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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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: [email protected]
Website: www.iso.org
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
...