Health Informatics - Interoperability and Integration Reference Architecture - Model and Framework (ISO 23903:2021)

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 - Interoperabilitätsreferenzarchitektur (ISO 23903:2021)

Informatique de santé - Architecture de Référence d'Interopérabilité et d'Intégration - Modèle et cadre (ISO 23903:2021)

Zdravstvena informatika - Referenčna arhitektura interoperabilnosti in integracije - Model in okvir (ISO 23903:2021)

General Information

Status
Published
Public Enquiry End Date
18-Jun-2020
Publication Date
25-May-2021
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
14-May-2021
Due Date
19-Jul-2021
Completion Date
26-May-2021

Buy Standard

Standard
SIST EN ISO 23903:2021 - BARVE na PDF-str 26,27,28,31,32,33,34
English language
35 pages
sale 10% off
Preview
sale 10% off
Preview

e-Library read for
1 day
Draft
oSIST prEN ISO 23903:2020 - BARVE na PDF-str 20,21,22,23,25,26,27
English language
30 pages
sale 10% off
Preview
sale 10% off
Preview

e-Library read for
1 day

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)

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
---------------------- Page: 2 ----------------------
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 23903:2021
EN ISO 23903:2021 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
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.

---------------------- Page: 5 ----------------------
SIST EN ISO 23903:2021
---------------------- Page: 6 ----------------------
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
---------------------- Page: 7 ----------------------
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
---------------------- Page: 9 ----------------------
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
---------------------- Page: 10 ----------------------
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
---------------------- Page: 11 ----------------------
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
---------------------- Page: 12 ----------------------
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

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
---------------------- Page: 13 ----------------------
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
---------------------- Page: 14 ----------------------
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
---------------------- Page: 15 ----------------------
SIST EN ISO 23903:2021
---------------------- Page: 16 ----------------------
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

(World Wide Web Consortium (W3C® ), languages for modeling and integrating business processes

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
---------------------- Page: 5 ----------------------
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

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
---------------------- Page: 7 ----------------------
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

vi © ISO 2020 – All rights reserved
---------------------- Page: 8 ----------------------
oSIST prEN ISO 23903:2020
ISO/DIS 23903:2020(E)

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.

© ISO 2020 – All rights reserved vii
---------------------- Page: 9 ----------------------
oSIST prEN ISO 23903:2020
ISO/DIS 23903:2020(E)

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.

viii © ISO 2020 – All rights reserved
---------------------- Page: 10 ----------------------
oSIST prEN ISO 23903:2020
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

© ISO 2020 – All rights reserved 1
---------------------- Page: 11 ----------------------
oSIST prEN ISO 23903:2020
ISO/DIS 23903:2020(E)
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]
2 © ISO 2020 – All rights reserved
---------------------- Page: 12 ----------------------
oSIST prEN ISO 23903:2020
ISO/DIS 23903:2020(E)
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
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.