The U.S. Food and Drug Administration is tracking the safety of drugs, biologics and medical devices through the Sentinel Initiative, a pilot program that mines billing codes to predict adverse drug events, according to an NPR report.
The Sentinel Initiative was launched in 2008 as a system to proactively track reports of adverse events through the Mini-Sentinel pilot project.
Employees at Mini-Sentinel's operations center send out queries to 18 data partners, including health plans and insurance companies that have the health records of nearly 180 million Americans, according to the report. Queries are sent when the FDA receives reports of adverse events that they believe may be linked to FDA-approved drugs and medical devices.
The data comes from pre-existing electronic healthcare data, largely billing codes, so providers do not have to send any additional reports to the agency.
The contract of the $116 million project expires in September, according to the report, and the FDA has not yet said what its next steps will be.
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