Health informatics — Clinical information models — Characteristics, structures and requirements

This document: — Specifies clinical information models (CIMs) as health and care concepts that can be used to define and to structure information for various purposes in health care, also enabling information reuse; — Describes requirements for CIMs content, structure and context and specification of their data elements, data element relationships, meta-data and versioning, and provides guidance and examples; — Specifies key characteristics of CIMs used in conceptual and logical analysis for use cases such as (reference) architectures, information layers, EHR and PHR systems, interoperability, systems integration in the health domain, and secondary use of data including for public health reporting; — Defines a Quality Management System (QMS) for a systematic and effective governance, quality management, and measurement of CIMs through their lifecycle of development, testing, distribution, application and maintenance; — Provides principles for the transformation and application of clinical information models through the wide variation of health information technology. This document excludes: — Requirements on the content or application of any particular clinical information model or clinical information modelling methodology; — Specific applications of clinical information models such as for dynamic modelling of workflow; — Specifications for modelling entire domains or aggregates of many CIMs such as complete assessment documents or discharge summaries. It does not specify CIMs compositions; — Specification of how to involve specific clinicians, how to carry out governance including information governance, or how to ensure patient safety.

Informatique de santé — Modèles d'informations cliniques — Caractéristiques, structures et exigences

Le présent document: — spécifie les modèles d'informations cliniques (CIM) comme des concepts de santé et de soins qui peuvent être utilisés pour définir et structurer les informations à diverses fins dans les soins de santé, permettant également la réutilisation des informations; — décrit les exigences relatives au contenu, à la structure et au contexte des CIM ainsi que la spécification de leurs éléments de données, les relations entre les éléments de données, les métadonnées et la gestion des versions, et fournit des recommandations et des exemples; — spécifie les principales caractéristiques des CIM utilisés dans l'analyse conceptuelle et logique pour les cas d'usage tels que les architectures (de référence), les couches d'information, les systèmes de DIS et de DSP, l'interopérabilité, l'intégration des systèmes dans le domaine de la santé et l'utilisation secondaire des données, notamment pour les rapports de santé publique; — définit un système de management de la qualité (SMQ) pour une gouvernance, un management de la qualité et un mesurage systématiques et efficaces des CIM tout au long de leur cycle de vie de développement, d'essai, de distribution, d'application et de maintenance; — fournit des principes pour la transformation et l'application des modèles d'informations cliniques grâce à la grande diversité des technologies d'information de santé. Le présent document exclut: — les exigences relatives au contenu ou à l'application de tout modèle d'informations cliniques particulier ou de toute méthodologie de modélisation des informations cliniques; — les applications spécifiques des modèles d'informations cliniques, telles que la modélisation dynamique des flux de travail; — les spécifications de modélisation de domaines entiers ou d'agrégats de nombreux CIM tels que des documents d'évaluation complets ou des résumés de sortie. La composition des CIM n’est pas précisée; — la spécification de méthodes permettant d'impliquer des cliniciens spécifiques, d'assurer la gouvernance, y compris la gouvernance de l'information, ou de garantir la sécurité des patients.

General Information

Status
Published
Publication Date
27-Feb-2022
Current Stage
5060 - Close of voting Proof returned by Secretariat
Completion Date
07-Dec-2021
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INTERNATIONAL ISO
STANDARD 13972
First edition
2022-02
Health informatics — Clinical
information models — Characteristics,
structures and requirements
Informatique de santé — Modèles d'informations cliniques —
Caractéristiques, structures et exigences
Reference number
ISO 13972:2022(E)
© ISO 2022
---------------------- Page: 1 ----------------------
ISO 13972:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022

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
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO 2022 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 13972:2022(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction .............................................................................................................................................................................................................................. vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ..................................................................................................................................................................................... 1

3 Terms, definitions and abbreviated terms .............................................................................................................................. 1

3.1 Terms and definitions ...................................................................................................................................................................... 1

3.2 Abbreviated terms .............................................................................................................................................................................. 7

4 Health care information models - Concept, purpose, contexts and position ......................................8

4.1 The Concept of Clinical Information Models ................................................................................................................ 8

4.2 Purpose for Clinical Information Models ..................................................................................................................... 10

4.3 Context of Health and Care Information Models ................................................................................................... 11

4.4 Architectural Considerations for Clinical Information Models ...............................................................13

4.4.1 General .....................................................................................................................................................................................13

4.4.2 CIMs in an architectural view.............................................................................................................................. 13

4.4.3 CIMs placed in the Generic Component Model ...................................................................................... 14

4.4.4 The Interoperability and Integration Reference Architecture in ISO 23903 ............15

4.4.5 Representation of ReEIF through the ISO Interoperability and Integration

Reference Architecture Framework .............................................................................................................. 17

5 Quality Management System for Clinical Information Models ........................................................................19

5.1 General ........................................................................................................................................................................................................ 19

5.2 CIMs quality management system ..................................................................................................................................... 19

5.3 CIMs Requirements ......................................................................................................................................................................... 20

5.4 CIMs acceptance, adoption and use................................................................................................................................... 21

5.5 Achieving quality CIMs ................................................................................................................................................................ 21

5.6 Governance of CIMs ......................................................................................................................................................................... 22

5.7 Repositories of CIMs .......................................................................................................................................................................22

5.8 CIMs Development Processes .................................................................................................................................................22

6 Clinical Information Model content, structure and requirements .............................................................23

6.1 Clinical Information Model content and context ................................................................................................... 23

6.2 Concept specification of a Clinical Information Model .................................................................................... 24

6.3 Purpose of the Concept ................................................................................................................................................................ 24

6.4 Patient Population for which the Clinical Information Model is intended ..................................... 24

6.5 Evidence Base for the Clinical Information Model topic ................................................................................ 24

6.6 Description of the information model and its data elements in CIMs ................................................25

6.6.1 General requirements for the information model ............................................................................. 25

6.6.2 Data elements ..................................................................................................................................................................... 26

6.6.3 Data Element Name and Identifier ..................................................................................................................28

6.6.4 Data Element descriptions ......................................................................................................................................29

6.6.5 Semantic coding of data elements....................................................................................................................29

6.6.6 Datatype..................................................................................................................................................................................30

6.6.7 Value ........................................................................................................................................................................................... 31

6.6.8 Value set expression ..................................................................................................................................................... 32

6.6.9 Relationships in CIMs .................................................................................................................................................. 32

6.6.10 Localization of CIMs .....................................................................................................................................................33

6.7 Example instances ............................................................................................................................................................................ 33

6.8 Interpretation ....................................................................................................................................................................................... 33

6.9 Constraints or Limitations for use .....................................................................................................................................34

6.10 Instructions for use of CIMs ........................................................................................................................................... .......... 35

6.11 Care process / dependence.......................................................................................................................................................36

6.12 Issues ............................................................................................................................................................................................................36

6.13 Example of the use of a CIM ..................................................................................................................................................... 37

6.14 References................................................................................................................................................................................................ 37

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ISO 13972:2022(E)

6.15 Intellectual property issues around Clinical Information Models ........................................................ 37

7 Metadata for clinical information models .............................................................................................................................39

7.1 General ........................................................................................................................................................................................................39

7.2 The metadata elements of the Clinical Information Models .......................................................................39

8 Version management of clinical information models................................................................................................43

Annex A (informative) Release and maintenance process example in the Netherlands ......................... 44

Annex B (informative) Version management backwards compatibility ....................................................................45

Annex C (informative) Guidelines and principles for Clinical Information Modelling ...............................46

Annex D (informative) Example mapping a CIM to ADL specification: Glasgow Coma Scale ...............53

Annex E (informative) Datatype profile used for the logical model parts for Clinical

Information Models .......................................................................................................................................................................................61

Annex F (informative) Example Clinical Information Model in UML and Table format .............................62

Annex G (informative) Example Clinical Information Model transformation in HL7® FHIR® .........64

Bibliography .............................................................................................................................................................................................................................74

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ISO 13972:2022(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).

This first edition of ISO 13972 cancels and replaces ISO/TS 13972:2015, which has been technically

revised.
The main changes are as follows:

— reduction of content that is not directly aiming at the clinical information models, such as clinician

involvement, governance, and patient safety matters;

— updates on modelling practices, e.g. the strict relationship to a RIM or RM has been loosened to

reflect ongoing practices, such as with HL7® FHIR®.

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.
© ISO 2022 – All rights reserved
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ISO 13972:2022(E)
Introduction

In current health care, the exchange of information from one healthcare professional to another and

hence, the exchange of data from one application to the other, has become a necessity. As sender and

receiver want to understand the exchanged information or data properly, it is of utmost importance

to achieve mutual understanding through ‘semantic interoperability’. Semantic interoperability

represents the core need for electronic health records (EHR) and other health ICT systems, and for

communication between these systems. This document provides an approach to achieve semantic

interoperability through Clinical Information Models (CIMs).
There are five reasons for this document:

a) CIMs describe the clinical world of patients and health professionals, representing the clinical

knowledge in ICT.

b) CIMs function as building blocks from which many different useful solutions can be created,

keeping the underlying data standardized.

c) CIMs are specific instances of representations of clinical concepts, contexts, and relations. CIMs

function as specific instances of health ICT architectures. CIMs bridge between real world clinical

processes and IT solutions supporting them. For example, when using ISO 23903, CIMs can be

represented in IT models using IT ontologies.

d) CIMs are independent from technology choices and can be used in any health information

technology.

e) CIMs define representations of clinical concepts independent of implementation, enabling safe

translation from one technological implementation of a CIM into another technology based on the

same CIM.
Each reason for CIMs is described further below.

Firstly, CIMs are models that describe the clinical world, the world of patients and health professionals,

in all kinds of fashions. CIMs provide views on the healthcare business at the most detailed level.

CIMs allow providers to represent and capture the meaning of specific types of clinical information

consistently and precisely to exchange that information without concerns about misinterpretation

and to re-use, re-purpose and re-position that information in multiple contexts. Consistent clinical

documentation in electronic health record systems (EHRs) and personal health record systems

(PHRs) is at the core of CIM’s benefit to assure and ascertain continuity of care across time, provider,

and location. This is a prerequisite for data use, data reuse and data exchange. In addition, semantic

interoperability addresses issues of how to enable health professionals and ICT professionals to

establish and maintain this meaning, coding and transmission of data across time and health services,

and to perform meaningful and cooperative care, based on shared knowledge. CIMs support exchanging

meaning between health care professionals, providers, patients, and citizens, with a focus on the end

user independent of the actual ICT system(s) used.

In addition, they facilitate mutual understanding between authorities, researchers, managers, policy

[2]

makers, educators and more . A key requirement to achieve meaningful data use and exchange is the

standardization of clinical concept representation within health data, including its content, structure,

context, and transmission processes. The ability to use and exchange information between clinical

information systems without loss of clinical meaning is also essential to enable safe and effective

implementation of automated decision support. Interoperability and system integration are challenges

that CIMs can help overcome to meet business objectives.

Standardization of clinical concept representation is a desirable and cost-effective way to aggregate

data from EHR systems for multiple data use and reuse, for example for decision support, clinical

quality, epidemiology, management, policy making, and research. These are the main information

processing activities in healthcare. With respect to the processes relevant to CIMs governance, a Quality

Management System (QMS) based on a framework such as ISO 9001 can be used. Defined processes for

development, application, and governance ensure the quality of CIM artefacts and its use.

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ISO 13972:2022(E)

A second important aspect of CIMs is that in any given implementation context, they will need to be

combined into larger interlinked structures or compositions. CIMs facilitate use as building blocks

from which meaningful and useful integrated information solutions can be composed. An individual

CIM does usually not actually facilitate anything. CIMs can best be grouped together to create a

working solution. CIMs are not specific for a particular use case but can be created and combined for

specific use cases to meet the clinical needs. CIMs facilitate a bottom up approach. A consequence of

such requirements is that mechanisms such as composition and decomposition are needed to enable

CIMs to be safely represented at different levels of detail. For example, a hospital discharge summary

will consist of many data elements, many of which might be CIMs. However, the data specification of

a discharge summary is a separate artefact making use of several CIMs and is not a CIM in itself. How

these combinations of CIMs can be achieved using ISO 23903 is not part of this document. For example,

a quality indicator or quality report will usually consist of several CIMs (as a composition): one CIM to

identify the patient (even if anonymous, but with a respondent number), the health organization CIM,

the clinical problem CIM, the clinical activities CIM, and so on. Similarly, for quality care, the same and

other CIMs will be used along a patient journey or clinical pathway.

The third reason for this document is the transformation of health care towards personalized ubiquitous

care. This requires the advancement of data exchange between computer systems to knowledge

sharing among the stakeholders involved, including patients, or even citizens. For that reason, CIMs

facilitate the representation of any clinical business processes’ clinical concepts, contexts, and relations

into finally implementable IT models, using IT ontologies. To perform this challenge correctly and

consistently, ISO 23903 can be deployed to formally represent the clinical business system based on the

knowledge space of the experts of the domains involved represented by those domains’ terminologies

and ontologies. In some policies, this level is referred to as the information layer, representing the

detailed semantic level of the healthcare business. As part of a standardized software development

process, this formalized system is then transformed into specific instances for specific enterprise and

information models to specify platform-specific models and implement them.

Another International Standard conceptualizing health care processes is ISO 13940. The need to

evidence the quality of the CIMs is inevitable. This document refers to standardized terminologies,

relationships, standardized datatypes, and the need to reference term or value sets, and units of

measure. CIMs model clinical concepts that are defined precisely at the logical level. CIMs are logical

constructs, specifying modular data for clinical information. This document reflects a pragmatic

consensus based on experience, regarding the level of detail in the breakdown and representation of a

CIM representing medical knowledge. Similarly, pragmatic views present examples of CIM, and support

how instance data based on CIMs can be used within Healthcare Information Architectures. The

development and management of CIMs requires common and more generic definitions/descriptions of

clinical concepts, such as health care processes and the constructs health professionals use within these

processes, as generally depicted in ISO 13940. Contsys is suitable as a common base for development of

CIMs.

A fourth reason is that CIMs do not force into taking one direction with respect to technologies. CIMs are

independent from technology choices, and are therefore core assets describing the healthcare domains,

which are crucial in the negotiations with health IT professionals. There is widespread acceptance that

CIMs need to be developed and standardized by stakeholders including health professionals, patients,

managers, and (clinical) researchers on one hand while being technology ‘neutral’ yet usable in real

systems. CIMs address the conceptual content for the logical levels of modelling, but do not intervene

in the physical implementation of IT systems in healthcare. Hence, each CIM can be used in various use

cases, IT architectures, and IT technologies.

An implementation technology standard should be chosen and the CIMs should be translated to this

document within the limits and the constraints of that standard before technical artefacts for that

specific implementation technology can be derived. These resources, artefacts, or archetypes themselves

can be transformed into various computational representations and programming languages such

as ISO/IEC 21778 JSON, or XML, OWL, Java, C# among many others. In such developments, CIMs are

the core source material and their main function is to offer all technologies the same core clinical

information model, so that the consistency and logic of data can remain in various systems, offering a

key benefit to stakeholders to retain knowledge when replacing old technologies with new. In the world

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ISO 13972:2022(E)

of ubiquitous personalized health, this applies for the new technologies used by patients themselves,

which offer highly dynamic interoperability services provided in real time.

NOTE For specific implementations, the use of a reference (information) model can be required or

recommended, but that is only in the stage where technology decisions are or have been made. Constraints that

technology choices impose on the clinical world do not apply at the CIMs level, hence the CIMs remain the “pure”

unconstrained descriptions of the healthcare business.

Fifth, CIMs define representations of clinical concepts independent of implementation, enabling safe

translation from one technological implementation of a CIM into another technology based on the

same CIM. CIMs facilitate various products from standards and technology developers to seamlessly

work together, hence, CIMs build bridges between different technologies, e.g. exchange data from an

1) 2)

archetype based EHR via HL7® FHIR® to a SQL based EHR. Data specifications similar to the CIMs

described in this document have been found to be useful in a wide range of health care information

and communication technologies, including but not limited to EHR systems, telehealth applications,

messaging integration, medical devices, computer algorithms, and deductive reasoning for decision

support (see References [6][7][8][9][10][11][12][13][14][15][16]).

CIMs also offer a migration path in perspective of ISO 23903, facilitating an approach in which old

systems or applications can be replaced by new ones, without affecting other layers or views in the

architecture, if of course the standards in the various layers are applied.

Standardized CIMs further underpin the coherence of Electronic Health Records (EHR), for instance

ISO 18308, where data needs to be accepted from multiple sources and stored in a consistent and

predetermined format. In addition, for a functional EHR system (ISO/HL7 10781), queries need to be

constructed based on clinical knowledge and tied to clinical context, content, semantics and workflow;

services need to be automated based on known values of patient data linked to agreed protocols and

terminologies; data display and data entry needs to reference clinical guidelines; and safety and quality

issues for clinicians moving from system to system can be minimized through consistent information

representation. In this way, standardized CIMs form the lingua franca of use, reuse and reusability

within and across various health, clinical and care related systems.

In summary, CIMs can be used as a set of accurate clinical building blocks representing clinical concepts

that together meet the requirements for specific healthcare related use cases for which a mixed set of

information and communication technological solutions are developed and/or deployed.

The target audience for this document includes health informaticians in general but it does have a

particular relevance for Chief Medical Information Officers, Chief Nursing Information Officers, Chief

Patient Information Officers, Healthcare Information Analysts, Healthcare Information Modelers, and

Healthcare Information Architects.
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “can” indicates a possibility or a capability;
— “may” indicates a permission.

1) HL7 is the 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) FHIR is a trademark of HL7®. 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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INTERNATIONAL STANDARD ISO 13972:2022(E)
Health informatics — Clinical information models —
Characteristics, structures and requirements
1 Scope
This document:

— Specifies clinical information models (CIMs) as health and care concepts that can be used to define

and to structure information for various purposes in health care, also enabling information reuse;

— Describes requirements for CIMs content, structure and context and specification of their

data elements, data element relationships, meta-data and versioning, and provides guidance and

examples;

— Specifies key characteristics of CIMs used in conceptual and logical analysis for use cases such

as (reference) architectures, information layers, EHR and PHR systems, interoperability, systems

integration in the health domain, and secondary use of data including for public health reporting;

— Defines a Quality Management System (QMS) for a systematic and effective governance, quality

management, and measurement of CIMs through their lifecycle of development, testing, distribution,

app
...

NORME ISO
INTERNATIONALE 13972
Première édition
2022-02
Informatique de santé — Modèles
d'informations cliniques —
Caractéristiques, structures et
exigences
Health informatics — Clinical information models — Characteristics,
structures and requirements
Numéro de référence
ISO 13972:2022(F)
© ISO 2022
---------------------- Page: 1 ----------------------
ISO 13972:2022(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2022

Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette

publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,

y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut

être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.

ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
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Web: www.iso.org
Publié en Suisse
© ISO 2022 – Tous droits réservés
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ISO 13972:2022(F)
Sommaire Page

Avant-propos ...............................................................................................................................................................................................................................v

Introduction .............................................................................................................................................................................................................................. vi

1 Domaine d'application ...................................................................................................................................................................................1

2 Références normatives ..................................................................................................................................................................................1

3 Termes, définitions et abréviations ................................................................................................................................................ 1

3.1 Termes et définitions ........................................................................................................................................................................ 1

3.2 Abréviations.............................................................................................................................................................................................. 8

4 Modèles d’informations de santé et de soins — Concept, objectif, contextes et

position .......................................................................................................................................................................................................................... 9

4.1 Le concept des modèles d'informations cliniques ................................................................................................... 9

4.2 Objectif des modèles d'informations cliniques ....................................................................................................... 11

4.3 Contexte des modèles d’informations de santé et de soins .........................................................................12

4.4 Considérations architecturales des modèles d'informations cliniques ............................................ 14

4.4.1 Généralités ............................................................................................................................................................................ 14

4.4.2 CIM dans une vue architecturale ...................................................................................................................... 14

4.4.3 CIM placés dans le modèle de composant générique ......................................................................15

4.4.4 Architecture de référence d'interopérabilité et d'intégration de l’ISO 23903 ......... 16

4.4.5 Représentation du ReEIF par le cadre de l’architecture de référence

d'interopérabilité et d'intégration ................................................................................................................... 18

5 Système de management de la qualité pour les modèles d'informations cliniques .................20

5.1 Généralités .............................................................................................................................................................................................. 20

5.2 Système de management de la qualité des CIM ...................................................................................................... 20

5.3 Exigences relatives aux CIM .................................................................................................................................................... 22

5.4 Acceptation, adoption et utilisation des CIM ............................................................................................................ 23

5.5 Obtenir des CIM de qualité ........................................................................................................................................... .............23

5.6 Gouvernance des CIM .................................................................................................................................................................... 24

5.7 Référentiels des CIM ....................................................................................................................................................................... 24

5.8 Processus de développement des CIM ............................................................................................................................ 25

6 Contenu, structure et exigences du modèle d'informations cliniques ....................................................26

6.1 Contenu et contexte du modèle d'informations cliniques ............................................................................. 26

6.2 Spécification du concept d’un modèle d'informations cliniques ............................................................. 26

6.3 Objectif du concept .......................................................................................................................................................................... 27

6.4 Population de patients à laquelle le modèle d'informations cliniques est destiné ................. 27

6.5 Base de connaissances concernant le modèle d'informations cliniques .......................................... 27

6.6 Description du modèle d'information et de ses éléments de données dans les CIM .............28

6.6.1 Exigences générales concernant le modèle d'information .........................................................28

6.6.2 Éléments de données ...................................................................................................................................................29

6.6.3 Nom et identificateur des éléments de données.................................................................................. 31

6.6.4 Description des éléments de données .......................................................................................................... 32

6.6.5 Codage sémantique des éléments de données ...................................................................................... 32

6.6.6 Type de données ..............................................................................................................................................................33

6.6.7 Valeur.........................................................................................................................................................................................34

6.6.8 Expression de l’ensemble de valeurs ............................................................................................................. 35

6.6.9 Relations dans les CIM ........................................................................................................................................... .....36

6.6.10 Localisation des CIM ....................................................................................................................................................36

6.7 Exemples d’instances ..................................................................................................................................................................... 36

6.8 Interprétation ....................................................................................................................................................................................... 37

6.9 Contraintes ou limites d'utilisation .................................................................................................................................. 37

6.10 Instructions d’utilisation des CIM ...................................................................................................................................... 39

6.11 Processus de soins/dépendance .......................................................................................................................................... 39

6.12 Problèmes ................................................................................................................................................................................................40

6.13 Exemple d'utilisation d’un CIM .............................................................................................................................................40

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ISO 13972:2022(F)

6.14 Références................................................................................................................................................................................................ 41

6.15 Questions de propriété intellectuelle relatives aux modèles d'informations

cliniques ........................................................................................................................................... .......................................................... 41

7 Métadonnées des modèles d'informations cliniques .................................................................................................42

7.1 Généralités .............................................................................................................................................................................................. 42

7.2 Éléments des métadonnées des modèles d'informations cliniques ..................................................... 43

8 Gestion des versions des modèles d'informations cliniques .............................................................................47

Annexe A (informative) Exemple de processus de publication et de maintenance aux Pays-

Bas ....................................................................................................................................................................................................................................49

Annexe B (informative) Rétrocompatibilité de la gestion des versions .....................................................................51

Annexe C (informative) Lignes directrices et principes pour la modélisation

des informations cliniques ........................................................................................................................................... ..........................52

Annexe D (informative) Exemple de mise en correspondance d’un CIM avec

la spécification ADL: Échelle de coma de Glasgow ........................................................................................................59

Annexe E (informative) Profil de type de données utilisé pour les parties du modèle logique

des modèles d'informations cliniques .......................................................................................................................................67

Annexe F (informative) Exemple de modèle d'informations cliniques au format UML et

sous forme de tableau ...................................................................... ............................................................................................................68

Annexe G (informative) Exemple de transformation de modèle d'informations cliniques en

HL7® FHIR® ..........................................................................................................................................................................................................70

Bibliographie ...........................................................................................................................................................................................................................80

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ISO 13972:2022(F)
Avant-propos

L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes

nationaux de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est

en général confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude

a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,

gouvernementales et non gouvernementales, en liaison avec l'ISO participent également aux travaux.

L'ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui

concerne la normalisation électrotechnique.

Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont

décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents

critères d'approbation requis pour les différents types de documents ISO. Le présent document a

été rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir

www.iso.org/directives).

L'attention est attirée sur le fait que certains des éléments du présent document peuvent faire l'objet de

droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable

de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant

les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de

l'élaboration du document sont indiqués dans l'Introduction et/ou dans la liste des déclarations de

brevets reçues par l'ISO (voir www.iso.org/brevets).

Les appellations commerciales éventuellement mentionnées dans le présent document sont données

pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un

engagement.

Pour une explication de la nature volontaire des normes, la signification des termes et expressions

spécifiques de l'ISO liés à l'évaluation de la conformité, ou pour toute information au sujet de l'adhésion

de l'ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles

techniques au commerce (OTC), voir www.iso.org/avant-propos.

Le présent document a été élaboré par le comité technique ISO/TC 215, [nom du comité], en collaboration

avec le comité technique CEN/TC 251, nom du comité, du Comité européen de normalisation (CEN)

conformément à l’Accord de coopération technique entre l’ISO et le CEN (Accord de Vienne).

Cette première édition de l'ISO 13972 annule et remplace l'ISO/TS 13972:2015, qui a fait l'objet d'une

révision technique.
Les principales modifications sont les suivantes:

— réduction du contenu qui ne vise pas directement les modèles d'informations cliniques, comme

l’implication des cliniciens, la gouvernance et les questions de sécurité des patients;

— mise à jour des pratiques de modélisation, par exemple, la relation stricte avec un RIM ou un RM a

été assouplie afin de refléter les pratiques actuelles, comme, par exemple, avec le HL7® FHIR®.

Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent

document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes

se trouve à l’adresse www.iso.org/fr/members.html.
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ISO 13972:2022(F)
Introduction

Dans le domaine des soins de santé actuels, l'échange d'informations d'un professionnel de soins de

santé à un autre et, donc, l'échange de données d'une application à une autre, est devenu une nécessité.

Comme l'expéditeur et le destinataire veulent comprendre convenablement les informations ou les

données échangées, il est de la plus haute importance de parvenir à une «interopérabilité sémantique»

permettant une compréhension mutuelle. L'interopérabilité sémantique représente le besoin essentiel

des dossiers informatisés de santé (DIS) et d'autres systèmes de TIC de santé, et de la communication

entre ces systèmes. Le présent document fournit une approche permettant d’obtenir une interopérabilité

sémantique par le biais de modèles d'informations cliniques (CIM).
Le présent document a été élaboré pour cinq raisons:

a) les CIM décrivent le monde clinique des patients et des professionnels de santé, et représentent les

connaissances cliniques en matière de TIC;

b) les CIM fonctionnent comme des modules à partir desquels différentes solutions utiles peuvent

être créées tout en gardant les données sous-jacentes normalisées;

c) les CIM sont des instances spécifiques des représentations de concepts, contextes et relations

cliniques. Ils fonctionnent comme des instances spécifiques des architectures de TIC de santé. Les

CIM servent de pont entre les processus cliniques du monde réel et les solutions informatiques qui

les soutiennent. Par exemple, en utilisant l'ISO 23903, les CIM peuvent être représentés dans des

modèles informatiques à l’aide d’ontologies informatiques;

d) les CIM sont indépendants des choix technologiques et peuvent être utilisés dans n'importe

quelle technologie d'information de santé;

e) les CIM définissent des représentations de concepts cliniques indépendantes de la mise en œuvre,

permettant une traduction sûre d'une mise en œuvre technologique d'un CIM dans une autre

technologie fondée sur le même CIM.
Chaque CIM est justifié plus en détail ci-dessous.

Tout d'abord, les CIM sont des modèles qui décrivent le monde clinique, le monde des patients et les

professionnels de santé, quelle que soit leur forme. Les CIM fournissent une vision des métiers de la

santé au niveau le plus détaillé. Les CIM permettent aux prestataires de représenter et de saisir la

signification de types spécifiques d'informations cliniques de manière cohérente et précise, afin

d'échanger ces informations sans craindre une mauvaise interprétation et de les réutiliser, les réorienter

et les repositionner selon différents contextes. La cohérence de la documentation clinique dans les

systèmes de dossiers informatisés de santé (DIS) et les systèmes de dossiers de santé personnels (DSP)

est un élément essentiel qui permet aux CIM d’assurer et de garantir la continuité des soins, quels que

soient la durée, le prestataire et le lieu. Il s’agit d’une condition préalable à l'utilisation, la réutilisation

et l'échange de données. L'interopérabilité sémantique traite en outre de méthodes permettant aux

professionnels de santé et aux professionnels des TIC d'établir et de maintenir la signification, le codage

et la transmission des données à travers le temps et les services de santé, et de réaliser des soins

significatifs et coopératifs, sur la base de connaissances partagées. Les CIM favorisent l'échange de sens

entre les professionnels de santé, les prestataires, les patients et les citoyens, en mettant l'accent sur

l'utilisateur final, indépendamment du ou des systèmes de TIC utilisés.

En outre, ils facilitent la compréhension mutuelle entre les autorités, les chercheurs, les gestionnaires,

[2]

les décideurs politiques, les éducateurs et bien d'autres . Une des exigences clés pour parvenir à une

utilisation et un échange de données significatifs est la normalisation de la représentation des concepts

cliniques dans les données de santé, qu'il s’agisse de leur contenu, de leur structure, de leur contexte ou

de leurs processus de transmission. La capacité à utiliser et à échanger des informations entre plusieurs

systèmes d'information clinique sans perte de signification clinique est également essentielle pour

permettre une mise en œuvre sûre et efficace de l'aide automatisée à la prise décision. L'interopérabilité

et l'intégration des systèmes sont des défis que les CIM peuvent aider à surmonter pour atteindre les

objectifs opérationnels.
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ISO 13972:2022(F)

La normalisation de la représentation des concepts cliniques est un moyen souhaitable et économique

d'agréger les données des systèmes de DIS en vue de l’utilisation et de la réutilisation de données

multiples, par exemple pour l'aide à la décision, la qualité clinique, l'épidémiologie, la gestion, l'élaboration

des politiques et la recherche. Il s'agit des principales activités de traitement de l'information dans le

domaine des soins de santé. Concernant les processus relatifs à la gouvernance des CIM, un système de

management de la qualité (SMQ) fondé sur un cadre tel que l’ISO 9001 peut être utilisé. Les processus

définis pour l’élaboration, l'application et la gouvernance garantissent la qualité des artéfacts du CIM et

leur utilisation.

Un second aspect important des CIM est que dans tout contexte de mise en œuvre donné, ils devront

être combinés en des structures ou des compositions interconnectées et de plus grande taille. Les

CIM facilitent l'utilisation en tant que modules à partir desquels des solutions d'information intégrées

significatives et utiles peuvent être composées. Un CIM individuel n’offre généralement aucun bénéfice.

Les CIM peuvent être aisément regroupés pour créer une solution fonctionnelle. Les CIM ne sont pas

spécifiques à un cas d'usage particulier, mais peuvent être créés et combinés pour des cas d'usage

spécifiques afin de répondre aux besoins cliniques. Les CIM facilitent une approche ascendante. Une

conséquence de ces exigences est que des mécanismes tels que la composition et la décomposition

sont nécessaires pour permettre une représentation fiable des CIM à différents niveaux de détail. Par

exemple, un résumé de sortie d'hôpital sera constitué de nombreux éléments de données, dont beaucoup

peuvent être des CIM. Toutefois, la spécification des données d'un résumé de sortie est un artéfact

distinct utilisant plusieurs CIM et n'est pas un CIM en soi. Les méthodes permettant de combiner des

CIM grâce à l’ISO 23903 ne relèvent pas du présent document. Par exemple, un indicateur de qualité ou

un rapport de qualité sera généralement constitué de plusieurs CIM (sous forme de composition): un

CIM pour identifier le patient (même s'il est anonyme, mais avec un numéro de répondant), le CIM de

l'organisme de santé, le CIM du problème clinique, le CIM des activités cliniques, et ainsi de suite. De

même, pour des soins de qualité, le même CIM et d'autres CIM seront utilisés tout au long du parcours

du patient ou du chemin clinique.

La troisième raison d’être du présent document est la transformation des soins de santé vers des soins

personnalisés et omniprésents. Cela nécessite une évolution de l'échange de données entre les systèmes

informatiques vers un partage de connaissances entre les acteurs concernés, y compris les patients, voire

les citoyens. Pour cette raison, les CIM facilitent la représentation des concepts cliniques, des contextes

et des relations de tout processus métier clinique en modèles informatiques pouvant finalement être

mis en œuvre à l’aide d’ontologies informatiques. Pour relever ce défi de manière correcte et cohérente,

l’ISO 23903 peut être déployée pour représenter formellement le système opérationnel clinique sur la

base de l'espace de connaissances des experts des domaines concernés, représenté par les terminologies

et ontologies de ces domaines. Dans certaines politiques, ce niveau est appelé «couche d'information» et

représente le niveau sémantique détaillé de l’activité de soins de santé. Dans le cadre d'un processus de

développement logiciel normalisé, ce système formalisé est ensuite transformé en instances spécifiques

destinées à des modèles d'entreprise et d'information spécifiques afin de définir et de mettre en œuvre

des modèles spécifiques à la plate-forme.

L’ISO 13940 est une autre norme internationale de conceptualisation des processus de soins de

santé. La nécessité de prouver la qualité des CIM est inévitable. Le présent document fait référence à

des terminologies normalisées, des relations, des types de données normalisés et à la nécessité de se

référer à des termes ou des ensembles de valeurs, ainsi qu’à des unités de mesure. Les CIM modélisent

des concepts cliniques qui sont définis précisément au niveau logique. Les CIM sont des constructions

logiques qui spécifient des données modulaires pour les informations cliniques. Le présent document

reflète un consensus pragmatique fondé sur l'expérience, en ce qui concerne le niveau de détail

dans la décomposition et la représentation d'un CIM représentant des connaissances médicales. De

même, des visions pragmatiques présentent des exemples de CIM et montrent comment les données

d'instance fondées sur les CIM peuvent être utilisées au sein des architectures d'information de soins

de santé. L’élaboration et la gestion des CIM nécessitent des définitions/descriptions communes et plus

génériques de concepts cliniques, tels que les processus de soins de santé et les constructions que les

professionnels de santé utilisent dans ces processus, comme le décrit généralement l’ISO 13940. Contsys

peut être utilisée comme base commune pour l’élaboration des CIM.

La quatrième raison est que les CIM ne forcent pas à prendre une direction particulière en matière de

technologie. Les CIM sont indépendants des choix technologiques, et sont donc des atouts essentiels

vii
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ISO 13972:2022(F)

pour la description des domaines de soins de santé, qui sont cruciaux dans les négociations avec les

professionnels des technologies de l'information en matière de santé. Il est largement admis que les

CIM doivent être développés et normalisés par les parties prenantes, notamment les professionnels

de santé, les patients, les gestionnaires et les chercheurs (cliniques), tout en restant «neutres» sur

le plan technologique et utilisables dans des systèmes réels. Les CIM traitent du contenu conceptuel

des niveaux logiques de modélisation, mais n'interviennent pas dans la mise en œuvre physique des

systèmes informatiques dans le domaine des soins de santé. Ainsi, chaque CIM peut être utilisé dans

différents cas d’usage, architectures informatiques et technologies informatiques.

Il convient de choisir une norme de technologie de mise en œuvre et de traduire les CIM dans le présent

document, en respectant les limites et les contraintes de la norme choisie, avant de pouvoir obtenir

des artéfacts techniques pour cette technologie de mise en œuvre spécifique. Ces ressources, artéfacts

ou archétypes eux-mêmes peuvent être transformés en différentes représentations informatiques

et langages de programmation, par exemple ISO/IEC 21778 JSON, ou XML, OWL, Java, ou encore C#.

Dans de tels développements, les CIM sont le matériau source essentiel et leur fonction principale

est d'offrir à toutes les technologies le même modèle d'informations cliniques de base, de sorte à

préserver la cohérence et la logique des données dans différents systèmes. Ils offrent ainsi un avantage

considérable aux parties prenantes pour conserver les connaissances lors du remplacement d’anciennes

technologies par de nouvelles. Dans le domaine des soins de santé personnalisés omniprésents, cela

s'applique aux nouvelles technologies utilisées par les patients eux-mêmes, qui fournissent des services

d'interopérabilité hautement dynamiques en temps réel.

NOTE Pour des mises en œuvre spécifiques, l'utilisation d'un modèle (d’information) de référence peut être

exigée ou recommandée. Cela n'est cependant possible que lorsque les décisions technologiques sont prises ou

ont été prises. Les contraintes imposées au monde clinique par les choix technologiques ne s'appliquent pas au

niveau des CIM. Ceux-ci restent donc des descriptions «pures» et sans contraintes du secteur des soins de santé.

Cinquièmement, les CIM définissent des représentations de concepts cliniques indépendantes de la

mise en œuvre, permettant une traduction sûre d'une mise en œuvre technologique d'un CIM dans une

autre technologie fondée sur le même CIM. Les CIM permettent à divers produits des développeurs de

normes et de technologies de travailler ensemble en toute transparence. Les CIM établissent ainsi des

1) 2)

ponts entre différentes technologies, par exemple en échangeant via HL7® FHIR® des données d'un

dossier informatisé de santé fondé sur un archétype avec un DIS fondé sur SQL. Des spécifications de

données similaires aux CIM décrites dans le présent document se sont révélées utiles dans un large

éventail de technologies d'information et de communication en matière de soins de santé, y compris

(sans toutefois s'y limiter) les systèmes de DI
...

INTERNATIONAL ISO
STANDARD 13972
First edition
Health informatics — Clinical
information models — Characteristics,
structures and requirements
Informatique de santé — Modèles d'informations cliniques —
Caractéristiques, structures et exigences
PROOF/ÉPREUVE
Reference number
ISO 13972:2021(E)
© ISO 2021
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ISO 13972:2021(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
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ISO 13972:2021(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction .............................................................................................................................................................................................................................. vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ..................................................................................................................................................................................... 1

3 Terms, definitions and abbreviated terms .............................................................................................................................. 1

3.1 Terms and definitions ...................................................................................................................................................................... 1

3.2 Abbreviated terms .............................................................................................................................................................................. 7

4 Health care information models - Concept, purpose, contexts and position ......................................8

4.1 The Concept of Clinical Information Models ................................................................................................................ 8

4.2 Purpose for Clinical Information Models ..................................................................................................................... 10

4.3 Context of Health and Care Information Models ................................................................................................... 11

4.4 Architectural Considerations for Clinical Information Models ...............................................................13

4.4.1 General .....................................................................................................................................................................................13

4.4.2 CIMs in an architectural view.............................................................................................................................. 13

4.4.3 CIMs placed in the Generic Component Model ...................................................................................... 14

4.4.4 The Interoperability and Integration Reference Architecture in ISO 23903 ............15

4.4.5 Representation of ReEIF through the ISO Interoperability and Integration

Reference Architecture Framework .............................................................................................................. 17

5 Quality Management System for Clinical Information Models ........................................................................19

5.1 General ........................................................................................................................................................................................................ 19

5.2 CIMs quality management system ..................................................................................................................................... 19

5.3 CIMs Requirements ......................................................................................................................................................................... 20

5.4 CIMs acceptance, adoption and use................................................................................................................................... 21

5.5 Achieving quality CIMs ................................................................................................................................................................ 21

5.6 Governance of CIMs ......................................................................................................................................................................... 22

5.7 Repositories of CIMs .......................................................................................................................................................................22

5.8 CIMs Development Processes .................................................................................................................................................22

6 Clinical Information Model content, structure and requirements .............................................................23

6.1 Clinical Information Model content and context ................................................................................................... 23

6.2 Concept specification of a Clinical Information Model .................................................................................... 24

6.3 Purpose of the Concept ................................................................................................................................................................ 24

6.4 Patient Population for which the Clinical Information Model is intended ..................................... 24

6.5 Evidence Base for the Clinical Information Model topic ................................................................................ 24

6.6 Description of the information model and its data elements in CIMs ................................................25

6.6.1 General requirements for the information model ............................................................................. 25

6.6.2 Data elements ..................................................................................................................................................................... 26

6.6.3 Data Element Name and Identifier ..................................................................................................................28

6.6.4 Data Element descriptions ......................................................................................................................................29

6.6.5 Semantic coding of data elements....................................................................................................................29

6.6.6 Datatype..................................................................................................................................................................................30

6.6.7 Value ........................................................................................................................................................................................... 31

6.6.8 Value set expression ..................................................................................................................................................... 32

6.6.9 Relationships in CIMs .................................................................................................................................................. 32

6.6.10 Localization of CIMs .....................................................................................................................................................33

6.7 Example instances ............................................................................................................................................................................ 33

6.8 Interpretation ....................................................................................................................................................................................... 33

6.9 Constraints or Limitations for use .....................................................................................................................................34

6.10 Instructions for use of CIMs ........................................................................................................................................... .......... 35

6.11 Care process / dependence.......................................................................................................................................................36

6.12 Issues ............................................................................................................................................................................................................36

6.13 Example of the use of a CIM ..................................................................................................................................................... 37

6.14 References................................................................................................................................................................................................ 37

iii
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ISO 13972:2021(E)

6.15 Intellectual property issues around Clinical Information Models ........................................................ 37

7 Metadata for clinical information models .............................................................................................................................39

7.1 General ........................................................................................................................................................................................................39

7.2 The metadata elements of the Clinical Information Models .......................................................................39

8 Version management of clinical information models................................................................................................43

Annex A (informative) Release and maintenance process example in the Netherlands ......................... 44

Annex B (informative) Version management backwards compatibility ....................................................................45

Annex C (informative) Guidelines and principles for Clinical Information Modelling ...............................46

Annex D (informative) Example mapping a CIM to ADL specification: Glasgow Coma Scale ...............53

Annex E (informative) Datatype profile used for the logical model parts for Clinical

Information Models .......................................................................................................................................................................................61

Annex F (informative) Example Clinical Information Model in UML and Table format .............................62

Annex G (informative) Example Clinical Information Model transformation in HL7® FHIR® .........64

Bibliography .............................................................................................................................................................................................................................74

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ISO 13972:2021(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).

This first edition of ISO 13972 cancels and replaces ISO/TS 13972:2015, which has been technically

revised.
The main changes are as follows:

— reduction of content that is not directly aiming at the clinical information models, such as clinician

involvement, governance, and patient safety matters;

— updates on modelling practices, e.g. the strict relationship to a RIM or RM has been loosened to

reflect ongoing practices, such as with HL7® FHIR®.

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 13972:2021(E)
Introduction

In current health care, the exchange of information from one healthcare professional to another and

hence, the exchange of data from one application to the other, has become a necessity. As sender and

receiver want to understand the exchanged information or data properly, it is of utmost importance

to achieve mutual understanding ‘semantic interoperability’. Semantic interoperability represents the

core need for electronic health records (EHR) and other health ICT systems, and for communication

between these systems. This document provides an approach to achieve semantic interoperability

through Clinical Information Models (CIMs).
There are five reasons for this document:

a) CIMs describe the clinical world of patients and health professionals, representing the clinical

knowledge in ICT.

b) CIMs function as building blocks from which many different useful solutions can be created,

keeping the underlying data standardized.

c) CIMs are specific instances of representations of clinical concepts, contexts, and relations. CIMs

function as specific instances of health ICT architectures. CIMs bridge between real world clinical

processes and IT solutions supporting them. For example, when using ISO 23903, CIMs can be

represented in IT models using IT ontologies.

d) CIMs are independent from technology choices and can be used in any health information

technology.

e) CIMs define representations of clinical concepts independent of implementation, enabling safe

translation from one technological implementation of a CIM into another technology based on the

same CIM.
Each reason for CIMs is described further below.

Firstly, CIMs are models that describe the clinical world, the world of patients and health professionals,

in all kinds of fashions. CIMs provide views on the healthcare business at the most detailed level.

CIMs allow providers to represent and capture the meaning of specific types of clinical information

consistently and precisely to exchange that information without concerns about misinterpretation

and to re-use, re-purpose and re-position that information in multiple contexts. Consistent clinical

documentation in electronic health record systems (EHRs) and personal health record systems

(PHRs) is at the core of CIM’s benefit to assure and ascertain continuity of care across time, provider,

and location. This is a prerequisite for data use, data reuse and data exchange. In addition, semantic

interoperability addresses issues of how to enable health professionals and ICT professionals to

establish and maintain this meaning, coding and transmission of data across time and health services,

and to perform meaningful and cooperative care, based on shared knowledge. CIMs support exchanging

meaning between health care professionals, providers, patients, and citizens, with a focus on the end

user independent of the actual ICT system(s) used.

In addition, they facilitate mutual understanding between authorities, researchers, managers, policy

[2]

makers, educators and more . A key requirement to achieve meaningful data use and exchange is the

standardization of clinical concept representation within health data, including its content, structure,

context, and transmission processes. The ability to use and exchange information between clinical

information systems without loss of clinical meaning is also essential to enable safe and effective

implementation of automated decision support. Interoperability and system integration are challenges

that CIMs can help overcome to meet business objectives.

Standardization of clinical concept representation is a desirable and cost-effective way to aggregate

data from EHR systems for multiple data use and reuse, for example for decision support, clinical

quality, epidemiology, management, policy making, and research. These are the main information

processing activities in healthcare. With respect to the processes relevant to CIMs governance, a Quality

Management System (QMS) based on a framework such as ISO 9001 can be used. Defined processes for

development, application, and governance ensure the quality of CIM artefacts and its use.

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A second important aspect of CIMs is that in any given implementation context, they will need to be

combined into larger interlinked structures or compositions. CIMs facilitate use as building blocks

from which meaningful and useful integrated information solutions can be composed. An individual

CIM does usually not actually facilitate anything. CIMs can best be grouped together to create a

working solution. CIMs are not specific for a particular use case but can be created and combined for

specific use cases to meet the clinical needs. CIMs facilitate a bottom up approach. A consequence of

such requirements is that mechanisms such as composition and decomposition are needed to enable

CIMs to be safely represented at different levels of detail. For example, a hospital discharge summary

will consist of many data elements, many of which might be CIMs. However, the data specification of

a discharge summary is a separate artefact making use of several CIMs and is not a CIM in itself. How

these combinations of CIMs can be achieved using ISO 23903 is not part of this document. For example,

a quality indicator or quality report will usually consist of several CIMs (as a composition): one CIM to

identify the patient (even if anonymous, but with a respondent number), the health organization CIM,

the clinical problem CIM, the clinical activities CIM, and so on. Similarly, for quality care, the same and

other CIMs will be used along a patient journey or clinical pathway.

The third reason for this document is the transformation of health care towards personalized ubiquitous

care. This requires the advancement of data exchange between computer systems to knowledge

sharing among the stakeholders involved, including patients, or even citizens. For that reason, CIMs

facilitate the representation of any clinical business processes’ clinical concepts, contexts, and relations

into finally implementable IT models, using IT ontologies. To perform this challenge correctly and

consistently, ISO 23903 can be deployed to formally represent the clinical business system based on the

knowledge space of the experts of the domains involved represented by those domains’ terminologies

and ontologies. In some policies, this level is referred to as the information layer, representing the

detailed semantic level of the healthcare business. As part of a standardized software development

process, this formalized system is then transformed into specific instances for specific enterprise and

information models to specify platform-specific models and implement them.

Another International Standard conceptualizing health care processes is ISO 13940. The need to

evidence the quality of the CIMs is inevitable. This document refers to standardized terminologies,

relationships, standardized datatypes, and the need to reference term or value sets, and units of measure.

CIMs model clinical concepts that are defined precisely at the logical level. CIMs are logical constructs,

specifying modular data for clinical information. This document reflects a pragmatic consensus based

on experience, regarding the level of detail in the breakdown and representation of a CIM representing

medical knowledge. Similarly, pragmatic views present examples of CIM, and support how instance

data based on CIMs can be used within Healthcare Information Architectures. The development and

management of CIMs requires common and more generic definitions/descriptions of clinical concepts,

such as health care processes and the constructs health professionals use within these processes, as

generally depicted in ISO 13940. Contsys is suitable as a common base for development of CIMs.

A fourth reason is that CIMs do not force into taking one direction with respect to technologies. CIMs are

independent from technology choices, and are therefore core assets describing the healthcare domains,

which are crucial in the negotiations with health IT professionals. There is widespread acceptance that

CIMs need to be developed and standardized by stakeholders including health professionals, patients,

managers, and (clinical) researchers on one hand while being technology ‘neutral’ yet usable in real

systems. CIMs address the conceptual content for the logical levels of modelling, but do not intervene

in the physical implementation of IT systems in healthcare. Hence, each CIM can be used in various use

cases, IT architectures, and IT technologies.

An implementation technology standard should be chosen and the CIMs should be translated to this

document within the limits and the constraints of that standard before technical artefacts for that

specific implementation technology can be derived. These resources, artefacts, or archetypes themselves

can be transformed into various computational representations and programming languages such

as ISO/IEC 21778 JSON, or XML, OWL, Java, C# among many others. In such developments, CIMs are

the core source material and their main function is to offer all technologies the same core clinical

information model, so that the consistency and logic of data can remain in various systems, offering a

key benefit to stakeholders to retain knowledge when replacing old technologies with new. In the world

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ISO 13972:2021(E)

of ubiquitous personalized health, this applies for the new technologies used by patients themselves,

which offer highly dynamic interoperability services provided in real time.

NOTE For specific implementations, the use of a reference (information) model can be required or

recommended, but that is only in the stage where technology decisions are or have been made. Constraints that

technology choices impose on the clinical world do not apply at the CIMs level, hence the CIMs remain the “pure”

unconstrained descriptions of the healthcare business.

Fifth, CIMs define representations of clinical concepts independent of implementation, enabling safe

translation from one technological implementation of a CIM into another technology based on the

same CIM. CIMs facilitate various products from standards and technology developers to seamlessly

work together, hence, CIMs build bridges between different technologies, e.g. exchange data from an

1) 2)

archetype based EHR via HL7® FHIR® to a SQL based EHR. Data specifications similar to the CIMs

described in this document have been found to be useful in a wide range of health care information

and communication technologies, including but not limited to EHR systems, telehealth applications,

messaging integration, medical devices, computer algorithms, and deductive reasoning for decision

support (see References [6][7][8][9][10][11][12][13][14][15][16]).

CIMs also offer a migration path in perspective of ISO 23903, facilitating an approach in which old

systems or applications can be replaced by new ones, without affecting other layers or views in the

architecture, if of course the standards in the various layers are applied.

Standardized CIMs further underpin the coherence of Electronic Health Records (EHR), for instance

ISO 18308, where data needs to be accepted from multiple sources and stored in a consistent and

predetermined format. In addition, for a functional EHR system (ISO/HL7 10781), queries need to be

constructed based on clinical knowledge and tied to clinical context, content, semantics and workflow;

services need to be automated based on known values of patient data linked to agreed protocols and

terminologies; data display and data entry needs to reference clinical guidelines; and safety and quality

issues for clinicians moving from system to system can be minimized through consistent information

representation. In this way, standardized CIMs form the lingua franca of use, reuse and reusability

within and across various health, clinical and care related systems.

In summary, CIMs can be used as a set of accurate clinical building blocks representing clinical concepts

that together meet the requirements for specific healthcare related use cases for which a mixed set of

information and communication technological solutions are developed and/or deployed.

The target audience for this document includes health informaticians in general but it does have a

particular relevance for Chief Medical Information Officers, Chief Nursing Information Officers, Chief

Patient Information Officers, Healthcare Information Analysts, Healthcare Information Modelers, and

Healthcare Information Architects.
In this document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “can” indicates a possibility or a capability;
— “may” indicates a permission.

1) HL7 is the 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) FHIR is a trademark of HL7®. 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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INTERNATIONAL STANDARD ISO 13972:2021(E)
Health informatics — Clinical information models —
Characteristics, structures and requirements
1 Scope
This document:

— Specifies clinical information models (CIMs) as health and care concepts that can be used to define

and to structure information for various purposes in health care, also enabling information reuse;

— Describes requirements for CIMs content, structure and context and specification of their

data elements, data element relationships, meta-data and versioning, and provides guidance and

examples;

— Specifies key characteristics of CIMs used in conceptual and logical analysis for use cases such

as (reference) architectures, information layers, EHR and PHR systems, interoperability, systems

integration in the health domain, and secondary use of data including for public health reporting;

— Defines a Quality Management System (QMS) for a systematic and effective governance, quality

management, and
...

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