BRIDGE pilot study: a bilateral regulatory investigation of data governance and exchange.
expert_opinion · Level V
Where this comes from
- Record sourced from PubMed, PMID 41703202.
- Also identified by DOI 10.1038/s41746-025-02322-6 and PMC identifier 13022335.
- Licence recorded as CC BY.
- The licence permits redistribution, so the abstract is shown in full and the full text is available from the publisher.
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.