Year: 2026
Type: article
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.
Source: npj Digital Medicine
Authors: Helen X. Hou, Tom Bisson, Sophia M. Leiss, Julia Thierauf, Ariel D. Stern, Hendrik Strobelt, Felix Nensa, Alena Buyx, Katharina M. Huster, Kira Furlano, Zisis Kozlakidis, Sachin Gupta, Danko Kostadinov, Peter Boor, Anna Slagman, Thorsten Tjardes, Pierre Cholet, Nick K. Schneider, Thorsten Schlomm, Saskia Biskup, Rainer Röhrig, Fruzsina Molnár-Gábor, Uta Schmidt-Straßburger, Katharina Ladewig, Marcel Weigand, Daniel Pinto dos Santos, Jason M. Johnson, Toralf Kirsten, Eric Sutherland, Norman Zerbe, Albert Hofman, Ralf Heyder, Georg Schmidt, Jochen K. Lennerz
Institutions: Harvard University, TUM Klinikum, Massachusetts General Hospital, Technical University of Munich, Humboldt-Universität zu Berlin, Charité - Universitätsmedizin Berlin, University of Gothenburg, Foundation Medicine (United States), Hasso Plattner Institute, University of Potsdam, Harvard-MIT Center for Regulatory Science, IBM (United States), Massachusetts Institute of Technology, Essen University Hospital, Deutscher Ethikrat, Centre international de recherche sur le cancer, American Society for Clinical Pathology, Princess Royal University Hospital, King's College Hospital NHS Foundation Trust, King's College Hospital, Universitätsklinikum Aachen, RWTH Aachen University, Witten/Herdecke University, Federal Ministry of Health, CeGaT (Germany), Heidelberg University, Universität Ulm, Robert Koch Institute, University Medical Center of the Johannes Gutenberg University Mainz, Dana-Farber Cancer Institute, University Hospital Leipzig, Leipzig University, Organisation de Coopération et de Développement Economiques
Language: English
Subfield: Law
Field: Social Sciences
Domain: Social Sciences
Open Access status: gold
Estimated APC paid: $4,090
Funder: Bundesministerium für Gesundheit
OpenAlex ID: W7129341535