Republicans put pressure on wireless health regulators

Last week six Republicans in the US House of Representatives sent a letter to the FDA and FCC that explains the importance of wireless health devices and medical apps, cautions against slow and inconsistent regulations, and asks for a progress report on how the two regulatory bodies are working together to co-regulate these technologies. The six House members that signed the letter were: Rep. Marsha Blackburn (R-TN), Rep. Joseph Pitts (R-PA), Rep. Greg Walden (R-OR), Rep. Brian Bilbray (R-CA), Rep. Michael Burgess MD (R-TX), and Rep. Phil Gingrey MD (R-GA).

The letter includes a nod to MobiHealthNews’ apps reports series: “Between 2010 and 2011 the number of medical applications (apps) available in the iTunes App Store subject to FDA evaluation under the draft guidance increased by 250 percent. The technology is changing rapidly. We are concerned that applying a complex regulatory framework could inhibit future growth and innovation in this promising market and could preclude tools that help patients better manage their care and allow the health system, as a whole, reduce costs and improve quality.”

“Innovative wireless medical devices play a vital role in addressing our nation’s unsustainable health care costs. These technologies enable physicians to know that a patient’s condition is worsening before the patient feels any symptoms, and provide treatment to keep the patient from having a health crisis that results in a trip to the emergency department,” the letter reads. “Additionally, the popularity of mobile medical applications reflects the desire of many Americans to use technology to actively engage in their own health. The abilities of smartphones and wireless devices to perform complex health and medical functions are increasing and the use of mobile medical applications is becoming more common. As policy makers, we must ensure a regulatory framework that encourages innovation while increasing access to care, protecting patient safety and lowering costs.”

The Congress members note that the FCC and FDA recognized the necessity of working together more closely to regulate wireless health back in July 2010 when it signed a Memorandum of Understanding (MOU): “We hope that the momentum generated by those actions continues and that collaboration between the agencies remains a priority,” the representatives write.

The representatives have asked the FDA and FCC to respond in writing to a series of questions about their co-regulation efforts by April 17, 2012 “so that [they] can better understand the progress FDA and FCC have made to date, future steps planned by the agencies, and how [they] may best assist the agencies’ efforts.”

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