German health regulation is spread across several federal bodies. BfArM authorises and monitors medicines and medical devices and runs the DiGA fast-track for reimbursable digital health applications, the Paul-Ehrlich-Institut oversees vaccines and biomedicines, and the Gemeinsame Bundesausschuss sets reimbursement and benefit rules.
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) · Germany