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

General Information

Status
Published
Publication Date
27-May-2021
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
10-Apr-2021
Completion Date
09-Apr-2021
Ref Project

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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
---------------------- Page: 1 ----------------------
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
CP 401 • Ch. de Blandonnet 8
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
---------------------- Page: 2 ----------------------
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 2021 – All rights reserved iii
---------------------- Page: 3 ----------------------
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
---------------------- Page: 4 ----------------------
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 2021 – All rights reserved v
---------------------- Page: 5 ----------------------
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
---------------------- Page: 6 ----------------------
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.
© ISO 2021 – All rights reserved vii
---------------------- Page: 7 ----------------------
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 2021 – All rights reserved 1
---------------------- Page: 8 ----------------------
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
...

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
---------------------- Page: 1 ----------------------
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
CP 401 • Ch. de Blandonnet 8
CH­1214 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
---------------------- Page: 2 ----------------------
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

© ISO 2021 – All rights reserved iii
---------------------- Page: 3 ----------------------
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

iv © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
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

© ISO 2021 – All rights reserved v
---------------------- Page: 5 ----------------------
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
---------------------- Page: 6 ----------------------
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.

© ISO 2021 – All rights reserved vii
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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/
© ISO 2021 – All rights reserved 1
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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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