ISO/TS 22756:2020
(Main)Health Informatics — Requirements for a knowledge base for clinical decision support systems to be used in medication-related processes
Health Informatics — Requirements for a knowledge base for clinical decision support systems to be used in medication-related processes
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.
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
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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
---------------------- Page: 1 ----------------------
ISO/TS 22756:2020(E)
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
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 .
...
TECHNICAL ISO/TS
SPECIFICATION 22756
First edition
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
PROOF/ÉPREUVE
Reference number
ISO/TS 22756:2020(E)
©
ISO 2020
---------------------- Page: 1 ----------------------
ISO/TS 22756:2020(E)
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii PROOF/ÉPREUVE © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
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 .
...
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