Digital Health in Germany
- Soledad
- Mar 27
- 2 min read
Why Germany is a Prime Market for Digital Health
Germany is Europe’s largest healthcare market, with over €498 billion in healthcare spending and a rapidly expanding digital health ecosystem. With a highly structured reimbursement system, strict data protection laws (GDPR), and evolving AI regulations, companies need a clear strategy to successfully enter the market.
Key Regulatory & Market Access Considerations
📌 1️⃣ Regulatory Approval: MDR, IVDR, and AI Act Compliance
All digital health solutions must comply with:
✔ Medical Devices Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR)
✔ AI Act (for AI-powered medical software)
✔ GDPR & cybersecurity standards (ISO27001, BSI TR-03161)
📌 2️⃣ Reimbursement Pathways: How to Get Paid in Germany
🔹 DiGA Fast-Track – Digital health applications (DiGA) can be reimbursed by statutory health insurers after approval by BfArM.
🔹 G-DRG & OPS Coding – For hospital-based solutions, integration into the Diagnosis-Related Groups (G-DRG) system is crucial.
🔹 Medical Aids Directory – For assistive devices and long-term care solutions, reimbursement is possible through GKV-Spitzenverband.
🔹 Selective Contracts – Custom agreements with insurers for non-standard treatments and digital therapies.
📌 3️⃣ Strategic Market Entry: What Startups Need to Consider
✅ Understand the German insurance landscape – Over 100 statutory health insurers (SHIs) and a strong private insurance sector (PHI).
✅ Develop strong clinical evidence – Even with a CE mark, insurers require proof of real-world effectiveness.
✅ Leverage regional innovation hubs – Healthy Hub, MedTech Cluster, and federal state funding programs can help accelerate adoption.
How AF Pharma Helps Digital Health Startups Enter the German Market
🔹 Regulatory compliance (MDR, IVDR, AI Act, GDPR)
🔹 DiGA & hospital reimbursement support
🔹 Negotiation with insurers and healthcare stakeholders
🔹 Market strategy for digital health expansion
📩 Need expert guidance? Contact us at www.afpharmaservice.com.
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