For many years, Electronic Data Capture (EDC) systems have played a crucial role in clinical trials, managing data through electronic case report forms (eCRFs). Despite the widespread adoption of Electronic Health Records (EHRs) after the enactment of the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009, their integration into clinical research has progressed slowly. EHRs serve as contemporary patient-focused records, consolidating information from various healthcare providers involved in patient care. The extensive adoption of EHR systems, with over 95% of U.S. hospitals embracing them, has heightened operational efficiency, increased reimbursements, and elevated the standard of patient care (ONC, 2019).
Electronic Health Records (EHRs) facilitate connectivity and compatibility, supporting the exchange of health information across platforms. This is evident in initiatives aiming to strengthen collaboration between regional and national Health Information Exchanges (HIEs). Serving as secure electronic hubs, HIEs enable authorized stakeholders to access and transmit patient data seamlessly. Some HIEs even provide the ability to access EHRs without the need for direct point-to-point integrations (ONC, 2023).
Despite longstanding efforts by clinical researchers to leverage EHR data for extensive clinical studies, numerous obstacles have hindered progress. Challenges include insufficient interoperability between EHRs and other systems, suboptimal data quality, and the substantial effort required from research sites to manually convert electronic data from EHRs (and other systems) into Electronic Data Capture (EDC) systems (Collen, 1990; Garza, 2020).
