Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled “House Subcommittee Chairman Fears Medical Device Tax on Mobile Health Apps.”
Following is an excerpt:
The chairman of the House Energy and Commerce Subcommittee on Communications and Technology suggested that the Obama administration wants to regulate the industry as broadly as possible in order to collect more medical device tax revenue.
“The wireless economy represents a tempting target for the 2.3 percent excise tax that the president’s health care law placed on medical devices,” Rep. Greg Walden, R-Ore, said in his opening statement at a March 19 hearing on regulation of mobile health applications. “The overbroad application of FDA regulation and the Obamacare medical device tax are not, as some have suggested, outside the realm of possibility.”
Although industry witnesses who testified at the hearing did not impute such motives, they unanimously urged FDA to issue final guidance clarifying the types of mobile medical apps that will face FDA pre-market regulation as medical devices. ?…
Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition, said that as a “nerdy lawyer” he could appreciate why FDA has taken so long. He speculated that perhaps the agency is delaying because it wants a “complete and definitive answer” on where to draw the regulatory line in the constantly evolving mHealth world.
“I think what they need to do is put something out there, and update the guidance periodically,” Thompson testified. He also suggested that FDA create a website to offer guidance on a real-time basis.
“FDA should clearly distinguish between disease-related apps that merit regulation and wellness-related apps that do not,” Thompson said. ?…
For mobile medical apps that do cross the line into clearly regulated territory, Thompson argued that FDA needs to apply consistent enforcement. He described a urinalysis app that promises to read the results of a dipstick test by using the camera on a cell phone. While acknowledging the promise of such technology, Thompson stressed the importance of FDA ensuring a level playing field by subjecting the app to the same manufacturing quality system requirements as apply to a traditional urinalysis instrument.