Launch of early payment for digital medical devices
Financing
31/03/2023
A one-year springboard to health insurance reimbursement
The anticipated reimbursement of digital medical devices (PECAN) enables operators to benefit for one year from a flat-rate reimbursement by the Assurance maladie for a medical device, provided it is prescribed by a doctor.
This one-year derogation period gives operators the opportunity tobegin operational deployment while finalizing their application for reimbursement under ordinary law. This application must therefore be submitted before the end of the derogation period in order to perpetuate the reimbursement of the digital medical device.
This innovative and long-awaited device is part of the "Digital Health" acceleration strategy.It was opened up by the social security financing law 2022.
Thedecree of 30/03/2023 specifies the terms and conditions, and now allows operators to submit their applications.
Accelerated assessment to obtain special funding
Who is eligible?
PECAN is aimed at presumably innovative digital medical devices:
- with a therapeutic purpose that are intended to be registered on the list of reimbursable products and services (LPPR);
- or allowing a remote medical monitoring activity and which are intended to be registered on the new list of remote medical monitoring activities (LATM).
Check if your device is eligible
What are the prerequisites for applying?
Applicant devices must demonstrate a certain level of maturity:
- Benefit from a valid medical CE mark, whatever the risk class;
- Provide initial results from clinical studies to assess the solution's potential benefit (clinical and/or organizational benefit);
- Be compliant with the RGPD and the MND interoperability and security repository;
These last two points aim to guarantee the exchange, sharing, security and confidentiality of patient health data with a view to more personalized medicine.