Health informatics -- Interoperability and integration reference architecture – Model and framework

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 Common Logic (CL) (ISO/IEC 24707[24]) and Web Ontology Language (OWL)[25] – specifically OWL 2[26] (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 Language (UML, also specified as ISO/IEC 19505[27]) based representation styles for the different ISO/IEC 10746 (all parts) views are outside the scope of this document. Â

Informatique de santé -- Architecture de référence d'interopérabilité et d'intégration -- Modèle et cadre

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Published
Publication Date
31-Mar-2021
Current Stage
5060 - Close of voting Proof returned by Secretariat
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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: 1 ----------------------
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: 2 ----------------------
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: 3 ----------------------
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: 4 ----------------------
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: 5 ----------------------
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: 6 ----------------------
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: 7 ----------------------
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: 8 ----------------------
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: 9 ----------------------
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 any amendments) applies.

ISO/IEC 10746 (all parts), Information technology — Open distributed processing — Reference model

ISO 22600 (all parts), Health informatics — Privilege management and access control

ISO/IEC 21838 (all parts), Information technology — Top-level ontologies (TLO)
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:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/

5) W3C is a registered trademark of the World Wide Web Consortium. This information is given for the convenience

of users of this document and does not constitute an endorsement by ISO of the products named.

6) OMG is a registered trademark of The Object Management Group®. This information is given for the convenience

of users of this document and does not constitute an endorsement by ISO of the products named.

© ISO 2021 – All rights reserved 1
---------------------- Page: 10 ----------------------
ISO 23903:2021(E)
3.1
architecture

set of rules to define the structure of a system (3.25) and the interrelationships between its parts

[SOURCE: ISO/IEC 10746-2:2009, 6.6, modified — "(of a system)" removed from term.]

3.2
axiom
statement that is taken to be true, to serve as a premise for further reasoning
[SOURCE: ISO/IEC/PRF 21838-1:— , 3.9, modified — Note to entry removed.]
3.3
business viewpoint

viewpoint (3.28) that is concerned with the purpose, scope and policies governing the activities of the

specified ecosystem (3.10)
3.4
class
type
general entity (3.11)

[SOURCE: ISO/IEC/PRF 21838-1:—, 3.2, modified — “type” added as second preferred term, note to

entry removed.]
3.5
collection
group of particulars (3.19)
[SOURCE: ISO/IEC/PRF 21838-2:— , 3.4, modified — Notes to entry removed.]
3.6
concept
unit of knowledge created by a unique combination of characteristics

Note 1 to entry: Concepts are not necessarily bound to particular natural languages. They are, however,

influenced by the social or cultural background which often leads to different categorizations.

Note 2 to entry: As a knowledge component, a concept can be specialized and generalized as components can.

[SOURCE: ISO 1087:2019, 3.2.7, modified — Note 2 to entry replaced.]
3.7
definition

representation of a concept by a descriptive statement which serves to differentiate it from related

concepts
[SOURCE: ISO 1087:2019, 3.3.1]
3.8
domain

collection (3.5) of entities (3.11) of interest to a certain community or discipline

[SOURCE: ISO/IEC/PRF 21838-1:—, 3.17, modified — Example and note to entry removed.]

7) Under preparation. Stage at the time of publication: ISO/IEC/PRF 21838-1:2021.

8) Under preparation. Stage at the time of publication: ISO/IEC/PRF 21838-2.2:2021.

2 © ISO 2021 – All rights reserved
---------------------- Page: 11 ----------------------
ISO 23903:2021(E)
3.9
domain ontology

ontology (3.18) whose terms (3.26) represent classes or types (3.4) and, optionally, certain particulars

(3.19) (called ‘distinguished individuals’) in some domain (3.8)
[SOURCE: ISO/IEC/PRF 21838-1:—, 3.18]
3.10
ecosystem
structured systems (3.25) and communities that are governed by general rules
3.11
entity
object
item that is perceivable or conceivable

Note 1 to entry: The terms ‘entity’ and ‘object’ are catch-all terms analogous to ‘something’. In terminology

circles ‘object’ is commonly used in this way. In ontology circles, ‘entity’ and ‘thing’ are commonly used.

[SOURCE: ISO/IEC/PRF 21838-1:—, 3.1]
3.12
expression

word or group of words or corresponding symbols that can be used in making an assertion

Note 1 to entry: Expressions are divided into natural language expressions and expressions in a formal language.

[SOURCE: ISO/IEC/PRF 21838-1:—, 3.5]
3.13
formal language
language that is machine readable and has well-defined semantics
[SOURCE: ISO/IEC/PRF 21838-1:—, 3.10, modified — Note removed.]
3.14
formal theory

collection (3.5) of definitions (3.7) and axioms (3.2) expressed in a formal language (3.13)

[SOURCE: ISO/IEC/PRF 21838-1: —, 3.11, modified — Note removed.]
3.15
instance
particular (3.19) that instantiates some universal (3.27)
[SOURCE: ISO/IEC/PRF 21838-2:—, 3.6, modified — Example removed.]
3.16
interoperability

ability of a system (3.25) or a product to work with other systems (3.25) or products without special

effort on the part of the customer

Note 1 to entry: Under traditional ICT focus, interoperability is ability of two or more systems or components to

[29]
exchange information and to use the information that has been exchanged .
[SOURCE: IEEE Standards Glossary]
© ISO 2021 – All rights reserved 3
---------------------- Page: 12 ----------------------
ISO 23903:2021(E)
3.17
model

unambiguous, abstract conception of some parts or aspects of the real world corresponding to the

modelling goals
Note 1 to entry: The relevant stakeholders define the provided view
...

INTERNATIONAL ISO
STANDARD 23903
First edition
Health informatics — Interoperability
and integration reference architecture
– Model and framework
Informatique de santé — Architecture de référence d'interopérabilité
et d'intégration — Modèle et cadre
PROOF/ÉPREUVE
Reference number
ISO 23903:2021(E)
ISO 2021
---------------------- Page: 1 ----------------------
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 PROOF/ÉPREUVE © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
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 PROOF/ÉPREUVE iii
---------------------- Page: 3 ----------------------
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.
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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.

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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 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

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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.
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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

5) [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.

5) Under preparation. Stage at the time of publication: ISO/DIS 13972:2020.
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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.

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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 any amendments) applies.

ISO/IEC 10746 (all parts), Information technology — Open distributed processing — Reference model:

Architecture

ISO 22600 (all parts), Health informatics — Privilege management and access control

ISO/IEC 21838 (all parts), Information technology — Top-level ontologies (TLO)
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:

— ISO Online browsing platform: available at https:// www .iso .org/ obp

6) W3C is a registered trademark of the World Wide Web Consortium. This information is given for the convenience

of users of this document and does not constitute an endorsement by ISO of the products named.

7) OMG is a registered trademark of The Object Management Group®. This information is given for the convenience

of users of this document and does not constitute an endorsement by ISO of the products named.

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ISO 23903:2021(E)
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
architecture

set of rules to define the structure of a system (3.25) and the interrelationships between its parts

[SOURCE: ISO/IEC 10746-2:2009, 6.6, modified — "(of a system)" removed from term.]

3.2
axiom
statement that is taken to be true, to serve as a premise for further reasoning
[SOURCE: ISO/IEC/PRF 21838-1:—, 3.9, modified — Note to entry removed.]
3.3
business viewpoint

viewpoint (3.28) that is concerned with the purpose, scope and policies governing the activities of the

specified ecosystem (3.10)
3.4
class
type
general entity (3.11)

[SOURCE: ISO/IEC/PRF 21838-1:— , 3.2, modified — “type” added as second preferred term, note to

entry removed.]
3.5
collection
group of particulars (3.19)
[SOURCE: ISO/IEC/PRF 21838-2:— , 3.4, modified — Notes to entry removed.]
3.6
concept
unit of knowledge created by a unique combination of characteristics

Note 1 to entry: Concepts are not necessarily bound to particular natural languages. They are, however,

influenced by the social or cultural background which often leads to different categorizations.

Note 2 to entry: As a knowledge component, a concept can be specialized and generalized as components can.

[SOURCE: ISO 1087:2019, 3.2.7, modified — Note 2 to entry replaced.]
3.7
definition

representation of a concept by a descriptive statement which serves to differentiate it from related

concepts
[SOURCE: ISO 1087:2019, 3.3.1]
3.8
domain

collection (3.5) of entities (3.11) of interest to a certain community or discipline

[SOURCE: ISO/IEC/PRF 21838-1:—, 3.17, modified — Example and note to entry removed.]

8) Under preparation. Stage at the time of publication: ISO/IEC/PRF 21838-1:2020.

9) Under preparation. Stage at the time of publication: ISO/IEC/PRF 21838-2.2:2020.

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ISO 23903:2021(E)
3.9
domain ontology

ontology (3.18) whose terms (3.26) represent classes or types (3.4) and, optionally, certain particulars

(3.19) (called ‘distinguished individuals’) in some domain (3.8)
[SOURCE: ISO/IEC/PRF 21838-1:—, 3.18]
3.10
ecosystem
structured systems (3.25) and communities that are governed by general rules
3.11
entity
object
item that is perceivable or conceivable

Note 1 to entry: The terms ‘entity’ and ‘object’ are catch-all terms analogous to ‘something’. In terminology

circles ‘object’ is commonly used in this way. In ontology circles, ‘entity’ and ‘thing’ are commonly used.

[SOURCE: ISO/IEC/PRF 21838-1:—, 3.1]
3.12
expression

word or group of words or corresponding symbols that can be used in making an assertion

Note 1 to entry: Expressions are divided into natural language expressions and expressions in a formal language.

[SOURCE: ISO/IEC/PRF 21838-1:—, 3.5]
3.13
formal language
language that is machine readable and has well-defined semantics
[SOURCE: ISO/IEC/PRF 21838-1:—, 3.10, modified — Note removed.]
3.14
formal theory

collection (3.5) of definitions (3.7) and axioms (3.2) expressed in a formal language (3.13)

[SOURCE: ISO/IEC/PRF 21838-1: —, 3.11, modified — Note removed.]
3.15
instance
particular (3.19) that instantiates some universal (3.27)
[SOURCE: ISO/IEC/PRF 21838-2:—, 3.6, modified — Example removed.]
3.16
interoperability

ability of a system (3.25) or a product to work with other systems (3.25) or products without special

effort on the part of the customer

Note 1 to entry: Under traditional ICT focus, interoperability is ability of two or more systems or components to

[29]
exchange information and to use the information that has been exchanged .
[SOURCE: IEEE Standards Glossary]
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