EN ISO 23903:2021

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

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

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

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23903:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 23903:2021) has been prepared by Technical Committee ISO/TC 215 "Health
informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by October 2021, and conflicting national standards shall
be withdrawn at the latest by October 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 23903:2021 has been approved by CEN as EN ISO 23903:2021 without any modification.

INTERNATIONAL ISO
STANDARD 23903
First edition
2021-04
Health informatics — Interoperability
and integration reference architecture
– Model and framework
Informatique de santé — Architecture de référence d'interopérabilité
et d'intégration — Modèle et cadre
Reference number
ISO 23903:2021(E)
©
ISO 2021
ISO 23903:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
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

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

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

ISO 23903:2021(E)
for living systems, manufacturing for technical systems, or a software development process, resulting
in a generic system model or Generic Reference Architecture presented in Figure 1. Details regarding
the dimensions of the model are explained in Clause 5 and Clause 6.
Figure 1 — Generic Reference Architecture model
To represent advanced interoperability and integration settings, different domain-specific
representations are linked to the same real world component. Therefore, an abstract and generic
reference architecture is needed which is able to represent any aspect or domain of interest. For
correctly and formally representing the concepts and relations of the domain-specific subsystems
involved in that business case, those subsystems are represented by their corresponding approved
domain ontologies, resulting in a system-theoretical, architecture-centric, top-level ontology driven
[10][11]
approach . Requirements for top level ontologies are specified in ISO 21838 (all parts). Health
3)
domain ontologies are SNOMED-CT® or specific ontologies such as the Open Biomedical Ontologies
[12] [13]
(OBO), including the Gene Ontology, maintained by the OBO Foundry .
As we can consistently model and compute only systems of reasonable complexity, the Generic Reference
Architecture model (Figure 1) can be used recursively at different granularity levels, so representing,
e.g. the continuum of real-world systems from elementary particles to the universe. The concepts of
the system’s components and their relations are represented in appropriate expressions in natural or
formal languages up to the basic level of primitives. The system analysis or design needs to address
partial systems when considering higher granularity levels of the system in question.
0.4  Technical approach
A system is a composition of interrelated components, ordered to accomplish a specific function or a
set of functions. Systems can be decomposed into subsystems or composed to form super-systems.
There are constructive or structural and behavioural or functional aspects of systems. According to
[14]
IEEE 1471, the architecture of a system is the fundamental organization of that system embodied in
its components, their relationships to each other and to the environment, and the principles guiding its
design and evolution. Rules for selecting and constraining components and functions as well as relations
according to a business case are called policies. Policies define the intended behaviour of a system. For
living systems, factors such as homeostasis, with the attributes of self-organization and self-regulation
as well as growth and development, reproduction, with the associated heredity (structure preservation)
and mutation (structural change), and higher development through selection of best-adapted variants
out of a large number make the description of living systems more complicated than that of technical
[15]
systems .
3) SNOMED CT is the registered trademark of the International Health Terminology Standards Development
Organisation (IHTSDO). This information is given for the convenience of users of this document and does not
constitute an endorsement by ISO of the product named.
ISO 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

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.
INTERNATIONAL STANDARD ISO 23903:2021(E)
Health informatics — Interoperability and integration
reference architecture – Model and framework
1 Scope
This document enables the advancement of interoperability from the data/information exchange
paradigm to knowledge sharing at decreasing level of abstraction, starting at IT concept level (semantic
coordination) through business domain concept level (agreed service function level cooperation),
domain level (cross-domain cooperation) up to individual context (skills-based end-user collaboration).
The document defines a model and framework for a harmonized representation of existing or intended
systems with a specific focus on ICT-supported business systems. The Interoperability and Integration
Reference Architecture supports ontology harmonization or knowledge harmonization to enable
interoperability between, and integration of, systems, standards and solutions at any level of complexity
without the demand for continuously adapting/revising those specifications. The approach can be
used for analysing, designing, integrating, and running any type of systems. For realizing advanced
interoperability, flexible, scalable, business-controlled, adaptive, knowledge-based, intelligent health
and social ecosystems need to follow a systems-oriented, architecture-centric, ontology-based and
policy-driven approach.
The languages for representing the different views on systems such as ontology languages like
[24] [25] [26]
Common Logic (CL) (ISO/IEC 24707 ) and Web Ontology Language (OWL) – specifically OWL 2
5)
(World Wide Web Consortium (W3C® ), languages for modeling and integrating business processes
6)
like Business Process Modeling Language (BPML) (OMG® ), but also OMG’s Unified Modeling
[27]
Language (UML, also specified as ISO/IEC 19505 ) based representation styles for the different
ISO/IEC 10746 (all parts) views are outside the scope of this document.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including 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 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
7)
[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)
8)
[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

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 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 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 should be used iteratively, where the first iteration is performed in a top-
down manner to guarantee the conceptual integrity of the model. This requires meeting design principles such
[30]
as orthogonality, generality, parsimony, and propriety .
3.18
ontology
collection (3.5) of terms (3.26), relational expressions (3.24) and associated natural-language definitions
(3.7) together with one or more formal theories (3.14) designed to capture the intended interpretations
of these definitions (3.7)
Note 1 to entry: An ontology defines a set of representational primitives with which to model a domain of
knowledge or discourse. The representational primitives are typically classes (or sets), attributes (or properties),
and relationships (or relations among class members). The definitions of the representational primitives include
[31]
information about their meaning and constraints on their logically consistent application .
[SOURCE: ISO/IEC/PRF 21838-1:—, 3.14, modified — Note to entry replaced.]
3.19
particular
individual entity (3.11)
Note 1 to entry: In contrast to classes or types, particulars are not exemplified or instantiated by further entities.
[SOURCE: ISO/IEC/PRF 21838-1:—, 3.3]
3.20
policy
set of legal, political, organizational, functional, and technical obligations for communication and
cooperation
Note 1 to entry: Policies define the intended behaviour of systems.
[SOURCE: ISO 22600-1:2014, 3.13 modified — Note to entry added.]
3.21
primitive
expression (3.12) for which no non-circular definition (3.7) can be provided
[SOURCE: ISO/IEC/PRF 21838-2:—, 3.1]
3.22
reference architecture
reference model for a class (3.4) of architectures (3.1)
3.23
relation
way in which entities (3.11) are related
[SOURCE: ISO/IEC/PRF 21838-1:—, 3.4, modified — Notes to entry removed.]
3.24
relational expression
expression (3.11) used to assert that a relation (3.22) obtains
[SOURCE: ISO/IEC/PRF 21838-1:—, 3.6, modified — Example and notes removed.]
4 © ISO 2021 – All rights reserved

ISO 23903:2021(E)
3.25
system
combination of interacting elements organized to achieve one or more stated purposes
Note 1 to entry: A system groups structurally and/or functionally interrelated components (elements). Systems
can be composed (aggregated/generalized) to super-systems or decomposed (specialized) to sub-systems.
[SOURCE: ISO/IEC/IEEE 15288:2015, 4.1.46, modified — Note 1 to entry replaced, notes 2 and 3 to
entry removed.]
3.26
term
expression (3.12) that refers to some class (3.4) or to some particular (3.19)
[SOURCE: ISO/IEC/PRF 21838-1:—, 3.7, modified — Note to entry removed.]
3.27
universal
type
entity (3.11) that has indefinitely many instances (3.15)
[SOURCE: ISO/IEC/PRF 21838-2:—, 3.2, modified — Example and note to entry removed.]
3.28
viewpoint
form of abstraction achieved using a selected set of architectural concepts and structuring rules, in
order to focus on particular concerns within a system
[SOURCE: ISO/IEC 10746-2:2009, 3.2.7, modified — "(on a system)" removed from term.]
4 Abbreviations
EHR Electronic Health Record
HL7® Health Level Seven®
UML Unified Modelling Language
RM-ODP Reference Model of Open Distributed Processing
5 Overview on standard system architecture
Acknowledging the different perspectives on a business system and its individual and shared context
provided by different disciplines or domains involved in the business case, the business system is
composed of subsystems represented by those domain-specific perspectives based on the domain-
specific methodologies, terminologies and ontologies. Examples of such subsystems are clinical care,
administration, legal/regulatory affairs, security, privacy, training, etc. Like any system, domains
can be composed to super-domains or de-composed to subdomains. For correctly and consistently
interrelating components of those subsystems in a way that enables the intended system behaviour
for meeting the use-case-specific business objectives, an abstract, domain-independent system
architecture with generic system components at different levels of granularity shall be defined,
enabling the composition/decomposition of any salient system. While the generic system with its
generic components and relations is represented using a domain neutral top-level ontology [see
ISO/IEC 21838 (all parts)], the business system and use-case-specifically instantiated systems
discussed as follows are represented using domain ontologies at lower level. At the first granularity
level, the domain specific subsystems (Level of Business Concepts) are specialized into sub-subsystems
representing the perspectives of specialized disciplines or subdomains within one domain, deploying
their specialized methodologies, terminologies and ontologies (Level of Relations Networks). Examples
of such subdomains within the clinical domain are microbiology, pathology, cardiology, ophthalmology,
ISO 23903:2021(E)
etc. Those subdomains are furthermore specialized into subdomain- and use-case specific services
(Level of Aggregations) and tasks (Level of Details). The architectural components and their
relationships are represented using the corresponding domain or subdomain ontologies respectively.
In this way, services and tasks can be interrelated across domains by interrelating the corresponding
components and mapping their concepts, thereby inheriting the related specializations/generalization
within the domains/subdomains. For representing the business system’s policies, ISO 22600 (all parts),
[32] [33]
which is the standardization of the policy ontology of PONDER , shall be used . For managing and
harmonizing different ontologies represented using different representation styles and languages, the
9)
OMG® Ontology Definition Metamodel (ODM™) , V1.1 shall be deployed.
Deploying systems theory, especially its white box approach, the GRA (see 0.3) adopts, but goes beyond,
[14] [34]
IEEE 1471:2000, which has been later on superseded by ISO/IEC/IEEE 42010:2011. Not being
limited to ICT systems, a multi-domain real world business system view has been added, transforming
IEEE 1471, ISO/IEC/IEEE 42010 as well as the software development standard ISO/IEC 10746 (all parts)
into a three-dimensional approach. This real world business system view formally represents the
domains’ knowledge spaces, so enabling the correct selection and constraining of components, their
functions and relations, that way supporting correct knowledge-level interoperability and systems
integration. Only at this viewpoint, correctness and consistency of concepts represented in ICT
specifications and standards can be justified.
6 Interoperability and Integration Reference Architecture for ICT Supported
Systems
6.1 Interoperability and Integration Reference Architecture domains and
granularity levels
Adopting the philosophy of ISO/IEC 10746 (all parts), this document fills a gap for real world
interoperability by extending the viewpoints defined in ISO/IEC 10746-1:1998 by an ICT-independent
Business View. This way, it corresponds to the OMG® approach for representation, management,
interoperability, and application of business semantics. The latter allows for formal multi-domain
knowledge representation, interchange and harmonization by providing relationships between symbols
in the logical “universe” and individuals in the “real world”. Figure 3 presents the Interoperability
and Integration Reference Architecture business viewpoint with its domain and its composition/
decomposition dimension.
9) ODM 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 product named.
6 © ISO 2021 – All rights reserved

ISO 23903:2021(E)
Figure 3 — Interoperability and Integration Reference Architecture domains and
granularity levels
6.2 Interoperability and Integration Reference Architecture model for ICT
supported systems
By combining that model with ISO/IEC 10746 (all parts) and its viewpoints and representational
means, the development, implementation and maintenance process of interoperable health and social
ecosystems is added to the approach, completing the Interoperability and Integration Reference
Architecture with its three dimensions system domains, system component composition, and system
viewpoints after RM-ODP (Figure 4).
ISO 23903:2021(E)
Figure 4 — The Interoperability and Integration Reference Architecture model
Due to the formal, correct and consistent representation of use-case specific context aware business
systems and their tool-supported automated transformation into finally implementable solutions,
the approach can also be deployed to perform a business system and business objective conformant
analysis of existing systems and specifications regarding their appropriateness, correctness and
consistency, but also to support an appropriate design of emerging system. As the components
presented in the different RM-ODP Viewpoints starting with the Business Viewpoint of the correctly
and consistently designed business system architecture, the transformed v
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