This repository is based on the one adopted on July 25, 2022,applicable to telemonitoring medical devices only, and extends the requirements to all digital medical devices (telemonitoring or for another use).

This updated repository was put out to consultation between August and December 2022. Comments made by operators have been taken into account.

It defines requirements in terms of electronic identification of professionals and users, in terms of health data portability, administration, security and traceability of system data and protection of personal data.

Three criteria must be met:

• Be up to date with medical CE marking obligations for marketing in France;
• Be intended for individual use;
• Integrate a processing of personal health data within the meaning of the General Data Protection Regulation n°2016/679 of April 27, 2016 or involve hosting of personal health data (HDS).

Four different care modalities are possible:

• List of remote medical monitoring activities (LATM);
• Prise en charge anticipée numérique (PECAN);
• Transitional load assessment (TLA);
• List of reimbursable products and services (LPPR).

Opening of the ANS window certifying in brand name

Through the French Social Security Financing Act for 2022, reimbursement for telemonitoring comes under common law. A décret d'application en Conseil d'Etat, issued on December 30, 2022, will determine the terms of assessment, registration for reimbursement in particular.
With the publication of the arrêté interopérabilité et sécurité, the Agence du Numérique en Santé opens up the brand-name window in certifying mode.