2023-05-09 11:05:43
Article 58 of the LFSS for 2022 created a device specific to digital medical devices, CE marked, presumed to be innovative :
- either at therapeutic aim upstream of coverage on the list of reimbursable products and services (LPPR);
- either remote monitoring upstream of coverage on the list of remote medical monitoring activities (LATM).
Early digital support is planned for a delay one year non-renewable. In particular, it is conditioned a positive assessment by HAS and compliance of the digital medical device (DMN) with the interoperability and safety standards established by the Digital Health Agency. These two assessments will be made concurrently once the ministers have acknowledged receipt of the complete file.
Terms of deposit
The request for early digital support is requested by the operator of the digital medical device (DMN) within the meaning of Article L. 165-1-1-1 of the Social Security Code, with the Ministers responsible for Health and Social Security. A copy of the request is simultaneously sent to the CNEDiMTS.
The description of the application procedure is available on the HAS website.
The elements relating to obtaining a certificate of compliance of the DMN with the interoperability and security reference systems are sent to the ANS.
For any request, the list of information required includes:
- the description of the medical telemonitoring activity or of the DMN for therapeutic purposes in the claimed indication;
- the presumed innovative nature of the DMN or remote monitoring activity, in particular in terms of clinical or organizational benefit according to the first available data and taking into account any relevant comparators;
- if the DMN is likely to bring progress in the organization of care, this progress must not alter the quality of care;
- the DMN is the subject of ongoing studies which are presumed to provide sufficient data for the CNEDiMTS to be able to issue an opinion on the request for reimbursement under the LPPR within 6 months or of the LATM within 9 months ;
- the target population that can benefit from early digital care;
- the elements relating to obtaining a certificate of conformity from the DMN to the interoperability and security reference systems;
- economic elements (see framework of the filing guide).
Reference texts:
Application texts:
- The Conseil d’Etat decree relating to the early coverage of digital medical devices for therapeutic purposes and medical telemonitoring activities by health insurance under Article L. 162-1-23 of the Safety Code social.
Useful links and documents:
- Link for filing a file with the ministers responsible for health and social security on the EVATECH platform
- Link for filing a file with the ANS
- General presentation of the deposit process on the G_NIUS platform
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