Using Health IT Standards to Facilitate Metadata Exchange Between Research Data Management Systems

Area of Science:

• Health Informatics
• Biomedical Research Data Management

Background:

• Research data management (RDM) systems often lack interoperability with application domain standards.
• Sharing sensitive personal health data for research requires robust management and controlled access.
• The National Research Data Infrastructure for Personal Health Data (NFDI4Health) aims to facilitate secure data sharing.

Purpose of the Study:

• To enhance interoperability of research study data, particularly clinical trials.
• To enable seamless data exchange with external registries.
• To support controlled data sharing of personal health data within the NFDI4Health initiative.

Main Methods:

• Defined a 17-attribute metadata profile for clinical trials.
• Implemented the metadata profile in the FAIRDOM SEEK RDM system using extended metadata features.
• Created a mapping to the Health Level 7 Fast Healthcare Interoperability Resources (FHIR) standard (R4).
• Developed a prototype interface for exporting data in FHIR-JSON format.

Main Results:

• Successfully implemented a metadata profile for clinical trials within the FAIRDOM SEEK RDM system.
• Established a mapping to the FHIR R4 standard, facilitating data interoperability.
• Developed a functional prototype for exporting research data in FHIR-JSON format.

Conclusions:

• The developed metadata profile and FHIR mapping enhance the interoperability of clinical trial data.
• The prototype interface supports controlled data sharing and exchange with external registries.
• Future work includes extending the interface to serve central registries and support specific FHIR Implementation Guides.