[2025-09-10] On September 10, 2025, France’s HAS (Haute Autorité de Santé) published a press release setting out the principles for evaluating Digital Medical Devices (DMDs).
This press release, entitled “Dispositifs médicaux numériques : la HAS explicite ses principes d’évaluation” (Digital medical devices: the HAS clarifies its evaluation principles), reviews the two reimbursement channels dedicated to certain DMDs. With just over two years’ experience of submitting reimbursement files for these devices, the HAS has clarified the expectations for improving the quality of files.
The “LATM” reimbursement route
This is the standard reimbursement route for remote medical monitoring activities based on DMDs.
To be eligible for inclusion on the list of telemedical monitoring activities (LATM), one condition must be met: the benefit must be greater than that of conventional medical monitoring in the indication(s) indicated (or be equivalent to or greater than that of a telemonitoring activity already registered in the same indication(s)).
The HAS specifies that particular attention is paid to organizational impact, a major issue in the transformation of healthcare organizations.
The guide named “Principes d’évaluation de la CNEDiMTS Volume 2 : Prise en charge via la liste des activités de télésurveillance médicale (LATM)” (CNEDiMTS evaluation principles Volume 2: reimbursement through the list of medical remote monitoring activities) explains the different scenarios and required elements used to assess the benefit of the telemonitoring activity submitted for evaluation.
The “PECAN” refund channel
This is the derogatory reimbursement route, allowing early reimbursement of presumably innovative DMDs. This route can be used at a stage where clinical studies are not yet fully completed, but where it is already possible to presume the interest of the device.
This pathway covers both remote monitoring activities and therapeutic DMDs.
Here, HAS stresses the importance of the quality of ongoing studies and their methodology in the assessment of dossiers. As with the LATM route, the organizational impact must be highlighted and documented.
The guide “Principes d’évaluation de la CNEDiMTS Volume 4 : la prise en charge anticipée des dispositifs médicaux numériques (PECAN)” (CNEDiMTS evaluation principles Volume 4: anticipated reimbursement of digital medical devices) sets out all the evaluation principles for this reimbursement route.
Conclusion
The summary table at the end of the press release identifies the different options available for each system.
The two guides issued by the “Commission nationale d’évaluation des dispositifs médicaux et des technologies de santé (CNEDiMTS)” are detailed enough to identify the strengths to be highlighted when preparing reimbursement files, depending on the route chosen. These guides are intended to evolve over time, notably following joint work with the HAS’s German counterpart in the context of European regulations.
In addition, a replay of the webinar “ Presentation and discussion of DMD evaluation principles” held on September 16, 2025 (duration 1 hour), is now available.
Article written by Karim Chelly, member of the DMEXPERTS network.