Data Operations Hub. This collaboration is part of an ongoing effort with the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) to establish an active surveillance program for medical devices.

NESTcc and the FDA have a joint vision to create and implement an active surveillance system for electronic health data, aiming to enhance the understanding of medical device safety within clinical practice. The envisioned system will optimize data collection, quality, completeness, and analysis in a comprehensive framework, enabling the timely assessment of potential and ongoing safety signals. The focus of the active surveillance program is to improve data capture, detect potential safety signals, and promptly assess findings for actionable insights. Additionally, the data structure developed for this system will be suitable for generating real-world evidence tailored for regulatory decisions.

Importantly, the selection of Booz Allen Hamilton as a partner for the Central Data Operations Hub aligns with NESTcc's commitment to advancing the use of real-world evidence in regulatory decision-making for medical devices. Booz Allen Hamilton's expertise and collaboration in building the active surveillance system will contribute to its effectiveness and success.

NESTcc, established in 2016 with FDA funding through a grant (U01 FD 006292), is dedicated to transforming the way medical device technologies are tested, approved, and monitored. Following the ideas of Quality Evidence by DesignTM, NESTcc speeds up patients' access to safe and effective medical technology by combining the infrastructure of real-world evidence systems with the vast knowledge of its network partners.

The collaboration with Booz Allen Hamilton is a critical step toward realizing an active surveillance system that enhances medical device safety and contributes to regulatory decision-making through comprehensive data analysis and surveillance capabilities.