The “linchpin” for effectively using big data to customize individual care and to personalize medicine--while finding cures faster and at lower costs--is accurate information, according to Jeffrey Shuren, M.D., director of the Food and Drug Administration's Center for Devices and Radiological Health.

“We want to make sure the information is accurate, reliable and meaningful because--if not--doctors and patients make the wrong decisions,” said Shuren at a June 24 roundtable on 21st Century Cures held by the House Energy and Commerce Committee.

“The stakes are even higher as we move into the world of big data as we’re able to pool large amounts of information and sift through it, not just with the eyes of a human, but with the smarts of analytical software and other technologies,” he warned. “If the information is wrong about the individuals when we put it together, we’re now wrong about the population and we go after the wrong cures or we don’t develop cures and miss the opportunities.”

Last week, the committee issued a white paper for public comment regarding potential digital and personalized healthcare technologies intended to enable 21st Century cures, highlighting a laundry list of technologies including data analytics, genomics, and health IT. Specifically, the committee’s paper called out the critical role that “large scale analysis and predictive modeling of big data” can play in providing patients with more personalized prevention or treatment options based on their unique set of circumstances.

Of the 7,000 known diseases, there are only treatments for about 500 of them, noted House Energy and Commerce Committee Chairman Fred Upton (R-Mich.). However, Upton said digital and personalized healthcare holds great promise for patients.

Nevertheless, a major obstacle is the lack of interoperability and sharing of health information. “We don’t have smooth, semantic interoperability to share information across our experiences as physicians and as the owners and curators of large data sets,” said Joseph M. Smith, M.D., chief medical and science officer at West Health. “We instead proprietize those things. We find business models that mandate keeping them separate and it frustrates our learning.”

“We desperately need that information to flow seamlessly at the point of care but also to be amalgamated in a way that fosters our discovery of these new relationships between variables we wouldn’t have otherwise imagined,” added Smith.

The purpose of the committee’s roundtable was to discuss the commercial and regulatory barriers that prevent healthcare technologies from being used on a larger scale at both the point of care and for additional research and development activities.

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