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Committee Weighs Pros, Cons of Regulated mHealth App Industry

March 20, 2013
by Gabriel Perna
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Members of the House Energy and Commerce Subcommittee on Communications and Technology openly weighed the pros and cons of having the Food and Drug Administration (FDA) regulate and tax mobile health (mHealth)-based applications. The committee, which is chaired by Rep. Greg Walden (R-OR), said it was necessary to regulate for patient safety purposes, but warned that over-regulation of wireless mHealth could thwart innovation.

Energy and Commerce Committee Chairman Fred Upton (R-MI) said the medical device tax, which is a component of the Affordable Care Act, when applied to the wireless world could “prove disastrous and grind this innovation cycle to a halt.”

“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,” Walden said during the meeting.

Representatives from the mobile app community expressed concern over the FDA not finalizing the rule that they say could apply to apps, smartphones, and tablets. They couldn’t rule out the tax could hamper innovation from their end and talked about how the “overbroad application of the arduous medical device approval process” would hurt the mHealth app marketplace. They also said over-regulation would be a deterrent to investment.

“These types of taxes, if they are applied to mobile medical applications and devices, will stifle innovation, will tempt entrepreneurs to pursue as you suggested other types of innovation, and apply their genius and their efforts to other parts of the mobile ecosystem rather than efforts to make our children, our families, our parents, healthier. So there is an impact, and we need to be very, very vigilant and cautious about going down this path,” said Jonathan Spalter, Chairman of Mobile Future, a non-profit mobile advocate group.

Video of part of the hearing. More can be seen here.



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