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)
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.
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.
ISO copyright office
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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
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
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
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
iv © ISO 2021 – All rights reserved
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
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.
vi © ISO 2021 – All rights reserved
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.
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/
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 privacy of the care recipient in society or social
life.
3.1.6
continuity of care
component of patient care quality consisting of the degree to which the care needed by a patient is
coordinated among practitioners and across organizations and time
[SOURCE: ISO/TR 18307:2001, 3.42]
EXAMPLE Continuity of healthcare especially when several healthcare professionals or organizations share
the delivery of services to a single care recipient.
3.1.7
dependability
ability to perform when and as required
EXAMPLE Dependability of healthcare for care recipients.
[SOURCE: ISO 9000:2015, 3.6.14]
2 © ISO 2021 – All rights reserved
ISO 13131:2021(E)
3.1.8
effectiveness
extent to which planned activities are realized and planned results achieved
[SOURCE: ISO 9000:2015, 3.7.11]
EXAMPLE Effectiveness of healthcare activities in improving the quality of life and health outcomes of care
recipients and their informal caregivers.
3.1.9
efficiency
relationship between the results achieved and the resources used
[SOURCE: ISO 9000:2015, 3.7.10]
EXAMPLE Efficiency of healthcare activities in improving the quality of life and health outcomes of care
recipients.
3.1.10
inclusivity
intention or policy of including people who might otherwise be excluded or marginalized, such as
people with physical disabilities, learning disabilities, or racial and sexual minorities
[SOURCE: The Oxford Pocket Dictionary of Current English, 2009]
EXAMPLE Inclusivity of the care recipient in society or social life
3.1.11
safety
freedom from unacceptable risk or harm
EXAMPLE Safety measures that maintain the health of care recipients.
3.1.12
transparency
openness about decisions and activities that affect society, the economy and the environment, and
willingness to communicate these in a clear, accurate, timely, honest and complete manner
[SOURCE: ISO 26000:2010, 2.24]
EXAMPLE Transparency of healthcare activities.
3.1.13
usability
extent to which a product can be used by specified users to achieve specified goals with effectiveness,
efficiency and satisfaction in a specified context of use
[SOURCE: ISO 9241-420:2011, 3.42]
EXAMPLE Usability of the systems providing healthcare for care recipients and healthcare professionals.
3.2 Actors
3.2.1
carer
caregiver
person who provides care
Note 1 to entry: A carer can be a healthcare professional or an informal caregiver.
ISO 13131:2021(E)
3.2.2
care recipient
patient
client
subject of care
service user
subject of healthcare
healthcare actor with a person role; who seeks to receive, is receiving or has received healthcare
Note 1 to entry: In applying this document it is possible that the subject of care is considered to be a group of
people
[SOURCE: ISO 13940:2015, 5.2.1]
3.2.3
care team
group of collaborating carers who provide care to a care recipient
EXAMPLE A group of caregivers who collaborate to support a diabetic child; the care team includes his
parents (informal caregivers), a primary healthcare professional, a community nurse (healthcare professionals),
a teacher and a sport coach (other professionals).
3.2.4
healthcare actor
organization or person participating in healthcare
Note 1 to entry: An individual person may be regarded as a legal entity in some situations depending on the
service being delivered and the relevant national legislation.
[SOURCE: ISO 13940:2015, 5.2]
3.2.5
healthcare organization
healthcare provider having an organization role
[SOURCE: ISO 13940:2015, 5.2.3.1]
EXAMPLE A care team, a group practice, a hospital department, a hospital care unit, a self-employed
healthcare professional, a service providing healthcare advice.
3.2.6
healthcare third party
healthcare actor other than a healthcare provider or the subject of care
[SOURCE: ISO 13940:2015, 5.2.4]
3.2.7
healthcare personnel
individual healthcare actor having a person role in a healthcare organization
[SOURCE: ISO 13940:2015, 5.2.3.3]
3.2.8
healthcare professional
healthcare personnel having a healthcare professional entitlement recognized in a given jurisdiction
[SOURCE: ISO 13940:2015, 5.2.3.3.1]
3.2.9
informal caregiver
person, other than healthcare professional, who provides care
EXAMPLE A family member, a neighbour.
4 © ISO 2021 – All rights reserved
ISO 13131:2021(E)
3.2.10
organization
persons or groups of people that has its own functions with responsibilities, authorities and
relationships to achieve its objectives
Note 1 to entry: An organization may in some cases be a single health professional
[SOURCE: ISO 9000:2015, 3.2.1, modified — Note 1 to entry replaced and note 2 to entry removed.]
3.2.11
subject of care proxy
healthcare third party having a person role with the right to take decisions on behalf of the subject of
care
[SOURCE: ISO 13940:2015, 5.2.4.3]
3.2.12
supporting organization
organization that provides services to healthcare organization but that does not provide healthcare
services
EXAMPLE Healthcare financing bodies such as insurance institutions, suppliers of pharmaceuticals and
other goods. Internet and application service providers. Manufacturers and suppliers of devices not related to
the health of an individual.
3.3 Care
3.3.1
adverse event
unintended event that has a negative influence on healthcare processes
[SOURCE: ISO 13940:2015, 8.2.4]
3.3.2
authorization by law
provision in legislation that in certain circumstances can overrule the need for informed consent
[SOURCE: ISO 13940:2015, 11.2.9]
3.3.3
care
interactions between a care recipient and a healthcare actor to benefit the health state of the care
recipient
Note 1 to entry: The term ‘care’ is frequently used in combination with other words, such as ‘healthcare’ or ‘care
recipient’.
Note 2 to entry: Care also includes interactions between carers who are not healthcare professionals such as
informal caregivers.
3.3.4
care plan
healthcare plan
dynamic, personalized plan including identified needed healthcare activities, health objectives and
healthcare goals, relating to one or more specified health issues in a healthcare process
[SOURCE: ISO 13940:2015, 9.2]
ISO 13131:2021(E)
3.3.5
clinical guideline
set of systematically developed statements to assist the decisions made by healthcare actors about
healthcare activities to perform with regard to specified health issues
[SOURCE: ISO 13940:2015, 9.2.4]
3.3.6
consent competence
capability of the subject of care and/or the subject of care proxy to give informed consent or dissent
[SOURCE: ISO 13940:2015, 11.2.8]
3.3.7
health record
data repository regarding the health and healthcare of a subject of care
[SOURCE: ISO 13940:2015, 12.2]
3.3.8
healthcare
care activities, services, or supplies related to the health of an individual
[SOURCE: ISO 13940:2015, 3.1.1, modified — "management" removed from definition and note to entry
removed.]
3.3.9
healthcare activity
activity intended directly or indirectly to improve or maintain a health state
[SOURCE: ISO 13940:2015, 7.2]
3.3.10
healthcare funds
financial resources provided for healthcare delivery
[SOURCE: ISO 13940:2015, 7.2.10]
3.3.11
healthcare mandate
mandate (commission) based on a commitment and either an informed consent or an authorization by
law, defining the rights and obligations of one healthcare actor with regard to his or her involvement in
healthcare processes performed for a specific subject of care
[SOURCE: ISO 13940:2015, 11.2]
3.3.12
healthcare needs assessment
healthcare assessment during which a healthcare professional considers a subject of care‘s health need
and determines the needed healthcare activities
[SOURCE: ISO 13940:2015, 7.2.7.5]
3.3.13
healthcare process
set of interrelated or interacting healthcare activities which transforms inputs into outputs
[SOURCE: ISO 13940:2015, 8.2]
6 © ISO 2021 – All rights reserved
ISO 13131:2021(E)
3.3.14
healthcare service
service that is the result of a healthcare process
[SOURCE: ISO 13940:2015, 8.2.6]
3.3.15
health state
physical and mental functions, body structure, personal factors, activity, participation, and
environmental aspects as the composite health of a subject of care
[SOURCE: ISO 13940:2015, 6.5]
Note 1 to entry: The WHO International Classification of Functioning, Disability and Health identifies five health
components; body function, body structure, activity, participation and environmental factors which form the
basis for this entry. The Constitution of the World Health Organization defines health as a state of complete
physical, mental and social well-being and not merely the absence of disease or infirmity.
3.3.16
informed consent
permission to perform healthcare activities, voluntarily given by a subject of care having consent
competence or by a subject of care proxy, after having been informed about the purpose and the possible
results of the healthcare activities
[SOURCE: ISO 13940:2015, 11.2.6]
3.3.17
procedure
specified way to carry out an activity or process
[SOURCE: ISO 9000:2015, 3
...
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