Streamlining Intersectoral Provision of Real-World Health Data: A Service Platform for Improved Clinical Research and Patient Care

Introduction: Obtaining real-world data from routine clinical care is of growing interest for scientific research and personalized medicine. Despite the abundance of medical data across various facilities - including hospitals, outpatient clinics, and physician practices - the intersectoral exchange of information remains largely hindered due to differences in data structure, content, and adherence to data protection regulations. In response to this challenge, the Medical Informatics Initiative (MII) was launched in Germany, focusing initially on university hospitals to foster the exchange and utilization of real-world data through the development of standardized methods and tools, including the creation of a common core dataset. Our aim, as part of the Medical Informatics Research Hub in Saxony (MiHUBx), is to extend the MII concepts to non-university healthcare providers in a more seamless manner to enable the exchange of real-world data among intersectoral medical sites. Methods: We investigated what services are needed to facilitate the provision of harmonized real-world data for cross-site research. On this basis, we designed a Service Platform Prototype that hosts services for data harmonization, adhering to the globally recognized Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) international standard communication format and the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM). Leveraging these standards, we implemented additional services facilitating data utilization, exchange and analysis. Throughout the development phase, we collaborated with an interdisciplinary team of experts from the fields of system administration, software engineering and technology acceptance to ensure that the solution is sustainable and reusable in the long term. Results: We have developed the pre-built packages "ResearchData-to-FHIR", "FHIR-to-OMOP" and "Addons", which provide the services for data harmonization and provision of project-related real-world data in both the FHIR MII Core dataset format (CDS) and the OMOP CDM format as well as utilization and a Service Platform Prototype to streamline data management and use. Conclusion: Our development shows a possible approach to extend the MII concepts to non-university healthcare providers to enable cross-site research on real-world data. Our Service Platform Prototype can thus pave the way for intersectoral data sharing, federated analysis, and provision of SMART-on-FHIR applications to support clinical decision making. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This research was funded by the German Federal Ministry of Education and Research (https://www.bmbf.de/en) within the project "Medical Informatics Hub in Saxony (MiHUBx)". Grant numbers 01ZZ2101A (Dresden) and 01ZZ2101E (Chemnitz). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The source code of the pre-built packages "ResearchData-to-FHIR v2.2.0", "FHIR-to-OMOP v1.1.0", "Addons v1.0.0" and "MiHUBx Service Platform v1.0.0" can be downloaded from the GitLab repository at https://gitlab.ukdd.de/pub/mihubx. These repositories include the test datasets, developer documentation and the initial installation instructions.