FCC Opens Medical Radio Proceeding
 
September 13, 2006
 

The Federal Communications Commission (FCC or Commission), on July 13, 2006, took the first step toward improving rules – first established in 1999 – that govern the operation of implanted radio communication enabled medical devices and to accommodate the operation of similar body-worn medical equipment. The Commission’s action responds to the growing number of advanced medical radio devices under development, or ready for commercial distribution, capable of improving patient health and dramatically lowering medical costs.

The New MedRadio Band

The FCC’s July Notice of Proposed Rulemaking and Notice of Inquiry and Order is focused on devices that serve to “actively manage and maintain body functions and/or health conditions” (such as cardiac pacemakers and defibrillators) and not wireless medical telemetry devices that are commonly used to transmit patient medical information to central hospital monitoring locations. (The latter services are regulated separately under the FCC’s Wireless Medical Telemetry Service rules.) The pending proceeding would establish a new, more flexible service for advanced medical radio communication, referred to as “MedRadio,” that would operate on the 401-406 MHz band. As proposed by the FCC, the new MedRadio band and rules would amend and rename the existing Medical Implant Communication Service (MICS) rules that are currently limited to implanted medical device operations on the 402-405 MHz band.

The rulemaking would provide two megahertz of additional spectrum to reflect the growing number and bandwidth needs of these devices. In addition, a greater variety of devices, including body-worn transmitting devices, would be allowed to operate in the new MedRadio band under the FCC’s proposal. Among other things, the proposed rules would allow health care providers to use low-power, low-duty cycle devices without requiring the frequency agility capability currently required by the MICS rules.

The Commission also seeks public comment on anticipated medical device developments and their likely spectrum requirements including: (1) new implant and body-worn medical radio-telecommunicaition technologies and how the FCC could anticipate and proactively address spectrum issues; (2) the relative benefits and tradeoffs that should be considered with respect to both licensed and unlicensed approaches to authorizing the operation of these devices; and (3) collaborative efforts between the FCC and the Food and Drug Administration regarding options for better educating device manufacturing industry leaders about medical radio device electromagnetic immunity issues in an RF environment.

Parties wishing to respond to the proposed rules and notice of inquiry must submit comments to the FCC on or before October 31, 2006. Reply comments must be filed on or before December 4, 2006.

For more information, e-mail Reginal Leichty at reg.leichty@hklaw.com or call toll free, 1-888-688-8500.