FDA Opens Up, Launches openFDA

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The FDA has launched a new open data project – openFDA, is designed to make it easier for web developers, researchers, and the public to access large, important public health datasets collected by the agency. OpenFDA utilizes a search-based API for data collection and access. The initiative was in response to the President’s Executive Order on Open Data and the Department of Health and Human Services Health Data Initiative.

The initiative 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. Based on this research, the FDA decided to phase in openFDA beginning with an initial pilot program involving the millions of reports of drug adverse events and medication errors that have been submitted to the FDA from 2004 to 2013. Previously, the data was only available through reports or Freedom of Information Act requests.

The adverse events data made available under this initiative do not contain any data that could potentially be used to identify individuals or other private information. The pilot will later be expanded to include the FDA’s databases on product recalls and product labeling.

CivSource previously reported on the early stages of this effort which are backed by technology from Captricity. Captricity uses mechanical turk to streamline forms information capture, digitization and organization.

“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 Taha Kass-Hout, M.D., the FDA’s chief health informatics officer.

In addition to providing datasets, openFDA will encourage the innovative use of the agency’s publicly available data by highlighting potential data applications and providing, a place for community interaction with each other and with FDA domain experts.