Roll Call: Latest News on Capitol Hill, Congress, Politics and Elections
February 10, 2016

Samsung’s Health Project: the FDA Factor

Samsung today announced the Simband, a “reference design” for a wearable sensor gadget that would allow people to track their health data. Along with Apple’s rumored upcoming launch of an iWatch with health apps, the Samsung move pushes the concept of real-time tracking of consumers’ health information closer to the point where regulators and lawmakers will have to revisit the issue.

There has been some activity in Washington, for sure, in recent months. The FDA issued a guidance on medical apps in September 2013, but it left some observers unsatisfied. In March of this year, a bipartisan group of senators urged the agency to work with Congress to make sure that Washington is doing what it can to protect consumers while ensuring that innovation continues.

CQ Roll Call’s Emily Ethridge noted back then that Rep. Marsha Blackburn, R-Tenn., has a bill “that she says would detail the FDA’s oversight responsibilities and ensure that ‘low risk’ applications are not subject to the agency’s regulation.” Sen. Deb Fischer, R-Neb., also has introduced similar legislation with Angus King, I-Maine, noted Ethridge. The Senate letter was from Michael Bennet, D-Colo., Orrin Hatch, R-Utah, Tom Harkin, D-Iowa, Lamar Alexander, R-Tenn., Mark Warner, D-Va., and Richard M. Burr, R-N.C.

Samsung, Apple and other companies have been laying the groundwork for awhile. Samsung got FDA clearance for a “cardiology signal transmitter” about six months ago for its S Health app on Galaxy model phones, and the New York Times reported that Apple met with agency officials “to discuss mobile medical applications” in December.

Today’s Samsung announcement included the launch of a $50 million fund that will help other companies participate in developing sensors and software. The regulatory questions were obvious to Gigaom’s Stacey Higginbotham:

Samsung also didn’t cover federal approvals in great depth, so it’s unclear how or when this reference design could even be used by doctors for assessing patient health. And it’s clear that to really break open the healthcare market, these devices and their algorithms will need some kind of scientific review to ensure accuracy and efficacy.

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