As mobile medical apps and devices gain market traction, lawmakers are stepping up with questions about how to best regulate the devices.
Global business in "mHealth" technology is predicted to grow 61% from 2013 and bring in $26 billion in revenue by 2017, The Hill reports. But the FDA is still ironing out its oversight of mobile medical apps and faces pushback from lawmakers who want the agency to take a more measured approach.
In September 2013, the FDA rolled out its final rules for companies developing mobile medical apps. The agency said it would exert control over apps designed to work with an already-regulated medical device or ones that transformed a smartphone/tablet into a de facto medical device.
"We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly," said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health (as quoted by The Hill). "Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products."
While some mHealth devices are easily regulated--an app that would transform a smartphone into an electrocardiography (ECG) machine, for example, would fall under the FDA's realm--others are not as cut-and-dried. The agency's guidance created a "gray zone" for products that are made for low-risk use but could be used for high-risk purposes and left unanswered questions in the minds of government officials, attorney Bradley Merrill Thompson told The Hill. Some new mobile devices will undoubtedly receive regulatory scrutiny, like blood glucose meters that allow patients to track their glucose levels on smartphones. But others remain in limbo, waiting for a regulatory blessing or curse.
Far from satisfied with the FDA's oversight, lawmakers responded to the agency's initial guidance with bipartisan legislation and lobbying efforts. In October, Rep. Marsha Blackburn (R-TN) filed a bill that asked the FDA to clarify its oversight of mobile medical apps. The bill stipulates that the FDA only regulate technology that directly affects patients and prevents mobile medical app makers from going through the regulatory process if their product doesn't carry a high risk.
Earlier this year, a bipartisan congressional group called upon the FDA to clarify its oversight of mobile medical apps. As MobiHealth News reported, 6 U.S. senators issued a letter to the agency stating that "more transparency is needed to avoid stakeholder confusion over how a wider range of medical software might be appropriately regulated." The note listed 9 questions, including inquiries about how the FDA regulates an app with an unclassified or complex function.
Thompson said the industry is waiting on the sidelines to see how the legislative debate plays out, but that action from lawmakers could have negative implications for companies' emerging business.
"Frankly what the issues are today will be different from what the issues are tomorrow because the technology is moving so quickly that freezing it in legislation would be very problematic," he said.
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