Digital DM evaluation: watch the replay of the HAS webinar
Regulations
05/10/2023
On September 20, 2023, the HAS organized a webinar onthe HAS assessment of digital medical devices (DMDs), dedicated to manufacturers and consultants.
The objectives are to know the reimbursement pathways and properly prepare your file.
Applying for cover for your digital DM: which route(s) to take?
In 2023, two decrees have opened up dedicated reimbursement channels for digital medical devices (DMDs):
- La prise en charge de droit commun de la télésurveillance médicale (liste des activités de télésurveillance médicale - LATM);
- La prise en charge anticipée des DMN présumés innovants à visée thérapeutique ou de télésurveillance médicale (PECAN).
The HAS has organized itself to respond to the specific features of these activities and accompany manufacturers in their application for evaluation, with a view to reimbursement.
A webinar was organized on September 20, 2023: over 600 people (mainly industrialists and consultants) followed the event live. Speakers presented the scope of assessment of the CNEDiMTS(commission nationale d'évaluation des dispositifs médicaux et des technologies de santé),the legislative framework as well asthe two new reimbursement routes PECAN and LATM (process, eligibility criteria, etc.).
Advice was provided on how to put together one's file for the HAS evaluation (documentation, pitfalls to avoid, support, etc.) and finally, a Q&A session clarified certain points and specifics related to MNDs.
Watch the replay and download presentation support.
Find on le site de la HAS les éléments de contexte pour comprendre l'évaluation des dispositifs médicaux.
