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CEN

CEN ISO/TS 5615:2025

(Main)

Health informatics - Accelerating safe, effective and secure remote connected care and mobile health through standards-based interoperability solutions addressing gaps revealed by pandemics (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 (ISO/TS 5615:2025)

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.

Medizinische Informatik - Beschleunigung einer sicheren, effektiven und geschützten vernetzten Fernbetreuung und mobilen Gesundheitsfürsorge durch auf Standards basierende Interoperabilitätslösungen, die die durch Pandemien aufgedeckten Lücken schließen (ISO/TS 5615:2025)

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 (ISO/TS 5615:2025)

Zdravstvena informatika - Pospeševanje varne, učinkovite in zanesljive povezane oskrbe na daljavo in mobilnega zdravja z interoperabilnostnimi rešitvami, ki temeljijo na standardih in odpravljajo vrzeli, ki so jih razkrile pandemije (ISO/DTS 5615:2024)

General Information

Status
Published
Publication Date
29-Jul-2025
ICS
35.240.80 - IT applications in health care technology
Technical Committee
CEN/TC 251 - Medical informatics
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
30-Jul-2025
Due Date
21-Jun-2025
Completion Date
30-Jul-2025
Ref Project
kSIST-TS FprCEN/TS ISO 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 (ISO/DTS 5615:2024)

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SLOVENSKI STANDARD
01-januar-2025
Zdravstvena informatika - Pospeševanje varne, učinkovite in zanesljive povezane
oskrbe na daljavo in mobilnega zdravja z interoperabilnostnimi rešitvami, ki
temeljijo na standardih in odpravljajo vrzeli, ki so jih razkrile pandemije (ISO/DTS
5615:2024)
Health informatics - Accelerating safe, effective and secure remote connected care and
mobile health through standards-based interoperability solutions addressing gaps
revealed by pandemics (ISO/DTS 5615:2024)
Medizinische Informatik - Beschleunigung einer sicheren, effektiven und geschützten
vernetzten Fernbetreuung und mobilen Gesundheitsfürsorge durch auf Standards
basierende Interoperabilitätslösungen, die die durch Pandemien aufgedeckten Lücken
schließen (ISO/DTS 5615:2024)
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 (ISO/DTS 5615:2024)
Ta slovenski standard je istoveten z: FprCEN/TS ISO 5615
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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: +41 22 749 01 11
Email: copyright@iso.org
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 .
...

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