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Germany's Data-Driven Healthcare: EHDS and AI Regulations Drive Transformation

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July 4, 2026Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)

Summary

Germany is advancing the construction of a data-driven healthcare system based on the European Health Data Space (EHDS) and EU AI regulations. It aims to standardize and securely share data through the introduction of electronic patient records (ePA) and national data centers.

Details

The German government is accelerating digitalization in healthcare through the Digital Law (DigiG) and the Health Data Utilization Act (GDNG). Key initiatives include the planned rollout of the electronic patient record (ePA), expected from around 2025, alongside the e-prescription (eRezept), strengthening the data foundation. The core of this effort is building standardized data sharing infrastructure. University hospitals are linking data using standard models like HL7 FHIR via initiatives such as MII. The European Health Data Space (EHDS) aims for secure circulation of medical data across Europe, serving both direct patient care and secondary use for research/innovation. The AI Act classifies medical AI as 'high risk,' mandating providers to demonstrate strict data governance, traceability, and continuous monitoring. This requires high reliability when implementing systems. Furthermore, based on GDPR, anonymization and minimal data usage are enforced, with all access logged. These developments aim to eliminate information silos in healthcare IT and enable cross-regional data sharing, emphasizing compliance with international healthcare standards.

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