Industry Experts Urge FDA Restraint In Regulation of Mobile Medical Technology

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Mobile health technology experts March 19 urged lawmakers to push for regulatory restraint concerning mobile medical applications, particularly in how the Food and Drug Administration oversees the industry.

The mobile health industry promises to improve the personal health of millions of Americans but could be stifled under burdensome regulation or taxation, experts told the House Energy and Commerce Subcommittee on Communications and Technology during a hearing titled “Health Information Technologies: Harnessing Wireless Innovation.”

“We must find the best way to advance the nation's health and wellness and protect our citizens' safety and privacy without stifling innovation and investment,” Jonathan Spalter, chairman of Mobile Future, an industry group representing mobile device makers, said.

Mobile health application and device developers “need a clear understanding of where regulation begins and ends, common-sense approval and review processes, low economic barriers to entry, timely decisions reflective of the short development cycle for mobile applications, and a cohesive approach across government agencies,” he said.

Regulation should “be commensurate to the risk the apps pose to the patient.”  


--Bradley Merrill Thompson, Epstein Becker & Green PC

Bradley Merrill Thompson, an attorney with Epstein Becker & Green PC in Washington and general counsel for the mHealth Regulatory Coalition, said many mobile health apps do not present any health risk to those who use them.

Thompson said regulation should “be commensurate to the risk the apps pose to the patient.”

Thompson said his coalition has also asked FDA to address mobile applications that deal with wellness, such as those that record exercise levels or diet, and to issue guidance addressing the extent to which those tools will be regulated by the agency.


Nearly all the Republican members of the subcommittee said that an overly stringent FDA regulatory stance on medical apps would create “unnecessary hurdles” that would stifle the industry.

Democrats argued that the hearing was called merely to criticize the Affordable Care Act--which created a new excise tax on medical devices. Rep. Henry A. Waxman (D-Calif.) called claims that consumer smartphones would be subject to a new tax “absolute myths.”

Waxman said FDA should, and has indicated it will, institute an approval process for invasive devices or those that claim to diagnosis diseases or conditions. He said such a process would be done without additional taxes or a burdensome approval process.

“There are legitimate concerns we ought to examine … but it is not going to require mobile apps to be regulated or to be taxed,” he said.

The hearing comes in the wake of a March 1 letter to FDA Commissioner Margaret A. Hamburg from leaders of the Energy and Commerce Committee, asking when a 2011 draft guidance would be issued in final form, whether FDA has considered the tax consequences for mobile device makers under the health care reform law, and specifics on mobile medical apps that have already sought FDA approval .

FDA in 2011 issued a draft guidance document outlining a proposal to oversee mobile medical applications that were used as an accessory to a medical device or that, by nature of their function, turned a mobile device, such as a smartphone, into a medical device.


Energy and Commerce Committee members raised concerns that mobile apps, if they are regulated as medical devices, could be subject to the medical device tax under ACA, and said any new taxes for the mobile health industry could “harm the innovation and economic benefits of the U.S. mobile marketplace.”

“The specter of costly and time-consuming regulation … looms large over this industry,” Rep. Greg Walden (R-Ore.), chair of the subcommittee, said. “Investors, wireless device manufacturers and application developers all face the uncertainty of an FDA regulatory regime that may or may not apply to them and the possibility of an additional excise tax that cuts into already thin margins.”

“Investors, wireless device manufacturers and application developers all face the uncertainty of an FDA regulatory regime that may or may not apply to them and the possibility of an additional excise tax that cuts into already thin margins.”  


--Rep. Greg Walden

Benjamin Chodor, chief executive officer for Happtique Inc., a mobile solutions company, agreed that any taxation of mobile devices would be passed down to consumers and damage the industry's promise of providing inexpensive personal health tools but noted that nearly all consumer mobile devices would not be subject to the medical device tax.

He said, based on FDA's draft guidance, consumer electronics would not be impacted by FDA regulations but the agency should explicitly specify its intentions for enforcing regulations on mobile devices in a final guidance. Chodor said final guidance would provide mobile application and device developers' confidence to invest more in new technologies.

“Frankly, the threat of tax stifles innovation too,” Chodor said.

Chodor argued that the “retail exemption,” a provision of ACA exempting consumer devices, does apply to smartphones such as Android and Blackberry mobile devices and Apple's iPhone and asked FDA to issue final guidance specifying that point. He said that while clinicians have begun to use such devices, they are not medical equipment.

Government officials were not on the witness panel for the hearing.

FDA's process for certifying medical equipment can be time-consuming and would stifle a developer's ability to issue software updates as issues arise, a typical industry practice, Chodor said.

Chodor said the rate of development for mobile health applications has been increased significantly over the past two years. Currently, there are more than 45,000 mobile health applications, ranging from scheduling reminders to urinalysis tools.

More Hearings to Come

More hearings are scheduled before Energy and Commerce subcommittees in the next two days.

On March 20, the Health Subcommittee will discuss how technological advancements benefit health care patients and “ways to promote innovations.”

Scheduled to speak March 20 are Joseph M. Smith, chief medical and chief science officer for West Health Institute; Jacqueline Mitus, senior vice president of clinical development for McKesson Health Solutions; Jim Bialick, executive director of the Newborn Coalition; Christine Bechtel, vice president of the National Partnership for Women and Families; and David Classen, chief medical information officer at Pascal Metrics and professor at the University of Utah School of Medicine.

On March 21, the Oversight and Investigations Subcommittee will hear directly from FDA and the Department of Health and Human Services on their plans for regulating mobile health applications. Speakers for that hearing, according to the committee website, are Farzad Mostashari, the national coordinator for health information technology at the Department of Health and Human Services; and Christy Foreman, director of FDA's Office of Device Evaluation, Center for Devices and Radiological Health.

By Alex Ruoff  

More about the hearings in the House panel is at