You may not think that the Affordable Care Act will have much of an effect on smartphones, tablets and apps. But 6 Republican U.S. representatives fear that the health reform law will qualify each as a device, subject them to the industry excise tax, and by default, hamper business growth and innovation.
The Hill highlights the details in its "Healthwatch" blog, which refers to a letter to the FDA issued by the House Committee on Energy and signed by 6 Republicans: Michigan Rep. Fred Upton, the committee chairman; Pennsylvania Rep. Tim Murphy, Tennessee Rep. Marsha Blackburn, Texas Reps. Michael Burgess and Joe Barton; and Oregon Rep. Greg Walden.
Several of the legislators' concerns focus on the ongoing uncertainty over the FDA's long process to develop and issue regulatory guidance. Those delays in regards to medical device apps, they note, come as medical device companies increasingly develop apps for smartphones and tablets specific for medical use, such as monitoring diet and fitness data, or conditions such as diabetes and high blood pressure. (There are more than 40,000 medical apps and growing, the letter notes.)
The query, issued from the House Committee on Energy and Commerce, points out that the FDA has been actively considering whether to regulate mobile medical apps at least since 2011, when it began to seek public input on how to regulate mobile medical apps as medical devices. Draft guidance would require FDA oversight for an app, device or tablet used an accessory to a medical device already regulated by the FDA. That wouldn't necessarily mean a smartphone is a medical device, but it would be regulated in the context of whether a product is being marketed for intended use as a medical device. But the Republican representatives fear that how the device is actually used will also come into play--"actual use" means that if it is used as a medical device, it will be deemed just that.
Their greatest concern is that if smartphones, tablets or certain medical apps are ruled to be medical devices under the final guidance, they'd be subject to new taxes under the Affordable Care Act. The law, of course, includes a 2.3% device tax intended to help raise revenue to pay for the law, and Republicans and the industry have bitterly opposed the measure as a killer of both jobs and innovation. And the FDA response is, needless to say, "to be continued."
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