Lawmakers Question FDA, FCC on Wireless Health Regulation

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Last week, six House Republicans sent a letter asking FDA Commissioner Margaret Hamburg and Federal Communications Commission Chair Julius Genachowski to provide information on how FDA and FCC plan to work together to regulate wireless health technology, MobiHealthNews reports.

Letter Signatories

The lawmakers who signed the letter are Reps.:

  • Brian Bilbray (R-Calif.);
  • Marsha Blackburn (R-Tenn.);
  • Michael Burgess (R-Texas);
  • Phil Gingrey (R-Ga);
  • Joseph Pitts (R-Pa.); and
  • Greg Walden (R-Ore.) (Dolan, MobiHealthNews, 4/10).

Questions in Letter

The letter includes several questions about how FDA and FCC plan to oversee the wireless health market. For example, the lawmakers asked Hamburg and Genachowski to explain how the agencies:

  • Have leveraged staff expertise on wireless medical devices;
  • Intend to coordinate reviews of wireless medical devices that might be subject to regulation by both agencies; and
  • Plan to approach the regulation of wireless network infrastructure (House of Representatives letter, 4/3).

The lawmakers asked the agencies to respond to the questions by April 17.

Concerns About Overregulation

Also in the letter, the lawmakers warned that overregulation of wireless health technology and mobile medical applications could stymie innovation in the industry. They wrote, "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."

They added, "As policy makers, we must ensure a regulatory framework that encourages innovation while increasing access to care, protecting patient safety and lowering costs."

The lawmakers noted that FDA and FCC in July 2010 signed a memorandum of understanding outlining their plans to collaborate on regulating wireless health technology. The lawmakers wrote, "We hope that the momentum generated by those actions continues and that collaboration between the agencies remains a priority" (MobiHealthNews, 4/10).


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