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FCC Releases Regulations Governing Medical Body Area Network Devices

Posted 11 September 2012 | By

The Federal Communications Commission (FCC) has released a final rule laying out its expectations for the development and approval of new Medical Body Area Networks (MBANs)-short-range, low-energy wireless networks capable of connecting numerous medical devices together.

The rule follows a May 2012 announcement by FCC approving the MBAN system concept. At the time, FCC said it was dedicating the 2360-2400 MHz spectrum band to the device class on a secondary-that is, shared-basis, and would require manufacturers whose devices used the spectrum to register with a to-be-formed MBAN coordinator.

FCC Chairman Julius Genachowski said in a statement that he believed the new spectrum will, "Eventually lead to technologies not just for health care facilities, but also for in-home use." The US is the only country thus far to have an MBAN framework in place, added Genachowski.

The Final Rule

FCC's 11 September 2012 final rule on MBANs is intended to, "Provide a flexible platform for the wireless networking of multiple body transmitters used for the purpose of measuring and recording physiological parameters and other patient information or for performing diagnostic or therapeutic functions, primarily in health care facilities," FCC wrote.

The devices have been hailed as holding the potential to improve patient care by increasing the coordination and monitoring of care while reducing the number or wires and sensors attached to any one patient. Though FCC said the potential for signal interference exists, it explained it felt the benefits "greatly outweighed" the risks in this particular case.

Under the rule, MBAN devices will only be approved if they can prove they do not interfere with other devices-something FCC refers to as a "non-interference basis"-and will be required to coordinate the use of certain equipment. This registration and cooperation process will be formed shortly, and FCC alluded to an unreleased Further Notice of Proposed Rulemaking in which it will designate a "frequency coordinator" based on a proposal by representatives of Aeronautical Mobile Telemetry licensees and other MBAN advocates. FCC said this joint proposal was desirable because it would resolve many potential issues regarding interference between existing and new devices.

Safety Concerns

MBAN devices operating in the 2360-2390 MHz spectrum band will be limited to indoor use and require processes to protect existing users of the spectrum band, FCC explained, while those in the 2390-2400 band will be allowed to operate wherever they wish and without coordination of spectrum. The latter spectrum was subject to intense concerns by some groups regarding the presence of amateur radio operators, whose interference on the spectrum band could prove, "Potentially disastrous."

In its final rule, FCC acknowledged the risk, but said MBAN devices will have built-in safety measures to sense for amateur in-band signals and the ability to shift their transmission to unoccupied channels. The agency added that it felt the physical separation between amateur broadcasters and medical settings would add another layer of protection for MBAN users. The 2390-2400 band is also adjacent to spectrum used by wireless devices, and FCC cautioned that MBAN facilities will, "Need to consider the potential for adverse interaction between their MBAN, Wi-FI and industrial, scientific and medical (ISM) resources."

Read more:

FCC - Medical Area Body Network

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