CEN ISO/TS 22756:2020

SLOVENSKI STANDARD
01-december-2020
Zdravstvena informatika - Zahteve glede zbirk znanja za sisteme v podporo
kliničnemu odločanju, ki se uporabljajo v postopkih, povezanih z zdravili (ISO/TS
22756:2020)
Health Informatics - Requirements for a knowledge base for clinical decision support
systems to be used in medication related processes (ISO/TS 22756:2020)
Medizinische Informatik - Anforderungen an eine Wissensbasis für medizinische
Entscheidungsunterstützungssysteme von medikationsbezogenen Prozessen (ISO/TS
22756:2020)
Informatique de santé - Exigences relatives aux bases de connaissances pour systèmes
d’aide à la décision clinique à utiliser dans le cadre des processus liés aux médicaments
(ISO/TS 22756:2020)
Ta slovenski standard je istoveten z: CEN ISO/TS 22756:2020
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 22756
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
September 2020
TECHNISCHE SPEZIFIKATION
ICS 35.240.80
English Version
Health Informatics - Requirements for a knowledge base
for clinical decision support systems to be used in
medication-related processes (ISO/TS 22756:2020)
Informatique de santé - Exigences relatives aux bases Medizinische Informatik - Anforderungen an eine
de connaissances pour systèmes d'aide à la décision Wissensbasis für medizinische
clinique à utiliser dans le cadre des processus liés aux Entscheidungsunterstützungssysteme von
médicaments (ISO/TS 22756:2020) medikationsbezogenen Prozessen (ISO/TS
22756:2020)
This Technical Specification (CEN/TS) was approved by CEN on 4 September 2020 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, 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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 22756:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (CEN ISO/TS 22756:2020) 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 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 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/TS 22756:2020 has been approved by CEN as CEN ISO/TS 22756:2020 without any
modification.
TECHNICAL ISO/TS
SPECIFICATION 22756
First edition
2020-09
Health Informatics — Requirements
for a knowledge base for clinical
decision support systems to be used in
medication-related processes
Informatique de santé — Exigences relatives aux bases de
connaissances pour systèmes d’aide à la décision clinique à utiliser
dans le cadre des processus liés aux médicaments
Reference number
ISO/TS 22756:2020(E)
©
ISO 2020
ISO/TS 22756:2020(E)
© ISO 2020
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Published in Switzerland
ii © ISO 2020 – All rights reserved

ISO/TS 22756:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Abbreviations. 4
5 Positioning of a CDS knowledge base . 5
5.1 Knowledge in healthcare . 5
5.2 Knowledge for drug-related problems that cohere with the intended drug use . 5
5.3 The structure of the knowledge . 6
5.4 Knowledge base in relation to the healthcare information system . 7
5.4.1 Introduction . 7
5.4.2 Relation with EHR . . 7
5.4.3 Relation with medicinal product data . 8
5.4.4 Relation with a CDSS . 8
6 Requirements for the development of a knowledge base . 8
6.1 Introduction . 8
6.2 The governance of a knowledge base . 8
6.3 Structure of the rules . 9
6.4 Scoping of the knowledge base content . 9
6.5 Evidence for the rules . 9
6.6 Medicinal product data used in the rules .10
6.6.1 Medicinal product dictionary .10
6.6.2 IDMP .10
6.6.3 Interface with an MPD or with IDMP .11
6.7 Dosage data used in the rules .11
6.8 Patient data variables used in the rules .12
6.8.1 Introduction .12
6.8.2 Interface with the EHR .12
6.9 Right information at the right time .13
6.10 Quality of the rules .13
6.11 Relation with a CDSS .14
6.12 Maintenance .14
Annex A (normative) Identifying IDMP fields in relation to a knowledge base .16
Annex B (informative) Example of a knowledge base rule .25
Bibliography .30
ISO/TS 22756:2020(E)
Foreword
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Attention is drawn to the possibility that some of the elements of this document may be the subject of
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