Supporting Interoperability and Transparency of Medical Research Studies with HL7 FHIR

Area of Science:

• Medical Informatics
• Health Data Management
• Clinical Research Informatics

Background:

• International research study registration offers community oversight but lacks harmonized interfaces.
• Transparency registers are crucial for study participants and researchers but are currently underdeveloped.
• The German Medical Informatics Initiative (MII) provides access to healthcare data for research.

Purpose of the Study:

• To develop a standardized method for representing research studies within the German Medical Informatics Initiative (MII).
• To create an extension module in HL7 FHIR for detailed study representation, including participant criteria.
• To lay the groundwork for semi-automatic synchronization with national transparency registers.

Main Methods:

• Specified and implemented an extension module for representing research studies using HL7 FHIR standards.
• Modeled key elements such as subject inclusion/exclusion criteria and patient-study connections.
• Designed the module to complement the MII core dataset for local and cross-site projects.

Main Results:

• An initial version of the HL7 FHIR extension module for research studies has been successfully implemented.
• The module effectively represents local and cross-site research projects, including participant eligibility criteria.
• The implementation facilitates better data management for research studies within the MII.

Conclusions:

• The developed HL7 FHIR module enhances the representation of research studies within the MII.
• This initiative addresses the need for harmonized interfaces in research data management.
• Future work will focus on expanding functionality for seamless synchronization with transparency registers like the FDPG.