Policy, Health IT

Light regulatory touch called appropriate for mobile health apps

In many aspects, witnesses recognized that a light regulatory touch was called for, as the FDA, FTC and Congress itself could not keep pace with the rate of industry innovation.

House energy commerce

Balancing the level of regulation needed to protect consumers from smartphone health apps that make fraudulent medical claims or fail to protect patient privacy while still allowing rapid innovation and adoption of new technologies was the subject of a Wednesday congressional hearing.

In many aspects, witnesses recognized that a light regulatory touch was called for, as the Food and Drug Administration, Federal Trade Commission and Congress itself could not keep pace with the rate of industry innovation.

“A continual problem that high-tech disruptive industries face is that the time frame for regulation is out of sync with the rapid iteration of these types of technologies,” Nicolas Terry, a professor at the Indiana University McKinney School of Law, said at the House Energy and Commerce Committee’s commerce, manufacturing and trade subcommittee hearing on healthcare apps.

Terry suggested that different levels of regulation could be imposed on apps determined to be risk-free or for different categories such as diagnosis or treatment apps.

“If not tightened up, good companies could get overwhelmed by the bad,” Terry said. “Finer corporations will embrace regulation because it brings certainty.”

Dr. Laura Ferris, an associate professor of dermatology at the University of Pittsburgh School of Medicine, said that less regulation may be needed for apps used in physician-to-physician consultation, while health apps offering medical advice directly to consumers would require more.

She also noted that, if full-bore FDA review and approval were required “any time we tweak an algorithm,” the only apps that would get developed would be those that could gain quick approval could be gained.

Rep. Jan Schakowsky (D-Illinois), the ranking minority member of the subcommittee, cited how the FTC had to take action against two app developers last year who made unsubstantiated claims for detecting skin cancer.

“Innovation is good and should be encouraged, but industry self-regulation does not work,” Schakowsky said in her opening remarks. “Bad actors will continue to make potentially life-threatening claims about what their products can do. We need a strong FTC to go to bat for consumers and stop bad actors from falsely claiming to diagnose skin cancer, for example.”

In her prepared remarks, Ferris noted that she had been invited to speak at the hearing in part because of her research that apps being marketed as melanoma detectors missed cancers one-third to 90 percent of the time and could dissuade patients from seeking needed care.

But she defended health apps and teledermatology as having been proven capable of providing high quality care and improving access.

Dr. E. Ray Dorsey, a professor of neurology at the University of Rochester (New York) Medical Center, told how health apps have helped increase patient participation in research efforts in Huntington’s disease and Parkinson’s disease.

More than 70,000 people had enrolled in a Parkinson’s study just seven months after Apple released its ResearchKit open-source research platform, Dorsey said, but “unfortunately, policy barriers limit adoption of these new tools.”

These barriers include restrictive Medicare payment policies and “antiquated” state licensure laws requiring doctors be licensed in the state where the patient they are treating remotely resides. According to Dorsey, Medicare pays a neurologist $150 to see a patient in a hospital setting, $80 in a community-based and clinic and nothing if they are seen remotely using telemedicine technology.

There are 165,000 health apps available and the market has grown from $85 million to $100 million in 2010 to $6 billion to $10 billion today, and is projected to increase to $31 billion by 2020, according to a subcommittee memo.

For healthcare providers, health apps have enabled instant, constant and real-time access to patient data, helped streamline decisions, allowed remote monitoring of patients and fostered collaboration and care improvement, Rep. Michael Burgess (R-Texas), a family physician and chairman of the subcommittee, said.

Burgess added that what was “particularly exciting” was how apps have allowed patients the ability to manage their health, gain faster access to routine medical services and electronically pay their bills. But they have also created a “growing appeal among data thieves and bad actors.”

If industry doesn’t address privacy and security concerns, then Congress will be forced to do so — which may likely limit the ultimate success of the health app market, Burgess warned.

Photo: Twitter user House Energy & Commerce Committee