FDA is opening up vast amount of datasets to researchers, web developers and the public in a bid to spur innovation.
Called OpenFDA, the effort opens up vast amount of de-identified datasets that reside within the bowels of the agency so that researchers, web developers and any interested person can access it, analyze and crunch it to make meaningful use out of it - be it in the form of mobile apps or interactive websites.
The first set of data being released is 3 million-plus drug adverse events information collected through the FDA Adverse Event Reporting System.
“Pharmaceutical companies, for example, send hundreds of Freedom of Information Act (FOIA) requests to FDA every year because that has been one of the ways they could get this data” Kass-Hout wrote. “Other methods called for downloading large amounts of files encoded in a variety of formats or not fully documented, or using a website to point-and-click and browse through a database – all slow and labor-intensive processes.”
Whereas with this announcement, the data will be available in a computer readable, searchable format.
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“Software developers can now build their own applications (such as a mobile phone app or an interactive website) that can quickly search, query or pull massive amounts of public information instantaneously and directly from FDA datasets in real time on an “as-needed” basis. Additionally, with this approach, applications can be built on one common platform that is free and open to use, he wrote.
FDA is launching this effort through the release of drug related adverse events data. It's quite conceivable that as the program gains traction, the agency will release datasets collected through its MAUDE(Manufacturer and User Facility Device Experience to understand the adverse events related to medical device usage.
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