Germany operates one of Europe's largest and most structured health systems, with regulation spread across several federal bodies. BfArM authorises and monitors medicines and medical devices, the Paul-Ehrlich-Institut oversees vaccines and biomedicines, the Gemeinsame Bundesausschuss (G-BA) sets reimbursement and benefit rules, and BfArM also runs the DiGA fast-track for reimbursable digital health applications. This page collects the German regulatory updates HealthSignal tracks across these bodies, from official public sources only.
DiGA reimbursement model shifts to outcome-based pricing where up to 20% of price calculated based on demonstrated success. Manufacturers must provide evidence of positive healthcare effects. Streamlined processes: he...
BfArM DiGA Fast TrackDigital health app (DiGA) manufacturers must implement continuous performance measurement and reporting (AbEM system) to BfArM. Results published in DiGA directory. Up to 20% of reimbursement price will be success-bas...
BfArM DiGA Fast Track