SIST-TS CEN/TS ISO 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/TS 5615:2025)
Ta dokument obravnava strukturne spremembe, ki jih je povzročila pandemija COVID-19 na področju povezane oskrbe na daljavo in mobilnega zdravja (RCC-MH). Obravnavan je vpliv pandemije COVID-19 na okolja oskrbe, kot so oskrba na domu, oskrba v skupnosti, akutna oskrba in ambulantna oskrba, s poudarkom na tem, kako dobro so bila ta zdravstvena okolja pripravljena na soočenje z izzivi povezljivosti z vidika standardov. Dokument obravnava tudi trenutne standarde in opredeljuje vrzeli, na podlagi česar so oblikovana priporočila za prihodnje delo na področju standardov.
General Information
Standards Content (Sample)
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
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ISO copyright office
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Phone: +41 22 749 01 11
Email: copyright@iso.org
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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 − 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
ISO/TS 5615:2025(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/TS 5615:2025(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,
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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
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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 standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
v
ISO/TS 5615:2025(en)
Introduction
The COVID-19 pandemic 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:
— reduction of pandemic-related risks typically associated with face-to-face visits.
— alleviation of care capacity pressures due to pandemic-induced patient influx.
— stemming the tide of continually increasing healthcare costs driven by aging populations and associated
growth of chronic disease.
— catering 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 can be considered when developing remote care / Mobile Health solutions?
— What safety, effectiveness & security (SES) standards can 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 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.
vi
Technical Specification ISO/TS 5615:2025(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 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.
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 terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
effective
successful in producing a desired or intended result
3.2
effectiveness
ability to produce the intended result
Note 1 to entry: Clinical effectiveness is based on valid scientific evidence that in a significant portion of the target
population the use of the device for its intended uses will provide clinically significant results.
[SOURCE: ISO 81001-1:2021, 3.2.5, modified — Note 1 to entry was added.]
3.3
harm
physical injury or damage, or both, to the health of people or damage to property or the environment
[SOURCE: ISO/IEC Guide 51:2014, 3.1, modified — “injury or damage” was changed to “physical injury or
damage, or both”.]
3.4
hazard
potential source of harm (3.3)
[SOURCE: ISO/IEC Guide 51:2014, 3.2]
ISO/TS 5615:2025(en)
3.5
gateway
network entity (software or hardware) that interfaces between networks that use different protocols, or are
of different, potentially incompatible, technology
Note 1 to entry: A gateway operates with a focus on network translation (network gateway) or service translation
(service gateway).
[SOURCE: Reference [27]]
3.6
interoperability
ability of two or more systems or components to exchange information and to use the information that has
been exchanged
Note 1 to entry: “Open Interoperability IS achieved using open (publicly available) protocols, syntax, semantics, etc.”
Note 2 to entry: “Proprietary Interoperability IS achieved using proprietary protocols, syntax, etc. AND is not
Open(accessible) to All and has issues sharing data”
Note 3 to entry: “Seamless Interoperability IS achieved ‘out of the box’ between components that have never been
tested together.”
[SOURCE: Reference [28]]
3.7
in vitro diagnostic medical device
IVMD
medical device (3.9), whether used alone or in combination, intended by the manufacturer (3.8) for the in-
vitro examination of specimens derived from the human body solely or principally to provide information
for diagnostic, monitoring or compatibility purposes.
Note 1 to entry: IVD medical devices include reagents, calibrators, control materials, specimen receptacles,
software, and related instruments or apparatus or other articles and are used, for example, for the following test
purposes: diagnosis, aid to diagnosis, screening, monitoring, predisposition, prognosis, prediction, determination of
physiological status.
Note 2 to entry: In some jurisdictions, certain IVD medical devices may be covered by other regulations.
[SOURCE: Reference [37]]
3.8
manufacturer
natural or legal person with responsibility for the design and/or manufacture of a medical device (3.9) with
the intention of making the medical device available for use, under their name, whether or not such a medical
device is designed and/or manufactured by that person themselves or on their behalf by another person(s)
[SOURCE: ISO 14971:2019, 3.9, modified — Notes to entry were removed.]
3.9
medical device
any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software,
material or other similar or related article, intended by the manufacturer (3.8) to be used, alone or in
combination, for human beings for one or more of the specific purpose(s) of
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury,
— investigation, replacement, modification, or support of the anatomy or of a physiological process,
— supporting or sustaining life,
— control of conception,
ISO/TS 5615:2025(en)
— disinfection of medical devices,
— providing information by means of in vitro examination of specimens derived from the human body,
and which does not achieve its primary intended action by pharmacological, immunological or metabolic
means, in or on the human body, but which may be assisted in its intended function by such means
Note 1 to entry: Products which may be considered to be medical devices in some jurisdictions but not in others
include:
— disinfection substances,
— aids for persons with disabilities,
— devices incorporating animal and/or human tissues,
— devices for.in-vitro fertilization or assisted reproduction technologies.
[SOURCE: ISO/IEC Guide 63:2019, 3.7]
3.10
patient monitoring
process of observing and measuring physiological parameters via medical devices (3.9) to guide patient care
EXAMPLE Monitoring via general hospital and personal use monitoring devices, anaesthesiology monitoring
devices, cardiovascular monitoring devices, etc.
3.11
remote patient monitoring
patient monitoring (3.10) from a distance over time
EXAMPLE Monitoring a patient’s health while they are at their home, while they are in a hospital from a central
location, while they are in an ambulatory, etc.
3.12
safety
freedom from unacceptable risk
[SOURCE: ISO/IEC Guide 51:2014, 3.14]
3.13
security
condition that results from the establishment and maintenance of protective measures that ensure a state of
inviolability from hostile acts or influences
Note 1 to entry: Hostile acts or influences can be intentional or unintentional.
[SOURCE: ISO/TS 82304-2:2021, 3.1.22]
3.14
social determinants of health
SDH
non-medical factors that influence health outcomes
Note 1 to entry: Social determinants of health are the conditions in which people are born, grow, work, live, and age,
and the wider set of forces and systems shaping the conditions of daily life. These forces and systems include economic
policies and systems, development agendas, social norms, social policies and political systems.
1)
Note 2 to entry: Adapted from World Health Organization .
1) https:// www .who .int/ health -topics/ social -determinants -of -health #tab = tab _1
ISO/TS 5615:2025(en)
3.15
telehealth
use of telecommunication techniques for the purposes of providing telemedicine, medical educations and
health education over distance
[SOURCE: ISO/TR 16056-2:2004, 3.75]
3.16
telehealth service
healthcare activity supported at a distance by information and communication technology service(s)
Note 1 to entry: It is possible that the subject of care is not directly involved in a telehealth service, e.g. in the case of
tele-dermatology where one physician consults another physician who is at a distant location.
Note 2 to entry: Healthcare activities may include healthcare provider activities such as diagnosis, treatment, review
or advice, and self-care activities as prescribed or recommended by a health professional, preventive (educational)
advice and management of healthcare processes.
Note 3 to entry: Healthcare activities may include both synchronous (real-time) and asynchronous (delayed)
interactions between actors. For example, a radiology examination can be transmitted and subsequently reported
by a radiologist over a communications network. A discussion on the diagnostic findings can occur real time over a
telephone or video conferencing connection between a patient and health professionals.
[SOURCE: ISO 13131:2021, 3.5.2]
4 Abbreviations
For the purposes of this document, the following abbreviations apply.
AAMI Association for the Advancement of Medical Instrumentation
AUDA African Union Development Agency
ANVISA Agência Nacional de Vigilância Sanitária (Brazil)
CCU critical care unit
CDC Centers for Disease Control (US)
CDSCO Central Drugs Standard Control Organization (India)
DICOM Digital Image Communication in Medicine
EHR electronic health record
EMR electronic medical record
ER emergency room
EU European Union
EUA emergency use authorization
FCC Federal Communications Commission (US)
FDA Food and Drug Association (US)
FW firmware
GP general practitioner
HCP health care provider
ISO/TS 5615:2025(en)
HHS Health and Human Services
HL7 Health Level 7
ICU intensive care unit
IEEE Institute of Electrical and Electronic Engineers
IoT Internet of Things
LTAC long-term acute care
MDIRA Medical Device Interoperability Reference Architecture
MFDS Ministry of Food and Drug Safety (South Korea)
NIST National Institute of Standards and Technology (US)
ONC Office of the National Coordinator (US)
PCP primary care physician
PHD personal health devices
PMDA Pharmaceutical and Medical Device Agency (Japan)
PoCD point-of-care devices
PPE personal protective equipment
RCC-MH Remote Connected Care – Mobile Health
SDC Service oriented Device Communication
SDO standards development organization
SFDA Saudi Food and Drug Association
SNF skilled nursing facility
SW software
TGA Therapeutic Goods Administration (Australia)
UDI unique device identifier
US United States
VCT virtual clinical trial
5 RCC-MH care locations and evolution
5.1 What is RCC-MH?
RCC-MH (Remote Connected Care – Mobile Health) belongs to the broader context of telehealth services that
allow health care providers (HCPs) and patients to connect using technology to deliver health care remotely.
Modalities include:
— synchronous, including real-time phone or live audio-video interaction, typically with a patient using a
smartphone, tablet, or computer;
ISO/TS 5615:2025(en)
— asynchronous, including “store and forward” technology where messages, images, or data are collected
at one point in time and interpreted or responded to later;
— remote patient monitoring, which allows direct transmission of a patient’s clinical measurements (such
as vital signs and point-of-care lab results) remotely (real time, intermittent, continuous, etc.);
— patient monitoring at a bedside in ICU (alerts, risk index, reports), which allows for healthcare staff to
provide care (as much as possible) while socially distancing themselves from the potentially infectious
patient, thus cutting down on infection risk and PPE consumption.
5.2 Care locations: hospitals, home and community, nursing, outpatient
RCC-MH is all about connecting patients and caregivers regardless of where they are located, also recognizing
that patients and caregivers can be mobile. There are many ways of grouping these locations and this is the
approach adopted in this document (see Annex K):
— Home and community care: patient home, extended family, senior housing.
— Outpatient care: clinic, procedure centre, office [primary care physician (PCP), general practitioner (GP),
specialist, etc.].
2)
— Post-acute care: skilled nursing facility (SNF), long-term acute care (LTAC) facility , hospice, nursing
home, assisted living.
— Hospital: emergency room (ER), intensive care unit (ICU), medical surgery unit (MedSurg), long term
rehabilitation hospital.
Figure 1 shows the main locations and pre-pandemic typical patient care locations and flows that have been
considered. Most pre-pandemic care was taking place in the hospital or in post-acute care facilities, with
much less care taking place in the home or in outpatient locations.
2) An LTAC is a hospital that treats patients with serious medical conditions that require ongoing complex care but no
longer need intensive care or extensive diagnostic procedures
ISO/TS 5615:2025(en)
NOTE The size of circles is not to scale with the amount of care taking place in the different locations.
Figure 1 — Pre-pandemic locations of care
What healthcare systems have experienced, and rapidly accelerated as a result of the COVID-19 pandemic,
is a huge shift of care locations away from traditional hospital and outpatient care areas to home and
community care and post-acute care. This transition was also enabled by adjustments to the regulatory and
reimbursement environments in various countries (see Annex A). There are numerous reports showing the
exponential increase in virtual visits using telehealth services platforms (see Annex H for some relevant
standards). Patients that would normally be monitored in the hospital, are being transitioned to home care
with a similar level of monitoring, sometimes termed the “hospital at home”. Figure 2 illustrates the shifts in
the flow of patients.
ISO/TS 5615:2025(en)
NOTE The size of circles is not to scale with the amount of care taking place in the different locations.
Figure 2 — Post-pandemic locations of care
While the changes were dramatic in the initial phases of the COVID-19 pandemic, only a partial return to the
state that existed pre-pandemic has occurred as the disease subsided and became endemic. Patients find the
convenience of telehealth visits and the benefits of being taken care of outside of an institutional setting to
be very alluring. There are also economic benefits that have been recognized and will certainly be popular
with reimbursement entities such as government and public or private insurers.
6 RCC-MH relevant care delivery modes and use cases
6.1 General
This clause reviews several high-level care delivery modes which illustrate the scope of RCC-MH. These
range from in-hospital environments where caregivers could be just around the corner to more ‘remote’
situations such as a nursing home or patient home. Each of these modes provide opportunities for remote
monitoring, diagnosis and care.
A longer list of care delivery locations can be found in Annex D.
6.2 Hospital care
6.2.1 Isolation room
During the COVID-19 pandemic the need to isolate patients became almost routine. However isolated patients
become more complicated to manage due to the desire to limit contact as much as possible. Therefore, the
ISO/TS 5615:2025(en)
ability to monitor the status of the patient from outside the room and potentially to change device settings
(e.g. ventilator or infusion pump settings) becomes increasingly important.
6.2.2 Remote patient surveillance
There are various forms of remote connected care for hospital-based patients, and they have been deployed
for decades. Typically, a nurse at a central station can manage patient alarms and alerts, adjust various
settings and sometimes control therapy devices. These types of traditional surveillance systems (central
stations) are located in the patient care unit/ward, while remote ICUs and remote central stations also focus
on patient surveillance but can be located anywhere in the hospital or off hospital premises.
6.3 Home and community care
6.3.1 Telehealth and virtual health
As a result of the pandemic, the number of telehealth or remote physician visits skyrocketed. Most of these
sessions were simple one-on-one video conferencing sessions but many were more complex and assisted by
linking in remote devices such as ECG monitors, blood pressure monitors and foetal monitors.
6.3.2 Remote delivery of care
6.3.2.1 Remote disease management
A diabetes patient has a continuous glucose monitor (CGM) which is connected to their smartphone.
The smartphone, in turn, is connected to a portal (via the cloud) where the data can be viewed by their
endocrinologist. The physician can contact the patient to provide feedback, adjust medication, etc. based on
the results.
6.3.2.2 “Hospital at home”/virtual ward
Due to the overcrowding and lack of beds in the acute care hospitals, many hospital systems have developed
an approach to take appropriate care of patients in their homes. In many cases, this requires setting up
a number of monitoring, in vitro medical devices and therapeutic modalities in the home setting and
connecting them to a monitoring facility which would typically be in the hospital and staffed by professional
nurses and physicians.
6.3.2.3 Virtual clinical trial (VCT)
With the advent of patient-worn sensors and other healthcare devices that can be used by clinical trial
subjects, virtual clinical trials are becoming more commonplace. Some of these are relatively small while
others can crowdsource data from many thousands of subjects such as users of smartwatches and connected
devices who are willing to share their data. There are many challenges in VCTs, including collecting this
data, normalizing data nomenclature and data sets, sharing data sets from previous clinical trials, etc.
6.4 Post-acute care
6.4.1 LTAC
A long-term acute care (LTAC) facility is a hospital that specializes in treating patients with serious medical
conditions that require intensive care for an extended period of time. LTACs provide more individualized care
than other facilities, such as skilled nursing facilities, and are often the right choice for critically ill patients.
Patients in an LTAC can be monitored remotely in a manner similar to the in-hospital care surveillance use
case discussed in 6.2.2.
ISO/TS 5615:2025(en)
6.4.2 Skilled nursing facility
While this is not typically done today, a skilled nursing facility can arrange to have its patient-connected
medical devices communicate to a remote monitoring service to better track their patients’ status. In some
ways, this would be similar to the “hospital at home” use case.
6.5 Outpatient care
6.5.1 Remote consultation
A patient is visiting their general practitioner/primary care physician (GP/PCP). The GP/PCP decides that
they require a consultation with a remote specialist (potentially across jurisdictional boundaries). Vital
signs and other information can be shared immediately and in real-time by the GP/PCP with the specialist.
6.5.2 GP/PCP visit
Currently, GPs/PCPs are just starting to look at data acquired by the patient during their daily activities in
real-time or on an as-needed basis. One potential use case would be looking at the CGM readings that have
been uploaded to a cloud-based portal, or current readings in the case of an emergency situation.
7 RCC-MH challenges and gaps
7.1 General
Based on the use cases, many clinical challenges have been identified which are listed in Tables 1
through 7. Each challenge is further described by the current state/situation and the desired future state/
situation. Finally, gaps are identified. Tables 8 through 14 in Clause 8 complete the analysis by providing
recommendations to address the gaps.
The challenges have been grouped into the following topics (based on ISO 13131):
— safety and quality;
— deployment;
— service support;
— infrastructure;
— interoperability;
— operations;
— security.
7.2 RCC-MH challenges and gaps − Safety and quality
Table 1 includes the current challenges, current states, desired states and resulting gaps and needs related
to caregiver or patient safety and services quality.
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