{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T13:25:14Z","timestamp":1789046714870,"version":"build-2803163510"},"reference-count":0,"publisher":"IOS Press","isbn-type":[{"value":"9781643686615","type":"electronic"}],"license":[{"start":{"date-parts":[[2026,5,21]],"date-time":"2026-05-21T00:00:00Z","timestamp":1779321600000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,5,21]]},"abstract":"<jats:p>The European Health Data Space (EHDS) requires a large set of harmonized governance regulations and processes as well as a robust technological infrastructure for successful EU-wide health data sharing for secondary use. In Germany, nation-wide data sharing of real-world data from all university hospitals\u2019 patient care documentation has been enabled by the Medical Informatics Initiative (MII) and the German Portal for Medical Research Data (FDPG). After the EU EHDS regulation went into force in March 2025, we conducted a comparison between the German MII\/FDPG framework and the stipulations set out by the EU, with a particular focus on the responsibilities of data holders and data access bodies. Our results illustrate that the national secondary use research infrastructure established over one decade of MII provides an excellent basis for Germany\u2019s path towards the EHDS.<\/jats:p>","DOI":"10.3233\/shti260447","type":"book-chapter","created":{"date-parts":[[2026,5,21]],"date-time":"2026-05-21T22:05:14Z","timestamp":1779401114000},"source":"Crossref","is-referenced-by-count":1,"title":["Medical Informatics Initiative and the German Portal for Medical Research Data: Alignment with EHDS Regulation"],"prefix":"10.3233","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7204-5329","authenticated-orcid":false,"given":"Julian","family":"Gruendner","sequence":"first","affiliation":[{"name":"Friedrich-Alexander-Universit\u00e4t Erlangen-N\u00fcrnberg, Medical Informatics, Erlangen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2451-0027","authenticated-orcid":false,"given":"Maximilian","family":"Kurscheidt","sequence":"additional","affiliation":[{"name":"GECKO Institute, Heilbronn University of Applied Sciences, Heilbronn, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3964-4877","authenticated-orcid":false,"given":"Philip","family":"Overton","sequence":"additional","affiliation":[{"name":"TMF - Technology, Methods, and Infrastructure for Networked Medical Research, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8547-6785","authenticated-orcid":false,"given":"Sebastian C.","family":"Semler","sequence":"additional","affiliation":[{"name":"TMF - Technology, Methods, and Infrastructure for Networked Medical Research, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6200-753X","authenticated-orcid":false,"given":"Hans-Ulrich","family":"Prokosch","sequence":"additional","affiliation":[{"name":"Friedrich-Alexander-Universit\u00e4t Erlangen-N\u00fcrnberg, Medical Informatics, Erlangen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6864-8936","authenticated-orcid":false,"given":"Thomas","family":"Ganslandt","sequence":"additional","affiliation":[{"name":"Friedrich-Alexander-Universit\u00e4t Erlangen-N\u00fcrnberg, Medical Informatics, Erlangen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"7437","container-title":["Studies in Health Technology and Informatics","Opening the Personal Gate between Technology and Health Care"],"original-title":[],"link":[{"URL":"https:\/\/ebooks.iospress.nl\/pdf\/doi\/10.3233\/SHTI260447","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,21]],"date-time":"2026-05-21T22:05:15Z","timestamp":1779401115000},"score":1,"resource":{"primary":{"URL":"https:\/\/ebooks.iospress.nl\/doi\/10.3233\/SHTI260447"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,21]]},"ISBN":["9781643686615"],"references-count":0,"URL":"https:\/\/doi.org\/10.3233\/shti260447","relation":{},"ISSN":["0926-9630","1879-8365"],"issn-type":[{"value":"0926-9630","type":"print"},{"value":"1879-8365","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,21]]}}}