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

## TL;DR

This study addresses legal and regulatory challenges in sharing health data between the EU and US to support cross-border medical research and AI innovation.

## Contribution

The study introduces a 30-step framework for compliant and interoperable EU-US health data collaboration through expert consensus.

## Key findings

- Experts developed a 30-step framework across three phases for transatlantic health data exchange.
- The framework emphasizes secure protocols and early data protection assessments.
- Ongoing stakeholder input ensures adaptability and scalability of the framework.

## 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.