My undergrad alma mater, La Salle University, has won its first NCAA tournament game. Not since the days of Lionel Simmons have they had a chance to compete in college basketball’s ultimate showdown. March Madness is a time of elation, frustration, and surprises. Ultimately the dust settles with a college basketball champion.
Now March Madness has come to Washington, D.C. as well. I’m not talking about the president’s annual filling out of the presidential bracket. I’m talking about an important hearing on mobile health held by the communications and technology subcommittee of the Committee on Energy and Commerce. They are hearing testimony on Health Information Technologies and focusing on “Harnessing Wireless Innovation.”
Mobile Health Debate
Marsha Blackburn (R-Tennessee) is focusing the debate on the taxation of medical devices. Here’s how it works: Medical devices have a 2.3% tax – this was established by the affordable care act – but this is a bit misleading. First off, this would not apply to mobile phones because they are sold at retail. Secondly, a phone is only a medical device when the FDA has approved a medical claim made by the manufacturer. Some members of the committee have insinuated that the 2.3% tax would apply to all mobile phones and tablets – this is flatly a distortion of the truth. Nonetheless, some members of congress are using this to put the regulatory agency under a microscope and suggest regulatory clearance be removed from their purview. Now that is March Madness.
There are 28,000 unique health apps (and another 500 new apps being added per month) in this booming area. But fewer than 80 have been cleared. Much of this is because the guidance from the FDA is still draft.
Comments from the Industry
Testimony from industry representatives is clear: the FDA needs to finalize the draft Mobile Medical Application (MMA) guidance and should look at how it can protect patient safety without hindering the realization of benefits being driven by health IT innovation.
Currently device manufacturers who use mobile phones are circumventing this by clearly stating, “This is not a medical device.” But this leaves a lot of value on the table, as this is precisely how they are being used – Only to be replicated by traditional tests and registered medical devices which are ultimately much more costly to the healthcare system.
Robert Jarrin from Quallcomm estimates there are currently about 1,200 medical apps which fall into this gray zone. There are apps and phone accessories which screen diseases of the retina, diagnose moles, screen for cancer, coordinate physicians across a care facility, or provide remote monitoring of the ICU. The time to bring more of these cost-saving, life-saving tools to market is now. Representative Burgess of Texas said it best during the hearing. “The market hates uncertainty.” Until the FDA regulations are finalized, real innovation won’t be unleashed. And there won’t have any mobile health champions crowned.