Health informatics - The International Patient Summary - Guideline for European Implementation

This Technical Specification (TS) provides implementation guidance to support the use of the International Patient Summary dataset in a European context. The focus of this technical specification takes into consideration European specific jurisdictional requirements, needs and contexts that Europe requires to be satisfied for effective implementation. It addresses both functional and non-functional requirements for the dataset’s interchange. As part of the usability of the International Patient Summary, European perspectives, directives and regulations contextualise and add value to generic reference implementations for use by Member States.
The TS applies the refined European Interoperability Framework (ReEIF), which describes legal, organisational, semantic and technological considerations for interoperability. These considerations highlight the eHealth Network’s (eHN) guidance for cross-border care and underpin the care process. The TS formalises principles to support the safe and legitimate use of patient summary data and afford protection for efficient cross-border data interchange within scenarios for unscheduled care.
This Technical Specification gives selection criteria and provides examples of various transport formats and terminologies shown to be suitable for interchanging the International Patient Summary dataset. Compliance, deployment & migration Guidance are also included. The TS distinguishes between cross-border only requirements for interchanging the dataset and those that are generally applicable within national borders.

Medizinische Informatik - Die internationale Patienten-Kurzakte: Leitfaden für die europäische Technische Spezifikation (TS) zur Umsetzung

Dieses Dokument fokussiert sich darauf, wie die Internationale Patienten-Kurzakte (IPS) in einem europäischen Kontext umgesetzt werden kann. Insbesondere bietet dieses Dokument einen Leitfaden für die Implementierung von prEN 17269:2018, „Die Patienten-Kurzakte für ungeplante, grenzüberschreitende medizinische Versorgung“ in Europa.
Der Leitfaden in diesem Dokument soll auch für eine eher lokale Umsetzung verwendbar sein und so Mitgliedsstaaten nützen, die die IPS innerhalb ihrer eigenen Grenzen [1] anwenden wollen; als zusätzlicher Vorteil dürfen ihre Komponenten zur Verbesserung der Interoperabilität von EHR durch gemeinsame Austauschformate [2] wiederverwendet werden.
Dieses Dokument behandelt Folgendes:
— Gesetzliche Anforderungen wie EU-Richtlinien und -Verordnungen, die für die Anwendbarkeit der Internationalen Patienten-Kurzakte relevant sind
— Lenkung, Privatsphäre und Datenschutz zur Sicherstellung der sicheren, gesetzeskonformen und nachhaltigen Verwendung von Daten aus der Patienten-Kurzakte. Kontinuität der Pflege und Koordination der Pflege werden in Bezug auf grenzüberschreitende Pflegeszenarien berücksichtigt.
— Konformität, unter Bereitstellung von Beispielen für konforme, abgeleitete Modell von prEN 17269:2018 für sowohl grenzüberschreitende als auch eher lokale Verwendungszwecke. Beispiele für Transportformate zur Weitergabe von Daten aus der Patienten-Kurzakte werden angegeben. Leitfäden zu Terminologie, Umsetzung und Migration werden auch behandelt.

Informatique de santé - Résumé international de dossier patient : Recommandations relatives aux spécifications techniques de mise en œuvre européenne

No Scope Available

Zdravstvena informatika - Mednarodni povzetek podatkov o pacientu - Smernica za evropsko implementacijo

General Information

Status
Published
Publication Date
28-Jul-2020
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
18-Jun-2020
Due Date
23-Aug-2020
Completion Date
29-Jul-2020

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SLOVENSKI STANDARD
SIST-TS CEN/TS 17288:2020
01-september-2020
Zdravstvena informatika - Mednarodni povzetek podatkov o pacientu - Smernica
za evropsko implementacijo
Health informatics - The International Patient Summary - Guideline for European
Implementation

Medizinische Informatik - Die internationale Patienten-Kurzakte: Leitfaden für die

europäische Technische Spezifikation (TS) zur Umsetzung

Informatique de santé - Résumé international de dossier patient : Recommandations

relatives aux spécifications techniques de mise en œuvre européenne
Ta slovenski standard je istoveten z: CEN/TS 17288:2020
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST-TS CEN/TS 17288:2020 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TS CEN/TS 17288:2020
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SIST-TS CEN/TS 17288:2020
CEN/TS 17288
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
May 2020
TECHNISCHE SPEZIFIKATION
ICS 35.240.80
English Version
Health informatics - The International Patient Summary -
Guideline for European Implementation

Informatique de santé - Le résumé international des Medizinische Informatik - Die internationale Patienten-

patients - Lignes directrices pour la mise en œuvre Kurzakte - Leitfaden für die europäische Technische

européenne Spezifikation (TS) zur Umsetzung

This Technical Specification (CEN/TS) was approved by CEN on 13 January 2020 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to

submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS

available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in

parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 17288:2020 E

worldwide for CEN national Members.
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Contents Page

European foreword ............................................................................................................................................ 4

Introduction .......................................................................................................................................................... 5

1 Scope ........................................................................................................................................................ 10

2 Normative references ........................................................................................................................ 10

3 Terms and definitions ....................................................................................................................... 10

4 Abbreviations ....................................................................................................................................... 14

5 Conformance ......................................................................................................................................... 15

5.1 General.................................................................................................................................................... 15

5.2 The relationship between this Document and EN 17269 ..................................................... 15

6 The IPS Use Case, 4 Scenarios, and the Subject of Care ......................................................... 15

6.1 The IPS Use Case .................................................................................................................................. 15

6.2 IPS Scenario 1: Cross border, Unscheduled care ..................................................................... 16

6.3 IPS Scenario 2: Cross border, Scheduled care .......................................................................... 16

6.4 IPS Scenario 3: Local, Unscheduled care .................................................................................... 16

6.5 IPS Scenario 4: Local, Scheduled care .......................................................................................... 16

6.6 The Subject of Care and Data, Chronic Health Conditions, and multiple versions of

PS .............................................................................................................................................................. 16

7 Governance Consideration .............................................................................................................. 17

7.1 Information Governance applicable to IPS ................................................................................ 17

7.2 Information Governance (Product View) ................................................................................... 18

7.3 Information Governance (Process View) ................................................................................... 20

7.3.1 General.................................................................................................................................................... 20

7.3.2 Request ................................................................................................................................................... 20

7.3.3 Export ...................................................................................................................................................... 21

7.3.4 Import ..................................................................................................................................................... 21

7.3.5 Access ...................................................................................................................................................... 21

7.3.6 Use and Reuse ...................................................................................................................................... 21

8 Data Protection, Privacy and Security Consideration ........................................................... 22

8.1 General.................................................................................................................................................... 22

8.2 Data Protection Requirements and Principles ........................................................................ 22

9 Legal and Regulatory Consideration ............................................................................................ 24

9.1 General.................................................................................................................................................... 24

9.2 Regional and National Legislation ................................................................................................ 24

9.3 European Legislation ......................................................................................................................... 24

9.4 Examples of Directives and Regulation with respect to the IPS ......................................... 25

10 Policy Consideration .......................................................................................................................... 25

10.1 General.................................................................................................................................................... 25

10.2 Organization Policy ............................................................................................................................ 25

10.3 European Policy ................................................................................................................................... 25

11 Care Process Consideration ............................................................................................................ 25

12 Information Consideration .............................................................................................................. 26

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12.1 General ................................................................................................................................................... 26

12.2 Common Data set ................................................................................................................................ 27

12.3 Value Sets ............................................................................................................................................... 27

12.4 Information Models ........................................................................................................................... 28

12.4.1 General ................................................................................................................................................... 28

12.4.2 Detailed Clinical Models (DCM) ..................................................................................................... 29

12.4.3 HL7 CDA Templates ........................................................................................................................... 30

12.4.4 HL7 FHIR Resources and FHIR Profiles ...................................................................................... 31

12.5 Terminology Requirements and Agreements .......................................................................... 31

12.6 Terminologies and structures for Implementation Now and in the Future .................. 32

13 Applications Consideration............................................................................................................. 32

13.1 General ................................................................................................................................................... 32

13.2 European eHealth Digital Service Infrastructure (eHDSI) .................................................. 34

14 Infrastructure Consideration ......................................................................................................... 34

15 Standards, Profiles and Evaluation .............................................................................................. 34

15.1 General ................................................................................................................................................... 34

15.2 Standards/Profiles ............................................................................................................................. 35

15.2.1 Scope ....................................................................................................................................................... 35

15.2.2 Data patterns ........................................................................................................................................ 35

15.2.3 Elements mapping .............................................................................................................................. 36

15.3 Projects ................................................................................................................................................... 56

15.3.1 General ................................................................................................................................................... 56

15.3.2 eHDSI ....................................................................................................................................................... 57

15.3.3 Trillium II .............................................................................................................................................. 57

15.4 Exchange Format Examples ............................................................................................................ 57

15.4.1 IPS CDA example ................................................................................................................................. 57

15.4.2 IPS FHIR example ................................................................................................................................ 63

15.5 Testing .................................................................................................................................................... 72

15.6 Deployment........................................................................................................................................... 73

15.7 Socio-technical Factors ..................................................................................................................... 73

15.8 Stakeholder evaluation .................................................................................................................... 74

Annex A (Informative) The Refined eHealth European Interoperability Framework ........... 76

Annex B (Informative) Detailed landscape for IPS .............................................................................. 77

B.1 Overview ................................................................................................................................................ 77

B.2 The eHealth Network ........................................................................................................................ 78

B.3 EC and European Projects concerning eHealth ........................................................................ 78

B.4 The Health Informatics SDO’s ........................................................................................................ 79

B.5 European Policy .................................................................................................................................. 79

B.6 European Stakeholders .................................................................................................................... 79

B.7 The IPS Standards for Europe ........................................................................................................ 79

B.8 European Citizens ............................................................................................................................... 80

Bibliography ....................................................................................................................................................... 81

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European foreword

This document (CEN/TS 17288:2020) has been prepared by Technical Committee CEN/TC 251 “Health

Informatics”, the secretariat of which is held by NEN.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

According to the CEN/CENELEC Internal Regulations, the national standards organisations of the

following countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United

Kingdom.
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Introduction

This document provides a European implementation guideline for the International Patient Summary

(EN 17269). The target audience is primarily software developers, and project implementation teams,

but policy makers and SDOs have a role in assuring that the guideline is relevant to IPS.

European policy, directives, organisational and professional culture, and a diverse market place require

implementation guidance that is technically relevant and contextually sensitive. This document describes

these implementation aspects from the European perspective. The different ways that the International

Patient Summary (IPS) and its content are communicated are the subject of this document. This

document will reference and credit initiatives, such as the eHealth Networks’ patient summary data set

and the multiple European projects, that have contributed to the shared vision embodied in the joint CEN

IPS and HL7 IPS Project.
The eHealth Network, the Cross border Directive, and the IPS Use Case

The requirements for the CEN IPS’ deliverables come directly from the eHealth Network (eHN) and their

support for the ‘Specific Guidelines for Electronic Exchange of Health Data under the Cross border

Directive 2011/24/EU’. “These guidelines, as adopted by the eHealth Network, are addressed to the

Member States of the European Union and apply to the implementation of a patient dataset for cross

border exchange.” [1]

The objective of the EU policy is to support continuity and coordination of care for EU citizens across

Member States (MS). In a cross border context, the eHN further asserts that “interoperability is essential

to the provision of high-quality care. Member States shall therefore engage in taking appropriate

measures to make their respective information systems interoperable, both technically and semantically,

for this Use Case”. [2]

The specific use case is more general, but the scenario from the eHN is to exchange a patient summary

(PS) between countries, comprising an agreed minimal data set, for unscheduled care. Member State

needs, however, require the IPS to also be useful for localized use, and to support scheduled care too. The

required, core data elements in the eHN guideline are the basis around which meaningful patient

summary (PS) implementations can be built. These data, their descriptions and definitions, have been

formalized and refined in EN 17269 with the intention of making them usable, and reusable, for different

communication purposes in the healthcare domain at a global level.
The relationship between the CEN IPS and other PS Initiatives

Patient Summaries are ubiquitous. The differences and diversity of existing implementations, however,

make it currently difficult to safely communicate content. In what is an increasingly complex ecosystem

there is a strong requirement to provide simple interoperable solutions for key applications. This has led

to a drive to standardize patient summaries for widespread use. The EC chose to support this need for

standardization by sponsoring a number of related projects, enabling international participation to

consider how to deliver interoperability with respect to cross border exchange of the Patient Summary.

The Health Informatics Committee of CEN (i.e. CEN/ TC 251) was commissioned to produce relevant IPS

Standards based upon the eHN guideline. Figure 1 shows a map of key CEN IPS stakeholders.

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Figure 1 — CEN/TC 251’s participative role in establishing the IPS Standards

The International Patient Summary Project comprises two concurrent standardization activities; one

lead by CEN/TC 251 and the other by HL7 International. The standards developed by each of them are

inter-related standard products, with informed coordination to realize coherent results.

The EC eHealth projects, aware of the EU/US MOU [3], have been supportive. The Trillium Bridge [4] and

Trillium II [5] projects have taken as input the initial work from both CEN/TC 251 and HL7 IPS as the

basis for its elaborations and analysis, thereby contributing to the new standardization approach,

described by the eStandards [6] project, as “Co-creation, governance and alignment (CGA)”. Concurrently,

the eHDSI [7] under the CEF [8] project is realizing the cross border services for the Patient Summary

based on the eHN PS guideline and using Patient Summary CDA specifications evolved from epSOS [9].

The lessons learnt by eHDSI (and its parent projects) have been taken into consideration for the

development of the IPS Project. Figure 2 provides an illustration as to how the various products of these

initiatives relate to each other.
The European Interoperability Framework

The Refined eHealth European Interoperability Framework (ReEIF) [10] is a “common refined

framework for managing interoperability and standardisation challenges in the eHealth domain in

Europe”; and it has been designed “for the communication and decision-making processes on projects

and solutions for eHealth. ReEIF offers a framework of terms and methodologies for reaching a common

language, a common starting point, for the analysis of problems and the description of eHealth solutions

throughout Europe”. To leverage that fact, ReEIF is used here to structure this document so as to provide

relevant European guidance material for the International Patient Summary (IPS). The clause structure

that maps to the Framework is presented in Table 1.
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Figure 2 — An overview of the IPS Project
Table 1 — Description of the Clause mapping to ReEIF
Clause # ReEIF’s Consideration Emphasis in this document
Clause 7 Governance Information Governance
Clause 8 Security, Privacy and Confidentiality Data Protection
Clause 9 Legal and Regulatory Statutory requirements
Clause 10 Policy European and organisational aspects
Clause 11 Care Process Clinical Process and workflows
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Clause # ReEIF’s Consideration Emphasis in this document
Clause 12 Information The Data sets, models and terminologies
Clause 13 Applications Standardized Interchange formats
Clause 14 Infrastructure IT and protocols of exchange
Clause 15 Standards and Profiles, Certification Examples, Conformance Testing,
deployment, and Evaluation

The single topic ‘Security, Privacy and Governance’ in ReEIF has been managed here as two separate

clauses to highlight their importance to the IPS; the original format of the ReEIF is illustrated in Annex A.

Frameworks and models are simplifications of the world they attempt to represent. Consequently,

interpretation plays a part in how the ReEIF categorizes and differentiates between the different

considerations. This document adapts the ReEIF to support this implementation guide.

The ReEIF provides a framework for the construction concepts, i.e. the identification and specifications

concerning what is needed to deploy the solutions (here ‘solution’ is synonymous with the IPS). However,

the operational aspects, including the project and deployment space, are not directly addressed by the

ReEIF. This document considers these operational aspects in the latter part of Clause 15.

One example of ReEIF adoption and adaptation by Member States is given by Nictiz, the eHealth

competency centre of the Netherlands. They make extensive use of the ReEIF in their national

architectures (i.e. large, e.g. hospital network) and in local ones (i.e. small, e.g. GP office). The Centre

deploys what are colloquially known as building blocks, positioned at the Information layer of ReEIF, as

a means of controlling communication which is “achieved by making agreements about the semantics,

the meaning of the data and data structures as well as establishing these agreements in the form of health

and care information models.” [11].
Standardization initiatives relevant to the IPS

From the European context there are a number of formal activities that are of interest to the Standards

Development Organisations (SDOs), which are mutually beneficial and compatible. They are:

• The Informative Joint Initiative Council (JIC) Patient Summary Standards Set (PSSS)

o This activity is not intended to create a new standard; it is essentially an informative activity and

its value is to inform the stakeholders about existing or developing standards in the PS space. The

PSSS has a wider scope, providing a catalogue. Both CEN and HL7 are members of JIC.

• The normative CEN IPS and HL7 IPS initiatives (known as the IPS Project) focus on delivering a single

consistent IPS information standard, guideline and implementation guides.

o The HL7 IPS project succeeds the earlier INTERPAS project, whereas the CEN IPS project was

intended to support standardization in Europe by formalizing the eHN Guideline through active

participation in global SDO activities.

o The IPS projects have been working together to produce a single compatible solution based on

vision and agreements made at the Oslo workshop organized by Trillium Bridge back in 2016.

o The IPS Project takes on board relevant detail from the JIC PSSS and will contribute to the PSSS

content as their joint work proceeds to develop the formal standards required.
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• The eHealth Digital Service Infrastructure (eHDSI) initiative for cross border health data exchange,

which builds on the outputs of the epSOS pilot with a view of providing implementations for

European Member States by 2019.

o Whilst not strictly SDO related, it is a deployment activity, and considerable effort has been made

by CEN and HL7, to harmonize their work to ensure European implementation is based upon a formal

set of standards.

All these initiatives rely heavily on the eHN guideline for a PS data set, version 2 of which was published

in November 2016.

NOTE 1 The JIC PSSS differs from the other initiatives in that it introduces extra items reflecting homecare

requirements but these are outside of the IPS Project’s current scope.

These eHN guideline has supported the harmonization efforts made by CEN/TC 251 and HL7. Policy

considerations, stakeholders’ interests, and technical changes provide the context for this document as

illustrated by a simplified overview given in Figure 3, with the lighter arrows representing the historic

influences and the darker arrows indicating specific inputs.

NOTE 2 There have been a number of projects and consortia that have been funded by EC initiatives that have

also contributed in direct and indirect ways to the IPS Standards. Details of these may be found in the Bibliography

of this document.
Figure 3 — Landscape affecting the IPS Guide for European Use

An amplified version of Figure 3, which explains the relationships between the CEN IPS and HL7 IPS

deliverables and the context of the project work in more detail, is presented in Annex B (Informative).

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1 Scope

This document is focussed on how the international patient summary (IPS) can be deployed within a

European context. Specifically, this document provides guidance for the European implementation of EN

17269.

The guideline is also intended to be usable for more localized deployment, benefitting Member States that

want to use the IPS within their own borders and, as an additional benefit, its components may be reused

to improve the interoperability of EHRs through common exchange formats.
This document addresses:

— Jurisdictional requirements, such as EU directives and regulations, relevant to the usability of the

International Patient Summary.

— Governance, privacy and data protection, so as to support the safe, legitimate and sustainable use of

patient summary data. Continuity of care and coordination of care are considered with respect to

cross border scenarios of care.

— Conformance, providing examples of conformant, derived models from EN 17269:2019 for both

cross border and more localized use. Examples of transport formats for carrying patient summary

data are given. Terminologies, deployment and migration guidance are also addressed.

Out of Scope:

This document will not recommend a particular delivery platform/service/template or terminology. The

IPS is not a Personal Health Record (PHR), nor is it a comprehensive Electronic Health Record (EHR) both

of which have different purposes.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

EN 17269:2019, Health Informatics - The International Patient Summary for unscheduled cross border care

3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminolo
...

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