Lawmakers: Smartphone health apps need to be smarter

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The reliability of healthcare apps and their consumers’ privacy came under fire at a bipartisan house panel Wednesday, targeting the gap in regulatory oversight and potential patient harm from consumer-based smartphone apps.

The House Energy and Commerce Subcommittee hearing highlighted the dangers of misdiagnosis and unprotected healthcare information that come with smartphone apps used to provide information about everything from calorie intake to potential risk for cancer.

{mosads}Most health apps are available for purchase from an app store without Food and Drug Administration oversight, even when the apps make claims similar to medical devices and lab tests providing a diagnosis or treatment recommendation — devices that routinely require agency approval.

The FDA does regulate technologies that act as accessories to medical devices and perform the function of a regulated medical device. Apps that dispense data or store information are not reviewed.

“You only need to do a brief search through the app stores amongst health-related apps to find apps that look like they are doing device-like things but are not approved medical devices,” Nicolas Terry, a professor of health law at Indiana University, told the subcommittee. “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 diagnosis. Unless that gets tightened up, I worry the good companies will find themselves overwhelmed by the bad.”

Commerce, Manufacturing and Trade Subcommittee Chairman Michael Burgess (R-Texas) warned a push for regulation could stifle innovation, but pointed to specific concerns over the impact on quality of care compared to an in-person visit and the risk to private patient information.

“For healthcare providers, health apps enable constant, instant and real-time access to patient data,” said Burgess, an obstetrician. “The emergence of mobile apps within the healthcare system is particularly exciting because of how they empower patients to gain access to and manage aspects of their health.”

Rep. Marsha Blackburn (R-Tenn.) cited FDA history in urging the agency to take a greater role in regulating smartphone apps.

“We have to go back and look historically at what we did with the FDA, Congress said in the ’30s ‘this is what a pharmaceutical is,’ in the ’70s we defined a medical device,” Blackburn said. “Now it is time for us to create a classification for healthcare technology and put the FDA on the right track.”

Laura Ferris, an assistant professor at University of Pittsburgh’s Department of Dermatology, told the subcommittee patients are most at risk of bad information from healthcare apps when the program interacts directly with a patient without a physician’s input at any point along the way.

“The oversight of such tools should reflect the risk,” Ferris said. “The risk in the hands of a physician is much lower than directly in the hands of a patient.”

Because most healthcare apps are not associated with a healthcare provider, the information collected is often not subject to privacy protections in the Health Insurance Portability and Accountability Act, which ensure confidentiality of personal health information. Despite that distinction, Burgess stressed the need for security of patient information.

“We have seen that healthcare data has a growing appeal among identity thieves and other bad actors,” Burgess said. “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.”

The 21st Century Cures Act that passed the House Friday includes provisions that mostly prohibit the FDA from regulating health software, but makes an exception for technology that is used to diagnose and treat patients, or “poses a significant risk to patient safety.”


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