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Compliance In Focus
Posted by Shawn Kennedy on Fri, Jun 27, 2014

openFDA – A new FDA program to Increase Transparency

On June 2nd, FDA announced the launch of openFDA, a new program through their Office of openFDA – A new FDA program to Increase TransparencyInformatics and Technology Innovation (OITI).  The program is the latest step in FDAs commitment to increase transparency, and makes health data sets collected by the agency available to the public.  Currently, openFDA is in beta testing mode.  A definitive timeframe for when it will be released in full is not indicated.  The press release posted to the FDA website indicates that the initiative has first made accessible the adverse drug reaction report dataset.  This application programming interface (API) is “search-based” and consists of over 3 million adverse drug reaction reports accumulated from 2004 to 2013.  Future APIs currently listed as “coming soon” through the program include “Product Labels” and “Recalls.” 

While this information has always been attainable through the Freedom of Information Act (FOIA), the datasets provided to industry have been traditionally difficult to access and use.  Dr. Taha Kass-Hout, the Chief Health Informatics Officer of FDA, indicated that the agency hopes the advent of the program will make it easier for consumers and industry to access the information in real time on an “as-needed” basis in the hopes that it will spur innovation.  One important thing they point out is that FDA will not release any data that could be used to identify individuals or reveal other private information that is restricted under the Health Insurance Portability and Accountability Act (HIPAA).

Here at IMARC, we strive to align our monitoring and auditing efforts to FDAs requirements and current thinking.  One way we have done so in the past is through review of Warning Letters and BIMO metrics FDA has made publicly available in our annual Top 10 lists.  We are excited about the possibility of increased transparency and how it will further increase our ability to protect human subjects.  We would love to hear your thoughts about their new program.

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Topics: openFDA, Freedom of Information Act, FDA, HIPAA

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