Liège, 20 Décembre 2023 – ComuniCare has been certified by the French Agence du Numérique en Santé (ANS) as a Digital Medical Device (DMD), enabling it to be reimbursed for remote monitoring of four chronic diseases in France.
France is at the forefront in Europe when it comes to funding digital medical applications. Following on from the Telemedicine Experiments for the Improvement of Health Care Paths (ETAPES) program, which came to an end on July 1, 2023, the Official Journal of June 24, 2023 published decrees including four generic telemedicine lines on the list of telemedicine activities as of July 1, 2023. By 2021, ComuniCare had already been officially approved by the French Ministry of Social Affairs and Health as a solution compliant with the ETAPES program specifications.
As early as March 2023, ComuniCare was submitted to the ANS for certification as compliant with the interoperability and security guidelines for digital medical devices as part of its entry into common law. The ANS has verified that the solution complies with the requirements of the interoperability and security repository for Digital Medical Devices of the “Generic Line” pathway, as well as the requirements relating to four chronic pathologies (diabetes, heart failure, respiratory failure, renal failure), and issued the certificates on November 30, 2023.
Medical devices are an integral part of medical care, and those incorporating a digital function can generate a large amount of real-life data, paving the way for more personalized medicine. This data can be used, for example, to reinforce follow-up between two consultations, contribute to therapeutic support, anticipate complications, or improve coordination between healthcare professionals.
Certification of compliance with the interoperability and security standards for digital medical devices is designed to guarantee the exchange, sharing, security and confidentiality of patient health data. It will also enable the system to be reimbursed by the French Assurance Maladie, thereby guaranteeing operators a sustainable level of remuneration.
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