· Dec 14, 2022

Entry into common law of remote monitoring: regulatory texts published before the end of the year

The texts relating to the entry into the common law of remote monitoring, initially planned for July 1, 2022 and postponed to July 1, 2023, must be published in the Official Journal "before the end of the year" said Wednesday the Ministerial Delegation for Digital Health during the Council of Digital Health (CNS).

Currently, the publication of three decrees setting interoperability standards and tariffs is still awaited. Two decrees will set the requirements for interoperability standards and the evaluation procedures for access to the market (reimbursement).

Windows driven by the Digital Health Agency (ANS) will be open "in certifying mode", starting in the first quarter of 2023 (ANS certification).
A window of the High Authority for Health (HAS) will also be opened "in brand name" from the first quarter of 2023.

Concerning the anticipated reimbursement of digital medical devices with a therapeutic purpose, the referral of the draft text to the Council of State "is underway". A launch is "envisaged in the first quarter of 2023 with the implementation of ANS (certification on the interoperability and safety reference system) and HAS (clinical evaluation) windows".