The U.S. Food and Drug Administration wants to leverage electronic medical records to probe for adverse drug events, according to a recent article in Regulatory Focus. Big data has the power to help expose adverse events more quickly than ever, and the FDA wants to use that to assess drug side effects.
Late last month, the FDA posted on the Federal Business Opportunities website that it is looking for a partner to develop a database of EMR data that has been scrubbed of individual-identifying patient information. Such as system, the FDA said, would allow them to "estimate the contribution of various risk factors" among a minimum of 10 million patients in the database, including information like demographics, health history, diagnoses and procedures, laboratory test orders and results, use of drugs and biologics and health encounters like hospitalizations or visits to a physician.
"FDA currently has several tools available to address postmarketing safety issues," the notice said. "These include a spontaneous reporting system for adverse events related to drug and biologics therapy; several complementary product utilization databases; and a scientific program to support epidemiologic investigations that provides indirect access to U.S. claims-based health encounter data for pharmacoepidemiology studies.
"To strengthen and complement these resources, FDA seeks to acquire direct access to a de-identified EMR data."
In February 2012, two health IT startups aimed to help patients sift through the reams of adverse event data collected by the U.S. Food and Drug Administration, according to a report in the Wall Street Journal.
The two companies, AdverseEvents and Clarimed, developed websites backed by algorithms that sort FDA adverse event reports, streamline the data, back out misspellings or inaccuracies, and make it easier for consumers to understand FDA's findings.
To learn more:
- read the article in Regulatory Focus
- see the notice in the FBO
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