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.
gematik explains ePA data protection and security architecture, confirming that only patients and authorised medical personnel can access records through Germany's secure health network.
gematik (German Digital Health) · GermanyWorking 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 · GermanyG-BA introduces a new U10 preventive health examination for children and integrates J1 adolescent screening documentation into the Yellow Booklet.
G-BA (Federal Joint Committee) · GermanyG-BA adds left heart catheterisation to the physician second-opinion programme and expands access pathways for patients.
G-BA (Federal Joint Committee) · GermanyG-BA found insufficient evidence to extend organised colorectal cancer screening to younger individuals with familial risk.
G-BA (Federal Joint Committee) · 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) · GermanyIQWiG General Methods 8.0 entered force in December 2025, introducing new methods for hospital minimum volume standards and HTA assessment.
IQWiG (German HTA) · GermanyPressemitteilung des Innovationsausschusses beim Gemeinsamen Bundesausschuss vom 21. August 2026.
G-BA (Federal Joint Committee) · 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) · GermanyIQWiG publishes Cancer Medicines Forum workshop results proposing a roadmap for systematic implementation of cancer treatment optimization studies.
IQWiG (German HTA) · GermanyIQWiG received six commissions from the Federal Ministry of Health to develop scientific recommendations for minimum volume standards in hospital care under the German Hospital Reform Act 2024.
IQWiG (German HTA) · GermanyIQWiG notes linvoseltamab received conditional marketing authorisation in April 2025 but comparative evidence is lacking until 2026.
IQWiG (German HTA) · GermanyRegeneron recalls one batch of Libtayo (Cemiplimab) 350 mg due to a sealing defect in the vial.
Paul-Ehrlich-Institut · GermanyIQWiG's benefit assessment of lecanemab for early-stage Alzheimer's disease, based on previously unpublished manufacturer data, finds no proven added benefit over current standard care.
IQWiG (German HTA) · GermanyIQWiG completed the first joint clinical assessment under the new EU HTA process for tovorafenib in paediatric low-grade glioma, approved by the Member State Coordination Group.
IQWiG (German HTA) · GermanyIQWiG determines considerable added benefit of trastuzumab deruxtecan for HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma based on DESTINY-Gastric04 trial.
IQWiG (German HTA) · Germany