FDA Launches openFDA Initiative to Open Up Data Access

The first data set is for drug-adverse events, with reports submitted from 2004 through 2013 currently available to view.

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The Food and Drug Administration (FDA) has launched a new initiative from the Office of Informatics and Technology Innovation (OITI) called openFDA, designed to make it easier for developers, researchers and the public to access and use the many large and important health data sets collected by the agency.

While this information has always been publicly available, it hasn’t been easy to obtain or search through—something the initiative is designed to change.

The openFDA makes the publicly available data accessible in a structured, computer-readable format, providing a search-based application programming interface (API) that makes it possible to find both structured and unstructured content online.

"The openFDA Initiative is a new initiative--formally launched with the creation of the Chief Health Informatics Officer (CHIO) and the Office of Informatics and Technology Innovation at the FDA," Taha Kass-Hout, chief health informatics officer of the FDA, told eWEEK. "It reflects FDA's intent to use new technologies and methods to unlock the tremendous publicly available data and resources at the FDA in a user-friendly way for general consumers, researchers and Web developers."

For example, software developers can now build their own applications, such as a mobile phone app or an interactive Website, that can search, query or pull public information and directly from FDA datasets in real time.

"Through openFDA, Web developers and researchers will have easy access to high-value, publicly available data from FDA via open Search APIs or structured file downloads," Kass-Hout said. "In short, the goal is to make it simple for any developers, researchers and other technically focused individuals to use publicly available data from the FDA in their work."

The first dataset is drug-adverse events, with reports submitted from 2004 through 2013 currently available to view. The FDA is also working on recall datasets, including enforcement report data containing information gathered from public notices about certain recalls of FDA-regulated products.

"In addition to providing datasets, openFDA will highlight projects using these data in both the public and private sector and it will also provide a platform for public challenges issued by the FDA and a place for the community to interact with each other and FDA domain experts with the goal of spurring innovation around FDA’s publicly available data," Kass-Hout said.

He also noted that since openFDA debuted on June 2, the Website has generated considerable interest.

"In the past five weeks, the site has had 34,000 sessions (two-thirds are new sessions) from 26,000 unique visitors worldwide that generated 80,000 page views," he explained. "The adverse events API has been accessed by 18,000 Internet-connected devices, with nearly 2.4 million API calls since the launch."