On May 24, 2012, the US Federal Communications Commission (FCC) released a Report & Order & Further Notice of Proposed Rulemaking (the "Order") in which the FCC established service rules for the world's first spectrum allocation for Medical Body Area Networks ("MBANs"). The Further Notice of Proposed Rulemaking seeks comment on the selection of an MBAN coordinator to fulfill the coordination functions and maintain a database of MBAN transmitter locations and operational information.

Comments are due 45 days after Federal Register publication; reply comments are due 20 days thereafter. The Federal Register Notice has not yet been published.

New Medical Device Spectrum Band Allocation and Service Rules

  • MBAN technology holds the promise to revolutionize the healthcare industry by reducing the cost and increasing the effectiveness of patient monitoring and treatment in hospitals, clinics, and in the home.
  • The new rules allocate a band of 40 MHz of spectrum between 2360 to 2400 MHz spectrum band to wireless medical devices on a secondary, non-interference basis, by allowing compatible users to share the band.
  1. The MBAN service rules expand upon the FCC's existing Medical Device Radiocommunication ("MedRadio") Service rules and include technical requirements as well as mandatory disclosure policies and device labeling requirements.
  2. An individual license is not required to operate a MBAN device, providing greater flexibility to device manufacturers.
  • The new allocation is allocated on a secondary basis to the existing primary users, which imposes some limitations on the use of the spectrum:
  1. Health care facilities are required to register all MBAN devices they propose to operate in the 2360-2390 MHz band with a frequency coordinator prior to commencing operation.
  2. All MBAN devices using in the 2360-2390 MHz band are limited to indoor operation within a health care facility registered with the MBAN coordinator.
  3. MBAN devices that operate within the 2390-2400 MHz band are not subject to registration and coordination, and may be used in any location, including in residential settings.

Implications

  • MBAN technology uses body sensors that capture clinical information, e.g., (temperature and respiratory function), and relay that information to a hub located away from the body for monitoring and analysis, providing patients with greater mobility and a higher level of care.
  • The creation of a spectrum allocation for MBANs will create significant opportunities to develop new wireless medical devices to address what has been projected to be a $2 to $6 billion industry by 2015.
  • While medical radio devices in the U.S. have previously operated on a variety of frequencies on an unlicensed basis (and in the MedRadio bands), the Order makes the United States the first in the world to allocate spectrum specifically for MBANs.
  • Companies interested in pursuing the development and commercialization of MBAN devices should familiarize themselves with the new rules and the FCC's MBAN licensing and registration process.

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