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Design Considerations in an Active Medical Product Safety Monitoring System

    Basic Details

    This article describes design considerations in developing an active medical product safety monitoring system that utilizes routinely collected electronic healthcare data. Suitable approaches to minimizing false positives and false negatives depend on the characteristics of 1) the monitored product, 2) the health outcome of interest (HOI), and 3) the potential link between them.


    Joshua J. Gagne PharmD, ScD; Bruce Fireman, MA; Patrick B. Ryan PhD; Malcolm Maclure SM, SD; Tobias Gerhard PhD; Sengwee Toh ScD; Jeremy A. Rassen ScD; Jennifer C. Nelson PhD; Sebastian Schneeweiss MD, ScD

    Corresponding Author

    J. J. Gagne, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Suite 3030, Boston, MA 02120, USA. Email: