A COVID‐19‐Ready Public Health Surveillance System: The FDA's Sentinel System

Basic Details
Date
Friday, April 2, 2021
Type
Publication
Description

The US Food and Drug Administration's Sentinel System was established in 2009 to use routinely collected electronic health data for improving the national capability to assess post‐market medical product safety. Over more than a decade, Sentinel has become an integral part of FDA's surveillance capabilities and has been used to conduct analyses that have contributed to regulatory decisions. FDA's role in the COVID‐19 pandemic response has necessitated an expansion and enhancement of Sentinel. Here we describe how the Sentinel System has supported FDA's response to the COVID‐19 pandemic. We highlight new capabilities developed, key data generated to date, and lessons learned, particularly with respect to working with inpatient electronic health record data.

Author(s)

Noelle M. Cocoros, Candace C. Fuller, Sruthi Adimadhyam, Robert Ball, Jeffrey S. Brown, Gerald Dal Pan, Sheryl A. Kluberg, Vincent Lo Re 3rd, Judith Maro, Michael Nguyen, Robert Orr, Dianne Paraoan, Jonathan Perlin, Russell E. Poland, Meighan Rogers Driscoll, Kenneth Sands, Sengwee Toh, W. Katherine Yih, Richard Platt, and the FDA‐Sentinel COVID‐19 Working Group

Corresponding Author

Noelle M. Cocoros, Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA. 
Email: noelle_cocoros@harvardpilgrim.org