CEN ISO/TS 13972:2015

Health informatics - Detailed clinical models, characteristics and processes (ISO/TS 13972:2015)

ISO/TS 13972:2015:
Describes requirements and recommended methods against which clinicians can gather, analyse and, specify the clinical context, content, and structure of Detailed Clinical Models.
Defines Detailed Clinical Models (DCMs) in terms of an underlying logical model. They are logical models of clinical concepts and can be used to define and to structure clinical information.
Describes requirements and principles for DCMs, meta-data, versioning, content and context specification, data element specification and data element relationships, and provide guidance and examples.
Specifies DCM governance principles to ensure conceptual integrity of all DCM attributes and logical model accuracy.
Describes DCM development and the methodology principles for use that will support the production of quality DCMs to minimize risk and ensure patient safety.

Medizinische Informatik - Detaillierte klinische Modelle, Charakteristika und Prozesse (ISO/TS 13972:2015)

Informatique de santé - Modèles cliniques détaillés, caractéristiques et processus (ISO/TS 13972:2015)

Zdravstvena informatika - Podrobni klinični modeli, značilnosti in procesi (ISO/TS 13972:2015)

Ta tehnična specifikacija:
– Opisuje zahteve in priporočene metode, na podlagi katerih lahko zdravniki zbirajo, analizirajo in označujejo klinične kontekste, vsebine ter strukture podrobnih kliničnih modelov.
– Določa podrobne klinične modele (DCM) na podlagi osnovnega logičnega modela. To so logični modeli kliničnih pojmov in jih je mogoče uporabiti za določitev in strukturiranje kliničnih informacij.
– Opisuje zahteve in načela za modele DCM, metapodatke, shranjevanje različic, specifikacijo vsebine in konteksta, specifikacijo podatkovnih elementov in razmerij med njimi ter podaja napotke in primere.
– Določa načela upravljanja modelov DCM za namene zagotavljanja zasnovne celovitosti vseh atributov DCM
in natančnosti logičnega modela.
– Opisuje razvoj modelov DCM in metodološka načela, s katerimi se podpre izdelava
kakovostnih modelov DCM za namene zmanjšanja tveganja in zagotavljanja varnosti pacientov.
Ta tehnična specifikacija se ne uporablja za:
– Podrobno vsebino primerkov podrobnih kliničnih modelov. Primer: ta tehnična specifikacija ne določa konkretnih podatkovnih elementov za Glasgowsko lestvico nezavesti, telesno višino ipd. (razen nekaterih primerov razlag členov). Vključuje pa navodila o tem, kako pravilno določiti klinično znanje po Glasgowski lestvici nezavesti ali telesni višini, kako pravilno prepoznati, poimenovati in modelirati podatkovne elemente za te klinične koncepte ter kako podati enolične kode posameznim podatkovnim elementom in (če je mogoče) naborom vrednosti. Povedano drugače, opisuje način ustvarjanja primerkov, vendar ne vključuje posameznih primerkov.
– Specifikacije dinamičnega modeliranja, npr. poteka dela.
– Specifikacije za modeliranje celotnih domen ali agregatov številnih podrobnih kliničnih modelov,
npr. celotne dokumentacije pregledov ali povzetkov odpustnic. Ne določa sestave modelov DCM.

General Information

• Status: Withdrawn
• Publication Date: 06-Oct-2015
• Withdrawal Date: 08-Mar-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: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 09-Mar-2022
• Ref Project: SIST-TS CEN ISO/TS 13972:2016 - Health informatics - Detailed clinical models, characteristics and processes (ISO/TS 13972:2015)

Relations

• Replaced By: EN ISO 13972:2022 - Health informatics - Clinical information models - Characteristics, structures and requirements (ISO 13972:2022)
• Effective Date: 16-Mar-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2016
=GUDYVWYHQDLQIRUPDWLND3RGUREQLNOLQLþQLPRGHOL]QDþLOQRVWLLQSURFHVL,6276

Health informatics - Detailed clinical models, characteristics and processes (ISO/TS
13972:2015)
Medizinische Informatik - Detailliertes klinisches Model, Charakteristika und Prozesse
(ISO/TS 13972:2015)
Informatique de santé - Modèles cliniques détaillés, caractéristiques et processus
(ISO/TS 13972:2015)
Ta slovenski standard je istoveten z: CEN ISO/TS 13972:2015
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

CEN ISO/TS 13972
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
October 2015
TECHNISCHE SPEZIFIKATION
ICS 35.240.80
English Version
Health informatics - Detailed clinical models,
characteristics and processes (ISO/TS 13972:2015)
Informatique de santé - Modèles cliniques détaillés, Medizinische Informatik - Detaillierte klinische
caractéristiques et processus (ISO/TS 13972:2015) Modelle, Charakteristika und Prozesse (ISO/TS
13972:2015)
This Technical Specification (CEN/TS) was approved by CEN on 24 August 2015 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 13972:2015 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
European foreword
This document (CEN ISO/TS 13972:2015) 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.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO/TS 13972:2015 has been approved by CEN as CEN ISO/TS 13972:2015 without any
modification.
TECHNICAL ISO/TS
SPECIFICATION 13972
First edition
2015-10-01
Health informatics — Detailed clinical
models, characteristics and processes
Informatique de santé — Modèles cliniques détaillés,
caractéristiques et processus
Reference number
ISO/TS 13972:2015(E)
©
ISO 2015
ISO/TS 13972:2015(E)
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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ii © ISO 2015 – All rights reserved

ISO/TS 13972:2015(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Terms and definition . 1
3 Abbreviated terms . 8
4 Definition, purpose, contexts and position of Detailed Clinical Models .8
4.1 Definition of Detailed Clinical Models . 8
4.2 Purpose for Detailed Clinical Models . .10
4.3 Reference (Information) Models and Detailed Clinical Models .11
4.4 Types of Detailed Clinical Models .11
4.5 Context of Detailed Clinical Models .12
4.6 Architectural approach to healthcare interoperability and Detailed Clinical Models .13
4.7 Architectural considerations for Detailed Clinical Models based on the GCM .14
5 Requirements and Methodology for Detailed Clinical Models .16
5.1 DCM application, structure and management .16
5.2 Clinical Requirements .19
5.2.1 General.19
5.2.2 Clinician/user requirements, involvement, and verification for Detailed
Clinical Models .20
5.3 Clinical acceptance, adoption, and use .20
5.4 DCM QMS Processes for the systematic approach for quality of DCMs .21
5.4.1 General.21
5.4.2 General requirements .21
5.4.3 General DCM documentation requirements .21
5.5 DCM Governance .22
5.5.1 General.22
5.5.2 Governance and Management responsibility for Detailed Clinical Models .22
5.5.3 Organizing Detailed Clinical Model governance .22
5.5.4 Submission criteria for Detailed Clinical Models .22
5.5.5 Search/access criteria for Detailed Clinical Models .23
5.5.6 Contributors and key competence .23
5.5.7 Clear Accountability .23
5.5.8 Quality .23
5.6 Stakeholder Participation.23
5.7 DCM Development Processes .24
5.7.1 General.24
5.7.2 Hazards in data exchange between clinical information systems .24
5.7.3 Include data exchange specifically in Detailed Clinical Model hazard analysis .25
5.7.4 Keep the Detailed Clinical Model as simple as possible .25
5.8 Detailed Clinical Model content and artefacts .25
5.8.1 General.25
5.8.2 Clinical concept specification of a particular Detailed Clinical Model .26
5.8.3 Context of clinical concept in a Detailed Clinical Model .26
5.8.4 Purpose of the Detailed Clinical Model at instance level .26
5.8.5 Evidence Base for the Detailed Clinical Model topic .27
5.8.6 Description of data elements in the Detailed Clinical Model .28
5.8.7 Instructions for documentation of DCM content .33
5.8.8 Care process / dependence .34
5.8.9 Issues .34
5.8.10 Example of the DCM .35
5.8.11 References .35
ISO/TS 13972:2015(E)
5.8.12 Copyrights of source materials, Disclaimer, Terms of use and Copyrights
for Detailed Clinical Model .36
5.8.13 Metadata .37
5.8.14 Version management .41
5.8.15 Guidelines and principles for Detailed Clinical Modelling .42
5.8.16 Inclusion of other Detailed Clinical Models .48
...