Panorama of digital healthcare regulation

As a reminder, according to the CNIL, a health data is data concerning an individual's physical or mental health, past, present or future. Your digital tools, connected objects and medical devices are likely to use, process or store personal health data. If this is the case with your innovation, you need to comply with a strict security framework to ensure the protection of personal data and patient health data.

This part of the site references all the regulatory topics applicable to digital health in the form of educational fact sheets. All these elements of the regulations are consolidated in the ministerial roadmap defined for the benefit of accelerating digital healthcare and are classified according to their functionality:

The security field

This section covers regulations relating to secure connection services (ApCV (Application carte vitale), e-CPS, Pro Santé Connect), the General Data Protection Regulation (RGPD), regulations and national services concerning medical directories and repositories (ROR, RPPS+,FINESS+), regulations concerning the hosting of healthcare data (HDS), regulations concerning the National Health Identity (INS), the general policy on the security of healthcare information systems (PGSSI-S), regulations applicable to medical devices...

The field of interoperability

The interoperability domain consists of the CI-SIS health information systems interoperability framework, which sets out the rules for communicating health information systems, the CGTS health terminology management center, which distributes semantic resources for the health-social sector free of charge, and the SMT Multi-Terminology Server, the tool for disseminating and managing health terminologies.

The socle services domain

Groups all the basic services such as the shared medical record (DMP), which is in fact the digital health record, e-Prescription, which consists of dematerializing the prescription circuit, and finally the secure messaging system for health professionals and citizens (MSSanté).

The field of digital platforms

A bouquet of services gives healthcare professionals one-stop access to several services, the Heath Data Hub, which facilitates access to healthcare data for innovative general interest projects under high security conditions and with respect for citizens' rights, Mon Espace Santé (MES), which is a personal space where users manage their healthcare data.

How can G_NIUS help me better understand regulatory issues?

The regulatory framework varies depending on the nature and purpose of your innovation project (medical device, digital application, healthcare service...), the technologies used for processing and/or storing personal data and its end users (healthcare professionals, healthcare facilities, general public...) etc.

The Guichet National de l'Innovation du Numérique en Santé (G_NIUS), a product of the Délégation ministérielle au Numérique en Santé (DNS) digital healthcare roadmap and operated by the Agence du Numérique en Santé (ANS), is a portal for services and content designed to accelerate the digital shift through the development of urbanized, communicating, interoperable digital services. Our platform helps you to know and understand the legal framework to be respected for your digital project, by offering you a toolbox made up of a personalized diagnostic and educational sheets, all with the aim of speeding up the time-to-market for your digital esanté tool.