Supporting Interoperability and Transparency of Medical Research Studies with HL7 FHIR

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).