{"id":90342,"date":"2026-02-17T13:19:34","date_gmt":"2026-02-17T12:19:34","guid":{"rendered":"https:\/\/cegat.com\/?p=90342"},"modified":"2026-04-08T13:24:20","modified_gmt":"2026-04-08T11:24:20","slug":"bridge-pilot-study-a-bilateral-regulatory-investigation-of-data-governance-and-exchange","status":"publish","type":"post","link":"https:\/\/cegat.com\/de\/bridge-pilot-study-a-bilateral-regulatory-investigation-of-data-governance-and-exchange\/","title":{"rendered":"BRIDGE pilot study: a bilateral regulatory investigation of data governance and exchange"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\" style=\"--awb-font-size:24px;\"><p style=\"text-align: justify;\">Helen X Hou <sup>1 2<\/sup>, Tom Bisson <sup>3 4<\/sup>, Sophia M Leiss <sup>5 6<\/sup>, Julia Thierauf <sup>7<\/sup>, Ariel D Stern <sup>8 9 10<\/sup>, Hendrik Strobelt <sup>11<\/sup>, Felix Nensa <sup>12 13<\/sup>, Alena Buyx <sup>14 15<\/sup>, Katharina M Huster <sup>16<\/sup>, Kira Furlano <sup>17<\/sup>, Zisis Kozlakidis <sup>18<\/sup>, Sachin Gupta <sup>19<\/sup>, Danko Kostadinov <sup>20<\/sup>, Peter Boor <sup>21<\/sup>, Anna Slagman <sup>22<\/sup>, Thorsten Tjardes <sup>23<\/sup>, Pierre Cholet <sup>24<\/sup>, Nick K Schneider <sup>25<\/sup>, Thorsten Schlomm <sup>17<\/sup>, Saskia Biskup <sup>26<\/sup>, Rainer R\u00f6hrig <sup>27 28<\/sup>, Fruzsina Moln\u00e1r-G\u00e1bor <sup>29<\/sup>, Uta Schmidt-Stra\u00dfburger <sup>30<\/sup>, Katharina Ladewig <sup>31<\/sup>, Marcel Weigand <sup>28<\/sup>, Daniel Pinto Dos Santos <sup>32<\/sup>, Jason M Johnson <sup>33<\/sup>, Toralf Kirsten <sup>34 35<\/sup>, Eric Sutherland <sup>36<\/sup>, Norman Zerbe <sup>3 21<\/sup>, Albert Hofman <sup>37<\/sup>, Ralf Heyder <sup>38<\/sup>, Georg Schmidt <sup>16 39<\/sup>, Jochen K Lennerz <sup>40<\/sup><\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:60px;--awb-padding-bottom:60px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-1 fusion-sep-none fusion-title-text fusion-title-size-two\" style=\"--awb-text-color:var(--awb-custom_color_1);--awb-margin-top-small:10px;--awb-margin-right-small:0px;--awb-margin-bottom-small:10px;--awb-margin-left-small:0px;\"><h2 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;text-transform:none;--fontSize:36;line-height:var(--awb-typography1-line-height);\">Abstract<\/h2><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-2\"><p style=\"text-align: justify;\">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.<\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-3 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--link_hover_color: var(--awb-color6);--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:60px;--awb-padding-bottom:60px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-3 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-tabs fusion-tabs-1 classic vertical-tabs icon-position-left mobile-mode-carousel\" style=\"--awb-title-border-radius-top-left:0px;--awb-title-border-radius-top-right:0px;--awb-title-border-radius-bottom-right:0px;--awb-title-border-radius-bottom-left:0px;--awb-title-padding-top:10px;--awb-title-padding-right:50px;--awb-title-padding-bottom:10px;--awb-title-padding-left:50px;--awb-alignment:start;--awb-inactive-color:var(--awb-color7);--awb-title-text-color:var(--awb-color5);--awb-title-active-text-color:var(--awb-custom_color_1);--awb-background-color:var(--awb-color5);--awb-border-color:rgba(0,0,0,0.05);--awb-active-border-color:var(--awb-custom_color_1);\"><div class=\"nav\"><ul class=\"nav-tabs\" role=\"tablist\" aria-orientation=\"vertical\"><li class=\"active\" role=\"presentation\"><a class=\"tab-link\" data-toggle=\"tab\" role=\"tab\" aria-controls=\"tab-282a216db15ffb7312c\" aria-selected=\"true\" tabindex=\"0\" id=\"fusion-tab-282a216db15ffb7312c\" href=\"#tab-282a216db15ffb7312c\"><h3 class=\"fusion-tab-heading\">Referenzen<\/h3><\/a><\/li><li  role=\"presentation\"><a class=\"tab-link\" data-toggle=\"tab\" role=\"tab\" aria-controls=\"tab-369d55d7f45a8ba343b\" aria-selected=\"false\" tabindex=\"-1\" id=\"fusion-tab-369d55d7f45a8ba343b\" href=\"#tab-369d55d7f45a8ba343b\"><h3 class=\"fusion-tab-heading\">Autorinnen\/Autoren<\/h3><\/a><\/li><\/ul><\/div><div class=\"tab-content\"><div class=\"tab-pane fade fusion-clearfix in active\" role=\"tabpanel\" tabindex=\"0\" aria-labelledby=\"fusion-tab-282a216db15ffb7312c\" id=\"tab-282a216db15ffb7312c\">\n<p><a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/41703202\/\" target=\"_blank\" rel=\"noopener\">Ver\u00f6ffentlichung auf NCBI anschauen<\/a><\/p>\n<\/div><div class=\"tab-pane fade fusion-clearfix\" role=\"tabpanel\" tabindex=\"0\" aria-labelledby=\"fusion-tab-369d55d7f45a8ba343b\" id=\"tab-369d55d7f45a8ba343b\">\n<ol>\n<li>Department of Radiation Oncology, TUM University Hospital, Technical University of Munich, Munich, Germany. hhou3@mgh.harvard.edu.<\/li>\n<li>Department of Pathology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. hhou3@mgh.harvard.edu.<\/li>\n<li>Charit\u00e9-Universit\u00e4tsmedizin Berlin, corporate member of Freie Universit\u00e4t Berlin, Humboldt-Universit\u00e4t zu Berlin, Institut f\u00fcr Medizinische Informatik, Berlin, Germany.<\/li>\n<li>Charit\u00e9-Universit\u00e4tsmedizin Berlin, corporate member of Freie Universit\u00e4t Berlin, Humboldt-Universit\u00e4t zu Berlin, Institut f\u00fcr Pathologie, Berlin, Germany.<\/li>\n<li>Department of Radiation Oncology, TUM University Hospital, Technical University of Munich, Munich, Germany.<\/li>\n<li>Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.<\/li>\n<li>Foundation Medicine Inc, Cambridge, MA, USA.<\/li>\n<li>Digital Health Cluster, Hasso-Plattner Institute, University of Potsdam, Potsdam, Germany.<\/li>\n<li>Harvard Business School Technology and Operations Management, Boston, MA, USA.<\/li>\n<li>Harvard-MIT Center for Regulatory Science, Boston, MA, USA.<\/li>\n<li>IBM Research\/MIT-IBM AI Lab, Cambridge, MA, USA.<\/li>\n<li>Institute of Diagnostic and Interventional Radiology and Neuroradiology, University Hospital Essen, Essen, Germany.<\/li>\n<li>Institute for Artificial Intelligence in Medicine (IKIM), University Hospital Essen, Essen, Germany.<\/li>\n<li>Institute of History and Ethics in Medicine, Technical University of Munich, Munich, Germany.<\/li>\n<li>German Ethics Council, Berlin, Germany.<\/li>\n<li>Ethics Committee, Technical University Munich, Munich, Germany.<\/li>\n<li>Charit\u00e9-Universit\u00e4tsmedizin Berlin, corporate member of Freie Universit\u00e4t Berlin, Humboldt-Universit\u00e4t zu Berlin, Klinik f\u00fcr Urologie, Berlin, Germany.<\/li>\n<li>International Agency for Research on Cancer, World Health Organization, Lyon, France.<\/li>\n<li>American Society for Clinical Pathology, Chicago, IL, USA.<\/li>\n<li>Colorectal and General Surgery, Princess Royal University Hospital, King&#8217;s College Hospital NHS Foundation Trust, London, United Kingdom.<\/li>\n<li>Institute of Pathology, University Clinic Aachen, RWTH Aachen University, Aachen, Germany.<\/li>\n<li>Charit\u00e9 &#8211; Universit\u00e4tsmedizin Berlin, corporate member of Freie Universit\u00e4t Berlin, Humboldt-Universit\u00e4t zu Berlin, Notfallmedizinische Versorgungsforschung, Berlin, Germany.<\/li>\n<li>Department of Trauma and Orthopedic Surgery, University of Witten\/Herdecke, Cologne, Germany.<\/li>\n<li>Decentriq, Berlin, Germany.<\/li>\n<li>German Federal Ministry of Health, Berlin, Germany.<\/li>\n<li>CeGaT und Zentrum f\u00fcr Humangenetik T\u00fcbingen, Tuebingen, Germany.<\/li>\n<li>Institute of Medical Informatics, University Hospital RWTH Aachen, Aachen, Germany.<\/li>\n<li>TMF-Technology and Methodology Plattform for Networked Medical Research e.V., Berlin, Germany.<\/li>\n<li>Bio Quant \/ Faculty of Law, Heidelberg University, Heidelberg, Germany.<\/li>\n<li>Master Online Study Program Advanced Oncology Ulm University Medical Faculty Division of Learning and Teaching, Ulm, Germany.<\/li>\n<li>Center for Artificial Intelligence in Public Health Research, Robert Koch Institute, Berlin, Germany.<\/li>\n<li>Department of Radiology, University Medical Center Mainz, Mainz, Germany.<\/li>\n<li>Dana-Farber Cancer Institute, Boston, MA, USA.<\/li>\n<li>Institute for Medical Informatics, Statistics and Epidemiology, Leipzig University, Leipzig, Germany.<\/li>\n<li>Dept. Medical Data Science, University of Leipzig Medical Center, Leipzig, Germany.<\/li>\n<li>Organization for Economic Co-operation and Development (OECD), Paris, France.<\/li>\n<li>Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.<\/li>\n<li>Charit\u00e9-Universit\u00e4tsmedizin Berlin, Corporate member of Freie Universit\u00e4t Berlin and Humboldt-Universit\u00e4t zu Berlin, Network of University Medicine Coordination Office, Berlin, Germany.<\/li>\n<li>Department of Internal Medicine I, TUM University Hospital, Technical University of Munich, Munich, Germany.<\/li>\n<li>BostonGene, Waltham, MA, USA.<\/li>\n<\/ol>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":25,"featured_media":54928,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[53],"tags":[],"class_list":["post-90342","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-veroeffentlichungen"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - 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