LS&HC Horizons 2023 - Flipbook - Page 19
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | Digital Health and AI
19
The Italian Ministry of Health issues new guidelines setting forth
requirements and service levels for telemedicine services
By Ministerial Decree of 21 September 2022
and effective from 2 November 2022, new
Guidelines for the design of telemedicine
services by Italian Regions and Autonomous
Provinces were approved (Guidelines).
• health care professionals will be able
to acquire the necessary skills to use
telemedicine services through specific
continuing medical education (CME)accredited training programs.
The Guidelines represent a significant step for
implementing telemedicine services uniformly
throughout the country as they are binding,
unlike the previous ones.
The Guidelines also clarify doubts arising from
previous national guidelines about whether
any software or hardware used in telemedicine
services must be certified as a medical device.
The Guidelines clarify that only software and
hardware that presents a medical device’s
functionality will have to be certified as such.
The Guidelines identify the minimum
technical, organizational and functional
requirements for telemedicine services in
regional frameworks and the competence and
training professionals and users must possess
to benefit from them. In this regard, the
Guidelines provide:
• information/training tools (e.g., video
tutorials, infographics, printed brochures)
and possible coaching activities will have to
be provided to ensure the appropriate use of
all technologies (including medical devices),
safely and independently by the patient and/
or caregiver; and
Giuseppe Aminzade
Counsel, Milan
Therefore, the Guidelines represent an
important document to be considered by
companies wishing to exploit all the business
opportunities related to the provision of
telemedicine products and services.
Chiara Perolari
Associate, Milan
Angelo Forte
Trainee Solicitor, Milan
