Evidence map›Paper›PMID 41703202›Full record

ArticleNPJ digital medicine2026

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

Helen X Hou, Tom Bisson, Sophia M Leiss, Julia Thierauf, Ariel D Stern, Hendrik Strobelt, Felix Nensa, Alena Buyx, Katharina M Huster, Kira Furlano and 24 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in NPJ digital medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

34 authors.

Helen X HouDepartment of Radiation Oncology, TUM University Hospital, Technical University of Munich, Munich, Germany. hhou3@mgh.harvard.edu.
Tom BissonCharité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Institut für Medizinische Informatik, Berlin, Germany.
Sophia M LeissDepartment of Radiation Oncology, TUM University Hospital, Technical University of Munich, Munich, Germany.
Julia ThieraufFoundation Medicine Inc, Cambridge, MA, USA.
Ariel D SternDigital Health Cluster, Hasso-Plattner Institute, University of Potsdam, Potsdam, Germany.
Hendrik StrobeltIBM Research/MIT-IBM AI Lab, Cambridge, MA, USA.
Felix NensaInstitute of Diagnostic and Interventional Radiology and Neuroradiology, University Hospital Essen, Essen, Germany.
Alena BuyxInstitute of History and Ethics in Medicine, Technical University of Munich, Munich, Germany.
Katharina M HusterEthics Committee, Technical University Munich, Munich, Germany.
Kira FurlanoCharité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Klinik für Urologie, Berlin, Germany.
Zisis KozlakidisInternational Agency for Research on Cancer, World Health Organization, Lyon, France.
Sachin GuptaAmerican Society for Clinical Pathology, Chicago, IL, USA.
Danko KostadinovColorectal and General Surgery, Princess Royal University Hospital, King's College Hospital NHS Foundation Trust, London, United Kingdom.
Peter BoorInstitute of Pathology, University Clinic Aachen, RWTH Aachen University, Aachen, Germany.
Anna SlagmanCharité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Notfallmedizinische Versorgungsforschung, Berlin, Germany.
Thorsten TjardesDepartment of Trauma and Orthopedic Surgery, University of Witten/Herdecke, Cologne, Germany.
Pierre CholetDecentriq, Berlin, Germany.
Nick K SchneiderGerman Federal Ministry of Health, Berlin, Germany.
Thorsten SchlommCharité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Klinik für Urologie, Berlin, Germany.
Saskia BiskupCeGaT und Zentrum für Humangenetik Tübingen, Tuebingen, Germany.
Rainer RöhrigInstitute of Medical Informatics, University Hospital RWTH Aachen, Aachen, Germany.
Fruzsina Molnár-GáborBio Quant / Faculty of Law, Heidelberg University, Heidelberg, Germany.
Uta Schmidt-StraßburgerMaster Online Study Program Advanced Oncology Ulm University Medical Faculty Division of Learning and Teaching, Ulm, Germany.
Katharina LadewigCenter for Artificial Intelligence in Public Health Research, Robert Koch Institute, Berlin, Germany.
Marcel WeigandTMF-Technology and Methodology Plattform for Networked Medical Research e.V., Berlin, Germany.
Daniel Pinto Dos SantosDepartment of Radiology, University Medical Center Mainz, Mainz, Germany.
Jason M JohnsonDana-Farber Cancer Institute, Boston, MA, USA.
Toralf KirstenInstitute for Medical Informatics, Statistics and Epidemiology, Leipzig University, Leipzig, Germany.
Eric SutherlandOrganization for Economic Co-operation and Development (OECD), Paris, France.
Norman ZerbeCharité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Institut für Medizinische Informatik, Berlin, Germany.
Albert HofmanDepartment of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
Ralf HeyderCharité-Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Network of University Medicine Coordination Office, Berlin, Germany.
Georg SchmidtEthics Committee, Technical University Munich, Munich, Germany.
Jochen K LennerzBostonGene, Waltham, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Identifiers

PMID41703202
PMCPMC13022335

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.