ISO 13131:2021
(Main)Health informatics — Telehealth services — Quality planning guidelines
Health informatics — Telehealth services — Quality planning guidelines
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.
Informatique de santé — Services de télésanté — Lignes directrices pour la planification de la qualité
L 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.
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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
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ISO 13131:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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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
7.1.2 Guidelines for sustainability .19
7.1.3 Guidelines for healthcare funds .19
7.1.4 Guidelines for service payment .19
8 Service planning .19
8.1 Quality characteristics .19
8.1.1 General.19
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ISO 13131:2021(E)
8.1.2 Guidelines for service design .19
8.1.3 Guidelines for service availability .20
8.1.4 Guidelines for duration of care .20
8.1.5 Guidelines for service level agreements .20
9 Human resources planning .21
9.1 Quality characteristics .21
9.1.1 General.21
9.1.2 Guidelines for human resources skills and training .21
9.1.3 Guidelines for consultation with human resources .22
10 Care planning .22
10.1 Quality characteristics .22
10.1.1 General.22
10.1.2 Guidelines for healthcare processes .22
10.1.3 Guidelines for care plans .22
10.1.4 Guidelines for healthcare continuity .22
10.1.5 Guidelines for emergency procedures .23
10.1.6 Guidelines for when clinical guidelines and protocols are unavailable .23
10.1.7 Guidelines for adverse event management .23
10.1.8 Guidelines for professional health record management .23
11 Responsibilities .24
11.1 Quality characteristics .24
11.1.1 General.24
11.1.2 Guidelines for healthcare mandates .24
11.1.3 Guidelines for informed consent .24
11.1.4 Guidelines for care recipient preferences .25
11.1.5 Guidelines for care recipients’ expenses .25
11.1.6 Guidelines for providing appropriate healthcare services .25
11.1.7 Guidelines for ensuring competence of care recipients .26
11.1.8 Guidelines for design of telehealth services .26
11.1.9 Guidelines for execution of care plans .26
12 Facilities management .27
12.1 Quality characteristics .27
12.1.1 General.27
12.1.2 Guidelines for healthcare organization facilities .27
12.1.3 Guidelines for care recipient facilities .27
13 Technology management .28
13.1 Quality characteristics .28
13.1.1 General.28
13.1.2 Guidelines for safety and quality .29
13.1.3 Guidelines for service support .29
13.1.4 Guidelines for service delivery .29
13.1.5 Guidelines for infrastructure management .30
13.1.6 Guidelines for deployment management .30
13.1.7 Guidelines for operations management .30
13.1.8 Guidelines for technical support .31
13.1.9 Guidelines for device management.31
14 Information management .32
14.1 Quality characteristics .32
14.1.1 General.32
14.1.2 Guidelines for privacy . .32
14.1.3 Guidelines to protect care recipient identity .32
14.1.4 Guidelines for confidentiality of health records .32
14.1.5 Guidelines for consultations, ordering and prescribing .33
14.1.6 Guidelines for coordination and scheduling .33
14.1.7 Guidelines for data quality .33
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ISO 13131:2021(E)
Annex A (informative) Procedures for the implementation of telehealth services by a large
organization .35
Annex B (informative) Using quality planning guidelines in real-world telehealth services .37
Bibliography .46
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ISO 13131:2021(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/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics.
This first edition cancels and replaces the ISO/TS 13131:2014, which has been technically revised.
The main changes compared to the previous edition are as follows:
— alignment with ISO 9000:2015, ISO 9001:2015, ISO 31000:2018 and ISO 13940:2015;
— addition of informative annexes providing use cases illustrating applications of this document;
— improvement in the clarity of the clauses on quality management and risk management.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
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ISO 13131:2021(E)
Introduction
Healthcare activities rely on communication between healthcare actors. When the point of care
is geographically separated from healthcare resources and healthcare actors are geographically
separated, technology enabled services can support healthcare activities. There are diverse forms of
healthcare activity, including care by a health professional, self-care activity, treatment, investigation,
management, assessment, and evaluation, provision of resources, documentation and education. (For
an explanation of these terms, refer to ISO 13940). Health services rely on many technical devices
and services including, but not limited to facsimile machines, telephones, cameras, mobile phones,
mobile devices, health state monitors, diagnostic scanners and communications services including
email, telephony, video conferencing, image transmission and electronic messaging to convey health
information and data between healthcare actors.
These services can be described as telehealth services because information and communication
technology services are being used to support healthcare activities. Telehealth services can include
but are not limited to telemedicine, telecare, mhealth (healthcare supported by mobile devices),
[30]
remote use of medical applications, tele-monitoring, tele-diagnostics and virtual care . Examples of
health services include but are not limited to tele-pathology, tele-dermatology, tele-cardiology, tele-
rehabilitation, tele-oncology, and tele-orthopaedics. Healthcare activities that directly or indirectly
support care recipients include but are not limited to teleconsultation, telephone advice, health alarm
systems and health status monitoring at home. Telehealth services can support immediate healthcare
activities using synchronous communications services such as a telephone or video conversation, or
delayed health care activities using asynchronous communications services such as messaging services.
Within the healthcare industry, these services are described as digital health or ehealth (electronic
health) products provided to support healthcare activity. Electronic health information systems are
an example of products that support the capture, storage and transmission of healthcare information
and data, which may or may not be used for telehealth services. It is expected that telehealth services
will improve the quality of health and healthcare. For example, healthcare professionals can have
health information about the care recipient available in the right place at the right time, and they will
have easier access to support from medical specialists. The care recipient can be monitored in his
or her home, and receive advice without the need to travel to consult a health advisor or healthcare
professional as well as having easier access to healthcare information and education to support self-
care.
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INTERNATIONAL STANDARD ISO 13131:2021(E)
Health informatics — Telehealth services — Quality
planning guidelines
1 Scope
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.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
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ISO 13131:2021(E)
3.1 Quality characteristics
3.1.1
accessibility
usability of a product, service, environment or facility by people within the widest range of capabilities
EXAMPLE Accessibility of healthcare for care recipients.
[SOURCE: ISO 9241-20:2008, 3.1, modified — Notes to entry removed and example added.]
3.1.2
accountability
state of being answerable for decisions and activities to the organization's governing bodies, legal
authorities and, more broadly, its stakeholders
[SOURCE: ISO 26000:2010, 2.1]
EXAMPLE Accountability for healthcare activities delivered by a healthcare organization.
3.1.3
appropriateness
extent to which healthcare activities enable care recipients to achieve specified objectives
3.1.4
competence
ability to apply knowledge and skills to achieve intended results
[SOURCE: ISO/IEC 17021-1:2015, 3.7]
EXAMPLE Competence to participate in healthcare activities of care recipients or healthcare professionals.
3.1.5
confidentiality
property that information is not made available or disclosed to unauthorized individuals, entities, or
processes
[SOURCE: ISO/IEC 27000:2018, 3.10]
EXAMPLE Confidentiality of information to maintain the pr
...
NORME ISO
INTERNATIONALE 13131
Première édition
2021-05
Informatique de santé — Services de
télésanté — Lignes directrices pour la
planification de la qualité
Health informatics — Telehealth services — Quality planning
guidelines
Numéro de référence
ISO 13131:2021(F)
© ISO 2021
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ISO 13131:2021(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2021
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
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CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
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ISO 13131:2021(F)
Sommaire Page
Avant-propos . vi
Introduction .vii
1 Domaine d'application .1
2 Références normatives .1
3 Termes et définitions . 1
3.1 Caractéristiques qualité . 2
3.2 Acteurs . 3
3.3 Soins . 5
3.4 Qualité et risques . 8
3.5 Services . 10
3.6 Dispositifs . 10
4 Application des présentes lignes directrices .11
5 Management de la qualité des services de télésanté .11
5.1 Management de la qualité . 11
5.1.1 Planification de la qualité des services de télésanté . 11
5.1.2 Lignes directrices pour le management de la qualité et le management du
risque .12
5.2 Management des caractéristiques qualité . 13
5.2.1 Généralités .13
5.2.2 Lignes directrices pour les caractéristiques qualité.13
5.3 Description du domaine d'application et du contexte du service .13
5.3.1 Généralités .13
5.3.2 Lignes directrices pour la description des services . 14
5.4 Description des processus de soins de santé. 14
5.4.1 Généralités . 14
5.4.2 Lignes directrices .15
5.5 Évaluation et suivi . 15
5.5.1 Généralités .15
5.5.2 Lignes directrices pour l'évaluation et le suivi . 15
6 Management du risque .16
6.1 Évaluation des risques, de la qualité et de la sécurité des services de télésanté . 16
6.2 Appréciation du risque – Identification . 17
6.2.1 Généralités . 17
6.2.2 Lignes directrices pour l'appréciation du risque . 18
6.3 Appréciation du risque – Analyse . 18
6.3.1 Généralités . 18
6.3.2 Lignes directrices pour l'analyse du risque . 18
6.4 Appréciation du risque – Évaluation. 18
6.4.1 Généralités . 18
6.4.2 Lignes directrices pour l'évaluation du risque . 19
6.5 Traitement du risque . 19
6.5.1 Généralités . 19
6.5.2 Lignes directrices pour le traitement du risque . 19
7 Gestion financière .20
7.1 Caractéristiques qualité . 20
7.1.1 Généralités .20
7.1.2 Lignes directrices pour la durabilité . 20
7.1.3 Lignes directrices pour le financement des soins de santé .20
7.1.4 Lignes directrices pour le paiement des services . 20
8 Planification des services . .21
8.1 Caractéristiques qualité . 21
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ISO 13131:2021(F)
8.1.1 Généralités . 21
8.1.2 Lignes directrices pour la conception des services . 21
8.1.3 Lignes directrices pour la disponibilité des services . 21
8.1.4 Lignes directrices pour la durée des soins .22
8.1.5 Lignes directrices pour les accords de niveau de service . .22
9 Planification des ressources humaines .23
9.1 Caractéristiques qualité .23
9.1.1 Généralités .23
9.1.2 Lignes directrices pour les compétences et la formation en matière de
ressources humaines . 23
9.1.3 Lignes directrices pour la consultation des ressources humaines .23
10 Planification des soins .24
10.1 Caractéristiques qualité . 24
10.1.1 Généralités . 24
10.1.2 Lignes directrices pour les processus de soins de santé . 24
10.1.3 Lignes directrices pour les plans de soins . . 24
10.1.4 Lignes directrices pour la continuité des soins de santé . 24
10.1.5 Lignes directrices pour les procédures d'urgence . 25
10.1.6 Lignes directrices applicables en cas d'absence de lignes directrices et de
protocoles cliniques .25
10.1.7 Lignes directrices pour la gestion des événements indésirables.25
10.1.8 Lignes directrices pour la gestion des dossiers médicaux professionnels .25
11 Responsabilités .26
11.1 Caractéristiques qualité .26
11.1.1 Généralités . 26
11.1.2 Lignes directrices pour les mandats de soins de santé .26
11.1.3 Lignes directrices concernant le consentement éclairé . 27
11.1.4 Lignes directrices concernant les préférences des bénéficiaires des soins . 27
11.1.5 Lignes directrices concernant les dépenses des bénéficiaires des soins . 27
11.1.6 Lignes directrices concernant la fourniture de prestations de soins de
santé appropriées .28
11.1.7 Lignes directrices visant à s'assurer de la compétence des bénéficiaires
des soins .28
11.1.8 Lignes directrices pour la conception des services de télésanté .28
11.1.9 Lignes directrices pour l'exécution des plans de soins .29
12 Gestion des installations .29
12.1 Caractéristiques qualité . 29
12.1.1 Généralités .29
12.1.2 Lignes directrices concernant les installations des organisations de soins
de santé .29
12.1.3 Lignes directrices concernant les installations à la disposition des
bénéficiaires des soins .30
13 Gestion des technologies .30
13.1 Caractéristiques qualité .30
13.1.1 Généralités .30
13.1.2 Lignes directrices pour la sécurité et la qualité . 31
13.1.3 Lignes directrices pour le support des services . 31
13.1.4 Lignes directrices pour la fourniture de services . 32
13.1.5 Lignes directrices pour la gestion de l'infrastructure . 32
13.1.6 Lignes directrices pour la gestion du déploiement. 33
13.1.7 Lignes directrices pour la gestion des opérations . 33
13.1.8 Lignes directrices pour le support technique .34
13.1.9 Lignes directrices pour la gestion des dispositifs .34
14 Gestion des informations .34
14.1 Caractéristiques qualité .34
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ISO 13131:2021(F)
14.1.1 Généralités .34
14.1.2 Lignes directrices concernant le respect de la vie privée . 35
14.1.3 Lignes directrices concernant la protection de l'identité des bénéficiaires
des soins . 35
14.1.4 Lignes directrices concernant la confidentialité des dossiers de santé . 35
14.1.5 Lignes directrices pour les consultations, les ordonnances et les
prescriptions .36
14.1.6 Lignes directrices concernant la coordination et l'établissement du
calendrier . 36
14.1.7 Lignes directrices pour la qualité des données .36
Annexe A (informative) Procédures d'implémentation de services de télésanté dans le cas
d'une organisation de grande taille .38
Annexe B (informative) Utilisation concrète des lignes directrices pour la planification de
la qualité dans le cadre des services de télésanté.41
Bibliographie .52
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ISO 13131:2021(F)
Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes
nationaux de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est
en général confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude
a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,
gouvernementales et non gouvernementales, en liaison avec l'ISO participent également aux travaux.
L'ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui
concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d'approbation requis pour les différents types de documents ISO. Le présent document a
été rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir
www.iso.org/directives).
L'attention est attirée sur le fait que certains des éléments du présent document peuvent faire l'objet de
droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable
de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant
les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de
l'élaboration du document sont indiqués dans l'Introduction et/ou dans la liste des déclarations de
brevets reçues par l'ISO (voir www.iso.org/brevets).
Les appellations commerciales éventuellement mentionnées dans le présent document sont données
pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un
engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifiques de l'ISO liés à l'évaluation de la conformité, ou pour toute information au sujet de l'adhésion
de l'ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles
techniques au commerce (OTC), voir www.iso.org/avant-propos.
Le présent document a été élaboré par le comité technique ISO/TC 215, Informatique de santé.
Cette première édition de l'ISO 13131 annule et remplace l'ISO/TS 13131:2014, qui a fait l'objet d'une
révision technique.
Les principales modifications par rapport à l'édition précédente sont les suivantes:
— alignement sur les normes ISO 9000:2015, ISO 9001:2015, ISO 31000:2018 et ISO 13940:2015;
— ajout d'annexes informatives qui contiennent des cas d'utilisation illustrant les applications du
présent document;
— amélioration de la clarté des articles et paragraphes sur le management de la qualité et le management
du risque.
Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent
document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes
se trouve à l’adresse www.iso.org/fr/members.html.
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ISO 13131:2021(F)
Introduction
Les activités de soins de santé reposent sur la communication entre les acteurs des soins de santé.
Lorsque le site de soins est géographiquement éloigné des ressources de soins de santé et que les acteurs
de soins de santé sont géographiquement dispersés, des services technologiques peuvent venir en appui
des activités de soins de santé. Il existe diverses formes d'activités de soins de santé, notamment les
soins dispensés par un professionnel de santé, les activités de soins auto-administrés, les traitements,
les enquêtes, la gestion, l'estimation et l'évaluation, la fourniture de ressources, la documentation et la
formation. (Pour plus de précisions sur ces termes, voir l'ISO 13940). Les services de santé s'appuient
sur de nombreux équipements et services techniques, notamment, sans s'y limiter, les télécopieurs,
les téléphones, les caméras, les téléphones portables, les dispositifs mobiles, les moniteurs d'état de
santé, les scanners de diagnostic et les services de communication, tels que le courrier électronique,
la téléphonie, les visioconférences, la transmission d'images et la messagerie électronique, pour
transmettre des informations et des données de santé entre les différents acteurs de soins de santé.
Ces services peuvent être assimilés à des services de télésanté, car les services issus des technologies
de l'information et de la communication qu'ils utilisent viennent à l'appui des activités de soins de
santé. Les services de télésanté peuvent inclure, sans s'y limiter, la télémédecine, le télésoin, la m-santé
(soins de santé soutenus par des dispositifs mobiles), l'utilisation à distance d'applications médicales,
[30]
la télésurveillance médicale, le télédiagnostic et les soins virtuels. À titre d'exemples de services
de santé, on peut citer, sans s'y limiter, la télépathologie, la télédermatologie, la télécardiologie,
la téléréhabilitation, la téléoncologie et la téléorthopédie. Les activités de soins de santé qui
s'adressent directement ou indirectement aux bénéficiaires de soins comprennent, sans s'y limiter, la
téléconsultation, les conseils téléphoniques, les systèmes d'alerte patient et le suivi de l'état de santé au
domicile. Les services de télésanté peuvent soutenir des activités de soins de santé immédiates à l'aide
de services de communication synchrones (par exemple conversation téléphonique ou vidéo), ou des
activités de soins de santé différées à l'aide de services de communication asynchrones (par exemple
services de messagerie).
Dans le secteur des soins de santé, ces services sont assimilés à des produits de santé numérique
ou de santé électronique (e-santé), destinés à soutenir les activités de soins de santé. Les systèmes
d'information utilisés dans le cadre de la santé électronique sont un exemple de produits qui permettent
la capture, le stockage et la transmission d'informations et de données de soins de santé qu'il est permis
ou non d'utiliser pour les services de télésanté. Ces services de télésanté sont présumés améliorer la
qualité de la santé et des soins de santé. Par exemple, les professionnels de santé peuvent accéder aux
informations de santé du bénéficiaire des soins, au bon endroit et au bon moment, et bénéficieront plus
facilement des conseils de médecins spécialistes. Le bénéficiaire des soins peut être suivi à son domicile
et recevoir des conseils sans avoir à se déplacer pour consulter un conseiller santé ou un professionnel
de santé. Il peut également accéder plus facilement aux informations sur les soins de santé et à une
formation en matière de soins auto-administrés.
vii
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NORME INTERNATIONALE ISO 13131:2021(F)
Informatique de santé — Services de télésanté — Lignes
directrices pour la planification de la qualité
1 Domaine d'application
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
c
...
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 13131
ISO/TC 215
Health informatics — Telehealth
Secretariat: ANSI
services — Quality planning
Voting begins on:
20210212 guidelines
Voting terminates on:
Informatique de santé — Services de télésanté — Lignes directrices
20210409
pour la planification de la qualité
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/FDIS 13131:2021(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN
DARDS TO WHICH REFERENCE MAY BE MADE IN
©
NATIONAL REGULATIONS. ISO 2021
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ISO/FDIS 13131:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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ISO/FDIS 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
7.1.2 Guidelines for sustainability .19
7.1.3 Guidelines for healthcare funds .19
7.1.4 Guidelines for service payment .19
8 Service planning .19
8.1 Quality characteristics .19
8.1.1 General.19
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ISO/FDIS 13131:2021(E)
8.1.2 Guidelines for service design .19
8.1.3 Guidelines for service availability .20
8.1.4 Guidelines for duration of care .20
8.1.5 Guidelines for service level agreements .20
9 Human resources planning .21
9.1 Quality characteristics .21
9.1.1 General.21
9.1.2 Guidelines for human resources skills and training .21
9.1.3 Guidelines for consultation with human resources .22
10 Care planning .22
10.1 Quality characteristics .22
10.1.1 General.22
10.1.2 Guidelines for healthcare processes .22
10.1.3 Guidelines for care plans .22
10.1.4 Guidelines for healthcare continuity .22
10.1.5 Guidelines for emergency procedures .23
10.1.6 Guidelines for when clinical guidelines and protocols are unavailable .23
10.1.7 Guidelines for adverse event management .23
10.1.8 Guidelines for professional health record management .23
11 Responsibilities .24
11.1 Quality characteristics .24
11.1.1 General.24
11.1.2 Guidelines for healthcare mandates .24
11.1.3 Guidelines for informed consent .24
11.1.4 Guidelines for care recipient preferences .25
11.1.5 Guidelines for care recipients’ expenses .25
11.1.6 Guidelines for providing appropriate healthcare services .25
11.1.7 Guidelines for ensuring competence of care recipients .26
11.1.8 Guidelines for design of telehealth services .26
11.1.9 Guidelines for execution of care plans .26
12 Facilities management .27
12.1 Quality characteristics .27
12.1.1 General.27
12.1.2 Guidelines for healthcare organization facilities .27
12.1.3 Guidelines for care recipient facilities .27
13 Technology management .28
13.1 Quality characteristics .28
13.1.1 General.28
13.1.2 Guidelines for safety and quality .29
13.1.3 Guidelines for service support .29
13.1.4 Guidelines for service delivery .29
13.1.5 Guidelines for infrastructure management .30
13.1.6 Guidelines for deployment management .30
13.1.7 Guidelines for operations management .30
13.1.8 Guidelines for technical support .31
13.1.9 Guidelines for device management.31
14 Information management .32
14.1 Quality characteristics .32
14.1.1 General.32
14.1.2 Guidelines for privacy . .32
14.1.3 Guidelines to protect care recipient identity .32
14.1.4 Guidelines for confidentiality of health records .32
14.1.5 Guidelines for consultations, ordering and prescribing .33
14.1.6 Guidelines for coordination and scheduling .33
14.1.7 Guidelines for data quality .33
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ISO/FDIS 13131:2021(E)
Annex A (informative) Procedures for the implementation of telehealth services by a large
organization .35
Annex B (informative) Using quality planning guidelines in real-world telehealth services .37
Bibliography .46
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ISO/FDIS 13131:2021(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/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics.
This first edition cancels and replaces the ISO/TS 13131:2014, which has been technically revised.
The main changes compared to the previous edition are as follows:
— alignment with ISO 9000:2015, ISO 9001:2015, ISO 31000:2018 and ISO 13940:2015;
— addition of informative annexes providing use cases illustrating applications of this document;
— improvement in the clarity of the clauses on quality management and risk management.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
vi © ISO 2021 – All rights reserved
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ISO/FDIS 13131:2021(E)
Introduction
Healthcare activities rely on communication between healthcare actors. When the point of care
is geographically separated from healthcare resources and healthcare actors are geographically
separated, technology enabled services can support healthcare activities. There are diverse forms of
healthcare activity, including care by a health professional, self-care activity, treatment, investigation,
management, assessment, and evaluation, provision of resources, documentation and education. (For
an explanation of these terms, refer to ISO 13940). Health services rely on many technical devices
and services including, but not limited to facsimile machines, telephones, cameras, mobile phones,
mobile devices, health state monitors, diagnostic scanners and communications services including
email, telephony, video conferencing, image transmission and electronic messaging to convey health
information and data between healthcare actors.
These services can be described as telehealth services because information and communication
technology services are being used to support healthcare activities. Telehealth services can include
but are not limited to telemedicine, telecare, mhealth (healthcare supported by mobile devices),
[30]
remote use of medical applications, telemonitoring, telediagnostics and virtual care . Examples of
health services include but are not limited to tele-pathology, tele-dermatology, tele-cardiology, tele-
rehabilitation, tele-oncology, and tele-orthopaedics. Healthcare activities that directly or indirectly
support care recipients include but are not limited to teleconsultation, telephone advice, health alarm
systems and health status monitoring at home. Telehealth services can support immediate healthcare
activities using synchronous communications services such as a telephone or video conversation, or
delayed health care activities using asynchronous communications services such as messaging services.
Within the healthcare industry, these services are described as digital health or ehealth (electronic
health) products provided to support healthcare activity. Electronic health information systems are an
example of products that support the capture, storage and transmission of healthcare information and
data, which may or may not be used for telehealth services. It is expected that telehealth services will
improve the quality of health and healthcare. For example, healthcare professionals can have health
information about the care recipient available in the right place at the right time, and they will have
easier access to support from medical specialists. The care recipient can be monitored in his or her home,
and receive advice without the need to travel to consult a health advisor or healthcare professional as
well as having easier access to healthcare information and education to support selfcare.
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 13131:2021(E)
Health informatics — Telehealth services — Quality
planning guidelines
1 Scope
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.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
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ISO/FDIS 13131:2021(E)
3.1 Quality characteristics
3.1.1
accessibility
usability of a product, service, environment or facility by people within the widest range of capabilities
EXAMPLE Accessibility of healthcare for care recipients.
[SOURCE: ISO 9241-20:2008, 3.1, modified — Notes to entry removed and example added.]
3.1.2
accountability
state of being answerable for decisions and activities to the organization's governing bodies, legal
authorities and, more broadly, its stakeholders
[SOURCE: ISO 26000:2010, 2.1]
EXAMPLE Accountability for healthc
...
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