Assessment of Digital Medical Devices by the HAS
Following the publication of the decree of December 30, 2022, which opens the way for the reimbursement of remote medical monitoring activities under the common law in France, the HAS has announced the creation of a one-stop shop that will be accessible via the EVATECH platform (link available soon), which will be open for the submission of all applications for inclusion on the list of remote medical monitoring activities for reimbursement and, as soon as the ad hoc decree is published, for early reimbursement (PECAN).
The application must be filed with the CNEDiMTS and the ministers of health and social security, in a dematerialized manner via the EVATECH platform. In order to submit files in the current versions, a filing guide as well as the matrix necessary to build a file will be put online soon.
For this activity dedicated to digital medical devices, the HAS also offers companies who wish to do so support via pre-submission meetings and early meetings.
As a reminder, an exciting webinar presented by MediTech Access about the developments of digital health in France is scheduled for January 25, 2023. It will address the following topics :
- New fast-track solution
- Permanent reimbursement process for remote monitoring
- Therapeutic digital solutions
- Organisational benefits
Want to know more on Digital health Market Access in France ? Do not miss our webinar on January 25th !
Zoom conference access link