Highlights
- 2024-01-17 16:17 Germany, the world’s third-largest medical technology market behind the US and Japan, boasts a mammoth industry worth €33.6 billion annually. Numbering over 250,000 employees, it is Europe’s largest market. The German Federal Ministry of Health introduced two key regulations in June 2023: the Health Data Use Act (GDNG) and the Digital Act (DigiG). The GDNG grants industry access to patient health data for research, priming Germany for pricing and the European Health Data Space (EHDS). DigiG revises pricing and reimbursement rules for Digital Health Apps (DiGA). DiGAs currently qualify for enhanced reimbursement depending on performance and success criteria. Contracts must include a 20% performance-based price element, utilising real-world data for assessment. Telemedicine applications in Germany will expand under the DigiG. In 2023, Germany has already embraced 40 digital health solutions qualifying for statutory health insurance reimbursement, setting a European benchmark.