OpenFDA to Encourage Public Scrutiny of Health Data

By Clinical Informatics News Staff

June 3, 2014 | This Monday, the FDA opened access to the beta version of openFDA, a web portal designed to make it easier for the public to access and search through medical data already collected by the agency. OpenFDA is meant to bypass lengthy Freedom of Information Act requests, placing data in a freely accessibly portal, and structuring it to be quickly read, searched, and compared, while stripping it of any information that could be used to personally identify specific patients.

At launch, openFDA contains roughly 3 million reports of adverse drug events. The FDA stated that adverse drug events were chosen as the first data to be released after "extensive research with internal officials and external developers to identify those datasets that are in recurrent demand and are traditionally fairly difficult to use." The agency has already identified product recalls and product labeling as other classes of reports that would be well-suited for inclusion in the openFDA portal, and may continue to expand from there.

The openFDA code is open source and available on GitHub. While openFDA is searchable as it stands, the agency hopes that the portal's API will help developers build more powerful applications to mine insights from the released data. “Through this new and novel approach to data organization, these reports will be available in their entirety so that software developers can build tools to help signal potential safety information, derive meaningful insights, and get information to consumers and health care professionals in a timely manner,” said FDA Chief Health Informatics Officer Taha Kass-Hout in a press statement.

The openFDA site can be visited at


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