Report: FDA's Medical Product Safety Tracking System Exceeding Goals

FDA has exceeded its goal of achieving access to the electronic health records of at least 25 million people through its Sentinel Initiative, according to a report released last week, Federal Computer Week reports.

About the Sentinel Initiative

FDA's Sentinel Initiative is an electronic surveillance network designed to monitor the safety of FDA-approved drugs and medical devices.

To investigate a particular product, FDA officials can develop questions that prompt its Sentinel partners to submit relevant data in a format that is compliant with HIPAA privacy and security rules.

FDA said the Sentinel system provides ample privacy and security protections because personally identifiable data remain stored with the partner agencies.

Report Details

According to the new report, FDA's Sentinel project has obtained access to 60 million patient records by pulling information from databases held by:

  • HHS;
  • The Department of Defense; and
  • The Department of Veterans Affairs.

The report states that FDA "is already working towards the patient data access goal of 100 million patients by 2012" (Lipowicz, Federal Computer Week, 11/12).

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