ISO/TS 13131:2014

TECHNICAL ISO/TS
SPECIFICATION 13131
First edition
2014-12-15
Health informatics — Telehealth
services — Quality planning
guidelines
Informatique de santé — Services de télésanté — Lignes directrices
pour la planification de la qualité
Reference number
ISO/TS 13131:2014(E)
©
ISO 2014

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ISO/TS 13131:2014(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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Published in Switzerland
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ISO/TS 13131:2014(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 Quality characteristics . 1
3.2 Actors . 3
3.3 Care . 5
3.4 Quality . 7
3.5 Risk . 8
3.6 Telehealth . 9
4 Conformance .10
5 Quality and risk management .10
5.1 Telehealth risk, safety and quality assessment .10
5.2 Telehealth quality characteristics .10
5.3 Management of quality characteristics .11
5.4 Establishing the context for telehealth services .12
5.5 Risk assessment — Identification .12
5.6 Risk assessment — Analysis .12
5.7 Risk assessment — Evaluation .12
5.8 Risk treatment and quality .13
6 Quality management of telehealth services .13
6.1 Quality characteristics .13
6.2 Services description .13
6.3 Processes description .14
6.4 Quality planning .14
6.5 Risk assessment .14
6.6 Risk treatment .15
6.7 Service improvement .15
6.8 Safety improvement .15
7 Financial management .15
7.1 Quality characteristics .15
7.2 Sustainability .16
7.3 Healthcare funds .16
8 Service planning .16
8.1 Quality characteristics .16
8.2 Service design .17
8.3 Service levels .17
8.4 Duration of care .17
9 Workforce planning.17
9.1 Quality characteristics .17
9.2 Workforce skills and training .18
9.3 Consultation with workforce .18
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ISO/TS 13131:2014(E)

10 Healthcare planning .18
10.1 Quality characteristics .18
10.2 Healthcare processes .18
10.3 Healthcare plans .19
10.4 Healthcare continuity .19
10.5 Unavailable clinical guidelines and protocols .19
10.6 Adverse event management .19
10.7 Professional health record management .20
11 Responsibilities .20
11.1 Quality characteristics .20
11.2 Healthcare mandate .20
11.3 Informed consent .21
11.4 Care recipient preferences .21
11.5 Care recipients expenses .22
11.6 Appropriate healthcare services .22
11.7 Competence of care recipients .22
11.8 Execution of healthcare plan .23
12 Facilities management .23
12.1 Quality characteristics .23
12.2 Healthcare organization facilities .23
12.3 Care recipient facilities .24
13 Technology management .24
13.1 Quality characteristics .24
13.2 Service support .25
13.3 Service delivery .25
13.4 Infrastructure management .25
13.5 Deployment management .26
13.6 Operations management .26
13.7 Technical support .27
14 Information management .27
14.1 Quality characteristics .27
14.2 Privacy .27
14.3 Care recipient identity .28
14.4 Confidentiality of health records .28
14.5 Consultations, ordering and prescribing .28
14.6 Coordination and scheduling .28
14.7 Data quality .29
Annex A (informative) Examples of telehealth risk assessments .30
Bibliography .32
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ISO/TS 13131:2014(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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 215, Health Informatics.
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ISO/TS 13131:2014(E)

Introduction
Aging populations are driving the demand for healthcare in many countries. Extended life expectancy
will bring increased health issues for many people. Health systems are seeking to lower the demand for
hospital beds by shortening the periods of hospitalization and providing more health care outside of the
acute sector. The acute sector can also be geographically concentrated in capital cities which increases
the potential demand for health services in primary care, community care settings, and preventative
health care. Despite such measures, the demand for healthcare professionals and resources is likely to
increase across all these care settings.
The use of information and communication technologies (ICT) is growing within the healthcare sector.
The applications for ICT include devices and equipment that have embedded software. Originally, ICT
was mainly used only within larger healthcare organizations, but has now spread throughout the
healthcare sector. Applications and devices that use many types of information and communication
technologies, including embedded software are now widely available for use in hospital clinics and the
homes of patients or clients.
Healthcare organizations and healthcare supporting organizations can provide or support healthcare
services using information and communications technologies (ICTs) to deliver health services and
transmit health information over both long and short distances. The use of ICT in this way is known as
telehealth or telemedicine services.
Although the use of ICT applications to deliver health care in community settings, in patient’s homes,
and connect healthcare professionals is seen as advantageous, there are additional risks to the quality
of health care services when delivered at a distance using ICT. This Technical Specification provides
guidelines on the development of quality plans to manage these risks. These guidelines are intended for
use by healthcare organizations and healthcare supporting organizations.
A quality plan identifies the desired quality characteristics, related quality objectives, and quality
procedures. This Technical Specification provides examples of generally applicable quality plans
applicable to telehealth services.
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TECHNICAL SPECIFICATION ISO/TS 13131:2014(E)
Health informatics — Telehealth services — Quality
planning guidelines
1 Scope
A growing number of initiatives in various countries around the world, most of them small-scale, are
described as telehealth or telemedicine or m-health projects. It is not yet clear when the term telehealth
or telemedicine should be used to describe such initiatives, because these terms can be described and
interpreted in different ways in the absence of a unifying concept.
Telehealth is the use of information and communications technologies to deliver healthcare and transmit
health information over both long and short distances. Telehealth is a form of care provision that extends
the reach of care, reduces the need for care recipient or client travel and mobility, supports choice in
healthcare service delivery, preventative care, individual self-care, and may also increase the efficiency
of care. Currently telemedicine is seen as a providing a subset of a broader suite of telehealth services.
Telehealth also includes ICT applications that support a wider set of activities including educational and
administrative use.
This Technical Specification provides advice and recommendations on how to develop quality objectives
and guidelines for telehealth services that that use information and communications technologies
(ICTs) to deliver healthcare over both long and short distances by using a risk management process.
The following key requirements are considered when developing quality objectives and guidelines for
telehealth services:
— management of telehealth quality processes by the healthcare organization;
— management of financial resources to support telehealth services;
— processes relating to people such as workforce planning, healthcare planning, and responsibilities;
— provision of infrastructure and facilities resources for telehealth services;
— management of information and technology resources used in telehealth services.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 31000:2009, Risk management — Principles and guidelines
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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 recipients.
[SOURCE: Based on ISO 9241-20]
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ISO/TS 13131:2014(E)

3.1.2
accountability
responsibility of an organization for its decisions and activities, and state of being answerable to its
governing bodies, legal authorities, and, more broadly, its other stakeholders regarding these decisions
and activities
EXAMPLE Accountability for healthcare activities delivered by a healthcare organization.
[SOURCE: ISO 26000, 2.1, modified]
3.1.3
appropriateness
extent to which healthcare activities enable care recipients to achieve specified objectives
EXAMPLE Appropriateness of a healthcare activity for care recipients and healthcare organizations.
[SOURCE: ISO/IEC 25010, modified]
3.1.4
competency
ability to apply knowledge and skills to achieve intended results
EXAMPLE Competency to participate in healthcare activities of care recipients or healthcare professionals.
[SOURCE: ISO/IEC 17021:2011, 3.7]
3.1.5
confidentiality
extent to which information is not made available or disclosed to unauthorized entities
Note 1 to entry: In this context, entities include individuals, processes, and healthcare actors.
EXAMPLE Confidentiality of information to maintain the privacy of the care recipient in society or social life.
[SOURCE: ISO/IEC 27000:2014, modified]
3.1.6
continuity
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
EXAMPLE Continuity of healthcare especially when several healthcare professionals or organizations share
the delivery of services to a single care recipient.
[SOURCE: ISO/TR 18307:2001]
3.1.7
dependability
collective term used to describe the availability performance and its influencing factors, reliability
performance, maintainability performance, and maintenance support performance
EXAMPLE Dependability of healthcare for care recipients and healthcare organizations.
[SOURCE: ISO 9000:2005, 3.5.3]
3.1.8
effectiveness
extent to which planned activities are realized and planned results achieved
EXAMPLE Effectiveness of healthcare activities in improving the quality of life and health outcomes of care
recipients and their informal caregivers.
[SOURCE: ISO 9000:2005, 3.2.14]
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3.1.9
efficiency
relationship between the results achieved and how well the resources have been used
EXAMPLE Efficiency of healthcare activities in improving the quality of life and health outcomes of care
recipients and healthcare providers.
[SOURCE: ISO/IEC 27000:2014, 2.14]
3.1.10
inclusivity
intention or policy of including people who might otherwise be excluded or marginalized, such as the
handicapped, learning-disabled, or racial and sexual minorities
EXAMPLE Inclusivity of the care recipient in society or social life.
Note 1 to entry: Refer to ISO 26000 for further discussion of this concept.
[SOURCE: The Oxford Pocket Dictionary of Current English, 2009]
3.1.11
safety
freedom from unacceptable risk or harm
EXAMPLE Safety measures that maintain the health of care recipients and healthcare professionals.
[SOURCE: ISO/IEC Guide 51:1999, modified]
3.1.12
transparency
openness about decisions and activities that affect the care recipient, and willingness to communicate
these in a clear, accurate, timely, honest, and complete manner
EXAMPLE Transparency of healthcare activities.
[SOURCE: ISO 26000:2010, 2.1.24, modified]
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
EXAMPLE Usability of the systems providing healthcare for care recipients and healthcare professionals.
[SOURCE: ISO 9241:2011]
3.2 Actors
3.2.1
care recipient
person seeking to receive, receiving, or having received healthcare
Note 1 to entry: Based on ISO 13940:—, 5.2.1 definition of subject of care
3.2.2
client
person seeking to receive, receiving, or having received healthcare
EXAMPLE A client may have a contract or agreement for the provision of healthcare using telehealth. If the
subject of care is not capable of engaging in an agreement, a subject of care proxy or a legally authorized proxy
may act on behalf of the client.
[SOURCE: Based on ISO 13940:—, 5.2.1]
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3.2.3
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: Based on ISO 13940:—, 5.2]
3.2.4
healthcare organization
organization whose healthcare personnel participate in the direct provision of healthcare
EXAMPLE A care team, a group practice, a hospital department, a self employed healthcare professional.
[SOURCE: ISO 13940:—, 5.2.2.1]
3.2.5
healthcare professional
healthcare personnel having a healthcare professional entitlement in a given jurisdiction
[SOURCE: ISO 13940:—, 5.2.3.2]
3.2.6
healthcare supporting organization
healthcare third party having organizational role
EXAMPLE Public health organization; organization that focus on wellness, fitness, and/or prevention, a
homecare service organization, a health insurance fund, the operator of a t
...