SIST EN ISO 23903:2021
(Main)Health Informatics - Interoperability and Integration Reference Architecture - Model and Framework (ISO 23903:2021, Corrected version 2021-07)
Health Informatics - Interoperability and Integration Reference Architecture - Model and Framework (ISO 23903:2021, Corrected version 2021-07)
This International Standard provides a model and framework for integrating different standards as well
as systems based on those specifications by supporting the use case specific identification and
consistent, formal representation including constraints of necessary components and their
relationships. It facilitates analysis and improvement of specifications under revision as well as the
design of new projects. The approach is future proof due to its scientific soundness, based on systems
theory, knowledge representation and knowledge management via ontology development and
harmonization, that way supporting advanced interoperability between dynamic, multi-domain systems
through knowledge and skills sharing in the context of intelligent cooperation. The approach is
successfully deployed in several standards such as ISO 22600, ISO 21298, ISO 13606, ISO 12967,
ISO 13940 and ISO 13972 (both under way), but also in most of the HL7 security specifications. The
intended International Standard adopts objectives, content and presentation style used in other
foundational standards such as ISO/IEC 10746, this way qualifying for a potential ISO/IEC 10746-6.
Medizinische Informatik - Interoperabilitäts- und Integrations-Referenzarchitektur - Modell und Framework (ISO 23903:2021, korrigierte Fassung 2021-07)
Informatique de santé - Architecture de Référence d'Interopérabilité et d'Intégration - Modèle et cadre (ISO 23903:2021, Version corrigée 2021-07)
Le présent document permet de faire progresser l'interopérabilité depuis le paradigme d'échange de données/d'informations vers le partage des connaissances à un niveau d'abstraction de moins en moins élevé, en commençant au niveau des concepts TI (coordination sémantique) en passant par le niveau des concepts de domaine d'activité (coopération convenue au niveau des fonctions de service), le niveau du domaine (coopération inter-domaines) jusqu'au contexte individuel (collaboration entre utilisateurs finaux fondée sur les compétences). Le présent document définit un modèle et un cadre pour une représentation harmonisée de systèmes existants ou prévus, portant plus particulièrement sur les systèmes professionnels pris en charge par les technologies de l'information et de la communication. L'architecture de référence d'interopérabilité et d'intégration prend en charge l'harmonisation ontologique ou l'harmonisation des connaissances afin de permettre l'interopérabilité entre, et l'intégration des, systèmes, normes et solutions à tout niveau de complexité sans exiger d'adapter ou réviser en continu ces spécifications. Cette démarche peut être utilisée pour analyser, concevoir, intégrer et faire fonctionner tout type de systèmes. Pour arriver à une interopérabilité avancée, il est nécessaire que des écosystèmes de santé et sociaux flexibles, évolutifs, contrôlés par les activités, adaptables, basés sur les connaissances et intelligents suivent une démarche orientée systèmes, centrée sur l'architecture, basée sur l'ontologie et dictée par une politique.
Les langages utilisés pour représenter les différentes vues des systèmes, comme les langages d'ontologie tels que Common Logic (CL) (ISO/IEC 24707[24]) et Web Ontology Language (OWL)[25] – spécifiquement OWL 2[26] (World Wide Web Consortium, W3C®6), les langages de modélisation et d'intégration de processus professionnels tels que Business Process Modeling Language (BPML) (OMG®7), mais également Unified Modeling Language d'OMG (UML, également spécifié comme l'ISO/IEC 19505[27]) basés sur les styles de représentation pour les différentes vues de l' ISO/IEC 10746 (toutes les parties) ne relèvent pas du domaine d'application du présent document.
6 W3C est une marque déposée du World Wide Web Consortium. Cette information est donnée par souci de commodité à l'intention des utilisateurs du présent document et ne saurait constituer un engagement de la part de l'ISO quant au produit désigné.
7 OMG est une marque déposée de l'OMG (Object Management Group®). Cette information est donnée par souci de commodité à l'intention des utilisateurs du présent document et ne saurait constituer un engagement de la part de l'ISO quant au produit désigné.
Zdravstvena informatika - Referenčna arhitektura interoperabilnosti in integracije - Model in okvir (ISO 23903:2021, popravljena različica 2021-07)
General Information
Buy Standard
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 23903:2021
01-julij-2021
Zdravstvena informatika - Referenčna arhitektura interoperabilnosti in integracije -
Model in okvir (ISO 23903:2021, popravljena različica 2021-07)
Health Informatics - Interoperability and Integration Reference Architecture - Model and
Framework (ISO 23903:2021, Corrected version 2021-07)
Medizinische Informatik - Interoperabilitäts- und Integrations-Referenzarchitektur -
Modell und Framework (ISO 23903:2021, korrigierte Fassung 2021-07)
Informatique de santé - Architecture de Référence d'Interopérabilité et d'Intégration -
Modèle et cadre (ISO 23903:2021, Version corrigée 2021-07)
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
SIST EN ISO 23903:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 23903:2021
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SIST EN ISO 23903:2021
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, Corrected version 2021-07)
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, Version corrigée 2021-07) Framework (ISO 23903:2021, korrigierte Fassung
2021-07)
This European Standard was approved by CEN on 9 March 2021.
This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 21 July 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 NORMALISATIO N
EUROPÄISCHES KOMITEE FÜR NO RMU N G
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.
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SIST EN ISO 23903:2021
EN ISO 23903:2021 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 23903:2021
EN ISO 23903:2021 (E)
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, Corrected version 2021-07 has been approved by CEN as
EN ISO 23903:2021 without any modification.
3
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SIST EN ISO 23903:2021
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SIST EN ISO 23903:2021
INTERNATIONAL ISO
STANDARD 23903
First edition
2021-04
Corrected version
2021-07
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
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SIST EN ISO 23903:2021
ISO 23903:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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SIST EN ISO 23903:2021
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 2021 – All rights reserved iii
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SIST EN ISO 23903:2021
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.
This corrected version of ISO 23903:2021 incorporates the following corrections:
— Figure E.1 has been corrected.
iv © ISO 2021 – All rights reserved
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SIST EN ISO 23903:2021
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 technologies (ICT) systems interoperability using ICT terminologies and ontologies
for representing data, information, or even concepts and knowledge, thereby distinguishing the three
interoperability levels: a) foundational, b) structural, and c) semantic interoperability.
On the move towards digital health, ICT systems get more closely integrated in the real world business
process. This move requires supporting advanced, knowledge-level and business process focused
interoperability between all principals acting in those ecosystems such as persons, organizations,
devices, applications, components, or objects to achieve the common business objectives. As knowledge,
methodologies and terminologies of the domains involved in the business case and represented through
those domains’ ontologies, but also individual contexts, abilities and capabilities are highly different,
they must be shared and adapted in advance or dynamically at runtime, enabling adequate cooperation
[5]
of actors and systems involved. Table 1 summarizes the different interoperability levels .
1) HL7 is a registered trademark of Health Level Seven International. This information is given for the convenience
of users of this document and does not constitute an endorsement by ISO of the product named.
2) openEHR is a registered trademark of the openEHR Foundation. This information is given for the convenience
of users of this document and does not constitute an endorsement by ISO of the product named.
© ISO 2021 – All rights reserved v
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SIST EN ISO 23903:2021
ISO 23903:2021(E)
Table 1 — Interoperability levels
Information Perspective Organization Perspective
Interoperability
Instances Interoperability Level
Level
Technical Technical plug&play, signal & protocol com- Light-weight interactions
patibility
Structural Simple EDI, envelopes Data sharing
Syntactic Messages and clinical documents with agreed Information sharing
vocabulary
Semantic Advanced messaging with common information Knowledge sharing at IT concept level in
models and terminologies computer-parsable form
Coordination
O rg a n iza t i o n / Common business process Knowledge sharing at business concept level
Service
Agreed service function level cooperation
Knowledge based Multi-domain processes Knowledge sharing at domain level
Cross-domain cooperation
Skills based Individual engagement in multiple domains Knowledge sharing in individual context
Moderated end-user collaboration
0.3 Motivation for the Interoperability and Integration Reference Architecture
Meeting the objectives of improving safety, quality and efficiency of care with ICT support requires
advancing interoperability between computer systems towards a business-process-specific co-
operation of actors representing the different domains participating in the business case. For that
purpose, the agreed domain knowledge, but also the individual and shared context (language, education,
skills, experiences, psychological, social, occupational, environmental aspects, etc.), need to be
represented correctly and formally for integration with the ICT system as part of the business system.
As the domain experts involved describe specific aspects of that business system in their own specific
contexts and using specific terminologies and ontologies, methodologies and frameworks, the resulting
informational representations are often quite inconsistent, requiring a peer-to-peer interoperability
adaptation process. Adapting existing standardized informational representations of domain-specific
use cases to changing contexts or contexts including multiple domains requires another common
harmonized informational representation, resulting in permanent revisions of specifications.
Modelling systems for multi-domain interoperability requires the advancement from the data model,
information model, and ICT domain knowledge perspective to the knowledge perspective of the
[6]
business domains . For achieving the latter, the relevant stakeholders are responsible to define the
provided view of the model as well as the way of structuring and naming the concepts of the problem
space. First capturing key concepts and key relations at a high level of abstraction, different abstraction
levels can be used iteratively. Thereby, the first iteration is performed in a top-down manner to
guarantee the conceptual integrity of the model. This demands meeting design principles such as
[7] [8]
orthogonality, generality, parsimony, and propriety. ISO 30401 defines the requirements for
knowledge management systems in organizations to meet business objectives.
It is impossible to represent the highly complex, highly dynamic, multi-disciplinary/multi-domain
healthcare system by one domain‘s terminology/ontology or – even worse for the reasons mentioned
right before - by exclusively using ICT ontologies and ICT specific representation styles.
The alternative is an abstract, domain-independent representation of systems using Universal Type
[9]
Theory and corresponding logics. The mathematical concept representation using a Meta Reference
[9]
Architecture according to the formal theory of the Barendregt Cube with Parameters in combination
with systems engineering methodologies allows representing any system architecturally (i.e. the
system’s components, their functions and internal as well as external relations) by generically describing
its composition/decomposition and behaviour from the perspectives of all domains of relevance in a
specific business case. A third dimension describes the system’s development process such as evolution
vi © ISO 2021 – All rights reserved
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SIST EN ISO 23903:2021
ISO 23903:2021(E)
for living systems, manufacturing for technical systems, or a software development process, resulting
in a generic system model or Generic Reference Architecture presented in Figure 1. Details regarding
the dimensions of the model are explained in Clause 5 and Clause 6.
Figure 1 — Generic Reference Architecture model
To represent advanced interoperability and integration settings, different domain-specific
representations are linked to the same real world component. Therefore, an abstract and generic
reference architecture is needed which is able to represent any aspect or domain of interest. For
correctly and formally representing the concepts and relations of the domain-specific subsystems
involved in that business case, those subsystems are represented by their corresponding approved
domain ontologies, resulting in a system-theoretical, architecture-centric, top-level ontology driven
[10][11]
approach . Requirements for top level ontologies are specified in ISO 21838 (all parts). Health
3)
domain ontologies are SNOMED-CT® or specific ontologies such as the Open Biomedical Ontologies
[12] [13]
(OBO), including the Gene Ontology, maintained by the OBO Foundry .
As we can consistently model and compute only systems of reasonable complexity, the Generic Reference
Architecture model (Figure 1) can be used recursively at different granularity levels, so representing,
e.g. the continuum of real-world systems from elementary particles to the universe. The concepts of
the system’s components and their relations are represented in appropriate expressions in natural or
formal languages up to the basic level of primitives. The system analysis or design needs to address
partial systems when considering higher granularity levels of the system in question.
0.4 Technical approach
A system is a composition of interrelated components, ordered to accomplish a specific function or a
set of functions. Systems can be decomposed into subsystems or composed to form super-systems.
There are constructive or structural and behavioural or functional aspects of systems. According to
[14]
IEEE 1471, the architecture of a system is the fundamental organization of that system embodied in
its components, their relationships to each other and to the environment, and the principles guiding its
design and evolution. Rules for selecting and constraining components and functions as well as relations
according to a business case are called policies. Policies define the intended behaviour of a system. For
living systems, factors such as homeostasis, with the attributes of self-organization and self-regulation
as well as growth and development, reproduction, with the associated heredity (structure preservation)
and mutation (structural change), and higher development through selection of best-adapted variants
out of a large number make the description of living systems more complicated than that of technical
[15]
systems .
3) SNOMED CT is the registered trademark of the International Health Terminology Standards Development
Organisation (IHTSDO). This information is given for the convenience of users of this document and does not
constitute an endorsement by ISO of the product named.
© ISO 2021 – All rights reserved vii
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SIST EN ISO 23903:2021
ISO 23903:2021(E)
In the 1970s and 1980s, a data level interoperability approach was developed by defining the
application and technology agnostic standard data exchange format EDI (electronic data interchange)
in order to transform proprietary data formats into the standard data format and vice versa.
[16]
Thus International Standards arose such as ISO 9735 (EDIFACT), or its healthcare-specific
[17]
pendant ISO/HL7 27931:2009, an application protocol for electronic data exchange in healthcare
environments. This document defines a generic system architecture for knowledge level interoperability.
It allows consistently transforming and interrelating any domain specific subsystem’s structure and
behaviour (e.g. domain specific standards and specifications) by ontologically representing its concepts
and relationships at the real world system component’s level of granularity in the abstract generic
component system. In other words, the domain specific subsystem (e.g. a domain specific standard or
specification) is re-engineered using the Interoperability and Integration Reference Architecture, by
that way providing a standardized interface to that specification. In this way, the methodology offered
in this document maps between domain specific or proprietary systems and their representation as
specification or domain specific standard by transforming them into a standard system architecture
and vice versa. Annex A demonstrates the integration of two domain specific standards by reengineering
[18]
the ISO 13606-1 Reference Model and the HL7® Composite Security and Privacy Domain Analysis
[19]
Model and combining them in an Interoperability and Integration Reference Architecture model
instance. Annex B demonstrates the integration of different communication standards by reengineering
4) 4)
HL7 v3® methodology and creating an adequate HL7 v2® methodology and transforming them into
an Interoperability and Integration Reference Architecture instance. In this way, the Interoperability
and Integration Reference Architecture supports the mutual transformation of those communications
standards for the sake of interoperability of existing solutions. For ontologically representing the
[20]
models, the Communication Standards Ontology (CSO) has been used. Figure 2 correspondingly
presents this standard’s interoperability approach. Annex C demonstrates the integration of different
[21]
standards in the light of ISO 12967(all parts) , while Annex D presents the approach in context of
[22]
ISO 13972 . Finally, Annex E demonstrates the deployment of this document’s Interoperability and
Integration Reference Architecture for the representation and harmonization of alternative reference
architectures.
4) HL7 v3 and HL7 v2 are registered trademarks of Health Level Seven International. This information is given for
the convenience of users of this document and does not constitute an endorsement by ISO of the products named.
viii © ISO 2021 – All rights reserved
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SIST EN ISO 23903:2021
ISO 23903:2021(E)
Figure 2 — Overview of this document’s interoperability approach
Bound to the GCM Framework, inter-domain relationships need to happen at the same level of
[23]
granularity . To get there, intra-domain specializations/generalizations are performed.
© ISO 2021 – All rights reserved ix
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SIST EN ISO 23903:2021
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SIST EN ISO 23903:2021
INTERNATIONAL STANDARD ISO 23903:2021(E)
Health informatics — Interoperability and integration
reference architecture — Model and framework
1 Scope
This document enables the advancement of interoperability from the data/information exchange
paradigm to knowledge sharing at decreasing level of abstraction, starting at IT concept level (semantic
coordination) through business domain concept level (agreed service function level cooperation),
domain level (cross-domain cooperation) up to individual context (skills-based end-user collaboration).
The document defines a model and framework for a harmonized representation of existing or intended
systems with a specific focus on ICT-supported business systems. The Interoperability and Integration
Reference Architecture supports ontology harmonization or knowledge harmonization to enable
interoperability between, and integration of, systems, standards and solutions at any level of complexity
without the demand for continuously adapting/revising those specifications. The approach can be
used for analysing, designing, integrating, and running any type of systems. For realizing advanced
interoperability, flexible, scalable, business-controlled, adaptive, knowledge-based, intelligent health
and social ecosystems need to follow a systems-oriented, architecture-centric, ontology-based and
policy-driven approach.
The languages for representing the different views on systems such as ontology languages like
[24] [25] [26]
Common Logic (CL) (ISO/IEC 24707 ) and Web Ontology Language (OWL) – specifically OWL 2
5)
(World Wide Web Consortium (W3C® ), languages for modeling and integrating business processes
6)
like Business Process Modeling Langua
...
SLOVENSKI STANDARD
SIST EN ISO 23903:2021
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
SIST EN ISO 23903:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 23903:2021
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SIST EN ISO 23903:2021
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.
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SIST EN ISO 23903:2021
EN ISO 23903:2021 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 23903:2021
EN ISO 23903:2021 (E)
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.
3
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SIST EN ISO 23903:2021
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SIST EN ISO 23903:2021
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
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SIST EN ISO 23903:2021
ISO 23903:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 23903:2021
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 2021 – All rights reserved iii
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SIST EN ISO 23903:2021
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
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SIST EN ISO 23903:2021
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 technologies (ICT) systems interoperability using ICT terminologies and ontologies
for representing data, information, or even concepts and knowledge, thereby distinguishing the three
interoperability levels: a) foundational, b) structural, and c) semantic interoperability.
On the move towards digital health, ICT systems get more closely integrated in the real world business
process. This move requires supporting advanced, knowledge-level and business process focused
interoperability between all principals acting in those ecosystems such as persons, organizations,
devices, applications, components, or objects to achieve the common business objectives. As knowledge,
methodologies and terminologies of the domains involved in the business case and represented through
those domains’ ontologies, but also individual contexts, abilities and capabilities are highly different,
they must be shared and adapted in advance or dynamically at runtime, enabling adequate cooperation
[5]
of actors and systems involved. Table 1 summarizes the different interoperability levels .
1) HL7 is a registered trademark of Health Level Seven International. This information is given for the convenience
of users of this document and does not constitute an endorsement by ISO of the product named.
2) openEHR is a registered trademark of the openEHR Foundation. This information is given for the convenience
of users of this document and does not constitute an endorsement by ISO of the product named.
© ISO 2021 – All rights reserved v
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SIST EN ISO 23903:2021
ISO 23903:2021(E)
Table 1 — Interoperability levels
Information Perspective Organization Perspective
Interoperability
Instances Interoperability Level
Level
Technical Technical plug&play, signal & protocol com- Light-weight interactions
patibility
Structural Simple EDI, envelopes Data sharing
Syntactic Messages and clinical documents with agreed Information sharing
vocabulary
Semantic Advanced messaging with common information Knowledge sharing at IT concept level in
models and terminologies computer-parsable form
Coordination
O rg a n iza t i o n / Common business process Knowledge sharing at business concept level
Service
Agreed service function level cooperation
Knowledge based Multi-domain processes Knowledge sharing at domain level
Cross-domain cooperation
Skills based Individual engagement in multiple domains Knowledge sharing in individual context
Moderated end-user collaboration
0.3 Motivation for the Interoperability and Integration Reference Architecture
Meeting the objectives of improving safety, quality and efficiency of care with ICT support requires
advancing interoperability between computer systems towards a business-process-specific co-
operation of actors representing the different domains participating in the business case. For that
purpose, the agreed domain knowledge, but also the individual and shared context (language, education,
skills, experiences, psychological, social, occupational, environmental aspects, etc.), need to be
represented correctly and formally for integration with the ICT system as part of the business system.
As the domain experts involved describe specific aspects of that business system in their own specific
contexts and using specific terminologies and ontologies, methodologies and frameworks, the resulting
informational representations are often quite inconsistent, requiring a peer-to-peer interoperability
adaptation process. Adapting existing standardized informational representations of domain-specific
use cases to changing contexts or contexts including multiple domains requires another common
harmonized informational representation, resulting in permanent revisions of specifications.
Modelling systems for multi-domain interoperability requires the advancement from the data model,
information model, and ICT domain knowledge perspective to the knowledge perspective of the
[6]
business domains . For achieving the latter, the relevant stakeholders are responsible to define the
provided view of the model as well as the way of structuring and naming the concepts of the problem
space. First capturing key concepts and key relations at a high level of abstraction, different abstraction
levels can be used iteratively. Thereby, the first iteration is performed in a top-down manner to
guarantee the conceptual integrity of the model. This demands meeting design principles such as
[7] [8]
orthogonality, generality, parsimony, and propriety. ISO 30401 defines the requirements for
knowledge management systems in organizations to meet business objectives.
It is impossible to represent the highly complex, highly dynamic, multi-disciplinary/multi-domain
healthcare system by one domain‘s terminology/ontology or – even worse for the reasons mentioned
right before - by exclusively using ICT ontologies and ICT specific representation styles.
The alternative is an abstract, domain-independent representation of systems using Universal Type
[9]
Theory and corresponding logics. The mathematical concept representation using a Meta Reference
[9]
Architecture according to the formal theory of the Barendregt Cube with Parameters in combination
with systems engineering methodologies allows representing any system architecturally (i.e. the
system’s components, their functions and internal as well as external relations) by generically describing
its composition/decomposition and behaviour from the perspectives of all domains of relevance in a
specific business case. A third dimension describes the system’s development process such as evolution
vi © ISO 2021 – All rights reserved
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SIST EN ISO 23903:2021
ISO 23903:2021(E)
for living systems, manufacturing for technical systems, or a software development process, resulting
in a generic system model or Generic Reference Architecture presented in Figure 1. Details regarding
the dimensions of the model are explained in Clause 5 and Clause 6.
Figure 1 — Generic Reference Architecture model
To represent advanced interoperability and integration settings, different domain-specific
representations are linked to the same real world component. Therefore, an abstract and generic
reference architecture is needed which is able to represent any aspect or domain of interest. For
correctly and formally representing the concepts and relations of the domain-specific subsystems
involved in that business case, those subsystems are represented by their corresponding approved
domain ontologies, resulting in a system-theoretical, architecture-centric, top-level ontology driven
[10][11]
approach . Requirements for top level ontologies are specified in ISO 21838 (all parts). Health
3)
domain ontologies are SNOMED-CT® or specific ontologies such as the Open Biomedical Ontologies
[12] [13]
(OBO), including the Gene Ontology, maintained by the OBO Foundry .
As we can consistently model and compute only systems of reasonable complexity, the Generic Reference
Architecture model (Figure 1) can be used recursively at different granularity levels, so representing,
e.g. the continuum of real-world systems from elementary particles to the universe. The concepts of
the system’s components and their relations are represented in appropriate expressions in natural or
formal languages up to the basic level of primitives. The system analysis or design needs to address
partial systems when considering higher granularity levels of the system in question.
0.4 Technical approach
A system is a composition of interrelated components, ordered to accomplish a specific function or a
set of functions. Systems can be decomposed into subsystems or composed to form super-systems.
There are constructive or structural and behavioural or functional aspects of systems. According to
[14]
IEEE 1471, the architecture of a system is the fundamental organization of that system embodied in
its components, their relationships to each other and to the environment, and the principles guiding its
design and evolution. Rules for selecting and constraining components and functions as well as relations
according to a business case are called policies. Policies define the intended behaviour of a system. For
living systems, factors such as homeostasis, with the attributes of self-organization and self-regulation
as well as growth and development, reproduction, with the associated heredity (structure preservation)
and mutation (structural change), and higher development through selection of best-adapted variants
out of a large number make the description of living systems more complicated than that of technical
[15]
systems .
3) SNOMED CT is the registered trademark of the International Health Terminology Standards Development
Organisation (IHTSDO). This information is given for the convenience of users of this document and does not
constitute an endorsement by ISO of the product named.
© ISO 2021 – All rights reserved vii
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SIST EN ISO 23903:2021
ISO 23903:2021(E)
In the 1970s and 1980s, a data level interoperability approach was developed by defining the
application and technology agnostic standard data exchange format EDI (electronic data interchange)
in order to transform proprietary data formats into the standard data format and vice versa.
[16]
Thus International Standards arose such as ISO 9735 (EDIFACT), or its healthcare-specific
[17]
pendant ISO/HL7 27931:2009, an application protocol for electronic data exchange in healthcare
environments. This document defines a generic system architecture for knowledge level interoperability.
It allows consistently transforming and interrelating any domain specific subsystem’s structure and
behaviour (e.g. domain specific standards and specifications) by ontologically representing its concepts
and relationships at the real world system component’s level of granularity in the abstract generic
component system. In other words, the domain specific subsystem (e.g. a domain specific standard or
specification) is re-engineered using the Interoperability and Integration Reference Architecture, by
that way providing a standardized interface to that specification. In this way, the methodology offered
in this document maps between domain specific or proprietary systems and their representation as
specification or domain specific standard by transforming them into a standard system architecture
and vice versa. Annex A demonstrates the integration of two domain specific standards by reengineering
[18]
the ISO 13606-1 Reference Model and the HL7® Composite Security and Privacy Domain Analysis
[19]
Model and combining them in an Interoperability and Integration Reference Architecture model
instance. Annex B demonstrates the integration of different communication standards by reengineering
4) 4)
HL7 v3® methodology and creating an adequate HL7 v2® methodology and transforming them into
an Interoperability and Integration Reference Architecture instance. In this way, the Interoperability
and Integration Reference Architecture supports the mutual transformation of those communications
standards for the sake of interoperability of existing solutions. For ontologically representing the
[20]
models, the Communication Standards Ontology (CSO) has been used. Figure 2 correspondingly
presents this standard’s interoperability approach. Annex C demonstrates the integration of different
[21]
standards in the light of ISO 12967(all parts) , while Annex D presents the approach in context of
[22]
ISO 13972 . Finally, Annex E demonstrates the deployment of this document’s Interoperability and
Integration Reference Architecture for the representation and harmonization of alternative reference
architectures.
4) HL7 v3 and HL7 v2 are registered trademarks of Health Level Seven International. This information is given for
the convenience of users of this document and does not constitute an endorsement by ISO of the products named.
viii © ISO 2021 – All rights reserved
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SIST EN ISO 23903:2021
ISO 23903:2021(E)
Figure 2 — Overview of this document’s interoperability approach
Bound to the GCM Framework, inter-domain relationships need to happen at the same level of
[23]
granularity . To get there, intra-domain specializations/generalizations are performed.
© ISO 2021 – All rights reserved ix
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SIST EN ISO 23903:2021
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SIST EN ISO 23903:2021
INTERNATIONAL STANDARD ISO 23903:2021(E)
Health informatics — Interoperability and integration
reference architecture – Model and framework
1 Scope
This document enables the advancement of interoperability from the data/information exchange
paradigm to knowledge sharing at decreasing level of abstraction, starting at IT concept level (semantic
coordination) through business domain concept level (agreed service function level cooperation),
domain level (cross-domain cooperation) up to individual context (skills-based end-user collaboration).
The document defines a model and framework for a harmonized representation of existing or intended
systems with a specific focus on ICT-supported business systems. The Interoperability and Integration
Reference Architecture supports ontology harmonization or knowledge harmonization to enable
interoperability between, and integration of, systems, standards and solutions at any level of complexity
without the demand for continuously adapting/revising those specifications. The approach can be
used for analysing, designing, integrating, and running any type of systems. For realizing advanced
interoperability, flexible, scalable, business-controlled, adaptive, knowledge-based, intelligent health
and social ecosystems need to follow a systems-oriented, architecture-centric, ontology-based and
policy-driven approach.
The languages for representing the different views on systems such as ontology languages like
[24] [25] [26]
Common Logic (CL) (ISO/IEC 24707 ) and Web Ontology Language (OWL) – specifically OWL 2
5)
(World Wide Web Consortium (W3C® ), languages for modeling and integrating business processes
6)
like Business Process Modeling Language (BPML) (OMG® ), but also OMG’s Unified Modeling
[27]
Language (UML, also specified as ISO/IEC 19505 ) based representation styles for the different
ISO/IEC 10746 (all parts) views are outside the scope of this document.
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
...
SLOVENSKI STANDARD
oSIST prEN ISO 23903:2020
01-junij-2020
Zdravstvena informatika - Referenčna arhitektura medobratovalnosti in integracije
- Model in okvir (ISO/DIS 23903:2020)
Health Informatics - Interoperability and Integration Reference Architecture - Model and
Framework (ISO/DIS 23903:2020)
Medizinische Informatik - Interoperabilitätsreferenzarchitektur (ISO/DIS 23903:2020)
Informatique de santé - Architecture de Référence d'Interopérabilité et d'Intégration -
Modèle et cadre (ISO/DIS 23903:2020)
Ta slovenski standard je istoveten z: prEN ISO 23903
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
oSIST prEN ISO 23903:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 23903:2020
---------------------- Page: 2 ----------------------
oSIST prEN ISO 23903:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23903
ISO/TC 215 Secretariat: ANSI
Voting begins on: Voting terminates on:
2020-04-17 2020-07-10
Health informatics — Interoperability and Integration
Reference Architecture – Model and Framework
ICS: 35.240.80
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 23903:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
---------------------- Page: 3 ----------------------
oSIST prEN ISO 23903:2020
ISO/DIS 23903:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 23903:2020
ISO/DIS 23903:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Abbreviations. 5
5 Overview on standard system architecture. 6
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 Health Informatics —
Service Architecture (HISA) .15
Annex D (informative) Deployment of the Interoperability and Integration Reference
Architecture Approach in ISO 13972 Health Informatics — Clinical Information Models .18
Annex E (informative) Reference Architecture Stack intended by the ISO/IEC JTC1 AG8
project “Meta Reference Architecture and Reference Architecture for Systems
Integration" .19
Bibliography .21
© ISO 2020 – All rights reserved iii
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oSIST prEN ISO 23903:2020
ISO/DIS 23903:2020(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 on 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 the following
URL: www .iso .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 251, Health informatics.
iv © ISO 2020 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 23903:2020
ISO/DIS 23903:2020(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, the DIS 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 DIS provides an overview of the Interoperability and Integration Reference Architecture (first
[1,2]
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 to be interpreted and applied by
its users, who may include standards writers and architects of interoperable systems, but also systems
integrators.
The ongoing organizational, methodological and technological paradigm changes in health and social
1)
care result in health systems transformation toward P5 systems medicine as fully distributed, highly
dynamic, strongly integrated, multi-disciplinary (or multi-domain) intelligent ecosystems, comprising
[3]
both structured systems, communities governed by rules, and combinations thereof .
0.2 Interoperability levels
Interoperability, defined by IEEE as the “ability of two or more systems or components to exchange
information and to use the information that has been exchanged”, has evolved during the last 30 years
from structured messaging (e.g. EDI, HL7 messaging) over sharing concepts (e.g. openEHR Archetypes,
EN/ISO 13940 ContSys concepts) – both representing the data/information exchange paradigm – to
cooperation at application level (e.g. Web services). All those solutions focus on information and
communication technologies (ICT) systems interoperability using ICT terminologies and ontologies
for representing data, information, or even concepts and knowledge, thereby distinguishing the three
interoperability levels: a) foundational, b) structural, and c) semantic interoperability.
On the move towards digital health, ICT systems get more closely integrated in the real world business
process. This move requires supporting advanced, knowledge-level and business process focused
interoperability between all principals acting in those ecosystems such as persons, organizations,
devices, applications, components, or objects to achieve the common business objectives. As knowledge,
methodologies and terminologies of the domains involved in the business case and represented
through those domains’ ontologies, but also individual contexts, abilities and capabilities are highly
different, they have to be shared and adapted in advance or dynamically at runtime, enabling adequate
[4]
cooperation of actors and systems involved. Table 1 summarizes the different interoperability levels .
1) Personalized, preventive, predictive, participative precision medicine.
© ISO 2020 – All rights reserved v
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oSIST prEN ISO 23903:2020
ISO/DIS 23903:2020(E)
Table 1 — Interoperability levels
Information Perspective Organization Perspective
Interoperability
Instances Interoperability Level
Level
Technical Technical plug&play, signal & protocol com- Light-weight interactions
patibility
Structural Simple EDI, envelopes Data sharing
Syntactic Messages and clinical documents with agreed Information sharing
vocabulary
Semantic Advanced messaging with common information Knowledge sharing at IT concept level in
models and terminologies computer-parsable form
Coordination
Organization/ Service Common business process Knowledge sharing at business concept level
Agreed service function level cooperation
Knowledge based Multi-domain processes Knowledge sharing at domain level
Cross-domain cooperation
Skills based Individual engagement in multiple domains Knowledge sharing in individual context
Moderated end-user collaboration
0.3 Motivation for the Interoperability and Integration Reference Architecture
Meeting the objectives of improving safety, quality and efficiency of care with ICT support requires
advancing interoperability between computer systems towards a business-process-specific co-
operation of actors representing the different domains participating in the business case. For that
purpose, the agreed domain knowledge, but also the individual and shared context (language, education,
skills, experiences, psychological, social, occupational, environmental aspects, etc.), have to be
represented correctly and formally for integration with the ICT system as part of the business system.
As the domain experts involved describe specific aspects of that business system in their own specific
contexts and using specific terminologies and ontologies, methodologies and frameworks, the resulting
informational representations are often quite inconsistent, requiring a peer-to-peer interoperability
adaptation process. Adapting existing standardized informational representations of domain-specific
use cases to changing contexts or contexts including multiple domains requires another common
harmonized informational representation, resulting in permanent revisions of specifications.
Modelling systems for multi-domain interoperability requires the advancement from the data model,
information model, and ICT domain knowledge perspective to the knowledge perspective of the
[5]
business domains. For achieving the latter, the relevant stakeholders shall define the provided view
of the model as well as the way of structuring and naming the concepts of the problem space. First
capturing key concepts and key relations at a high level of abstraction, different abstraction levels
can be used iteratively. Thereby, the first iteration is performed in a top-down manner to guarantee
the conceptual integrity of the model. This requires meeting design principles such as orthogonality,
[6]
generality, parsimony, and propriety .
It is impossible to represent the highly complex, highly dynamic, multi-disciplinary/multi-domain
healthcare system by one domain‘s terminology/ontology or – even worse for the reasons mentioned
right before - by exclusively using ICT ontologies and specific representation styles.
The alternative is an abstract domain-independent representation of systems using Universal
Type Theory and corresponding logics. The mathematical concept representation using a Meta
[7]
Reference Architecture according to the Barendregt Cube with Parameters in combination with
systems engineering methodologies allows representing any system architecturally (i.e. the system’s
components, their functions and internal as well as external relations) by generically describing
its composition/decomposition and behavior from the perspectives of all domains of relevance in a
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specific business case. A third dimension describes the system’s development process such as evolution
for living systems, manufacturing for technical systems, or a software development process, resulting
in a generic system model or Generic Reference Architecture presented in Figure 1. Details regarding
the dimensions of the model are explained in the next sections.
Figure 1 — Generic Reference Architecture model
To represent advanced interoperability and integration settings, different domain-specific
representations must be linked to the same real world component. Therefore, an abstract and generic
reference architecture is needed which is able to represent any aspect or domain of interest. For
correctly and formally representing the concepts and relations of the domain-specific subsystems
involved in that business case, those subsystems are represented by their corresponding approved
domain ontologies, resulting in a system-theoretical, architecture-centric, top-level ontology driven
[8,9]
approach. Top level ontologies are specified in ISO 30401, health domain ontologies are SNOMED
International’s SNOMED-CT or specific ontologies such as the Open Biomedical Ontologies (OBO),
[10] [11]
including the Gene Ontology, maintained by the OBO Foundry .
As we can consistently model and compute only systems of reasonable complexity, the Generic
Reference Architecture model (Figure 1) can be used recursively at different granularity levels, so
representing, e.g., the continuum of real-world systems from elementary particles to the universe. The
system analysis or design has to address partial systems when considering higher granularity levels of
the system in question.
0.4 Technical approach
A system is a composition of interrelated components, ordered to accomplish a specific function or a
set of functions. Systems can be decomposed into subsystems or composed to form super-systems.
There are constructive or structural and behavioral or functional aspects of systems. According to
IEEE 1471, the architecture of a system is the fundamental organization of that system embodied in
its components, their relationships to each other and to the environment, and the principles guiding its
design and evolution. Rules for selecting and constraining components and functions as well as relations
according to a business case are called policies. Policies define the intended behavior of a system. For
living systems, factors such as homeostasis, with the attributes of self-organization and self-regulation
as well as growth and development, reproduction, with the associated heredity (structure preservation)
and mutation (structural change), and higher development through selection of best-adapted variants
out of a large number make the description of living systems more complicated than that of technical
[12]
systems .
In the seventies and eighties of the last century, a data level interoperability approach was developed
by defining the application and technology agnostic standard data exchange format EDI in order to
transform proprietary formats into the standard format and vice versa. Thus standards arose such as
ISO 9735 EDIFACT, or its healthcare-specific pendant ISO/HL7 27931:2009 Data Exchange Standards
– Health Level Seven Version 2.5 – An application protocol for electronic data exchange in healthcare
environments. The latter defines a generic system architecture for knowledge level interoperability.
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It allows consistently transforming and interrelating any domain specific subsystem’s structure and
behavior (e.g. domain specific standards and specifications) by ontologically representing its concepts
and relationships at the real world system component’s level of granularity in the abstract generic
component system. In other words, the domain specific subsystem (e.g. a domain specific standard
or specification) is re-engineered using the Interoperability and Integration Reference Architecture,
by that way providing a standardized interface to that specification. In this way, the methodology
offered in this DIS maps between domain specific or proprietary systems and their representation as
specification or domain specific standard by transforming them into a standard system architecture
and vice versa. Annex A demonstrates the integration of two domain specific standards by reengineering
the ISO 13606-1 Reference Model and the HL7 Composite Security and Privacy Domain Analysis Model
and combining them in an Interoperability and Integration Reference Architecture model instance.
Annex B demonstrates the integration of different communication standards by reengineering
HL7 v3 methodology and creating an adequate HL7 v2 methodology and transforming them into an
Interoperability and Integration Reference Architecture instance. In this way, the Interoperability
and Integration Reference Architecture supports the mutual transformation of those communications
standards for the sake of interoperability of existing solutions. For ontologically representing the
[13]
models, the Communication Standards Ontology (CSO) has been used. Figure 2 correspondingly
presents this standard’s interoperability approach. Annex C demonstrates the integration of different
standards in the light of ISO 12967 Health Informatics Service Architecture, while Annex D presents the
approach in context of ISO 13972 Clinical Information Models. Finally, Annex E presents the Reference
Architecture Stack the ISO/IEC JTC1 AG8 project “Meta Reference Architecture and Reference
Architecture for Systems Integration" is looking for, completely derived from this DIS’s Interoperability
and Integration Reference Architecture.
Figure 2 — Overview of this document’s interoperability approach
Bound to the GCM Framework, inter-domain relationships must happen at the same level of granularity.
[14]
To get there, intra-domain specializations/generalizations have to be performed.
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DRAFT INTERNATIONAL STANDARD ISO/DIS 23903:2020(E)
Health informatics — Interoperability and Integration
Reference Architecture – Model and Framework
1 Scope
This DIS enables the advancement of interoperability from the data/information exchange paradigm to
knowledge sharing at decreasing level of abstraction, starting at IT concept level (semantic coordination)
through business domain concept level (agreed service function level cooperation), domain level (cross-
domain cooperation) up to individual context (skills-based end-user collaboration). The DIS defines a
model and framework for a harmonized representation of existing or intended systems with a specific
focus on ICT-supported business systems. The Interoperability and Integration Reference Architecture
supports ontology harmonization or knowledge harmonization to enable interoperability between,
and integration of, systems, standards and solutions at any level of complexity without the demand for
continuously adapting/revising those specifications. The approach can be used for analyzing, designing,
integrating, and running any type of systems. For realizing advanced interoperability, flexible, scalable,
business-controlled, adaptive, knowledge-based, intelligent health and social ecosystems must follow a
systems-oriented, architecture-centric, ontology-based and policy-driven approach.
The languages for representing the different views on systems such as ontology languages like
Common Logic (CL) (ISO/IEC 24707) and Web Ontology Language (OWL) – specifically OWL 2 (WWW
Consortium), languages for modeling and integrating business processes like Business Process
Modeling Language (BPML) (OMG), but also OMG’s Unified Modeling Language (UML, also specified as
ISO/IEC 19505) based representation styles for the different ISO/IEC 10746 views are outside the scope
of this document.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO/IEC 10746-1:1998, Information technology — Open distributed processing — Reference model:
Overview
ISO/IEC 10746-2:2009, Information technology — Open distributed processing — Reference model:
Foundations
ISO/IEC 10746-3:2009, Information technology — Open distributed processing — Reference model:
Architecture
ISO/IEC 10746-4:1998, Information technology — Open distributed processing — Reference model:
Architectural semantics
ISO 22600-1:2014, Health informatics — Privilege management and access control — Part 1: Overview
and policy management
ISO 22600-2:2014, Health informatics — Privilege management and access control — Part 2: Formal models
ISO 22600-3:2014, Health informatics — Privilege management and access control — Part 3:
Implementations
ISO/IEC/DIS 21838-1, Information technology — Top-level ontologies — Part 1: Requirements
ISO/IEC/DIS 21838-2, Information technology — Top-level ontologies — Part 2: Basic formal ontology
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OMG Ontology Definition Metamodel V1.1
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
3.1
axiom
statement that is taken to be true, to serve as a premise for further reasoning
[SOURCE: ISO/IEC CD 21838-1, 3.9]
3.2
business viewpoint
viewpoint, which is concerned with the purpose, scope and policies governing the activities of the
specified ecosystem
3.3
class/type
general entity (3.9)
[SOURCE: ISO/IEC CD 21838-1, 3.2]
3.4
collection
group of particulars (3.19)
[SOURCE: ISO/IEC CD 21838-2, 3.4]
3.5
concept
A concept is a model. It shall be uniquely identifiable, accepted by experts and users, as well as
independent.
Note 1 to entry: A concept as a knowledge component can be specialized and generalized as components can.
3.6
definition
concise statement of the meaning of an expression (3.11)
[SOURCE: ISO/IEC CD 21838-1, 3.8]
3.7
domain
collection of entities (3.10) of interest to a certain community or discipline
[SOURCE: ISO/IEC CD 21838-1, 3.17]
3.8
domain ontology
ontology (3.18) whose terms (3.27) represent classes (3.3) or types and, optionally, certain particulars
(3.19) (called ‘distinguished individuals’) in some domain (3.7)
[SOURCE: ISO/IEC CD 21838-1, 3.18]
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3.9
ecosystem
structured systems and communities that are governed by general rules
Note 1 to entry: to entry: Ecosystems are controlled both by external and internal factors.
Note 2 to entry: to entry: The World Health Organization (WHO) described an ecosystem as combined
physical and biological components of an environment, forming complex sets of relationships and function as a
unit as they interact with their physical environment [SOURCE: World Health Organization. Ecosystem. http://
www .who .int/ globalchange/ ecosystems/ en/ ] .
3.10
entity/object
anything perceivable or conceivable
[SOURCE: ISO/IEC CD 21838-1, 3.1]
Note 1 to entry: to entry: ISO/IEC CD 21838-1 defines entity and object equally, and it follows the object
definition of ISO 1087.
3.11
expression
word or group of words or corresponding symbols that can be used in making an assertion
[SOURCE: ISO/IEC CD 21838-1, 3.5]
3.12
formal language
language that is machine readable and has a well-defined semantics
[SOURCE: ISO/IEC CD 21838-1, 3.10]
3.13
formal theory
collection (3.4) of definitions (3.6) and axioms (3.1) expressed in a formal language (3.12)
[SOURCE: ISO/IEC CD 21838-1, 3.11]
3.14
instance
particular (3.18) that instantiates some universal (3.28)
[SOURCE: ISO/IEC CD 21838-2, 3.4]
3.15
interoperability
ability of a system or a product to work with other systems or products without special effort on the
part of the customer
[SOURCE: IEEE Standards University]
Note 1 to entry: to entry: Under traditional ICT focus, interoperability is ability of two or more systems
or components to exchange information and to use the information that has been exchanged [SOURCE: IEEE
Standard Computer Dictionary: A Compilation of IEEE Standard Computer Glossaries (New York, NY: 1990)].
Note 2 to entry: to entry: In an ecosystem context, interoperability describes motivation, willingness,
ability, and capability to cooperate for achieving common goals or b
...
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