FDA Wants To Use EMRs To Streamline Adverse Drug Event Reporting

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.