FDA needs streamlined, clear mHealth regulations, critics say

The U.S. Food and Drug Administration came under fire Wednesday in a congressional subcommittee hearing for being slow to finalize the agency's draft guidance for mobile medical applications, which critics charge remain unclear and unpredictable.

"This subcommittee has examined in the past the negative impacts that FDA regulation--with its uncertainty, high costs, and long approval times--has had on the medical device industry," said Rep. Joe Pitts (R-Penn.), chairman of the House Energy and Commerce Committee's Subcommittee on Health. "If we allow the same to happen in this [mHealth] space, such negative impacts could cripple a still evolving and promising industry, where the average developer is small and the cost of these apps are relatively inexpensive."

Pitts also raised the concern that the FDA "may further expand the definition of 'medical device' in the future to include other technologies, such as smartphones or tablets, and thus the medical device tax passed in the Affordable Care Act could apply to them." However, in a continuing theme from yesterday's Communications and Technology Subcommittee hearing, ranking House Energy and Commerce Committee member Rep. Henry Waxman (D-Calif.) blasted Pitts and his Republican colleagues for "trying to scare people that they won't be able to develop what we want to see developed--innovative ways to communicate in the health space."

Despite the committee's "history of bipartisan accomplishments," Waxman expressed his disappointment that some members were engaging in "partisan hyperbole" that included spending "far too much of yesterday's hearing debating an imaginary tax on smartphones." These sentiments were echoed by Rep. Frank Pallone (D-N.J.), a senior member of the House Energy and Commerce Committee and the top Democrat on the Committee's Subcommittee on Health.

"I am afraid that my Republican friends are going to spend this day making up false stories about how the Affordable Care Act and FDA regulations are stifling innovation, and how our smartphones are going to be taxed and Apple's manufacturing plants will be inspected, but I have to say this is nonsense," said Pallone. "The reality is the future of mobile health is very bright."

Yet, he warned that "if a technology developer is going to make health-based claims, then there must be a role for FDA to ensure it's safe and effective." Waxman also advocated for a regulatory approach to mHealth apps that "strikes the correct balance between innovation and patient safety."   

Nevertheless, Rep. Michael Burgess (R-Tex.), vice chairman of the Subcommittee on Health and an M.D., said the "biggest impediment to innovation" is the uncertainty of regulation. "Companies will build it, doctors will use it, and patients will benefit, if we can just get out of the way and ensure responsible regulation in a timely fashion," stated Burgess. "The lack of a reliable and consistent regulatory process signals an inability to handle the advancements for technology in the future."  

Joseph Smith, Chief Medical and Chief Science Officer for the West Health Institute, testified before the subcommittee that the healthcare industry's innovation and experimentation requires a "clear, consistent and timely approach" to regulation.

"It is an open question whether the existing medical device regulatory framework can be sufficiently modified to provide the applicability, clarity,  predictability and timeliness required," Smith told lawmakers. "The FDA's draft guidance on mobile medical apps offered some improved clarity but still described significant areas of regulatory discretion, and now after lengthy delay without becoming finalized, has left an industry in limbo."

He added that "we must drive regulation at the pace of innovation and not vice versa." A West Health Institute report advocating for improved medical device interoperability also was unveiled at the hearing by Smith.

In yesterday's Communications and Technology Subcommittee hearing, Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition, argued that "regulation should be commensurate to the risk the apps pose to the patients." Thompson made the case that "mobile apps such as apps that function as an electrocardiogram device, or apps intended to diagnose skin cancer present a risk to the patient, and therefore ought to be regulated." 

Similarly, Robert Jarrin, senior director of government affairs for Qualcomm, asserted that whether a mobile health app is a medical device or not depends heavily on the "intended use" or public marketing claims of that app. Although comments by FDA officials "would suggest that many low-risk apps would not need to pursue listing as a regulated medical device with FDA," stated Jarrin, the agency's position is still uncertain. "In clarifying its position on certain types of low-risk devices, the agency would go far to ensure predictability, consistency and transparency," he said.

Rep. Marsha Blackburn (R-Tenn.), the committee's vice chair, today told the Subcommittee on Health: "I don't think it's up to the FDA to provide that certainty" but rather "it's up to Congress to decide what FDA's role should be." Jim Bialick, Executive Director of the Newborn Coalition, a volunteer organization that promotes the use of mobile apps for newborn and infant health, also questioned the appropriateness of the FDA's role in crafting mHealth regulations.

"While the FDA has a legitimate role to play in maintaining patient safety for the highest risk products, it is readily apparent that Congress can and should adopt a more flexible model for products that simply manage information," stated Bialick in his written testimony to the subcommittee. "A concern shared by many is whether FDA possesses the manpower and expertise, as well as whether the regulatory science has been fully developed to take on regulation of the mobile medical app market."

On Thursday, FDA and U.S. Department of Health & Human Services officials will get a chance to answer their critics in an Oversight and Investigations Subcommittee hearing. Christy Foreman, FDA's Director of the Office of Device Evaluation, Center for Devices and Radiological Health, is slated to be a witness. In addition, Farzad Mostashari, National Coordinator for Health IT, will appear before the subcommittee.

To learn more:
- read written testimony from hearing