House Committee to Consider FDA Regulation of Medical Mobile Apps

The House Energy and Commerce Committee will hold hearings on March 19, 20 and 21 on possible Food and Drug Administration regulation of medical mobile apps that could be considered medical devices.

In particular, the committee wants to know “how federal regulations could threaten patient safety and innovation and increase costs for consumers,” according to a notice from the committee. Leaders of the committee recently sent a letter to FDA Commissioner Margaret Hamburg, M.D., seeking clarification of the agency’s evolving policy. The committee is concerned that regulation of some medical mobile apps means they could fall under the health care reform law’s excise taxes on medical devices.

The communications and technology subcommittee on March 19 will consider how FDA regulations and taxes could affect innovation in medical mobile apps and devices. The health subcommittee on March 20 will look at how technological advances benefit patients and ways to ensure that innovation continues. The oversight and investigations committee on March 21 will hear testimony from federal officials on the Obama Administration’s perspective and future plans, according to the notice.

More information will be available here in coming days.