Bridging The Gap – TEFCA, Healthcare Data Interoperability, And Clinical Research Use Cases

In November 2023, Medidata NEXT New York brought together more than 500 participants from the clinical trials industry. During the event, insightful discussions took place, and groundbreaking initiatives were unveiled. One of the noteworthy announcements was a transformative initiative aimed at addressing persistent issues in healthcare data interoperability and integration. These challenges have long been an obstacle to the provision of quality healthcare, jeopardizing patient safety and hindering access to comprehensive source data for analysis and research, thereby affecting the efficiency of clinical trials. Despite previous attempts to solve these problems, the annual excess cost in the US alone remains an astonishing $30 billion.

In a pivotal session, Medidata presented a promising solution to this long-standing problem, introducing the Trusted Exchange Framework and Common Agreement (TEFCA) as a transformative initiative under the 21st Century Cures Act. This framework, mandated by the Office of the National Coordinator for Health Information Technology (ONC), envisions a hub-and-spoke network concept that would standardize data output, making interoperability more scalable, efficient, and faster to implement.

This article delves into the core challenges faced by the industry, the intricacies of TEFCA, and the potential impact on healthcare and clinical trials, shedding light on a pivotal moment in the ongoing quest to bridge the gap between healthcare and clinical research data.