House Committee on Energy and Commerce Holds First of Three Days of mHealth Hearings

3-19-2013 11-23-05 PM

The House Committee on Energy and Commerce kicks off what will be three days of hearings focused on mHealth in a session titled “Health Information Technologies: Harnessing Wireless Innovation.” The meeting was presided over by the Subcommittee on Communications and Technology.

The hearing focused on innovation within the industry and the potentially dampening effect that government regulation and additional taxes might have on what Rep. Fred Upton calls an industry “characterized by low barriers to entry, quick time to market, inexpensive retail prices, and rapid upgrade cycles.”

In attendance to testify from the industry was Ben Chodor, CEO of Happtique; Robert Jarrin, senior director of Qualcomm; Bradley Merrill Thompson of the mHealth Regulatory Commission; Jonathan Spalter, chairman of Mobile Future; and T. Forcht Dagi, partner of HLM Venture Partners.

The overriding theme from industry testimony was that FDA regulation of mobile medical apps would be a welcome improvement over the current lack of clarity. Happtique CEO Ben Chodor pointed to that lack of clarity as the primary reason he chose to develop a private industry standard and certification path for mHealth app developers. In addition, Chodor explained that under currently published standards, the FDA would only exercise regulatory authority over apps that directly connected with medical devices. This limited regulatory role would prevent a vast majority of medical apps from regulation.

Industry figures also addressed concerns regarding the medical device tax and its potential application on smartphones and tablets. All representatives testifying were unanimously opposed to any application of the medical device tax on mobile devices, suggesting that it would be an inappropriate application of the tax, citing text from within the law that excludes commonly available retail devices.

The session concluded with a reiteration by House Representatives that the industry’s unified position favors clarity on FDA regulation of medical apps but is strongly opposed to taxation.

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