A new online initiative from the U.S. Food and Drug Administration (FDA) may offer a partial antidote to the government tech hangover the botched launch of HealthCare.gov gave the American people last fall. When openFDA went live on June 2, 2014, announced by U.S. chief technology officer Todd Park to great acclaim at the 5th Health Datapalooza in Washington D.C., the public gained the ability to search through millions of adverse drug reactions.
"This is only the beginning for openFDA," he said. "Throughout the summer, the openFDA initiative will be adding APIs for product recalls and product labels as well. We can't wait to see what [people] will build using this information as fuel."
Park also announced that the Blue Button now enables personal data access to more than 150 million Americans.
The new open data platform, operated by the FDA's Office of Informatics and Technology Innovation (OITI), joins a growing number of online efforts that the Obama administration is starting up in its second term.
As I've highlighted before, these open government data feeds represent an important class of public infrastructure for researchers, industry, media, and the American people to use. Open data fuels economic activity, enables resilience against climate change, provides insight into healthcare costs and fraud, energy efficiency and cost savings, and many other outcomes, from transparency and accountability to public participation. The 20 gigabytes of data (compressed) behind openFDA are now part of that list, with a potential outcome that goes beyond efficiency: increased consumer safety.
"Pharmaceutical companies already use this data," said Sean Herron, a Presidential Innovation Fellow who worked on the openFDA project. "There is vast potential for finding more drug-to-drug interactions. The FDA uses this data right now as a huge part of surveillance activity and already is using it quite a bit internally to get insights. Our hope is by putting it out to the public, it will inform consumers. If people do research or scientific inquiry on it, it will help the FDA. Currently, researchers have a hard time citing events data. Our hope is that by having data in the open, it will help research."
How did the new platform come to be? That success story involves many major players: leadership at the FDA that supported the initiative, a Presidential Innovation Fellow dedicated to it, a small team of contractors that used current web technologies and standards, and a technology startup that used the power of cloud computing and crowdsourcing to digitize documents.
OpenFDA was announced in February 2014 at the Safety Datapalooza, after the agency quietly put up open.fda.gov in January 2014. Alexander Gaffney, a sharp-eyed observer at the Regulatory Affairs Professionals Society, noted that the effort to free the data was unprecedented at the agency. That means leadership mattered.
While there was a top-down mandate from a 2013 Presidential Executive Order on open data and momentum from years of the Department of Health and Human Services' Community Health Data Initiative, the FDA still had to decide to commit to putting this data online and follow through with harmonization, digitization, and publishing. The agency hired Dr. Taha Kass-Hout as its first health informatics officer in March 2013. Dr. Kass-Hout came over from the Centers for Disease Control and Prevention (CDC), where he'd helped the CDC adopt cloud computing. Here's an excerpt from his introductory blog post on openFDA:
What may not be clear from this post or the FDA's other public statements is that these open datasets weren't just hard to access in digital form — there was also cost involved to acquiring it. Before openFDA went online, the way to get the data was to visit the site AdverseEvents, which acquires the data using the FOIA and resells it for a couple of hundred dollars.
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