FDA Launches openFDA, Gives Developers Access to Public Health Data Sets

Patricio Robles
Jun. 09 2014, 01:15AM EDT

More and more government agencies are opening up their data to the public, creating plentiful opportunities for developers to mine significant amounts of high-value data for insight and build innovative tools that can help millions of people.

One of the most important and highly anticipated open government initiatives launched last week. The U.S. Food and Drug Administration's openFDA promises to give developers access to the agency's vast trove of public health data sets.

The first data set available through openFDA is the FDA's 3 million-plus-record database of adverse event and medication error reports submitted to the agency between 2004 and 2013. These voluntary reports come from healthcare professionals and consumers, and cover all the drugs the agency regulates. While adverse event data was publicly available previously, and companies have used it to build commercial product offerings, openFDA, which was led by the FDA’s Office of Informatics and Technology Innovation, adds the structure and API-based access that is needed to make the data usable by a greater number of researchers, companies and developers.

OpenFDA's API is RESTful and returns data in JSON format. Developers using the API are not required to authenticate, but those building applications that need to issue more than 40 requests per minute or 1,000 requests per day can register for an API key that offers increased limits.

Market-Driven Development

The FDA chose to launch openFDA with adverse events data in response to market demand. "The FDA conducted an extensive research, both internally and with potential external developers, to identify data sets that are in recurrent demand and are traditionally fairly difficult to use," an FDA spokesperson said in an interview. "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 FDA from 2004 to 2013. Previously, this data has only been available through difficult-to-use reports or would have to be accessed through Freedom of Information Act requests."

In the future, the FDA plans to expand openFDA to include other in-demand data sets, including product recalls and product labeling data.

In the meantime, adoption of openFDA's adverse-event API is evident. For instance, one company, Social Health Insights, has already launched an online service called openFDA Search, which enables users to search for adverse drug events through an easy-to-use interface. While the FDA isn't endorsing specific applications, openFDA Search is the type of service the FDA had in mind when it decided to launch the initiative.

To help encourage adoption and support developers who are building innovative applications around FDA data, openFDA "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," the FDA's spokesperson said. To that end, openFDA team members are making themselves available on GitHub, Twitter and Stack Exchange. "You will be shocked at how fast they get back with you to answer your question. We saw questions over Twitter being answered by the community and openFDA team members within minutes (pretty cool)!" Social Health Insights CEO Brian Norris said in a blog post.

That level of community involvement isn't surprising given the importance of openFDA to the agency's future. If the FDA has its way, openFDA will play an increasingly important role in helping the FDA carry out its mission. "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 COO and acting CIO, said in a press release.

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