IPS implementationguide 1

Document Information

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

{{{Topright}}}

HL7 International Patient Summary
based on Clinical Document Architecture Release 2

International Patient Summary

Implementation Guide

© 2016-2017 Health Level Seven International ® ALL RIGHTS RESERVED.
The reproduction of this material in any form is strictly forbidden without the written permission of the publisher. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. Pat & TM Off.

Important Notes

HL7 licenses its standards and select IP free of charge. If you did not acquire a free license from HL7 for this document, you are not authorized to access or make any use of it. To obtain a free license, please visit http://www.HL7.org/implement/standards/index.cfm.

If you are the individual that obtained the license for this HL7 Standard, specification or other freely licensed work (in each and every instance "Specified Material"), the following describes the permitted uses of the Material.

A. HL7 INDIVIDUAL, STUDENT AND HEALTH PROFESSIONAL MEMBERS, who register and agree to the terms of HL7’s license, are authorized, without additional charge, to read, and to use Specified Material to develop and sell products and services that implement, but do not directly incorporate, the Specified Material in whole or in part without paying license fees to HL7.

INDIVIDUAL, STUDENT AND HEALTH PROFESSIONAL MEMBERS wishing to incorporate additional items of Special Material in whole or part, into products and services, or to enjoy additional authorizations granted to HL7 ORGANIZATIONAL MEMBERS as noted below, must become ORGANIZATIONAL MEMBERS of HL7.

B. HL7 ORGANIZATION MEMBERS, who register and agree to the terms of HL7's License, are authorized, without additional charge, on a perpetual (except as provided for in the full license terms governing the Material), non-exclusive and worldwide basis, the right to (a) download, copy (for internal purposes only) and share this Material with your employees and consultants for study purposes, and (b) utilize the Material for the purpose of developing, making, having made, using, marketing, importing, offering to sell or license, and selling or licensing, and to otherwise distribute, Compliant Products, in all cases subject to the conditions set forth in this Agreement and any relevant patent and other intellectual property rights of third parties (which may include members of HL7). No other license, sublicense, or other rights of any kind are granted under this Agreement.

C. NON-MEMBERS, who register and agree to the terms of HL7’s IP policy for Specified Material, are authorized, without additional charge, to read and use the Specified Material for evaluating whether to implement, or in implementing, the Specified Material, and to use Specified Material to develop and sell products and services that implement, but do not directly incorporate, the Specified Material in whole or in part. NON-MEMBERS wishing to incorporate additional items of Specified Material in whole or part, into products and services, or to enjoy the additional authorizations granted to HL7 ORGANIZATIONAL MEMBERS, as noted above, must become ORGANIZATIONAL MEMBERS of HL7. Please see http://www.HL7.org/legal/ippolicy.cfm for the full license terms governing the Material.

Ownership. Licensee agrees and acknowledges that HL7 owns all right, title, and interest, in and to the Materials. Licensee shall take no action contrary to, or inconsistent with, the foregoing.

Licensee agrees and acknowledges that HL7 may not own all right, title, and interest, in and to the Materials and that the Materials may contain and/or reference intellectual property owned by third parties (“Third Party IP”). Acceptance of these License Terms does not grant Licensee any rights with respect to Third Party IP. Licensee alone is responsible for identifying and obtaining any necessary licenses or authorizations to utilize Third Party IP in connection with the Materials or otherwise. Any actions, claims or suits brought by a third party resulting from a breach of any Third Party IP right by the Licensee remains the Licensee’s liability.

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 CT® 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)

Obtaining a CPT Sublicense from HL7

Contact hq@hl7.org about how to obtain a sublicense from HL7 for non-production use of CPT for (i) the development and publication of value sets, profiles, and other artifacts as part of the HL7 Implementation Guides, (ii) as part of defined VSAC value sets, and (iii) to support HL7's terminology services within the Territory.

Flow Down Clauses for CPT Sublicense from HL7

CPT content is copyrighted by the American Medical Association and CPT is a registered trademark of the AMA.

HL7, as a party to a license agreement with the AMA, is authorized to grant user a limited, non-exclusive, non-transferable, non-sublicensable license for user to use CPT content for (i) the development and publication of value sets, profiles, and other artifacts as part of the HL7 Implementation Guides, (ii) as part of defined VSAC value sets, and (iii) to support HL7's terminology services within the Territory, each of which shall be considered a non-production use. The sublicense granted hereunder shall automatically terminate upon termination of the agreement between HL7 and AMA, unless prior written consent of AMA is obtained.

The provision of updated CPT content is dependent on a continuing contractual relationship between HL7 and the AMA.

User acknowledge a separate license agreement shall be required, and shall govern any proposed use, including any distribution of CPT content for any other purposes not expressly permitted under this Agreement, and the terms of such agreement will govern such use (e.g., a separate license agreement shall govern production use and commercial purposes). AMA reserves the right to accept or reject licenses based on AMA's evaluation of the proposed use of the CPT content.

User acknowledge that User's development and commercialization of CPT-informed works developed with reference to Licensed Products may only be implemented in the Territory.

User is prohibited from making CPT content publicly available, creating derivative works (including translating), transferring, selling, leasing, licensing, or otherwise making available to any unauthorized party the CPT content, or a copy or portion of CPT content to any unauthorized party, including a subsidiary, affiliate, or other legal entity, however designated, for any purpose whatsoever except as expressly permitted under a separate agreement.

User expressly acknowledges and agrees to the extent permitted by applicable law, use of CPT content is at User's sole risk and CPT content is provided "as is" without warranty of any kind. The AMA does not directly or indirectly practice medicine or dispense medical services. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. CPT content herein does not replace the AMA's Current Procedural Terminology book or other appropriate coding authority. The coding information contained in CPT content should be used only as a guide.

U.S. Government End Users. CPT is commercial technical data, which was developed exclusively at private expense by the American Medical Association (AMA), 330 North Wabash Avenue, Chicago, Illinois 60611. This agreement does not grant the Federal Government a direct license to use CPT based on FAR 52.227- 14 (Data Rights - General) and DFARS 252.227-7015 (Technical Data - Commercial Items).

User expressly consents to the release of its name to the AMA.

Authors and Contributors

Introduction

Responsible: Philip Scott

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.

Purpose

See PSS

The goal of this Implementation Guide is to identify the required clinical data with associated vocabulary bindings and value sets for patient summary, in the context of specific use cases, and to build an international document and associated templates based on HL7 CDA R2 (or a future CDA release), and evenually FHIR , with value sets to support data elements within those templates. The initial use case will be providing support for cross-border emergency and unplanned care.

These templates/profiles aim to:

• Serve for cross-jurisdictional patient summaries (through adaptation/extension for multi-language and realm scenarios, including translation).
• Support emergency and unplanned care in any country, regardless of language
• Define value sets based on international vocabularies that are usable and understandable in any country

The deliverable(s) will address the requirements of an international patient summary:

• For the exchange of structured and coded information (section headings, entries)
• For administrative data in order to support content commitment, audit/logging/provenance

The Implementation Guide has received input from the EHR WG regarding the specification of functional requirements on patient summaries.

This Implementation Guide includes a compilation of the required clinical data, based on results of multiple previous projects on patient summaries (including but not limited to epSOS, ONC, Trillium Bridge, eHealth Exchange), rules and recommendations for the use and maintenance of associated vocabulary bindings and value sets (in multilingual settings), and templates for the implementation of international patient summary documents.

The international patient summary defines SNOMED CT as the primary terminology (the meaning of "primary terminology" is discussed further in section XXX), but uses LOINC for laboratory tests, UCUM for units of measure and EDQM for dose forms and routes.

Therefore this Implementation Guide has its primary focus on provisions for semantic interoperability.

Templates/profiles should take in consideration, where applicable, legal, organizational, security and infrastructure requirements based on experiences of pilot implementations (such as Trillium Bridge).

The white paper on Comparative Analysis Between HL7 C-CDA R1.1 CCD and epSoS PS v1.4 informed the development of the harmonized template and associated value sets.

Background

In 2010 a MoU was signed between EU and US to strengthen global cooperation in eHealth/Health. As a result, the ONC S&I “Interoperability of EHR” work group was launched in US in 2013 (http://wiki.siframework.org/EU-US+eHealth+Cooperation+Initiative) and the Trillium Bridge Project (www.trilliumbridge.eu) in Europe to compare the CDA templates specified at that time in Europe (epSOS PS V1.4) and in US (MU – C-CDA CCD v1.1) for Patient Summaries (PSs) and to build a Trans-Atlantic exchange proof of concept. Both initiatives resulted identifying the need for a common template and vocabularies for the Patient Summary, in particular the following recommendation was offered and endorsed by all members of the Joint Initiative Council and by the HL7 International Council: “to advance an International Patient Summary (IPS) standard and enable people to access and share their health information for emergency or unplanned care anywhere and as needed. At minimum the IPS should include immunizations, allergies, medications, clinical problems, past operations and implants.”

Meanwhile

• A new version of the EU/US MOU Transatlantic eHealth/health IT Cooperation Roadmap entered consultation in November 2015 , ;
• (US) a Shared Nationwide interoperability roadmap was published in November 2015 ;
• The Joint Initiative Council (JIC) on SDO Global Health Informatics Standardization, initiated the standard sets project with patient summary as its pilot ;
• A maintenance process for the European Patient Summary Guidelines is in progress (expected release on Nov 2016);
• The European eHealth Digital Service Infrastructure (project for the operational deployment of the EU cross-borders services) has been launched (2016-2018)
• ART-DECOR® and the HL7 DSTU (now STU) template exchange format are being more and more used by European countries, including for the European Patient Summary templates (aka epSOS PS template). ART DECOR is also connected to the IHE

Scope

scope text from PSS

Ballot Status of the Document

This Implementation Guide is a draft.

Relationships with other projects and guides

• Connection with CEN IPS - quote/cite HL7/CEN agreement
• epSOS/eHDSI; C-CDA; IHE-PCC

Prerequisite Knowledge

CDA template concepts/terminology

How to read this document

Slowly

Contributions

what does this cover? secton authorship?

Principles and background

Responsible: Kai Heitmann, Giorgio Cangioli

IPS Principles

(here or in the introduction?)

Identifiers

• (OID,...)

Terminologies

• Focus on Value Sets

Design conventions and principles

How to use terminology (preferred binding)

Responsible: Rob Hausam

Notion of "Primary Code"

Responsible: Rob Hausam

Usage of translations

Responsible: Rob Hausam

Principle on negations, data known absent and data unknown

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

• See Paris slides
• Usage of negations
• The choice for negation it is not that of using negation indicator @negationInd but rely on the terminologies to do this
• To do: add a description in the introduction
• @negationInd in CDA has been superseded in V3 later by two other negation indicators: actNegationInd valueNegationInd
• Alignment with FHIR

The representation of “condition/activity unknown” and of “condition/activity known absent”is normalized for the IPS by leveraging the expressiveness of SNOMED CT as opposed to relying on specific mechanisms of the underlying syntactical standard (such as nullFlavor and negationInd for CDA). The main rationale for this choice is 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. The other rationale is 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).

General implementation guidance

Responsible: Kai Heitmann

How to populates IDs, where I can get IDs

Relevant times for a patient summary

Description of the different status definitions

Authorship

Go here or somewhere else?

Standards used

SNOMED-CT, ...

Legend

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

Conformance clause

Responsible: Steven Chu

Different conformance levels (to be explored)

Functional requirements and high-level use cases

Responsible: NN

• 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.

Appendix

Responsible: NN

Integrated examples, links to instances

Responsible: Kai Heitmann

Validation artifacts (xsd, schematrons)

Responsible: Kai Heitmann

List of all artifacts used in this guide

Responsible: Autogenerated, assisted by Kai Heitmann

Examples (in progress)

Responsible: NN