ISO/TS 5615:2025

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
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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
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informatics, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
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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
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]

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,
— 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

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
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;

— 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

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.
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

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.
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.

Table 1 — RCC-MH challenges, gaps and needs − Safety and quality
Challenge Current state Desired state Gap/need
1. Minimize contact Caregivers need to enter Caregivers can remotely Devices that can be
with infectious the patient room to ob- obtain readings and ad- monitored and adjusted
patients for device tain readings and adjust just settings on devices. remotely.
reading and settings on devices. Caregivers have reduced
adjustment. This usually requires a patient contact and do
change of PPE for each not need to change PPE if
instance. they don’t enter the room.
2. Devices are always Devices that were Devices actively moni- In some cases, vendors
at the latest warehoused need to be tor their SW/FW status support remote SW up-
software release manually updated. and can auto-update or dates, but they are done
and patch levels Devices in active use request an update as the via proprietary proto-
with the intention also need be taken out of need arises. cols and approaches.
of improving their service to be manually Ideally, an indus-
safety and security. updated. try-wide stand-
ards-based interoper-
able approach can be
developed and adopted
(see Annex B).
Device cannot be updat- Devices can actively mon- This can be difficult
ed to a new OS level be- itor their SW/FW status in practice especially
cause the manufacturer and can auto-update only on mobile platforms
has not yet verified and when the update has been such as iOS or Android
released it for deploy- authorized by the manu- where multiple apps
ment. facturer have different depend-
encies on the underly-
ing operating system
(OS).
3. MH apps are MH apps on Android MH app updates need to Support of an open
always at the latest or iOS platforms have be synchronized with approach to acquiring
software releases the ability to update connected sensor/device and updating connect-
and patch levels their SW. There can be SW and FW. ed sensor/device SW or
with the intention challenges if there are FW, or both.
In some cases, the update
of improving their compatibility issues
will need to be delayed. In
safety and security. with connected sensors/
other cases, the app can
devices.
update the sensor/device
SW and/or FW.
4. Selection of It is not possible to Given the rapid increase Users require a con-
appropriate apps assess the millions of in the number and the sistent way of labelling
when there are mobile health apps in variable quality of mobile mobile health apps in
millions to choose an objective manner. health apps, users and order to better com-
from. Information such as professionals need some pare them. Ideally, they
app support for privacy, way of assessing these would be evaluated by
security, etc. is very apps in a consistent independent parties
difficult to obtain. manner, especially in to provide users with
the areas of privacy and objective feedback.
security.
a
https:// www .fda .gov/ medical -devices/ unique -device -identification -system -udi -system/ udi -basics

TTabablele 1 1 ((ccoonnttiinnueuedd))
Challenge Current state Desired state Gap/need
5. Track device usage, Most devices are Devices can also be Although there are
status for recall or tracked by association tracked via a globally unique device identifi-
infection control with other devices at a unique ID which can help cation (UDI) schemes
purposes. location. When they are trace the device as well as in Europe, the United
moved that information understand its prove- States, China, etc., there
is lost. nance. are no requirements for
electronic reporting of
the UDI (unique device
a
identifier) .
6. Integrators of Medical devices are typi- Standards are written to Standards that explic-
RCC-MH solutions cally tested for conform- support easy conformity itly support conformity
need to understand ity with IEC 60601 series assessment and discovery assessment.
which standards the and ISO/IEC 80601 se- of appropriate devices
Device registries that
components comply ries standards. Conform- including apps and appli-
include conformity
with. ity testing with other cations.
details.
standards is very rare
and difficult to uncover.
7. Regulatory From a regulatory per- Devices that can demon- Regulatory recognized
approval of RCC- spective conformity and strate interoperability certification bodies
MH components certification of a device’s and/or cybersecurity cer- that can attest to device
takes advantage cybersecurity and in- tifications benefit from conformity with specif-
of uniform teroperability functions a regulatory oversight ic standards.
conformance does not currently bring perspective. Certified
Acceptance of certifica-
testing approaches any additional benefits interoperable devices can
tions by the regulatory
and product to the manufacturer. claim compatibility with
bodies.
certification. other certified devices
For example, 1:1 pair-
conforming with the
wise testing is required
same standards.
in order to claim
interoperability for a An example would be the
specified use. FDA ASCA scheme (see
Annex L).
a
https:// www .fda .gov/ medical -devices/ unique -device -identification -system -udi -system/ udi -basics
7.3 RCC-MH challenges and gaps − Deployment
Table 2 includes the current challenges, current states, desired states and resulting gaps and needs related
to the deployment and operation of RCC-MH solutions.

Table 2 — RCC-MH Challenges, gaps and seeds − Deployment
Challenge Current state Desired state Gap/need
8. Elimination of inter- System component Components can automat- This is a complex topic
and intra-system (device, smartphone, PC, ically check the compat- that is not currently
dependencies that etc.) updates can break ibility of updates with addressed, potentially
prevent SW/FW or affect the perfor- other components being leading to unsafe up-
updates or break mance of the app or used. dates or an inability to
integration when application. do any updates.
updat
...