France has just entered a new era of digital health by becoming the very first country in the European Union to introduce the reimbursement of remote medical monitoring solutions.
To obtain reimbursement for their telemonitoring solutions, manufacturers must demonstrate that it brings a benefit to the health of patients or an improvement in the organization of care, excluding any form of experimentation. This decision aims to strengthen the medical follow-up of patients by offering interactive remote care, personalized and coordinated with their place of residence. It also contributes to preventing medical complications, in particular by reducing the risk of hospitalization and therefore by improving the comfort of life.
The assessment of the request for reimbursement of a remote monitoring device is done in two key stages. To obtain reimbursement for its remote monitoring solution, the operator must first confirm compliance with the interoperability and security standards with the Digital Health Agency (ANS). Once this step has been completed, the file will be evaluated by the High Authority for Health (HAS) before registration on the medical telemonitoring list can be made. A diversified choice of routes for operators depending in particular on the nature of the device, the data available on it and the strategic choice of the manufacturer. First, here is what is planned for each course: For the brand name route: · Obtaining ANS certification through the use of the Convergence tool. · Planned opening of the Convergence window for this initial phase.
Generic online course: · Simplified course to meet the requirements of the HAS specifications, including interoperability and safety standards verified by the ANS. · Planned opening in April 2023 of the Convergence platform for this nominal phase.
Early care pathway: · Intended for innovative solutions providing clinical and/or organizational benefits or presenting relevant clinical efficacy with a significant impact. · Funding planned for 1 year to finalize the solution and bring it up to standard. · Accelerated process with parallel processing of ANS and HAS files. Planned opening of the Convergence counter in March 2023. Prices dependent on the clinical impact of the device on the quality of life, morbidity and mortality of patients and regressive in relation to the number of patients treated.