Germany

Fact check: Are information and data in the ePA really secure and cannot fall into the hands of unauthorised persons?

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.

TI-Messenger: Integration into healthcare software systems via new specification

New TI-Messenger specification enables integration into primary healthcare software systems, allowing secure messaging directly within existing practice and pharmacy applications.

Patient portals, primary systems and ePA interoperability: position paper and recommendations

Guidance on integration of hospital patient portals with the electronic health record (ePA) and primary systems in downstream care settings, with process and care pathway recommendations.

New impulse paper provides recommendations for cross-process digital transformation

Working group recommends criteria and priorities for digitising paper-based healthcare and care processes under the 'Gemeinsam Digital' strategy.

New Guide: 'How to' KIM for Care Facilities

gematik publishes guidance on implementing and using KIM (secure healthcare email) in care facilities, based on pilot experience in Hamburg region.

Outpatient psychotherapy: consultation reports to become more informative, digital transmission to be enabled

G-BA amends rules for outpatient psychotherapy consultation reports to improve content and enable digital transmission.

Mammography screening expanded to women aged 45–49 years – G-BA updates early detection programme

G-BA expands the statutory mammography screening programme to include women aged 45–49 years.

Disruptions to Telematikinfrastruktur (TI) connectivity

Connection disruptions to Germany's secure health data network (TI) affecting secunet and RISE connector users; manufacturers releasing updates to resolve.

Bundestag passes emergency care reform

Linnemann: „Diese Reform ist seit vielen Jahren überfällig“

Cabinet approves Care Reorganisation Act

German cabinet approves the Care Reorganisation Act (Pflegeneuordnungsgesetz) to reform the care system.

Early detection in children and adolescents: G-BA introduces new U10 examination and integrates J1 documentation into the Yellow Booklet

G-BA establishes a new U10 preventive health screening examination for children and integrates J1 adolescent screening documentation into the Yellow Booklet.

Organ donation declarations via GesundheitsID increasing: 75% of submissions now digital

Organ donation declarations submitted via GesundheitsID have reached 300,000 total, with 75% of new declarations now submitted digitally through the ePA app.

IQWiG General Methods 8.0: new version in force

IQWiG General Methods 8.0 entered force in December 2025, introducing new methods for hospital minimum volume standards and HTA assessment.

3 Questions for Sebastian Labinski, Head of Cyber Defense Center

gematik's Cyber Defense Center head describes vulnerability detection, threat analysis and protective measures for the German health IT infrastructure.

New functions for the ePA (electronic patient record)

ePA apps are receiving updates enabling push notifications for patient activity, allowing users to control alerts about record access and document uploads.

gematik shareholders decide next steps for modernisation of the Telematic Infrastructure

Shareholders mandate gematik to create a roadmap for consolidating and unifying the operation of core Telematic Infrastructure components.

Physician Second Opinion: G-BA adds left heart catheterisation examinations and expands access options

G-BA adds left heart catheterisation to the physician second-opinion programme and expands access pathways for patients.

G-BA: No reliable evidence for expanding organised colorectal cancer screening to younger persons with family risk

G-BA found insufficient evidence to extend organised colorectal cancer screening to younger individuals with familial risk.

TI-Atlas 2026: Digital applications are anchored in care provision and increasingly delivering added value

Annual 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.

TI-Forum 2026: Building trust together for the further development of the Telematic Infrastructure

Over 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.

Colorectal cancer screening: No informative evidence for adjusting age limits or colonoscopy frequency

IQWiG finds insufficient evidence to change colorectal cancer screening age thresholds or colonoscopy intervals; recommends screening from age 50.

Problems in study implementation often affect patient-reported outcomes

IQWiG guidance on the importance of patient-reported outcomes in clinical trials and benefit assessments, illustrated by asciminib for chronic myeloid leukaemia.

Joint Clinical Assessments: a new chapter in European pharmaceutical policy

IQWiG and LSE researchers discuss the first Joint Clinical Assessment under the EU HTA Regulation and its implications for evidence generation.

Acupuncture for migraine prophylaxis: benefit limited to narrow therapeutic indication

IQWiG assessed manual acupuncture for migraine prophylaxis in adults, finding limited benefit compared with prevention medication and identifying evidence gaps.

Last Call: Healthcare Professional Credentials Exchange Now

gematik announces final deadline for healthcare professionals to exchange digital credentials (Heilberufsausweise).

Innovation Committee: Record number of applications for medical guideline development and advancement projects

The Innovation Committee of the Federal Joint Committee received a record number of applications for project funding to develop and advance medical guidelines.

Skin cancer screening and check-up: G-BA discusses current early detection services

Meldung des Gemeinsamen Bundesausschusses vom 15. Oktober 2026.

Dialogue process on menopause: women's health in focus – strengthening research and care

IQWiG Autumn Symposium 2026: Focus on low-value care

Register now for the IQWiG Autumn Symposium on 20 November 2026 in Cologne! Cost pressures within the health care system are mounting, making the issue of low-value care all the more pressing: but how can medical serv...

Care Structure Commission established

Linnemann: "Pflege muss bezahlbar und zielgerecht sein"

Linnemann: Average supplementary contribution rate remains stable

Three completed funding projects provide insights for better healthcare provision

Pressemitteilung des Innovationsausschusses beim Gemeinsamen Bundesausschuss vom 21. August 2026.

BfArM: News from the divisions

New 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...

Diagnosing and treating hyperlipidaemia in children and adolescents: Innovation Committee project develops S3 guideline

The G-BA Innovation Committee has developed an S3 clinical guideline for diagnosis and treatment of hyperlipidaemia in children and adolescents.

BfArM Blog Archive

Until 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 Statistics: Licensing, Medicinal Products, Clinical Trials and Advice Procedures

Here 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 30th Anniversary (1994–2024)

We 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 Publications

The 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

Conduct disorders in children and adolescents: Innovation Fund project advances S3 guideline

The G-BA Innovation Committee announces that an Innovation Fund project has further developed an S3 guideline on conduct disorders in children and adolescents.

Expert panel highlights opportunities for improving cancer studies

IQWiG publishes Cancer Medicines Forum workshop results proposing a roadmap for systematic implementation of cancer treatment optimization studies.

Completed health services research projects: multimodal concepts for older adults and analyses of guideline-concordant treatment of chronic heart disease

Pressemitteilung des Innovationsausschusses beim Gemeinsamen Bundesausschuss vom 17. Juli 2026.

New Chair Optendrenk: 'Framework conditions for effective project funding becoming more difficult'

Pressemitteilung des Innovationsausschusses beim Gemeinsamen Bundesausschuss vom 10. Juli 2026.

Minimum volume standards in hospitals: the first IQWiG projects have started

IQWiG 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 assessment: linvoseltamab for relapsed or refractory multiple myeloma – unmet evidence need

IQWiG notes linvoseltamab received conditional marketing authorisation in April 2025 but comparative evidence is lacking until 2026.

Dear Healthcare Professional Letter: Ocrevus (ocrelizumab) – new risk of drug-induced liver injury

New safety concern identified for ocrelizumab regarding drug-induced liver injury; liver function monitoring recommended before and during treatment.

Recall: Libtayo (Cemiplimab) 350 mg concentrate for infusion solution, batch 8494100007, quality defect

Regeneron recalls one batch of Libtayo (Cemiplimab) 350 mg due to a sealing defect in the vial.

Cemiplimab for cutaneous squamous cell carcinoma: IQWiG benefit assessment – insufficient follow-up data

IQWiG finds insufficient long-term follow-up data in cemiplimab trials for cutaneous squamous cell carcinoma, echoing prior EMA concerns.

Lecanemab for early-stage Alzheimer's disease: IQWiG benefit assessment concludes no added benefit

IQWiG'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.

Recall: Yimmugo 100mg/ml infusion solution, batch C795316P01

Biotest Pharma recalls batch C795316P01 of Yimmugo (human normal immunoglobulin) 100mg/ml, 100ml vials, expiry 31.08.2028.

EU HTA Regulation: first joint clinical assessment completed (tovorafenib)

IQWiG 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.