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

Le résumé fourni par la source

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.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.