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OpenFDA provides easy access to public data

Tuesday June 10, 2014
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Data on adverse drug events are now easily accessible to researchers and tech experts via the U.S. Food and Drug Administration’s newly launched openFDA system. The new system is designed to make accessing large health datasets collected by the agency less labor-intensive and slow for researchers, Web developers and the public, according to a news release.

OpenFDA makes the FDA’s publicly available data accessible via a structured format and a search-based application program that allows researchers and technology specialists, including mobile application creators and Web developers, to quickly search or pull massive amounts of information instantaneously and directly from FDA datasets.

The FDA phased in openFDA beginning with an initial pilot program involving the more than 3 million reports of adverse drug events and medication errors submitted to the FDA from 2004 to 2013. This information previously was accessible only via complicated reports or Freedom of Information Act requests. The pilot will later be expanded to include the FDA’s databases on product recalls and product labeling.

“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 healthcare professionals in a timely manner,” said Taha Kass-Hout, MD, the FDA’s chief health informatics officer.

Users can search through text within that data, ranking results much like a search using Google would do, according to the release. They also can build their own applications that allow for more flexibility in determining what types of data they would like to search.

“OpenFDA is a valuable resource that will help those in the private and public sectors use FDA public data to spur innovation, advance academic research, educate the public and protect public health,” Walter S. Harris, the FDA’s chief operating officer and acting chief information officer, said in the release.

Using this data, a mobile developer could potentially create a search app for a smart phone, for example and a consumer could then use that app to determine whether anyone else has experienced the same adverse event they did after taking a certain drug, according to the FDA website.

The adverse events data made available under this initiative do not contain any details that could be used to identify individuals or other private information.

The FDA plans to work to identify additional public datasets that can be made available through openFDA.

For more information, go to https://Open.FDA.gov or email open@fda.hhs.gov.


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