United States: FCC Proposes Medical Device Radio Communications Services

The Federal Communications Commission (FCC) recently issued a notice of proposed rule making and notice of inquiry ("Notice") which would modify its rules to accommodate the development and use of new medical devices that utilize radiocommunication. The proposed rules focus specifically on spectrum needs and appropriate operational protocols for implanted and body-worn medical radiocommunication devices that manage and maintain body functions and/or health conditions. These devices would, for example, allow physicians to wirelessly retrieve data and make adjustments to an insulin pump implanted in a diabetes patient or wirelessly treat tremors from Parkinson’s disease through deep brain stimulation implants. However, these advances necessitate the adoption of a new set of rules for wireless medical radiocommunication technologies.

Today, implanted and body-worn devices are covered by FCC rules governing the Medical Implant Communications Service (MICS). MICS operations originally contemplated a matched pair of devices: a medical implant transmitter in the body which has the ability to sense body functions and conditions and which transmits data regarding those functions; and an implant programmer/control transmitter which records or passes along the data through interconnection with an external telecommunications system. MICS devices are limited to a very low maximum EIRP of 25 microwatts, which is intended to prevent the devices from interfering with other in-band operations. The current rules also mandate that the programmer/control transmitter utilize a frequency monitoring mechanism that identifies available channels. Additionally, the MICS channels are only available on a shared basis, therefore requiring MICS transmitters to cooperate in the selection and use of channels in order to minimize interference and maximize the use of authorized facilities.

The FCC proposes to add spectrum for implanted and body-worn medical transmitters to the existing MICS allocation at 402-405 MHz. Specifically, the FCC proposal would add the 401-402 MHz and 405-406 ("wing" bands) to the existing MICS allocation. This new spectrum would be available for low-power, low-duty cycle operations. As a result, the entire 401-406 MHz band would be available for implanted and body-worn devices, while maintaining the core 402-405 MHz (the existing MICS) band for devices which contain frequency agility capability. According to the FCC, these new "wing" bands are better suited for implanted and body-worn medical radiocommunication devices and provide greater efficiency of design and operation.

The existing MICS rules would be largely maintained under the proposal. In particular, the FCC proposes to continue licensing use of MICS devices by rule. The new rules would clarify that body-worn devices (and not merely implanted devices) would be covered by the services (although the FCC seeks comment on a proposal that body worn devices be within 6 cm of the body). In recognition of the expanded use of the spectrum, the FCC will rename the service the "Medical Device Radiocommunication Service," ("MedRadio") rather than MICS. This would decrease the ambiguity caused by the current implication that MICS is intended exclusively for implanted radios or implanted devices.

The proposed rules allow data to be transmitted from medical devices on a periodic basis in the wing bands of 0.1% during any one hour interval, rather than simply responding to a programmer/control transmitter. Additionally, the proposed rules provide for the use of a single channel without the previously required frequency monitoring capability. The new spectrum would function with a maximum EIRP of 250 nanowatts and low duty cycles to minimize interference. The current MICS spectrum operates with 300 kHz channel bandwidth. The FCC seeks comments on whether it would be appropriate to establish 100 kHz as the maximum channel bandwidth and whether it should make more stringent the current attenuation limits, particularly for body-worn devices. The FCC also seeks comment on the appropriate out-of-band limits necessary to protect certain satellite services.

Guidant Corporation proposed that the FCC amend the Part 95 Rules to include medical implant devices that use inductive telemetry in the 90-110 kHz band. The proposal requests that the FCC create an exception to the Part 15 restricted band prohibitions for medical implants. Guidant contends that the proposed rules are useful because without such a provision, the requirement to modify devices to suppress RF energy would lead to increased device costs and heightened complexity without any decrease in interference. The FCC seeks comments on the Guidant proposal.

The FCC previously issued rule waivers to Biotronik and DexCom to operate in the MICS spectrum. In this Notice, the FCC extended the time that the two companies could operate pursuant to their waivers. However, the FCC sought comment on whether the waivers should be extended beyond the time provided in the Notice.

FCC Inquiry

The Notice also launched an inquiry addressing anticipated developments in the medical devices field and the expected spectrum requirements in the future. Specifically, the inquiry encompasses new implant and body-worn medical radiocommunication technologies and how the FCC can proactively address the challenging spectrum sharing issues that will likely arise due to the increasing use of these medical devices. The Commission also seeks comments concerning the positive and negative impact of the licensing approaches involved in the authorization of these medical devices. Additionally, the Commission seeks comment regarding "options for better educating device manufacturing industry leaders and RF wireless technology leaders about medical radio device electromagnetic compatibility (EMC) coexistence issues in an RF environment."

Deadlines

The FCC has established October 31 and December 4 as the deadlines for the submission of comments and reply comments in this proceeding.