New FCC Rules for Medical Body Area Networks

by Cooley LLP

On August 21, 2014, the Federal Communications Commission (“FCC”) released an Order with new and clarified rules to foster the development and deployment of Medical Body Area Networks (MBANs). The Order provides more flexibility in the design and use of MBAN facilities and specifies procedures and qualifications for the FCC’s selection of an MBAN coordinator to administer an MBAN registration program.

Background: MBAN technology connects multiple body-worn sensors that measure and record physiological parameters or perform diagnostic or therapeutic functions primarily in health care facilities. An MBAN consists of a patient’s programmer/control transmitter, together with body-worn devices that communicate information about the patient to the programmer/control transmitter. MBANs will operate under the FCC’s Medical Device Radiocommunication Service on the 2360-2390 MHz and 2390-2400 MHz bands. MBANs in the 2360-2390 MHz band may operate only at indoor locations within a health care facility and require prior registration and coordination with an FCC-appointed MBAN coordinator to avoid interference with primary use of the band by Aeronautical Mobile Telemetry (AMT) Service stations. MBAN devices in the 2390-2400 MHz band may operate indoors or outdoors and do not have to be registered or coordinated if the equipment used cannot operate in the 2360-2390 MHz band.

Reconsideration of MBAN Rules: On reconsideration of its initial order authorizing MBANs, the FCC more narrowly defined the institutions that may use MBANs operating in the 2360-2390 band, with the idea to make the 2390-2400 MHz band the preferred band for MBANs. The FCC also addressed the application of the new rules to interconnection of bedside devices and antenna installations on outdoor roof terraces and similar locations. In addition, the FCC clarified information requirements for registering new MBAN installations and affirmed that the MBAN coordinator must consult with the AMT coordinator before a registered MBAN changes its location or operation. The FCC also clarified that MBAN transmitters must be capable of ceasing transmissions when necessary to avoid interference in the 2360-2390 MHz band and that health care facilities using equipment capable of transmission in the 2360-2390 MHz band must register with the MBAN coordinator even if they have no plans to use the capability.

The FCC also provided additional flexibility for MBANS. Under the revised rules,

  • Programming/control transmitters from separate MBAN systems may communicate with other MBANS for the limited purpose of choosing channels to avoid interference;
  • Two medical body-worn devices in the same MBAN may communicate directly with each other to coordinate in situations such as the loss of communications from one device from a patient’s change in position;
  • A body-worn medical device rather than the programmer/controller device may perform coordinator node functions; and
  • The antenna on an MBAN device need not be permanently affixed to its associated transmitter (but must be provided with the device and considered part of the transmitter subject to FCC equipment authorization).

Role and Selection of MBAN Frequency Coordinator: The new MBAN frequency coordinator for the 2360-2390 MHz band must maintain an MBAN registration database, determine when MBAN sites are within line-of-sight of AMT facilities, coordinate MBAN operations with an AMT coordinator, notify MBAN users when they must change frequencies or cease operations to comply with an AMT coordination agreement, and develop procedures to ensure that MBAN users comply with coordination requirements.

The MBAN coordinator will provide service to all eligible health care institutions on a non-discriminatory basis, charge fees that reflect only its actual costs, and serve for a ten-year term, subject to removal by the FCC on six months’ notice

The new rules will become effective thirty days after publication in the Federal Register, with rules involving data collection subject to additional approval by the Office of Management and Budget.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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