The Federal Communications Commission (FCC) recently published a final rule dedicating specified bandwidths for the operation of Medical Body Area Networks (MBANs), low power networks that will allow non-voice data communication between medical device sensors worn on the body and a programmer/control transmitter. Although Wireless Medical Telemetry Service (WMTS) is already used in some health care facilities, WMTS use is restricted to in-building networks and, more specifically, to critical care patient use in certain areas of a hospital. MBANs will allow for wireless monitoring of patients and allow freedom of movement of a patient within a hospital facility or at home. MBANs therefore represent a potentially significant healthcare advance; however, this technology also presents some unique technological challenges and risks.
MBANs will measure and record patient physiological information and perform diagnostic and therapeutic functions using electromagnetic signals in a wireless environment. Body data sensors will transmit data to a hub, which will aggregate the patient data and transmit it via a hospital’s local area network (LAN) to a place where it can be analyzed. MBANs will be authorized on a license-by-rule basis under the FCC’s existing MedRadio rules (47 C.F.R. Part 95) and will operate in the 2360-2400 megahertz (MHz) range.
MBANs will only be secondary users in the 2360-2390 MHz portion of the band, however, subject to primary use of the band by Aeronautical Mobile Telemetry (AMT) licensees. Healthcare facilities must operate within this range, and all use must be indoors. Significantly, any MBAN operating within this segment must be capable of receiving and complying with control messages notifying the device to limit or cease operations if there is interference with a primary user. MBANs operating here must therefore not only be capable of receiving and operating with interference from a primary user, but they must not cause interference for a primary user. FCC expects to appoint an MBAN coordinator by June 2013 who will handle MBAN licensing and work with the AMT coordinator to resolve any interference issues.
Because the primary users in the 2390-2400 MHz portion of the band are amateur radio users, this segment will have fewer use restrictions. MBAN use here may be either indoor or outdoor, and any at-home use of this technology will use this 10 MHz portion of the allocated bandwidth.
Although MBANs have the potential to be a significant medical advance that could allow patient monitoring from remote locations, including in the patient’s home, there are a number of issues that could pose significant challenges:
- First, hospital MBAN users in the 2360-2390 MHz band must be subject to interference caused by AMT licensees and must be capable of shutting down or defaulting to the 2390-2400 MHz range. These devices must, therefore, be capable of functioning through interference without the loss of potentially critical patient monitoring functions. FCC has stated that it will have no restriction on MBANs performing “life-critical” or “time-sensitive” functions, as these determinations should be made by health care professionals “in concert with FDA-required risk management processes.” However, even these critical functions must operate secondarily and must accept interference, which could affect their performance.
- Second, FCC has stated that MBAN users must consider the significance of “adjacent band services” within their facilities, such as Wi-Fi, wireless local area networks (WLANs), and industrial, scientific, and medical (ISM) equipment. As a result, FCC notes that MBAN users must therefore consider the “potential for adverse interaction.”
- Third, MBANs will have to be designed, tested, and implemented to meet U.S. Food and Drug Administration (FDA) medical device requirements to ensure the reliability and accuracy of data transmission – a concern that FDA has already expressed with respect to mobile medical apps.
- Fourth, the overall importance of this technology – and its costs – will have to be considered within the framework of the new Affordable Care Act, particularly as more provisions become effective.
- Finally, FCC has noted that a 40 MHz range allows for MBAN use within “high density settings” (e.g., hospital waiting rooms) where many MBAN patient users may congregate. However, there must be concern about the possible future shortage of bandwidth for MBAN users, particularly if the number of primary AMT users increases.
MBANs appear to offer significant improvements in overall patient monitoring and data collection. However, as with any medical device, developers and users must be aware of both the capabilities and limitations of the device. Furthermore, MBAN developers and users will have to be cognizant of both FDA and FCC relevant regulations, and operate within the framework of two federal agencies as they navigate this still-emerging territory.
For additional information, please contact Edward John Allera (202-452-7906; email@example.com) or Barbara A. Binzak Blumenfeld (202-452-7906; firstname.lastname@example.org).