The framework for developing and regulating digital healthcare

The regulation of digital health aims to implement a legal, organizational and technical framework to develop the uses of digital services, through the sharing of health data, between patients and professionals.

This framework is based on the following principles:

  • The development of packaged sector-specific repositories fed by thematic repositories based on core rules (interoperability, ethics, security), identity core services (INS, Pro Santé Connect, etc.) and exchange core services (MSS, etc.).
  • The establishment of governance with the participation of ENSs and their federations in the development of repositories, with a systematic consultation period.
  • A legislative and regulatory framework to make the standards applicable and award certificates of conformity.
  • The opening of windows to enable ENSs to apply for certification/referencing schemes
  • Reinforced support from the public authorities throughout the application process.

This means that Digital Healthcare Companies must :

  • Guarantee their users the quality and smooth operation of their services, with verification of their compliance with ethical, interoperability and security requirements during certification procedures, or a posteriori during compliance audits;
  • Contribute to the development and collective improvement of repositories, while retaining their capacity to innovate for the development of new services;
  • Obtain certifications for patient reimbursement by Health Insurance (digital medical devices for remote monitoring) and referencing to finance state-of-the-art version upgrades (Ségur du numérique en santé).

To meet the expectations of professionals and patients :

  1. Simplify the daily use of digital services to avoid re-entering the same data, guarantee the digital identity of players;
  2. Strengthen trust in digital servicesby enabling patients or professionals to identify digital services that comply with interoperability, security and ethical guidelines, examples: Ségur-referenced digital services, certified digital medical devices;
  3. Benefit from digital equipment grants for healthcare professionals (funding for upgrades, software, etc.) and/or reimbursement by the Assurance Maladie for patients.

The framework and tools for regulating digital health :

Governance of digital health regulation:

The legislative and regulatory framework for digital health regulation

Article L1470-5

du Code de la santé publique

Article L1470-6

du Code de la santé publique

The life cycle of a sector-specific repository is made up of the following phases:

  • The co-construction of the sector-specific repository with ENSs, professionals and patients;
  • The implementation and issuance of compliance certificates;
  • The obligation to hold a certificate of compliance;
  • The a posteriori audit of certified digital services.

Conformity certification counters :

There are certification windows for compliance with sector-specific standards operated by ANS and by GIE SESAM Vitale for Mon espace santé.

These windows are based on approval and authorization procedures operated by other organizations (for example, the Centre National d'Agrément (CNDA), which verifies the compliance of ENS solutions with Assurance Maladie teleservices (DMPi, INSi, etc.), or the GIE SESAM-Vitale for the criteria of the Mon espace santé service catalog.)

Le Ségur

The ambition of the Ségur du numérique en santé is to generalize the fluid and secure sharing of healthcare data, between healthcare professionals and with the patient, for better prevention, better care and better support. This program corresponds to an unprecedented investment of 2 billion euros, carried as part of the European component of the French recovery plan.

Find out more about SEGUR