FDA launches public data access initiative

The FDA has announced it will provide access to “large, important public health datasets” of information the agency has collected, with Web developers, members of public health organizations, researchers and the public in mind.

According to a press release, the openFDA program is “the result of 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 information is available at openFDA.gov. It eliminates the need for Freedom of Information Act requests for certain kinds of data and will be provided in a “structured” and highly searchable, digital format, according to the release.

“The openFDA initiative leverages new technologies and methods to unlock the tremendous public data and resources available from the FDA in a user-friendly way,” Walter S. Harris, the FDA’s chief operating officer and acting chief information officer, said in the release. “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.”

An initial pilot program is focused on providing data related to adverse drug reactions and medication error events that occurred from 2004 to 2013. The data released will not include any private patient information and will be expanded later to include information on product recalls and labeling issues.

“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,” Taha Kass-Hout, MD, FDA chief health informatics officer, said in the release. “OpenFDA offers a scalable platform that can be easily searched and queried across many distinct datasets, and can be easily redeployed or altered to fit a variety of purposes, and provides an innovative public data search and analytics solution.”

The agency said it also will encourage technology development by programmers, such as Web and mobile application developers, to use innovative approaches to utilizing the datasets, described as “massive.”

The initiative is said to have been part of a presidential executive order on open access to data and included the development of chief health informatics officer and the office of informatics and technology innovation roles at the FDA.