EN 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 - Klinisches Informationsmodell - Charakteristika, Strukturen und Anforderungen (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

• Status: Published
• Publication Date: 08-Mar-2022
• Withdrawal Date: 29-Sep-2022
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: CEN/TC 251 - Medical informatics
• Drafting Committee: CEN/TC 251/WG 1 - Information models
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 09-Mar-2022
• Completion Date: 09-Mar-2022
• Ref Project: SIST EN ISO 13972:2022 - Health informatics - Clinical information models - Characteristics, structures and requirements (ISO 13972:2022)

Relations

• Replaces: CEN ISO/TS 13972:2015 - Health informatics - Detailed clinical models, characteristics and processes (ISO/TS 13972:2015)
• Effective Date: 16-Mar-2022

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

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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.

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