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<p>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 <i>Data for Health initiative</i>, 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 (<i>n</i> = 56 expert responses), ranking of steps via <i>relative importance indexing</i>, 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.</p>

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

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年2月17日

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  • 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

摘要

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.