A decree dated August 21, 2026, amends the cost-sharing provisions for digital medical devices intended for therapeutic use, for telemonitoring, and for the general list of reimbursable medical devices. It takes effect on January 1, 2027.

To clarify: Unlike in Germany, the French public health insurance system generally does not cover the full cost of a service, but only a percentage set by law. The remaining balance is covered by private supplemental insurance, which virtually the entire population—about 95 percent—has, often through their employer. Under standard insurance policies, there is a legal obligation to cover this remaining portion. Patients with a recognized chronic condition are exempt from this copayment, but only for treatments related to that condition. For these patients, the national health insurance system covers 100 percent of the cost.

The following table lists the specific changes—first, from the insurance provider’s perspective, and second, what they mean for patients:

Cost Allocation in France for Digital Medical Devices Intended for Therapeutic Use and Telemonitoring

 

Cost Allocation in France for Digital Medical Devices Intended for Therapeutic Use and Telemonitoring

This also affects the early reimbursement pathway through which the first digital therapy applications are currently being reimbursed in France (PECAN). For manufacturers, it is not the price that changes, but the payer structure: the reliable payer becomes a minority payer. The government health insurance fund is a single partner with a fixed rate and automatic cash flow. In the future, at least half of revenue will come from numerous private insurers, each with their own review processes, rate cycles, and payment terms. The reimbursement amount for the product remains unchanged.

It should also be noted that the decree merely establishes the permissible range. The portion not covered by the state health insurance fund is determined separately by the umbrella organization and currently stands at 40 percent. Since this percentage will fall below the new lower limit starting in 2027, a new resolution setting the rate will be required. The increase to at least 50 percent is therefore mandated by law, but is not automatically implemented by the decree.

Read the decree here: https://www.legifrance.gouv.fr/eli/decret/2026/8/21/2026-810/jo/texte