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A policy framework for public health uses of electronic health data
Author(s) -
McGraw Deven,
Rosati Kristen,
Evans Barbara
Publication year - 2012
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.2319
Subject(s) - medicine , public health , public relations , compliance (psychology) , dissemination , information dissemination , internet privacy , health data , state (computer science) , computer science , world wide web , law , telecommunications , political science , health care , nursing , psychology , social psychology , algorithm
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.