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Early coverage scheme for digital medical devices and medical telemonitoring solutions launched in France
On March 31, 2023, the Ministry of Health and Prevention published the Decree in the Official Journal of the French Republic that defines an application process for the early coverage of digital medical devices for therapeutic purposes and medical telemonitoring by health insurance.
Early coverage of digital technologies (PECAN) as a part of the “Digital Health” acceleration strategy allows temporary coverage by the health insurance of presumably innovative digital medical devices for therapeutic purposes (intended to be included on the list of reimbursable products and services, LPPR) or for medical telemonitoring (intended to be registered on the new list of medical telemonitoring activities, LATM).
The temporary coverage is provided for one year with the requirement that companies provide the data necessary for the evaluation of their medical device and that the latter already complies with safety requirements. The whole process of including the technology under early coverage lasts no more than 90 days (60 days for the assessment by the Digital Health Agency (ANS) and the National Authority for Health (HAS) and 30 days for the decision by the Ministry of Health).
When the early coverage is established, manufacturers of digital medical devices for therapeutic purposes have six months to apply for the registration of their device in the LPPR. Manufacturers of medical telemonitoring solutions have to apply for reimbursement through LATM during nine months from the start of the early coverage.
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