The public consultation identified a need for information regarding the evaluation methods required to prove the medical, organizational or economic added value of digital medical devices with a view to a CNEDIMTS filing and a request for reimbursement by the Assurance maladie.

Project developers and innovation coaches find it difficult to find their way around the various existing methodologies for providing proof of benefit for their digital medical device.

This lack of knowledge in terms of methodological expectations can lead to poor clinical study design, and ultimately to negative assessments by the authorities.

The creation of a methodological course on G_NIUS will inform project leadersts but will also enable players in innovation support and funding to guide their project leaders from the early stages of development(e.g. as soon as the first grants are awarded, for example).