FDA Pilot Uses EHR, Claims Data To Track Product Safety

June 24, 2014 in News

An FDA pilot program is using electronic health record and claims data to monitor the safety of medical products regulated by the agency, Health Data Management reports.

The program, called Mini-Sentinel, is a pilot project of FDA’s Sentinel surveillance system.

According to Health Data Management, 18 large U.S. health care groups — including Aetna, Humana and Kaiser Permanente — currently serve as data partners for the program (Slabodkin, Health Data Management, 6/24).

In an “FDA Voice” blog post, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, wrote, “Each partner organization maintains its own secure and privacy-protected data, in some but not all cases including EHR as well as claims data, but with the use of a common data model, the necessary information from all of the different systems can be analyzed in the same way.”

According to Woodcock, the system can examine:

  • More than 350 million person years of observation;
  • Four billion pharmaceutical dispensings; and
  • 4.1 billion patient meetings.

She added that “the Mini-Sentinel system can use the information from potentially more than 150 million covered lives in our nation’s health care system to help answer important drug safety questions” (Woodcock, “FDA Voice,” 6/23).

Under the pilot project, the health care organizations provide data and expertise, while FDA provides funding, sets system priorities and makes all final decisions (Health Data Management, 6/24).

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