title: A policy framework for public health uses of electronic health data.
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.
authors.affiliation: Center for Democracy & Technology, Washington, DC 20006, USA. deven@cdt.org
authors.forename: Deven
authors.initials: D
authors.lastname: McGraw
authors.forename: Kristen
authors.initials: K
authors.lastname: Rosati
authors.forename: Barbara
authors.initials: B
authors.lastname: Evans
mesh_terms: D003219:Confidentiality / Q000331:legislation & jurisprudence; D064420:Drug-Related Side Effects and Adverse Reactions; D057286:Electronic Health Records / Q000331:legislation & jurisprudence*; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000009:adverse effects; D006801:Humans; D017146:Models, Organizational; D016134:Organizational Policy; D010865:Pilot Projects; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D011639:Public Opinion; D035502:Trust; D014481:United States; D014486:United States Food and Drug Administration