IPS implementationguide 1

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This document contains: Implementation Guide International Patient Summary (0.10). The text materials belong to category cdaips.

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HL7 International Patient Summary
based on Clinical Document Architecture Release 2

International Patient Summary

Implementation Guide

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Authors and Contributors

Introduction

Responsible: Philip Scott

In Review

The International Patient Summary (IPS) is a minimal and non-exhaustive patient summary, specialty-agnostic, condition-independent, but readily usable by clinicians for the cross-border unscheduled care of a patient.

Please Note

Missing some explanation about the actual meaning of “specialty-agnostic, condition-independent”: not specialty or condition filtered PS, focused on actual situation and not the patient history... (Kai)

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 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.
• Where possible, 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, Trillium Bridge, 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 [1]]. 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 declared goal “to enable a standardized international patient summary (IPS) to be in use by 2020” [2].

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 both 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 European standard (EN) "The Patient Summary for Unscheduled, Cross-border Care" (the CEN/TC 251 EN PS in the figure); the HL7 ones on its implementation based on HL7 CDA R2 - this guide - and hopefully on FHIR (the HL7 IPS IGs in the figure). The figure shows how the products of these standardization activities are placed 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, which is specialty-agnostic and condition-independent, but still clinically relevant.”.

Scope

to be written

Responsible: Kai Heitmann

...a minimal and non-exhaustive patient summary, which is specialty-agnostic and condition-independent, but still clinically relevant. ...global use

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.

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 free
   • 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 specifications 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 specifications 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 unplanned (cross-border) 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 implementers;with that of optimizing the fitness for purpose within the IPS scope. All this trying to avoid a pure technical exercise of templates harmonization; or, on the other hand, an academic exercise that does not take in account what is already implemented.
• Cooperate with the HL7 Terminology Authority and the organizations that own the used code systems (e.g. SNOMED International) to make available a set of free value sets that could be globally usable when the IPS would be implemented.
• 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 the global identification of that element.
• Select a set of reference global terminologies, leaving however space for the inclusion of the locally used terminologies.
• Do not choose solutions (e.g. identifiers, terminologies, standards) , even promising in the resolution of some of the well-known issues (as the medicinal product identification), that are not yet available for concrete global use. When possible, the IPS has been however already designed in order to be ready when these solutions will be made available for real use (e.g. the IDMP identifiers) or to support since now the parts of those solutions that could be used today.
• Within the scope of the IPS and of the “implementable” principle, attempt to be enough generic in the design of the templates in order that the IPS templates might be hopefully extensible to support new scenarios; or specific specialties or conditions; through templates specialization or adaptation mechanisms.

Structuring Choices

Please Note

to be completed and reviewed

The international patient summary is specified as a templated document using HL7 CDA R2. The specification has taken account of how FHIR STU3 represents equivalent concepts and in some cases has followed a FHIR style of representation rather than a conventional CDA style. The variations from CDA R2 are explained in the relevant detail sections. The mechanism for negation, unknown data and known absent data does not follow the CDA conventions and is explained here.

The international patient summary defines SNOMED CT as the primary terminology (the meaning of "primary terminology" is explained in a later section) for the majority of value sets, but uses LOINC for observations (e.g., laboratory tests) and document sections, UCUM for units of measure and EDQM for dose forms and routes.

The EU eHealth Digital Service Infrastructure (eHDSI) project for the operational deployment of the EU cross-borders services was launched in 2016. ART-DECOR® and the HL7 template exchange format are increasingly used by European countries, including for the European patient summary (epSOS) templates, so has been adopted as the specification platform for this Implementation Guide.

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 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 EHRs unplanned care system, personal health records and mobile health data applications.
• System integrators.
• Organizations that manage regional and national patient summaries.

Relationships with other projects and guidelines

Please Note

No abbrevs, a minimal paragraph about the distinct items

• CEN/TC 251 Project International Patient Summary (add explicit refernce to the CEN /TC 251 work items (Giorgio))
• epSOS/EXPAND/eHDSI
• GUIDELINE on the electronic exchange of health data under Cross-. Border Directive 2011/24/EU. Release 2 (https://ec.europa.eu/health/sites/health/files/ehealth/docs/ev_20161121_co10_en.pdf)
• Consolidated CDA (C-CDA)
• IHE-PCC
• Input from the EHR work group about how to define the source(s) of the IPS content, described in the provenance section .

How to read this document

• Kai to write a paragraph
• Balloter instructions

Responsible: Kai Heitmann

Responsible: Kai Heitmann, Giorgio Cangioli

Technical Background

What is a CDA

from famous sources like C-CDA

Responsible: Kai Heitmann

Templated CDA

from famous sources like C-CDA, Templates Standard

Responsible: Kai Heitmann

Open and Closed Templates

from famous sources like C-CDA, Templates Standard

Responsible: Kai Heitmann

Template versioning

from famous sources like Templates Standard

Responsible: Kai Heitmann

Identifiers for Templates and Value Sets

Some hints

• OIDs for Templates and Value Sets
• coming fro the HL7 OID Registry, mention the branches

Responsible: Giorgio Cangioli

Terminologies

Some hints

Responsible: Rob Hausam

• Focus on Value Sets, as they are the main artefacts used for validation
• General Info about Terminology Binding

How to extend Value Sets

•  ? Coded with Extensibility / no Extensions ? or other topics ?
• If needed: Example binding

Design conventions and principles

Responsible: Rob Hausam

Representing "known absent" and "not known"

In Review

Responsible: Philip Scott, Giorgio Cangioli, Kai Heitmann, Francois Macary

In line with the properties of minimalism and non-exhaustiveness for the IPS (see the IPS definition above) two main cases have been explicitly considered by this guide about "known absent" and "not known":

1. the “condition/activity unknown”; and
2. the “condition/activity known absent”.

This choice has been made also based on the experience gained with the European cross-borders services. Other kinds of negations 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, even if it is not precluded to provide them.

This specification represents this core set of negations (“condition/activity unknown” and “condition/activity known absent” ) by leveraging the expressiveness of SNOMED CT to use explicit coded elements rather than relying on specific mechanisms of the underlying syntactical standard (such as nullFlavor and negationInd attributes for CDA).

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 have a representation of the clinical content of the patient summary which is 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 either 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.

In some cases this required the creation of new SNOMED CT concepts. For example, a known absent Allergy/Intolerance would be represented by "716186003 |No known allergy (situation)|" (or any combination of its descendants), whereas no information about Allergy/Intolerance would be represented by a code with the meaning "Allergic disposition not known (situation)". For these cases an HL7 extension to SNOMED CT has been created, working for their future inclusion in the SNOMED CT International Release.

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.

Please Note

Should we recommend not to use nullFlvaor or negation ?

Medicinal Product Identifications

Responsible: Giorgio Cangioli

Medication Statement

Responsible: Giorgio Cangioli, Kai Heitmann

Provenance

Responsible: Philip Scott; Gary Dickinson

In Review

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:

• Require document-level, not section level, provenance.
• Define IPS document provenance as one of two types: human-curated or software-assembled.
  • 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 document 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, this is not the same as legalAuthenticator. 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.

The 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.

General Implementation Guidance

Responsible: Kai Heitmann

• How to populate IDs in an CDA XML instance, e.g. ClinicalDocument.id, setId
• Where I can get IDs
• Relevant times for a patient summary
• Description of the different status definitions (condition, concern, observation) --> Giorgio
• (Authorship is probably a part to go to Provenance)

Conformance clause

Responsible: Stephen Kay, Giorgio Cangioli

Different conformance levels (to be explored)

Functional requirements and high-level use cases

Responsible: Giorgio Cangioli

• Add a reference to the CEN prEN. (to be analyzed)
• PSS
• Add a reference to the data set included in the html package
• Include in the functional area that no assumption on transport has been made…
• PS comes from one source, and covers different cases.
• Specify, how the provenance could be managed without going into details) to be included in next versions.
• To be further discussed, in any case add a paragraph in which explain the problem and how it might be faced.

Reading Guide

Responsible: Kai Heitmann

Description of formalisms used, symbols, icons, how to read ART-DECOR artefacts

Information

Here comes the Template Rendition of all Templates

Appendix

Responsible: NN

Licenses

• for the artifacts used, for the code systems, etc.

Integrated examples

Responsible: Kai Heitmann

• links to example instances in the publication package

Validation artifacts

Responsible: Kai Heitmann

• links to xsd
• links to schematrons

Links to platforms, binaries, software libraries

• This should go away?!

Operational information

Responsible: Kai Heitmann

• share the ips HL7 email list address
• also offer info at international-patient-summary.net email address for inquiries regarding the specification
• actual endpoints or user interfaces for testing/validation

List of all artifacts used in this guide

Responsible: Autogenerated, assisted by Kai Heitmann

Datatypes

Responsible: Kai Heitmann

(This will be a list from ART-DECOR)

Examples (in progress)

( a set of link with explanations)

Responsible: Stephen Chu, Giorgio Cangioli (Translation), Kai Heitmann (Translation)

Plan:

• Create one or more storyboards (Stephen?)
• Turn the storyboards into real IPS example CDA instances
• Allow for multilingual CDA (Italian, German)
• Offer all XSD in the publication package
• include schematrons (generated by ART-DECOR)