FDA's open data initiatives driving innovation

BOSTON—The FDA is working on building community openness through initiatives that aim to drive innovation, explained Taha Kass-Hout, MD, MS, the agency’s first chief health informatics officer as well as director of its Office of Health Informatics, speaking at Bio-IT World Congress.

precisionFDA was launched in 2015 and is part of the Precision Medicine initiative. This ecosystem includes both community and private space, Kass-Hout said. PrecisionFDA is a crowd-sourced, cloud-based informatics platform designed to advance the science and collaboration needed to ensure that genomic tests provide accurate and reliable genetic results.

OpenFDA, launched in June 2014, provides public access to high-value FDA datasets and serves as a community for FDA domain experts to spur innovation around FDA data. It also offers APIs around medical products including drugs and devices. The goal is to help users access APIs without having to go through more than 80 datasets, Kass-Hout said. Users can search through all adverse events for drugs by chemical structure, generic name, patented named—“you name it,” said Kass-Hout. The app lets users simply take a picture of a pill they’re taking to get back information back on cost, alternative medications and more.

There are 7,600 registered API users and 2 million queries a day. He said there are more than 24,000 IP addresses logged in on an average day.

When openFDA debuted in June 2014, the APIs received more than 100 hits per second. To date, there are more than 100,000 internet-connected systems or devices worldwide plus mobile and web health apps and research tools built by the community.

The agency had a lot of complaints before about researchers not able to easily access data, he said. Since openFDA’s launch, more than 52 peer review publication articles have been generated.