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FDA opens up datasets on drug adverse events to developers, researchers

The U.S. Food and Drug Administration has launched a division for health IT entrepreneurs, researchers and interested members of the public to access data on medication errors and drug adverse events using its API, according to a statement by the FDA. The initiative is part of a broader trend as government health administrators see the […]

The U.S. Food and Drug Administration has launched a division for health IT entrepreneurs, researchers and interested members of the public to access data on medication errors and drug adverse events using its API, according to a statement by the FDA. The initiative is part of a broader trend as government health administrators see the benefits of working with developers to make health data more accessible.

OpenFDA  is the result of extensive research internally and with developers outside the FDA to identify datasets that are in demand and tend to be “fairly difficult to use.” Because information on drug adverse events and medication errors tend to be the most sought after datasets, this became the pilot program. The datasets are compiled from reports dating from 2004 to 2013. Up until now, the data was only available through difficult to use reports or Freedom of Information Act requests, according to the statement.

Dr. Taha Kass-Hout, the FDA’s chief health informatics officer, said the reports will be available “so that software developers can build tools to help signal potential safety information, derive meaningful insights, and get information to consumers and health care professionals in a timely manner.”

The Open FDA initiative also includes the creation of the Office of Informatics and Technology Innovation at the FDA along with Kass-Hout’s chief health informatics officer post. The plan is to expand the pilot to include the FDA’s databases on product recalls and product labeling.

Even before the FDA decided to make this move, startups have been stepping in to make the data released four times each year more easily available, such as AdverseEventsInc. In an interview with MedCity News, CEO Brian Overstreet said OpenFDA doesn’t address the data quality, something that its own filter does.

As part of a challenge by Health and Human Services, Social Health Insights developed a way to mine Twitter data looking for disease term trends as a predictor of disease outbreaks. Earlier this year, two NIH departments said they would award grants for mobile health research projects across the National Institute of Nursing Research and the National Institute of Biomedical Imaging and Bioengineering.