About
Rule Part
47 C.F.R, Part 95
The Medical Device Radiocommunications Service (MedRadio) is in the 401 – 406, 413 – 419, 426 – 432, 438 – 444, and 451 – 457 MHz range. MedRadio spectrum is used for diagnostic and therapeutic purposes in implanted medical devices as well as devices worn on a body. For example, MedRadio devices include implanted cardiac pacemakers and defibrillators as well as neuromuscular stimulators that help restore sensation, mobility, and other functions to limbs and organs. In addition, Medical Body Area Networks (MBANs), which are low power networks of sensors worn on the body controlled by a hub device that is located either on the body or in close proximity to it, operate in the 2360-2400 MHz band.
Similar services include Wireless Medical Telemetry Service (WMTS).
Background
The Medical Device Radiocommunications Service (MedRadio) dates back to 1999 when the FCC established the Medical Implant Communication Service (MICS). At that time, the FCC set aside three megahertz of spectrum at 402 – 405 MHz for medical implant devices. In 2009, the FCC created the Medical Device Radiocommunications Service (MedRadio) in the 401 – 406 MHz range. The creation of the MedRadio Service incorporated the existing MICS spectrum at 402 – 405 MHz and added additional spectrum at 401 – 402 MHz and 405 – 406 MHz for a total of five megahertz of spectrum for implanted devices as well as devices worn on the actual body.
Also in 2009, the FCC released a Notice of Proposed Rulemaking seeking comment on a petition for rulemaking filed by Alfred Mann Foundation to allow up to 24 MHz of additional spectrum in the MedRadio Service for implanted devices that help restore sensation, mobility, and other functions to limbs and organs. The technical term for these devices is Medical Micro-Power Networks (MMNs). The FCC released an Order in November 2011 that expanded the amount of spectrum in MedRadio Service based on the Alfred Mann petition for rulemaking.
In 2012, the Commission released a first Report and Order modifying the MedRadio rules to enable the deployment of MBAN devices in the 2360-2400 MHz band. In the Order on Reconsideration and Second Report and Order, released in 2014, the Commission modified certain requirements and finalized the process for selecting the MBAN frequency coordinator for the 2360-2390 portion of the band. In 2015, the Enterprise Wireless Alliance was designated as the MBAN frequency coordinator.
Data
Channels
The rules do not specify a channeling scheme for Medical Device Radiocommunications Service (MedRadio) devices. They may operate on any frequency in the MedRadio spectrum that does not exceed these authorized bandwidths:
401 – 401.85 MHz: 100 kHz
401.85 – 402 MHz: 150 kHz
402 – 405 MHz: 300 kHz
405 – 406 MHz: 100 kHz
413 - 419 MHz: 6 MHz
426 - 432 MHz: 6 MHz
438 - 444 MHz: 6 MHz
451 - 457 MHz: 6 MHz
2360 - 2390 MHz: 5 MHz
2390 - 2400 MHz: 5 MHz
Licensing
The Medical Device Radiocommunications Service (MedRadio) is licensed by rule. Licensed by rule means an individual license is not required to operate a MedRadio device.
In order to protect aeronautical mobile telemetry operations from harmful interference, MBAN devices capable of operating in the 2360-2390 MHz band may only be operated indoors at eligible health care facilities, and must be registered with the MBAN frequency coordinator, which will notify the health care facility when it may begin MBAN operations.
The FCC service rules for the Medical Device Radiocommunications Service (MedRadio) are located in 47 C.F.R. Part 95.
Operations
Only authorized health care providers are eligible to operate Medical Device Radiocommunications Service (MedRadio) devices. An authorized health care provider is a physician or other individual authorized under state or federal law to provide health care services using medical implant devices. MBAN devices may be operated in the 2360-2390 MHz band only by hospitals and other establishments that offer services, facilities, and beds for use beyond a 24-hour period in rendering medical treatment.
Manufacturers of MedRadio devices and their representatives are authorized to operate such devices only for the purpose of demonstrating, installing and maintaining the equipment for the benefit of duly authorized health care providers.
Because MedRadio devices are authorized on a secondary status, the devices must not cause harmful interference to devices that are authorized on a primary basis and must accept interference from devices authorized on a primary basis.