Comparing the Accuracy of Traditional vs. FHIR®-Based Extraction of Electronic Health Record Data for Two Clinical Trials

While pilots and production use of software based on the Health Level Seven (HL7®) Fast Healthcare Interoperability Resources (FHIR®) standard are increasing in clinical research, we lack consistent evaluative data on important outcomes, such as data accuracy. We compared the accuracy of EHR collected, FHIR® extracted data (called EHR-to-eCRF data collection) to traditional clinical trial data collection. The accuracy rate for EHR-collected data was significantly higher than for the same data collected through traditional methods. It is possible that EHR-collected (FHIR® extracted) data can substantially improve data quality in clinical studies while decreasing the burden on study sites.