Bill Would Help FDA Assess Mobile Health Technology
Rep. Mike Honda says he wants to help the federal government keep pace with the fast-growing mobile health industry. Honda has introduced a bill that would create an FDA Office of Wireless Health Technology.
Smart phones these days can take your blood pressure or even monitor your heart. That prompted officials with the Food and Drug Administration last year, to begin regulating mobile health applications.
Honda said some app developers–and investors–have raised concerns that FDA oversight could stifle innovation.
“In this area, I think that anxiety's real,” Honda said. “Because it's like trying to bring an adult into the digital era when the kids have been doing it since they were three.”
Honda said an Office of Wireless Health Technology would bring much needed expertise to the FDA, and get mobile medical technologies to market faster.
Michael Righter works for a San Francisco company that can turn a smartphone into a heart monitor. He thinks a separate office is a great idea.
“When you talk about using mobile apps, you're mostly talking about software,” Righter said. “And software is a different beast in its own.”
Honda’s bill would also establish a program to help mobile app developers build their devices in line with federal privacy regulations. He projects the office’s operating costs would be about one million dollars a year, in the first few years.
The FDA regulates apps that act like medical devices, not “wellness” apps that count calories or send reminders to exercise.