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.
Working group recommends criteria and priorities for digitising paper-based healthcare and care processes under the 'Gemeinsam Digital' strategy.
gematik (German Digital Health) · Germanygematik publishes guidance on implementing and using KIM (secure healthcare email) in care facilities, based on pilot experience in Hamburg region.
gematik (German Digital Health) · GermanyDiGA manufacturers must implement continuous performance measurement (AbEM) and report to BfArM; up to 20% of reimbursement price becomes outcome-dependent.
BfArM DiGA Fast Track · GermanyDiGA reimbursement shifts to outcome-based pricing with up to 20% contingent on demonstrated healthcare effects; insurer activation codes reduced to 2-day requirement.
BfArM DiGA Fast Track · GermanyePA apps are receiving updates enabling push notifications for patient activity, allowing users to control alerts about record access and document uploads.
gematik (German Digital Health) · GermanyShareholders mandate gematik to create a roadmap for consolidating and unifying the operation of core Telematic Infrastructure components.
gematik (German Digital Health) · GermanyAnnual survey of 5,000 healthcare facilities and 1,400 insured persons shows electronic patient record adoption at 70% in practices and 50% in hospitals, with TI-Gateway improving stability.
gematik (German Digital Health) · GermanyOver 300 representatives from manufacturers, providers and partner organisations met at the TI-Forum 2026 to discuss operation, security and future development of Germany's Telematic Infrastructure.
gematik (German Digital Health) · Germanygematik announces final deadline for healthcare professionals to exchange digital credentials (Heilberufsausweise).
gematik (German Digital Health) · GermanyNew information and updates on our website. New information in the topic medicinal products New information in the topic licensing New information in the topic clinical trials New information in the topic Pharmacovigi...
BfArM (Federal Institute for Drugs) · GermanyUntil 2024, the “BfArM4Health” blog provided insights intoBfArM’s work and key developments in healthcare. Experts introduced their areas of responsibility and presented selected projects.
BfArM (Federal Institute for Drugs) · GermanyHere you will find all statistics listed in the topic Licensing. Processing Statistics Marketable Medicinal Products in the Responsibility of theBfArM Statistics "Complementary and Alternative Medicines and Traditiona...
BfArM (Federal Institute for Drugs) · GermanyWe move forward - since 1994! In 2024 the Federal Institute for Drugs and Medical Devices (BfArM) celebrated its 30th anniversary. Since 1994, the agency is working to ensure the efficacy and safety of medicinal produ...
BfArM (Federal Institute for Drugs) · GermanyThe publications of the Federal Institute for Drugs and Medical Devices offer a further source of information. Annual reports of the Federal Institute for Drugs and Medical Devices
BfArM (Federal Institute for Drugs) · GermanyPressemitteilung des Innovationsausschusses beim Gemeinsamen Bundesausschuss vom 17. Juli 2026.
G-BA (Federal Joint Committee) · GermanyPressemitteilung des Innovationsausschusses beim Gemeinsamen Bundesausschuss vom 10. Juli 2026.
G-BA (Federal Joint Committee) · Germany