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
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
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.
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.
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:
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.
All MBAN devices using in the 2360-2390 MHz band are limited to
indoor operation within a health care facility registered with the
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.
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
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guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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