 30954-2 @codeSystem 1 … 1 F 2.16.840.1.113883.6.1 (LOINC) hl7:title ST 1 … 1 M (IPS...ion) hl7:text SD.TEXT 1 … 1 M (IPS...ion)   hl7ips-data​element-142  Result Description  CEN/TC 251 prEN 17269 hl7:author 0 … * Contains 2.16.840.1.113883.10.22.4.14 IPS Body Author (DYNAMIC) (IPS...ion) hl7:informant 0 … * Contains 2.16.840.1.113883.10.12.319 CDA Informant (Body) (DYNAMIC) (IPS...ion) hl7:entry 1 … * M Contains 2.16.840.1.113883.10.22.4.9 IPS Result Organizer (DYNAMIC) (IPS...ion)   hl7ips-data​element-126  Observations results list  CEN/TC 251 prEN 17269 @typeCode cs 1 … 1 R   CONF The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19446 x_ActRelationshipEntry (DYNAMIC) @context​Conduction​Ind bl 0 … 1 F true hl7:component 0 … * Contains 2.16.840.1.113883.10.22.3.15 IPS Translation Section (DYNAMIC) (IPS...ion)

IPS Social History Section

Id	2.16.840.1.113883.10.22.3.10	Effective Date	2020‑05‑10 18:52:32 Other versions this id: IPSSocialHistorySection as of 2020‑05‑10 18:52:19 IPSSocialHistorySection as of 2017‑04‑13
Status	Under pre-publication review	Version Label	TI-2020
Name	IPSSocialHistorySection	Display Name	IPS Social History Section
Description The social history section contains a description of the person’s Health related “lifestyle factors" or "lifestyle observations" (e.g. smoke habits; alcohol consumption; diets, risky habits.) The optional author and informant elements are used when necessary to convey the provenance and authoring of the section content in case it is different from what is announced in the CDA header.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.3.10
Classification	CDA Section Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 3 concepts Id Name Data Set hl7ips-data​element-147  Life Style Factor list  CEN/TC 251 prEN 17269 hl7ips-data​element-149  Description  CEN/TC 251 prEN 17269 hl7ips-data​element-20  Social History  CEN/TC 251 prEN 17269
Uses	Uses 6 templates Uses as Name Version 2.16.840.1.113883.10.22.4.14 Containment IPS Body Author (STU1) DYNAMIC 2.16.840.1.113883.10.12.319 Containment CDA Informant (Body) DYNAMIC 2.16.840.1.113883.10.22.4.34 Containment IPS Social History Tobacco Use (STU1) DYNAMIC 2.16.840.1.113883.10.22.4.35 Containment IPS Social History Alcohol Use (STU1) DYNAMIC 2.16.840.1.113883.10.22.4.48 Containment IPS Social History Observation (TI-2020) DYNAMIC 2.16.840.1.113883.10.22.3.15 Containment IPS Translation Section (2021) DYNAMIC
Relationship	Version: template 2.16.840.1.113883.10.22.3.10 IPS Social History Section (2017‑04‑13) Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.3.16 IHE Social History Section (DYNAMIC) ref IHE-PCC- Adaptation: template 2.16.840.1.113883.10.20.1.15 Social history section (DYNAMIC) ref ccd1- Adaptation: template 2.16.840.1.113883.10.20.22.2.17 Social History Section (V3) (DYNAMIC) ref bccdapilot-
Example	Example <section classCode="DOCSECT">   <templateId root="2.16.840.1.113883.10.22.3.10"/>  <id root="1.2.3.999" extension="__example only__"/>  <code code="29762-2" codeSystem="2.16.840.1.113883.6.1" displayName="Social history Narrative"/>  <title>Social History</title>  <text> Social History text </text>  <author>     <!-- template 2.16.840.1.113883.10.22.4.14 'IPS Body Author' (dynamic) -->   </author>  <informant>     <!-- template 2.16.840.1.113883.10.12.319 'CDA Informant (Body)' (dynamic) -->   </informant>  <entry typeCode="COMP" contextConductionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.34 'IPS Social History Tobacco Use' (dynamic) -->   </entry>  <entry typeCode="COMP" contextConductionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.35 'IPS Social History Alcohol Use' (dynamic) -->   </entry>  <component>     <!-- template 2.16.840.1.113883.10.22.3.15 'IPS Translation Section' (dynamic) -->   </component></section>
Item DT Card Conf Description Label hl7:section 1 … 1 M (IPS...ion)   hl7ips-data​element-20  Social History  CEN/TC 251 prEN 17269 @classCode cs 0 … 1 F DOCSECT hl7:templateId II 1 … 1 M (IPS...ion) @root uid 1 … 1 F 2.16.840.1.113883.10.22.3.10 hl7:id II 0 … * R (IPS...ion) hl7:code CE.IPS 1 … 1 M (IPS...ion) @code CONF 1 … 1 F 29762-2 @codeSystem 1 … 1 F 2.16.840.1.113883.6.1 (LOINC) hl7:title ST 1 … 1 M Social History (IPS...ion) hl7:text SD.TEXT 1 … 1 M (IPS...ion)   hl7ips-data​element-149  Description  CEN/TC 251 prEN 17269 hl7:author 0 … * Contains 2.16.840.1.113883.10.22.4.14 IPS Body Author (DYNAMIC) (IPS...ion) hl7:informant 0 … * Contains 2.16.840.1.113883.10.12.319 CDA Informant (Body) (DYNAMIC) (IPS...ion) hl7:entry 0 … 1 Contains 2.16.840.1.113883.10.22.4.34 IPS Social History Tobacco Use (DYNAMIC) (IPS...ion)   hl7ips-data​element-147  Life Style Factor list  CEN/TC 251 prEN 17269 @typeCode cs 1 … 1 R   CONF The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19446 x_ActRelationshipEntry (DYNAMIC) @context​Conduction​Ind bl 0 … 1 F true hl7:entry 0 … 1 Contains 2.16.840.1.113883.10.22.4.35 IPS Social History Alcohol Use (DYNAMIC) (IPS...ion)   hl7ips-data​element-147  Life Style Factor list  CEN/TC 251 prEN 17269 @typeCode cs 1 … 1 R   CONF The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19446 x_ActRelationshipEntry (DYNAMIC) @context​Conduction​Ind bl 0 … 1 F true hl7:entry 0 … * Contains 2.16.840.1.113883.10.22.4.48 IPS Social History Observation (DYNAMIC) (IPS...ion) @typeCode cs 1 … 1 R   CONF The value of @typeCode shall be drawn from value set 2.16.840.1.113883.1.11.19446 x_ActRelationshipEntry (DYNAMIC) @context​Conduction​Ind bl 0 … 1 F true hl7:component 0 … * Contains 2.16.840.1.113883.10.22.3.15 IPS Translation Section (DYNAMIC) (IPS...ion)

IPS Translation Section

Id	2.16.840.1.113883.10.22.3.15	Effective Date	2021‑09‑02 12:04:41 Other versions this id: IPSTranslationSection as of 2017‑07‑12
Status	Draft	Version Label	2021
Name	IPSTranslationSection	Display Name	IPS Translation Section
Description	Template CDA Section to carry the translations of a Parent Section
Classification	CDA Section Level Template
Open/Closed	Open (other than defined elements are allowed)
Relationship	Version: template 2.16.840.1.113883.10.22.3.15 IPS Translation Section (2017‑07‑12) Specialization: template 2.16.840.1.113883.10.12.201 CDA Section (2005‑09‑07) ref ad1bbr-
Example	Example <section>   <title>Translated title</title>  <!-- subordinate section carrying a translation of the parent section -->   <text>This is an English text</text>  <languageCode code="en-US"/></section>
Item DT Card Conf Description Label hl7:section (IPS...ion) hl7:id II 0 … * R (IPS...ion) hl7:title ST 1 … 1 R (IPS...ion) hl7:text SD.TEXT 1 … 1 R (IPS...ion) hl7:language​Code CS 1 … 1 R (IPS...ion)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.4.642.3.21 All Languages (DYNAMIC)

CDA Entry Level Templates

IPS Allergy and Intolerance Concern

Id	2.16.840.1.113883.10.22.4.5	Effective Date	2016‑11‑11
Status	Under pre-publication review	Version Label	STU1
Name	IPSAllergyAndIntoleranceConcern	Display Name	IPS Allergy and Intolerance Concern
Description This template reflects an ongoing concern on behalf of the person that placed the allergy on a patient’s allergy list. A concern may refer to one or more allergies or intolerances. There are different kinds of status that could be related to an allergy, or more in general to a condition: The status of the concern (active, inactive,..) The status of the condition (e.g. active, inactive, resolved,..) The confirmation status [clinical workflow status, certainty] (e.g. confirmed, likely, unlikely,…) Not all of them can be represented in a CDA using the statusCode elements of the concern (ACT) and observation (condition). As long as the underlying condition is of concern to the author (i.e., as long as the allergy, whether active or resolved, is of ongoing concern and interest to the author), the statusCode is “active”. In case the clinician deems that there is no longer any need to track the underlying conditions then the concern is inactive and the statusCode is set to "completed". The effectiveTime/low of the Allergy Concern Act asserts when the concern became active. This equates to the time the concern was authored in the patient's chart. The effectiveTime/high asserts when the concern became inactive, and it is present if the statusCode of the concern act is "completed"
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.5
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Uses	Uses 1 template Uses as Name Version 2.16.840.1.113883.10.22.4.1 Containment IPS Allergy or Intolerance (STU1) DYNAMIC
Relationship	Adaptation: template 2.16.840.1.113883.10.12.301 CDA Act (2005‑09‑07) ref ad1bbr- Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.5.3 IHE Allergy and Intolerance Concern Entry (2013‑12‑20) ref IHE-PCC-
Example	Example <act classCode="ACT" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.5"/>  <id root="1.2.3.999" extension="__example only__"/>  <code code="CONC" codeSystem="2.16.840.1.113883.5.6"/>  <statusCode code="active"/>  <effectiveTime>     <low value="..."/>    <high value="..."/>  </effectiveTime>  <entryRelationship typeCode="SUBJ" inversionInd="false">     <!-- template 2.16.840.1.113883.10.22.4.1 'IPS Allergy or Intolerance' (dynamic) -->   </entryRelationship></act>
Item DT Card Conf Description Label hl7:act 0 … * R (IPS...ern) @classCode cs 1 … 1 F ACT @moodCode cs 1 … 1 F EVN hl7:templateId II 1 … 1 M (IPS...ern) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.5 hl7:id II 0 … * R (IPS...ern) hl7:code CD 1 … 1 M (IPS...ern) @code CONF 1 … 1 F CONC @codeSystem 1 … 1 F 2.16.840.1.113883.5.6 (HL7ActClass) hl7:statusCode CS 1 … 1 R As long as the underlying conditions are of concern to the author (i.e., as long as allergies, whether active or resolved, is of ongoing concern and interest to the author), the statusCode is “active”. The concern is tracked by the author. Only when the underlying allergies are no longer of concern then the statusCode is set to “completed”. The author is no more tracking this concern and no further actions are expected. (IPS...ern)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.19890 x_ActStatusActiveComplete (DYNAMIC) hl7:effectiveTime IVL_TS 1 … 1 R (IPS...ern) hl7:low IVXB_TS 1 … 1 R This element asserts when the concern became active. This equates to the time the concern was authored in the patient's chart and the author started tracking this concern. (IPS...ern) hl7:high IVXB_TS 0 … 1 C This element asserts when the clinician deemed there is no longer any need to track the underlying conditions. (IPS...ern)   Constraint If statusCode/@code="completed" Completed, then effectiveTime *SHALL* contain [1..1] high   Schematron assert role  error     test not(../hl7:statusCode[@code='completed']) or hl7:high     Message If statusCode/@code="completed" Completed, then effectiveTime *SHALL* contain [1..1] high   hl7:entryRelationship 1 … * R Contains 2.16.840.1.113883.10.22.4.1 IPS Allergy or Intolerance (DYNAMIC) (IPS...ern) @typeCode cs 1 … 1 F SUBJ @inversionInd bl 0 … 1 F false

IPS Allergy Certainty Observation

{{: 2.16.840.1.113883.10.22.10/dynamic}}

IPS Allergy or Intolerance

Id	2.16.840.1.113883.10.22.4.1	Effective Date	2016‑11‑10
Status	Under pre-publication review	Version Label	STU1
Name	IPSEntryAllergyOrIntolerance	Display Name	IPS Allergy or Intolerance
Description This template reflects a discrete observation about a patient's allergy or intolerance. Because it is a discrete observation, it will have a statusCode of "completed". The effectiveTime, also referred to as the "biologically relevant time" is the time at which the observation holds for the patient. For a provider seeing a patient in the clinic today, observing a history of penicillin allergy that developed five years ago, the effectiveTime is five years ago. The effectiveTime of the Allergy - Intolerance Observation gives an indication of whether or not the underlying allergy/intolerance is resolved. If known to be resolved, then an effectiveTime/high would be present.  If the date of resolution is not known, then effectiveTime/high will be present with a nullFlavor of "UNK".  It is recommended that the agent responsible for an allergy or adverse reaction would be used for describing the allergy, however the possibility that pre-coordinate codes (e.g. "allergy to nuts") will be used has been here also considered. The agent responsible for  an allergy or adverse reaction it is not always a manufactured material (for example, food allergies), nor is it necessarily consumed; however  the playingEntity classCode = "MMAT" for all agents, manufactured or not is expected to be used. This choice depends on thecharacteristics of the base CDA R2 specification.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.1
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 12 concepts Id Name Data Set hl7ips-data​element-173  Agent  CEN/TC 251 prEN 17269 hl7ips-data​element-182  Allergies/Intolerances Content Status  CEN/TC 251 prEN 17269 hl7ips-data​element-184  Allergy/Intolerance  CEN/TC 251 prEN 17269 hl7ips-data​element-185  Diagnosis  CEN/TC 251 prEN 17269 hl7ips-data​element-186  Clinical Status  CEN/TC 251 prEN 17269 hl7ips-data​element-187  Onset date  CEN/TC 251 prEN 17269 hl7ips-data​element-188  End Date  CEN/TC 251 prEN 17269 hl7ips-data​element-189  Criticality  CEN/TC 251 prEN 17269 hl7ips-data​element-190  Certainty  CEN/TC 251 prEN 17269 hl7ips-data​element-191  Type of propensity  CEN/TC 251 prEN 17269 hl7ips-data​element-192  Reaction  CEN/TC 251 prEN 17269 hl7ips-data​element-196  Agent code  CEN/TC 251 prEN 17269
Uses	Uses 4 templates Uses as Name Version 2.16.840.1.113883.10.22.4.6 Containment IPS Reaction Manifestation (STU1) DYNAMIC 2.16.840.1.113883.10.22.4.18 Containment IPS Criticality Observation (STU1) DYNAMIC 2.16.840.1.113883.10.22.10 Containment IPS Allergy Certainty Observation (STU1) DYNAMIC 2.16.840.1.113883.10.22.4.21 Containment IPS Allergy Status Observation (STU1) DYNAMIC
Relationship	Adaptation: template 2.16.840.1.113883.10.20.1.18 Alert observation (DYNAMIC) ref ccd1- Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.5 IHE Problem Entry (DYNAMIC) ref ch-pcc- Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.6 eHDSI Allergies And Intolerances (DYNAMIC) ref epsos-
Example	Example <observation classCode="OBS" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.1"/>  <id root=" " extension=" "/>  <!-- This is the code that shows what kind of allergy or intolerance -->   <code code="OINT" displayName="Allergy or Intolerance" codeSystem="2.16.840.1.113883.5.4"/>  <text>     <reference value="#ref1"/>  </text>  <statusCode code="completed"/>  <effectiveTime>     <low value="20170701"/>  </effectiveTime>  <!-- This is the allergen - the substance that caused the allergy -->   <participant typeCode="CSM">     <participantRole classCode="MANU">       <playingEntity classCode="MMAT">         <code code=" " codeSystem=" ">           <originalText>             <reference value="#substance"/>          </originalText>        </code>        <name>...</name>      </playingEntity>    </participantRole>  </participant>  <!-- This is how the allergy manifests itself -->   <entryRelationship typeCode="MFST" inversionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.6 'IPS Reaction Manifestation' (dynamic) -->   </entryRelationship>  <entryRelationship typeCode="SUBJ" inversionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.18 'IPS Criticality Observation' (dynamic) -->   </entryRelationship>  <entryRelationship typeCode="SUBJ" inversionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.19 'IPS Certainty Observation' (dynamic) -->   </entryRelationship>  <entryRelationship typeCode="REFR" inversionInd="false">     <!-- template 2.16.840.1.113883.10.22.4.21 'IPS Allergy Status Observation' (dynamic) -->   </entryRelationship></observation>
Example	No Known Allergies <observation classCode="OBS" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.1"/>  <code code="allergy" displayName="Allergy" codeSystem="2.16.840.1.113883.4.642.1.122"/>  <statusCode code="completed"/>  <effectiveTime>     <low nullFlavor="UNK"/>  </effectiveTime>  <value code="X-NoKnownAllergy" displayName="No known allergy" codeSystem="2.16.840.1.113883.5.1150.2"/></observation>
Example	No Information available about allergies or intolerances <observation classCode="OBS" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.1"/>  <code code="OINT" displayName="Allergy or Intolerance" codeSystem="2.16.840.1.113883.5.4"/>  <statusCode code="completed"/>  <effectiveTime>     <low nullFlavor="NA"/>  </effectiveTime>  <value code="no-allergy-info" displayName="No information about allergies" codeSystem="2.16.840.1.113883.5.1150.1"/></observation>
Example	Minimum Set (active propensity; agent known) <observation classCode="OBS" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.1"/>  <code code="OINT" displayName="Allergy or Intolerance" codeSystem="2.16.840.1.113883.5.4"/>  <statusCode code="completed"/>  <effectiveTime>     <low nullFlavor="UNK"/>  </effectiveTime>  <participant typeCode="CSM">     <participantRole classCode="MANU">       <playingEntity classCode="MMAT">         <code code="13577000" codeSystem="2.16.840.1.113883.6.96" displayName="Nut"/>      </playingEntity>    </participantRole>  </participant></observation>
Item DT Card Conf Description Label hl7:observation R (IPS...nce)   hl7ips-data​element-184  Allergy/Intolerance  CEN/TC 251 prEN 17269 @classCode cs 1 … 1 F OBS @moodCode cs 1 … 1 F EVN hl7:templateId II 1 … 1 M (IPS...nce) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.1 hl7:id II 0 … * R (IPS...nce) hl7:code CD.IPS 1 … 1 M This element describes whether this condition refers to an allergy, non-allergy intolerance, or unknown class of intolerance (not known to be allergy or intolerance). (IPS...nce)   hl7ips-data​element-191  Type of propensity  CEN/TC 251 prEN 17269   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.2 Allergy or Intolerance Type (DYNAMIC) hl7:text ED 0 … 1 R The text element if present points to the text describing the problem being recorded; including any dates, comments, et cetera. The <reference> contains a URI in value attribute. This URI points to the free text description of the problem in the document that is being described.</reference> (IPS...nce) hl7:reference TEL 1 … 1 M (IPS...nce) @value 1 … 1 R When used it shall refer to the narrative, typically #{label}-{generated-id}, e.g. #xxx-1 hl7:statusCode CS 1 … 1 M A clinical document normally records only those condition observation events that have been completed, not observations that are in any other state. Therefore, the <statusCode> shall always have code='completed'.</statusCode> (IPS...nce) @code cs 1 … 1 F completed hl7:effectiveTime IVL_TS 1 … 1 M The effectiveTime, also referred to as the "biologically relevant time" is the time at which the observation holds for the patient. For a provider seeing a patient in the clinic today, observing a history of penicillin allergy that developed five years ago, the effectiveTime is five years ago. The effectiveTime of the Allergy - Intolerance  Observation may give an indication of whether or not the underlying allergy/intolerance is resolved.  The <low> and <high> values should be no more precise than known, but as precise as possible. (IPS...nce) hl7:low IVXB_TS 1 … 1 R The effectiveTime/low (a.k.a. "onset date") asserts when the allergy/intolerance became biologically active. (IPS...nce)   hl7ips-data​element-187  Onset date  CEN/TC 251 prEN 17269 hl7:high IVXB_TS 0 … 1 C The effectiveTime/high (a.k.a. "resolution date") asserts when the allergy/intolerance became biologically resolved. If the date of resolution is not known, then effectiveTime/high will be present with a nullFlavor of "UNK". (IPS...nce)   hl7ips-data​element-188  End Date  CEN/TC 251 prEN 17269   Constraint If this condition is known to be resolved, then the effectiveTime/high would be present. Choice 0 … 1 The coded form of the observation value can be used : either to indicate known absent conditions (e.g. NKA) or the nonavailability of information;  or to provide pre-coordinated codes describing the propensity to specific substances (e.g. allergy to nuts).  The choice reflects these options. Elements to choose from: hl7:value[1] hl7:value[2] hl7:value CD.IPS (preferred) 0 … 1 (IPS...nce) where [1]   hl7ips-data​element-185  Diagnosis  CEN/TC 251 prEN 17269   CONF The value of @code comes preferably from value set 2.16.840.1.113883.11.22.10 IPS Allergy or Intolerance Conditions (DYNAMIC) hl7:value CD.IPS (required) 0 … 1 C When the value is used to describe the absence of information the participant used for indicating the allergy agent shall be omitted. (IPS...nce) where [2]   hl7ips-data​element-182  Allergies/Intolerances Content Status  CEN/TC 251 prEN 17269   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.9 Absent or Unknown Allergies (DYNAMIC) hl7:participant 0 … 1 C The substance that causes the allergy or intolerance should be specified in the <participant> structure.  This is the preferred way an allergy is supposed to be expressed. However it is recognized that in some contexts a controlled vocabulary is used for describing the allergy to a substance; or for asserting known absence or unavailability of information.  In this case the <participant> structure shall be omitted. The agent responsible for an allergy or adverse reaction is not always a manufactured material (for example, food allergies), nor is it necessarily consumed. The following constraints reflect limitations in the base CDA R2 specification, and should be used to represent any type of responsible agent, i.e., use playingEntity classCode = "MMAT" for all agents, manufactured or not. (IPS...nce)   hl7ips-data​element-173  Agent  CEN/TC 251 prEN 17269 @typeCode cs 1 … 1 F CSM   Constraint IF the observation/value element is present and valued with a code derived form the  2.16.840.1.113883.11.22.9 Absent or Unknown Allergies value set THEN the  observation/participant element used to describe the agent SHALL be omitted. hl7:participantRole 1 … 1 R (IPS...nce) @classCode cs 1 … 1 F MANU hl7:playingEntity 1 … 1 R (IPS...nce) @classCode cs 1 … 1 F MMAT hl7:code CD.IPS (preferred) 1 … 1 R Code for the substance causing the allergy or intolerance. (IPS...nce)   hl7ips-data​element-196  Agent code  CEN/TC 251 prEN 17269   CONF The value of @code comes preferably from value set 2.16.840.1.113883.11.22.11 Adverse Reaction Agents (DYNAMIC) hl7:entryRelationship 0 … * R The contained entry describes the reactions that are manifestations (typeCode='MFST') of the reported allergy or intolerance. Contains 2.16.840.1.113883.10.22.4.6 IPS Reaction Manifestation (DYNAMIC) (IPS...nce)   hl7ips-data​element-192  Reaction  CEN/TC 251 prEN 17269 @typeCode cs 1 … 1 F MFST @inversionInd cs 1 … 1 F true hl7:entryRelationship 0 … 1 R Criticality The contained entry describes the gravity of the potential risk for future life-threatening adverse reactions when exposed to a substance known to cause an adverse reaction in that individual. Contains 2.16.840.1.113883.10.22.4.18 IPS Criticality Observation (DYNAMIC) (IPS...nce)   hl7ips-data​element-189  Criticality  CEN/TC 251 prEN 17269 @typeCode cs 1 … 1 F SUBJ @inversionInd cs 1 … 1 F true hl7:entryRelationship 0 … 1 R Certainty or Verification Status The contained entry describes the certainty associated with a propensity, or potential risk, of a reaction to the identified substance. Contains 2.16.840.1.113883.10.22.10 IPS Allergy Certainty Observation (DYNAMIC) (IPS...nce)   hl7ips-data​element-190  Certainty  CEN/TC 251 prEN 17269 @typeCode cs 1 … 1 F SUBJ @inversionInd cs 1 … 1 F true hl7:entryRelationship 0 … 1 R Status of the Allergy or Intolerance  The contained entry describes the current status of the allergy or intolerance, for example, whether it is active, in remission, resolved, and so on ... Contains 2.16.840.1.113883.10.22.4.21 IPS Allergy Status Observation (DYNAMIC) (IPS...nce)   hl7ips-data​element-186  Clinical Status  CEN/TC 251 prEN 17269 @typeCode cs 1 … 1 F REFR @inversionInd cs 1 … 1 F false

IPS Allergy Status Observation

Id	2.16.840.1.113883.10.22.4.21	Effective Date	2017‑05‑24
Status	Under pre-publication review	Version Label	STU1
Name	IPSAllergyStatusObservation	Display Name	IPS Allergy Status Observation
Description This subordinated observation used by the allergy observation records information about the current status of an allergy or intolerance, for example, whether it is active, in remission, resolved, et cetera.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.21
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 1 concept Id Name Data Set hl7ips-data​element-186  Clinical Status  CEN/TC 251 prEN 17269
Relationship	Specialization: template 2.16.840.1.113883.10.22.4.20 IPS Problem Status Observation (DYNAMIC) Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.1.1 IHE Problem Status Observation (2013‑12‑20) ref IHE-PCC-
Example	Example <observation classCode="OBS" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.21"/>  <templateId root="2.16.840.1.113883.10.22.4.20"/>  <code code="33999-4" codeSystem="2.16.840.1.113883.6.1" displayName="Status"/>  <text>     <reference value="#cstatus-2"/>  </text>  <statusCode code="completed"/>  <value code="active" displayName="Active" codeSystem="2.16.840.1.113883.4.642.3.155"/></observation>
Item DT Card Conf Description Label hl7:observation (IPS...ion) @classCode cs 0 … 1 F OBS @moodCode cs 0 … 1 F EVN hl7:templateId II 1 … 1 M (IPS...ion) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.21 hl7:templateId II 1 … 1 M (IPS...ion) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.20 hl7:code CD 1 … 1 R This observation is of clinical status, as indicated by the <code> element. This element must be present. (IPS...ion) @code CONF 0 … 1 F 33999-4 @codeSystem 0 … 1 F 2.16.840.1.113883.6.1 (LOINC) hl7:text ED 0 … 1 R The <text> element is required and points to the text describing the problem being recorded; including any dates, comments, et cetera. The <reference> contains a URI in value attribute. This URI points to the free text description of the problem in the document that is being described. (IPS...ion) hl7:reference TEL 1 … 1 M (IPS...ion) @value 1 … 1 R Reference pointing to the narrative, typically #{label}-{generated-id}, e.g. #xxx-1 hl7:statusCode CS 1 … 1 M The code attribute of <statusCode> for all clinical status observations shall be completed. While the <statusCode> element is required in all acts to record the status of the act, the only sensible value of this element in this context is completed. (IPS...ion) @code CONF 1 … 1 F completed hl7:value CE.IPS 1 … 1 R The value element contains the clinical status. (IPS...ion)   hl7ips-data​element-186  Clinical Status  CEN/TC 251 prEN 17269   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.42 IPS Allergy Status Code (DYNAMIC)

IPS Body Author

Id	2.16.840.1.113883.10.22.4.14	Effective Date	2017‑03‑02
Status	Under pre-publication review	Version Label	STU1
Name	IPSBodyAuthor	Display Name	IPS Body Author
Description This template represents the Author Participation (including the author timestamp). CDA R2 requires that Author and Author timestamp be asserted in the document header. From there, authorship propagates to contained sections and contained entries, unless explicitly overridden. The Author Participation template was added to those templates in scope for analysis in R2. Although it is not explicitly stated in all templates the Author Participation template can be used in any template.
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Uses	Uses 1 template Uses as Name Version 2.16.840.1.113883.10.22.9.2 Containment IPS CDA Device (STU1) DYNAMIC
Relationship	Adaptation: template 2.16.840.1.113883.10.12.318 CDA Author (Body) (2005‑09‑07) ref ad1bbr- Adaptation: template 2.16.840.1.113883.10.20.22.4.119 Author Participation (2015‑08‑13) ref ccda-
Example	Example <templateId root="2.16.840.1.113883.10.22.4.14"/><time/><assignedAuthor>   <id root="1.2.3.999" extension="__example only__"/>  <code code="..." codeSystem="1.2.3.999"/>  <!-- choice: 0..1 element hl7:assigned​Person element hl7:assigned​Authoring​Device containing template 2.16.840.1.113883.10.22.9.2 (dynamic) -->   <representedOrganization>     <id root="1.2.3.999" extension="__example only__"/>    <name>...</name>    <telecom value="tel:+1-12345678"/>    <addr>addr</addr>  </representedOrganization></assignedAuthor>
Item DT Card Conf Description Label hl7:templateId II 1 … 1 M (IPS...hor) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.14 hl7:time TS.IPS.TZ 1 … 1 R (IPS...hor) hl7:assignedAuthor 1 … 1 M (IPS...hor) hl7:id II 1 … * R (IPS...hor) hl7:code 0 … 1 R (IPS...hor) Choice 0 … 1 Elements to choose from: hl7:assigned​Person hl7:assigned​Authoring​Device containing template 2.16.840.1.113883.10.22.9.2 IPS CDA Device (DYNAMIC) hl7:assigned​Person 0 … 1 C (IPS...hor) @classCode cs 0 … 1 F PSN @determiner​Code cs 0 … 1 F INSTANCE hl7:name PN 1 … * R Name of the person (e.g. the Healthcare Professional)  authoring this document (IPS...hor)   Example <name>   <given>John</given>  <family>Español Smith</family></name> hl7:family 1 … * R (IPS...hor) hl7:given 1 … * R (IPS...hor) hl7:assigned​Authoring​Device 0 … 1 C Contains 2.16.840.1.113883.10.22.9.2 IPS CDA Device (DYNAMIC) (IPS...hor)   Example <assignedAuthoringDevice classCode="DEV" determinerCode="INSTANCE">   <softwareName displayName="Turriano"/></assignedAuthoringDevice> hl7:represented​Organization 0 … 1 (IPS...hor) hl7:id II 0 … * (IPS...hor) hl7:name 0 … * (IPS...hor) hl7:telecom TEL 0 … * (IPS...hor) hl7:addr AD 0 … * (IPS...hor)

IPS CDA Device

Id	2.16.840.1.113883.10.22.9.2	Effective Date	2017‑04‑12
Status	Under pre-publication review	Version Label	STU1
Name	IPSCDADevice	Display Name	IPS CDA Device
Description	This template provides basic information about a device
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Relationship	Adaptation: template 2.16.840.1.113883.10.12.315 CDA Device (2005‑09‑07) ref ad1bbr-
Item DT Card Conf Description Label @classCode cs 0 … 1 F DEV @determiner​Code cs 0 … 1 F INSTANCE hl7:code CE 0 … 1 (IPS...ice) hl7:manufacturer​Model​Name SC 0 … 1 (IPS...ice) hl7:softwareName SC 0 … 1 (IPS...ice)

IPS Certainty Observation

Id	2.16.840.1.113883.10.22.4.19	Effective Date	2017‑03‑29
Status	Under pre-publication review	Version Label	STU1
Name	IPSCertaintyObservation	Display Name	IPS Certainty Observation
Description	This observation represents the verification status to support the clinical status of the condition.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.19
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Relationship	Adaptation: template 2.16.840.1.113883.10.20.22.4.145 Criticality Observation (2015‑08‑13) ref ccda- Adaptation: template 2.16.840.1.113883.10.12.303 CDA Observation (2005‑09‑07) ref ad1bbr-
Example	Example <observation classCode="OBS" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.19"/>  <code code="66455-7" codeSystem="2.16.840.1.113883.6.1" displayName="Condition status"/>  <statusCode code="completed"/>  <value code="unconfirmed" displayName="Unconfirmed" codeSystem="2.16.840.1.113883.4.642.3.115"/></observation>
Item DT Card Conf Description Label hl7:observation (IPS...ion) @classCode cs 1 … 1 F OBS @moodCode cs 1 … 1 F EVN hl7:templateId II 1 … 1 M (IPS...ion) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.19 hl7:code CD 1 … 1 M (IPS...ion) @code CONF 1 … 1 F 66455-7 @codeSystem 1 … 1 F 2.16.840.1.113883.6.1 (LOINC) @codeSystemName 1 … 1 F LOINC @displayName 1 … 1 F Condition status hl7:statusCode CS 1 … 1 M (IPS...ion) @code CONF 1 … 1 F completed hl7:value CD.IPS (required) 1 … 1 M (IPS...ion)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.8 IPS Condition Verification Status (DYNAMIC)

IPS Comment Activity

Id	2.16.840.1.113883.10.22.4.22	Effective Date	2017‑04‑05
Status	Under pre-publication review	Version Label	STU1
Name	IPSCommentActivity	Display Name	IPS Comment Activity
Description Comments are free text data that cannot otherwise be recorded using data elements already defined by this specification. They are not to be used to record information that can be recorded elsewhere. For example, a free text description of the severity of an allergic reaction would not be recorded in a comment.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.22
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Relationship	Adaptation: template 2.16.840.1.113883.10.20.22.4.64 Comment Activity (2015‑08‑13) ref ccda- Adaptation: template 2.16.840.1.113883.10.12.301 CDA Act (2005‑09‑07) ref ad1bbr-
Example	Example <act classCode="ACT" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.22"/>  <code code="48767-8" codeSystem="2.16.840.1.113883.6.1"/>  <text>     <reference value="#example"/>  </text>  <author>     <time/>    <assignedAuthor>       <id root="1.2.3.999" extension="__example only__"/>      <addr>addr</addr>      <!-- choice: 1..1 element hl7:assigned​Person element hl7:represented​Organization -->     </assignedAuthor>  </author></act>
Item DT Card Conf Description Label hl7:act (IPS...ity) @classCode cs 1 … 1 F ACT @moodCode cs 1 … 1 F EVN   Constraint Data elements defined elsewhere in the specification SHALL NOT be recorded using the Comment Activity hl7:templateId II 1 … 1 M (IPS...ity) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.22 hl7:code CD.IPS 1 … 1 M (IPS...ity) @code CONF 1 … 1 F 48767-8 @codeSystem 1 … 1 F 2.16.840.1.113883.6.1 (LOINC) hl7:text ED 1 … 1 M (IPS...ity) hl7:reference 1 … 1 M (IPS...ity) @value 1 … 1 R   Schematron assert role  error     test not(@value) or starts-with(@value, '#')     Message This reference/@value SHALL begin with a '#' and SHALL point to its corresponding narrative (using the approach defined in CDA Release 2, section 4.3.5.1)   hl7:author 0 … 1 (IPS...ity) hl7:time TS.IPS.TZ 1 … 1 R (IPS...ity) hl7:assignedAuthor 1 … 1 M (IPS...ity)   Constraint The author, if present, SHALL include assignedPerson/name or representedOrganization/name hl7:id II 1 … 1 R (IPS...ity) hl7:addr AD 1 … * M (IPS...ity) Choice 1 … 1 Elements to choose from: hl7:assigned​Person hl7:assigned​Authoring​Device hl7:assigned​Person 0 … 1 C (IPS...ity) hl7:name 0 … * R (IPS...ity) hl7:assigned​Authoring​Device 0 … 1 C (IPS...ity) hl7:softwareName 0 … 1 R (IPS...ity)

IPS Criticality Observation

Id	2.16.840.1.113883.10.22.4.18	Effective Date	2017‑03‑27
Status	Under pre-publication review	Version Label	STU1
Name	IPSCriticalityObservation	Display Name	IPS Criticality Observation
Description This observation represents the gravity of the potential risk for future life-threatening adverse reactions when exposed to a substance known to cause an adverse reaction in that individual. When the worst case result is assessed to have a life-threatening or organ system threatening potential, it is considered to be of high criticality.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.18
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 1 concept Id Name Data Set hl7ips-data​element-189  Criticality  CEN/TC 251 prEN 17269
Relationship	Adaptation: template 2.16.840.1.113883.10.20.22.4.145 Criticality Observation (2015‑08‑13) ref ccda- Adaptation: template 2.16.840.1.113883.10.12.303 CDA Observation (2005‑09‑07) ref ad1bbr-
Example	Example <observation classCode="OBS" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.18"/>  <code code="82606-5" codeSystem="2.16.840.1.113883.6.1"/>  <statusCode code="completed"/>  <value code="CRITH" displayName="high criticality" codeSystem="2.16.840.1.113883.5.1063"/></observation>
Item DT Card Conf Description Label hl7:observation (IPS...ion) @classCode cs 1 … 1 F OBS @moodCode cs 1 … 1 F EVN hl7:templateId II 1 … 1 M (IPS...ion) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.18 hl7:code CD 1 … 1 M (IPS...ion) @code CONF 1 … 1 F 82606-5 @codeSystem 1 … 1 F 2.16.840.1.113883.6.1 (LOINC) hl7:statusCode CS 1 … 1 M (IPS...ion) @code CONF 1 … 1 F completed hl7:value CD.IPS (required) 1 … 1 M (IPS...ion)   hl7ips-data​element-189  Criticality  CEN/TC 251 prEN 17269   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.60 Allergy-intolerance Criticality (DYNAMIC)

IPS Immunization

Id	2.16.840.1.113883.10.22.4.15	Effective Date	2017‑03‑08
Status	Under pre-publication review	Version Label	STU1
Name	IPSImmunization	Display Name	IPS Immunization
Description	An Immunization entry describes immunization substance administrations that have actually occurred.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.15
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 3 concepts Id Name Data Set hl7ips-data​element-215  Product Administration Process  CEN/TC 251 prEN 17269 hl7ips-data​element-45  Immunization  CEN/TC 251 prEN 17269 hl7ips-data​element-53  Date of Immunization  CEN/TC 251 prEN 17269
Uses	Uses 2 templates Uses as Name Version 2.16.840.1.113883.10.22.4.16 Containment IPS Immunization Medication Information (STU1) DYNAMIC 2.16.840.1.113883.10.12.318 Containment CDA Author (Body) DYNAMIC
Relationship	Adaptation: template 2.16.840.1.113883.10.12.308 CDA SubstanceAdministration (2005‑09‑07) ref ad1bbr- Adaptation: template 2.16.840.1.113883.10.20.22.4.52 Immunization Activity (V3) (2015‑08‑01) ref ccda-
Example	Example <substanceAdministration classCode="SBADM" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.15"/>  <id root="1.2.3.999" extension="__example only__"/>  <code code="IMMUNIZ" displayName="Immunization" codeSystem="2.16.840.1.113883.5.4"/>  <statusCode code="completed"/>  <effectiveTime value="20170721082737"/>  <consumable>     <!-- template 2.16.840.1.113883.10.22.4.16 'IPS Immunization Medication Information' (dynamic) -->   </consumable>  <author>     <!-- template 2.16.840.1.113883.10.12.318 'CDA Author (Body)' (dynamic) -->   </author></substanceAdministration>
Item DT Card Conf Description Label hl7:substanceAdministration (IPS...ion)   hl7ips-data​element-215  Product Administration Process  CEN/TC 251 prEN 17269 hl7ips-data​element-45  Immunization  CEN/TC 251 prEN 17269 @classCode cs 1 … 1 F SBADM @moodCode cs 1 … 1 F EVN hl7:templateId II 1 … 1 M (IPS...ion) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.15 hl7:id II 0 … * (IPS...ion) hl7:code CV.IPS 1 … 1 M (IPS...ion)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.19709 ActSubstanceAdministrationImmunizationCode (DYNAMIC) hl7:statusCode CS 1 … 1 M (IPS...ion) @code CONF 1 … 1 F completed hl7:effectiveTime TS 1 … 1 (IPS...ion)   hl7ips-data​element-53  Date of Immunization  CEN/TC 251 prEN 17269   Example <effectiveTime value="20170322"/> hl7:consumable 1 … 1 M Contains 2.16.840.1.113883.10.22.4.16 IPS Immunization Medication Information (DYNAMIC) (IPS...ion) hl7:author 0 … * R Contains 2.16.840.1.113883.10.12.318 CDA Author (Body) (DYNAMIC) (IPS...ion)

IPS Immunization Medication Information

Id	2.16.840.1.113883.10.22.4.16	Effective Date	2017‑03‑08
Status	Under pre-publication review	Version Label	STU1
Name	IPSImmunizationMedicationInformation	Display Name	IPS Immunization Medication Information
Description The Immunization Medication Information represents product information about the immunization substance. The vaccine manufacturer and vaccine lot number are typically recorded in the medical record and should be included if known.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.16
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 3 concepts Id Name Data Set hl7ips-data​element-46  Immunizations Content Status  CEN/TC 251 prEN 17269 hl7ips-data​element-52  Vaccine for type of disease  CEN/TC 251 prEN 17269 hl7ips-data​element-54  Product Administered  CEN/TC 251 prEN 17269
Uses	Uses 1 template Uses as Name Version 2.16.840.1.113883.10.22.9.1 Containment IPS CDA Organization (STU1) DYNAMIC
Relationship	Adaptation: template 2.16.840.1.113883.10.12.312 CDA ManufacturedProduct (2005‑09‑07) ref ad1bbr- Adaptation: template 2.16.840.1.113883.10.20.22.4.54 Immunization Medication Information (V2) (2014‑06‑09) ref ccda-
Example	No previous immunizations <manufacturedProduct classCode="MANU">   <templateId root="2.16.840.1.113883.10.22.4.16"/>  <manufacturedMaterial>     <code code="no-known-immunizations" displayName="No known immunizations" codeSystem="2.16.840.1.113883.5.1150.1"/>  </manufacturedMaterial>  <manufacturerOrganization/></manufacturedProduct>
Example	MMR Vaccine <manufacturedProduct classCode="MANU">   <templateId root="2.16.840.1.113883.10.22.4.16"/>  <manufacturedMaterial>     <code code="61153008" displayName="Measles + Mumps + Rubella vaccine" codeSystem="2.16.840.1.113883.6.96"/>    <lotNumberText/>  </manufacturedMaterial>  <manufacturerOrganization/></manufacturedProduct>
Item DT Card Conf Description Label hl7:manufacturedProduct (IPS...ion)   hl7ips-data​element-54  Product Administered  CEN/TC 251 prEN 17269 @classCode cs 1 … 1 F MANU hl7:templateId II 1 … 1 M (IPS...ion) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.16 hl7:manufactured​Material 1 … 1 M (IPS...ion) hl7:code CD.IPS (preferred) 1 … 1 R (IPS...ion)   hl7ips-data​element-46  Immunizations Content Status  CEN/TC 251 prEN 17269 hl7ips-data​element-52  Vaccine for type of disease  CEN/TC 251 prEN 17269   CONF The value of @code comes preferably from value set 2.16.840.1.113883.11.22.43 Absent or Unknown Immunization (DYNAMIC) or The value of @code comes preferably from value set 2.16.840.1.113883.11.22.44 IPS Vaccines (DYNAMIC) hl7:translation CE 0 … * (IPS...ion)   CONF shall be drawn from concept domain "Product Code" hl7:lotNumberText ST 0 … 1 (IPS...ion) hl7:manufacturerOrganization 0 … 1 R Contains 2.16.840.1.113883.10.22.9.1 IPS CDA Organization (DYNAMIC) (IPS...ion)

IPS Internal Reference

Id	2.16.840.1.113883.10.22.4.31	Effective Date	2017‑05‑02
Status	Under pre-publication review	Version Label	STU1
Name	IPSEntryInternalReference	Display Name	IPS Internal Reference
Description	This template is used to reference (point to) information contained in other entries within the same document.
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Relationship	Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.4.1 IHE Internal Reference Entry (2013‑12‑20) ref IHE-PCC-
Example	Reference to an uncoded element <act classCode="ACT" moodCode="cs">   <templateId root="2.16.840.1.113883.10.22.4.31"/>  <id root="1.2.3.999" extension="__example only__"/>  <code nullFlavor="NA"/></act>
Item DT Card Conf Description Label hl7:act R (IPS...nce) @classCode cs 1 … 1 F ACT @moodCode cs 1 … 1 R The @moodCode of the reference SHALL match the @moodCode of the referenced element   Variable let Name refMoodCode     Value @moodCode     Variable let Name refID     Value concat(hl7:id[1]/@root,'#',hl7:id[1]/@extension)     Variable let Name refCode     Value concat(hl7:code[1]/@code,'#',hl7:code[1]/@codeSystem)     Variable let Name reffedObject     Value (ancestor::hl7:ClinicalDocument//*:id[concat(@root,'#',@extension)=$refID][not(preceding-sibling::hl7:templateId/@root='1.3.6.1.4.1.19376.1.5.3.1.4.4.1')]/parent::*)[1]     Schematron assert role  error     test not(exists($reffedObject)) or $reffedObject[@moodCode=$refMoodCode]     Message The @moodCode of the reference SHALL match the @moodCode of the referenced element     Schematron assert role  error     test exists($reffedObject)     Message The root and extension attributes SHALL identify an element defined elsewhere in the same document.     Schematron assert role  error     test not(exists($reffedObject)) or ($reffedObject[not(*:code/@code)] and hl7:code[@nullFlavor='NA']) or $reffedObject/*:code[concat(@code,'#',@codeSystem)=$refCode]     Message The code of the reference SHALL match the code of the referenced element   hl7:templateId II 1 … 1 M (IPS...nce) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.31 hl7:id II 1 … 1 R This element shall be present. The root and extension attributes shall identify an element defined elsewhere in the same document. (IPS...nce) hl7:code CD 1 … 1 R This element shall be present. It shall be valued when the internal reference is to element that has a <code> element, and shall have the same attributes as the <code> element in the act it references. If the element it references does not have a <code> element, then the nullFlavor attribute should be set to "NA". (IPS...nce) @nullFlavor cs 0 … 1 F NA

IPS Laboratory Result Observation

Id	2.16.840.1.113883.10.22.4.13	Effective Date	2017‑03‑21
Status	Under pre-publication review	Version Label	STU1
Name	IPSLaboratoryResultObservation	Display Name	IPS Laboratory Result Observation
Description This template constrains the results of a clinical laboratory observation. The result observation includes a statusCode to allow recording the status of an observation. “Pending” results (e.g., a test has been run but results have not been reported yet) should be represented as “active” ActStatus.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.13
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Uses	Uses 2 templates Uses as Name Version 2.16.840.1.113883.10.22.4.14 Containment IPS Body Author (STU1) DYNAMIC 2.16.840.1.113883.10.22.4.22 Containment IPS Comment Activity (STU1) DYNAMIC
Relationship	Adaptation: template 2.16.840.1.113883.10.12.303 CDA Observation (2005‑09‑07) ref ad1bbr- Adaptation: template 2.16.840.1.113883.10.20.22.4.2 Result Observation (V3) (2015‑08‑01) ref ccda- Adaptation: template 2.16.840.1.113883.10.22.4.10 IPS Result Observation (2017‑03‑02)
Example	Example <observation classCode="OBS" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.13"/>  <id root="1.2.3.999" extension="--example only--"/>  <code codeSystem="2.16.840.1.113883.6.1" code="41995-2" displayName="Hemoglobin A1c [Mass/volume] in Blood"/>  <statusCode code="completed"/>  <effectiveTime>     <low value="20171113173215"/>  </effectiveTime>  <value xsi:type="PQ" value="4.8" unit="%"/>  <interpretationCode code="H" displayName="High" codeSystem="2.16.840.1.113883.5.83"/>  <author>     <!-- template 2.16.840.1.113883.10.22.4.14 'IPS Body Author' (dynamic) -->   </author>  <referenceRange>     <observationRange>       <value xsi:type="IVL_PQ">         <low value="1.5" unit="%"/>        <high value="4.5" unit="%"/>      </value>      <interpretationCode code="N" codeSystem="2.16.840.1.113883.5.83"/>    </observationRange>  </referenceRange>  <entryRelationship typeCode="COMP">     <!-- template 2.16.840.1.113883.10.22.4.22 'IPS Comment Activity' (dynamic) -->   </entryRelationship></observation>
Item DT Card Conf Description Label hl7:observation (IPS...ion) @classCode cs 1 … 1 F OBS @moodCode cs 1 … 1 F EVN hl7:templateId II 1 … 1 M (IPS...ion) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.13 hl7:id II 0 … * R (IPS...ion) hl7:code CD.IPS 1 … 1 M (IPS...ion)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.39 IPS Results Observation Laboratory (DYNAMIC) hl7:statusCode CS 1 … 1 M (IPS...ion)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.19890 x_ActStatusActiveComplete (DYNAMIC) hl7:effectiveTime IVL_TS 1 … 1 R (IPS...ion) Choice 1 … 1 Elements to choose from: hl7:value[@xsi:type='CE.IPS'] hl7:value[@xsi:type='PQ'] hl7:value[@xsi:type='IVL_PQ'] hl7:value[@xsi:type='ST'] hl7:value[@xsi:type='TS'] hl7:value[@xsi:type='RTO_QTY_QTY'] hl7:value CE.IPS (extensible) 0 … 1 R (IPS...ion) where [@xsi:type='CE.IPS']   CONF The value of @code should be drawn from value set 2.16.840.1.113883.11.22.46 IPS Results Coded Values Laboratory (DYNAMIC)   Example Blood group A+ from SNOMED CT <value xsi:type="CE" code="278149003" codeSystem="2.16.840.1.113883.6.96" displayName="Blood group A Rh(D) positive"/>   Example Germ susceptible to antimicrobial agent from HL7 vocabulary <value xsi:type="CE" code="S" codeSystem="2.16.840.1.113883.11.78" displayName="susceptible"/> hl7:value PQ 0 … 1 R (IPS...ion) where [@xsi:type='PQ']   Constraint If Observation/value is a physical quantity (xsi:type="PQ"), the unit of measure SHALL be selected from ValueSet UnitsOfMeasureCaseSensitive 2.16.840.1.113883.1.11.12839 DYNAMIC   Example Result physical quantity (data type PQ): 136 mmol per liter <value xsi:type="PQ" value="136" unit="mmol/L"/> hl7:value IVL_PQ 0 … 1 R (IPS...ion) where [@xsi:type='IVL_PQ']   Example Result interval of physical quantities (data type IVL_PQ): 150 - 400 Billion per 10 exp 9 liter <value xsi:type="IVL_PQ">   <low value="150" unit="10+9/l"/>  <high value="400" unit="10+9/l"/></value> hl7:value ST 0 … 1 R (IPS...ion) where [@xsi:type='ST']   Example Result free text (data type ST) <value xsi:type="ST">slight macrocytosis, check on alcohol consumption</value> hl7:value TS 0 … 1 R (IPS...ion) where [@xsi:type='TS']   Example Result time stamp (data type TS): 6-Aug-2014 <value xsi:type="TS" value="20140806"/> hl7:value RTO_QTY_QTY 0 … 1 R (IPS...ion) where [@xsi:type='RTO_QTY_QTY']   Example Result ratio (data type RTO_QTY_QTY): 1/179 <value xsi:type="RTO_QTY_QTY">   <numerator xsi:type="INT" value="1"/>  <denominator xsi:type="INT" value="179"/></value> hl7:interpretationCode CE.IPS 0 … 1 R (IPS...ion)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.78 ObservationInterpretation (DYNAMIC) hl7:author 0 … * R Contains 2.16.840.1.113883.10.22.4.14 IPS Body Author (DYNAMIC) (IPS...ion) hl7:referenceRange 0 … 1 R The referenceRange is constrained to represent the normal range for this observation and this patient. (IPS...ion) hl7:observationRange 1 … 1 M (IPS...ion) hl7:code CD NP (IPS...ion) hl7:value ANY 1 … 1 M (IPS...ion) hl7:interpretationCode CE.IPS 0 … 1 (IPS...ion) @code CONF 0 … 1 F N @codeSystem 0 … 1 F 2.16.840.1.113883.5.83 (Observation Interpretation) hl7:entryRelationship 0 … * Contains 2.16.840.1.113883.10.22.4.22 IPS Comment Activity (DYNAMIC) (IPS...ion) @typeCode cs 1 … 1 F COMP

IPS Manufactured Material

Id	2.16.840.1.113883.10.22.4.3	Effective Date	2021‑08‑02 16:52:27 Other versions this id: IPSMedMaterial as of 2016‑11‑10
Status	Draft	Version Label	2021
Name	IPSMedMaterial	Display Name	IPS Manufactured Material
Description This entry provides details about the medicinal product. Due to the current absence of global product identifiers the product is described through a set of identification and descriptive attributes (e.g. active substances, strength, unit of presentation,...)  that may be used to integrate jurisdictional product codes. This shortage will be likely overcome when the ISO IDMP identifiers will be available for concrete usage in the next years, as well as the globally used value sets for products attributes agreed by the ISO IDMP implemention guides. (e.g. GInAs for substances). Even though there is a quite common consensus about the attributes that should be provided in order to describe a medicine in the context of the international patient summary (e.g. the list of active substances, the strength(s); the administrable pharmaceutical forms;..), this template doesn't require any of them, recommending, above all for cross-borders services, to provide all the available information that could be helpful for the identification of medications Jurisdictions could specialize this template making some ofthese attributes required. It is also recognized that in many contexts structured information about the product, might not be available, and only textual information for describing products (e.g. the product scientific name "amoxicillin 400mg/5mL suspension”) or some of their attributes (e.g. textual strength "875 mg + 125 mg" ; "amoxycillin and clavulanic acid") could be used. This template attempts to provide a solution that takes in account this current complexity being also ready for including the future IDMP-based solution as soon as they will become available for concrete use. Since the CDA R2.0 model support only a very limited set of information about the products, extensions based on the R_ProductList (Common Product Model) CMET have been used for conveying such information, aiming to align this solution with that that will be likely used for the IDMP implementation Guide.
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 7 concepts Id Name Data Set hl7ips-data​element-105  Product Code  CEN/TC 251 prEN 17269 hl7ips-data​element-117  Brand Name  CEN/TC 251 prEN 17269 hl7ips-data​element-132  Substance code  CEN/TC 251 prEN 17269 hl7ips-data​element-133  Strength  CEN/TC 251 prEN 17269 hl7ips-data​element-170  Active ingredient List  CEN/TC 251 prEN 17269 hl7ips-data​element-171  Product Common Name (and Strength)  CEN/TC 251 prEN 17269 hl7ips-data​element-227  Pharmaceutical dose form  CEN/TC 251 prEN 17269
Relationship	Adaptation: template 2.16.840.1.113883.10.12.311 CDA Material (2005‑09‑07) ref ad1bbr- Adaptation: template 2.16.840.1.113883.3.1937.777.11.10.147 OpenMed Material (2016‑05‑10 22:43:03) ref epsos-
Example	Example <manufacturedMaterial>   <!-- Example with all the IDMP Levels (PhPID,MPID, PCID) and other product attributes (e.g. ingredients, ATC Code, strengths) -->   <templateId root="2.16.840.1.113883.10.22.4.3"/>  <code codeSystem="" code="MPID" displayName="" CodeSystemName="MP EMA"/>  <name>Medicinal Product Name</name>  <formCode codeSystem="0.4.0.127.0.16.1.1.2.1" code="10219000" displayName="tablet" CodeSystemName="EDQM"/>  <asContent>     <!-- Packaged Medicinal Product (PC) -->     <containerPackagedProduct>       <!-- PC ID-->       <code codeSystem=" " code="PCID" displayName=" "/>      <name>...</name>      <formCode codeSystem="0.4.0.127.0.16.1.1.2.1" code="" displayName="" CodeSystemName="EDQM"/>    </containerPackagedProduct>  </asContent>  <asSpecializedKind classCode="GRIC">     <!-- Pharmaceutical Substance (ATC Code)-->     <generalizedMaterialKind classCode="MMAT">       <!-- Pharmaceutical Substance (ATC Code)-->       <code code=" " codeSystem="2.16.840.1.113883.6.73" displayName=" " codeSystemName="WHO ATC"/>    </generalizedMaterialKind>  </asSpecializedKind>  <asSpecializedKind>     <!-- Pharmaceutical Product (PhP)-->     <generalizedMaterialKind classCode="MMAT">       <code code="PhPID" codeSystem=" " displayName=" " codeSystemName="PhP EMA"/>      <name>....</name>    </generalizedMaterialKind>  </asSpecializedKind>  <!-- list of active ingredients -->   <ingredient classCode="ACTI" determinerCode="KIND">     <quantity>       <!-- strength -->       <numerator type="PQ" value="20" unit="mg"/>      <denominator type="PQ" value="1" unit="{tablet}"/>    </quantity>    <ingredientSubstance>       <code codeSystem=" " code="SubstanceID" displayName=" " CodeSystemName="G-SRS"/>      <name>...</name>    </ingredientSubstance>  </ingredient></manufacturedMaterial>
Example	Example <manufacturedMaterial classCode="MMAT" determinerCode="KIND">   <templateId root="2.16.840.1.113883.10.22.4.3"/>  <code code="..." codeSystem="1.2.3.999"/>  <name>name</name>  <formCode code="10101000" displayName="Oral drops, solution" codeSystem="0.4.0.127.0.16.1.1.2.1"/>  <asContent classCode="CONT">     <containerPackagedProduct classCode="CONT" determinerCode="KIND">       <code/>      <name/>      <formCode code="..." displayName="..." codeSystem="0.4.0.127.0.16.1.1.2.1"/>      <capacityQuantity value="..." unit="..."/>      <asContent classCode="CONT">         <containerPackagedProduct classCode="CONT" determinerCode="KIND">           <code/>          <name/>          <formCode code="..." displayName="..." codeSystem="0.4.0.127.0.16.1.1.2.1"/>          <asContent classCode="CONT">             <containerPackagedProduct classCode="CONT" determinerCode="KIND">               <code/>              <name/>              <formCode code="..." displayName="..." codeSystem="0.4.0.127.0.16.1.1.2.1"/>            </containerPackagedProduct>          </asContent>        </containerPackagedProduct>      </asContent>    </containerPackagedProduct>  </asContent>  <asSpecializedKind classCode="GRIC">     <generalizedMaterialKind classCode="MMAT">       <code code="..." codeSystem="2.16.840.1.113883.6.73"/>      <name/>    </generalizedMaterialKind>  </asSpecializedKind>  <asSpecializedKind classCode="GRIC">     <generalizedMaterialKind classCode="MMAT">       <code/>      <name/>    </generalizedMaterialKind>  </asSpecializedKind>  <ingredient classCode="ACTI" determinerCode="KIND">     <quantity>       <numerator value="20" unit="mg"/>      <denominator value="100" unit="mL"/>    </quantity>    <ingredientSubstance>       <code/>      <name/>    </ingredientSubstance>  </ingredient></manufacturedMaterial>
Item DT Card Conf Description Label hl7:manufactured​Material 0 … * R (IPS...ial) @classCode cs 0 … 1 F MMAT @determiner​Code cs 0 … 1 F KIND hl7:templateId II 1 … 1 M (IPS...ial) @root oid 1 … 1 F 2.16.840.1.113883.10.22.4.3 hl7:code CE.IPS 0 … 1 R This element is generally used to identify a medicinal product. When the IDMP identifiers will be concretely available for usage this element will be used for conveying the Medicinal Product Identifier (MPID). For the time being, it could be optionally used for conveying jurisdictional or agreed cross jurisdictional medicinal product code. (IPS...ial)   hl7ips-data​element-105  Product Code  CEN/TC 251 prEN 17269 hl7:name EN 0 … 1 R This element is supposed to be valorized with the complete Medicinal Product Name as approved by the Medicines Regulatory Agency in a jurisdiction. The name may be applicable in one or more country/language combinations. (IPS...ial)   hl7ips-data​element-117  Brand Name  CEN/TC 251 prEN 17269 hl7ips-data​element-171  Product Common Name (and Strength)  CEN/TC 251 prEN 17269 pharm:formCode CE.IPS 0 … 1 R Administrable Pharmaceutical Dose Form. This code represents the form of the medication (e.g. tablet, capsule, liquid) Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected  as referecne terminology for representing Pharmaceutical Dose forms;Pakages and Route of Administration. It is known that also alternative jurisdictional and international terminologies are known to be used for this concept domain, as NCI or SNOMED CT. (IPS...ial)   hl7ips-data​element-227  Pharmaceutical dose form  CEN/TC 251 prEN 17269   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.25 Medicine Doseform (DYNAMIC)   Example <formCode code="10211000" codeSystem="0.4.0.127.0.16.1.1.2.1" codeSystemName="EDQM" displayName="Capsule, soft">...</formCode> pharm:asContent 0 … * This structure describes the packaging of the medication. The <pharm:formCode> element provides the code for the particular package. If the package has a brand name, it can be described in the <pharm:name> element. The <pharm:capacity​Quantity> element describes the capacity of the packaging, while the <pharm:quantity> the actual quantity of inner packaged items in the outer packaging container. The product might have a single (30 pills bottle) or multiple (5 vials 10 ml; box with 2 blisters of 20 tablets) layers of packaging. In the latter case, the most inner (nested) item represents the most outer package item. For example the case    \--Box    \-----2 blisters    \--------20 tablets  is described as "20 tablets" contained by "a blister"; "2 blisters" contained by one box. The most inner package represents the Packaged Medicinal Product. When the IDMP Packaged Medicinal Product ID (PCID) will become actually available for usage, the most inner package <code> element will be used to convey the IDMP PCID. (IPS...ial) @classCode cs 1 … 1 F CONT   Example Packaged Medicinal Product with multiple layers packaging <asContent>   <containerPackagedProduct>     <!-- Inner Package -->     <code codeSystem="..." code="..." displayName="..."/>    <asContent>       <containerPackagedProduct>         <!-- Intermediate Package -->         <asContent>           <containerPackagedProduct>             <!-- Outer Package / Packaged Medicinal Product -->           </containerPackagedProduct>        </asContent>      </containerPackagedProduct>    </asContent>  </containerPackagedProduct></asContent>   Example Packaged Medicinal Product with formCode <asContent>   <containerPackagedProduct>     <!-- Packaged Medicinal Product -->     <code codeSystem="1.999.999" code="PC_ID" displayName="Packaged Product Name"/>    <name>100 MIRACLE PILLS(TM)</name>    <formCode codeSystem="0.4.0.127.0.16.1.1.2.1" code="30009000" displayName="Box" CodeSystemName="EDQM"/>  </containerPackagedProduct></asContent> pharm:quantity PQ 0 … 1 The quantity which specified how many inner packaged content entities are in an outer packaging container entity. (IPS...ial) @unit cs 0 … 1     CONF The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) @value 1 … 1 R   Example <quantity value="20" unit="{tablet}"/>   Example <quantity value="10" unit="mL"/> pharm:containerPackagedProduct 1 … 1 R It represents the most inner Package Item or the Packaged Medicinal Product. (IPS...ial) @classCode cs 1 … 1 F CONT @determiner​Code cs 1 … 1 F KIND pharm:code 0 … 1 If this is also the most outer <pharm:containerPackagedProduct> than the <code> element can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).   The presence of the PCID indicates that that element represents the "Packaged Medicinal Product". (IPS...ial) pharm:name ST 0 … 1 It represents the Name of the Package Item or of the Packaged Medicinal Product. If this is also the most outer <pharm:containerPackagedProduct> than this element can be used for the brand name. (IPS...ial)   hl7ips-data​element-117  Brand Name  CEN/TC 251 prEN 17269   Example <name>AMOXIFEN(R) 20 compresse 20 mg</name> pharm:formCode CE.IPS 0 … 1 R This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product. Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected  as referecne terminology for representing Pharmaceutical Dose forms; Packages and Route of Administration. (IPS...ial)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC)   Example <formCode code="30007000" codeSystem="0.4.0.127.0.16.1.1.2.1" codeSystemName="EDQM" codeSystemVersion="2010" displayName="Blister">...</formCode> pharm:capacity​Quantity PQ 0 … 1 It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml. (IPS...ial) @unit cs 0 … 1     CONF The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) @value 1 … 1 R pharm:asContent 0 … * R In case of multiple layers of packaging (5 vials 10 ml; box with 2 blisters of 20 tablets) this element can be used for describing the intermediate Packaged Medicinal Product Item or the Packaged Medicinal Product. For example in the case    \--Box    \-----2 blisters    \--------20 tablets  it describes the "2 blisters"  In the case of    \--Box    \-----5 vials it represents the Packaged Medicinal Product.  (IPS...ial) @classCode cs 1 … 1 F CONT pharm:quantity PQ 0 … 1 R The quantity which specified how many inner packaged content entities are in an outer packaging container entity. (IPS...ial) @unit cs 0 … 1     CONF The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) @value 1 … 1 R   Example <quantity value="20" unit="{tablet}"/>   Example <quantity value="10" unit="mL"/> pharm:containerPackagedProduct 1 … 1 R It represents the intermediate Package Item or the Packaged Medicinal Product (IPS...ial) @classCode cs 1 … 1 F CONT @determiner​Code cs 1 … 1 F KIND pharm:code CD.IPS 0 … 1 If this is also the most inner  <pharm:containerPackagedProduct> than the <code> element can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).   The presence of the PCID indicates that that element represents the "Packaged Medicinal Product". (IPS...ial) pharm:name ST 0 … 1 R It represents the Name of the Package Item or of the Packaged Medicinal Product If this is also the most inner  <pharm:containerPackagedProduct> than this element can be used for the brand name. (IPS...ial)   Example <name>...</name> pharm:formCode CE.IPS 1 … 1 R This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product. Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected  as reference terminology for representing Pharmaceutical Dose forms; Packages and Route of Administration. (IPS...ial)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC) pharm:capacity​Quantity PQ 0 … 1 It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml. (IPS...ial) @unit cs 0 … 1     CONF The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) @value 1 … 1 R pharm:asContent 0 … * R In case of multiple layers of packaging (box with 2 blisters of 20 tablets) this element is used for describing the most outer Packaged Medicinal Product Item or the Packaged Medicinal Product. For example in the case    \--Box    \-----2 blisters    \--------20 tablets  it describes the Packaged Medicinal Product.  (IPS...ial) @classCode cs 1 … 1 F CONT pharm:quantity PQ 0 … 1 R The quantity which specified how many inner packaged content entities are in an outer packaging container entity. (IPS...ial) @unit cs 0 … 1     CONF The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) @value 1 … 1 R   Example <quantity value="20" unit="{tablet}"/>   Example <quantity value="10" unit="mL"/> pharm:containerPackagedProduct 1 … 1 R When present, it represents the Packaged Medicinal Product (IPS...ial) @classCode cs 1 … 1 F CONT @determiner​Code cs 1 … 1 F KIND pharm:code CD.IPS 0 … 1 When present, it can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage). (IPS...ial) pharm:name ST 0 … 1 R When present, it can be used for the representing the brand name. (IPS...ial) pharm:formCode CE.IPS 1 … 1 R When present, it encodes the type of the outer package. Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected  as referecne terminology for representing Pharmaceutical Dose forms; Packages and Route of Administration. (IPS...ial)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC) pharm:capacity​Quantity PQ 0 … 1 It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml. (IPS...ial) @unit cs 0 … 1     CONF The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) @value 1 … 1 R pharm:asSpecializedKind 0 … 1 R This module is used for representing the classification of the Substance according to the WHO Anatomical Therapeutic Chemical (ATC) Classification System. The classCode of "GRIC" identifies this structure as the representation of a generic equivalent of the medication described in the current Medicine entry. (IPS...ial) where [generalizedMaterialKind/code/@codeSystem='2.16.840.1.113883.6.73'] @classCode cs 1 … 1 F GRIC   Example <asSpecializedKind classCode="GRIC">   <generalizedMaterialKind classCode="MMAT">     <!-- Pharmaceutical Substance (ATC Code)-->     <code code=" " codeSystem="2.16.840.1.113883.6.73" displayName=" " codeSystemName="WHO ATC"/>  </generalizedMaterialKind></asSpecializedKind> pharm:generalizedMaterialKind 1 … 1 M (IPS...ial) @classCode cs 1 … 1 F MMAT pharm:code CD.IPS 1 … 1 R The element contains the ATC code of this medicine. (IPS...ial)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.29 WHO ATC (DYNAMIC)   Example <code codeSystem="2.16.840.1.113883.6.73" code=" " displayName=" " codeSystemName="WHO ATC"/> pharm:name 0 … * (IPS...ial) pharm:asSpecializedKind 0 … * R The Medicinal Product can be classified according to various classification systems, which may be jurisdictional or international. The classification system itself is specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. When the IDMP Pharmaceutical Product Identifier(s) (PhPID Set) will become actually available for use, the PhPID will be represented by the generalizedMaterialKind/code element. (IPS...ial) @classCode cs 1 … 1 F GRIC   Example <asSpecializedKind classCode="GRIC">   <generalizedMaterialKind classCode="MMAT">     <code code="PhPID_Lvl1" codeSystem="1.999.999" displayName="Pharmaceutical Product Name" codeSystemName="PhPID Level 1"/>    <name/>  </generalizedMaterialKind></asSpecializedKind> pharm:generalizedMaterialKind R (IPS...ial) @classCode cs 1 … 1 F MMAT pharm:code CD.IPS 1 … 1 R When the IDMP Pharmaceutical Product Identifier(s) (PhPID Set) will become actually available for use, this element will be used for representing the IDMP PhP Id. The level and the stratum of the PhPID will be distiguished by the OID of the code system. (IPS...ial) pharm:name 0 … * R (IPS...ial)   hl7ips-data​element-171  Product Common Name (and Strength)  CEN/TC 251 prEN 17269 pharm:ingredient 0 … * R This module provides the list of the ingredients (substances with a role) used for this product; one or more ingredients may be present. The classCode of "ACTI" indicates that this is an active ingredient. (IPS...ial)   hl7ips-data​element-170  Active ingredient List  CEN/TC 251 prEN 17269 @classCode cs 1 … 1 R   CONF The value of @classCode shall be drawn from value set 2.16.840.1.113883.1.11.10430 RoleClassIngredientEntity (DYNAMIC) pharm:quantity 1 … 1 M The medication strength is represented as the ratio of the active ingredient(s) to a unit of medication. The <quantity> element contains the numerator and denominator of the strength ratio.</quantity> (IPS...ial)   hl7ips-data​element-133  Strength  CEN/TC 251 prEN 17269   Example <quantity>...</quantity> hl7:numerator PQ 1 … 1 R (IPS...ial) @unit cs 1 … 1 R   CONF The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.30 Medicine Strength Numerator (DYNAMIC) @value 1 … 1 R hl7:denominator PQ 1 … 1 R (IPS...ial) @unit cs 1 … 1 R   CONF The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.31 Medicine Strength Denominator (DYNAMIC) @value 1 … 1 R pharm:ingredientSubstance 1 … 1 R (IPS...ial) @classCode cs 1 … 1 F MMAT @determiner​Code cs 1 … 1 F KIND pharm:code CD.IPS (extensible) 0 … 1 C The IDMP ISO 11238 standard addresses the identification and exchange of regulated information on substances.  The Global Ingredient Archival System (GInAS)  will provide a common global identifier for all of the substances used in medicinal products, providing a definition of substances globally consistent with this standard. Those identifiers however are yet available for concrete usage, therefore in this version of the template, SNOMED CT has been chosen as reference terminology also for the active substances. This choice will be revised based on the availability and the maturity of GInAS. (IPS...ial)   hl7ips-data​element-132  Substance code  CEN/TC 251 prEN 17269   CONF The value of @code should be drawn from value set 2.16.840.1.113883.11.22.32 Medicine Active Substances (DYNAMIC) hl7:originalText ED 0 … * (IPS...ial) hl7:reference TEL 0 … * (IPS...ial) hl7:translation CD 0 … * This element can be used to provide alternative identifications for the described substance. (IPS...ial) pharm:name 0 … 1 C Name of the substance (IPS...ial)   Schematron assert role  error     test pharm:code or pharm:name     Message Either the name or the code of the substance (or both) shall be provided

IPS Medical Device

Id	2.16.840.1.113883.10.22.4.26	Effective Date	2017‑04‑11
Status	Under pre-publication review	Version Label	STU1
Name	IPSMedicalDevice	Display Name	IPS Medical Device
Description	The medical devices entry content module describes the kind of device that is, or has been used by the patient
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.26
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 6 concepts Id Name Data Set hl7ips-data​element-150  Use end date  CEN/TC 251 prEN 17269 hl7ips-data​element-218  Device content Status  CEN/TC 251 prEN 17269 hl7ips-data​element-57  Device  CEN/TC 251 prEN 17269 hl7ips-data​element-58  Device Type  CEN/TC 251 prEN 17269 hl7ips-data​element-59  Use start date  CEN/TC 251 prEN 17269 hl7ips-data​element-60  Device Identifier  CEN/TC 251 prEN 17269
Relationship	Adaptation: template 1.3.6.1.4.1.12559.11.10.1.3.1.3.5 Medical Devices (2013‑12‑20) ref epsos-
Example	Example <supply moodCode="EVN" classCode="SPLY">   <templateId root="2.16.840.1.113883.10.22.4.26"/>  <id root="2.16.840.1.113883.19.811.3"/>  <text>     <reference value="#dev_1"/>  </text>  <effectiveTime xsi:type="IVL_TS">     <low value="20070728"/>  </effectiveTime>  <participant typeCode="DEV">     <participantRole classCode="MANU">       <id/>      <playingDevice classCode="DEV" determinerCode="INSTANCE">         <code code="304184000" displayName="Ankle joint implant" codeSystem="2.16.840.1.113883.6.96"/>      </playingDevice>    </participantRole>  </participant></supply>
Item DT Card Conf Description Label hl7:supply R The <supply> element shall be present. The moodCode attribute shall be EVN to reflect that a medical device has been provided.</supply> (IPS...ice) @classCode cs 1 … 1 F SPLY @moodCode cs 1 … 1 F EVN hl7:templateId II 1 … 1 M (IPS...ice) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.26 hl7:id II 0 … * R This optional element identifies the provision of the device (e.g. implant procedure) (IPS...ice) hl7:text ED 0 … 1 R (IPS...ice) hl7:reference TEL 1 … 1 M (IPS...ice) @value 1 … 1 R Reference pointing to the narrative, typically #{label}-{generated-id}, e.g. #xxx-1 hl7:effectiveTime IVL_TS 1 … 1 R This element provides the interval of time corresponding to the device usage by/presence in the patient. (IPS...ice) @xsi:type 1 … 1 F IVL_TS hl7:low TS 1 … 1 R The lower bound of the interval represents the start date/time. (IPS...ice)   hl7ips-data​element-59  Use start date  CEN/TC 251 prEN 17269 hl7:high TS 0 … 1 C The upper bound represents the end date/time. If it is not present, the device is still used by or present in the patient. (IPS...ice)   hl7ips-data​element-150  Use end date  CEN/TC 251 prEN 17269 hl7:participant 1 … * R The device is represented as a participant in the supply structure. The following descriptions apply to the device structure. (IPS...ice)   hl7ips-data​element-57  Device  CEN/TC 251 prEN 17269 @typeCode cs 1 … 1 F DEV   Example <participant typeCode="DEV">   <participantRole classCode="MANU">     <id root="1.2.3.999" extension="__example_only__"/>    <playingDevice classCode="DEV" determinerCode="INSTANCE">       <code code="" codeSystem=""/>      <!-- ... -->     </playingDevice>  </participantRole></participant>   Example Presence of implanted device not known (situation) <participant typeCode="DEV">   <participantRole classCode="MANU">     <playingDevice>       <code code="000000" codeSystem="2.16.840.1.113883.6.96" displayName="Presence of implanted device not known (situation)"/>    </playingDevice>    <scopingEntity>       <id root="2.16.840.1.113883.3.3719"/>    </scopingEntity>  </participantRole></participant>   Example No implant in situ (situation) <participant typeCode="DEV">   <participantRole classCode="MANU">     <playingDevice>       <code code="000000" codeSystem="2.16.840.1.113883.6.96" displayName="No implant in situ (situation)"/>    </playingDevice>    <scopingEntity>       <id root="2.16.840.1.113883.3.3719"/>    </scopingEntity>  </participantRole></participant> hl7:participantRole 1 … 1 R (IPS...ice) @classCode cs 1 … 1 F MANU hl7:id II 0 … * R The device ID, e.g. using UDI, is represented by the id element of the participant role. This element is optional, as not all production identifiers (e.g., serial number, lot/batch number, distinct identification number) may be known to the provider or patient. (IPS...ice)   hl7ips-data​element-60  Device Identifier  CEN/TC 251 prEN 17269   Example UDI GS1: DeviceIdentifier 00844588003288, Serial# 10987654d321, Lot# 7654321D <id root="2.16.840.1.113883.3.3719" extension="{01}00844588003288{17}141120{10}7654321D{21}10987654d321"/>   Example UDI ICCBBA: DeviceIdentifier 00844588003288 <id root="2.16.840.1.113883.3.3719" extension="A9999XYZ100T0474"/>   Example UDI HIBCC: Serial# XYZ456789012345678, Lot# LOT123456789012345 <id root="2.16.840.1.113883.3.3719" extension="+H123PARTNO1234567890120/$$420020216LOT123456789012345/SXYZ456789012345678/16D20130202C"/> hl7:playingDevice 1 … 1 R The playingDevice element describes the device instance.  (IPS...ice) @classCode cs 1 … 1 F DEV @determiner​Code cs 1 … 1 F INSTANCE hl7:code CE.IPS (preferred) 1 … 1 R The device code describes the type of device (e.g. arm prosthesis, arterial stent). (IPS...ice)   hl7ips-data​element-218  Device content Status  CEN/TC 251 prEN 17269 hl7ips-data​element-58  Device Type  CEN/TC 251 prEN 17269   CONF The value of @code comes preferably from value set 2.16.840.1.113883.11.22.23 IPS Medical Devices (DYNAMIC) or The value of @code comes preferably from value set 2.16.840.1.113883.11.22.61 Absent or Unknown Devices (DYNAMIC)

IPS Medication Information (detail)

Id	2.16.840.1.113883.10.22.4.2	Effective Date	2016‑11‑10
Status	Under pre-publication review	Version Label	STU1
Name	IPSManufacturedProduct	Display Name	IPS Medication Information (detail)
Description	This entry describes the consumable subject of the medication statement. All the information about the medication is provided in the included IPS Manufactured Material template.
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 1 concept Id Name Data Set hl7ips-data​element-2  Medicinal Product  CEN/TC 251 prEN 17269
Uses	Uses 1 template Uses as Name Version 2.16.840.1.113883.10.22.4.3 Include IPS Manufactured Material (2021) DYNAMIC
Relationship	Adaptation: template 2.16.840.1.113883.10.12.312 CDA ManufacturedProduct (2005‑09‑07) ref ad1bbr- Specialization: template 2.16.840.1.113883.10.21.4.11 UV Medication Information (detail) (DYNAMIC) ref pharmcda-
Example	Example <manufacturedProduct classCode="MANU">   <templateId root="2.16.840.1.113883.10.22.4.2"/>  <!-- include template 2.16.840.1.113883.10.22.4.3 'IPS Manufactured Material' (dynamic) 1..1 R --> </manufacturedProduct>
Item DT Card Conf Description Label hl7:manufacturedProduct 0 … * R (IPS...uct)   hl7ips-data​element-2  Medicinal Product  CEN/TC 251 prEN 17269 @classCode cs 0 … 1 F MANU hl7:templateId II 1 … 1 M (IPS...uct) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.2 Included 1 … 1 R from 2.16.840.1.113883.10.22.4.3 IPS Manufactured Material (DYNAMIC) hl7:manufactured​Material 1 … 1 R (IPS...uct) @classCode cs 0 … 1 F MMAT @determiner​Code cs 0 … 1 F KIND hl7:templateId II 1 … 1 M (IPS...uct) @root oid 1 … 1 F 2.16.840.1.113883.10.22.4.3 hl7:code CE.IPS 0 … 1 R This element is generally used to identify a medicinal product. When the IDMP identifiers will be concretely available for usage this element will be used for conveying the Medicinal Product Identifier (MPID). For the time being, it could be optionally used for conveying jurisdictional or agreed cross jurisdictional medicinal product code. (IPS...uct)   hl7ips-data​element-105  Product Code  CEN/TC 251 prEN 17269 hl7:name EN 0 … 1 R This element is supposed to be valorized with the complete Medicinal Product Name as approved by the Medicines Regulatory Agency in a jurisdiction. The name may be applicable in one or more country/language combinations. (IPS...uct)   hl7ips-data​element-117  Brand Name  CEN/TC 251 prEN 17269 hl7ips-data​element-171  Product Common Name (and Strength)  CEN/TC 251 prEN 17269 pharm:formCode CE.IPS 0 … 1 R Administrable Pharmaceutical Dose Form. This code represents the form of the medication (e.g. tablet, capsule, liquid) Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected  as referecne terminology for representing Pharmaceutical Dose forms;Pakages and Route of Administration. It is known that also alternative jurisdictional and international terminologies are known to be used for this concept domain, as NCI or SNOMED CT. (IPS...uct)   hl7ips-data​element-227  Pharmaceutical dose form  CEN/TC 251 prEN 17269   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.25 Medicine Doseform (DYNAMIC)   Example <formCode code="10211000" codeSystem="0.4.0.127.0.16.1.1.2.1" codeSystemName="EDQM" displayName="Capsule, soft">...</formCode> pharm:asContent 0 … * This structure describes the packaging of the medication. The <pharm:formCode> element provides the code for the particular package. If the package has a brand name, it can be described in the <pharm:name> element. The <pharm:capacity​Quantity> element describes the capacity of the packaging, while the <pharm:quantity> the actual quantity of inner packaged items in the outer packaging container. The product might have a single (30 pills bottle) or multiple (5 vials 10 ml; box with 2 blisters of 20 tablets) layers of packaging. In the latter case, the most inner (nested) item represents the most outer package item. For example the case    \--Box    \-----2 blisters    \--------20 tablets  is described as "20 tablets" contained by "a blister"; "2 blisters" contained by one box. The most inner package represents the Packaged Medicinal Product. When the IDMP Packaged Medicinal Product ID (PCID) will become actually available for usage, the most inner package <code> element will be used to convey the IDMP PCID. (IPS...uct) @classCode cs 1 … 1 F CONT   Example Packaged Medicinal Product with multiple layers packaging <asContent>   <containerPackagedProduct>     <!-- Inner Package -->     <code codeSystem="..." code="..." displayName="..."/>    <asContent>       <containerPackagedProduct>         <!-- Intermediate Package -->         <asContent>           <containerPackagedProduct>             <!-- Outer Package / Packaged Medicinal Product -->           </containerPackagedProduct>        </asContent>      </containerPackagedProduct>    </asContent>  </containerPackagedProduct></asContent>   Example Packaged Medicinal Product with formCode <asContent>   <containerPackagedProduct>     <!-- Packaged Medicinal Product -->     <code codeSystem="1.999.999" code="PC_ID" displayName="Packaged Product Name"/>    <name>100 MIRACLE PILLS(TM)</name>    <formCode codeSystem="0.4.0.127.0.16.1.1.2.1" code="30009000" displayName="Box" CodeSystemName="EDQM"/>  </containerPackagedProduct></asContent> pharm:quantity PQ 0 … 1 The quantity which specified how many inner packaged content entities are in an outer packaging container entity. (IPS...uct) @unit cs 0 … 1     CONF The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) @value 1 … 1 R   Example <quantity value="20" unit="{tablet}"/>   Example <quantity value="10" unit="mL"/> pharm:containerPackagedProduct 1 … 1 R It represents the most inner Package Item or the Packaged Medicinal Product. (IPS...uct) @classCode cs 1 … 1 F CONT @determiner​Code cs 1 … 1 F KIND pharm:code 0 … 1 If this is also the most outer <pharm:containerPackagedProduct> than the <code> element can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).   The presence of the PCID indicates that that element represents the "Packaged Medicinal Product". (IPS...uct) pharm:name ST 0 … 1 It represents the Name of the Package Item or of the Packaged Medicinal Product. If this is also the most outer <pharm:containerPackagedProduct> than this element can be used for the brand name. (IPS...uct)   hl7ips-data​element-117  Brand Name  CEN/TC 251 prEN 17269   Example <name>AMOXIFEN(R) 20 compresse 20 mg</name> pharm:formCode CE.IPS 0 … 1 R This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product. Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected  as referecne terminology for representing Pharmaceutical Dose forms; Packages and Route of Administration. (IPS...uct)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC)   Example <formCode code="30007000" codeSystem="0.4.0.127.0.16.1.1.2.1" codeSystemName="EDQM" codeSystemVersion="2010" displayName="Blister">...</formCode> pharm:capacity​Quantity PQ 0 … 1 It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml. (IPS...uct) @unit cs 0 … 1     CONF The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) @value 1 … 1 R pharm:asContent 0 … * R In case of multiple layers of packaging (5 vials 10 ml; box with 2 blisters of 20 tablets) this element can be used for describing the intermediate Packaged Medicinal Product Item or the Packaged Medicinal Product. For example in the case    \--Box    \-----2 blisters    \--------20 tablets  it describes the "2 blisters"  In the case of    \--Box    \-----5 vials it represents the Packaged Medicinal Product.  (IPS...uct) @classCode cs 1 … 1 F CONT pharm:quantity PQ 0 … 1 R The quantity which specified how many inner packaged content entities are in an outer packaging container entity. (IPS...uct) @unit cs 0 … 1     CONF The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) @value 1 … 1 R   Example <quantity value="20" unit="{tablet}"/>   Example <quantity value="10" unit="mL"/> pharm:containerPackagedProduct 1 … 1 R It represents the intermediate Package Item or the Packaged Medicinal Product (IPS...uct) @classCode cs 1 … 1 F CONT @determiner​Code cs 1 … 1 F KIND pharm:code CD.IPS 0 … 1 If this is also the most inner  <pharm:containerPackagedProduct> than the <code> element can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage).   The presence of the PCID indicates that that element represents the "Packaged Medicinal Product". (IPS...uct) pharm:name ST 0 … 1 R It represents the Name of the Package Item or of the Packaged Medicinal Product If this is also the most inner  <pharm:containerPackagedProduct> than this element can be used for the brand name. (IPS...uct)   Example <name>...</name> pharm:formCode CE.IPS 1 … 1 R This element encodes the type of the most inner package item or of the or the Packaged Medicinal Product. Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected  as reference terminology for representing Pharmaceutical Dose forms; Packages and Route of Administration. (IPS...uct)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC) pharm:capacity​Quantity PQ 0 … 1 It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml. (IPS...uct) @unit cs 0 … 1     CONF The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) @value 1 … 1 R pharm:asContent 0 … * R In case of multiple layers of packaging (box with 2 blisters of 20 tablets) this element is used for describing the most outer Packaged Medicinal Product Item or the Packaged Medicinal Product. For example in the case    \--Box    \-----2 blisters    \--------20 tablets  it describes the Packaged Medicinal Product.  (IPS...uct) @classCode cs 1 … 1 F CONT pharm:quantity PQ 0 … 1 R The quantity which specified how many inner packaged content entities are in an outer packaging container entity. (IPS...uct) @unit cs 0 … 1     CONF The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) @value 1 … 1 R   Example <quantity value="20" unit="{tablet}"/>   Example <quantity value="10" unit="mL"/> pharm:containerPackagedProduct 1 … 1 R When present, it represents the Packaged Medicinal Product (IPS...uct) @classCode cs 1 … 1 F CONT @determiner​Code cs 1 … 1 F KIND pharm:code CD.IPS 0 … 1 When present, it can be used to convey the (IDMP) Packaged Medicinal Product ID (e.g. the IDMP PCID when it will become actually available for usage). (IPS...uct) pharm:name ST 0 … 1 R When present, it can be used for the representing the brand name. (IPS...uct) pharm:formCode CE.IPS 1 … 1 R When present, it encodes the type of the outer package. Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected  as referecne terminology for representing Pharmaceutical Dose forms; Packages and Route of Administration. (IPS...uct)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.27 Medicine Package (DYNAMIC) pharm:capacity​Quantity PQ 0 … 1 It represents the functional capacity of the container: e.g. bottle containing up to 20 tablets or ampule of 10 ml. (IPS...uct) @unit cs 0 … 1     CONF The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.28 Quantity Units (DYNAMIC) @value 1 … 1 R pharm:asSpecializedKind 0 … 1 R This module is used for representing the classification of the Substance according to the WHO Anatomical Therapeutic Chemical (ATC) Classification System. The classCode of "GRIC" identifies this structure as the representation of a generic equivalent of the medication described in the current Medicine entry. (IPS...uct) where [generalizedMaterialKind/code/@codeSystem='2.16.840.1.113883.6.73'] @classCode cs 1 … 1 F GRIC   Example <asSpecializedKind classCode="GRIC">   <generalizedMaterialKind classCode="MMAT">     <!-- Pharmaceutical Substance (ATC Code)-->     <code code=" " codeSystem="2.16.840.1.113883.6.73" displayName=" " codeSystemName="WHO ATC"/>  </generalizedMaterialKind></asSpecializedKind> pharm:generalizedMaterialKind 1 … 1 M (IPS...uct) @classCode cs 1 … 1 F MMAT pharm:code CD.IPS 1 … 1 R The element contains the ATC code of this medicine. (IPS...uct)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.29 WHO ATC (DYNAMIC)   Example <code codeSystem="2.16.840.1.113883.6.73" code=" " displayName=" " codeSystemName="WHO ATC"/> pharm:name 0 … * (IPS...uct) pharm:asSpecializedKind 0 … * R The Medicinal Product can be classified according to various classification systems, which may be jurisdictional or international. The classification system itself is specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. When the IDMP Pharmaceutical Product Identifier(s) (PhPID Set) will become actually available for use, the PhPID will be represented by the generalizedMaterialKind/code element. (IPS...uct) @classCode cs 1 … 1 F GRIC   Example <asSpecializedKind classCode="GRIC">   <generalizedMaterialKind classCode="MMAT">     <code code="PhPID_Lvl1" codeSystem="1.999.999" displayName="Pharmaceutical Product Name" codeSystemName="PhPID Level 1"/>    <name/>  </generalizedMaterialKind></asSpecializedKind> pharm:generalizedMaterialKind R (IPS...uct) @classCode cs 1 … 1 F MMAT pharm:code CD.IPS 1 … 1 R When the IDMP Pharmaceutical Product Identifier(s) (PhPID Set) will become actually available for use, this element will be used for representing the IDMP PhP Id. The level and the stratum of the PhPID will be distiguished by the OID of the code system. (IPS...uct) pharm:name 0 … * R (IPS...uct)   hl7ips-data​element-171  Product Common Name (and Strength)  CEN/TC 251 prEN 17269 pharm:ingredient 0 … * R This module provides the list of the ingredients (substances with a role) used for this product; one or more ingredients may be present. The classCode of "ACTI" indicates that this is an active ingredient. (IPS...uct)   hl7ips-data​element-170  Active ingredient List  CEN/TC 251 prEN 17269 @classCode cs 1 … 1 R   CONF The value of @classCode shall be drawn from value set 2.16.840.1.113883.1.11.10430 RoleClassIngredientEntity (DYNAMIC) pharm:quantity 1 … 1 M The medication strength is represented as the ratio of the active ingredient(s) to a unit of medication. The <quantity> element contains the numerator and denominator of the strength ratio.</quantity> (IPS...uct)   hl7ips-data​element-133  Strength  CEN/TC 251 prEN 17269   Example <quantity>...</quantity> hl7:numerator PQ 1 … 1 R (IPS...uct) @unit cs 1 … 1 R   CONF The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.30 Medicine Strength Numerator (DYNAMIC) @value 1 … 1 R hl7:denominator PQ 1 … 1 R (IPS...uct) @unit cs 1 … 1 R   CONF The value of @unit shall be drawn from value set 2.16.840.1.113883.11.22.31 Medicine Strength Denominator (DYNAMIC) @value 1 … 1 R pharm:ingredientSubstance 1 … 1 R (IPS...uct) @classCode cs 1 … 1 F MMAT @determiner​Code cs 1 … 1 F KIND pharm:code CD.IPS (extensible) 0 … 1 C The IDMP ISO 11238 standard addresses the identification and exchange of regulated information on substances.  The Global Ingredient Archival System (GInAS)  will provide a common global identifier for all of the substances used in medicinal products, providing a definition of substances globally consistent with this standard. Those identifiers however are yet available for concrete usage, therefore in this version of the template, SNOMED CT has been chosen as reference terminology also for the active substances. This choice will be revised based on the availability and the maturity of GInAS. (IPS...uct)   hl7ips-data​element-132  Substance code  CEN/TC 251 prEN 17269   CONF The value of @code should be drawn from value set 2.16.840.1.113883.11.22.32 Medicine Active Substances (DYNAMIC) hl7:originalText ED 0 … * (IPS...uct) hl7:reference TEL 0 … * (IPS...uct) hl7:translation CD 0 … * This element can be used to provide alternative identifications for the described substance. (IPS...uct) pharm:name 0 … 1 C Name of the substance (IPS...uct)   Schematron assert role  error     test pharm:code or pharm:name     Message Either the name or the code of the substance (or both) shall be provided

IPS Medication Statement

Id	2.16.840.1.113883.10.22.4.4	Effective Date	2021‑09‑02 12:17:54 Other versions this id: IPSMedicationStatement as of 2016‑11‑11
Status	Draft	Version Label	2021
Name	IPSMedicationStatement	Display Name	IPS Medication Statement
Description An IPS Medication entry describes a medication statement, that is a substance administration that has actually occurred (e.g., pills ingested or injections given) or are intended to occur (e.g., "take 2 tablets twice a day for the next 10 days"). Medication activities in "INT" mood are reflections of what a clinician intends a patient to be taking. For example, a clinician may intend that a patient to be administered Lisinopril 20 mg PO for blood pressure control. If what was actually administered was Lisinopril 10 mg., then the Medication activities in the "EVN" mood would reflect actual use. The source of this information can be the patient, significant other (such as a family member or spouse), or a clinician. A common scenario where this information is captured is during the history taking process during a patient visit or stay, but it could be derived from the medications information recorded into a GP's EHR-system, in form of prescribed medication, or administration statements. The medication information may come from sources such as the patient's memory, from a prescription bottle, or from a list of medications the patient, clinician or other party maintains. A medication statement is usually less specific than an a prescription or a medication administration record.   This entry is composed by a main substanceAdministration act and a subordinate substanceAdministration act, unless it is asserted that there are no medications data.  The first conveys information as the product, the period of administration and the route of administration; the latter is used to provide dosage information as the frequency of intakes or the amount of the medication given.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.4
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 3 concepts Id Name Data Set hl7ips-data​element-102  Route of administration  CEN/TC 251 prEN 17269 hl7ips-data​element-104  Medication  CEN/TC 251 prEN 17269 hl7ips-data​element-220  Medication Summary content status  CEN/TC 251 prEN 17269
Uses	Uses 4 templates Uses as Name Version 2.16.840.1.113883.10.21.9.1 Include UV Use Period (2023) DYNAMIC 2.16.840.1.113883.10.22.4.2 Containment IPS Medication Information (detail) (STU1) DYNAMIC 2.16.840.1.113883.10.22.4.14 Containment IPS Body Author (STU1) DYNAMIC 2.16.840.1.113883.10.21.4.6 Containment UV Subordinate Substance Administration (2023) DYNAMIC
Relationship	Version: template 2.16.840.1.113883.10.22.4.4 IPS Medication Statement (2016‑11‑11) Adaptation: template 1.3.6.1.4.1.12559.11.10.1.3.1.3.4 Medication Item (2013‑12‑20) ref epsos- Specialization: template 2.16.840.1.113883.10.21.4.7 UV Medication Statement (DYNAMIC) ref pharmcda-
Example	Example <substanceAdministration classCode="SBADM" moodCode="INT">   <templateId root="2.16.840.1.113883.10.22.4.4"/>  <code code="DRUG" codeSystem="2.16.840.1.113883.5.4" displayName="Drug"/>  <statusCode code="active"/>  <effectiveTime>     <width value="2" unit="wk"/>  </effectiveTime>  <consumable typeCode="CSM">     <!-- template 'IPS ManufacturedProduct' (dynamic) -->   </consumable>  <entryRelationship typeCode="COMP">     <substanceAdministration classCode="SBADM" moodCode="EVN">       <statusCode code="active"/>      <effectiveTime xsi:type="PIVL_TS" institutionSpecified="true">         <period value="12" unit="h"/>      </effectiveTime>      <doseQuantity value="2" unit="{puff}"/>      <consumable>         <manufacturedProduct>           <manufacturedMaterial nullFlavor="NA"/>        </manufacturedProduct>      </consumable>    </substanceAdministration>  </entryRelationship></substanceAdministration>
Example	No medication infos <substanceAdministration classCode="SBADM" moodCode="INT">   <templateId root="2.16.840.1.113883.10.22.4.4"/>  <code code="no-medication-info" codeSystem="2.16.840.1.113883.5.1150.1" displayName="No information about medications"/>  <statusCode code="completed"/>  <effectiveTime nullFlavor="NA" xsi:type="IVL_TS"/>  <consumable>     <manufacturedProduct>       <manufacturedMaterial nullFlavor="NA"/>    </manufacturedProduct>  </consumable></substanceAdministration>
Item DT Card Conf Description Label hl7:substanceAdministration R (IPS...ent)   hl7ips-data​element-104  Medication  CEN/TC 251 prEN 17269 @classCode cs 1 … 1 F SBADM @moodCode cs 1 … 1 R If the statement refers to a prescribed medication then a <substanceAdministration> intent (moodCode='INT') is used; otherwise, to record medications which are stated to have taken, the moodCode shall be set to 'EVN'.</substanceAdministration>   CONF The value of @moodCode shall be drawn from value set 2.16.840.1.113883.11.20.9.18 MoodCodeEvnInt (DYNAMIC) hl7:templateId II 1 … 1 M (IPS...ent) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.4 hl7:id II 0 … * R (IPS...ent) hl7:code CD.IPS 1 … 1 R The <code> element is valorized with the Substance Administration ACT code "DRUG" unless it is used for asserting the  known absence of medication treatments or no information about them. (IPS...ent)   hl7ips-data​element-220  Medication Summary content status  CEN/TC 251 prEN 17269   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.14 DRUGActCode (DYNAMIC) or The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.15 Absent or Unknown Medication (DYNAMIC) hl7:text ED 0 … 1 R The URI given in the value attribute of the <reference> element points to an element in the narrative content that contains the complete text describing the medication. In a CDA document, the URI given in the value attribute of the <reference> element points to an element in the narrative content that contains the complete text describing the medication. (IPS...ent) hl7:reference TEL 1 … 1 M (IPS...ent) @value 1 … 1 R Reference pointing to the narrative, typically #{label}-{generated-id}, e.g. #xxx-1 hl7:statusCode CS 1 … 1 M (IPS...ent)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.12 ActStatusActiveCompletedAbortedSuspended (DYNAMIC)   Example <statusCode code="active"/> Included 1 … 1 R from 2.16.840.1.113883.10.21.9.1 UV Use Period (DYNAMIC) Choice 1 … 1 The effectiveTime element encodes the use period of the medication, it is always expressed as an interval of time. It may be expressed using the low and high OR with the width element. The first is used to indicate a specified interval (e.g. from march 15th, 2017); the latter for indicating a 'floating' period (e.g. 2 weeks). Elements to choose from: hl7:effectiveTime[hl7:low | hl7:high][not(hl7:width)] hl7:effectiveTime[hl7:width][not(hl7:low|hl7:high)] hl7:effectiveTime[hl7:low | hl7:width][not(hl7:high)] hl7:effectiveTime IVL_TS 0 … 1 C Case 1: specified interval The low and high values of the first effectiveTime element represent the start and stop times for the medication. The low value represents the start time, and the high value represents the stop time. If either the low or the high value is unknown, this shall be recorded by setting the nullFlavor attribute to UNK. In case of unbounded period (continuous therapy) the high element will be valued with the nullFlavor attribute to NA. The high value records the end of the medication regime according to the information provided in the prescription or order. For example, if the prescription is for enough medication to last 30 days, then the high value should contain a date that is 30 days later then the low value. The rationale is that a provider, seeing a prescription that has not been refilled would normally assume that the medication is no longer being taken, even if the intent of the treatment plan is to continue the medication indefinitely. (IPS...ent) where [hl7:low or [not(hl7:width)] @nullFlavor cs 0 … 1     Example Known Interval <effectiveTime type="IVL_TS">   <low value="20130321"/>  <high value="20140321"/></effectiveTime>   Example Information not available about the period <effectiveTime type="IVL_TS" nullFlavor="NI"/>   Example Unknown end date <effectiveTime type="IVL_TS">   <low value="20130321"/>  <high nullFlavor="UNK"/></effectiveTime>   Example continous therapy <effectiveTime type="IVL_TS">   <low value="20130321"/>  <high nullFlavor="NA"/></effectiveTime> hl7:low IVXB_TS 1 … 1 R (IPS...ent) hl7:high IVXB_TS 0 … 1 R (IPS...ent) hl7:effectiveTime IVL_TS 0 … 1 C Case 2: 'floating' period: The width element is used to specify a period of (actual or intended) administration that is not anchored to any specific date (e.g. a two weeks therapy) (IPS...ent) where [hl7:width] [not(hl7:lowor hl7:high)]   Example 2 week period <effectiveTime type="IVL_TS">   <width value="2" unit="w"/></effectiveTime> hl7:low NP (IPS...ent) hl7:high NP (IPS...ent) hl7:center NP (IPS...ent) hl7:width PQ 1 … 1 R (IPS...ent) @unit cs 1 … 1 R   CONF The value of @unit shall be drawn from value set 2.16.840.1.113883.11.21.1 Medication Time Units (UCUM) (DYNAMIC) hl7:effectiveTime IVL_TS 0 … 1 C Case 3: anchored period: The width element is used to specify a period of (actual or intended) administration anchored to a specific date (e.g. a two weeks therapy starting today) (IPS...ent) where [hl7:low or [not(hl7:high)]   Example 2 week period starting on 2013-03-21 <effectiveTime type="IVL_TS">   <low value="20130321"/>  <width value="2" unit="w"/></effectiveTime> hl7:low IVXB_TS 0 … 1 C (IPS...ent) hl7:width PQ 1 … 1 R (IPS...ent) @unit cs 1 … 1 R   CONF The value of @unit shall be drawn from value set 2.16.840.1.113883.11.21.1 Medication Time Units (UCUM) (DYNAMIC) hl7:routeCode CE.IPS 0 … 1 R The <routeCode> element specifies the route of administration using the EDQM route of administration vocabulary. A code must be specified if the route is known.  Since the EDQM Standards Terms, together with UCUM, is one of the IDMP terminologies actually available for usage, this code system has been selected  as referecne terminology for representing Pharmaceutical Dose forms; Packages and Route of Administration. It is known that also alternative jurisdictional and international terminologies are also used for this concept domain, as NCI or SNOMED CT. Official NCI and EDQM maps for the route of administration are available from the EDQM site. (IPS...ent)   hl7ips-data​element-102  Route of administration  CEN/TC 251 prEN 17269   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.33 Medicine Route of Administration (DYNAMIC) hl7:doseQuantity IVL_PQ NP (IPS...ent) hl7:rateQuantity IVL_PQ NP (IPS...ent) hl7:administrationUnitCode CE NP (IPS...ent) hl7:consumable 1 … 1 M Contains 2.16.840.1.113883.10.22.4.2 IPS Medication Information (detail) (DYNAMIC) (IPS...ent) @typeCode cs 1 … 1 F CSM hl7:author 0 … * Contains 2.16.840.1.113883.10.22.4.14 IPS Body Author (DYNAMIC) (IPS...ent) hl7:entryRelationship 0 … * C Subordinate Substance Administration Statement as a component of the overall medication statement. Unless medications are unknown or known absent, at least one subordinated <substanceAdministration> has to be present to convey information about dosages (dose, frequency of intakes,..). Subordinated <substanceAdministration> elements can be also used either to handle split dosing, or to support combination medications. Contains 2.16.840.1.113883.10.21.4.6 UV Subordinate Substance Administration (DYNAMIC) (IPS...ent) @typeCode cs 1 … 1 F COMP   Constraint At least one subordinate <substanceAdministration> element SHALL be present unless medications are unknown or known absent. </substanceAdministration>   Example <hl7:entryRelationship typeCode="COMP">   <!-- component: Subordinate Substance Administration Statement. -->   <hl7:substanceAdministration classCode="SBADM" moodCode="EVN">     <hl7:templateId root="2.16.840.1.113883.10.22.4.33"/>    <!-- .. -->   </hl7:substanceAdministration>  <hl7:sequenceNumber value="1"/></hl7:entryRelationship> hl7:sequenceNumber INT 0 … 1 Sequence number of the Subordinate Substance Administration (IPS...ent)

IPS ObservationMedia

Id	2.16.840.1.113883.10.22.4.23	Effective Date	2021‑09‑02 12:02:16 Other versions this id: IPSObservationMedia as of 2017‑04‑06
Status	Draft	Version Label	2021
Name	IPSObservationMedia	Display Name	IPS ObservationMedia
Description Template CDA ObservationMedia for IPS (prototype, directly derived from POCD_RM000040 MIF) This element is intended to carry a small multimedia content, like an image or a graph to be rendered in the body of the patient summary document.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.23
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Uses	Uses 2 templates Uses as Name Version 2.16.840.1.113883.10.12.323 Containment CDA Performer (Body) DYNAMIC 2.16.840.1.113883.10.12.318 Containment CDA Author (Body) DYNAMIC
Relationship	Version: template 2.16.840.1.113883.10.22.4.23 IPS ObservationMedia (2017‑04‑06) Adaptation: template 2.16.840.1.113883.10.12.304 CDA ObservationMedia (2005‑09‑07) ref ad1bbr-
Example	Example <observationMedia ID="Unique_String" moodCode="EVN" classCode="OBS">   <!-- The rendering of the multimedia object in the body of the CDA document is triggered by a <renderMultiMedia referencedObject="Unique_String"/> in the narrative of the <section> -->   <templateId root="2.16.840.1.113883.10.22.4.23"/>  <value mediaType="image/png" representation="B64">content encoded in Base 64</value>  <performer>     <!-- template 2.16.840.1.113883.10.12.323 'CDA Performer (Body)' (dynamic) -->   </performer>  <author>     <!-- template 2.16.840.1.113883.10.12.318 'CDA Author (Body)' (dynamic) -->   </author></observationMedia>
Item DT Card Conf Description Label hl7:observationMedia This element must have an ID attribute  to be referenced from a <renderMultimedia> element in the narrative of the section</renderMultimedia> (IPS...dia) @classCode cs 0 … 1 F OBS @moodCode cs 0 … 1 F EVN hl7:templateId II 1 … 1 M (IPS...dia) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.23 hl7:language​Code CS 0 … 1 (IPS...dia)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.4.642.3.21 All Languages (DYNAMIC) hl7:value ED 1 … 1 M (IPS...dia) @representation cs 1 … 1 R @mediaType cs 1 … 1 R hl7:performer 0 … 1 Contains 2.16.840.1.113883.10.12.323 CDA Performer (Body) (DYNAMIC) (IPS...dia) hl7:author 0 … * Contains 2.16.840.1.113883.10.12.318 CDA Author (Body) (DYNAMIC) (IPS...dia)

IPS Pathology Result Observation

Id	2.16.840.1.113883.10.22.4.11	Effective Date	2017‑03‑21
Status	Under pre-publication review	Version Label	STU1
Name	IPSPathologyResultObservation	Display Name	IPS Pathology Result Observation
Description This template constrains the results of an  anatomic pathology observation. The result observation includes a statusCode to allow recording the status of an observation. “Pending” results (e.g., a test has been run but results have not been reported yet) should be repnresented as “active” ActStatus.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.11
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Uses	Uses 2 templates Uses as Name Version 2.16.840.1.113883.10.22.4.14 Containment IPS Body Author (STU1) DYNAMIC 2.16.840.1.113883.10.22.4.22 Containment IPS Comment Activity (STU1) DYNAMIC
Relationship	Adaptation: template 2.16.840.1.113883.10.12.303 CDA Observation (2005‑09‑07) ref ad1bbr- Adaptation: template 2.16.840.1.113883.10.20.22.4.2 Result Observation (V3) (2015‑08‑01) ref ccda- Adaptation: template 2.16.840.1.113883.10.22.4.10 IPS Result Observation (2017‑03‑02)
Example	Example <observation classCode="OBS" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.11"/>  <id root="1.2.3.999" extension="__example only__"/>  <code code="44638-5" codeSystem="2.16.840.1.113883.6.1" displayName="Histologic type in Breast tumor by CAP cancer protocols"/>  <statusCode code="completed"/>  <effectiveTime>     <low value="20171210085407"/>  </effectiveTime>  <value xsi:type="CD" code="399935008" displayName="Ductal carcinoma in situ - category (morphologic abnormality)" codeSystem="2.16.840.1.113883.6.96"/>  <methodCode code="104157003" displayName="Light microscopy" codeSystem="2.16.840.1.113883.6.96"/></observation>
Item DT Card Conf Description Label hl7:observation (IPS...ion) @classCode cs 1 … 1 F OBS @moodCode cs 1 … 1 F EVN hl7:templateId II 1 … 1 M (IPS...ion) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.11 hl7:id II 0 … * R (IPS...ion) hl7:code CD.IPS 1 … 1 M (IPS...ion)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.41 IPS Results Observation Pathology (DYNAMIC) hl7:statusCode CS 1 … 1 M (IPS...ion)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.19890 x_ActStatusActiveComplete (DYNAMIC) hl7:effectiveTime IVL_TS 1 … 1 R (IPS...ion) Choice 1 … 1 Elements to choose from: hl7:value[@xsi:type='CE.IPS'] hl7:value[@xsi:type='PQ'] hl7:value[@xsi:type='IVL_PQ'] hl7:value[@xsi:type='ST'] hl7:value[@xsi:type='TS'] hl7:value[@xsi:type='RTO_QTY_QTY'] hl7:value CE.IPS (extensible) 0 … 1 R (IPS...ion) where [@xsi:type='CE.IPS']   CONF The value of @code should be drawn from value set 2.16.840.1.113883.11.22.47 IPS Results Coded Values Pathology (DYNAMIC)   Example Result code: code '201' from code system 2.16.840.1.113883.2.4.4.30.1045 <value xsi:type="CE" code="399935008" displayName="Ductal carcinoma in situ - category (morphologic abnormality)" codeSystem="2.16.840.1.113883.6.96"/>   Example Result code: code 'POS' from code system 2.16.840.1.113883.5.83 <value xsi:type="CE" code="369790002" displayName="Nottingham Combined Grade I: 3-5 points (finding)" codeSystem="2.16.840.1.113883.6.96"/> hl7:value PQ 0 … 1 R (IPS...ion) where [@xsi:type='PQ']   Constraint If Observation/value is a physical quantity (xsi:type="PQ"), the unit of measure SHALL be selected from ValueSet UnitsOfMeasureCaseSensitive 2.16.840.1.113883.1.11.12839 DYNAMIC   Example Result physical quantity (data type PQ): 136 mmol per liter <value xsi:type="PQ" value="85" unit="%"/> hl7:value IVL_PQ 0 … 1 R (IPS...ion) where [@xsi:type='IVL_PQ']   Example Result interval of physical quantities (data type IVL_PQ): 150 - 400 Billion per 10 exp 9 liter <value xsi:type="IVL_PQ">   <low value="150" unit="10+9/l"/>  <high value="400" unit="10+9/l"/></value> hl7:value ST 0 … 1 R (IPS...ion) where [@xsi:type='ST']   Example Result free text (data type ST) <value xsi:type="ST">This is a result as a free text</value> hl7:value TS 0 … 1 R (IPS...ion) where [@xsi:type='TS']   Example Result time stamp (data type TS): 6-Aug-2014 <value xsi:type="TS" value="20140806"/> hl7:value RTO_QTY_QTY 0 … 1 R (IPS...ion) where [@xsi:type='RTO_QTY_QTY']   Example Result ratio (data type RTO_QTY_QTY): 1/179 <value xsi:type="RTO_QTY_QTY">   <numerator xsi:type="INT" value="1"/>  <denominator xsi:type="INT" value="179"/></value> hl7:interpretationCode CE.IPS 0 … 1 R (IPS...ion)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.78 ObservationInterpretation (DYNAMIC) hl7:author 0 … * R Contains 2.16.840.1.113883.10.22.4.14 IPS Body Author (DYNAMIC) (IPS...ion) hl7:referenceRange 0 … * R (IPS...ion) hl7:observationRange 1 … 1 M (IPS...ion) hl7:code CD NP (IPS...ion) hl7:value ANY 1 … 1 M (IPS...ion) hl7:interpretationCode CE 0 … 1 (IPS...ion) @code CONF 0 … 1 F N @codeSystem 0 … 1 F 2.16.840.1.113883.5.83 (Observation Interpretation) hl7:entryRelationship 0 … * Contains 2.16.840.1.113883.10.22.4.22 IPS Comment Activity (DYNAMIC) (IPS...ion) @typeCode cs 1 … 1 F COMP

IPS Pregnancy Expected Delivery Date Observation

Id	2.16.840.1.113883.10.22.4.29	Effective Date	2017‑04‑13
Status	Under pre-publication review	Version Label	STU1
Name	IPSPregnancyExpectedDeliveryDateObservation	Display Name	IPS Pregnancy Expected Delivery Date Observation
Description This observation records the Pregnancy Expected Delivery Date for pregnant patients, expressed as a time stamp. The code reflects the method (operationalisation) of how the date was determined, e.g. clinically estimated, estimated from last menstruation date or last ovulation date.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.29
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 1 concept Id Name Data Set hl7ips-data​element-213  Expected delivery date  CEN/TC 251 prEN 17269
Relationship	Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.13.5 Pregnancy Observation (2013‑12‑20) ref epsos- Adaptation: template 2.16.840.1.113883.10.20.1.33 Social history observation (DYNAMIC) ref ccd1-
Example	Example <observation typeCode="OBS" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.29"/>  <code code="11778-8" codeSystem="2.16.840.1.113883.6.1" displayName="Delivery date estimated (clinical)" codeSystemName="LOINC"/>  <text>     <reference value="#xxx"/>  </text>  <statusCode code="completed"/>  <effectiveTime value="20160819"/>  <value xsi:type="TS" value="20170414"/></observation>
Item DT Card Conf Description Label hl7:observation R (IPSPregnancyExpectedDeliveryDateObservation ) hl7:templateId II 1 … 1 M (IPSPregnancyExpectedDeliveryDateObservation ) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.29 hl7:code CD.IPS 1 … 1 M (IPSPregnancyExpectedDeliveryDateObservation )   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.20 IPS Expected Delivery Date Method (DYNAMIC) hl7:statusCode CS 1 … 1 R (IPSPregnancyExpectedDeliveryDateObservation ) @code CONF 0 … 1 F completed hl7:effectiveTime IVL_TS 0 … 1 R The effectiveTime, also referred to as the “biologically relevant time” is the time at which the observation holds for the patient. For a provider seeing a patient in the clinic today, observing a history of heart attack that occurred five years ago, the effectiveTime is five years ago. (IPSPregnancyExpectedDeliveryDateObservation ) hl7:value TS 1 … 1 R (IPSPregnancyExpectedDeliveryDateObservation )   hl7ips-data​element-213  Expected delivery date  CEN/TC 251 prEN 17269

IPS Pregnancy Outcome Observation

Id	2.16.840.1.113883.10.22.4.28	Effective Date	2017‑04‑13
Status	Under pre-publication review	Version Label	STU1
Name	IPSPregnancyOutcomeObservation	Display Name	IPS Pregnancy Outcome Observation
Description	A pregnancy outcome observation records a summary over all pregnancies.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.28
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 1 concept Id Name Data Set hl7ips-data​element-214  Summary Metric  CEN/TC 251 prEN 17269
Relationship	Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.13.5 Pregnancy Observation (2013‑12‑20) ref epsos- Adaptation: template 2.16.840.1.113883.10.20.1.33 Social history observation (DYNAMIC) ref ccd1-
Example	Example <observation>   <templateId root="2.16.840.1.113883.10.22.4.28"/>  <code code="11636-8" displayName="[#] Births.live" codeSystem="2.16.840.1.113883.6.1"/>  <statusCode code="completed"/>  <value value="1"/></observation>
Item DT Card Conf Description Label hl7:observation R (IPS...ion) hl7:templateId II 1 … 1 M (IPS...ion) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.28 hl7:code CD.IPS 1 … 1 M (IPS...ion)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.21 IPS Pregnancies Summary (DYNAMIC) hl7:statusCode CS 1 … 1 R (IPS...ion) @code CONF 0 … 1 F completed hl7:value INT 1 … 1 R (IPS...ion)   hl7ips-data​element-214  Summary Metric  CEN/TC 251 prEN 17269

IPS Pregnancy Status Observation

Id	2.16.840.1.113883.10.22.4.27	Effective Date	2020‑07‑14 16:31:53 Other versions this id: IPSPregnancyStatusObservation as of 2020‑07‑14 16:31:28 IPSPregnancyStatusObservation as of 2020‑05‑07 19:22:01 IPSPregnancyStatusObservation as of 2017‑04‑13
Status	Draft	Version Label	2021
Name	IPSPregnancyStatusObservation	Display Name	IPS Pregnancy Status Observation
Description	A pregnancy status observation records whether the patient is currently pregnant or not. If pregnant, an Expected Delivery Date may be specified as an subordinate observation.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.27
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 3 concepts Id Name Data Set hl7ips-data​element-211  Date of Observation  CEN/TC 251 prEN 17269 hl7ips-data​element-212  Pregnancy State  CEN/TC 251 prEN 17269 hl7ips-data​element-213  Expected delivery date  CEN/TC 251 prEN 17269
Uses	Uses 1 template Uses as Name Version 2.16.840.1.113883.10.22.4.29 Containment IPS Pregnancy Expected Delivery Date Observation (STU1) DYNAMIC
Relationship	Version: template 2.16.840.1.113883.10.22.4.27 IPS Pregnancy Status Observation (2020‑05‑07 19:22:01) Version: template 2.16.840.1.113883.10.22.4.27 IPS Pregnancy Status Observation (2017‑04‑13) Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.13.5 Pregnancy Observation (2013‑12‑20) ref epsos- Adaptation: template 2.16.840.1.113883.10.20.1.33 Social history observation (DYNAMIC) ref ccd1-
Example	Example <observation>   <templateId root="2.16.840.1.113883.10.22.4.27"/>  <code code="82810-3" codeSystem="2.16.840.1.113883.6.1"/>  <statusCode code="completed"/>  <value value="false"/>  <entryRelationship typeCode="COMP">     <!-- template 2.16.840.1.113883.10.22.4.29 'IPS Pregnancy Expected Delivery Date Observation' (dynamic) -->   </entryRelationship></observation>
Item DT Card Conf Description Label hl7:observation R (IPS...ion) hl7:templateId II 1 … 1 M (IPS...ion) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.27 hl7:code CD.IPS (extensible) 1 … 1 M (IPS...ion) @code CONF 1 … 1 F 82810-3 @codeSystem 1 … 1 F 2.16.840.1.113883.6.1 (LOINC) hl7:statusCode CS 1 … 1 R (IPS...ion) @code CONF 0 … 1 F completed hl7:effectiveTime IVL_TS 1 … 1 R The effectiveTime, also referred to as the “biologically relevant time” is the time at which the observation holds for the patient. For a provider seeing a patient in the clinic today, observing a history of heart attack that occurred five years ago, the effectiveTime is five years ago. (IPS...ion)   hl7ips-data​element-211  Date of Observation  CEN/TC 251 prEN 17269 hl7:value CE.IPS (required) 1 … 1 R (IPS...ion)   hl7ips-data​element-212  Pregnancy State  CEN/TC 251 prEN 17269   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.68 IPS Pregnancy Status (DYNAMIC) hl7:entryRelationship 0 … 1 R Contains 2.16.840.1.113883.10.22.4.29 IPS Pregnancy Expected Delivery Date Observation (DYNAMIC) (IPS...ion)   hl7ips-data​element-213  Expected delivery date  CEN/TC 251 prEN 17269 @typeCode cs 1 … 1 F COMP

IPS Problem Concern Entry

Id	2.16.840.1.113883.10.22.4.7	Effective Date	2021‑08‑04 08:49:27 Other versions this id: IPSProblemConcernEntry as of 2017‑02‑15
Status	Draft	Version Label	2021
Name	IPSProblemConcernEntry	Display Name	IPS Problem Concern Entry
Description This template reflects an ongoing concern on behalf of the provider that placed the concern on a patient’s problem list.  The purpose of the concern act is that of supporting the tracking of a problem or a condition. There are different kinds of status that could be related to a condition: The status of the concern (active, inactive,..)  The status of the condition (e.g. active, inactive, resolved,..)  The confirmation status [clinical workflow status, certainty] (e.g. confirmed, likely, unlikely,…)  Not all of them can be represented in a CDA using the statusCode elements of the concern (ACT) and observation (condition).  So long as the underlying conditions are of concern to the provider (i.e., as long as the condition, whether active or resolved, is of ongoing concern and interest to the provider), the statusCode is “active”. Only when the underlying conditions are no longer of concern is the statusCode set to “completed”.  The effectiveTime reflects the time that the underlying condition was felt to be a concern; it may or may not correspond to the effectiveTime of the condition (e.g., even five years later, the clinician may remain concerned about a prior heart attack). The effectiveTime/low of the Problem Concern Act asserts when the concern became active. This equates to the time the concern was authored in the patient's chart.  The effectiveTime/high asserts when the concern become inactive, and it is present if the statusCode of the concern act is "completed". A Problem Concern Act can contain many Problem Observations. The many Problem Observations nested under a Problem Concern Act reflect the change in the clinical understanding of a condition over time. For instance, a Concern may initially contain a Problem Observation of “chest pain”: - Problem Concern 1 --- Problem Observation: Chest Pain Later, a new Problem Observation of “esophagitis” will be added, reflecting a better understanding of the nature of the chest pain. The later problem observation will have a more recent author time stamp. - Problem Concern 1 --- Problem Observation (author/time Jan 3, 2012): Chest Pain --- Problem Observation (author/time Jan 6, 2012): Esophagitis Many systems display the nested Problem Observation with the most recent author time stamp, and provide a mechanism for viewing prior observations.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.7
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Uses	Uses 1 template Uses as Name Version 2.16.840.1.113883.10.22.4.8 Containment IPS Problem Entry (2021) DYNAMIC
Relationship	Version: template 2.16.840.1.113883.10.22.4.7 IPS Problem Concern Entry (2017‑02‑15) Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.5.1 IHE Concern Entry (DYNAMIC) ref IHE-PCC- Adaptation: template 2.16.840.1.113883.10.20.1.27 Problem act (DYNAMIC) ref ccd1- Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.5.2 eHDSI Problem Concern (DYNAMIC) ref epsos-
Example	Active Concern with several conditions <act classCode="ACT" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.7"/>  <id root="1.2.3.999" extension="__example only__"/>  <code code="CONC" codeSystem="2.16.840.1.113883.5.6"/>  <statusCode code="active"/>  <effectiveTime>     <low value="20170309"/>  </effectiveTime>  <entryRelationship typeCode="SUBJ" inversionInd="false">     <!-- template 2.16.840.1.113883.10.22.4.8 'IPS Problem Entry' (dynamic) -->     <!-- A condition could be active, inactive,.... -->   </entryRelationship>  <entryRelationship typeCode="SUBJ" inversionInd="false">     <!-- template 2.16.840.1.113883.10.22.4.8 'IPS Problem Entry' (dynamic) -->   </entryRelationship></act>
Example	Concern no longer tracked <act classCode="ACT" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.7"/>  <id root="1.2.3.999" extension="__example only__"/>  <code code="CONC" codeSystem="2.16.840.1.113883.5.6"/>  <statusCode code="completed"/>  <effectiveTime>     <low value="20161210"/>    <low value="20170309"/>  </effectiveTime>  <entryRelationship typeCode="SUBJ" inversionInd="false">     <!-- template 2.16.840.1.113883.10.22.4.8 'IPS Problem Entry' (dynamic) -->   </entryRelationship></act>
Item DT Card Conf Description Label hl7:act R (IPS...try) @classCode cs 1 … 1 F ACT @moodCode cs 1 … 1 F EVN hl7:templateId II 1 … 1 M (IPS...try) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.7 hl7:id II 0 … * R (IPS...try) hl7:code CD 1 … 1 M (IPS...try) @code 1 … 1 F CONC @codeSystem 1 … 1 F 2.16.840.1.113883.5.6 hl7:statusCode CS 1 … 1 R So long as the underlying conditions are of concern to the provider (i.e., as long as the condition, whether active or resolved, is of ongoing concern and interest to the provider), the statusCode is “active”.  Only when the underlying conditions are no longer of concern is the statusCode set to “completed”. (IPS...try)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.19890 x_ActStatusActiveComplete (DYNAMIC) hl7:effectiveTime IVL_TS 1 … 1 M (IPS...try) hl7:low IVXB_TS 1 … 1 R This element asserts when the concern became active. This equates to the time the concern was authored in the patient's chart and the author started tracking this concern. (IPS...try) hl7:high IVXB_TS 0 … 1 C This element asserts when the clinician deemed there is no longer any need to track the underlying conditions. (IPS...try)   Constraint If the statusCode is completed this element is required hl7:entryRelationship 1 … * R Contains 2.16.840.1.113883.10.22.4.8 IPS Problem Entry (DYNAMIC) (IPS...try) @typeCode cs 1 … 1 F SUBJ @inversionInd bl 0 … 1 F false

IPS Problem Entry

Id	2.16.840.1.113883.10.22.4.8	Effective Date	2021‑08‑04 08:52:52 Other versions this id: IPSProblemEntry as of 2017‑02‑15
Status	Draft	Version Label	2021
Name	IPSProblemEntry	Display Name	IPS Problem Entry
Description This template reflects a discrete observation about a patient's problem. Because it is a discrete observation, it will have a statusCode of "completed". The effectiveTime, also referred to as the “biologically relevant time” is the time at which the observation holds for the patient. For a provider seeing a patient in the clinic today, observing a history of heart attack that occurred five years ago, the effectiveTime is five years ago. The effectiveTime of the Problem Observation is the definitive indication of whether or not the underlying condition is resolved. If the problem is known to be resolved, then an effectiveTime/high would be present. If the date of resolution is not known, then effectiveTime/high will be present with a nullFlavor of "UNK".
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.8
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 12 concepts Id Name Data Set hl7ips-data​element-101  Problem type  CEN/TC 251 prEN 17269 hl7ips-data​element-115  Problem content status  CEN/TC 251 prEN 17269 hl7ips-data​element-127  Onset date  CEN/TC 251 prEN 17269 hl7ips-data​element-128  Severity  CEN/TC 251 prEN 17269 hl7ips-data​element-131  Diagnosis  CEN/TC 251 prEN 17269 hl7ips-data​element-136  Severity  CEN/TC 251 prEN 17269 hl7ips-data​element-140  Problem  CEN/TC 251 prEN 17269 hl7ips-data​element-209  Health condition / Problem  CEN/TC 251 prEN 17269 hl7ips-data​element-210  Problem Type  CEN/TC 251 prEN 17269 hl7ips-data​element-32  Onset Date  CEN/TC 251 prEN 17269 hl7ips-data​element-34  Date resolved  CEN/TC 251 prEN 17269 hl7ips-data​element-36  Diagnosis  CEN/TC 251 prEN 17269
Uses	Uses 3 templates Uses as Name Version 2.16.840.1.113883.10.22.4.25 Containment IPS Severity Observation (STU1) DYNAMIC 2.16.840.1.113883.10.22.4.19 Containment IPS Certainty Observation (STU1) DYNAMIC 2.16.840.1.113883.10.22.4.20 Containment IPS Problem Status Observation (STU1) 2017‑03‑29
Relationship	Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.5 IHE Problem Entry (DYNAMIC) ref ch-pcc-
Example	Active Problem <observation classCode="OBS" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.8"/>  <id root="1.2.3.999" extension="__example only__"/>  <code code="75326-9" codeSystem="2.16.840.1.113883.6.1" displayName="Problem"/>  <text>     <reference value="#problem-1"/>  </text>  <statusCode code="completed"/>  <effectiveTime>     <low value="20100507"/>  </effectiveTime>  <value code="38341003" displayName="Hypertensive disorder, systemic arterial (disorder)" codeSystem="2.16.840.1.113883.6.96"/>  <entryRelationship typeCode="SUBJ" inversionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.25 'IPS Severity Observation' (dynamic) -->   </entryRelationship>  <entryRelationship typeCode="SUBJ" inversionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.19 'IPS Certainty Observation' (dynamic) -->   </entryRelationship>  <entryRelationship typeCode="REFR" inversionInd="false">     <!-- template 2.16.840.1.113883.10.22.4.20 'IPS Problem Status Observation' (2017-03-29T00:00:00) -->     <!-- this referred observation should report that the condition is still active -->   </entryRelationship></observation>
Example	Closed Problem (resolution date known) <observation classCode="OBS" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.8"/>  <id root="1.2.3.999" extension="__example only__"/>  <code code="75326-9" codeSystem="2.16.840.1.113883.6.1" displayName="Problem"/>  <statusCode code="completed"/>  <effectiveTime>     <low value="2010"/>    <high value="2015"/>  </effectiveTime>  <value code="38341003" displayName="Hypertensive disorder, systemic arterial (disorder)" codeSystem="2.16.840.1.113883.6.96"/>  <entryRelationship typeCode="SUBJ" inversionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.25 'IPS Severity Observation' (dynamic) -->   </entryRelationship>  <entryRelationship typeCode="SUBJ" inversionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.19 'IPS Certainty Observation' (dynamic) -->   </entryRelationship>  <entryRelationship typeCode="REFR" inversionInd="false">     <!-- template 2.16.840.1.113883.10.22.4.20 'IPS Problem Status Observation' (2017-03-29T00:00:00) -->     <!-- this referred observation should report that the condition is resolved -->   </entryRelationship></observation>
Example	Known absent problems <observation classCode="OBS" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.8"/>  <id root="1.2.3.999" extension="__example only__"/>  <code code="75326-9" codeSystem="2.16.840.1.113883.6.1" displayName="Problem"/>  <statusCode code="completed"/>  <effectiveTime>     <low nullFlavor="NI"/>  </effectiveTime>  <value code="no-known-problems" displayName="No known problems" codeSystem="2.16.840.1.113883.5.1150.1"/></observation>
Item DT Card Conf Description Label hl7:observation R (IPS...try)   hl7ips-data​element-140  Problem  CEN/TC 251 prEN 17269 hl7ips-data​element-209  Health condition / Problem  CEN/TC 251 prEN 17269 @classCode cs 0 … 1 F OBS @moodCode cs 1 … 1 F EVN hl7:templateId II 1 … 1 M (IPS...try) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.8 hl7:id II 0 … * R (IPS...try) hl7:code CD.IPS 1 … 1 R This element describes the type of condition this observation is referring to. (IPS...try)   hl7ips-data​element-101  Problem type  CEN/TC 251 prEN 17269 hl7ips-data​element-210  Problem Type  CEN/TC 251 prEN 17269   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.16 Problem Type (DYNAMIC)   Example <code code="75326-9" codeSystem="2.16.840.1.113883.6.1" displayName="Problem"/> hl7:text ED 0 … 1 R The <text> element if present points to the text describing the problem being recorded; including any dates, comments, et cetera. The <reference> contains a URI in value attribute. This URI points to the free text description of the problem in the document that is being described.</reference></text> (IPS...try)   Example <text>   <reference value="#problem-1"/></text> hl7:reference TEL 1 … 1 M (IPS...try) @value 1 … 1 R When used it shall refer to the narrative, typically #{label}-{generated-id}, e.g. #xxx-1 hl7:statusCode CS 1 … 1 M A clinical document normally records only those condition observation events that have been completed, not observations that are in any other state. Therefore, the <statusCode> shall always have code='completed'.</statusCode> (IPS...try) @code CONF 1 … 1 F completed hl7:effectiveTime IVL_TS 1 … 1 M The effectiveTime, also referred to as the “biologically relevant time” is the time at which the observation holds for the patient. For a provider seeing a patient in the clinic today, observing a history of heart attack that occurred five years ago, the effectiveTime is five years ago. The <low> and <high> values should be no more precise than known, but as precise as possible. (IPS...try)   Example Known onset date (active condition) <effectiveTime>   <low value="20100507"/></effectiveTime>   Example Unknown onset date (active condition) <effectiveTime>   <low nullFlavor="UNK"/></effectiveTime>   Example Unknown resolution date <effectiveTime>   <low value="2010"/>  <high nullFlavor="UNK"/></effectiveTime>   Example Known resolution date <effectiveTime>   <low value="201007"/>  <high value="201703"/></effectiveTime> hl7:low IVXB_TS 1 … 1 R The effectiveTime/low (a.k.a. "onset date") asserts when the condition became biologically active. (IPS...try)   hl7ips-data​element-127  Onset date  CEN/TC 251 prEN 17269 hl7ips-data​element-32  Onset Date  CEN/TC 251 prEN 17269 hl7:high IVXB_TS 0 … 1 C The effectiveTime/high (a.k.a. "resolution date") asserts when the condition e became biologically resolved. If the date of resolution is not known, then effectiveTime/high will be present with a nullFlavor of "UNK". (IPS...try)   hl7ips-data​element-34  Date resolved  CEN/TC 251 prEN 17269   Constraint If this condition is known to be resolved, then the effectiveTime/high would be present. hl7:value CD.IPS (preferred) 1 … 1 M The <value> is the condition that was found. It may a coded or an un-coded string, but its type is always coded. The coded form shall be used also to indicate known absent conditions or the nonavailability of information about them. (IPS...try)   hl7ips-data​element-115  Problem content status  CEN/TC 251 prEN 17269 hl7ips-data​element-131  Diagnosis  CEN/TC 251 prEN 17269 hl7ips-data​element-36  Diagnosis  CEN/TC 251 prEN 17269 @xsi:type 0 … 1 F CD   CONF The value of @code comes preferably from value set 2.16.840.1.113883.11.22.5 CORE Problem List Disorders (DYNAMIC) or The value of @code comes preferably from value set 2.16.840.1.113883.11.22.17 Absent or Unknown Problems (DYNAMIC)   Example Multiple Coding <value code="302231008" displayName="Salmonella infection" codeSystem="2.16.840.1.113883.6.96">   <translate code="A02.9" displayName="Infezioni da Salmonella non specificate" codeSystem="2.16.840.1.113883.6.3"/></value>   Example Local code not mappable in the reference terminology <value nullFlavor="OTH">   <translate code="12345" displayName="Not in the reference value set" codeSystem="1.2.3.999" codeSystemName="--example only--"/></value>   Example Textual Information <value nullFlavor="NI">   <originalText>     <reference value="#value_as_text"/>  </originalText></value>   Example Known absent problems <value code="160245001" displayName="No current problems or disability" codeSystem="2.16.840.1.113883.6.96"/> hl7:originalText R The <originalText> element within the <code> element described above is used as follows: the <value> contains a <reference> to the <originalText> in order to link the coded value to the problem narrative text (minus any dates, comments, et cetera). The <reference> contains a URI in value attribute. This URI points to the free text description of the problem in the document that is being described. (IPS...try) hl7:reference 0 … 1 R The URI given in the value attribute of the <reference> element points to an element in the narrative content that contains the complete text describing the medication. In a CDA document, the URI given in the value attribute of the <reference> element points to an element in the narrative content that contains the complete text describing the medication. </reference></reference> (IPS...try)   Example <reference value="#value_as_text"/> hl7:qualifier CR 0 … * (IPS...try) hl7:translation CD.IPS 0 … * The translation element may be used to transmit a set of other concept descriptors, using for example ICD-10 or other international or jurisdictional code systems. (IPS...try) hl7:entryRelationship 0 … 1 R Severity The contained entry describes a subjective assessment of the severity of the condition as evaluated by the clinician. Contains 2.16.840.1.113883.10.22.4.25 IPS Severity Observation (DYNAMIC) (IPS...try)   hl7ips-data​element-128  Severity  CEN/TC 251 prEN 17269 hl7ips-data​element-136  Severity  CEN/TC 251 prEN 17269 @typeCode cs 1 … 1 F SUBJ @inversionInd bl 1 … 1 F true hl7:entryRelationship 0 … 1 R Certainty or Verification Status  The contained entry describes the certainty associated with a condition. Contains 2.16.840.1.113883.10.22.4.19 IPS Certainty Observation (DYNAMIC) (IPS...try) @typeCode cs 1 … 1 F SUBJ @inversionInd bl 1 … 1 F true hl7:entryRelationship 0 … 1 R Status of the Problem   The contained entry describes the current status of the condition, for example, whether it is active, in remission, resolved, and so on ... Contains 2.16.840.1.113883.10.22.4.20 IPS Problem Status Observation (2017‑03‑29) (IPS...try) @typeCode cs 1 … 1 F REFR @inversionInd bl 0 … 1 F false

IPS Problem Status Observation

Id	2.16.840.1.113883.10.22.4.20	Effective Date	2021‑09‑02 11:41:28 Other versions this id: IPSProblemStatusObservation as of 2017‑03‑29
Status	Draft	Version Label	2021
Name	IPSProblemStatusObservation	Display Name	IPS Problem Status Observation
Description	This subordinated observation used by the problem observation records information about the current status of a condition, for example, whether it is active, in remission, resolved, et cetera.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.20
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Relationship	Version: template 2.16.840.1.113883.10.22.4.20 IPS Problem Status Observation (2017‑03‑29) Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.1.1 IHE Problem Status Observation (2013‑12‑20) ref IHE-PCC-
Example	Example <observation classCode="OBS" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.20"/>  <code code="33999-4" codeSystem="2.16.840.1.113883.6.1" displayName="Status"/>  <text>     <reference value="#example"/>  </text>  <statusCode code="completed"/>  <value code="active" displayName="Active" codeSystem="2.16.840.1.113883.4.642.3.155"/></observation>
Item DT Card Conf Description Label hl7:observation (IPS...ion) @classCode cs 0 … 1 F OBS @moodCode cs 0 … 1 F EVN hl7:templateId II 1 … 1 M (IPS...ion) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.20 hl7:code CD.IPS 1 … 1 R This observation is of clinical status, as indicated by the <code> element. This element must be present. (IPS...ion) @code CONF 0 … 1 F 33999-4 @codeSystem 0 … 1 F 2.16.840.1.113883.6.1 (LOINC) hl7:text ED 0 … 1 R The <text> element is required and points to the text describing the problem being recorded; including any dates, comments, et cetera. The <reference> contains a URI in value attribute. This URI points to the free text description of the problem in the document that is being described. (IPS...ion) hl7:reference TEL 1 … 1 M (IPS...ion) @value 1 … 1 R Reference pointing to the narrative, typically #{label}-{generated-id}, e.g. #xxx-1 hl7:statusCode CS 1 … 1 M The code attribute of <statusCode> for all clinical status observations shall be completed. While the <statusCode> element is required in all acts to record the status of the act, the only sensible value of this element in this context is completed. (IPS...ion) @code CONF 1 … 1 F completed hl7:value CE.IPS 1 … 1 R The value element contains the clinical status. (IPS...ion)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.4.642.3.164 Condition Clinical Status Codes (DYNAMIC)

IPS Procedure Entry

Id	2.16.840.1.113883.10.22.4.17	Effective Date	2020‑07‑14 16:35:58 Other versions this id: IPSProcedureEntry as of 2017‑03‑27
Status	Draft	Version Label	2021
Name	IPSProcedureEntry	Display Name	IPS Procedure Entry
Description	The procedure entry is used to record procedures that have occurred, or which are planned for in the future.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.17
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 5 concepts Id Name Data Set hl7ips-data​element-216  Body site  CEN/TC 251 prEN 17269 hl7ips-data​element-44  Procedures Content Status  CEN/TC 251 prEN 17269 hl7ips-data​element-47  Procedure  CEN/TC 251 prEN 17269 hl7ips-data​element-48  Procedure date  CEN/TC 251 prEN 17269 hl7ips-data​element-49  Procedure code  CEN/TC 251 prEN 17269
Uses	Uses 1 template Uses as Name Version 2.16.840.1.113883.10.22.4.31 Containment IPS Internal Reference (STU1) DYNAMIC
Relationship	Version: template 2.16.840.1.113883.10.22.4.17 IPS Procedure Entry (2017‑03‑27) Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.19 IHE Procedure Entry (2016‑09‑28 10:37:28) ref IHE-PCC- Adaptation: template 2.16.840.1.113883.10.12.306 CDA Procedure (2005‑09‑07) ref ad1bbr-
Example	Example <hl7:procedure classCode="PROC" moodCode="EVN">   <hl7:templateId root="2.16.840.1.113883.10.22.4.17"/>  <hl7:id root="1.2.3.999" extension="--example only--"/>  <hl7:code/>  <hl7:text>     <hl7:reference value="value"/>  </hl7:text>  <hl7:statusCode code="completed"/>  <hl7:effectiveTime>     <hl7:low value="20200714163551"/>  </hl7:effectiveTime>  <hl7:targetSiteCode/>  <hl7:entryRelationship typeCode="COMP" inversionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.31 'IPS Internal Reference' (2017-05-02T00:00:00) -->   </hl7:entryRelationship></hl7:procedure>
Item DT Card Conf Description Label hl7:procedure (IPS...try)   hl7ips-data​element-47  Procedure  CEN/TC 251 prEN 17269 @classCode cs 1 … 1 F PROC @moodCode cs 1 … 1 R   CONF The value of @moodCode shall be drawn from value set 2.16.840.1.113883.11.20.9.18 MoodCodeEvnInt (DYNAMIC) hl7:templateId II 1 … 1 M (IPS...try) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.17 hl7:id II 0 … * R (IPS...try) hl7:code CD.IPS (preferred) 1 … 1 R (IPS...try)   hl7ips-data​element-44  Procedures Content Status  CEN/TC 251 prEN 17269 hl7ips-data​element-49  Procedure code  CEN/TC 251 prEN 17269   CONF The value of @code comes preferably from value set 2.16.840.1.113883.11.22.35 IPS Procedures (DYNAMIC) or The value of @code comes preferably from value set 2.16.840.1.113883.11.22.36 Absent or Unknown Procedures (DYNAMIC) hl7:text ED 0 … 1 R The <text> element if present points to the text describing the data being recorded; including any dates, comments, et cetera. The <reference> contains a URI in value attribute. This URI points to the free text description of the element (problem, procedure,...) in the document that is being described.</reference> </text> (IPS...try) hl7:reference TEL 1 … 1 M (IPS...try) @value st 1 … 1 R When used it shall refer to the narrative, typically #{label}-{generated-id}, e.g. #xxx-1 hl7:statusCode CS 1 … 1 M (IPS...try)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.22 ActStatusActiveCompletedAbortedCancelled (DYNAMIC) hl7:effectiveTime IVL_TS 1 … 1 R (IPS...try)   hl7ips-data​element-48  Procedure date  CEN/TC 251 prEN 17269 hl7:target​Site​Code CD.IPS (preferred) 0 … * (IPS...try)   hl7ips-data​element-216  Body site  CEN/TC 251 prEN 17269   CONF The value of @code comes preferably from value set 2.16.840.1.113883.11.22.55 IPS Target Site (DYNAMIC) hl7:participant 1 … * R The device is represented as a participant in the procedure structure. The following descriptions apply to the device structure. (IPS...try) @typeCode cs 1 … 1 F DEV   Example <participant typeCode="DEV">   <participantRole classCode="MANU">     <id root="1.2.3.999" extension="__example_only__"/>    <playingDevice classCode="DEV" determinerCode="INSTANCE">       <code code="" codeSystem=""/>      <!-- ... -->     </playingDevice>  </participantRole></participant> hl7:participantRole 1 … 1 R (IPS...try) @classCode cs 1 … 1 F MANU hl7:id II 0 … * R The device ID, e.g. using UDI, is represented by the id element of the participant role. This element is optional, as not all production identifiers (e.g., serial number, lot/batch number, distinct identification number) may be known to the provider or patient. (IPS...try)   Example UDI GS1: DeviceIdentifier 00844588003288, Serial# 10987654d321, Lot# 7654321D <id root="2.16.840.1.113883.3.3719" extension="{01}00844588003288{17}141120{10}7654321D{21}10987654d321"/>   Example UDI ICCBBA: DeviceIdentifier 00844588003288 <id root="2.16.840.1.113883.3.3719" extension="A9999XYZ100T0474"/>   Example UDI HIBCC: Serial# XYZ456789012345678, Lot# LOT123456789012345 <id root="2.16.840.1.113883.3.3719" extension="+H123PARTNO1234567890120/$$420020216LOT123456789012345/SXYZ456789012345678/16D20130202C"/> hl7:playingDevice 1 … 1 R The playingDevice element describes the device instance.  (IPS...try) @classCode cs 1 … 1 F DEV @determiner​Code cs 1 … 1 F INSTANCE hl7:code CE.IPS (preferred) 1 … 1 R The device code describes the type of device (e.g. arm prosthesis, arterial stent). (IPS...try)   CONF The value of @code comes preferably from value set 2.16.840.1.113883.11.22.23 IPS Medical Devices (DYNAMIC) or The value of @code comes preferably from value set 2.16.840.1.113883.11.22.61 Absent or Unknown Devices (DYNAMIC) hl7:entryRelationship 0 … * Contains 2.16.840.1.113883.10.22.4.31 IPS Internal Reference (DYNAMIC) (IPS...try) @typeCode cs 1 … 1 F COMP @inversionInd bl 1 … 1 F true

IPS Radiology Result Observation

Id	2.16.840.1.113883.10.22.4.12	Effective Date	2017‑03‑21
Status	Under pre-publication review	Version Label	STU1
Name	IPSRadiologyResultObservation	Display Name	IPS Radiology Result Observation
Description This template represents an observation produced as one of the results of a radiology or other imaging study performed on a patient.  In most cases, in the context of a patient summary this observation is final and validated, which is recorded with the value "completed" in the statusCode element. Should  the observation be not final, the statusCode would indicate "active", instead.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.12
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Uses	Uses 2 templates Uses as Name Version 2.16.840.1.113883.10.22.4.14 Containment IPS Body Author (STU1) DYNAMIC 2.16.840.1.113883.10.22.4.22 Containment IPS Comment Activity (STU1) DYNAMIC
Relationship	Adaptation: template 2.16.840.1.113883.10.12.303 CDA Observation (2005‑09‑07) ref ad1bbr- Adaptation: template 2.16.840.1.113883.10.20.22.4.2 Result Observation (V3) (2015‑08‑01) ref ccda- Adaptation: template 2.16.840.1.113883.10.22.4.10 IPS Result Observation (2017‑03‑02)
Example	Example <observation classCode="OBS" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.12"/>  <id root="1.2.3.999" extension="__example only__"/>  <code code="..." codeSystem="1.2.3.999"/>  <statusCode code="active"/>  <effectiveTime>     <low value="20170721091625"/>  </effectiveTime>  <!-- choice: 1..1 element hl7:value element hl7:value element hl7:value -->   <interpretationCode code="CAR" displayName="Carrier" codeSystem="2.16.840.1.113883.5.83"/>  <methodCode code="..." codeSystem="1.2.3.999"/>  <targetSiteCode>     <qualifier>       <name code="272741003" codeSystem="2.16.840.1.113883.6.96" displayName="Laterality"/>      <value code="..." codeSystem="2.16.840.1.113883.6.96"/>    </qualifier>    <qualifier>       <name code="106233006" codeSystem="2.16.840.1.113883.6.96" displayName="Topographical modifier"/>      <value code="..." codeSystem="2.16.840.1.113883.6.96"/>    </qualifier>  </targetSiteCode>  <author>     <!-- template 2.16.840.1.113883.10.22.4.14 'IPS Body Author' (dynamic) -->   </author>  <referenceRange>     <observationRange>       <value xsi:type="ANY"/>      <interpretationCode code="N" codeSystem="2.16.840.1.113883.5.83" displayName="Normal"/>    </observationRange>  </referenceRange>  <entryRelationship typeCode="COMP">     <!-- template 2.16.840.1.113883.10.22.4.22 'IPS Comment Activity' (dynamic) -->   </entryRelationship></observation>
Item DT Card Conf Description Label hl7:observation (IPS...ion) @classCode cs 1 … 1 F OBS @moodCode cs 1 … 1 F EVN hl7:templateId II 1 … 1 M (IPS...ion) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.12 hl7:id II 0 … * R (IPS...ion) hl7:code CD.IPS (extensible) 1 … 1 M (IPS...ion)   CONF The value of @code should be drawn from value set 2.16.840.1.113883.11.22.40 IPS Results Observation Radiology (DYNAMIC) hl7:statusCode CS 1 … 1 M (IPS...ion)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.19890 x_ActStatusActiveComplete (DYNAMIC) hl7:effectiveTime IVL_TS 1 … 1 R (IPS...ion) Choice 1 … 1 Elements to choose from: hl7:value[@xsi:type='CE.IPS'] hl7:value[@xsi:type='PQ'] hl7:value[@xsi:type='IVL_PQ'] hl7:value[@xsi:type='ST'] hl7:value[@xsi:type='TS'] hl7:value[@xsi:type='RTO_QTY_QTY'] hl7:value CE.IPS 0 … 1 R (IPS...ion) where [@xsi:type='CE.IPS']   Example Result code: code '201' from code system 2.16.840.1.113883.2.4.4.30.1045 <value xsi:type="CE" code="201" codeSystem="2.16.840.1.113883.2.4.4.30.1045" displayName="regular"/>   Example Result code: code 'POS' from code system 2.16.840.1.113883.5.83 <value xsi:type="CE" code="POS" codeSystem="2.16.840.1.113883.5.83"/> hl7:value PQ 0 … 1 R (IPS...ion) where [@xsi:type='PQ']   Constraint If Observation/value is a physical quantity (xsi:type="PQ"), the unit of measure SHALL be selected from ValueSet UnitsOfMeasureCaseSensitive 2.16.840.1.113883.1.11.12839 DYNAMIC   Example Result physical quantity (data type PQ): 136 mmol per liter <value xsi:type="PQ" value="136" unit="mmol/L"/> hl7:value IVL_PQ 0 … 1 R (IPS...ion) where [@xsi:type='IVL_PQ']   Example Result interval of physical quantities (data type IVL_PQ): 150 - 400 Billion per 10 exp 9 liter <value xsi:type="IVL_PQ">   <low value="150" unit="10+9/l"/>  <high value="400" unit="10+9/l"/></value> hl7:value ST 0 … 1 R (IPS...ion) where [@xsi:type='ST']   Example Result free text (data type ST) <value xsi:type="ST">This is a result as a free text</value> hl7:value TS 0 … 1 R (IPS...ion) where [@xsi:type='TS']   Example Result time stamp (data type TS): 6-Aug-2014 <value xsi:type="TS" value="20140806"/> hl7:value RTO_QTY_QTY 0 … 1 R (IPS...ion) where [@xsi:type='RTO_QTY_QTY']   Example Result ratio (data type RTO_QTY_QTY): 1/179 <value xsi:type="RTO_QTY_QTY">   <numerator xsi:type="INT" value="1"/>  <denominator xsi:type="INT" value="179"/></value> hl7:interpretationCode CE.IPS 0 … 1 R (IPS...ion)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.78 ObservationInterpretation (DYNAMIC) hl7:target​Site​Code CD.IPS (preferred) 0 … 1 (IPS...ion)   Constraint If the observation site is not precoordinated in the observation/code or observation/value it SHALL be specified in the observation/targetSiteCode   CONF The value of @code comes preferably from value set 2.16.840.1.113883.11.22.55 IPS Target Site (DYNAMIC) hl7:qualifier CR 0 … 1 Laterality (IPS...ion)   Constraint The qualifier element for laterality SHALL be present if the targetSiteCode represents a paired body part and laterality is not pre-coordinated in the targetSiteCode hl7:name CV (preferred) 1 … 1 M (IPS...ion) @code CONF 1 … 1 F 272741003 @codeSystem 1 … 1 F 2.16.840.1.113883.6.96 (SNOMED Clinical Terms) hl7:value CD.IPS (preferred) 1 … 1 M (IPS...ion)   CONF The value of @code comes preferably from value set 2.16.840.1.113883.11.22.57 Laterality (qualifier) (DYNAMIC) hl7:qualifier CR 0 … 1 Topographical modifier (IPS...ion) hl7:name CV (preferred) 1 … 1 M (IPS...ion) @code CONF 1 … 1 F 106233006 @codeSystem 1 … 1 F 2.16.840.1.113883.6.96 (SNOMED Clinical Terms) hl7:value CD.IPS (preferred) 1 … 1 M (IPS...ion)   CONF The value of @code comes preferably from value set 2.16.840.1.113883.11.22.58 Topographical modifier (qualifier) (DYNAMIC) hl7:author 0 … * R Contains 2.16.840.1.113883.10.22.4.14 IPS Body Author (DYNAMIC) (IPS...ion) hl7:referenceRange 0 … * R (IPS...ion) hl7:observationRange 1 … 1 M (IPS...ion) hl7:code CD NP (IPS...ion) hl7:value ANY 1 … 1 M (IPS...ion) hl7:interpretationCode CE 0 … 1 (IPS...ion) @code CONF 0 … 1 F N @codeSystem 0 … 1 F 2.16.840.1.113883.5.83 (Observation Interpretation) hl7:entryRelationship 0 … * Contains 2.16.840.1.113883.10.22.4.22 IPS Comment Activity (DYNAMIC) (IPS...ion) @typeCode cs 1 … 1 F COMP

IPS Reaction Manifestation

Id	2.16.840.1.113883.10.22.4.6	Effective Date	2016‑11‑15
Status	Under pre-publication review	Version Label	STU1
Name	IPSAdverseReactionMFST	Display Name	IPS Reaction Manifestation
Description This clinical statement represents the response to an undesired symptom, finding, etc. due to administered or exposed substance. This reaction may be an undesired symptom, finding, etc. or it could be a desired response to a treatment. A reaction can be defined with respect to its severity, and can have been treated by one or more interventions.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.6
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 2 concepts Id Name Data Set hl7ips-data​element-193  Manifestation of the reaction  CEN/TC 251 prEN 17269 hl7ips-data​element-194  Severity  CEN/TC 251 prEN 17269
Uses	Uses 1 template Uses as Name Version 2.16.840.1.113883.10.22.4.25 Containment IPS Severity Observation (STU1) DYNAMIC
Relationship	Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.5 IHE Problem Entry (DYNAMIC) ref ch-pcc-
Example	Example <observation classCode="OBS" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.6"/>  <id root="1.2.3.999" extension="__example only__"/>  <code code="404684003" displayName="Clinical finding" codeSystem="2.16.840.1.113883.6.96"/>  <text>     <reference value="#ref1"/>  </text>  <statusCode code="completed"/>  <effectiveTime>     <low value="201611"/>  </effectiveTime>  <value xsi:type="CD" code="1985008" displayName="Vomitus" codeSystem="2.16.840.1.113883.6.96">     <originalText>       <reference value="#ref2"/>    </originalText>  </value>  <entryRelationship typeCode="SUBJ" inversionInd="true">     <!-- template 2.16.840.1.113883.10.22.4.25 'IPS Severity Observation' (dynamic) -->   </entryRelationship></observation>
Item DT Card Conf Description Label hl7:observation R (IPS...FST) @classCode cs 0 … 1 F OBS @moodCode cs 1 … 1 F EVN hl7:templateId II 1 … 1 M (IPS...FST) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.6 hl7:id II 0 … * R (IPS...FST) hl7:code CD.IPS 1 … 1 R This element describes the type of condition this observation is referring to. (IPS...FST)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.16 Problem Type (2017‑04‑07) hl7:text ED 0 … 1 R The <text> element if present points to the text describing the problem being recorded; including any dates, comments, et cetera. The <reference> contains a URI in value attribute. This URI points to the free text description of the problem in the document that is being described. (IPS...FST) hl7:reference TEL 1 … 1 M (IPS...FST) @value 1 … 1 R When used it shall refer to the narrative, typically #{label}-{generated-id}, e.g. #xxx-1 hl7:statusCode CS (required) 0 … 1 R A clinical document normally records only those condition observation events that have been completed, not observations that are in any other state. Therefore, the <statusCode> shall always have code='completed'. (IPS...FST) @code CONF 0 … 1 F completed hl7:effectiveTime IVL_TS 1 … 1 M The effectiveTime, also referred to as the “biologically relevant time” is the time at which the observation holds for the patient. For a provider seeing a patient in the clinic today, observing a history of heart attack that occurred five years ago, the effectiveTime is five years ago. The <low> and <high> values should be no more precise than known, but as precise as possible. (IPS...FST) hl7:low IVXB_TS 1 … 1 R The effectiveTime/low (a.k.a. "onset date") asserts when the condition became biologically active. (IPS...FST) hl7:high IVXB_TS 0 … 1 C The effectiveTime/high (a.k.a. "resolution date") asserts when the condition e became biologically resolved. If the date of resolution is not known, then effectiveTime/high will be present with a nullFlavor of "UNK". (IPS...FST)   Constraint If this condition is known to be resolved, then the effectiveTime/high would be present. hl7:value CD.IPS (preferred) 1 … 1 R The <value> is the condition that was found. While the value may be a coded or an un-coded string, the type is always a coded value.  If uncoded, it shall contain a <reference> to the <originalText> in the narrative where the reaction is described. (IPS...FST)   hl7ips-data​element-193  Manifestation of the reaction  CEN/TC 251 prEN 17269 @xsi:type 1 … 1 F CD   CONF The value of @code comes preferably from value set 2.16.840.1.113883.11.22.3 Allergy Reaction (2017‑02‑23) hl7:originalText 0 … 1 R The <originalText> element within the <code> element described above is used as follows: the <value> contains a <reference> to the <originalText> in order to link the coded value to the problem narrative text (minus any dates, comments, et cetera). The <reference> contains a URI in value attribute. This URI points to the free text description of the problem in the document that is being described. (IPS...FST) hl7:reference 0 … 1 R The URI given in the value attribute of the <reference> element points to an element in the narrative content that contains the complete text describing the medication. In a CDA document, the URI given in the value attribute of the <reference> element points to an element in the narrative content that contains the complete text describing the medication. (IPS...FST)   Example <reference value="#AdvReaction_1"/> hl7:translation CD 0 … * (IPS...FST) hl7:entryRelationship 0 … 1 R Severity The contained entry describes a subjective assessment of the severity of the condition as evaluated by the clinician. Contains 2.16.840.1.113883.10.22.4.25 IPS Severity Observation (DYNAMIC) (IPS...FST)   hl7ips-data​element-194  Severity  CEN/TC 251 prEN 17269 @typeCode cs 1 … 1 F SUBJ @inversionInd bl 1 … 1 F true

IPS Result Observation

Id	2.16.840.1.113883.10.22.4.10	Effective Date	2017‑03‑02
Status	Under pre-publication review	Version Label	STU1
Name	IPSResultObservation	Display Name	IPS Result Observation
Description This generic template is the basic set of constraints, which apply to any kind of observation grouped in a Result Organizer. The IPS Result Observation template is generic. It is further specialized by child templates, which  constrain  clinical laboratory observations or radiology observations or anatomic pathology observations. The generic IPS Result Observation template is usable in a patient summary for observations, which do not fall within one of the specialized categories.   The result observation includes a statusCode to allow recording the status of an observation. “Pending” results (e.g., a test has been run but results have not been reported yet) should be represented as “active” ActStatus. However, in most cases, observations selected for an international patient summary are  results that are final and approved, and thus, have a "completed" statusCode. The result of the observation may be commented through an entryRelationship introducing an "IPS Comment activity" template.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.10
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 4 concepts Id Name Data Set hl7ips-data​element-106  Observation Result  CEN/TC 251 prEN 17269 hl7ips-data​element-143  Date of observation  CEN/TC 251 prEN 17269 hl7ips-data​element-144  Observation Type  CEN/TC 251 prEN 17269 hl7ips-data​element-145  Value  CEN/TC 251 prEN 17269
Uses	Uses 2 templates Uses as Name Version 2.16.840.1.113883.10.22.4.14 Containment IPS Body Author (STU1) DYNAMIC 2.16.840.1.113883.10.22.4.22 Containment IPS Comment Activity (STU1) DYNAMIC
Relationship	Adaptation: template 2.16.840.1.113883.10.12.303 CDA Observation (2005‑09‑07) ref ad1bbr- Adaptation: template 2.16.840.1.113883.10.20.22.4.2 Result Observation (V3) (2015‑08‑01) ref ccda-
Example	Example <observation classCode="OBS" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.10"/>  <id root="1.2.3.999" extension="__example only__"/>  <code code="..." codeSystem="1.2.3.999"/>  <statusCode/>  <effectiveTime>     <low value="20170721091742"/>  </effectiveTime>  <value xsi:type="PQ" value="136" unit="mmol/L"/>  <interpretationCode code="..." codeSystem="2.16.840.1.113883.5.83"/>  <methodCode code="..." codeSystem="1.2.3.999"/>  <targetSiteCode code="..." codeSystem="1.2.3.999"/>  <author>     <!-- template 2.16.840.1.113883.10.22.4.14 'IPS Body Author' (dynamic) -->   </author>  <referenceRange>     <observationRange>       <value xsi:type="PQ" value=".." unit="..."/>      <interpretationCode code="N" codeSystem="2.16.840.1.113883.5.83" displayName="Normal"/>    </observationRange>  </referenceRange>  <entryRelationship typeCode="COMP">     <!-- template 2.16.840.1.113883.10.22.4.22 'IPS Comment Activity' (dynamic) -->   </entryRelationship></observation>
Item DT Card Conf Description Label hl7:observation (IPS...ion)   hl7ips-data​element-106  Observation Result  CEN/TC 251 prEN 17269 @classCode cs 1 … 1 F OBS @moodCode cs 1 … 1 F EVN hl7:templateId II 1 … 1 M (IPS...ion) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.10 hl7:id II 0 … * R (IPS...ion) hl7:code CD.IPS 1 … 1 M (IPS...ion)   hl7ips-data​element-144  Observation Type  CEN/TC 251 prEN 17269   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.38 IPS Results Observation (DYNAMIC) hl7:statusCode CS 1 … 1 M (IPS...ion) hl7:effectiveTime IVL_TS 1 … 1 R (IPS...ion)   hl7ips-data​element-143  Date of observation  CEN/TC 251 prEN 17269 Choice 1 … 1 Elements to choose from: hl7:value[@xsi:type='CE.IPS'] hl7:value[@xsi:type='PQ'] hl7:value[@xsi:type='IVL_PQ'] hl7:value[@xsi:type='ST'] hl7:value[@xsi:type='TS'] hl7:value[@xsi:type='RTO_QTY_QTY'] hl7:value CE.IPS 0 … 1 R (IPS...ion) where [@xsi:type='CE.IPS']   hl7ips-data​element-145  Value  CEN/TC 251 prEN 17269   Example Result code: code '201' from code system 2.16.840.1.113883.2.4.4.30.1045 <value xsi:type="CE" code="201" codeSystem="2.16.840.1.113883.2.4.4.30.1045" displayName="regular"/>   Example Result code: code 'POS' from code system 2.16.840.1.113883.5.83 <value xsi:type="CE" code="POS" codeSystem="2.16.840.1.113883.5.83"/> hl7:value PQ 0 … 1 R (IPS...ion) where [@xsi:type='PQ']   Constraint If Observation/value is a physical quantity (xsi:type="PQ"), the unit of measure SHALL be selected from ValueSet UnitsOfMeasureCaseSensitive 2.16.840.1.113883.1.11.12839 DYNAMIC   Example Result physical quantity (data type PQ): 136 mmol per liter <value xsi:type="PQ" value="136" unit="mmol/L"/> hl7:value IVL_PQ 0 … 1 R (IPS...ion) where [@xsi:type='IVL_PQ']   Example Result interval of physical quantities (data type IVL_PQ): 150 - 400 Milliard per 10 exp 9 liter <value xsi:type="IVL_PQ">   <low value="150" unit="10+9/l"/>  <high value="400" unit="10+9/l"/></value> hl7:value ST 0 … 1 R (IPS...ion) where [@xsi:type='ST']   Example Result free text (data type ST) <value xsi:type="ST">This is a result as a free text</value> hl7:value TS 0 … 1 R (IPS...ion) where [@xsi:type='TS']   Example Result time stamp (data type TS): 6-Aug-2014 <value xsi:type="TS" value="20140806"/> hl7:value RTO_QTY_QTY 0 … 1 R (IPS...ion) where [@xsi:type='RTO_QTY_QTY']   Example Result ratio (data type RTO_QTY_QTY): 1/179 <value xsi:type="RTO_QTY_QTY">   <numerator xsi:type="INT" value="1"/>  <denominator xsi:type="INT" value="179"/></value> hl7:interpretationCode CE.IPS 0 … 1 R (IPS...ion)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.78 ObservationInterpretation (DYNAMIC) hl7:target​Site​Code CD.IPS (preferred) 0 … 1 (IPS...ion)   CONF The value of @code comes preferably from value set 2.16.840.1.113883.11.22.55 IPS Target Site (DYNAMIC) hl7:author 0 … * R Contains 2.16.840.1.113883.10.22.4.14 IPS Body Author (DYNAMIC) (IPS...ion) hl7:referenceRange 0 … * R (IPS...ion) hl7:observationRange 1 … 1 M (IPS...ion) hl7:code CD NP (IPS...ion) hl7:value ANY 1 … 1 M (IPS...ion) hl7:interpretationCode CE 0 … 1 (IPS...ion) @code CONF 0 … 1 F N @codeSystem 0 … 1 F 2.16.840.1.113883.5.83 (Observation Interpretation) hl7:entryRelationship 0 … * Contains 2.16.840.1.113883.10.22.4.22 IPS Comment Activity (DYNAMIC) (IPS...ion) @typeCode cs 1 … 1 F COMP

IPS Result Organizer

Id	2.16.840.1.113883.10.22.4.9	Effective Date	2017‑03‑02
Status	Under pre-publication review	Version Label	STU1
Name	IPSResultOrganizer	Display Name	IPS Result Organizer
Description This template provides a mechanism for grouping result observations. It contains information applicable to all of the contained result observations. The Result Organizer code categorizes the contained results into one of several commonly accepted values (e.g., “Hematology”, “Chemistry”, “Nuclear Medicine”). If any Result Observation within the organizer has a statusCode of "active", the Result Organizer must also have a statusCode of "active". However, the results selected for a patient summary are most often final results, with status "completed". So in most cases, the statusCode of the Organizer is "completed". The  result observations contained within the organizer may use either of these templates: Laboratory Result Observation Radiology Result Observation Pathology Result Observation Result Observation (most generic template used whenever none of the above is applicable) One Result Organizer entry groups results, which have a common context of production: common specialty (imaging, bacteriology, serology, chemistry,  surgical pathology, clinical, radiology ...),  common overall interpretation, (which interprets the set of results of the Organizer), common biologic specimen for in vitro diagnostic observations,  common associated illustrative image (ObservationMedia). The ultimate choice for sorting out results between Organizer entries belongs to the authoring person or system of the section.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.9
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 6 concepts Id Name Data Set hl7ips-data​element-106  Observation Result  CEN/TC 251 prEN 17269 hl7ips-data​element-143  Date of observation  CEN/TC 251 prEN 17269 hl7ips-data​element-144  Observation Type  CEN/TC 251 prEN 17269 hl7ips-data​element-146  Performer  CEN/TC 251 prEN 17269 hl7ips-data​element-177  Observer  CEN/TC 251 prEN 17269 hl7ips-data​element-23  Observation Result  CEN/TC 251 prEN 17269
Uses	Uses 9 templates Uses as Name Version 2.16.840.1.113883.10.12.323 Containment CDA Performer (Body) DYNAMIC 2.16.840.1.113883.10.22.4.14 Containment IPS Body Author (STU1) DYNAMIC 2.16.840.1.113883.10.22.4.13 Containment IPS Laboratory Result Observation (STU1) DYNAMIC 2.16.840.1.113883.10.22.4.12 Containment IPS Radiology Result Observation (STU1) DYNAMIC 2.16.840.1.113883.10.22.4.11 Containment IPS Pathology Result Observation (STU1) DYNAMIC 2.16.840.1.113883.10.22.4.10 Containment IPS Result Observation (STU1) DYNAMIC 2.16.840.1.113883.10.22.4.30 Containment IPS Specimen Collection (STU1) DYNAMIC 2.16.840.1.113883.10.22.4.22 Containment IPS Comment Activity (STU1) DYNAMIC 2.16.840.1.113883.10.22.4.23 Containment IPS ObservationMedia (2021) DYNAMIC
Relationship	Adaptation: template 2.16.840.1.113883.10.12.305 CDA Organizer (2005‑09‑07) ref ad1bbr- Adaptation: template 2.16.840.1.113883.10.20.22.4.1 Result Organizer (V3) (2015‑08‑01) ref ccda-
Example	Example <organizer classCode="BATTERY" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.9"/>  <code code="11529-5" displayName="Surgical pathology studies (set)" codeSystemName="LOINC" codeSystem="2.16.840.1.113883.6.1"/>  <satusCode code="completed"/>  <author>     <!-- template 2.16.840.1.113883.10.12.318 'CDA Author (Body)' - a pathologist -->   </author>  <component>     <!-- template 2.16.840.1.113883.10.22.4.11 'IPS Pathology Result Observation' -->   </component>  <component>     <!-- template 2.16.840.1.113883.10.22.4.30 'IPS Specimen Collection' - excised tissue specimen -->   </component>  <component>     <!-- template 2.16.840.1.113883.10.22.4.22 'IPS Comment Activity' - pathologist's interpretation -->   </component>  <component>     <!-- template 2.16.840.1.113883.10.22.4.23 'IPS ObservationMedia' - an illustrative slide image -->   </component></organizer>
Example	Example <organizer classCode="BATTERY" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.9"/>  <code code="18719-5" displayName="Chemistry studies (set)" codeSystemName="LOINC" codeSystem="2.16.840.1.113883.6.1"/>  <satusCode code="completed"/>  <author>     <!-- template 2.16.840.1.113883.10.12.318 'CDA Author (Body)' - a clinical laboratory director -->   </author>  <component>     <!-- template 2.16.840.1.113883.10.22.4.13 'IPS Laboratory Result Observation' -->   </component>  <component>     <!-- template 2.16.840.1.113883.10.22.4.13 'IPS Laboratory Result Observation' -->   </component>  <component>     <!-- template 2.16.840.1.113883.10.22.4.30 'IPS Specimen Collection' - common blood serum specimen -->   </component>  <component>     <!-- template 2.16.840.1.113883.10.22.4.22 'IPS Comment Activity' - interpretation of chemistry results -->   </component></organizer>
Example	Example <organizer classCode="BATTERY" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.9"/>  <code code="18748-4" displayName="Diagnostic imaging study" codeSystemName="LOINC" codeSystem="2.16.840.1.113883.6.1"/>  <satusCode code="completed"/>  <author>     <!-- template 2.16.840.1.113883.10.12.318 'CDA Author (Body)' - a radiologist -->   </author>  <component>     <!-- template 2.16.840.1.113883.10.22.4.12 'IPS Radiology Result Observation' -->   </component>  <component>     <!-- template 2.16.840.1.113883.10.22.4.23 'IPS ObservationMedia' - an illustrative image -->   </component>  <component>     <!-- template 2.16.840.1.113883.10.22.4.22 'IPS Comment Activity' - overall interpretation -->   </component></organizer>
Item DT Card Conf Description Label hl7:organizer (IPS...zer)   hl7ips-data​element-106  Observation Result  CEN/TC 251 prEN 17269 @classCode cs 1 … 1 R @moodCode cs 1 … 1 F EVN hl7:templateId II 1 … 1 M (IPS...zer) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.9 hl7:id II 0 … * (IPS...zer) hl7:code CD.IPS 1 … 1 R (IPS...zer)   hl7ips-data​element-144  Observation Type  CEN/TC 251 prEN 17269   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.37 IPS Results Organizer (DYNAMIC) hl7:statusCode CS 1 … 1 M (IPS...zer)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.19890 x_ActStatusActiveComplete (DYNAMIC) hl7:effectiveTime IVL_TS 0 … 1 (IPS...zer)   hl7ips-data​element-143  Date of observation  CEN/TC 251 prEN 17269 hl7:low IVXB_TS 0 … 1 (IPS...zer) hl7:high IVXB_TS 0 … 1 (IPS...zer) hl7:performer 0 … * R When present, this element represents the organization who performed the set of observations grouped under this organizer. Contains 2.16.840.1.113883.10.12.323 CDA Performer (Body) (DYNAMIC) (IPS...zer)   hl7ips-data​element-146  Performer  CEN/TC 251 prEN 17269 hl7:author 0 … * R Contains 2.16.840.1.113883.10.22.4.14 IPS Body Author (DYNAMIC) (IPS...zer)   hl7ips-data​element-177  Observer  CEN/TC 251 prEN 17269 Choice 1 … * Elements to choose from: hl7:component containing template 2.16.840.1.113883.10.22.4.13 IPS Laboratory Result Observation (DYNAMIC) hl7:component containing template 2.16.840.1.113883.10.22.4.12 IPS Radiology Result Observation (DYNAMIC) hl7:component containing template 2.16.840.1.113883.10.22.4.11 IPS Pathology Result Observation (DYNAMIC) hl7:component containing template 2.16.840.1.113883.10.22.4.10 IPS Result Observation (DYNAMIC) hl7:component containing template 2.16.840.1.113883.10.22.4.30 IPS Specimen Collection (DYNAMIC) hl7:component containing template 2.16.840.1.113883.10.22.4.22 IPS Comment Activity (DYNAMIC) hl7:component containing template 2.16.840.1.113883.10.22.4.23 IPS ObservationMedia (DYNAMIC) hl7:component 0 … * Contains 2.16.840.1.113883.10.22.4.13 IPS Laboratory Result Observation (DYNAMIC) (IPS...zer) hl7:component 0 … * Contains 2.16.840.1.113883.10.22.4.12 IPS Radiology Result Observation (DYNAMIC) (IPS...zer) hl7:component 0 … * Contains 2.16.840.1.113883.10.22.4.11 IPS Pathology Result Observation (DYNAMIC) (IPS...zer) hl7:component 0 … * Contains 2.16.840.1.113883.10.22.4.10 IPS Result Observation (DYNAMIC) (IPS...zer)   hl7ips-data​element-23  Observation Result  CEN/TC 251 prEN 17269 hl7:component 0 … * Contains 2.16.840.1.113883.10.22.4.30 IPS Specimen Collection (DYNAMIC) (IPS...zer)   Constraint An IPS Specimen Collection SHALL be present only if the organizer carries anatomic pathology or microbiology laboratory observations, which need to be associated with the specific anatomic site the specimen was collected from. hl7:component 0 … * Contains 2.16.840.1.113883.10.22.4.22 IPS Comment Activity (DYNAMIC) (IPS...zer)   Constraint An IPS Comment Activity SHALL contain a general comment applying to the whole set of observations present in the organizer hl7:component 0 … * Contains 2.16.840.1.113883.10.22.4.23 IPS ObservationMedia (DYNAMIC) (IPS...zer)

IPS Severity Observation

Id	2.16.840.1.113883.10.22.4.25	Effective Date	2017‑04‑07
Status	Under pre-publication review	Version Label	STU1
Name	EntrySeverity	Display Name	IPS Severity Observation
Description This clinical statement represents the subjective assessment of the severity of the condition as evaluated by the clinician. The Severity Observation can be associated with a Reaction Observation.  When the Severity Observation is associated with a Reaction Observation it characterizes a reaction. A person may manifest many symptoms in a reaction to a single substance, and each reaction to the substance can be represented. However, each reaction observation can have only one severity observation associated with it. For example, someone may have a rash reaction observation as well as an itching reaction observation, but each can have only one level of severity.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.25
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 3 concepts Id Name Data Set hl7ips-data​element-128  Severity  CEN/TC 251 prEN 17269 hl7ips-data​element-136  Severity  CEN/TC 251 prEN 17269 hl7ips-data​element-194  Severity  CEN/TC 251 prEN 17269
Relationship	Adaptation: template 1.3.6.1.4.1.19376.1.5.3.1.4.1 eHDSI Severity (DYNAMIC) ref epsos-
Example	Example <observation classCode="OBS" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.25"/>  <id root="1.2.3.999" extension="__example only__"/>  <code code="SEV" displayName="Severity Observation" codeSystem="2.16.840.1.113883.5.4"/>  <text>     <reference value="#example"/>  </text>  <statusCode code="completed"/>  <value code="255604002" displayName="Mild" codeSystem="2.16.840.1.113883.6.96"/></observation>
Item DT Card Conf Description Label hl7:observation R (Ent...ity)   hl7ips-data​element-128  Severity  CEN/TC 251 prEN 17269 hl7ips-data​element-194  Severity  CEN/TC 251 prEN 17269 @classCode cs 0 … 1 F OBS @moodCode cs 1 … 1 F EVN hl7:templateId II 1 … 1 M (Ent...ity) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.25 hl7:id II 0 … * R (Ent...ity) hl7:code CD 1 … 1 R (Ent...ity)   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.20386 SeverityObservationCode (DYNAMIC) hl7:text ED 0 … 1 R If present, the <text> element shall contain a <reference> element pointing to the narrative where the severity is recorded</reference></text> (Ent...ity) hl7:reference TEL 1 … 1 M (Ent...ity) @value 1 … 1 R Reference pointing to the narrative, typically #{label}-{generated-id}, e.g. #xxx-1 hl7:statusCode CS 1 … 1 M (Ent...ity) @code CONF 1 … 1 F completed hl7:value CD.IPS (preferred) 1 … 1 R The <value> element contains the level of severity. (Ent...ity)   hl7ips-data​element-136  Severity  CEN/TC 251 prEN 17269   CONF The value of @code comes preferably from value set 2.16.840.1.113883.11.22.18 Problem Severity (DYNAMIC)

IPS Social History Alcohol Use

Id	2.16.840.1.113883.10.22.4.35	Effective Date	2017‑06‑29
Status	Under pre-publication review	Version Label	STU1
Name	IPSSocialHistoryObsAlcoholUse	Display Name	IPS Social History Alcohol Use
Description	This template is a specialization of the Social History Observation that may be used to represent alcohol consumption habits.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.35
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 2 concepts Id Name Data Set hl7ips-data​element-151  Reference date range  CEN/TC 251 prEN 17269 hl7ips-data​element-176  Life Style Factor  CEN/TC 251 prEN 17269
Relationship	Adaptation: template 2.16.840.1.113883.10.20.22.4.38 Social History Observation (V3) (2015‑08‑01) ref ccda- Adaptation: template 2.16.840.1.113883.10.12.303 CDA Observation (2005‑09‑07) ref ad1bbr-
Example	Example <observation classCode="OBS" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.35"/>  <id root="1.2.3.999" extension="__example only__"/>  <code code="74013-4" codeSystem="2.16.840.1.113883.6.96" displayName="Alcoholic drinks per day"/>  <statusCode code="completed"/>  <effectiveTime>     <low value="20170719113711"/>  </effectiveTime>  <value xsi:type="PQ" value="1" unit="d"/></observation>
Item DT Card Conf Description Label hl7:observation (IPS...Use)   hl7ips-data​element-176  Life Style Factor  CEN/TC 251 prEN 17269 @classCode cs 1 … 1 F OBS @moodCode cs 1 … 1 F EVN hl7:templateId II 1 … 1 M (IPS...Use) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.35 hl7:id II 0 … * (IPS...Use) hl7:code CD.IPS (preferred) 1 … 1 R (IPS...Use) @code CONF 0 … 1 F 74013-4 @codeSystem 0 … 1 F 2.16.840.1.113883.6.1 (LOINC) hl7:translation 0 … * R (IPS...Use) hl7:statusCode CS 1 … 1 M (IPS...Use) @code CONF 1 … 1 F completed hl7:effectiveTime IVL_TS 1 … 1 R (IPS...Use)   hl7ips-data​element-151  Reference date range  CEN/TC 251 prEN 17269 hl7:value PQ 1 … 1 R (IPS...Use) @xsi:type cs 1 … 1 F PQ @unit 1 … 1 F /d

IPS Social History Tobacco Use

Id	2.16.840.1.113883.10.22.4.34	Effective Date	2017‑06‑20
Status	Under pre-publication review	Version Label	STU1
Name	IPSSocialHistoryObsTobaccoUse	Display Name	IPS Social History Tobacco Use
Description	This template is a specialization of the Social History Observation that may be used to represent smoking or tobacco habits.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.34
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 1 concept Id Name Data Set hl7ips-data​element-176  Life Style Factor  CEN/TC 251 prEN 17269
Relationship	Adaptation: template 2.16.840.1.113883.10.20.22.4.38 Social History Observation (V3) (2015‑08‑01) ref ccda- Adaptation: template 2.16.840.1.113883.10.12.303 CDA Observation (2005‑09‑07) ref ad1bbr-
Example	Example <observation>   <templateId/>  <id root="1.2.3.999" extension="--example only--"/>  <code code="72166-2" codeSystem="2.16.840.1.113883.6.1" displayName="Tobacco smoking status NHIS"/>  <statusCode code="completed"/>  <effectiveTime>     <low value="20171214094510"/>  </effectiveTime>  <value code="LA18976-3" codeSystem="2.16.840.1.113883.6.1" displayName="Current every day smoker"/></observation>
Item DT Card Conf Description Label hl7:observation (IPS...Use)   hl7ips-data​element-176  Life Style Factor  CEN/TC 251 prEN 17269 @classCode cs 1 … 1 F OBS @moodCode cs 1 … 1 F EVN hl7:templateId II 1 … 1 M (IPS...Use) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.34 hl7:id II 0 … * (IPS...Use) hl7:code CD.IPS 1 … 1 M (IPS...Use) @code CONF 1 … 1 F 72166-2 @codeSystem 1 … 1 F 2.16.840.1.113883.6.1 (LOINC) hl7:translation 0 … * R (IPS...Use) hl7:statusCode CS 1 … 1 M (IPS...Use) @code CONF 1 … 1 F completed hl7:effectiveTime IVL_TS 1 … 1 R (IPS...Use) hl7:value CD.IPS 1 … 1 R (IPS...Use) @xsi:type cs 1 … 1 F CD   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.59 IPS Current Smoking Status (DYNAMIC)

IPS Specimen Collection

Id	2.16.840.1.113883.10.22.4.30	Effective Date	2017‑04‑14
Status	Under pre-publication review	Version Label	STU1
Name	IPSSpecimenCollection	Display Name	IPS Specimen Collection
Description Specimen Collection is used when a set of laboratory or pathology observations  produced on one or more specimens need to be associated with the minimal characteristics of the specimen(s): specimen source site and type of specimen. In addition this template enables to convey when the specimen was collected. In a patient summary there is no need to provide more data than these 4: collection method,  source site,  type of specimen and  time of collection. An occurrence of this template describes one specimen collected, used by the set of observations present in the same Result Organizer.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.30
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Relationship	Adaptation: template 1.3.6.1.4.1.19376.1.3.1.2 Specimen Collection (2008‑08‑08) ref XDLAB- Adaptation: template 2.16.840.1.113883.10.12.301 CDA Act (2005‑09‑07) ref ad1bbr-
Example	Example <procedure classCode="PROC" moodCode="EVN">   <templateId root="2.16.840.1.113883.10.22.4.30"/>  <code code="33882-2" codeSystem="2.16.840.1.113883.6.1" displayName="Collection date of Unspecified specimen"/>  <effectiveTime>     <low value="20170719123716"/>  </effectiveTime>  <targetSiteCode/>  <participant typeCode="PRD">     <participantRole classCode="SPEC">       <id root="1.2.3.999" extension="__example only__"/>      <playingEntity classCode="ENT" determinerCode="INSTANCE">         <code code="122555007" codeSystem="2.16.840.1.113883.6.96" displayName="Venous blood specimen (specimen)"/>      </playingEntity>    </participantRole>  </participant></procedure>
Item DT Card Conf Description Label hl7:procedure (IPS...ion) @classCode cs 1 … 1 F PROC @moodCode cs 1 … 1 F EVN hl7:templateId II 1 … 1 M (IPS...ion) @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.30 hl7:code CD.IPS 0 … 1 R LOINC code representing the act of specimen collection (IPS...ion) @code CONF 0 … 1 F 33882-2 @codeSystem 0 … 1 F 2.16.840.1.113883.6.1 (LOINC) hl7:effectiveTime IVL_TS 0 … 1 R Date and time of specimen collection (IPS...ion) hl7:target​Site​Code 0 … 1 R (IPS...ion) hl7:participant 0 … 1 R One single participant, which is the product of the procedure (PRD), role of specimen (SPEC) played by the playingEntity, which conveys the type of specimen collected (blood, urine, tissue, ...) (IPS...ion) @typeCode cs 1 … 1 F PRD hl7:participantRole 1 … 1 M (IPS...ion) @classCode cs 0 … 1 F SPEC hl7:id II 0 … 1 R (IPS...ion) hl7:playingEntity 1 … 1 R (IPS...ion) @determiner​Code cs 0 … 1 F INSTANCE @classCode cs 0 … 1 F ENT hl7:code CE (preferred) 1 … 1 M (IPS...ion)   CONF The value of @code comes preferably from value set 2.16.840.1.113883.11.22.56 IPS Specimen Type (DYNAMIC)

IPS Subordinate SubstanceAdministration

Id	2.16.840.1.113883.10.22.4.33	Effective Date	2017‑06‑15
Status	Under pre-publication review	Version Label	STU1
Name	IPSSubordinateSubstanceAdministration	Display Name	IPS Subordinate SubstanceAdministration
Description	This entry is used by a main substanceAdministration act to provide dosage information as the frequency of intakes or the amount of the medication given.
Context	Parent nodes of template element with id 2.16.840.1.113883.10.22.4.33
Label	IPSSubordSBADM
Classification	CDA Entry Level Template
Open/Closed	Open (other than defined elements are allowed)
Associated with	Associated with 3 concepts Id Name Data Set hl7ips-data​element-119  Dose Instruction  CEN/TC 251 prEN 17269 hl7ips-data​element-223  Number of units per intake  CEN/TC 251 prEN 17269 hl7ips-data​element-224  Frequency of intake  CEN/TC 251 prEN 17269
Relationship	Specialization: template 2.16.840.1.113883.10.21.4.6 UV Subordinate Substance Administration (DYNAMIC) ref pharmcda-
Example	Example <hl7:substanceAdministration classCode="SBADM" moodCode="EVN">   <hl7:templateId root="2.16.840.1.113883.10.22.4.33"/>  <hl7:statusCode code="active"/>  <!-- choice: 1..1 element hl7:effectiveTime[@value or @nullFlavor] element hl7:effectiveTime[@xsi:type='PIVL_TS'] element hl7:effectiveTime[@xsi:type='EIVL_TS'] element hl7:effectiveTime[@xsi:type='SXPR_TS'] -->   <hl7:effectiveTime xsi:type="PIVL_TS" institutionSpecified="true">     <hl7:period value="12" unit="h"/>  </hl7:effectiveTime>  <hl7:doseQuantity xsi:type="IVL_PQ" value="2" unit="{puff}"/>  <hl7:consumable>     <hl7:manufacturedProduct>       <hl7:manufacturedMaterial nullFlavor="NA"/>    </hl7:manufacturedProduct>  </hl7:consumable></hl7:substanceAdministration>
Item DT Card Conf Description Label hl7:substanceAdministration IPSS...BADM   hl7ips-data​element-119  Dose Instruction  CEN/TC 251 prEN 17269 @classCode cs 1 … 1 F SBADM @moodCode cs 1 … 1 R If the statement refers to a prescribed medication then a <substanceAdministration> intent (moodCode='INT') is used; otherwise, to record medications which are stated to have taken, the moodCode shall be set to 'EVN'.</substanceAdministration>   CONF The value of @moodCode shall be drawn from value set 2.16.840.1.113883.11.20.9.18 MoodCodeEvnInt (DYNAMIC)   Constraint The moodCode of this subordinate <substanceAdministration> SHALL be the same of the parent <substanceAdministration> . hl7:templateId II 1 … 1 M IPSS...BADM @root uid 1 … 1 F 2.16.840.1.113883.10.22.4.33 hl7:statusCode CS 1 … 1 M IPSS...BADM   Constraint The statusCode of this subordinate <substanceAdministration> SHALL be the same of that of the parent <substanceAdministration>.   CONF The value of @code shall be drawn from value set 2.16.840.1.113883.11.22.12 ActStatusActiveCompletedAbortedSuspended (2017‑03‑30)   Example <statusCode code="active"/> Choice 1 … 1 Elements to choose from: hl7:effectiveTime[@value or @nullFlavor] hl7:effectiveTime[@xsi:type='PIVL_TS'] hl7:effectiveTime[@xsi:type='EIVL_TS'] hl7:effectiveTime[@xsi:type='SXPR_TS'] hl7:effectiveTime TS 0 … 1 C This required element describes the frequency of intakes. If not known it shall be valued with the nullflavor "UNK" IPSS...BADM where [@value or @nullFlavor]   hl7ips-data​element-224  Frequency of intake  CEN/TC 251 prEN 17269   Example Once (known date) <effectiveTime value="20170404"/>   Example Unknown <effectiveTime nullFlavor="UNK"/> hl7:effectiveTime PIVL_TS 0 … 1 C IPSS...BADM where [@xsi:type='PIVL_TS']   hl7ips-data​element-224  Frequency of intake  CEN/TC 251 prEN 17269   Example Every 4 hours <effectiveTime xsi:type="PIVL_TS" institutionSpecified="false">   <period value="4" unit="h"/></effectiveTime>   Example Twice a day <effectiveTime xsi:type="PIVL_TS" institutionSpecified="true">   <period value="12" unit="h"/></effectiveTime> hl7:effectiveTime EIVL_TS 0 … 1 C IPSS...BADM where [@xsi:type='EIVL_TS']   hl7ips-data​element-224  Frequency of intake  CEN/TC 251 prEN 17269   Example After meal <effectiveTime xsi:type="EIVL_TS">   <event code="PC" codeSystem="2.16.840.1.113883.5.139"/></effectiveTime>   Example One hour before breakfast <effectiveTime xsi:type="EIVL_TS">   <event code="ACM" codeSystem="2.16.840.1.113883.5.139"/>  <offset>     <low value="1" unit="h"/>  </offset></effectiveTime> hl7:event EIVL.event 0 … 1 C IPSS...BADM @code cs 0 … 1     CONF The value of @code shall be drawn from value set 2.16.840.1.113883.1.11.10706 TimingEvent (DYNAMIC) hl7:effectiveTime SXPR_TS 0 … 1 R IPSS...BADM where [@xsi:type='SXPR_TS']   hl7ips-data​element-224  Frequency of intake  CEN/TC 251 prEN 17269 hl7:doseQuantity IVL_PQ 0 … 1 R The <doseQuantity> describes the amount of the medication given (the dosage). If a dose range is given (e.g., 1-2 tablets, or 325-750mg), then the <low> and <high> bounds are specified in their respective elements; otherwise only one physical quantity is specified (e.g. 2 drops) The dose can be in some known and measurable unit, such as grams, milligrams,or described in "administration" units (unit of presentation, such as capsules). If the dose is in countable items (tablets, caplets, "eaches"), then the unit could be omitted or valorized using the UCUM annotations for describing the type of countable items (e.g. .{tablet}, {puff},..). The unit attribute – when expresses unit of measures- shall be derived from the UCUM code system. The used elements should contain a <translation> element that provides a <reference> to the <originalText> found in the narrative body of the document. IPSS...BADM   hl7ips-data​element-223  Number of units per intake  CEN/TC 251 prEN 17269 @unit cs 0 … 1     Example Not pre-coordinated consumable <doseQuantity value="25" unit="mg"/>   Example Pre-coordinated consumable - Dose Range <doseQuantity>   <low value="1" unit="{tablet}"/>  <high value="2" unit="{tablet}"/></doseQuantity>   Example Pre-coordinated consumable <doseQuantity value="2" unit="{puff}"/>   Example Pre-coordinated consumable with text reference <doseQuantity value="2" unit="{puff}">   <translation>     <originalText>       <reference value="#text-ref-1"/>    </originalText>  </translation></doseQuantity>   Example Textual dosage <doseQuantity nullFlavor="OTH">   <translation>     <originalText>       <reference value="#text-ref-1"/>    </originalText>  </translation></doseQuantity> hl7:rateQuantity IVL_PQ 0 … 1 IPSS...BADM hl7:consumable 1 … 1 R IPSS...BADM hl7:manufacturedProduct 1 … 1 R IPSS...BADM hl7:manufactured​Material 1 … 1 R IPSS...BADM @nullFlavor cs 1 … 1 F NA

HL7 V2/V3 Datatype Level Template

IPS Address

Id	2.16.840.1.113883.10.22.11	Effective Date	2018‑04‑04 15:41:36 Other versions this id: IPSAddress as of 2018‑04‑04 15:42:34 IPSAddress as of 2018‑04‑04 15:41:43
Status	Under pre-publication review	Version Label	STU1
Name	IPSAddress	Display Name	IPS Address
Description	Reusable address template
Classification	HL7 V2/V3 Datatype Level Template
Open/Closed	Open (other than defined elements are allowed)
Relationship	Adaptation: template 2.16.840.1.113883.10.20.22.5.2 US Realm Address (AD.US.FIELDED) (2015‑08‑13) ref ccda-
Example	Example <addr use="HP">   <country>TR</country>  <city>Ankara</city>  <streetAddressLine>Silikon Blok Kat:1</streetAddressLine></addr>
Example	Example <addr use="WP">   <state>FI</state>  <city>FIRENZE</city>  <country>IT</country>  <postalCode>50122</postalCode>  <streetAddressLine>Palazzo Vecchio, Piazza della Signoria</streetAddressLine></addr>
Example	Example <addr nullFlavor="NI"/>
Item DT Card Conf Description Label @use set_cs 0 … 1     CONF The value of @use shall be drawn from value set 2.16.840.1.113883.1.11.10637 PostalAddressUse (2005‑05‑01) @nullFlavor cs 0 … 1 F NI   Constraint SHALL NOT have mixed content except for white space If there is no information, the nullFlavor attribute shall have a value of 'NI' and no address parts shall be present, otherwise there shall be no nullFlavor attribute, and at least one of the address parts listed below shall be present.   Schematron assert role  error     test @nullFlavor or hl7:*     Message If addr is not nullflavored at least one sub element has to be provided   hl7:streetAddressLine ADXP 0 … * C Subject's or Organization's Street Address Line (IPS...ess)   Schematron assert role  error     test hl7:streetAddressLine and (hl7:city or hl7:postalCode)     Message If the address line is included either the city or the zip code has to be provided   hl7:city ADXP 0 … 1 C Subject's or Organization's City (IPS...ess) hl7:postalCode ADXP 0 … 1 C Subject's or Organization's Postal Code (IPS...ess) hl7:state ADXP 0 … 1 C Subject's or Organization's State or Province (IPS...ess) hl7:country ADXP 0 … 1 C Subject's Country. (IPS...ess)   Constraint The content of this element SHALL be selected EITHER from ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300  DYNAMIC OR MAY be selected from ISO Country Alpha-3 2.16.840.1.113883.1.11.171 DYNAMIC, IF the country is not specified in ValueSet ISO Country Alpha-2 urn:oid:2.16.840.1.113883.1.11.20300.

Appendix (Informative)

Acronyms and abbreviations

• CCD: Continuity of Care Document
• C-CDA: Consolidated CDA
• CDA: Clinical Document Architecture
• CEN: Comité Européen de Normalisation (European Committee for Standardization)
• CEN/TC 251 : CEN Technical Committe 251
• DSTU: Draft Standard for Trial Use
• EC: European Commission
• EDQM: European Directorate for the Quality of Medicines & Healthcare
• eHDSI: Digital Service Infrastructure for eHealth
• eHN: eHealth Network
• EHR: Electronic Healthcare Record
• EN: European Normative [or Standard] (CEN)
• epSOS: European Patient Smart Open Services
• EU: European; Europe
• FDA: Food and Drug Administration (USA)
• GP: General Practitioner
• HL7: Health Level Seven
• HP: Healthcare Professional
• IDMP: IDentification of Medicinal Products (ISO Standard)
• IHE: Integrating the Healthcare Enterprise
• INTERPAS: International Patient Summary (HL7 International Project)
• IPS: International Patient Summary
• ISO: International Organization for Standardization
• JAseHN: Joint Action to Support the eHealth Network
• JIC: Joint Initiative Council on SDO Global Health Informatics Standardization
• LOINC: Logical Observation Identifiers Names & Codes
• MOU: Memorandum of Understanding (on cooperation surrounding health related information and communication technologies, that between EU and US)
• MPID: Medicinal Product Identifier
• ONC: Office of the National Coordinator for Health Information Technology (USA)
• PCC: Patient Care Coordination
• PCID : Medicinal Product Package Identifier
• PhPID(s): Pharmaceutical Product Identifier(s)
• prEN: Draft European Normative [or Standard] (CEN)
• prTS: Draft Technical Specifications (CEN)
• PS: Patient Summary
• S&I: Standards and Interoperability (S&I) Framework (run by ONC)
• SAIF: Service Aware Interoperability Framework
• SDO: Standards Developing Organization
• STU: Standard for Trial Use
• TS: Technical Specifications (CEN)
• UCUM: Unified Code for Units of Measure
• WHO: World Health Organization

Glossary

• Compliance. A standard or specification is compliant with another standard or specification if all propositions that are true in the initial standard are also true in the complying standard. The target artifact is compliant with the source artifact if and only if all conforming implementations of the target are also conforming with the source (RM-ODP). The term compliance is also used to state expectations as to how certain specifications need to satisfy possible legislative or regulatory constraints or requirements.
• Conformance relates an implementation to a standard. Any proposition that is true of the specification must be true in its implementation. (ISO, 2010).
• Conformance Assessment is a process whereby a given implementation instance is evaluated to determine which of its various Conformance Assertions are valid implementations of a given specification’s Conformance Statements.
• Conformance Statement is a statement that identifies testable requirements at a specified Conformance Point within a specification, explicitly defining the behavior which must be satisfied at these points. Conformance Statements will only occur in standard which are intended to constrain some feature of a real implementation, so that there exists, in principle, the possibility of testing.
• Conformance Assertion is a testable, verifiable statement made about a specific implementation instance against a corresponding Conformance Statement.
• Conformance Points are the evaluation of conformance at specific points in the implementation or specification. See Conformance.
• Electronic Patient Summary: electronic health record extract containing essential healthcare information intended for specific uses . (EN ISO 13940: 2016)
• International Patient Summary : electronic patient summary for use in the unscheduled, cross-border care scenario comprising at least the required elements of the IPS dataset.
• International Patient Summary dataset: a minimal and non-exhaustive patient summary dataset, specialty-agnostic, condition-independent, but readily usable by clinicians for the cross-border unscheduled care of a patient.

Real World User Stories

This section reports a series of real world user stories adapted from the Trillium Bridge project and the eHDSI initiative .

IPS Storyboard 1: Martha, a traveling corporate executive

Martha, a 45-year old corporate executive and breast cancer survivor travels frequently on business between the US and EU countries. She carries a clinical summary on her mobile phone and on paper just in case she needs to seek medical care regarding recurring symptoms. Martha’s summary includes

• Breast cancer Stage II with no evidence of recurrence following treatment
• hot flashes as problems
• Anastrozole 1 mg. once daily
• Black Cohosh Extract herbal supplement as medications
• the indication of an allergy to Penicillin
• and finally as Plan of Care, to continue hormone medication with Anastrozole for total of 5 years
• and monitor for potential breast cancer recurrence.

During a visit in Austria, Martha walks up a hill and experiences shortness of breath, faints, and wakes up a few minutes later after hitting her head on a stone step. A passerby helps her get to the emergency department of a local hospital. An ambulance is called and she is brought to the emergency ward.

During registration and admission, Martha hands in her patient summary in a USB key. At the hospital, Martha is evaluated by an oncologist and a cardiologist.

Following care provision, Martha receives an encounter report. When back home she hands in the encounter report to her primary physician, who updates her record.

IPS Storyboard 2: Paolo, a retired businessman

Paolo Cerruti is a 67-year-old retired businessman, who normally lives in the outskirts Bergamo, near Lake Como, in Lombardy. He is generally healthy, but has long-standing hypertension. His regular physician changed his medication two weeks ago because of poor blood pressure control on his previous medication. He is on holiday going through New England, US, travelling on his own to enjoy the autumn foliage, and is presently in Boston, MA. He is nearing the end of his holiday, and will be returning to Italy in three days’ time. Two days ago he lost his day bag. The bag included his hypertension medication, and he has not been able to take his tablets for two days.

This morning he has woken up feeling dizzy and has blurred vision. The hotel is able to put him in urgent contact with a local general practitioner (GP). Having assessed him, the GP noted a raised blood pressure, but is uncertain about whether to attribute these symptoms to the raised blood pressure or a side effect of the new medication. Now, the GP in Boston needs to know the medication, and the past few blood pressure readings to determine how exceptional the present reading is and manage Paolo appropriately.

Immediate access to his International Patient Summary would be the perfect answer. Paolo may retrieve his online European Patient Summary for emergency access that is retrieved, transformed into an IPS and shown its content translated in English.

The GP notes that visual disturbances are a recognized side effect of this medication. No specific treatment is indicated, and Paolo is reassured that side effects will gradually subside, and his GP can prescribe a suitable antihypertensive medication upon his return to Lake Como.

IPS Storyboard 3: Diana, a pregnant woman

Diana is a 34-year-old pregnant woman from Lisbon with a past medical history of allergic asthma and thyroid cancer during adolescence; for the latter she had a surgical procedure done (thyroidectomy) and, as a consequence, suffers hypothyroidism which requires hormone replacement for life (levothyroxine). At the age of 31 she was diagnosed with a hereditary cardiac disorder – Brugada Syndrome – and had a cardioverter defibrillator implanted to control potentially lethal arrhythmias.

During the pregnancy of her first child (C-section delivery), she suffered gestational diabetes that developed into type 2 diabetes after giving birth and needs now to receive subcutaneous insulin. As chronic treatment she also needs nebulizations three-time per day for her asthma - this condition is aggravated in her case by being a smoker (1 pack per day) as included in the Social History Section.

At this moment, she presents severe pre-eclampsia (hypertension during pregnancy) in treatment with two oral antihypertensive agents (a combination medication). Additionally, she is following a 14-day-course of antibiotic treatment due to an acute pyelonephritis (kidney infection more likely to be develop in pregnant women due to the physiological changes that may interfere with the flow of urine).

Other sections of her Summary include allergies to latex and kiwi (which are very often associated) and to aspirin, and intolerance to lactose; immunizations administered during childhood and adolescence are also present.

Although being real choices for the different diseases and conditions, the selection of the patient's current medication tries to present some easily described medication as well as not so easily ones: e.g. insulin degludec, amoxicilin+clavulanic acid, and the combination of ipratropium bromide+salbutamol for nebulization. For the oral treatment of the pre-eclampsia the agents selected would not be used in real practice during pregnancy.

Integrated examples

The IPS specification releases are published at hl7intl.art-decor.org the International Patient Summary Project Publication Page . The actual release has a link to the XML materials that the W3C schemas are part of; it also includes example CDA document instances. A set of use cases have been defined and represented in IPS format. Also multiple languages are covered.

It is likely that the publication site will move to hl7.org permanently, and we will inform the community about that process.

Validation artifacts

You can test your implementation (instances) against the IPS specification. To download materials to your computer for local testing and validation consider...

• ...the W3C schemas (actually valid for any CDA specification) located at the Publication Page. The actual release has a link to the XML materials as which the W3C schemas are part of; it also includes example CDA document instances.
• ..the ISO schematron, automatically generated by the tool. These are files to do validation locally by associating IPS CDA instances with the main schematron using an XML editor or to use the derived XSLT conversions and apply the according XSLT derivation to your local IPS CDA instance.

For further information you can follow the documentation.

Operational information

• The IPS project has an official mailing list address ips(at)lists.hl7.org, hosted at the HL7 listserver. Visit your Listserv Subscriptions at hl7.org and subscribe to the International Patient Summary (IPS) that is summarised under the Structured Documents Work Group.
• The original specification is hosted on the logical ART-DECOR main server art-decor.org under the Governance Group HL7 International, the project is reachable at the Live Project Landing Page.
• Any IPS specification release in HTML format resides at the Publication Page. It is likely that the publication site will move to hl7.org permanently, we will inform about that process.
• The IPS specification on the wiki is hosted here (international-patient-summary.net). It is likely that the publication site will move to hl7.org permanently, we will inform about that process.

Licenses

Following is a non-exhaustive list of third-party terminologies that may require a separate license:

• SNOMED CT: SNOMED International (formerly know as International Healthcare Terminology Standards Development Organization IHTSDO) or info@ihtsdo.org
• Logical Observation Identifiers Names & Codes (LOINC): This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core, LOINC Panels and Forms File, LOINC Answer File, LOINC Part File, LOINC Group File, LOINC Document Ontology File, LOINC Hierarchies, LOINC Linguistic Variants File, LOINC/RSNA Radiology Playbook, and LOINC/IEEE Medical Device Code Mapping Table are copyright © 1995-2017, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.
• Unified Code for Units of Measure (UCUM) : Regenstrief Institute, Inc. and the UCUM Organization
• EDQM Standard Terms  : European Directorate for the Quality of Medicines & Healthcare (EDQM)

FAQ’s

This is a placeholder for future Frequently Asked Questions about the International Patient Summary.

List of all artifacts used in this guide

CDA Templates

• 2.16.840.1.113883.10.22.1.1 International Patient Summary
• 2.16.840.1.113883.10.22.2.1 IPS CDA recordTarget
• 2.16.840.1.113883.10.22.2.2 IPS CDA author
• 2.16.840.1.113883.10.22.2.3 IPS CDA custodian
• 2.16.840.1.113883.10.22.2.4 IPS CDA legalAuthenticator
• 2.16.840.1.113883.10.22.2.5 IPS Patient Contacts
• 2.16.840.1.113883.10.22.2.6 IPS CDA documentationOf
• 2.16.840.1.113883.10.22.2.7 IPS CDA relatedDocument
• 2.16.840.1.113883.10.22.3.1 IPS Medication Summary Section
• 2.16.840.1.113883.10.22.3.2 IPS Allergies and Intolerances Section
• 2.16.840.1.113883.10.22.3.3 IPS Problems Section
• 2.16.840.1.113883.10.22.3.4 IPS History of Procedures Section
• 2.16.840.1.113883.10.22.3.5 IPS Immunizations Section
• 2.16.840.1.113883.10.22.3.6 IPS Medical Devices Section
• 2.16.840.1.113883.10.22.3.7 IPS History of Past Illness Section
• 2.16.840.1.113883.10.22.3.8 IPS Functional Status Section
• 2.16.840.1.113883.10.22.3.9 IPS Plan of Care Section
• 2.16.840.1.113883.10.22.3.10 IPS Social History Section
• 2.16.840.1.113883.10.22.3.11 IPS History of Pregnancy Section
• 2.16.840.1.113883.10.22.3.12 IPS Advance Directives Section
• 2.16.840.1.113883.10.22.3.14 IPS Results Section
• 2.16.840.1.113883.10.22.3.15 IPS Translation Section
• 2.16.840.1.113883.10.22.4.1 IPS Allergy or Intolerance
• 2.16.840.1.113883.10.22.4.2 IPS ManufacturedProduct
• 2.16.840.1.113883.10.22.4.3 IPS Manufactured Material
• 2.16.840.1.113883.10.22.4.4 IPS Medication Entry
• 2.16.840.1.113883.10.22.4.5 IPS Allergy and Intolerance Concern
• 2.16.840.1.113883.10.22.4.6 IPS Reaction Manifestation
• 2.16.840.1.113883.10.22.4.7 IPS Problem Concern Entry
• 2.16.840.1.113883.10.22.4.8 IPS Problem Entry
• 2.16.840.1.113883.10.22.4.9 IPS Result Organizer
• 2.16.840.1.113883.10.22.4.10 IPS Result Observation
• 2.16.840.1.113883.10.22.4.11 IPS Pathology Result Observation
• 2.16.840.1.113883.10.22.4.12 IPS Radiology Result Observation
• 2.16.840.1.113883.10.22.4.13 IPS Laboratory Result Observation
• 2.16.840.1.113883.10.22.4.14 IPS Body Author
• 2.16.840.1.113883.10.22.4.15 IPS Immunization
• 2.16.840.1.113883.10.22.4.16 IPS Immunization Medication Information
• 2.16.840.1.113883.10.22.4.17 IPS Procedure Entry
• 2.16.840.1.113883.10.22.4.18 IPS Criticality Observation
• 2.16.840.1.113883.10.22.4.19 IPS Certainty Observation
• 2.16.840.1.113883.10.22.4.20 IPS Problem Status Observation
• 2.16.840.1.113883.10.22.4.21 IPS Allergy Status Observation
• 2.16.840.1.113883.10.22.4.22 IPS Comment Activity
• 2.16.840.1.113883.10.22.4.23 IPS ObservationMedia
• 2.16.840.1.113883.10.22.4.25 IPS Severity Observation
• 2.16.840.1.113883.10.22.4.26 IPS Medical Device
• 2.16.840.1.113883.10.22.4.27 IPS Pregnancy Status Observation
• 2.16.840.1.113883.10.22.4.28 IPS Pregnancy Outcome Observation
• 2.16.840.1.113883.10.22.4.29 IPS Pregnancy Expected Delivery Date Observation
• 2.16.840.1.113883.10.22.4.30 IPS Specimen Collection
• 2.16.840.1.113883.10.22.4.31 IPS Internal Reference
• 2.16.840.1.113883.10.22.4.33 IPS Subordinate SubstanceAdministration
• 2.16.840.1.113883.10.22.4.34 IPS Social History Tobacco Use
• 2.16.840.1.113883.10.22.4.35 IPS Social History Alcohol Use
• 2.16.840.1.113883.10.22.9.1 IPS CDA Organization
• 2.16.840.1.113883.10.22.9.2 IPS CDA Device
• 2.16.840.1.113883.10.22.9.3 IPS CDA Person
• 2.16.840.1.113883.10.22.11 IPS Address

CDA Template References

• 2.16.840.1.113883.10.21.9.1 UV Use Period

Unconstrained Templates from the original CDA specification

• 2.16.840.1.113883.10.12.151 CDA Organization
• 2.16.840.1.113883.10.12.152 CDA Person
• 2.16.840.1.113883.10.12.153 CDA AssignedEntity
• 2.16.840.1.113883.10.12.318 CDA Author (Body)
• 2.16.840.1.113883.10.12.315 CDA Device
• 2.16.840.1.113883.10.12.319 CDA Informant (Body)
• 2.16.840.1.113883.10.12.323 CDA Performer (Body)
• 2.16.840.1.113883.10.12.313 CDA PlayingEntity
• 2.16.840.1.113883.10.12.316 CDA RelatedEntity

Value Sets

• 2.16.840.1.113883.11.22.2 Allergy or Intolerance Type
• 2.16.840.1.113883.11.22.3 Allergy Reaction
• 2.16.840.1.113883.11.22.5 CORE Problem List Disorders
• 2.16.840.1.113883.11.22.8 IPS Condition Verification Status
• 2.16.840.1.113883.11.22.9 Absent or Unknown Allergies
• 2.16.840.1.113883.11.22.10 Allergies to substances
• 2.16.840.1.113883.11.22.11 Adverse Reaction Agents
• 2.16.840.1.113883.11.22.12 ActStatusActiveCompletedAbortedSuspended
• 2.16.840.1.113883.11.22.13 Time units (UCUM)
• 2.16.840.1.113883.11.22.14 DRUGActCode
• 2.16.840.1.113883.11.22.15 Absent or Unknown Medication
• 2.16.840.1.113883.11.22.16 Problem Type
• 2.16.840.1.113883.11.22.17 Absent or Unknown Problems
• 2.16.840.1.113883.11.22.18 Problem Severity
• 2.16.840.1.113883.11.22.19 Language Code
• 2.16.840.1.113883.11.22.20 IPS Expected Delivery Date Method
• 2.16.840.1.113883.11.22.21 IPS Pregnancies Summary
• 2.16.840.1.113883.11.22.22 ActStatusActiveCompletedAbortedCancelled
• 2.16.840.1.113883.11.22.23 IPS Medical Devices
• 2.16.840.1.113883.11.22.24 IPS Condition Status Code
• 2.16.840.1.113883.11.22.25 Medicine Doseform
• 2.16.840.1.113883.11.22.27 Medicine Package
• 2.16.840.1.113883.11.22.28 Quantity Units
• 2.16.840.1.113883.11.22.29 WHO ATC
• 2.16.840.1.113883.11.22.30 Medicine Strength Numerator
• 2.16.840.1.113883.11.22.31 Medicine Strength Denominator
• 2.16.840.1.113883.11.22.32 Medicine Active Substances
• 2.16.840.1.113883.11.22.33 Medicine Route of Administration
• 2.16.840.1.113883.11.22.34 IPS No Drug Substances
• 2.16.840.1.113883.11.22.35 IPS Procedures
• 2.16.840.1.113883.11.22.36 Absent or Unknown Procedures
• 2.16.840.1.113883.11.22.37 IPS Results Organizer
• 2.16.840.1.113883.11.22.38 IPS Results Observation
• 2.16.840.1.113883.11.22.39 IPS Results Observation Laboratory
• 2.16.840.1.113883.11.22.40 IPS Results Observation Radiology
• 2.16.840.1.113883.11.22.41 IPS Results Observation Pathology
• 2.16.840.1.113883.11.22.42 IPS Allergy Status Code
• 2.16.840.1.113883.11.22.43 Absent or Unknown Immunization
• 2.16.840.1.113883.11.22.44 IPS Vaccines
• 2.16.840.1.113883.11.22.45 IPS Multingredients Products
• 2.16.840.1.113883.11.22.46 IPS Results Coded Values Laboratory
• 2.16.840.1.113883.11.22.47 IPS Results Coded Values Pathology
• 2.16.840.1.113883.11.22.48 IPS Results Coded Values Radiology
• 2.16.840.1.113883.11.22.49 IPS Results Microorganism
• 2.16.840.1.113883.11.22.50 IPS Results Blood Group phenotypes
• 2.16.840.1.113883.11.22.51 IPS Results ABO+RH GROUP
• 2.16.840.1.113883.11.22.52 IPS Results Presence/Absence
• 2.16.840.1.113883.11.22.53 IPS Healthcare Professional Roles
• 2.16.840.1.113883.11.22.54 IPS Personal Relationship
• 2.16.840.1.113883.11.22.55 IPS Target Site
• 2.16.840.1.113883.11.22.56 IPS Specimen Type
• 2.16.840.1.113883.11.22.57 Laterality (qualifier)
• 2.16.840.1.113883.11.22.58 Topographical modifier (qualifier)
• 2.16.840.1.113883.11.22.59 IPS Current Smoking Status
• 2.16.840.1.113883.11.22.60 Allergy-intolerance Criticality

Value Sets References

• 2.16.840.1.113883.1.11.1 AdministrativeGender
• 2.16.840.1.113883.1.11.10706 Timing Event
• 2.16.840.1.113883.1.11.11610 x_ActRelationshipDocument
• 2.16.840.1.113883.1.11.15933 ActStatus
• 2.16.840.1.113883.1.11.16926 HL7 BasicConfidentialityKind
• 2.16.840.1.113883.1.11.19446 x_ActRelationshipEntry
• 2.16.840.1.113883.1.11.19563 PersonalRelationshipRoleType
• 2.16.840.1.113883.1.11.19601 x_ServiceEventPerformer
• 2.16.840.1.113883.1.11.19709 ActSubstanceAdministrationImmunizationCode
• 2.16.840.1.113883.1.11.19890 x_ActStatusActiveComplete
• 2.16.840.1.113883.1.11.201 TelecommunicationAddressUse
• 2.16.840.1.113883.1.11.20386 SeverityObservationCode
• 2.16.840.1.113883.1.11.78 Observation Interpretation
• 2.16.840.1.113883.11.20.9.18 MoodCodeEvnInt
• 2.16.840.1.113883.11.20.9.33 INDRoleclassCodes
• 2.16.840.1.113883.3.88.12.80.60 Social History Type

Data Types

Data types for element definitions used

• AD – Address
• AD.IPS – IPS Address (see [1])
• ANY – ANY
• BL – Boolean
• CD – Concept Descriptor
• CD.IPS – IPS CD (see [2])
• CE – Coded with Equivalents
• CE.IPS – IPS CE (see [3])
• CR – Concept Role
• CS – Coded Simple Value
• CV – Coded Value
• CV.IPS – IPS CV (see [4])
• ED – Encapsulated Data
• EIVL.event – Event-Related Interval of Time
• EIVL_TS – Event-related time interval
• EN – Entity Name
• ENXP – Entity Name Part
• II – Instance Identifier
• INT – Integer
• IVL_PQ – Interval of Physical Quantity
• IVL_TS – Interval of Time Stamp
• IVL_TS.IPS.TZ – IPS IVL Time Stamp TZ (see [5])
• IVL_TS.IPS.TZ.OPT
• IVXB_TS – Interval Boundary of Time Stamp
• ON – Organization Name
• PIVL_TS – Periodic Interval of Timezone
• PN – Person Name
• PQ – Physical Quantity
• SC – String with Codes
• SD.TEXT – Structured Document Text
• ST – Character String
• SXPR_TS – Parenthetic Set Expression of Time Stamp
• TEL – Telecommunication Address
• TEL.IPS – IPS TEL (see [6])
• TS – Time Stamp
• TS.IPS.TZ – IPS Time Stamp TZ (see [7])

Data types for attributes used

• bl – boolean code
• cs – code
• oid – identifier
• set_cs – code
• st – string
• uid – identifier

Extensions

Detailed medications information

This specification uses CDA extensions in order to provide details about medications, as further described in the section on the design conventions for Medicinal Product Identification and as used in template 2.16.840.1.113883.10.22.4.3 IPS Manufactured Material. The extension uses the namespace urn:hl7-org:pharm.

This is the list of elements defined for that template.

• pharm:formCode (Administrable Pharmaceutical Dose Form)
• pharm:asContent (Packaging of the medication)
  • pharm:quantity
  • pharm:containerPackagedMedicine (Most inner Package Item or the Packaged Medicinal Product)
    • pharm:code
    • pharm:name (Name of the Package Item or of the Packaged Medicinal Product)
    • pharm:formCode (type of the most inner package item or of the or the Packaged Medicinal Product)
    • pharm:capacityQuantity (the functional capacity of the container)
    • pharm:asContent (Containing package)
      • pharm:quantity
      • pharm:containerPackagedMedicine (Intermediate Package Item or the Packaged Medicinal Product)
        • pharm:code
        • pharm:name (Name of the Package Item or of the Packaged Medicinal Product)
        • pharm:formCode (type of the intermediate package item or of the or the Packaged Medicinal Product)
        • pharm:capacityQuantity (the functional capacity of the container)
        • pharm:asContent (Containing package)
          • pharm:quantity
          • pharm:containerPackagedMedicine (Packaged Medicinal Product)
            • pharm:code
            • pharm:name (Name of the Packaged Medicinal Product)
            • pharm:formCode (type of the Packaged Medicinal Product)
            • pharm:capacityQuantity (the functional capacity of the container)
• pharm:asSpecializedKind (used to represent any classification of the product (ATC code, future PhPIDs,..) )
  • pharm:generalizedMaterialKind
    • pharm:code
    • pharm:name
• pharm:ingredient (list of active substances used for this product)
  • pharm:quantity (strength)
  • pharm:ingredientSubstance (active substance)
    • pharm:code
    • pharm:name

Translation of designations

This specification recommends the introduction of an optional extension for properly recording multilingual designations, that is further described in the section on the translation of designations

• ips:designation

How to read the table view for templates

The template definitions are shown in a table view. It is comprised of Template Meta data and the Template Design. For further information please refer to the HL7 Templates Standard: Specification and Use of Reusable Information Constraint Templates, Release 1.

Templates may also be included in the hierarchical graph view (often used for CDA), see below.

Template Meta data

The upper right part of the template table contains the template meta data. Template id, status and the template name are shown (1). Furthermore the Version (effective date), a possible version label and the display name are shown (2).

The description area (plain or an accordion) contains the template descriptions/purpose (3), followed by classifications and whether the template is defined as open or closed (4).

The usage part (5) may list templates that uses this template or what templates this templates uses. A relationship list (6) may show all relationships to other templates or models.

Examples may show the correct use of the template by an XML fragment (7).

The relationship list shows all relationships to other templates or models for this template. It is divided in the "Used by" part listing templates that make use of this template, and a "Uses" listing all templates that are used by this templates, either as inclusion or containment. Indirect relationships like the parent Document Level Template for a Section Level Template are marked with a chain symbol.

The PDF version is rendered in the same way, but maybe with different fonts etc. to fit customized publication requirements.

Table view of Template Design

The headings of the table view of a template design are:

Item (1) contains the XML document tree view of all elements and attributes specified in the template design. Elements are denoted by a preceding triangle and attributes by a preceding "@".

DT (2) data types, contains the data type of the item, for more information on valid data types for element and attributes (see ).

Card / Conf (3) cardinality (Card) and conformance (Conf) of the item. Cardinality is the usual notion of min and max occurrences of the element. For attributes 0..1 denotes optionality, 1..1 say that the attribute is required and NP denotes prohibited attributes. Conformance may display values as shown in the following table.

Values of the conformance column

Conf	Short	Description
O	optional	Data is truly optional
R	required	If data is present and not masked (e.g. for privacy reasons), it must be provided, otherwise it may be omitted or explicitly null flavored. Sender and receiver must support this element.
M	mandatory	The data must be populated with a valid value from the associated value domain, otherwise the instance is not valid and may not be communicated. Sender and receiver must support this element.
C	conditional	There are conditions when data has to be provided (e.g. co-constraints like "information about pregnancy IF the patient is "female". Sender and receiver must support this element.
F	fixed	The data has a fixed value.
NP	not permitted	Data shall not be present

Description (4) contains a textual description of the item, may also contain constraints and values for fixed attributes.

Label (5) is a human readable label that is displayed upon errors, warnings or notes during validation.

Details of the table view

The actual template design shows the XML structure in a hierarchical list of elements (items) that are typically prefixed by the namespace "hl7:" or "cda:" (1).

Elements are denoted with a triangle, attributes with an @ sign (2).

Data types are specified according to the list of supported data types (3). They may be simple data types (lowercase), regular data types (uppercase) or flavors thereof. In case of coded elements, the coding strength (Required/CNE, Extensible/CWE, Preferred or Example) can be highlighted near the datatype (e.g. “CD.IPS (Extensible/CWE)”) ; the absence of indications about the strength (e.g. “CE.IPS”) shall be interpreted as “Required/CNE”.

Values of the coding strength column

Strength	Displayed as	Description
Required	Required/CNE	Coded with no exceptions; this element SHALL be from the specified value set
Extensible	Extensible/CWE	Coded with Exceptions; this element SHALL be from the specified value set if any of the codes within the value set can apply to the concept being communicated. If the value set does not cover the concept (based on human review), alternate codings (or, data type allowing, text) may be included instead.
Preferred	Preferred	Instances are encouraged to draw from the specified codes for interoperability purposes but are not required to do so to be considered conformant.
Example	Example	Instances are not expected or even encouraged to draw from the specified value set. The value set merely provides examples of the types of concepts intended to be included.

The cardinality and conformance column is explained above (4).

Fixed values for e.g. attributes are also shown in the "description" column (5), preceded by a "F" in the Conf column.

Conformance statements are shown together with a CONF box, e.g. a @code and a @codeSystem with fixed and required values (6).

An optional label is displayed at the rightmost column (7).

Inclusion or containments of other templates, e.g. an entry within a section, are shown accordingly (8) along with their template id, display name and flexibility/stability indication, i.e. "DYNAMIC" (the most recent version) or a STATIC binding together with a version date.

Choices of elements are shown as a choice list with the elements in questions summarised in a bullet point list.

A typical Conformance Statement is the binding of a coded element to a value set. This is expressed in the way shown. The value set is represented with the id, display name and the flexibility/stability of the binding.

In case a constraint is expressed in words, a box "Constraint" accompanies the textual expression of the constraint.

In cases where constraints are expressed by formalised rules in ISO Schematron, the rule along with the role (error, warning), the test and the assertion message is shown.

How to read the Templates hierarchical graph view

Templates are often included in the hierarchical graph view (often used for CDA). It gives an overview of e.g. section and entries and their nesting/relationships.

In case a template has more that one type (CDA Person for header, section and entry templates), it is denoted with a *, if a recursive definition is detected, this is shown with the symbol @.

How to read the where criteria

Templates sometimes include criteria for identifying distinct elements from a list (e.g. in a choice).

The criteria used to identify the items are shown in square brackets using the assertion where [ criteria ]

Criteria can be:

1. an xpath expression as in the example : where [hl7:low or hl7:high]
2. or an integer indexing the items of the list: e.g. where [1]; where [2]

References

Literature

• Whiting-O'Keefe QE, Simborg DW, Epstein WV, Warger A: A computerized summary medical record system can provide more information than the standard medical record. JAMA. 1985 Sep 6;254(9):1185-92.
• Boone KW: The CDA Book. Springer 2011, ISBN 978-0-85729-336-7