Three subcommittees of the House Committee on Energy and Commerce held hearings March 18-21 to investigate issues involving mobile health – particularly how to keep innovation flowing without over-regulating, or endangering patients.
“The collision of worlds in the mobile health – or mHealth – market is a study in contrasts,” said Greg Walden (R-Ore.), chair of the House Subcommittee on Communications and Technology. “The app economy is characterized by low barriers to entry, quick time to market and the ability to adapt to quickly changing user needs.”
“Medical devices, on the other hand, face a long and costly pre-market approval process at the FDA,” Walden said. “We all want to ensure patient safety, but why would we treat mobile applications the same as a dialysis machine? Wireless has and can continue to bring the mobile revolution to our nation’s health and wellness sector. But we must ensure that as we bring the innovation of the wireless economy to health and wellness that we not place unnecessary hurdles in the way of the developers and investors that are fueling mHealth.”
Jonathan Spalter, chairman of Mobile Future, who testified March 18, said progress in mobile health could proceed “as rapidly as government allows.”
“Nowhere is that promise of future innovation and opportunity greater than mobile health," he said. "Our message today is that the innovation and vision exist now in both the medical and technology communities working together collaboratively.”
Robert Jarrin, senior director of government affairs at Qualcomm, said he would like to see FDA promptly finalize the Mobile Medical Applications draft guidance document, issued in July 2011. "The final MMA guidance should offer specific examples of low-risk regulated mobile medical devices that FDA, through enforcement discretion, would not regulate," he said.
FDA "should continue its commitment to consistency, predictability and transparency by coordinating internal and external efforts through a single dedicated office of mobile health within FDA” said Jarrin.
George S. Ford, chief economist for the Phoenix Center for Advanced Legal & Economic Public Policy said “low barriers to entry, quick time to market, inexpensive retail prices and rapid upgrade cycles have made the mobile application economy an American economic success story.”
“Overbroad application of this classification could stall the innovation, investment, and job creation that wireless smartphones and apps are bringing to healthcare, as well as ultimately impact the larger wireless ecosystem,” Ford warns.
According to FDA witness Christy Foreman, director of the Office of Device Evaluation, Center for Devices and Radiological Health Food and Drug Administration, the FDA will not regulate mobile devices in the future that it currently doesn’t regulate now, unless “strong safety signals” would indicate it.
Many at the hearings observed, the gray area between obvious personal wellness apps and diagnostic tools is large and murky. Many apps fall into the regulation zone for FDA, and some apps could be potentially harmful to a patient if the results were incorrect.