Republican members of the House Energy and Commerce Committee have asked the U.S. Food and Drug Administration if it intends to regulate smartphones, tablets and mobile apps as medical devices under the Affordable Care Act, as reported by The Hill newspaper in a blog.
The ACA imposes an excise tax on medical devices. In a March 1 letter to FDA Commissioner Margaret Hamburg, six GOP committee members expressed their concerns that if the agency determined that certain smartphone, tablet, or mobile medical apps are devices, "it raises the possibility that they would also be subject to new taxes under the PPACA."
A tax on these apps "could affect the growth and innovation" of the mHealth industry, they warned.
Although the FDA's July 2011 draft guidance focused on the "intended use" of the application when determining whether it should be regulated as a medical device, the Republican lawmakers wrote in their letter in The Hill that they "are concerned about the potential of 'actual use' becoming a factor in the future."
The Republican House members asked that the FDA provide the committee with written answers to its specific questions by March 15, including the following:
- When will the FDA issue final or updated guidance with respect to the July 19, 2011, request for input on its oversight approach for mobile medical apps designed for use on smartphones or other mobile computing devices?
- Has the FDA discussed, prepared or analyzed the effect of the medical device tax on smartphones (as well as tablets or similar devices) or the creators or distributors of applications for those products?
- Will the actual use of a smartphone, tablet, or app be a factor in whether the FDA chooses to regulate the device or app as a medical device?
The FDA has yet to issue final rules for regulating mobile medical apps. Industry observers have expressed concerns that when the agency releases final guidance later this year, mobile medical application developers will be subjected to the same slow, burdensome approval process that medical devices must go through.
Not so, says a prominent Silicon Valley lawyer quoted in a Jan. 30 Wall Street Journal blog. The financial newspaper quotes Mavis Yee, a partner at Silicon Valley law firm Nixon Peabody, who believes the regulatory environment for mobile medical apps could be more benign than many industry observers fear.
According to the draft guidance, the FDA has little interest in regulating the vast majority of the 40,000 or more mobile medical apps that currently are available for mobile devices, said Yee, whose firm has a dedicated health-technology legal practice.