[Ed. We are pleased to present this in-depth report on the important new spectrum for wireless medical devices by FCC expert Robert Primosch. The second of two parts  can be found 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 two part series, I will cover:

  • examples of how MBANs might be used
  • how MBANs work
  • what spectrum MBANs will use
  • what equipment certification and technical rules will apply to MBANs
  • how interference will be regulated
  • effective date

Read below to learn more about how MBANs work and how the FCC was able to allocate this large swathe of spectrum for medical devices.

Tomorrow, I will discuss MBAN equipment certification and how radio intereference will be regulated.

How will MBANs be used ?

The following are just a few examples of how MBANs might be used:

  • Fetal Telemetry: A small, lightweight, and noninvasive way to continuously monitor a baby’s health, while allowing the mother to move freely.
  • LifeLine Home Care Pendants: A device that collects health information for the elderly or those with chronic diseases, allowing them to live independently with the security and peace of mind that they are being monitored.
  • Predictive and Early Warning Systems: Devices that provide continuous monitoring to help prevent sudden and acute deterioration of a patient’s condition.

In both form and function, MBANs are somewhat comparable to MedRadio and Wireless Medical Telemetry Service (WMTS) devices, previously authorized by the FCC. MBANs will offer several notable improvements however, largely because they will have access to more contiguous spectrum and, will provide other cost savings. By the same token, MBANs are not merely a matter of “plug and play”.

Device manufacturers, physicians and medical facilities need to familiarize themselves with the FCC’s new rules, particularly those relating to licensing, interference protection, registration of devices and frequency coordination. The FCC has launched a follow-up rulemaking to determine how MBAN frequency coordinators will be selected and the fees they may charge for their services.

A copy of the FCC’s decision and the new rules is available here.

Some of the more important items in the document are summarized below.

How Do MBANs Work?

As described by the FCC, an MBAN is a low power network of one or more sensors that are worn on the body and controlled by a hub device that is located in close proximity to the patient. Body sensors may either collect a patient’s diagnostic information or deliver medical therapy to particular areas of the body.

As currently contemplated by the main proponents of the new rules (GE Healthcare and Phillips Healthcare Systems), a typical MBAN arrangement will include a programmer/control transmitter (“hub device”) that controls the body sensors’ transmissions by telling them which frequencies they may use. Frequencies are likely to be assigned on a dynamic basis, which will significantly minimize the potential for interference among devices worn by numerous patients in the same vicinity.

The programmer/control transmitter will aggregate the patient data it receives from the body sensors and, using the health care facility’s local area network (LAN), backhaul that information to monitoring locations where it is available to medical personnel or to a central facility.

MBANs thus are immediately distinguishable from WMTS (Wireless Medical Telemetry Service), which the FCC describes as an in-building network used primarily for monitoring critical care patients in a specific area within a medical facility, an intensive care unit, for example.

By contrast, MBANs are designed to accommodate a much broader area within a health care facility, or in outdoors areas, the home, or at other locations that do not compromise the patient’s comfort or mobility. Indeed, the 40 MHz of spectrum that the FCC has allocated for MBANs may provide enough spectrum to support operations in high-density settings such as waiting rooms, elevator lobbies, preparatory areas, and other locations where patients congregate.

Under the FCC’s new rules, neither MBAN body sensors nor programmer/control transmitters may communicate directly with each other.

The purpose of these limitations is to prevent medical facilities from using MBANs to create de-facto “mesh” networks that might aggravate potential interference risks. As above, though, they may be interconnected via the medical facility’s telecommunications network so that patient data can be sent to monitoring stations.

As in the case of MedRadio devices, the FCC will license MBANs to be operated by persons who are duly authorized health care professionals orunder their direction. However, the health care professional will remain responsible for assuring that the MBAN network complies with the FCC’s rules. Manufacturers and their representatives may operate MBANs for the purpose of demonstrating such equipment to duly authorized health care professionals.

What Spectrum Will MBANs Use?

Although the FCC has allocated the 2360–2400 MHz band for MBAN use, MBAN users will not have to obtain individual licenses. In effect, upon completing any required frequency coordination and installation of its MBANs, the health care facility or provider will be automatically licensed (i.e., “licensed by rule”).

MBANs are designated as “secondary” users of the 2360–2400 MHz band 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”. Primary users include Federal and non-Federal providers of Aeronautical Mobile Telemetry (AMT) services, Federal providers of radiolocation services and Amateur Radio services.

To accommodate the existing uses of the 2360–2400 MHz spectrum by primary services, the FCC has decided that the 2360–2390 MHz portion of the band will be available only for indoor use at health care facilities. The remaining 10 MHz at 2390–2400 MHz will be available for use at other locations. In addition, as noted below, the 2360–2390 MHz band will be subject to different technical and prior coordination requirements than the 2390–2400 MHz band.

Nonetheless, the 2360–2400 MHz band offers potential advantages for MBAN licensees. Most important, the 40 MHz allocation is the largest block of contiguous licensed spectrum available for wireless medical devices. Except in a few geographic areas where primary licensees have significant operations, the band should be more than sufficient for MBANs and other licensees to share without interfering with each other, particularly since MBANs will operate at low power and, in most cases, indoors.

Because the 2360–2400 MHz band also is adjacent to the unlicensed WiFi/Bluetooth spectrum in the 2400–2483.5 MHz (2.4 GHz) band, equipment manufacturers have indicated that 2.4 GHz chipsets can be easily modified for MBAN use at 2360–2400 MHz. As a result, it is anticipated that MBAN devices can be manufactured and deployed at greater volumes and lower price points. At the same time, medical facilities must pay close attention to potential interference MBANs may cause to, or receive from, their own indoor WiFi, wireless LAN or ISM devices operating at 2.4 GHz.

…To be continued…

Read on tomorrow when I will cover:

  • what equipment certification and technical rules will apply to MBANs?
  • how interference will be regulated
  • effective date

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.