Broadening the reach of the FDA Sentinel system: A roadmap for integrating electronic health record data in a causal analysis framework
Abstract 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 re...
Main Authors: | Rishi J. Desai, Michael E. Matheny, Kevin Johnson, Keith Marsolo, Lesley H. Curtis, Jennifer C. Nelson, Patrick J. Heagerty, Judith Maro, Jeffery Brown, Sengwee Toh, Michael Nguyen, Robert Ball, Gerald Dal Pan, Shirley V. Wang, Joshua J. Gagne, Sebastian Schneeweiss |
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Format: | Article |
Language: | English |
Published: |
Nature Portfolio
2021-12-01
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Series: | npj Digital Medicine |
Online Access: | https://doi.org/10.1038/s41746-021-00542-0 |
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