Identify the regulators involved in eHealth and how they would interact with your project.
Many players contribute to the regulation of the health sector, including
- the central agencies of the Ministry of Health (DNS, DSS, DGOS, etc.),
- the regional health agencies (ARS),
- public operators (ANS, ANSM, ANSSI, CNAM, etc.)
- independent institutions (HAS, CNIL, etc.).
Several of them are involved in the eHealth sector and it is therefore important for any innovation promoter to know who they are, the differences in what they do, and when they get involved in the development cycle of a digital solution, or even to meet with them if necessary.
At the national level
The DNS (Délégation ministérielle du Numérique en Santé)
The DNS is leading the implementation of the eHealth Roadmap and coordinating all the national and regional institutional players involved.
The ANSM (Agence Nationale de Sécurité du Médicament et des produits de santé)
The ANSM is in charge of monitoring the market for health products, including medical devices (MDs)
The ANS (Agence du Numérique en Santé)
The ANS creates the conditions for the development and regulation of eHealth. It creates IT architecture, security and interoperability frameworks.
The HAS (Haute Autorité de Santé)
The HAS evaluates health products to decide on their reimbursability by Social Security.
As part of this mission, it can produce best practice guidelines for innovation promoters aimed at encouraging appropriate evaluation approaches.
The 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 encounter problems exercising their rights.
At the regional level
The ARS (regional health agencies)
As regulators and funders of the regional health system, the ARS, in conjunction with their GRADeS, are closely involved in the deployment of eHealth at the regional level.
In this respect, the ARS and the GRADeS are relevant contacts for information on eHealth projects and priorities at the regional or territorial level