PresentationHarmonizing Electronic Health Record and Claims Data Across FDA Sentinel Initiative Data Partners: Case Study and Lessons Learned

Oregon Convention Center 

The US Food and Drug Administration (FDA) Sentinel Initiative is a national surveillance system with a distributed data network of electronic health records (EHR) and claims data on >100 million patient lives from 17 data partners to monitor the safety of FDA-regulated medical products. The Sentinel System uses the Sentinel Common Data Model to standardize data elements and unify the medical coding "vocabulary" across participating sites. However, the coding "dialect" (i.e., the use and interpretation of codes) may still differ due to heterogeneity in care practice and financial drivers. With increasingly diverse data partners and medical coding systems, there is more and more variation in the way a clinical concept can be coded. Existing manually curated medical code ontology and mapping are not scalable and are error-prone. Data sharing constraints bring additional challenges. In this talk, we present data-driven and privacy-preserving statistical methods for detecting and reducing coding differences between healthcare systems. We share our findings from a case study of data harmonization between two Sentinel data partners among a diabetic population.