Experts Call for FDA To Finalize Rules on Health App Oversight

During a congressional hearing Tuesday, experts called for FDA to quickly finalize its draft guidance on the agency’s plans to regulate mobile health applications, Clinical Innovation & Technology reports (Pedulli, Clinical Innovation & Technology, 3/19).

The hearing was the first in a three-day series of meetings organized by the House Energy and Commerce Committee to examine how FDA should regulate mobile medical apps.


In 2011, FDA requested public comment on how it should regulate smartphones, tablet computers and apps that collect health information or are used to monitor medical conditions.

The agency has yet to issue final guidance about how it plans to regulate such technology. However, FDA in its draft guidance said that the medical device regulations would apply only to mobile technologies that are marketed explicitly for medical uses (iHealthBeat, 3/13).

Experts Urge FDA To Issue Final Guidance

During the first day of hearings, Bradley Merrill Thompson — general counsel for the mHealth Regulatory Coalition — recommended that FDA quickly issue its final guidance on regulating mobile medical apps and then provide updates to the guidance as needed. He noted that “there’s an awful lot of business that is frozen on the sidelines waiting to see what that guidance says.”

Ben Chodor — CEO of Happtique, a mobile health app store and evaluation service — said, “The public needs to know, the developers need to know, hospitals need to know, doctors need to know what’s going to be regulated, what’s not going to be regulated.”

Robert Jarrin — senior director of government affairs for Qualcomm Incorporated, a provider of wireless technologies — said that “the failure to release final guidance has created uncertainty among countless budding entrepreneurs and large corporations that fear the prospect of facing FDA regulation” (Attias, CQ Roll Call, 3/19).

Concerns About Taxing of Health Apps

Also at the hearing, stakeholders expressed concern about whether mobile health apps would be subject to the Affordable Care Act’s 2.3% excise tax on medical devices.

Chodor said that the tax would “slow innovation by placing burdensome costs on apps developers in a new and growing market.”

George Ford — chief economist at the Phoenix Center for Advanced Legal and Economic Public Policy Studies — said, “Economists would broadly agree that such taxes will reduce the rate of innovation and the introductions of new mobile medical applications and devices by lowering the returns on such innovations.”

However, ranking committee member Henry Waxman (D-Calif.) said he believes that most mobile health apps would be exempt from the medical device tax because of IRS’ “retail exemption” provision. Under the provision, devices that are widely available to consumers and not primarily intended for medical use are exempt from the tax (Slabodkin, FierceMobileHealthcare, 3/19).

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Concierge Medicine Journal (CMJ) curates breaking concierge medicine news, and editorial opinion on a wide variety of topics relevant to the practice of Concierge Medicine.

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