EN ISO 23903:2021

SLOVENSKI STANDARD
01-julij-2021
Zdravstvena informatika - Referenčna arhitektura interoperabilnosti in integracije -
Model in okvir (ISO 23903:2021)
Health Informatics - Interoperability and Integration Reference Architecture - Model and
Framework (ISO 23903:2021)
Medizinische Informatik - Interoperabilitätsreferenzarchitektur (ISO 23903:2021)
Informatique de santé - Architecture de Référence d'Interopérabilité et d'Intégration -
Modèle et cadre (ISO 23903:2021)
Ta slovenski standard je istoveten z: EN ISO 23903:2021
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 23903
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2021
EUROPÄISCHE NORM
ICS 35.240.80
English Version
Health Informatics - Interoperability and integration
reference architecture - Model and framework (ISO
23903:2021)
Informatique de santé - Architecture de référence Medizinische Informatik - Interoperabilitäts- und
d'interopérabilité et d'intégration - Modèle et cadre Integrations-Referenzarchitektur - Modell und
(ISO 23903:2021) Framework (ISO 23903:2021)
This European Standard was approved by CEN on 9 March 2021.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23903:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 23903:2021) has been prepared by Technical Committee ISO/TC 215 "Health
informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by October 2021, and conflicting national standards shall
be withdrawn at the latest by October 2021.
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 organizations of the
following countries are bound to implement this European Standard: 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.
Endorsement notice
The text of ISO 23903:2021 has been approved by CEN as EN ISO 23903:2021 without any modification.

INTERNATIONAL ISO
STANDARD 23903
First edition
2021-04
Health informatics — Interoperability
and integration reference architecture
– Model and framework
Informatique de santé — Architecture de référence d'interopérabilité
et d'intégration — Modèle et cadre
Reference number
ISO 23903:2021(E)
©
ISO 2021
ISO 23903:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
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below or ISO’s member body in the country of the requester.
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Phone: +41 22 749 01 11
Email: copyright@iso.org
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Published in Switzerland
ii © ISO 2021 – All rights reserved

ISO 23903:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviations. 5
5 Overview on standard system architecture. 5
6 Interoperability and Integration Reference Architecture for ICT Supported Systems .6
6.1 Interoperability and Integration Reference Architecture domains and granularity levels . 6
6.2 Interoperability and Integration Reference Architecture model for ICT supported
systems . 7
6.3 Interoperability and Integration Reference Architecture framework . 8
6.3.1 Basic requirements . 8
6.3.2 Management of relationships in the Interoperability and Integration
Reference Architecture . 9
6.3.3 Business process modelling using the Interoperability and Integration
Reference Architecture . 9
Annex A (informative) Cross-domain interoperability for security and privacy aware EHR
communication .11
Annex B (informative) Interoperability between different communication standards .13
Annex C (informative) Integration of Standards in ISO 12967 (all parts) .15
Annex D (informative) Deployment of the Interoperability and Integration Reference
Architecture Approach in ISO 13972.18
Annex E (informative) Deployment of the Interoperability and Integration Reference
Architecture Approach for the Representation and Harmonization of Alternative
Reference Architectures .19
Bibliography .21
ISO 23903:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration
with the European Committee for Standardization (CEN) Technical Committee CEN/TC 251, Health
informatics, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement).
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved

ISO 23903:2021(E)
Introduction
0.1  Preface
This document supports the integration of a) specifications from different domains with their specific
methodologies, terminologies and ontologies including specific specification style as well as b) systems
based on those specifications. Enabling the use-case-specific identification and consistent, formal
representation including constraints of necessary components with their specific concepts and their
relationships, this document facilitates the deployment of existing standards and systems, the analysis
and improvement of specifications under revision as well as the design of new projects.
This document provides an overview of the Interoperability and Integration Reference Architecture
[1][2]
(first introduced in the 1990s as the Generic Component Model – GCM ), providing scope, justification
and explanation of key concepts and the resulting model and framework. It contains explanatory
material on how this Interoperability and Integration Reference Architecture is interpreted and applied
by its users, who might include standards writers and architects of interoperable systems, but also
systems integrators.
The ongoing organizational, methodological and technological paradigm changes in health and
social care result in health systems transformation toward P5 (personalized, preventive, predictive,
participative precision) systems medicine as fully distributed, highly dynamic, strongly integrated,
multi-disciplinary (or multi-domain) intelligent ecosystems, comprising both structured systems,
[3]
communities governed by rules, and combinations thereof .
0.2  Interoperability levels
Interoperability (see 3.16) has evolved during the last 30 years from structured messaging (e.g. EDI,
1) 2) [4]
HL7® messaging) over sharing concepts [e.g. openEHR® Archetypes, ISO 13940 (system of
concepts to support continuity of care)] – both representing the data/information exchange paradigm
– to cooperation at application level (e.g. Web services). All those solutions focus on information and
communication techno
...