When the House Energy and Commerce Committee announced plans earlier this month for its subcommittees to hold three days of hearings on mobile healthcare, it seemed like a promising development, especially given Congress' reputation as a do-nothing legislature. However, last week's congressional proceedings on mHealth were not immune to the kind of partisan politics and gridlock that dominate Washington these days, crippling our political process.
For three days last week, House Republicans attempted to make political points by linking the Affordable Care Act's 2.3 percent medical device excise tax to mobile devices and mHealth apps. Yet, in the final analysis, the tax issue proved to be a red herring. Rep. Henry Waxman (D-Calif.) rightfully and repeatedly pointed out during the hearings that most medical apps will fall under the Internal Revenue Service's "retail exemption" provision and will not be taxed, while "allegations that ordinary smartphones and tablets could be subject to added red tape or new taxes under [the Affordable Care Act] are absolute myths."
The good that did come out of the hearings was that the FDA firmly committed the agency to issuing its final mobile medical applications guidance by the end of fiscal 2013 (October 1). Granted, that would be more than two years after the FDA's July 2011 draft mobile medical applications guidance was released, a long delay that has only created uncertainty for the mobile healthcare industry. But, at least the mHealth community at large now has a closure date for when it can expect to see a finalized document.
In addition, testimony from an FDA official provided much-needed reassurance that the FDA will only regulate "a small subset of mobile apps" that fit the definition of a medical device under the Food, Drug, and Cosmetic Act. Based on this definition, mobile apps would qualify in that category if they "are intended for use as either: an accessory to a regulated medical device, or transform a mobile platform into a regulated medical device."
Another promising revelation from the FDA's subcommittee testimony was that on average, over the past three years, it has taken the agency 67 days to review mobile medical apps, which is within the statutory 90-day timeframe under the 510(k) process. If that timeframe holds true, it is very encouraging news for mHealth developers who have expressed their fears that they will be subjected to a slow, bureaucratic approval process.
House Republicans should be commended for attempting to shine a light on the regulatory issues surrounding a nascent mHealth industry and devoting three days of subcommittee hearings to testimony from valuable witnesses. However, by making taxes and the Affordable Care Act center stage, they only served to divert attention from the important issues at hand and to demonstrate once again their embrace of partisanship over the national interest. - Greg (@Slabodkin)