Requirements for taking on a remote medical monitoring activity

This new framework requires companies operating digital medical devices (DMNs) to comply with the security and interoperability obligations laid down by the Agence du Numérique en Santé (ANS) and to obtain a certificate of compliance with the interoperability and security guidelines for remote monitoring DMNs in force.
To be registered for reimbursement, remote monitoring solutions will be assessed by the CNEDiMTS, a specialized commission of the Haute Autorité de santé (HAS).

Telemonitoring players are supported in their efforts to obtain reimbursement for their solution:

• As of August 2022, the ANS has opened a guichet to enable manufacturers to anticipate their procedures and start submitting their evidence;
• The HAS offers companies support in putting together their dossier (pre-filing appointments or early meetings), which they can then file on a dedicated platform (contact: guichetnumerique@has-sante.fr);
• G_NIUS guides project developers in understanding the applicable regulations and the ecosystem.

In parallel, several windows of the France 2030 "Digital Health" acceleration strategy provide financial support for medical device manufacturers to set up a quality process, obtain CE marking or develop a clinical (or medico-economic) investigation, and thus achieve the level of requirements required for market access. To this end, the acceleration strategy has launched the guichet Diagnostic Médical operated by Bpifrance and endowed with €20M.

Continuity of support assured from the ETAPES experiment to the new common law until July 1, 2023

Until July 1, 2023, experimenters involved in ETAPES will continue to benefit from the financial coverage provided under the experiment, for patients already included as well as for new patients, provided that the operators concerned send the Ministry (dss-sd1C@sante.gouv.fr) and the HAS a commitment to file a registration application by January 31, 2023 at the latest.
Framework decrees on remuneration for operators and digital solutions will be published shortly.