The U.S. Food and Drug Administration is leveraging the cloud as part of its openFDA initiative to make data on recalls and adverse events easily accessible to software developers and researchers.

Cloud computing technology and related tools are providing an unprecedented ability to access and mine health data provided by FDA, which has been releasing datasets under the openFDA initiative since this past summer. For example, an API provides developers and researchers direct access to millions of reports on drug adverse events and medication errors that have been submitted to the regulatory agency since 2004.

Another API returns data from the FDA’s Manufacturer and User Facility Device Experience. This is a dataset that contains medical device adverse event reports and provides a way for software to interact directly with the data, enabling developers and researchers to query thousands of reports dating back to the early 1990s.

“You can take the data and further enhance on it,” said Taha Kass-Hout, chief health informatics officer at FDA, during a Nov. 19 webinar. However, he emphasized that the APIs—which sit on top of a search engine in a public cloud environment—are not meant for “clinical or decision use” but for open source “beta research and development.”

Kass-Hout said that software developers using the API “can literally start coding within minutes” and the goal is to have them develop search/analytics apps allowing consumers to ask questions in an easy query format. However, he added that FDA has put in place some measures to better track how the data is being used and to ensure that the data is “not being abused.” As of earlier this month, the agency has seen more than 6 million API calls since the launch, with about half originating in the United States and the rest globally.

“We have received very positive feedback so far from industry, consumers, researchers, and software developers that now find it a lot easier to access information,” said Kass-Hout. “The main lesson learned is that you have to engage everybody early on, whether it is openFDA or other initiatives. The users are key.”

In June, FDA launched openFDA to make it easier for developers, researchers, and the public to access large public health datasets collected by the agency. The initiative leverages a search-based API to collect large amounts of existing publicly available data, with the ability to search through text within that data, rank results, and to build apps.

To achieve greater transparency, FDA last month released a new online tool to provide insight into its inspection, compliance, and recall data. The new dashboard—which is hosted in a cloud environment—provides information for fiscal years 2009 to 2013, offering access to such data as warning letters, seizures and injunctions, as well as statistics for recalls.

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