By: Robert D. Primosch, Esq. Robert is an attorney at Wilkinson Barker Knauer, LLP in Washington, D.C. and Co-Chair of the Federal Communications Bar Association’s Telemedicine Committee.
In 2012 the Federal Communications Commission adopted rules permitting use of Medical Body Area Network (MBAN) devices in the 2360-2400 MHz frequency band. MBANs use wireless body sensors 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. Using dedicated spectrum for medical data, rather than having to use the same spectrum all of your mobile data goes through, should mean more reliable and potentially faster data transmission.
The FCC recently put the finishing touches on those rules, setting the stage for full scale introduction of MBANs throughout the medical community.
An MBAN is a low power network of body sensors controlled on a localized basis by a single programmer/control transmitter (also known as a “hub device”) that is located either on the body or in close proximity to it. Typically, the programmer/control transmitter controls the body sensors’ transmissions by telling them which frequencies they may use. The hub device aggregates the patient data it receives from the body sensors and, using the health care facility’s local area network (LAN), sends that information to monitoring locations where medical personnel review it.
Thus, for day-to-day medical practice in hospitals and other patient care facilities, MBANs provide practitioners with the ability to remotely and continuously monitor a patient’s vital signs and other physiological data in real time, allowing for faster intervention should problems arise. Importantly, because MBAN sensors are portable, monitoring continues even if the patient is moved. The MBAN concept would allow medical professionals to place multiple inexpensive wireless sensors at different locations on or around a patient’s body.
MBANs have equally valuable applications in the home. The patient is no longer tethered to medical apparatus – he or she can move freely within the home while monitoring continues. An MBAN also can be used to detect a diabetic patient’s blood glucose level and auto-inject insulin through a pump when hyperglycemic. Other potential MBAN uses include, among other things, fetal telemetry, collection of health information for the elderly or those with chronic diseases, and immediate diagnosis and monitoring of patients in life-threatening environments (e.g., law enforcement, military personnel, first responders etc.)
For equipment manufacturers and practitioners who may be considering MBANs, the key issues include (1) obtaining proper FCC certification for MBAN equipment before offering it for sale; (2) designing and positioning the equipment so it permits continuous patient monitoring; (3) avoiding interference from or to the other users of the 2360-2400 MHz band and (4) ensuring the privacy of the information transmitted over an MBAN system.
Nuts and Bolts of the Rules
For anyone interested in taking advantage of this opportunity, here are some of the nuts and bolts of the relevant FCC rules and policies:
MBAN devices must be certified, labeled and marketed in accordance with the FCC’s equipment authorization rules for MedRadio devices. Subject to certain limited exceptions, any marketing of equipment that is not certified or properly labeled may expose a vendor to a significant FCC fine (and some unhappy customers). Earlier this year, the FCC announced that all equipment certification applications must be submitted to FCC-approved third-party Telecommunications Certification Bodies, or “TCBs.” The FCC will no longer take such applications directly.
What Types of Medical Facilities May Use MBANs?
The FCC has assigned certain portions of the MBAN spectrum to certain types of medical facilities. Use of the 2360-2390 MHz segment is limited to hospitals and other establishments that offer services and beds for use beyond a 24-hour period. Facilities not in this category (including the patient’s home) are limited to the 2390-2400 MHz segment. According to one industry estimate, the 2390-2400 MHz segment permits usage by approximately 18 patients in a typical office setting (frequency re-use techniques may be necessary to accommodate more patients). All totaled MBANs have more contiguous spectrum available to them than other types of wireless medical devices, and thus are able to carry more data. Also, unlike Bluetooth and Wi-Fi devices that operate in the unlicensed 2.4 GHz band, MBANs are able to operate on “clear channels” that are free of interference from the myriad of products that use unlicensed spectrum.
Other Users of the MBAN Spectrum
MBANs are designated as “secondary” in the FCC’s Table of Frequency Allocations. This means that MBAN devices may not cause interference to, but must accept interference from, licensees designated as “primary” in the 2360-2400 MHz spectrum. Primary users include Federal and non-Federal providers of Aeronautical Mobile Telemetry (AMT) services, Federal providers of radiolocation services and Amateur Radio services.
The 2360-2400 MHz band also is adjacent to the unlicensed WiFi/Bluetooth spectrum in the 2400-2483.5 MHz (2.4 GHz) band. Manufacturers have indicated that they can easily modify 2.4 GHz Bluetooth and WiFi transceiver chips for operation in the MBAN spectrum, at cost-effective prices.
Frequency Coordination and Registration Communications Between Multiple MBANs
Hub devices of different MBANs may communicate with each other for the sole purpose of avoiding interference to each other. Body-worn devices may communicate with other body-worn devices (for example, where the signal strength of a particular body-worn device is no longer sufficient to deliver its data message to the hub device).
Further details about the FCC’s MBAN rules are available in the FCC’s 2012 and 2014 MBAN decisions, Part 95 of the FCC’s rules, and the articles cited above. iMedicalapps.com will continue to report on MBAN developments at the FCC as they occur.
These developments shouldn’t be taken to mean that all remotely captured medical data is shifting to this dedicated spectrum. From a practical perspective, using this spectrum requires dedicated communications hardware that is not yet as ubiquitous as the chips that enable WiFi, Bluetooth, or 4G communications. For some types of data, however, the benefits of using licensed, dedicated spectrum for data transmissions will outweigh the costs and any associated inconvenience with building in the necessary hardware.
Regardless, the FCC’s decision to support the development of medical body area networks will likely be a catalyst to the development of new and innovative ways to monitor patients in a variety of settings.