European Reimbursement Process Overview of Digital Medical Device

OBJECTIVES: Our research reviews reimbursement modalities for AI-based SaMD, E-health, and other DMDs, aiming to: 1) identify dedicated reimbursement paths for these digital technologies, and 2) determine if general medical device reimbursement routes or innovation funding can accommodate digital technologies. The research includes nine European countries: United Kingdom, Germany, Spain, Italy, France, Sweden, Poland, Croatia, and the Netherlands.

METHODS: We investigated the literature, including country-specific publications, official Health Authorities websites and conducted expert interviews.

RESULTS: Our research finds significant disparities in the implementation of reimbursement pathways for digital health technologies across Europe. The UK exhibits the most comprehensive approach, whereas France and Germany have dedicated pathways with limited scopes (patient-use DMD and tele-monitoring in France; "DIGA" apps in Germany). Reimbursement for AI-based technologies is still unclear in these countries. Sweden and the Netherlands focus on remote care with no specific reimbursement routes, while Spain and Italy lack structured pathways despite having DMD evaluation frameworks. Poland shows efforts in progress but faces uncertainties, while in Croatia, there is no clear access to reimbursement for DMDs.

CONCLUSIONS: Digital devices, integral to modern healthcare, still lack clear reimbursement measures for timely market access and effective integration. Patient apps and remote care have clearer reimbursement paths in some markets, but in most countries, there are no processes for AI-based SaMD. Our findings also underscore the need for further development and harmonization, including reevaluating funding models, ensuring equitable access to digital medical innovations across Europe.