EN ISO 13131:2022
(Main)Health informatics - Telehealth services - Quality planning guidelines (ISO 13131:2021)
Health informatics - Telehealth services - Quality planning guidelines (ISO 13131:2021)
This document provides processes that can be used to analyze the risks to the quality and safety of healthcare and continuity of care when telehealth services are used to support healthcare activities. Using risk management processes, quality objectives and procedures are derived which provide guidelines for the operations of telehealth services. These include but are not limited to the following domains:
— management of telehealth quality processes by the healthcare organization;
— strategic and operational process management relating to regulations, knowledge management (best practice) and guidelines;
— healthcare processes relating to people such as healthcare activities, planning, and responsibilities;
— management of financial resources to support telehealth services;
— management of information management and security used in telehealth services;
— processes related to the planning and provision of human resources, infrastructure, facilities and technology resources for use by telehealth services.
This document provides a set of example guidelines containing quality objectives and procedures for each domain. Organizations can apply the quality and risk management processes described in Clauses 5 and 6 to develop quality objectives and procedures appropriate to the telehealth services they provide.
This document does not provide guidance for the manufacture, assembly, configuration, interoperability or management of devices, products or technical systems.
Annex A provides procedures for the implementation of telehealth services by a large organization. Annex B provides use cases for the application of quality planning guidelines in different types of real-world telehealth services.
Medizinische Informatik - Telemedizinische Dienste - Leitlinien für die Qualitätsplanung (ISO 13131:2021)
Informatique de santé - Services de télésanté - Lignes directrices pour la planification de la qualité (ISO 13131:2021)
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Le présent document fournit différents processus pouvant être utilisés pour analyser les risques liés à la qualité et à la sécurité des soins de santé ainsi qu'à la continuité des soins lorsque des services de télésanté sont utilisés pour venir en appui d'activités de soins de santé. Les processus de management du risque permettent d'établir des objectifs et des procédures de qualité qui fournissent des lignes directrices déterminant le fonctionnement des services de télésanté. Ces processus comprennent notamment les domaines suivants:
— la gestion des processus de qualité en ce qui concerne la télésanté par l'organisation de soins de santé;
— la gestion des processus stratégiques et opérationnels concernant les réglementations, la gestion des connaissances (bonnes pratiques) et les lignes directrices;
— les processus de soins de santé liés aux personnes, tels que les activités, la planification et les responsabilités en matière de soins de santé;
— la gestion des ressources financières permettant de prendre en charge les services de télésanté;
— le management de la gestion et de la sécurité des informations utilisées dans les services de télésanté;
— les processus liés à la planification et à la fourniture de ressources humaines, d'infrastructure, d'installations et de ressources technologiques destinées à être utilisées par les services de télésanté.
Le présent document fournit un ensemble d'exemples de lignes directrices contenant des procédures et des objectifs de qualité pour chaque domaine. Les organisations peuvent appliquer les processus de management de la qualité et de management du risque décrits dans les Articles 5 et 6 pour élaborer des objectifs et des procédures qualité adaptés aux services de télésanté qu'ils fournissent.
Le présent document ne fournit pas de recommandations pour la fabrication, l'assemblage, la configuration, l'interopérabilité ou la gestion des dispositifs, produits ou systèmes techniques.
L'Annexe A propose des procédures d'implémentation de services de télésanté par un organisme de grande taille. L'Annexe B décrit des cas d'utilisation permettant d'appliquer les lignes directrices de planification de la qualité dans différents types de services de télésanté en situation réelle.
Zdravstvena informatika - Telezdravstvene storitve - Smernice za načrtovanje kakovosti (ISO 13131:2021)
Ta dokument določa postopke, ki jih je mogoče uporabiti za analizo tveganj v zvezi s kakovostjo in varnostjo zdravstvene oskrbe in neprekinjenostjo oskrbe, če za podporo zdravstvenih dejavnosti uporabljajo zdravstvene storitve na daljavo. Z uporabo postopkov za obvladovanje tveganj so izpeljani kakovostni cilji in postopki, ki zagotavljajo smernice za delovanje zdravstvenih storitev na daljavo. Ti lahko med drugim vključujejo naslednja področja:
– upravljanje kakovostnih postopkov zdravstvenih storitev na daljavo, ki ga izvaja zdravstvena organizacija;
– upravljanje strateških in operativnih postopkov v zvezi s predpisi, upravljanje znanja (najboljša praksa) in smernice;
– postopki zdravstvenega varstva v zvezi z ljudmi, npr. zdravstvene dejavnosti, načrtovanje in odgovornosti;
– upravljanje finančnih virov za podporo zdravstvenim storitvam na daljavo;
– upravljanje informacij in informacijske varnosti pri zdravstvenih storitvah na daljavo;
– postopki v zvezi z načrtovanjem in zagotavljanjem človeških virov, infrastrukture, objektov in tehnoloških virov, ki jih uporabljajo zdravstvene storitve na daljavo.
Ta dokument določa sklop primerov smernic, ki vsebujejo kakovostne cilje in postopke za vsako področje. Organizacije lahko uporabijo te postopke za upravljanje kakovosti in obvladovanje tveganj, opisane v točkah 5 in 6, pri razvijanju kakovostnih ciljev in postopkov, ki ustrezajo zdravstvenim storitvam na daljavo, ki jih zagotavljajo.
Ta dokument ne podaja smernic za izdelavo, sestavo, konfiguracijo, interoperabilnost ali upravljanje naprav, izdelkov ali tehničnih sistemov.
Dodatek A vsebuje postopke za izvedbo zdravstvenih storitev na daljavo, ki jih izvaja velika organizacija. Dodatek B vsebuje primer uporabe smernic za kakovostno načrtovanje v različnih vrstah zdravstvenih storitev na daljavo v resničnem svetu.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2023
Zdravstvena informatika - Telezdravstvene storitve - Smernice za načrtovanje
kakovosti (ISO 13131:2021)
Health informatics - Telehealth services - Quality planning guidelines (ISO 13131:2021)
Medizinische Informatik - Telemedizinische Dienste - Leitlinien für die Qualitätsplanung
(ISO 13131:2021)
Informatique de santé - Services de télésanté - Lignes directrices pour la planification de
la qualité (ISO 13131:2021)
Ta slovenski standard je istoveten z: EN ISO 13131:2022
ICS:
11.020.01 Vodenje kakovosti in Quality and environmental
ravnanje z okoljem v management in health care
zdravstvu
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.
EN ISO 13131
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2022
EUROPÄISCHE NORM
ICS 35.240.80
English Version
Health informatics - Telehealth services - Quality planning
guidelines (ISO 13131:2021)
Informatique de santé - Services de télésanté - Lignes Medizinische Informatik - Telemedizinische Dienste -
directrices pour la planification de la qualité (ISO Leitlinien für die Qualitätsplanung (ISO 13131:2021)
13131:2021)
This European Standard was approved by CEN on 14 November 2022.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
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, Türkiye 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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13131:2022 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Endorsement notice . 3
European foreword
The text of ISO 13131:2021 has been prepared by Technical Committee ISO/TC 215 "Health
informatics” of the International Organization for Standardization (ISO) and has been taken over as
is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by May 2023, and conflicting national standards shall be
withdrawn at the latest by May 2023.
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.
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 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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 13131:2021 has been approved by CEN as EN ISO 13131:2022 without any modification.
INTERNATIONAL ISO
STANDARD 13131
First edition
2021-05
Health informatics — Telehealth
services — Quality planning
guidelines
Informatique de santé — Services de télésanté — Lignes directrices
pour la planification de la qualité
Reference number
ISO 13131:2021(E)
©
ISO 2021
ISO 13131:2021(E)
© ISO 2021
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.
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Published in Switzerland
ii © ISO 2021 – All rights reserved
ISO 13131:2021(E)
Contents Page
Foreword .vi
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 Quality characteristics . 2
3.2 Actors . 3
3.3 Care . 5
3.4 Quality and risk . 7
3.5 Services .10
3.6 Devices .10
4 Application of these guidelines .10
5 Quality management of telehealth services .11
5.1 Quality management .11
5.1.1 Telehealth service quality planning .11
5.1.2 Guidelines for quality and risk management .12
5.2 Management of quality characteristics .12
5.2.1 General.12
5.2.2 Guidelines for quality characteristics .13
5.3 Description of service scope and context .13
5.3.1 General.13
5.3.2 Guidelines for description of services .13
5.4 Description of healthcare processes .14
5.4.1 General.14
5.4.2 Guidelines .14
5.5 Evaluation and monitoring .14
5.5.1 General.14
5.5.2 Guidelines for evaluation and monitoring .14
6 Risk management .15
6.1 Telehealth service risk, quality and safety assessment .15
6.2 Risk assessment - Identification .16
6.2.1 General.16
6.2.2 Guidelines for risk assessment .16
6.3 Risk assessment - analysis .17
6.3.1 General.17
6.3.2 Guidelines for risk analysis .17
6.4 Risk assessment - evaluation .17
6.4.1 General.17
6.4.2 Guidelines for risk evaluation .17
6.5 Risk treatment .18
6.5.1 General.18
6.5.2 Guidelines for risk treatment .18
7 Financial management .18
7.1 Quality characteristics .18
7.1.1 General.18
...
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