CEN ISO/TS 22703:2021
(Main)Health informatics - Requirements for medication safety alerts (ISO/TS 22703:2021)
Health informatics - Requirements for medication safety alerts (ISO/TS 22703:2021)
This document specifies the requirements for medication safety alert systems and the topics which are relevant to alert system vendors. This document applies to clinical decision support systems (CDSSs) whether or not these are medical devices.
This document addresses:
— requirements for terminology used in medication safety alerts;
— requirements for choosing a knowledge base for medication safety alert systems;
— requirements for the proper functionality of CDSSs as related to medication safety alert systems;
— requirements for medication safety alert display;
— requirements for quality measurements to improve the effectiveness of medication safety alerts.
The following are out of the scope of this document:
— the development of content (rule-based knowledge base) for CDSS;
— the development of algorithms for generating medication safety alerts in CDSS;
— the development of alert processors for medication safety alerts in CDSS.
Medizinische Informatik - Anforderungen an Arzneimittel-Warnmeldungen (ISO/TS 22703:2021)
Dieses Dokument legt die Anforderungen an Arzneimittelsicherheitswarnsysteme und die für Warnsystemanbieter relevanten Themen fest. Dieses Dokument ist für klinische Entscheidungsunter-stützungssysteme (CDSS) anzuwenden, egal ob diese Medizinprodukte sind oder nicht.
Dieses Dokument behandelt Folgendes:
— Anforderungen an die in Arzneimittelsicherheitswarnungen verwendeten Begriffe;
— Anforderungen an die Auswahl einer Wissensdatenbank für Arzneimittelsicherheitswarnsysteme;
— Anforderungen an die korrekte Funktionalität von CDSS in Verbindung mit Arzneimittelsicherheits-warnsystemen;
— Anforderungen an die Anzeige von Arzneimittelsicherheitswarnungen;
— Anforderungen an Qualitätsmessungen zur Verbesserung der Effektivität von Arzneimittelsicherheits-warnungen.
Folgendes liegt außerhalb des Anwendungsbereichs dieses Dokuments:
— die Entwicklung von Inhalten (regelbasierte Wissensbasis) für CDSS;
— die Entwicklung von Algorithmen für die Erzeugung von Arzneimittelsicherheitswarnungen in CDSS;
— die Entwicklung von Warnprozessoren für Arzneimittelsicherheitswarnungen in CDSS.
Informatique de santé - Exigences relatives aux alertes de sécurité sur les médicaments (ISO/TS 22703:2021)
Zdravstvena informatika - Zahteve za opozorila o varnosti zdravil (ISO/TS 22703:2021)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2021
Zdravstvena informatika - Zahteve za opozorila o varnosti zdravil (ISO/TS
22703:2021)
Health informatics - Requirements for medication safety alerts (ISO/TS 22703:2021)
Medizinische Informatik - Anforderungen an Arzneimittel-Warnmeldungen (ISO/TS
22703:2021)
Informatique de santé Exigences relatives aux alertes de sécurité sur les médicaments
(ISO/TS 22703:2021)
Ta slovenski standard je istoveten z: CEN ISO/TS 22703:2021
ICS:
11.120.10 Zdravila Medicaments
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 22703
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
October 2021
TECHNISCHE SPEZIFIKATION
ICS 35.240.80
English Version
Health informatics - Requirements for medication safety
alerts (ISO/TS 22703:2021)
Informatique de santé - Exigences relatives aux alertes Medizinische Informatik - Anforderungen an
de sécurité sur les médicaments (ISO/TS 22703:2021) Arzneimittel-Warnmeldungen (ISO/TS 22703:2021)
This Technical Specification (CEN/TS) was approved by CEN on 12 September 2021 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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 22703:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (CEN ISO/TS 22703:2021) 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.
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 announce this Technical Specification: 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 22703:2021 has been approved by CEN as CEN ISO/TS 22703:2021 without any
modification.
TECHNICAL ISO/TS
SPECIFICATION 22703
First edition
2021-10
Health informatics — Requirements
for medication safety alerts
Informatique de santé — Exigences relatives aux alertes de sécurité
sur les médicaments
Reference number
ISO/TS 22703:2021(E)
ISO/TS 22703:2021(E)
© ISO 2021
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Published in Switzerland
ii
ISO/TS 22703:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 5
5 Requirements . 5
5.1 General . 5
5.2 Potential medication problem types for medication safety alerts. 7
5.2.1 General . 7
5.2.2 Selection of potential medication problem types . 7
5.2.3 Other potential medication problem types . 10
5.2.4 Predetermined standards for potential medication problem types . 10
5.3 Data sources of potential medication problem types and predetermined standards . 11
5.3.1 Evidence-based resources . 11
5.3.2 Other resources . 11
5.3.3 Patient data sources .12
5.4 Alert processor .12
5.5 Alerting guidelines (methods) . 14
5.5.1 General . 14
5.5.2 Severity or safety risk grading . 14
5.5.3 Alert schema . . 16
5.5.4 Display of medication safety alert . 16
5.5.5 Alert receivers . 17
5.5.6 Alert timings . 18
5.5.7 Alert interventions . 18
5.5.8 Audit trail . 18
5.6 Interfaces and relations . 19
5.6.1 General . 19
5.6.2 Clinical information system . 19
5.6.3 Pharmacy information system . 20
5.6.4 Relation to international standards . 21
6 Other recommendations .21
6.1 General . 21
6.2 Pre-development steps . 22
6.3 Development steps . 22
6.4 Implementation step . 23
6.5 M onitoring and management of the system . 23
Annex A (informative) Example of definition and requirement of predetermined standards .24
Annex B (informative) A flexibility configuration setting screen shot of a CDSS system (a
case in Korea) .25
Annex C (informative) Recommendations for DDI alert display .27
Annex D (informative) An alert display screen shot of a CDSS system (a case in Korea) .31
Bibliography .33
iii
ISO/TS 22703:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO
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