BRIDGE pilot study: a bilateral regulatory investigation of data governance and exchange
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.
Authors
- Katharina Ladewig (ORCID: https://orcid.org/0000-0003-3397-1308)
- Julia Thierauf (ORCID: https://orcid.org/0000-0002-9607-3866)
- Peter Böör (ORCID: https://orcid.org/0000-0001-9921-4284)
- Tom Bisson (ORCID: https://orcid.org/0000-0002-7743-0792)
- Katharina M. Huster
- Ralf Heyder
- Belinda Lennerz (ORCID: https://orcid.org/0000-0002-8021-7984)
- Ariel Dora Stern (ORCID: https://orcid.org/0000-0002-3586-1041)
- Marcel Weigand
- Zisis Kozlakidis (ORCID: https://orcid.org/0000-0002-3836-7209)
- Kira Furlano (ORCID: https://orcid.org/0000-0003-1724-7061)
- Alena Buyx (ORCID: https://orcid.org/0000-0002-5726-7633)
- Helen X. Hou (ORCID: https://orcid.org/0009-0007-3326-4319)
- Jason M. Johnson (ORCID: https://orcid.org/0000-0001-8677-6237)
- Norman Zerbe (ORCID: https://orcid.org/0000-0002-0314-3037)
- Hendrik Strobelt (ORCID: https://orcid.org/0000-0002-8995-1683)
- Anna Slagman (ORCID: https://orcid.org/0000-0003-2608-0347)
- Felix Nensa
- Sachin Gupta (ORCID: https://orcid.org/0000-0002-7143-248X)
- Sophia M. Leiss (ORCID: https://orcid.org/0009-0007-4463-5314)
- Rainer Röhrig
- Nick Schneider
- Thorsten Schlomm
- Saskia Biskup
- Danko Kostadinov
- Uta Schmidt-Straßburger
- Pierre Cholet
- Thorsten Tjardes
- Fruzsina Molnár-Gábor
- Georg Schmidt
- Daniel Pinto dos Santos
- Eric Sutherland
Institutions
- Organisation de Coopération et de Développement Economiques (FR)
- IBM (United States) (US)
- Harvard University (US)
- Hasso Plattner Institute (DE)
- Witten/Herdecke University (DE)
- Universität Ulm (DE)
- Johannes Gutenberg University Mainz (DE)
- Heidelberg University (DE)
- Robert Koch Institute (DE)
- Princess Royal University Hospital (GB)
- German Council on Foreign Relations (DE)
- Humboldt-Universität zu Berlin (DE)
- Massachusetts General Hospital (US)
- University Medical Center of the Johannes Gutenberg University Mainz (DE)
- Institute for Research Information and Quality Assurance (DE)
- Addgene (US)
- Praxis für Humangenetik Tübingen (DE)
- Dana-Farber Cancer Institute (US)
- Essen University Hospital (DE)
- Dana-Farber/Harvard Cancer Center (US)
- Committee on Publication Ethics (GB)
- Network Group (Czechia) (CZ)
- Federal Ministry of Health (DE)
- Centre international de recherche sur le cancer (FR)
- Foundation Medicine (United States)
- Technical University of Munich (DE)
- American Society for Clinical Pathology (US)
- Heidelberg University (US)
- University of Gothenburg (SE)
- RWTH Aachen University (DE)
- Leipzig University (DE)
Publication Details
- Journal
- npj Digital Medicine
- Published
- 2026-02-17
- DOI
- https://doi.org/10.1038/s41746-025-02322-6
- Primary Topic
- COVID-19 Digital Contact Tracing
- Type
- article
- Field-Weighted Citation Impact
- 0.00