Overview of Digital Health Regulations

As a reminder, according to the CNIL, a health data is any personal data related to the physical or mental health of an individual, whether past, present, or future. All digital tools, connected devices, and medical devices may use, process, or store such personal medical data. If your innovation falls into this category, you must comply with strict security standards to ensure the protection of personal and health data of patients.

This section of the website lists all regulatory topics applicable to digital health in the form of educational fact sheets. All these regulations stem from the ministerial roadmap aimed at accelerating digital health and are categorized by functionality:

Security Domain

This includes regulations related to secure connection services (ApCV – Carte Vitale Application, e-CPS, Pro Santé Connect), the General Data Protection Regulation (GDPR), regulations concerning directories and reference systems in the medical field (ROR, RPPS+, FINESS+), health data hosting regulations (HDS), the regulation of the National Health Identifier (INS), Secure Health Messaging for professionals and citizens (MSSanté), the general policy on health information systems security (PGSSI-S), and regulations for medical devices.

Interoperability Domain

This domain includes the Health Information System (SIS), which sets the rules for communicative health IT, the Health Terminology Management Center (CGTS), which provides free access to semantic resources in the health and social sectors, and the Multi-Terminology Server (SMT), a tool for distributing and managing health terminologies.

Core Services Domain

Covers basic services such as the Shared Medical Record (DMP), which serves as a digital health notebook, e-Prescription, which digitizes the prescription circuit, and once again, secure health messaging for professionals and citizens (MSSanté).

Digital Platforms Domain

This includes a suite of services giving healthcare professionals unified access to various tools, the Health Data Hub which facilitates access to health data for innovative projects of public interest under strict security and in compliance with citizens' rights, and Mon Espace Santé (MES), a personal space where users manage their health data.

How can G_NIUS help me better understand regulatory topics?

The regulatory framework varies depending on the nature of your innovation project (medical device, digital application, care service…), the technologies used to process and/or store personal data, and the end users (healthcare professionals, care institutions, general public…).

The National Digital Health Innovation Desk (G_NIUS), a collaboration between the Ministry’s Digital Health Delegation (DNS) and the Digital Health Agency (ANS), serves as a showcase for risk prevention related to the use of health data in digital innovation projects. Our platform helps you understand the legal framework to follow for your medical project by offering a toolbox that includes a personalized diagnostic and educational fact sheets, all aimed at accelerating your medical solution’s time to market.