Broadening the reach of the FDA Sentinel system: A roadmap for integrating electronic health record data in a causal analysis framework.

Journal Article (Journal Article;Review)

The Sentinel System is a major component of the United States Food and Drug Administration's (FDA) approach to active medical product safety surveillance. While Sentinel has historically relied on large quantities of health insurance claims data, leveraging longitudinal electronic health records (EHRs) that contain more detailed clinical information, as structured and unstructured features, may address some of the current gaps in capabilities. We identify key challenges when using EHR data to investigate medical product safety in a scalable and accelerated way, outline potential solutions, and describe the Sentinel Innovation Center's initiatives to put solutions into practice by expanding and strengthening the existing system with a query-ready, large-scale data infrastructure of linked EHR and claims data. We describe our initiatives in four strategic priority areas: (1) data infrastructure, (2) feature engineering, (3) causal inference, and (4) detection analytics, with the goal of incorporating emerging data science innovations to maximize the utility of EHR data for medical product safety surveillance.

Full Text

Duke Authors

Cited Authors

  • Desai, RJ; Matheny, ME; Johnson, K; Marsolo, K; Curtis, LH; Nelson, JC; Heagerty, PJ; Maro, J; Brown, J; Toh, S; Nguyen, M; Ball, R; Dal Pan, G; Wang, SV; Gagne, JJ; Schneeweiss, S

Published Date

  • December 20, 2021

Published In

Volume / Issue

  • 4 / 1

Start / End Page

  • 170 -

PubMed ID

  • 34931012

Pubmed Central ID

  • PMC8688411

Electronic International Standard Serial Number (EISSN)

  • 2398-6352

Digital Object Identifier (DOI)

  • 10.1038/s41746-021-00542-0


  • eng

Conference Location

  • England