FDA officials: Context key to examining complex health datasets

While information pushed out by the increased use of fitness and mobile health apps and devices holds vast potential to improve the healthcare industry, much work is left to be done by patients, providers, payers and government entities to tap that potential, according to Isaac Chang of the U.S. Food and Drug Administration.

At an FDA workshop held Sept. 11 at the University of Maryland, Chang, who serves as director of the division of postmarket surveillance at the agency's Center for Devices and Radiological Health, said, for instance, that context is incredibly important to understanding analytics from such tools, but often is overlooked.

"The first thing you need to understand about medical device use is, it's complex," Chang said. "You're not just talking about monolithic data. You're not just talking about how to analyze adverse event reports."

Those different points of view, Chang said, are key to understanding the large swaths of data culled from such devices, whether they focus on adverse events or fitness levels.

"Why do we need to look at perceptions? Because not everybody has access to every piece of information," he said. "The public doesn't have all of the data that [the FDA] has, so their perceptions and their judgments of what is actually there are completely different" than our perspectives.

Chang said understanding different interpretations of data allows individuals to form an idea of orientation of who people are reporting to, which in turn makes it easier to build models based on that data and to ultimately capitalize on it.

Bakul Patel, associate director for digital health at the FDA, compared the increased use of such devices and social media to the tagging of animals by wildlife experts and organizations, but like Chang, thought that the data produced can be overwhelming.

"Now you're going to have more information" than you thought you could ever have, Patel said. "We need to figure out how to make all of this big data meaningful so we can actually do something with it."