ISO 13972:2022
(Main)Health informatics — Clinical information models — Characteristics, structures and requirements
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
Relations
Buy Standard
Standards Content (Sample)
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO 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
iii
© ISO 2022 – All rights reserved
---------------------- Page: 3 ----------------------
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
iv
© ISO 2022 – All rights reserved
---------------------- Page: 4 ----------------------
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.
v
© ISO 2022 – All rights reserved
---------------------- Page: 5 ----------------------
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.
vi
© ISO 2022 – All rights reserved
---------------------- Page: 6 ----------------------
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
vii
© ISO 2022 – All rights reserved
---------------------- Page: 7 ----------------------
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.
viii
© ISO 2022 – All rights reserved
---------------------- Page: 8 ----------------------
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
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
ii
© ISO 2022 – Tous droits réservés
---------------------- Page: 2 ----------------------
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
iii
© ISO 2022 – Tous droits réservés
---------------------- Page: 3 ----------------------
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
iv
© ISO 2022 – Tous droits réservés
---------------------- Page: 4 ----------------------
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.
v
© ISO 2022 – Tous droits réservés
---------------------- Page: 5 ----------------------
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.
vi
© ISO 2022 – Tous droits réservés
---------------------- Page: 6 ----------------------
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
© ISO 2022 – Tous droits réservés
---------------------- Page: 7 ----------------------
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
---------------------- Page: 1 ----------------------
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
ii
PROOF/ÉPREUVE © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
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
© ISO 2021 – All rights reserved PROOF/ÉPREUVE
---------------------- Page: 3 ----------------------
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
iv
PROOF/ÉPREUVE © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
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.
v
© ISO 2021 – All rights reserved PROOF/ÉPREUVE
---------------------- Page: 5 ----------------------
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.
vi
PROOF/ÉPREUVE © ISO 2021 – All rights reserved
---------------------- Page: 6 ----------------------
ISO 13972:2021(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
vii
© ISO 2021 – All rights reserved PROOF/ÉPREUVE
---------------------- Page: 7 ----------------------
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.
viii
PROOF/ÉPREUVE © ISO 2021 – All rights reserved
---------------------- Page: 8 ----------------------
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
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.