[Ed. We are pleased to present this in-depth report on the important new spectrum for wireless medical devices by experienced FCC attorney Robert Primosch. Be sure to check out the first of this two part series here.]
By: Robert D. Primosch, Esq
Partner, Wilkinson Barker Knauer, LLP.
After many years of discussions, debate and, ultimately, consensus, the Federal Communications Commission (FCC) has adopted rules that will permit development and use of Medical Body Area Network (MBAN) devices.
MBAN devices or MBANs use wireless technology to provide remote patient monitoring and therapeutic services inside a medical facility and at external locations such as an ambulance or a patient’s home.
In this part, I will cover:
- what equipment certification and technical rules will apply to MBANs?
- how interference will be regulated
- effective date
What Equipment Certification and Technical Rules Will Apply to MBANs
MBAN devices must be certified as compliant with FCC rules prior to sale, and must be labeled and marketed in accordance with the FCC’s existing rules for MedRadio devices. Manufacturers should note that the FCC elected not to adopt a mandatory spectrum sharing protocol for MBAN devices. This was done to avoid limiting future technological developments and enhancements for MBANs.
Nevertheless, because the MBAN spectrum will be shared heavily, MBAN manufacturers must remain cognizant of the need to avoid interference both to primary licensees and to other MBANs networks employed in the same or nearby hospital or health care facility.
MBAN devices must comply with the relevant FCC technical rules related to permissible bandwidth, power, transmitter operation, unwanted emissions, frequency stability, and RF safety.
For example, an MBAN device can operate with:
- an aggregate channel bandwidth of up to 5 MHz (consistent with the existing MedRadio rules)
- a maximum authorized power of 1 mW EIRP measured over a 1 MHz bandwidth in the 2360–2390 MHz band
- a maximum permitted power of 20 mW measured over a 5 MHz bandwidth in the 2360–2390 MHz band
How Will Interference Be Regulated?
It is essential that health care facilities and practitioners who wish to deploy MBANs understand the FCC’s rules for registration and frequency coordination. The rules are designed to eliminate or minimize the risk of interference from an MBAN to nearby Aeronautical Mobile Telemetry (“AMT”) operations before it happens. What follows is only a brief overview. Further details are available in the FCC’s decision and in the text of the new rules.
If a health care facility intends to operate an MBAN device in the 2360–2390 MHz band in areas where that spectrum is utilized by AMT systems, the facility must register the device with a frequency coordinator (the MBAN coordinator) that the FCC will designate at a later date. The registration requirement will ensure that all in-facility MBAN locations, operating parameters (frequencies, power, number of hub devices) and relevant contact personnel are recorded in a third party database.
Health care facilities will be required to keep their registration information current and to notify the MBAN coordinator of any material changes to the location or operating parameters of a registered MBAN. Notification also is required where a programmer/control transmitter for a registered MBAN is permanently taken out of service, unless it is replaced by another transmitter with the same operating parameters.
Upon registration, the MBAN coordinator will determine if the proposed MBAN will be within line-of-sight of an AMT-receive device. If so, the MBAN coordinator will work with the relevant AMT coordinator to determine how to best avoid the potential for interference to either network. The MBAN must then operate in accordance with whatever parameters the MBAN and AMT coordinators have agreed. If there is no agreement, the MBAN cannot operate in the 2360–2390 MHz band.
In these types of situations, it is anticipated that the MBAN and AMT coordinators will work with the health care facility to create a plan for mitigating any interference so that the facility’s MBANs do not impact AMT operations. Such a plan may include, for instance, an orderly transition of the interfering MBAN network to different MBAN frequencies.
Conversely, the AMT coordinator must give the MBAN coordinator at least seven days notice where an AMT licensee intends to change its area of operations such that a previously registered MBAN device might cause interference to the new AMT operation. If the MBAN and AMT coordinators cannot reach an accommodation during the seven-day period, the affected MBAN devices may be required to vacate some or all of the spectrum they are using.
As noted above, the FCC has issued a Further Notice of Proposed Rulemaking requesting comment on how many MBAN coordinators are necessary, and on the eligibility criteria for entities that wish to become an MBAN coordinator. Presently, the FCC is proposing to designate only one MBAN coordinator, which would serve for a 10-year term. The FCC has asked for comment on whether it should limit the designated MBAN coordinator to any particular fee structure or, alternatively, permit the MBAN coordinator to establish the fee structure itself.
Most of the FCC’s new MBAN rules will be effective 30 days after they are published in the Federal Register. Those rules that impose new paperwork obligations will not become effective until after they have been reviewed and cleared by the Office of Management and Budget. MBAN operations in the 2360-2390 MHz band cannot commence until sometime after the FCC designates a MBAN coordinator (expected by June 2013 or before). Also, in a separate proceeding, the FCC is also working on new experimental licensing rules that may give medical facilities expanded opportunities to test MBANs and other new wireless medical devices.
In other words, stay tuned.
Robert Primosch, JD is DC-based attorney with over 20 years experience in representing both well-established and startup wireless and wired providers and is a partner at Wilkinson Barker Knauer, LLP. You can find him via email: RPrimosch @ wbklaw.com.