oSIST prEN ISO 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)

Zdravstvena informatika - Klinični informacijski modeli - Značilnosti, strukture in zahteve (ISO/DIS 13972:2020)

General Information

• Status: Not Published
• Public Enquiry End Date: 17-Dec-2020
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ITC - Information technology
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 01-Oct-2020
• Due Date: 18-Feb-2021
• Completion Date: 05-Jan-2021
• Ref Project: prEN ISO 13972 - Health informatics - Clinical information models - Characteristics, structures and requirements (ISO/DIS 13972:2020)

RELATIONS

• Revised: SIST-TS CEN ISO/TS 13972:2016 - Health informatics - Detailed clinical models, characteristics and processes (ISO/TS 13972:2015)
• Effective Date: 02-Oct-2019

Standards Content (sample)

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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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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Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
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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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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
...