Medical Informatics Initiative and the German Portal for Medical Research Data: Alignment with EHDS Regulation

The European Health Data Space (EHDS) requires a large set of harmonized governance regulations and processes as well as a robust technological infrastructure for successful EU-wide health data sharing for secondary use. In Germany, nation-wide data sharing of real-world data from all university hospitals' patient care documentation has been enabled by the Medical Informatics Initiative (MII) and the German Portal for Medical Research Data (FDPG). After the EU EHDS regulation went into force in March 2025, we conducted a comparison between the German MII/FDPG framework and the stipulations set out by the EU, with a particular focus on the responsibilities of data holders and data access bodies. Our results illustrate that the national secondary use research infrastructure established over one decade of MII provides an excellent basis for Germany's path towards the EHDS.