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Evaluating the Coverage of the HL7® FHIR® Standard to Support eSource Data Exchange Implementations for use in Multi-Site Clinical Research Studies

The direct use of EHR data in research, often referred to as 'eSource', has long-been a goal for researchers because of anticipated increases in data quality and reductions in site burden. eSource solutions should rely on data exchange standards for consistency, quality, and efficiency. The utility of any data standard can be evaluated by its ability to meet specific use case requirements. The Health Level Seven (HL7 ® ) Fast Healthcare Interoperability Resources (FHIR ® ) standard is widely recognized for clinical data exchange; however, a thorough analysis of the standard's data coverage in supporting multi-site clinical studies has not been conducted. We developed and implemented a systematic mapping approach for evaluating HL7 ® FHIR ® standard coverage in multi-center clinical trials. Study data elements from three diverse studies were mapped to HL7 ® FHIR ® resources, offering insight into the coverage and utility of the standard for supporting the data collection needs of multi-site clinical research studies.