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Journal Article > Commentary
U.S. Food and Drug Administration Precertification pilot program for digital health software: weighing the benefits and risks.
Lee TT, Kesselheim AS. Ann Intern Med. 2018;168:730-732.
Innovation is a valuable process in health care. However, when innovations are rapidly deployed, efforts to proactively identify and address safety concerns may fall short and lead to unintended consequences. This commentary describes a new program to expedite the review of digital health software and summarizes the benefits and potential harms that could result from the program.
Web Resource > Multi-use Website
Silverspring, MD: US Food and Drug Administration.
This Web site provides access to large publicly available datasets for adverse drug events to enable developers, researchers, and consumers to use this information when designing medication safety improvement plans or projects. Planned updates to this site include data on recalls and product documentation.
Journal Article > Study
Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration.
Brajovic S, Piazza-Hepp T, Swartz L, Pan GD. Pharmacoepidemiol Drug Saf. 2012;21:565-570.
The Food and Drug Administration is piloting a new system that allows triggered reporting of suspected adverse drug events, with data automatically supplied from existing electronic medical record systems. This study evaluates the quality of such reports and identifies areas where the reports could be improved.