SIST EN ISO 13972:2022
(Main)Health informatics - Clinical information models - Characteristics, structures and requirements (ISO 13972:2022)
Health informatics - Clinical information models - Characteristics, structures and requirements (ISO 13972:2022)
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.
Medizinische Informatik - Detaillierte klinische Modelle - Charakteristika und Prozesse (ISO 13972:2022)
Informatique de santé - Modèles d'informations cliniques - Caractéristiques, structures et exigences (ISO 13972:2022)
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.
Zdravstvena informatika - Klinični informacijski modeli - Značilnosti, strukture in zahteve (ISO 13972:2022)
Ta dokument:
– določa klinične informacijske modele (CIM) kot koncepte varovanja zdravja in oskrbe, ki jih je mogoče uporabiti za opredelitev in strukturiranje informacij za različne namene v zdravstvu, s čimer se omogoči tudi vnovična uporaba informacij;
– opisuje zahteve za vsebino kliničnih informacijskih modelov, strukturo, kontekst in specifikacijo njihovih podatkovnih elementov, razmerja med podatkovnimi elementi, metapodatke in shranjevanje različic ter podaja smernice in primere;
– določa ključne značilnosti kliničnih informacijskih modelov, ki se uporabljajo pri konceptualni in logični analizi za primere uporabe, kot so (referenčne) arhitekture, plasti informacij, sistemi elektronskih zdravstvenih zapisov (EHR) in osebnih zdravstvenih zapisov (PHR), interoperabilnost, integracija sistemov na področju varovanja zdravja ter sekundarna uporaba podatkov, vključno s poročanjem o javnem zdravju;
– določa sistem vodenja kakovosti (QMS) za sistematično in učinkovito upravljanje, vodenje
kakovosti ter merjenje kliničnih informacijskih modelov v življenjskem ciklu njihovega razvoja, preskušanja, distribucije,
uporabe in vzdrževanja;
– zagotavlja načela za preoblikovanje in uporabo kliničnih informacijskih modelov z
najrazličnejšo zdravstveno informacijsko tehnologijo.
Ta dokument ne zajema:
– zahtev glede vsebine in uporabe določenega kliničnega informacijskega modela oziroma metodologije
za oblikovanje kliničnih informacijskih modelov;
– določenih vrst uporabe kliničnih informacijskih modelov, npr. za dinamično modeliranje poteka dela;
– specifikacij za modeliranje celotnih domen ali agregatov številnih podrobnih kliničnih informacijskih modelov, npr. celotne dokumentacije pregledov ali povzetkov odpustnic. Ne določa sestave kliničnih informacijskih modelov;
– specifikacije o vključevanju posameznih zdravnikov, izvajanju upravljanja (vključno z upravljanjem
informacij) ali zagotavljanju varnosti bolnikov.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 13972:2022
01-maj-2022
Nadomešča:
SIST-TS CEN ISO/TS 13972:2016
Zdravstvena informatika - Klinični informacijski modeli - Značilnosti, strukture in
zahteve (ISO 13972:2022)
Health informatics - Clinical information models - Characteristics, structures and
requirements (ISO 13972:2022)
Medizinische Informatik - Detaillierte klinische Modelle - Charakteristika und Prozesse
(ISO 13972:2022)
Informatique de santé - Modèles d'informations cliniques - Caractéristiques, structures et
exigences (ISO 13972:2022)
Ta slovenski standard je istoveten z: EN ISO 13972:2022
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 13972:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 13972:2022
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SIST EN ISO 13972:2022
EN ISO 13972
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2022
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes CEN ISO/TS 13972:2015
English Version
Health informatics - Clinical information models -
Characteristics, structures and requirements (ISO
13972:2022)
Informatique de santé - Modèles d'informations Medizinische Informatik - Detaillierte klinische
cliniques - Caractéristiques, structures et exigences Modelle - Charakteristika und Prozesse (ISO
(ISO 13972:2022) 13972:2022)
This European Standard was approved by CEN on 20 October 2021.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13972:2022 E
worldwide for CEN national Members.
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SIST EN ISO 13972:2022
EN ISO 13972:2022 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 13972:2022
EN ISO 13972:2022 (E)
European foreword
This document (EN ISO 13972:2022) has been prepared by Technical Committee ISO/TC 215 "Health
informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by September 2022, and conflicting national standards
shall be withdrawn at the latest by September 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes CEN ISO/TS 13972:2015.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 13972:2022 has been approved by CEN as EN ISO 13972:2022 without any modification.
3
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SIST EN ISO 13972:2022
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SIST EN ISO 13972:2022
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
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SIST EN ISO 13972:2022
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
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© ISO 2022 – All rights reserved
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SIST EN ISO 13972:2022
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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SIST EN ISO 13972:2022
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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SIST EN ISO 13972:2022
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.
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SIST EN ISO 13972:2022
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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SIST EN ISO 13972:2022
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,
...
SLOVENSKI STANDARD
oSIST prEN ISO 13972:2020
01-december-2020
Zdravstvena informatika - Klinični informacijski modeli - Značilnosti, strukture in
zahteve (ISO/DIS 13972:2020)
Health informatics - Clinical information models - Characteristics, structures and
requirements (ISO/DIS 13972:2020)
Medizinische Informatik - Detaillierte klinische Modelle - Charakteristika und Prozesse
(ISO/DIS 13972:2020)
Informatique de santé - Modèles d'informations cliniques - Caractéristiques, structures et
exigences (ISO/DIS 13972:2020)
Ta slovenski standard je istoveten z: prEN ISO 13972
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
oSIST prEN ISO 13972:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 13972:2020
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oSIST prEN ISO 13972:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 13972
ISO/TC 215 Secretariat: ANSI
Voting begins on: Voting terminates on:
2020-10-02 2020-12-25
Health informatics — Clinical information models —
Characteristics, structures and requirements
ICS: 35.240.80
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 13972:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
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oSIST prEN ISO 13972:2020
ISO/DIS 13972:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
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oSIST prEN ISO 13972:2020
ISO/DIS 13972:2020(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms, definitions, abbreviations and synonyms . 1
3.1 Terms and definitions . 1
3.2 For the purposes of this document, the following abbreviations apply. . 7
3.3 Synonyms . 8
4 Definition, purpose, contexts and position of health and care information models
[informative] . 8
4.1 Definition of Clinical Information Models . 8
4.2 Purpose for Clinical Information models .10
4.3 Context of Health and Care Information models .10
4.4 Architectural Considerations for Clinical Information Models .12
4.4.1 General.12
4.4.2 CIMs in an architectural view .13
4.4.3 CIMs placed in the Generic Component Model .13
4.4.4 The ISO/DIS 23903 Interoperability and Integration Reference Architecture.15
4.4.5 Representation of Re EIF through the ISO Interoperability and Integration
Reference Architecture Framework .16
5 Quality Management System for Clinical Information Models .17
5.1 General .17
5.2 CIMs quality management system .17
5.3 CIMs Requirements .19
5.4 CIMs acceptance, adoption, and use .19
5.5 Achieving quality CIMs .19
5.6 Governance of CIMs .20
5.7 Repositories of CIMs .20
5.8 CIMs Development Processes .21
6 Clinical Information Model content, structure and requirements .22
6.1 General .22
6.2 Clinical Information Model content and context .22
6.3 Concept specification of a Clinical Information Model .22
6.4 Purpose of the Concept .23
6.5 Patient Population for which the Clinical Information Model is intended .23
6.6 Evidence Base for the Clinical Information Model topic .23
6.7 Description of the information model and its data elements in CIMs .24
6.7.1 General requirements for the information model.24
6.7.2 Data Elements .25
6.7.3 Data Element Name and Identifier .27
6.7.4 Data Element descriptions .27
6.7.5 Semantic coding of data elements .28
6.7.6 Datatype .28
6.7.7 Value .29
6.7.8 Value set expression.30
6.7.9 Relationships in CIMs .31
6.7.10 Localization of CIMs .31
6.8 Example instances . .32
6.9 Interpretation .32
6.11 Instructions for use of CIMs .34
6.12 Care process / dependence .34
6.13 Issues .35
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6.14 Example of the use of a CIM .35
6.15 References .36
6.16 Legal issues around Clinical Information Models .36
7 Metadata for clinical information models .37
7.1 General .37
7.2 The metadata elements of the Clinical Information Models .38
8 Version management of clinical information models .41
Annex A (informative) Release and maintenance process example the Netherlands .43
Annex B (informative) Version management backwards compatibility .44
Annex C (informative) Guidelines and principles for Clinical Information Modelling .45
Annex D (informative) Example mapping a CIM to ADL specification: Glasgow Coma Scale .51
Annex E (informative) Datatype profile used for the logical model parts for Clinical
Information Models .59
Annex F (informative) Example Clinical Information Model in UML and Table format .60
Annex G (informative) Example Clinical Information Model transformation in HL7 FHIR .65
Bibliography .74
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oSIST prEN ISO 13972:2020
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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.
This second edition cancels and replaces the first edition (ISO TS 13972: 2015) which has been
technically revised.
The main changes compared to the previous edition 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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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. Of course, sender
and receiver want to understand the exchanged information or data properly. To achieve mutual
understanding ‘semantic interoperability’ is of utmost importance. Semantic interoperability represents
the core need for electronic health records (EHR) and other health ICT systems and for communication
between these systems. Semantic interoperability is defined as “ensuring that the precise meaning of
exchanged information is understandable by any other system or application not initially developed for
this purpose” [EC Recommendation, COM (2008) 3282 final]. This standard provides an approach to
achieve semantic interoperability through Clinical Information Models (CIMs). There are five reasons
for this standard. These include:
1. CIMs describe the clinical world of patients and health professionals, representing the clinical
knowledge in ICT.
2. CIMs function as building blocks from which many different useful solutions can be created,
keeping the underlying data standardized.
3. 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 the ISO/DIS 23903
Interoperability and Integration Reference Architecture, CIMs can be represented in IT models
using IT ontologies.
4. CIMs are independent from technology choices and can be used in any health information
technology.
5. 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. This 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
makers, educators and more (modified from Semantic Health, 2009). 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 which 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
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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.
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 must 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/DIS 23903 is not part of this standard. 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 standard 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. For correctly and consistently performing
this challenge, ISO/DIS 23903 Interoperability and Integration Reference Architecture can be deployed to
formally represent the clinical business system based on the knowledge space of the involved domains’
experts 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 standard conceptualizing health care processes is ISO 13940 Health informatics — System
of concepts to support continuity of care. The need to evidence the quality of the CIMs is inevitable.
Therefore, the standard specifies clinical model quality requirements, principles, development
methodology, and governance. This standard 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 standard reflects a pragmatic consensus based
on experience, regarding the level of detail in the breakdown and representation of a CIM. 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 (but not required) 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 has to be chosen and the CIMs have to be translated to this
technical standard 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
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themselves can be transformed into various computational representations and programming
languages such as JSON, 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
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 Of course, 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. Any 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 archetype based EHR via HL7 FHIR to a SQL based EHR. Data specifications similar to the CIMs
described in this standard 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 (e.g. Huff et al., 2004, Hoy et al., 2007, 2009, Kalra et al., 2008, Rector, Qamar, Marley, 2008,
Goossen et al., 2010, Shafarman and Gilliam, 2010, Moreno - Conde et al, 2015, González-Ferrer et al,
2016, among others).
CIMs also offer a migration path in perspective of the ISO 23903 Interoperability and Integration
Reference Architecture, 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, 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 (EHR System Funct
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