FDA & FCC, RU Health IT BFFs? OMG!
You've heard of sex, and drugs and rock and roll. How about food, and drugs and communication?
You've heard of sex, drugs and rock and roll. How about food, drugs and communication?
That's the upshot of the first-ever partnership between the Food and Drug Administration and the Federal Communications Commission, which convened this week for a two-day summit in Washington, D.C. The goal is to promote innovation and investment in wireless medical devices.
The collaboration recognizes that "the use of communications devices and networks in the provision of health care is increasingly transforming medicine by allowing doctors to treat patients anywhere, anytime, while improving quality and cutting costs," according to a joint statement released by the agencies.
The partnership was conceived by the National Broadband Plan, which called on the FCC and FDA to "clarify regulatory requirements and the approval process for converged communications and health care devices."
Given that the FCC oversees use of the airwaves, and that the FDA regulates medical devices, "it's vitally important that we work together on issues where wireless meets medical," said FCC Chairman Julius Genachowski said in a speech announcing the partnership, reports InternetNews.com.
To guide the collaboration, the agencies have formulated a Joint Statement on Wireless Medical Devices and a Memorandum of Understanding.
The challenge is to "navigate a delicate balance between innovation and safety and effectiveness," said Margaret Hamburg, commissioner of the FDA. "Working alongside the FCC, we can improve the efficiency of regulatory processes in areas where our jurisdictions overlap."
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