House panel debates greater FDA role in regulating health apps

The safety, effectiveness and data security of mobile healthcare applications were examined by a U.S. House subcommittee in a July 13 hearing, with lawmakers alternating between excitement over the potential of apps and concern that consumers’ data isn’t being protected.

The House Subcommittee on Commerce, Manufacturing and Trade wasn’t considering a particular piece of legislation, but trying to gain a better understanding of how mobile apps are “disrupting” the ways physicians and patients engage, and their potential impact on costs, access and care delivery.

“The potential stemming from this technology is undeniable and exciting. To ensure that these life-saving tools are accessible to folks in Michigan and every corner of the country, we need the right regulatory framework in place,” said Rep. Fred Upton, R-Michigan. “A framework that encourages innovation, removes barriers to investment and advances new opportunities for patients and providers to engage in the healthcare system. At the same time, privacy and security are absolute musts.”

What regulatory framework would be appropriate was the main concern.

While the Food and Drug Administration (FDA) does evaluate and approve health apps that complement medical devices, it doesn’t have a say in many apps most readily available to consumers through stores on their smartphones and tablets. Nicolas Terry, a health law professor at Indiana University, said those unregulated apps may still function like a medical device outside of the FDA’s normal approval process.

“It will proudly tell you this is for information, education or is a game for enjoyment only, and should not be sold for diagnosis. Yet at the same time, they are selling these things for what look like diagnoses,” Terry said. “Unless that gets tightened up, I worry the good companies will find themselves overwhelmed by the bad.”

Terry also argued many apps represent a “HIPAA-free zone,” leaving patient data similar to what physicians have to collect unprotected.

Speaking from the perspective of the mobile health application industry, AirStrip President Matthew Patterson, MD, said his company and others aren’t against extra scrutiny from the FDA, but want it done in a collaborative fashion.

“Innovation will always outpace classification and regulation,” Patterson said. “Therefore, real-time dialogue is essential to expedite classification and clearance.”

The committee members seemed convinced of the benefits mobile apps could have for patients, but subcommittee chairman Rep. Michael Burgess, R-Texas, said the value of the data stored by these apps to identity thieves and hackers means greater government oversight is likely, even if Congress itself isn’t thrilled about the regulations.

“It is critical that every actor in this space start by addressing privacy and security. If industry fails to do this then Congress will be forced to address it. And unfortunately, whatever Congress would do would likely limit the potential in this space and limit the success of the health apps market,” Burgess said.