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 "Congress Explores Potential Regulation of Mobile Health Apps."
Following is an excerpt:
Health care professionals and mobile applications developers who kept a close eye on last week's mobile health app hearings convened by three separate U.S. House of Representatives Energy and Commerce subcommittees didn't get many answers. However, the hearings did precipitate more questions.
Republican members of the Communication and Technology, Health and Oversight and Investigations Subcommittees scheduled the hearings to examine how the Food and Drug Administration (FDA) plans to regulate mobile medical applications (MMAs), how these regulations might impact innovation and whether the Affordable Care Act's 2.3% tax on the revenues of medical device companies would apply to MMAs and mobile platforms. ...
But Bradley Merrill Thompson, general counsel at the mHealth Regulatory Coalition, said this is unlikely. He explained that the provision of the Affordable Care Act that codifies the medical device tax has an exemption for retail purchases. Any platform or application that is intended for purchase by the general public is exempt from the tax, even if that platform or application functions as a regulated medical device.
"Stuff sold to consumers through the app store would not be subject to the tax," Thompson said.