{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,8,15]],"date-time":"2025-08-15T01:04:51Z","timestamp":1755219891830,"version":"3.43.0"},"reference-count":0,"publisher":"IOS Press","isbn-type":[{"type":"electronic","value":"9781643686080"}],"license":[{"start":{"date-parts":[[2025,8,7]],"date-time":"2025-08-07T00:00:00Z","timestamp":1754524800000},"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":[[2025,8,7]]},"abstract":"<jats:p>The broad registration of research studies in international registries would give the research community a good oversight of ongoing projects, but would also serve the information needs of study participants. However, there is currently a lack of widely accepted transparency registers as well as harmonized interfaces for populating and managing them. The German Medical Informatics Initiative (MII) makes healthcare data from German university hospitals available for a variety of research purposes. As a complement to the MII core dataset, an extension module for representing research studies was specified and implemented in HL7 FHIR. This allows both local research projects at the sites and cross-site projects to be represented. One focus was on modeling the criteria for the inclusion or exclusion of subjects and the connection of patients to study participants. This initial version will be supplemented with additional functionalities in the future to enable a semi-automatic synchronization with transparency registers such as the German Portal for Medical Research Data (FDPG).<\/jats:p>","DOI":"10.3233\/shti250798","type":"book-chapter","created":{"date-parts":[[2025,8,7]],"date-time":"2025-08-07T11:31:28Z","timestamp":1754566288000},"source":"Crossref","is-referenced-by-count":0,"title":["Supporting Interoperability and Transparency of Medical Research Studies with HL7 FHIR"],"prefix":"10.3233","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2344-0426","authenticated-orcid":false,"given":"Matthias","family":"L\u00f6be","sequence":"first","affiliation":[{"name":"Institute for Medical Informatics (IMISE), University of Leipzig, Germany"}]},{"given":"Martin","family":"Bartow","sequence":"additional","affiliation":[{"name":"TMF \u2013 Technologie- und Methodenplattform f\u00fcr die vernetzte medizinische Forschung e.V., Berlin, Germany"}]},{"given":"Martin","family":"Bialke","sequence":"additional","affiliation":[{"name":"Institut f\u00fcr Community Medicine, Universit\u00e4tsmedizin Greifswald, Germany"}]},{"given":"Margaux","family":"Gatrio","sequence":"additional","affiliation":[{"name":"Core Facility Digital Medicine and Interoperability, Berlin Institute of Health at Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin, Germany"}]},{"given":"Christian","family":"Gulden","sequence":"additional","affiliation":[{"name":"Friedrich-Alexander-Universit\u00e4t Erlangen-N\u00fcrnberg, Institute for Medical Informatics, Biometrics and Epidemiology, Medical Informatics, Erlangen, Germany"}]},{"given":"Julian","family":"Sass","sequence":"additional","affiliation":[{"name":"Core Facility Digital Medicine and Interoperability, Berlin Institute of Health at Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin, Germany"}]},{"given":"Sebastian","family":"St\u00e4ubert","sequence":"additional","affiliation":[{"name":"Institute for Medical Informatics (IMISE), University of Leipzig, Germany"}]},{"given":"Alexander","family":"Zautke","sequence":"additional","affiliation":[{"name":"HL7 Deutschland, Berlin, Germany"}]}],"member":"7437","container-title":["Studies in Health Technology and Informatics","MEDINFO 2025 \u2014 Healthcare Smart \u00d7 Medicine Deep"],"original-title":[],"link":[{"URL":"https:\/\/ebooks.iospress.nl\/pdf\/doi\/10.3233\/SHTI250798","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,8,7]],"date-time":"2025-08-07T11:31:28Z","timestamp":1754566288000},"score":1,"resource":{"primary":{"URL":"https:\/\/ebooks.iospress.nl\/doi\/10.3233\/SHTI250798"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8,7]]},"ISBN":["9781643686080"],"references-count":0,"URL":"https:\/\/doi.org\/10.3233\/shti250798","relation":{},"ISSN":["0926-9630","1879-8365"],"issn-type":[{"type":"print","value":"0926-9630"},{"type":"electronic","value":"1879-8365"}],"subject":[],"published":{"date-parts":[[2025,8,7]]}}}