Registration in the form of a brand or trade name on the list of medical telemonitoring activities provided for in Article L. 162-52 of the Social Security Code

The list provided for in Article L. 162-52 of the Social Security Code provides for common law coverage of medical telemonitoring activities with:

• specific remuneration for medical telemonitoring operators carrying out medical monitoring via an “operator” package;
• remuneration for the digital medical device (DMN) for medical telemonitoring, and, where applicable, collection accessories via a “technical” package.

registration in the form of a trademark or trade namemodification or renewal of this registration, is requested by the operator of the digital medical device (DMN) for remote medical monitoring within the meaning of article L. 165-1-1-1 of the social security codeto the ministers in charge of Health and Social Security. A copy of the request is simultaneously sent to the CNEDiMTS and to the national professional councils concerned.

CE marking and compliance of the DMN with the safety and interoperability standards established by the Digital Health Agency (ANS) are prerequisites for this support. The certificates will be requested when applying for registration.You can access the ANS certification window here.

Procedures for filing files for filing in the form of a trademark or trade name

For any application for registration, renewal or modification of registration in the form of a trademark or trade name on the list of medical telemonitoring activities, the entire file must be submitted to the ministers responsible for health and safety. social security and the CNEDiMTS in a dematerialized way.

The description of the application procedure is available on the HAS website.

For any request, the list of necessary information includes:

• the description of the remote monitoring activity in the claimed indication;
• the expected interest of the medical telemonitoring activity for the medical service;
• the target population;
• medico-economic elements (see filing guide framework).

You will find here on the HAS website the file framework corresponding to be completed for a deposit.

In accordance with article R. 162-78 of the CSS, you must send a copy of your request to the national professional councils (CNP) mentioned in article L. 4021-3 of the public health code concerned.

The CNPs concerned will also receive the draft CNEDiMTS opinion and the opinion issued by the CNEDiMTS at the end of the contradictory phase (art. R. 162-80 of the CSS).

You will mention a single correspondent who will be the sole recipient and interlocutor of exchanges with HAS and the Ministry of Health throughout the examination of the file.

Reference texts

Article 36 of the LFSS for 2022 amended:

Section 11: Telemedical monitoring (Articles L162-48 to L162-57)

Application texts

• The Conseil d’Etat decree relating to the payment and reimbursement of telemonitoring medical activities
• The simple decree relating to the content of the declaration of medical telemonitoring activities to regional health agencies

Useful links and documentation