Digital health regulators

Identify the regulators involved in digital health and how they interact with your project.

There are many players involved in regulating the healthcare sector, including

  • the central administrations of the Ministry of Solidarity and Health (DNS, DSS, DGOS, etc.),
  • regional health agencies (ARS),
  • public operators (ANS, ANSM, ANSSI, CNAM, etc.)
  • independent institutions (HAS, CNIL, etc.).

Many of them are involved in the digital health sectorand it is therefore important for any innovation promoter to identify them, distinguish the missions of each and the point at which they intervene in the development cycle of a digital solution or even meet with them where appropriate.

At national level

  • DNS (ministerial delegation for digital health)

    Consult the DNS data sheet

  • ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé - French Agency for the Safety of Medicines and Health Products)

    The ANSM is in charge of market surveillance for healthcare products, includingmedical devices (MD)

    .
    Consult the ANSM fact sheet

  • ANS (digital health agency)

    The ANS creates the conditions for the development and regulation of digital healthcare. It builds urbanization, security and interoperability reference systems.

    Consult the ANS fact sheet

  • The HAS (French National Authority for Health)

    The HAS evaluates healthcare products with a view to their reimbursement by social security.

    As part of this mission, it can produce best-practice guidelines for innovation promoters aimed at promoting appropriate evaluation approaches.

    Consult the HAS data sheet

  • CNIL (Commission Nationale Informatique et Libertés)

    The CNIL is the regulator of personal data and as such supports professionals in their compliance and responds to requests from individuals who have problems exercising their rights.

    Consult the CNIL fact sheet

At regional level

  • ARS (regional health agencies)

    As regulators and funders of the regional healthcare system, ARS in conjunction with their GRADeS are closely involved in the deployment of digital health on a regional scale.

    As such, ARS and GRADeS are the relevant interlocutors for finding out about e-health projects and priorities on a regional or local scale.

    Consult the ARS fact sheet

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