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

Why Health Data Sharing Across Oceans Matters

Modern medicine increasingly depends on large pools of health data to develop better treatments, train safe artificial intelligence tools, and respond quickly to public health threats. Yet hospitals and researchers in Europe and the United States often struggle to share this information because their privacy laws do not fully match. This article describes the BRIDGE Pilot Study, an effort by experts on both sides of the Atlantic to create a practical, step‑by‑step guide for moving health data across borders in ways that are both legally sound and technically safe.

Two Worlds of Privacy Rules

Health data in Europe and the United States is protected by different legal traditions. In the European Union, data protection is treated as a fundamental right, shaping sweeping rules such as the General Data Protection Regulation and the new European Health Data Space. In the United States, protections grow from a patchwork of federal and state laws, including the HIPAA health privacy rule and newer state‑level consumer privacy acts. These systems use different definitions for basic ideas like what counts as “identifiable” data or when information is considered truly anonymous. As a result, what one side sees as safely protected, the other may still treat as sensitive, making international projects hard to run.

The Need for a Practical Playbook

At the same time, advances in artificial intelligence for medicine demand rich, diverse datasets that no single country can easily provide. Without a clear playbook, researchers must navigate complex regulations case by case, slowing progress and raising the risk of mistakes. To address this, the German Ministry of Health and U.S. partners launched the Data for Health initiative, out of which the BRIDGE Pilot Study emerged. BRIDGE aims to turn high‑level legal principles into a concrete checklist that research teams can follow from the first idea for a study through data transfer, analysis, and publication. The project’s broader goal is to build trust and consistency so that cross‑border collaboration becomes routine rather than exceptional.

How Experts Built the Framework

The BRIDGE team combined surveys, expert discussions, and consensus meetings to design its guidance. They started with an initial list of 30 steps, organized into three phases: planning and development, core data activities, and data integration and analysis. This draft drew on the experience of clinicians, legal scholars, data scientists, and policy specialists from Germany, the wider EU, and the U.S. An online survey, distributed through professional societies, asked participants to reorder the steps, rate their importance, and comment on gaps or problems. Fifty‑six complete responses, representing hundreds of years of combined experience with health data, provided a rich picture of how real‑world projects unfold.

What the Framework Emphasizes

Across responses, several themes were clear. Experts stressed the importance of building privacy and security into a project from the very beginning, including early assessments of data protection risks and consultations with oversight bodies. They highlighted the need for secure data transfer channels, careful testing of technical systems, and repeated quality checks rather than one‑time approvals. Participants also called for clear roles and responsibilities—such as designating a central data officer—and for regular communication among partners. In later phases, they emphasized early exploratory analysis to check data readiness, strong validation of models trained on shared data, and thoughtful plans for archiving results and explaining them to non‑technical audiences.

From One‑Off Project to Living Guide

Through four structured online meetings, the team refined the order and content of the steps, using a formal method to reach consensus. They also proposed a quality management system that would keep the framework up to date as laws and technologies change. The result is not a rigid recipe but a living tool that institutions can adapt to their own legal and technical environments while following a common structure.

What This Means for Patients and Society

The BRIDGE framework does not change the underlying laws in Europe or the United States, and it still needs to be tested in full‑scale, real‑world data exchanges. However, it gives researchers and policymakers a shared map for navigating one of today’s thorniest challenges: how to use health data for the public good without sacrificing people’s rights. For patients, that could mean faster development of new treatments and better‑informed care, achieved through international cooperation that respects privacy from the outset rather than as an afterthought.

Citation: Hou, H.X., Bisson, T., Leiss, S.M. et al. BRIDGE pilot study: a bilateral regulatory investigation of data governance and exchange. npj Digit. Med. 9, 244 (2026). https://doi.org/10.1038/s41746-025-02322-6

Keywords: health data sharing, data privacy, digital medicine, artificial intelligence in healthcare, EU US collaboration