BRIDGE pilot study: a bilateral regulatory investigation of data governance and exchange

17. Februar, 2026

Helen X Hou 1 2, Tom Bisson 3 4, Sophia M Leiss 5 6, Julia Thierauf 7, Ariel D Stern 8 9 10, Hendrik Strobelt 11, Felix Nensa 12 13, Alena Buyx 14 15, Katharina M Huster 16, Kira Furlano 17, Zisis Kozlakidis 18, Sachin Gupta 19, Danko Kostadinov 20, Peter Boor 21, Anna Slagman 22, Thorsten Tjardes 23, Pierre Cholet 24, Nick K Schneider 25, Thorsten Schlomm 17, Saskia Biskup 26, Rainer Röhrig 27 28, Fruzsina Molnár-Gábor 29, Uta Schmidt-Straßburger 30, Katharina Ladewig 31, Marcel Weigand 28, Daniel Pinto Dos Santos 32, Jason M Johnson 33, Toralf Kirsten 34 35, Eric Sutherland 36, Norman Zerbe 3 21, Albert Hofman 37, Ralf Heyder 38, Georg Schmidt 16 39, Jochen K Lennerz 40

Abstract

National privacy laws diverge between the European Union and United States, hindering transatlantic health data exchange and slowing AI-driven medical innovation. In response, the German Ministry of Health launched the pre-competitive Data for Health initiative, leading to the BRIDGE Pilot Study (2023-2025), a researcher-led effort to address this regulatory and legal gap. Using a mixed-methods approach, including structured surveys (n = 56 expert responses), ranking of steps via relative importance indexing, and 4 Delphi meetings, experts co-developed a practical framework composed of 30 steps in 3 consecutive phases for legally compliant and technically interoperable EU-US health data collaboration. The framework emphasizes early data protection assessments, secure transfer protocols, and iterative governance checks. The final consensus framework provides a stepwise guide to navigate regulatory and legal complexities and operationalize cross-border research. Ongoing input from researchers and stakeholders will help ensure the framework remains adaptable and provides a clear, scalable foundation for cross-border health data exchange.

  1. Department of Radiation Oncology, TUM University Hospital, Technical University of Munich, Munich, Germany. hhou3@mgh.harvard.edu.
  2. Department of Pathology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. hhou3@mgh.harvard.edu.
  3. Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Institut für Medizinische Informatik, Berlin, Germany.
  4. Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Institut für Pathologie, Berlin, Germany.
  5. Department of Radiation Oncology, TUM University Hospital, Technical University of Munich, Munich, Germany.
  6. Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
  7. Foundation Medicine Inc, Cambridge, MA, USA.
  8. Digital Health Cluster, Hasso-Plattner Institute, University of Potsdam, Potsdam, Germany.
  9. Harvard Business School Technology and Operations Management, Boston, MA, USA.
  10. Harvard-MIT Center for Regulatory Science, Boston, MA, USA.
  11. IBM Research/MIT-IBM AI Lab, Cambridge, MA, USA.
  12. Institute of Diagnostic and Interventional Radiology and Neuroradiology, University Hospital Essen, Essen, Germany.
  13. Institute for Artificial Intelligence in Medicine (IKIM), University Hospital Essen, Essen, Germany.
  14. Institute of History and Ethics in Medicine, Technical University of Munich, Munich, Germany.
  15. German Ethics Council, Berlin, Germany.
  16. Ethics Committee, Technical University Munich, Munich, Germany.
  17. Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Klinik für Urologie, Berlin, Germany.
  18. International Agency for Research on Cancer, World Health Organization, Lyon, France.
  19. American Society for Clinical Pathology, Chicago, IL, USA.
  20. Colorectal and General Surgery, Princess Royal University Hospital, King’s College Hospital NHS Foundation Trust, London, United Kingdom.
  21. Institute of Pathology, University Clinic Aachen, RWTH Aachen University, Aachen, Germany.
  22. Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Notfallmedizinische Versorgungsforschung, Berlin, Germany.
  23. Department of Trauma and Orthopedic Surgery, University of Witten/Herdecke, Cologne, Germany.
  24. Decentriq, Berlin, Germany.
  25. German Federal Ministry of Health, Berlin, Germany.
  26. CeGaT und Zentrum für Humangenetik Tübingen, Tuebingen, Germany.
  27. Institute of Medical Informatics, University Hospital RWTH Aachen, Aachen, Germany.
  28. TMF-Technology and Methodology Plattform for Networked Medical Research e.V., Berlin, Germany.
  29. Bio Quant / Faculty of Law, Heidelberg University, Heidelberg, Germany.
  30. Master Online Study Program Advanced Oncology Ulm University Medical Faculty Division of Learning and Teaching, Ulm, Germany.
  31. Center for Artificial Intelligence in Public Health Research, Robert Koch Institute, Berlin, Germany.
  32. Department of Radiology, University Medical Center Mainz, Mainz, Germany.
  33. Dana-Farber Cancer Institute, Boston, MA, USA.
  34. Institute for Medical Informatics, Statistics and Epidemiology, Leipzig University, Leipzig, Germany.
  35. Dept. Medical Data Science, University of Leipzig Medical Center, Leipzig, Germany.
  36. Organization for Economic Co-operation and Development (OECD), Paris, France.
  37. Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
  38. Charité-Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Network of University Medicine Coordination Office, Berlin, Germany.
  39. Department of Internal Medicine I, TUM University Hospital, Technical University of Munich, Munich, Germany.
  40. BostonGene, Waltham, MA, USA.