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

Gründner J, Kurscheidt M, Overton P, Semler SC, Prokosch HU, Ganslandt T (2026)

Publication Type: Journal article

Publication year: 2026

Journal

Studies in Health Technology and Informatics IOS Press

Book Volume: 336

Pages Range: 1440-1445

DOI: 10.3233/SHTI260447

Abstract

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.

Authors with CRIS profile

Julian Gründner Lehrstuhl für Medizinische Informatik Hans-Ulrich Prokosch Lehrstuhl für Medizinische Informatik Thomas Ganslandt Lehrstuhl für Medizinische Informatik

Involved external institutions

Hochschule Heilbronn DE Germany (DE) TMF – Technologie- und Methodenplattform für die vernetzte medizinische Forschung e.V. DE Germany (DE)

How to cite

APA:

Gründner, J., Kurscheidt, M., Overton, P., Semler, S.C., Prokosch, H.-U., & Ganslandt, T. (2026). Medical Informatics Initiative and the German Portal for Medical Research Data: Alignment with EHDS Regulation. Studies in Health Technology and Informatics, 336, 1440-1445. https://doi.org/10.3233/SHTI260447

MLA:

Gründner, Julian, et al. "Medical Informatics Initiative and the German Portal for Medical Research Data: Alignment with EHDS Regulation." Studies in Health Technology and Informatics 336 (2026): 1440-1445.

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