Three days of reckoning for mHealth regulations
Today begins the first of three days of hearings held by the House Energy and Commerce Committee to consider the weighty issue of how the U.S. Food and Drug Administration should regulate mobile medical applications. It is a central question that has far-reaching consequences for a mobile healthcare industry still trying to get off the ground.
At the center of these proceedings stand two laws passed by Congress: the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Affordable Care Act. What remains uncertain is whether the FDA will classify mHealth apps--as well as the smartphones and tablets that run them--as medical devices under the former.
If the regulatory agency makes such a classification, that interpretation could subject those products to the Affordable Care Act's 2.3 percent medical device tax. A March 15 memo from the Energy and Commerce Committee's Republican majority staff warns that "overbroad" application by the FDA 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."
The FDA won't get its chance to testify before the Oversight and Investigations Subcommittee until Thursday, so we'll have to wait and see what the agency has to say for itself. If nothing else, the three days of congressional hearings will serve to prod the FDA to publicly articulate its current thinking, and to promptly finalize its Mobile Medical Applications (MMA) guidance document. After all, it's been more than a year and a half since the agency issued its draft guidance in July 2011. An update is long overdue and sorely needed to remove the uncertainty that currently clouds the future of mHealth.
Congressional hearings are supposed to be a forum for collecting and analyzing information derived from witness testimony in the early stages of legislative policymaking. However, oftentimes, they disintegrate into political theater.
A recent report indicates that conservative tax-reform activist Grover Norquist is putting some of his organization's political muscle behind a "mostly GOP-fueled effort to paint the medical device excise tax as a danger to smartphones and tablets." In setting the stage for this week's hearings, Energy and Commerce Committee Chairman Fred Upton (R-Mich.) in an announcement said that "most Americans have no idea that their smartphone, tablet or the mobile apps that have become part of their daily lives could be subject to added red tape or a new tax under Obamacare."
Republican members of the House Energy and Commerce Committee are the ones driving the agenda for these hearings. Hopefully, they will conduct the proceedings in a constructive and civil manner that doesn't disintegrate into partisan rancor. It would be a shame if Congress were to squander this important opportunity to gain insight into the regulatory issues facing the mobile healthcare industry. - Greg (@Slabodkin)