Implementing early access to digital medical devices
What is the purpose of the action?
As of 2022, early access for digital medical devices is planned, in order to facilitate the reimbursement access mechanisms
Who is it for ?
• Companies offering digital therapy solutions (DTx)
• Companies offering remote monitoring solutions
During 2022: implementation of the system
The innovation and life cycle of digital MDs is shorter and faster than non-digital MDs. The public consultation highlighted the need for clarity in the mechanisms for access to reimbursement.
The Social Security Financing Act 2022 provides for a new transitional and temporary one-year reimbursement access scheme allowing :
- Ensure rapid acess to innovation
- Require companies to provide the required data for the evaluation of their coverage
It will be restricted, after validation of technical criteria, to digital solutions presumed to be innovative in terms of remote monitoring and digital therapies also known as "digital therapeutics" or DTx.
Second semester of 2022
Launch of early access for digital medical devices