Medical Micropower Networks: Coming Soon to a Medical Device Near You?

The Federal Communications Commission (FCC or the Commission) recently adopted rules aiding the development of new wireless medical device technologies, known as Medical Micropower Networks (MMNs), which rely on ultra-low power wideband networks. On November 30, 2011, the FCC expanded the Medical Device Radiocommunication (MedRadio) Service under its rules to allow MMNs to operate as licensed secondary services on specified bandwidths. These rules are part of the FCC's broader efforts to expand the capabilities and use of the broadband network in health care and other critical technology areas, outlined in its 2010 National Broadband Plan.

MMNs are ultra-low power wideband networks that consist of a MedRadio programmer/control (P/C) transmitter and medical implant transmitters that receive or transmit non-voice data or device control commands to facilitate electric stimulation of nerves and muscles. MMNs use electric currents, and can therefore substitute for damaged nerves to restore limb and body part functions. They are intended for human use under the care of an authorized health care professional.

FCC's actions create developmental requirements for MMN manufacturers, including:

• The devices cannot interfere with, but must accept interference from, a primary service on the specified bandwidths (413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz). The FCC rules incorporate interference mitigation provisions.
• All MMNs must be capable of operating in any of the four bandwidths established, and must be able to switch to a different frequency within these bands when interference arises.
• MMNs may only be used for diagnostic and therapeutic purposes in human patients under medical supervision.
• A P/C transmitter will not be permitted to communicate with non-implanted devices for other purposes.
• Implant-to-implant communications will not be permitted.
• The limited transmit power allowed will limit the placement of a P/C to locations on or close to the patient.

MMNs may be the latest example of using cutting-edge technology to advance health care. However, manufacturers will face the challenge of complying with the requirements of two federal agencies - both FCC and FDA. The 2010 National Broadband Plan recommends that these two agencies "should clarify regulatory requirements and the approval process for converged communications and health care devices," but how the agencies will implement this recommendation and interact with each other remains to be seen. As additional new technologies involving wireless networks are developed, industry will have a clearer idea of where each agency stands. At present, industry must hope that the FCC and FDA can forge a useful collaboration that will aid - not hinder - the development of MMNs and other wireless medical devices.

For additional information, please contact Edward John Allera (202-452-7985; edward.allera@bipc.com) or Barbara A. Binzak (202-452-7906; barbara.binzak@bipc.com).