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Keywords:

  • privacy;
  • Health Insurance Portability and Accountability Act (HIPAA);
  • distributed;
  • Mini-Sentinel Common Data Model (MSCDM);
  • compliance;
  • accountability;
  • policies

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.