Overview
Electronic health records (EHRs) are an important tool to inform clinically relevant research. As a source of real-world data (RWD), EHR systems can provide unique depth and detail on patients’ health and their care. Although EHR data can fill evidence gaps and improve decisions, several important limitations can affect its validity and relevance.
The ISPOR Good Practices Report, published by an ISPOR Task Force including Flatiron experts, describes challenges faced when extracting and transforming structured and unstructured information from the EHR into high-quality real-world data, specifically focusing on a framework to assess suitability of EHR data for use in health technology assessments (HTAs).
EHR-derived data may be better suited than other types of RWD for critical components of HTAs, including identifying patient demographics, describing the natural history of diseases, understanding clinical rationale behind testing and treatment patterns, generating comparative effectiveness evidence, and determining factors related to adverse events or outcomes. The ISPOR Good Practices Report introduces a framework and SUITABILITY checklist for evaluating EHR-derived data in HTAs and offers specific guidance for HTA agencies and policy makers.
Why this matters
Validating the use of EHR-derived RWD will remain critical as the scope and applications of EHR-derived RWD continues to increase. Standardized utilization guidelines enable effective, consistent decision making while promoting use of high-quality data. The report provides actionable guidance for HTA agencies and policy makers, promoting collaborative efforts among stakeholders to identify best practices, increase dissemination of exemplary case studies, and invest in workforce training for this field.