PECAN requirements and opportunities – read the whitepaper now
Digital health applications (DiGA), the apps on prescription, are now also available on the French market. This is because France is adopting the concept, including a variant of the German fast-track procedure – PECAN.
The aim is to create a standardized framework for new and existing providers. German DiGA manufacturers could also strive for an additional reimbursement pathway here. In addition, France is opening up the market for digital medical devices in risk classes IIb and III, while in Germany only products up to risk class IIb are eligible as DiGAs.
France is therefore becoming a particularly attractive market. In our new whitepaper, you can read about the challenges and opportunities for manufacturers entering the French market and how the fast-track system works according to French specifications.
A look at the white paper: Interoperability under PECAN
An interoperability certificate is required for permanent reimbursement. While this certificate is not yet mandatory for provisional listing under the PECAN procedure (Program for Evaluation of Digital Health Applications and Devices), it is required for final inclusion in the List of Reimbursable Products and Services (LPPR).
Furthermore, the requirements for the portability of health data are similarly high as in Germany. Users must be clearly identified and data protection must be particularly guaranteed.
And how does the approval process work?
The fast-track procedure is a two-stage process that is strongly based on the German model. It enables provisional approval and reimbursement before comprehensive clinical evidence is available. And this is how the PECAN approval process works:
- 1
First stage: Application and initial assessment
- 2
Second stage: Early assumption of costs
- 3
Regular check