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A policy framework for public health uses of electronic health data
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2012
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Active safety surveillance of drugs and medical products requires public trust for successful implementation. The article summarizes how the FDA’s Sentinel Initiative pilot, Mini‑Sentinel, is conducted in compliance with federal and state laws. Mini‑Sentinel enhances privacy and public trust through a distributed data system that keeps identifiable data at partners and mandatory policies implementing fair information practices. The authors discuss how this model can inform other secondary health data uses. © 2012 John Wiley & Sons, Ltd.
ABSTRACT Successful implementation of a program of active safety surveillance of drugs and medical products depends on public trust. This article summarizes how the initial pilot phase of the FDA's Sentinel Initiative, Mini‐Sentinel, 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, including the use of a distributed data system (where identifiable information remains at the data partners) and the adoption by participants of additional mandatory policies and procedures implementing fair information practices. The authors conclude by discussing the implications of this model for other types of secondary health data uses. Copyright © 2012 John Wiley & Sons, Ltd.