Legislator – FDA Should Create New Office to Regulate Mobile Apps (Additional Information)


Honda first introduced the measure in September 2012, late in the 112th Congress. By rule, all measures not passed during the previous two-year congressional session must be reintroduced during the new session.

His bill, the Healthcare Innovation and Marketplace Technologies Act (HIMTA), is intended to reduce barriers to entry for developers of mobile health applications, many of whom work or reside in his Silicone Valley district.

FDA currently regulates those applications, or ‘apps,’ as medical devices under a framework intended to adhere to the definitions of the Federal Food, Drug and Cosmetic Act (FD&C Act).

Under the FD&C Act, medical devices are defined as being any “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is either intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease or intended to affects the structure of any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body.”

Thus, an application like a fitness tracking application or a calorie-counting application would not, by itself, be considered a medical device under that framework. However, an application which claims that by following its regimen you can reduce obesity, or an application that claims to emit a frequency that can cure tinnitus, would both be considered a medical device under the FD&C Act and would be required to undergo a review process.

Sector Problems

The latter types of apps—those that should be regulated by FDA—are increasingly being seen by some as modern-day snake oil. Few applications have been shown to be effective at their given purpose, and others are outright scams masquerading as cures. As we wrote in November 2012, “Once, charlatans peddled snake oil medicines as cure-alls. Now, there’s an app for that.”

The sector is not without other, more intrinsic problems as well. A May 2012 report by the US Department of Homeland Security (DHS) noted that medical devices—mobile applications included—are able to be compromised by hackers. A mobile application that controls a diabetes pump or one that contains a patient’s medical records could both be tempting targets for those looking to do harm to a patient. The sector is also regulated in part by the Federal Trade Commission, which put out guidance in September 2012 regarding acceptable claims practices by applications that are medical in nature but do not make claims that subject them to regulation by FDA.

The sector—and its problems—has gained enough attention to warrant the release of an FDA draft guidance document in 2011, Mobile Medical Applications, which establishes agency definitions for mobile platforms, mobile medical applications, mobile applications, and the manufacturer of such an application. FDA’s Center for Devices and Radiological Health (CDRH) announced in November 2012 that it plans to finalize the guidance document in 2013.

But inherent in the regulation of mobile medical apps is a problem, and one identified in a recent session at 2012 RAPS: The Regulatory Convergence: How do you ensure a device— in this case, an application—is safe and effective for its given purpose while maintaining the nimble, fast-paced atmosphere that has made the mobile app sector so alluring?

Honda’s Bill

That question seems to weigh heavily on Honda, who sat down recently for an interview with
the Wall Street Journal’s “Venture Capital Dispatch” blog.

Honda said he hopes that “someone with a lot of experience in technology” would lead the office if it were created, saying current FDA talent may be too antiquated to deal with the novelty of the sector.

“The situation today is kind of like the judicial system, back when there were early lawsuits about technology,” he explained. “No judge really knew about that stuff. They had to be trained.” Regulators will either need to find or develop this expertise, he added.

Honda also said the need for such an office is clear to him, noting that the current app industry does not have confidence in the regulatory framework as it now stands. Without a “consistent, reliable framework,” people will be less able to actively participate in their own care by accessing medical records or other data, he added.

His bill—not yet introduced—will reportedly make a number of changes relative to the 2012 version to accommodate suggestions and feedback Honda has received, he said.

“We don’t expect resistance from the FDA,” he added.

REFERENCE: By Alexander Gaffney, RF News Editor