🇩🇪 Germany Digital Healthcare: A Transformation Towards "Opt-Out" Connectivity
As of late 2025, Germany's Digital Healthcare sector has moved from a voluntary, fragmented ecosystem to a mandatory, integrated "opt-out" model. Driven by the Digital Act (DigiG) and the Health Data Use Act (GDNG), the German system—traditionally known for its strict data privacy—is now prioritizing nationwide data liquidity to address the challenges of an aging population and a critical shortage of healthcare professionals.
The Three Pillars of German Digital Health
The current digital landscape is defined by three primary technological and regulatory pillars:
1. Electronic Patient Record (ePA) for All
Since January 15, 2025, the ePA (elektronische Patientenakte) has transitioned to an opt-out model. Every individual with public health insurance now automatically receives a digital record unless they explicitly object.
Functionality: It centrally stores diagnoses, medication lists, lab results, and discharge letters.
Access: Patients control access via an app provided by their health insurer, but doctors can now view relevant history by default to prevent dangerous drug interactions.
Research Linkage: Starting mid-2025, pseudonymized data from the ePA is shared with the Health Data Lab at the BfArM to support national medical research.
2. Digital Health Applications (DiGA)
Germany remains the global pioneer in "Prescription Apps" (DiGA). These are CE-certified medical devices that doctors can prescribe, with costs fully reimbursed by statutory health insurance.
Security Standards: As of January 1, 2025, all new and existing DiGAs are subject to heightened data security requirements introduced by the Federal Office for Information Security (BSI), including "app hardening" to protect sensitive health data.
Success-Based Pricing: A new regulation now requires at least 20% of DiGA remuneration to be linked to clinical success and patient outcomes, moving away from flat-fee models.
3. The E-Prescription (E-Rezept) & Telemedicine
The E-Prescription is now the binding standard for all prescription-only medicines in Germany.
Redemption Methods: Patients can redeem prescriptions using their electronic health card (eGK), an app, or a paper printout.
Telehealth Expansion: The previous 30% cap on the volume of video consultations for doctors has been lifted. Furthermore, as of May 31, 2025, pharmacies are authorized to provide assisted telemedical services on-site to help patients navigate digital care.
Key Legislative Catalysts
The rapid acceleration in 2025 is the result of a "Digital Offensive" led by the Federal Ministry of Health:
Digital Act (DigiG): Focused on making digital tools like the ePA and e-prescription a standard part of daily medical care.
Health Data Use Act (GDNG): Facilitates the use of health data for research, creating a decentralized infrastructure with a central data access point at the BfArM.
Hospital Care Improvement Act (KHVVG): Modernizes hospital structures, with digitalization serving as a central pillar for restructuring care and improving efficiency.