The House Committee on Energy and Commerce's Subcommittee on Communications and Technology has launched a three-day series of hearings to investigate issues involving mobile health – in particular, how to keep innovation flowing without over-regulating the mHealth industry.
Scheduled as a witness in Tuesday’s hearing, Jonathan Spalter, chairman of Mobile Future, an organization that represents innovators across the wireless ecosystem, writes in his testimony that his group is united in its commitment to advance a policy environment that encourages mobile investment and innovation.
“Nowhere is that promise of future innovation and opportunity greater than mobile health,” he writes. “Our message today is that the innovation and vision exist now in both the medical and technology communities working together collaboratively. This progress will proceed, in many respects, as rapidly as government allows.”
Kerry McDermott, the former director of healthcare for the Federal Communications Commission who's now senior director of healthcare technology policy for West Health Institute, says there is “a lot of consternation in the market.”
Vendors "can innovate faster than the regulatory environment can keep up with,” she said in a recent interview. “The FDA is trying to set up guidance in the mobile app space. They are really trying to take a light-touch approach. There are so many apps that can do good, they want to let them flourish. Policy is a very blunt instrument and you’re asking the agency to snap a chalk on that curve. In today's world that doesn't cut it anymore. We need something to be more tailored.”
Because of that, the FDA is leaning more heavily on guidance and less on regulations. So far, it is limiting its regulation to apps that can turn a phone into a medical device, McDermott said.
Robert Jarrin, senior director of government affairs at Qualcomm, said he would like to see the FDA finalize the Mobile Medical Applications (MMA) draft guidance document, issued in July 2011. mHealth executives have been awaiting the FDA's final word, with several hoping it would have been released at the 2013 HIMSS Conference and Expositions earlier this month.
“The final MMA guidance should offer specific examples of low-risk regulated mobile
medical devices that FDA, through enforcement discretion, would not regulate," Jarrin, who spoke at HIMSS13, said in prepared comments for this week's hearing.
“(The) 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,” he added.
Also in prepared comments, 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.”
“Anyone with a good idea and computer coding ability can get into the business and distribute their innovation around the world,” Ford added. “And thanks to the proliferation of subsidized smartphones and the popularity of 'app stores,' mobile apps are projected to be a $25 billion industry this year and are estimated to have already produced 500,000 jobs.”
Health-related applications are a growing segment of the market. Five percent of smartphone owners have downloaded an app to track or manage their health, according to a September 2012 Pew study. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), the FDA could potentially classify these applications – as well as the smartphones and tablets that run them – as medical devices, subjecting them to a lengthy clearance or approval process. Further, this classification could subject these products to the 2.3 percent medical device tax under the Affordable Care Act.
“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 warned.
“How will the FDA handle small, iterative updates to apps to accommodate operating system changes?” he asked. “Does the FDA process contemplate the potentially short life span of a particular wireless device or version of an operating system? Does the FDA intend to reevaluate apps each time there’s a change anywhere in the ecosystem? Why is an app even considered a medical device under the FFDCA?”
“The lack of clarity surrounding the definition and guidelines has also exacerbated the problem by creating a cloud of uncertainty around applications and device uses that do not fit clearly into the examples the FDA provides," Ford wrote.
Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition, is also calling for FDA clarification on mobile apps. “The development and adoption of these technologies has been so swift that thousands of mobile health apps are already on the market,” he wrote.
“Now we need final guidance on mobile medical apps to assure innovative products get to market so that healthcare professionals, patients and consumers all have access to needed tools to manage their health. A final guidance would provide the regulatory predictability necessary for investors to support, and manufacturers to develop, important new products,” Merrill said.
Tuesday's hearing, which was scheduled to begin at 10:30 a.m., will focus on harnessing wireless innovation, and the other two hearings will address patient benefits and regulation. Witness testimony will be posted prior to the hearings, which are available via webcast at http://energycommerce.house.gov/hearings
