SIST-TS CEN/TS ISO 5615:2025

SLOVENSKI STANDARD
01-oktober-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/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)
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)
Ta slovenski standard je istoveten z: CEN ISO/TS 5615:2025
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.

CEN ISO/TS 5615
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
July 2025
TECHNISCHE SPEZIFIKATION
ICS 35.240.80
English Version
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)
Informatique de santé - Augmentation de la sûreté, de Medizinische Informatik - Beschleunigung einer
l'efficacité et de la sécurité des soins à distance et de la sicheren, effektiven und geschützten vernetzten
santé mobile par l'intermédiaire de solutions Fernbetreuung und mobilen Gesundheitsfürsorge
d'interopérabilité fondées sur les normes, en durch auf Standards basierende
remédiant aux insuffisances mises en évidence par la Interoperabilitätslösungen, die die durch Pandemien
pandémie (ISO/TS 5615:2025) aufgedeckten Lücken schließen (ISO/TS 5615:2025)
This Technical Specification (CEN/TS) was approved by CEN on 22 March 2025 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 5615:2025 E
worldwide for CEN national Members.

CEN ISO/TS 5615 (E)
Contents Page
European foreword . 3

CEN ISO/TS 5615 (E)
European foreword
This document (CEN ISO/TS 5615) has been prepared by Technical Committee ISO/TC 215 "Health
informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO/TS 5615:2025 has been approved by CEN as CEN ISO/TS 5615 without any
modification.
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/TS 5615:2025(en) © ISO 2025

ISO/TS 5615:2025(en)
© 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
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or ISO’s member body in the country of the requester.
ISO copyright office
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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO/TS 5615:2025(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 − Operatio
...