CEN ISO/TS 22756:2020
(Main)Health Informatics - Requirements for a knowledge base for clinical decision support systems to be used in medication-related processes (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)
This document specifies the requirements for developing a knowledge base for drug-related problems that cohere with the intended drug use, to be used in rule-based clinical decision support systems (CDSS), such as the criteria for selecting a raw data source and the quality criteria for the development and maintenance for the rules or clinical rules for drug safety. It also describes the process of how to develop a knowledge base, the topics to be considered by the developers of a knowledge base, and it gives guidance on how to do this.
This document gives guidelines for the development of a knowledge base:
— with rules to enhance decisions and actions in drug-related problems that cohere with the intended drug use;
— which can be used by all kinds of healthcare professionals, such as those who prescribe, dispense, administer or monitor medicines;
— which can be used in every care setting, including chronic and acute care, primary and specialized care;
— which is a repository of evidence/practice bases rules, assessed by experts;
— which is meant to be used in conjunction with a medicinal product dictionary;
— whose knowledge is structured in rules and therefore to be used in the type of rule-based CDSS.
This document does not:
— describe the exact content of a knowledge base i.e. the outcome of the process of developing rules.
— provide the requirements for a clinical decision support system, the software that uses the knowledge base combined with the patient's data, and presents the outcome of the rules to the healthcare professional. These requirements are described in ISO/DTS 22703[1].
— give the requirements for non-medication knowledge bases. Some aspects of the requirements in this document are general in nature and applicable to other kinds of knowledge bases, but this document does not address all of the requirements of non-medication knowledge bases.
[1] Under preparation. Stage at the time of publication: ISO/DTS 22703.
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)
Zdravstvena informatika - Zahteve glede zbirk znanja za sisteme v podporo kliničnemu odločanju, ki se uporabljajo v postopkih, povezanih z zdravili (ISO/TS 22756:2020)
General Information
Standards Content (Sample)
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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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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