GDNG im Praxistest – von Reformanspruch zu Realität und Resilienz (XtraTrack Season 2026)

20-05-2025 16:00

The German Health Data Use Act (Gesundheitsdatennutzungsgesetz, GDNG) aims to strengthen medical research by facilitating data use, reducing bureaucratic burden, and improving cross-sector collaboration. This presentation reports on a pilot application of the GDNG conducted within the BMBF-funded consortium Medical Informatics Hub in Saxony (MiHUBx), using the ambulatory study TeleBPM-Impact as an example. TeleBPM-Impact was the first study in Germany to be submitted to the competent data protection authority on the basis of the GDNG. The presentation traces the regulatory trajectory from the pre-GDNG legal framework through the enactment of the law in March 2024 to its practical implementation. Particular focus is placed on interactions with the responsible data protection authority, the interpretation of Section 6(3) GDNG with respect to the concept of “collaborative research projects,” and the resulting procedural uncertainties and lessons learned. The presentation summarizes the insights gained, discusses the implications for participatory research involving office-based physicians, and derives concrete recommendations for regulatory clarification and nationally consistent procedures in collaborative research projects. In doing so, it provides an empirically grounded assessment of the GDNG in a real-world research context.

The Talk will be given in German

M.Sc. Benny Platte, - Hochschule Mittweida, Fakultät Computer- und Biowissenschaften, Germany

Benny Platte is a researcher at the Institute of Computer and Bioscience at the University of Applied Sciences Mittweida. His research focuses on the participatory integration of office-based physicians into medical research and on the secondary use of telemedical routine data under real-world conditions. A central objective of his work is to enable ambulatory care settings to actively contribute to evidence generation by establishing sustainable methodological, technical, and regulatory frameworks. Within the BMBF-funded consortium MiHUBx, Benny Platte leads the study _TeleBPM-Impact_. The project develops and evaluates approaches for the structured integration of long-term telemedical data from primary care into medical research, with particular emphasis on hypertension management. Physicians are not treated as passive data providers but as equal research partners involved in study design, data interpretation, and publication. This work addresses a structural gap in medical research, as chronic diseases are predominantly treated in the outpatient sector, while research infrastructures are traditionally hospital-centered. A further focus of his research is telemedical data integration and the development of interoperable, privacy-preserving analysis concepts for heterogeneous practice software systems. He has contributed methodological innovations for retrospective studies and digital study support systems that bridge clinical research, routine care, and continuing medical education. Benny Platte brings extensive regulatory expertise from highly regulated environments. He is actively involved in the practical implementation and evaluation of the German Health Data Use Act (Gesundheitsdatennutzungsgesetz, GDNG) and is a member of the TMF Task Force GDNG, contributing to the assessment and design of research-friendly regulatory processes for the ambulatory sector. Before entering academic research, he worked for many years in industry as a development engineer and project manager for complex measurement systems and ran his own engineering office as a developer and consultant. During his studies in electrical engineering, he had already been involved from mid-degree onward in the development of medical measurement technology, thereby establishing an early link between engineering practice and healthcare applications. Prior to his academic education, his professional path began outside the field of medical informatics and far removed from today’s highly regulated data environments: following secondary education, he completed vocational training as a heavy truck and tank mechanic in the German Armed Forces, a pragmatic decision to finance his engineering studies. This progression—from working with mechanically robust systems to precision electronics and, eventually, data-driven medical research—continues to shape his pragmatic, resilient, and application-oriented approach at the interface of technology, regulation, and healthcare practice.

Organized by GMDS AG MoCoMed / Impressum / Privacy