Article authored by Geoffroy Lacroix, Soulier Avocats, France
GLE Expert, Health Law
In a series of articles published this month, the Haute Autorité de
Santé (French Health Authority) recalled the materials it has produced in
connection with the deployment of e-health in France.
The French Health Authority has indeed developed tools, guides and
guidelines to support developers of apps and smart devices, practitioners
wishing to set up teleconsultation activities or healthcare professionals
approved industry-specific software solutions and approved databases.
As part of its missions, the French Health Authority contributes to the
development of e-health, an area that covers many applications of information
and telecommunications technologies in the field of health.
In particular, this concerns mobile health (i.e. smart devices and software
applications related to health or well-being), software for health
professionals (including prescription support software or electronic medical
records), telemedicine (including teleconsultation and tele-expertise
activities), or user information.
Regarding mobile health (or “m-health”), the French Health Authority has
produced a set of good practice guidelines for manufacturers and evaluators
(evaluating bodies, consumer associations or medical professional
These recommendations cover apps and smart devices that have no stated medical
purpose. In other words, they apply specifically to apps and smart devices
dedicated to well-being and prevention that are not medical devices.
In these guidelines, the French Health Authority lays down criteria for the
delivery of reliable and quality health content as well as the guarantee of
confidentiality and security of personal data by a health app. or smart device.
These guidelines include 101 good practices divided into five categories:
“informing users” (description and consent), “health content” (design of
initial content, standardization, generated content, interpreted content),
“technical content” (technical design, data flow), “security/reliability”
(cybersecurity and confidentiality) and “usability/use” (usability/design,
In addition to these good practices, the guidelines prepared by the French
Health Authority include a risk matrix that makes it possible to tailor the
level of applicability of these good practices according to the relevant app
and/or smart device. This modulation depends on the main target user
(healthcare professionals, patients, the general public, etc.) and the main
intended use axis (information, prevention, data analysis, etc.).
Regarding the exercise of remote medical practice based on a device that
uses information and communication technologies (telemedicine), the French
Health Authority has, in particular, published guidelines to facilitate the
implementation of teleconsultation, tele-expertise and tele-imaging by
As detailed in a previous article,
the French Health Authority insists inter alia on the need to use
specific IT tools for the exchange, sharing and storage of data, including a
secure health messaging system and a sharing platform guaranteeing the
confidentiality and security conditions required for the processing of health
data. With regard to the conduct of the activities, the French Health Authority
also recommends identifying the patient and knowing his/her geolocation. The
healthcare professional must authenticate himself/herself via a strong
Regarding industry-specific software used by healthcare professionals, the
French Health Authority’s mission is to develop procedures for the
certification of software to support the processes of prescription and
dispensation. This optional certification certifies that the software meets the
quality and safety criteria set out in the guidelines published the French
Health Authority (i.e. patient information, drug information, health product
display, prescription, data security and confidentiality).
Through these work products, the French Health Authority provides tools for
improving professional practices as part of the deployment of e-health in
France. All professionals operating in this industry will also have to ensure
compliance with applicable legal and regulatory provisions, in particular as
regards medical devices, the exchange of information and the processing of
personal health data.
guidelines on health apps and smart devices, French Health Authority (October
Best practice guide for
“the quality and safety of teleconsultation and tele-expertise activities”,
French Health Authority (May 2019); best practice guide for “the quality and
safety of tele-imaging activities”, French Health Authority (May 2019)
Pursuant to Decree No.
2019-856 of August 20, 2019 on the certification of software to assist in the
processes of prescription and dispensation, and the daily allowance in the
event of part-time work for therapeutic reasons, the certification standards
are being updated to take into account the new expected minimum functionalities