ISO/TS 5615:2025

Health informatics — Accelerating safe, effective and secure remote connected care and mobile health through standards-based interoperability solutions addressing gaps revealed by pandemics

This document reviews the structural changes that have been precipitated by the COVID-19 pandemic in Remote Connected Care and Mobile Health (RCC-MH). The impact of the COVID-19 pandemic on care settings such as home and community care, acute care and outpatient care are reviewed discussing how well these healthcare environments were prepared to address the encountered connectivity challenges from a standards point of view. The current standards landscape is reviewed and gaps are identified leading to recommendations for future standards work.

Informatique de santé — Augmentation de la sûreté, de l’efficacité et de la sécurité des soins à distance et de la santé mobile par l’intermédiaire de solutions d’interopérabilité fondées sur les normes, en remédiant aux insuffisances mises en évidence par la pandémie

General Information

• Status: Published
• Publication Date: 14-Jul-2025
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215 - Health informatics
• Current Stage: 6060 - International Standard published
• Start Date: 15-Jul-2025
• Due Date: 19-Sep-2025
• Completion Date: 15-Jul-2025

Standards Content (Sample)

Technical
Specification
ISO/TS 5615
First edition
Health informatics — Accelerating
2025-07
safe, effective and secure remote
connected care and mobile
health through standards-
based interoperability solutions
addressing gaps revealed by
pandemics
Informatique de santé — Augmentation de la sûreté, de
l’efficacité et de la sécurité des soins à distance et de la santé
mobile par l’intermédiaire de solutions d’interopérabilité fondées
sur les normes, en remédiant aux insuffisances mises en évidence
par la pandémie
Reference number
© ISO 2025
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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviations . 4
5 RCC-MH care locations and evolution . 5
5.1 What is RCC-MH? .5
5.2 Care locations: hospitals, home and community, nursing, outpatient .6
6 RCC-MH relevant care delivery modes and use cases . 8
6.1 General .8
6.2 Hospital care.8
6.2.1 Isolation room .8
6.2.2 Remote patient surveillance .9
6.3 Home and community care.9
6.3.1 Telehealth and virtual health .9
6.3.2 Remote delivery of care .9
6.4 Post-acute care .9
6.4.1 LTAC .9
6.4.2 Skilled nursing facility .10
6.5 Outpatient care .10
6.5.1 Remote consultation .10
6.5.2 GP/PCP visit .10
7 RCC-MH challenges and gaps .10
7.1 General .10
7.2 RCC-MH challenges and gaps − Safety and quality . .10
7.3 RCC-MH challenges and gaps − Deployment . 12
7.4 RCC-MH challenges and gaps − Service support .14
7.5 RCC-MH challenges and gaps − Infrastructure . 15
7.6 RCC-MH challenges and gaps − Interoperability . 15
7.7 RCC-MH challenges and gaps ‒ Operations .16
7.8 RCC-MH challenges and gaps − Security.17
8 RCC-MH recommendations . 19
8.1 Recommendations .19
8.2 RCC-MH recommendations − Safety and quality .19
8.3 RCC-MH recommendations − Deployment .21
8.4 RCC-MH recommendations − Service support . 23
8.5 RCC-MH recommendations − Infrastructure .24
8.6 RCC-MH recommendations − Interoperability.24
8.7 RCC-MH recommendations − Operations . 25
8.8 RCC-MH recommendations − Security . 26
9 Conclusions and path forward .28
9.1 Recommended standards work items . 28
9.2 Final thoughts . 30
Annex A (informative) Regulatory and legal reactions to the pandemic .31
Annex B (informative) RCC-MH interoperability challenges .44
Annex C (informative) Nomenclature standards landscape for medical devices . 47
Annex D (informative) Accelerating safe effective and secure (SES) RCC-MH .53
Annex E (informative) RCC-MH socio-technical challenges .56

iii
Annex F (informative) RCC-MH communications standards landscape .57
Annex G (informative) RCC-MH cybersecurity standards landscape .72
Annex H (informative) RCC-MH telehealth standards landscape .79
Annex I (informative) Device specializations .81
Annex J (informative) Summary of applicable standards .82
Annex K (informative) Care delivery locations .85
Annex L (informative) Conformance landscape .87
Bibliography .89

iv
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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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, in collaboration with
HL7 and with the European Committee for Standardization (CEN) Technical Committee CEN/TC 251, Health
informatics, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement).
Any feedback or questions on this document should be directed to the user’s national stand
...

FINAL DRAFT
Technical
Specification
ISO/DTS 5615
ISO/TC 215
Health informatics — Accelerating
Secretariat: ANSI
safe, effective and secure remote
Voting begins on:
connected care and mobile
2024-11-29
health through standards-
Voting terminates on:
based interoperability solutions
2025-02-21
addressing gaps revealed by
pandemics
Informatique de santé — Augmentation de la sûreté, de
l’efficacité et de la sécurité des soins à distance et de la santé
mobile par l’intermédiaire de solutions d’interopérabilité fondées
sur les normes, en remédiant aux insuffisances mises en évidence
par la pandémie
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
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING 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.
Reference number
ISO/DTS 5615:2024(en) © ISO 2024

FINAL DRAFT
ISO/DTS 5615:2024(en)
Technical
Specification
ISO/DTS 5615
ISO/TC 215
Health informatics — Accelerating
Secretariat: ANSI
safe, effective and secure remote
Voting begins on:
connected care and mobile
health through standards-
Voting terminates on:
based interoperability solutions
addressing gaps revealed by
pandemics
Informatique de santé — Augmentation de la sûreté, de
l’efficacité et de la sécurité des soins à distance et de la santé
mobile par l’intermédiaire de solutions d’interopérabilité fondées
sur les normes, en remédiant aux insuffisances mises en évidence
par la pandémie
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.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DTS 5615:2024(en) © ISO 2024

ii
ISO/DTS 5615:2024(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviations . 4
5 RCC-MH care locations and evolution . 5
5.1 What is RCC-MH? .5
5.2 Care locations: hospitals, home and community, nursing, outpatient .6
6 RCC-MH relevant care delivery modes and use cases . 8
6.1 General .8
6.2 Hospital care.8
6.2.1 Isolation room .8
6.2.2 Remote patient surveillance .9
6.3 Home and community care.9
6.3.1 Telehealth and virtual health .9
6.3.2 Remote delivery of care .9
6.4 Post-acute care .9
6.4.1 LTAC .9
6.4.2 Skilled nursing facility .10
6.5 Outpatient care .10
6.5.1 Remote consultation .10
6.5.2 GP/PCP visit .10
7 RCC-MH challenges and gaps .10
7.1 General .10
7.2 RCC-MH challenges and gaps − Safety and quality . .10
7.3 RCC-MH challenges and gaps − Deployment . 12
7.4 RCC-MH challenges and gaps − Service support .14
7.5 RCC-MH challenges and gaps − Infrastructure . 15
7.6 RCC-MH challenges and gaps − Interoperability . 15
7.7 RCC-MH challenges and gaps ‒ Operations .16
7.8 RCC-MH challenges and gaps − Security.17
8 RCC-MH recommendations . 19
8.1 Recommendations .19
8.2 RCC-MH recommendations − Safety and quality .19
8.3 RCC-MH recommendations − Deployment .21
8.4 RCC-MH recommendations − Service support . 23
8.5 RCC-MH recommendations − Infrastructure .24
8.6 RCC-MH recommendations − Interoperability.24
8.7 RCC-MH recommendations − Operations . 25
8.8 RCC-MH recommendations − Security . 26
9 Conclusions and path forward .28
9.1 Recommended standards work items . 28
9.2 Final thoughts . 30
Annex A (informative) Regulatory and legal reactions to the pandemic .31
Annex B (informative) RCC-MH interoperability challenges .44
Annex C (informative) Nomenclature standards landscape for medical devices . 47
Annex D (informative) Accelerating safe effective & secure (SES) RCC-MH .53
Annex E (informative) RCC-MH socio-technical challenges .56

iii
ISO/DTS 5615:2024(en)
Annex F (informative) RCC-MH communications standards landscape .57
Annex G (informative) RCC-MH cybersecurity standards landscape .72
Annex H (informative) RCC-MH telehealth standards landscape .79
Annex I (informative) Device specializations .81
Annex J (informative) Summary of applicable standards .82
Annex K (informative) Care delivery locations .85
Annex L (informative) Conformance landscape .87
Bibliography .89

iv
ISO/DTS 5615:2024(en)
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 Di
...

ISO/DTS 5615
ISO/TC 215
Secretariat: ANSI
Date: YYYY-MM-DD2024-11-15
Health informatics - — Accelerating safe, effective and secure remote
connected care and mobile health through standards-based
interoperability solutions addressing gaps revealed by pandemics
Informatique de santé — Augmentation de la sûreté, de l’efficacité et de la sécurité des soins à distance et de la
santé mobile par l’intermédiaire de solutions d’interopérabilité fondées sur les normes, en remédiant aux
insuffisances mises en évidence par la pandémie

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
E-mail: [e-mail]
Website: www.iso.org
Published in Switzerland
Contents
Foreword . 4
Introduction . 5
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviations . 5
5 RCC-MH care locations and evolution . 8
5.1 What is RCC-MH? . 8
5.2 Care locations: hospitals, home and community, nursing, outpatient . 8
6 RCC-MH relevant care delivery modes and use cases . 12
6.1 General . 12
6.2 Hospital care . 12
6.3 Home and community care . 12
6.4 Post-acute care . 13
6.5 Outpatient care . 13
7 RCC-MH challenges and gaps . 13
7.1 General . 13
7.2 RCC-MH challenges and gaps − Safety and quality . 14
7.3 RCC-MH challenges and gaps − Deployment . 17
7.4 RCC-MH challenges and gaps − Service support . 18
7.5 RCC-MH challenges and gaps − Infrastructure . 20
7.6 RCC-MH challenges and gaps − Interoperability . 21
7.7 RCC-MH challenges and gaps ‒ Operations . 21
7.8 RCC-MH challenges and gaps − Security . 23
8 RCC-MH recommendations . 24
8.1 Recommendations . 24
8.2 RCC-MH recommendations − Safety and quality . 25
8.3 RCC-MH recommendations − Deployment . 27
8.4 RCC-MH recommendations − Service support . 29
8.5 RCC-MH recommendations − Infrastructure . 31
8.6 RCC-MH recommendations − Interoperability . 31
8.7 RCC-MH recommendations − Operations . 32
8.8 RCC-MH recommendations − Security . 33
9 Conclusions and path forward . 35
9.1 Recommended standards work items . 35
9.2 Final thoughts . 39
Annex A (informative) Regulatory and legal reactions to the pandemic . 40
Annex B (informative) RCC-MH interoperability challenges . 56
Annex C (informative) Nomenclature standards landscape for medical devices . 60
Annex D (informative) Accelerating safe effective & secure (SES) RCC-MH . 69
Annex E (informative) RCC-MH socio-technical challenges . 73
Annex F (informative) RCC-MH communications standards landscape . 74

ISO/DTS 5615 – Technical Specification on Remote Connected Care and Mobile Health (RCC-MH)
Annex G (informative) RCC-MH cybersecurity standards landscape . 96
Annex H (informative) RCC-MH telehealth standards landscape . 105
Annex I (informative) Device specializations . 108
Annex J (informative) Summary of applicable standards . 110
Annex K (informative) Care delivery locations . 113
Annex L (informative) Conformance landscape . 115
Bibliography . 117

Page - 3
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 documentsdocument 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 drawnISO draws attention to the possibility that some of the elementsimplementation
of this document may beinvolve the subjectuse of (a) patent(s). ISO takes no position concerning the
evidence, validity or applicability of any claimed patent rights in respect thereof. As of the date of
publication of this document, ISO had not received notice of (a) patent(s) which may be required to
implement this document. However, implementers are cautioned that this may not represent the
latest information, which may be obtained from the patent database available at
www.iso.org/patents. 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 ).
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.htmlwww.iso.org/iso/foreword.html.
This document was prepared by the Technical Committee ISO/TC 215, Health
Informatics.informatics, in collaboration with the European Committee for Standardization (CEN)
Technical Committee CEN/TC 251, Health informatics, in accordance with the Agreement on
technical cooperation between ISO and CEN (Vienna Agreement).
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.htmlwww.iso.org/members.html.

ISO/DTS 5615 – Technical Specification on Remote Connected Care and Mobile Health (RCC-MH)
Introduction
The COVID-19 Pandemicpandemic has created an enormous need to allow patients and clinicians to
communicate with each other and report in a more flexible and virtual way outside of the traditional
care delivery infrastructure. Numerous studies and reports from healthcare organizations have
shown the dramatic increase in the use of telehealth visits and their associated benefits:
— Reductionreduction of pandemic-related risks is typically associated with face-to-face visits.
— Alleviationalleviation of care capacity pressures due to pandemic-induced patient influx.
— Stemmingstemming the tide of continually increasing healthcare costs driven by aging
populations and associated growth of chronic disease.
— Cateringcatering to patient preferences and enabling patients to stay in their home longer, return
sooner, or manage their condition at home altogether.
Many healthcare organizations have gone beyond telehealth in an attempt to deploy remote care
approaches to interact with patients in the hospital as well as track the status of patients at home or
alternate care institutions. This technology is also used for clinical trial data collection, real word
evidence and patient surveillance, especially under the limitations and pressure of a pandemic. This
is termed as “Remote Connected Care and Mobile Health (RCC-MH)”.
This document explores the current challenges of deploying RCC-MH widely in the current
environment. In addition to technical gaps, this document also identifies techno-social gaps that will
need to be overcome. The question then becomes: how to educate and motivate manufacturers and
‘consumers’ (hospitals, alternate care settings, patients and their advocacy groups, etc.) so they
understand the benefits of interoperability and, since RCC-MH will not be realizable without
interoperability, begin to demand interoperable devices and apps that take advantage of
interoperable devices?
This document answers questions such as:
— What informatics standards couldcan be considered when developing remote care / Mobile
Health solutions?
— What safety, effectiveness & security (SES) standards couldcan be leveraged to balance solution
options with risk-based public good assessments?
— How can the application of these standards be scaled in crisis situations where resources and
time are highly constrained?
— How can we develop more efficient interoperability solutions to rapidly address the needs of
telehealth in pandemics cases?
This document was initially prepared as part of the Gemini joint project between HL7 and IHE. That
work was used as a baseline for this document. Content has considered standards work from IEEE
11073, ISO, IEC as well as international regulatory and legal frameworks.

Page - 5
This document is intended to inform a diverse set of stakeholders, including:
— industry − medical device vendors, point-of-care lab systems, pharma, SW and IoT vendors, apps vendors;
— government − regulatory, public health, state and local government;
— providers – primary care physicians (PCPs), general practitioners (GPs), specialists, healthcare delivery
organizations (HDOs);
— SDOs (standards development organizations);
— patients (including advocacy groups);
— payors − government, private, and public insurers;
— infrastructure vendors – networking, security, cloud, mobile devices and apps.

ISO/DTS 5615:(en)
Health informatics - — Accelerating safe, effective and secure remote
connected care and mobile health through standards-based
interoperability solutions addressing gaps revealed by pandemics
1 Scope
This document reviews the structural changes that have been precipitated by the COVID-19
Pandemicpandemic in Remote Connected Care and Mobile Health (RCC-MH). The impact of the COVID-19
Pandemicpandemic on care settings such as home/ and community care, acute care and outpatient care are
reviewed discussing how well these healthcare environments were prepared to address the encountered
connectivity challen
...