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 for CNEDIMTS filing and application for reimbursement by the French Health Insurance Fund.

Project leaders and innovation supporters have difficulty finding their way around the various existing methods that allow them to provide proof that their digital medical device has real benefits.

This lack of knowledge in terms of methodological expectations can lead to poorly designed clinical studies, and ultimately to negative evaluations by the authorities.

Creating a step-by-step guide on G_NIUS will inform project leaders while also enabling those who support and finance innovation to guide their project leaders starting from the early stages of development (e.g.: when the first subsidies are granted, for example).