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A Policy Framework for Public Health uses of Electronic Health Data

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    Description

    This article describes how the FDA's Mini-Sentinel pilot is being conducted in compliance with applicable federal and state laws. The article also sets forth the attributes of Mini-Sentinel that enhance privacy and public trust. The authors conclude by discussing the implications of this model for other types of secondary health data uses.

    Author(s)

    Deven McGraw JD, LLM; Kristen B. Rosati JD; Barbara Evans PhD, JD

    Corresponding Author

    D. McGraw, Center for Democracy & Technology (CDT), 1634 I Street, NW, #1100, Washington, DC 20006, USA. E-mail: deven@cdt.org