GET ON FDA’S CLOUD (Orthopedics This Week)
The FDA’s collective heads are in the clouds when it comes to “Big Data.” And the agency wants you to get on their cloud.
openFDA
On June 2, 2014, the agency launched openFDA, a system designed to make it easier for web developers, researchers, and the public to access and use health data sets collected by the agency.
For example, over 3 million reports of drug adverse reactions or medication errors have been submitted to the FDA Adverse Event Reporting System (FAERS) since 2004. But obtaining that information hasn’t been easy. Companies send hundreds of Freedom of Information Act (FOIA) requests to the FDA every year to get the data. Other methods required downloading large amounts of files encoded in a variety of formats that were slow and labor intensive.
This year alone, the FDA expects to receive somewhere between 1.5 and 2 million submissions through its eSubmission Gateway—and some submissions can now be as large as a terabyte (one trillion bytes) in size. This is the very definition of a big data.
openFDA will make publicly available data accessible in a structured, computer-readable format. It provides a “search-based” application programming interface that makes it possible to find both structured and unstructured content online.
Build Your Own Apps
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. Publicly available data provided through openFDA are in the public domain with a CC0 Public Domain Dedication.
Drug adverse events is the first dataset—with reports submitted from 2004 through 2013 available now.
The agency says Big Data is important to the agency carries out regulatory science, which is the science of developing new tools and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. “Through innovative methods such as cloud computing, we are taking advantage of this flood tide of new information to continue to protect and promote the public health,” said the agency through FDA Voice blog.