Daily Rules, Proposed Rules, and Notices of the Federal Government
This is a summary of the Commission's First Report and Order, ET Docket No. 08-59, FCC 12-54, adopted May 24, 2012 and released May 24, 2012. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center (Room CY-A257), 445 12th Street SW., Washington, DC 20554. The complete text of this document also may be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., 445 12th Street SW., Room, CY-B402, Washington, DC 20554. The full text may also be downloaded at:
1. This First Report and Order (R&O) expands the Commission's part 95 MedRadio rules to permit the development of new Medical Body Area Network (MBAN) devices in the 2360-2400 MHz band. The MBAN technology will provide a flexible platform for the wireless networking of multiple body transmitters used for the purpose of measuring and recording physiological parameters and other patient information or for performing diagnostic or therapeutic functions, primarily in health care facilities. This platform will enhance patient safety, care and comfort by reducing the need to physically wire sensors to essential monitoring equipment. As the numbers and types of medical radio devices continue to expand, these technologies offer tremendous power to improve the state of health care in the United States. The specific MBAN technology that can be deployed under our revised rules promises to enhance patient care as well as to achieve efficiencies that can reduce overall health care costs.
3. The Commission concludes that there are significant public interest benefits associated with the development and deployment of new MBAN technologies. Existing wired technologies inevitably result in reduced patient mobility and increased difficulty and delay in transporting patients. Caregivers, in turn, can spend inordinate amounts of time managing and arranging monitor cables, as well as gathering patient data. The introduction of Wireless Medical Telemetry Service (WMTS) in health care facilities has overcome some of the obstacles presented by wired sensor networks. Nonetheless, the WMTS is restricted to in-building networks that are often used primarily for monitoring critical care patients in only certain patient care areas. The MBAN concept would allow medical professionals to place multiple inexpensive wireless sensors at different locations on or around a patient's body and to aggregate data from the sensors for backhaul to a monitoring station using a variety of communications media. The Commission concludes that an MBAN represents an improvement over traditional medical monitoring devices (both wired and wireless) in several ways, and will reduce the cost, risk and complexity associated with health care. The Commission also concludes that these benefits can be achieved with minimal cost. The only cost resulting from these new regulations is the risk of increased interference, and we are have minimizing that risk by adopting rules that permit an MBAN device to operate only over relatively short distances and as part of a low power networked system. This approach will permit us to provide frequencies where an MBAN can co-exist with existing spectrum users and engage in robust frequency re-use, which will result in greater spectral efficiency. As a result, the Commission believes that the risk of increased interference is low and is greatly outweighed by the substantial benefits of this new technology.
4. The rules adopted are based on and largely reflect the provisions of the
5. The Commission's rules are based on the basic framework set forth in the
6. The Commission adopted rules that focus primarily on the service and technical rules for operating MBAN sensors and hubs, as well as the registration and coordination requirements to protect primary AMT operations in the 2360-2390 MHz band. The adopted rules do not extend to the communications links between the hubs and central control points and the MBAN hubs and the MBAN frequency coordinator. The Commission recognizes that MBAN users will have to consider additional factors when they deploy their systems—such as how to relay the data collected at the MBAN hubs to control points at remote locations by technologies that do not use the 2360-2400 MHz band, and what method the users will use to establish communication links to an MBAN coordinator. However, the Commission also recognizes that each health care facility is unique and needs flexibility to decide how best to accomplish these backhaul/interface functions. Thus, the Commission does not include here the
7. In the Report and Order, the Commission first discussed MBAN spectrum requirements and determined that a secondary allocation in the 2360-2400 MHz band is best suited to support MBAN operations. Second, it concludes that MBAN operations would be most efficiently implemented by modifying our existing part 95 MedRadio rules. Third, the Commission discusses the service and technical rules that will apply to MBAN operations. Finally, it discusses the registration and coordination requirements for MBAN operation in the 2360-2390 MHz band. As part of our analysis, the Commission recognizes that the
8. The Commission finds that the best way to promote MBAN development is by allocating the entire 40 megahertz of spectrum in the 2360-2400 MHz band proposed in the
9. The Commission also concludes that the 40 megahertz of spectrum in the 2360-2400 MHz band it proposed to allocate in the
10. The Commission further concludes that an MBAN will be able to share the 2360-2400 MHz band with incumbent users. The
11. MBAN operators in the 2390-2400 MHz band will also have to account for amateur radio users, which are authorized on a primary basis in this spectrum. Both Philips and GEHC assert that interference from MBAN devices to amateur radio is unlikely, citing factors such as the low transmission power and low duty cycle proposed for MBAN devices, as well as geographic separation and the frequency agility of MBAN devices. ARRL, The National Association for Amateur Radio, (ARRL) does not anticipate that an MBAN would cause “a significant amount of harmful interference” to amateur users, but it cautions that some amateur operations—such as weak signal communications, that occur on a “completely unpredictable basis”- could receive interference. The Commission believes that MBAN devices can successfully share the band with the amateur service. These frequencies are part of the larger “13 cm band” in which amateur radio operators already share the adjacent 2400-2450 MHz portion of the band with low-powered equipment authorized under part 15 of our rules. The Commission expects that the amateur service will likewise be able to share the 2390-2400 MHz portion of the band with MBAN devices because the power limits for MBAN operations will be even lower than that allowed for the unlicensed equipment that operates in the 2400-2450 MHz range. It further believes that MBAN and amateur operations are highly unlikely to occur in close proximity to each other. An MBAN, which will use very low transmitted power levels compared to the amateur service, is not intended for mass market types of deployment and instead will be used only under the direction of health care professionals. The Commission also believes that the majority of MBAN operations in the 2390-2400 MHz band will be located indoors. It envisions that the most likely outdoor use will occur in ambulances or while patients are otherwise in transit, thus we do not believe that prolonged outdoor use in a single location is likely. In such a situation, any interference that might occur would likely be transitory in nature and would not seriously degrade, obstruct or repeatedly interrupt amateur operations and thus would not be considered harmful under our definition of harmful interference. In the unlikely event that an atypical scenario occurs where amateur operators do receive harmful interference from MBAN operations, the Commission notes that amateur operators would be entitled to protection from MBAN interference.
12. The Commission also addressed the potential for interference from licensed amateur operations to MBAN operations. ARRL states that amateur operation in the band is unpredictable. The “substantial power levels and exceptionally high antenna gain figures used by radio Amateurs in the 2390-2400 MHz band will provide no reliability of MBANs in this segment whatsoever,” it observes, calling the results of such interference “potentially disastrous.” MBAN proponents assert that MBAN devices will have built-in capabilities such as spectrum sensing techniques to detect in-band amateur signals and frequency agility capability to move MBAN transmissions to other available channels. As to ARRL's concerns about MBAN's reliability and the risk presented by interference caused by amateur operation, GEHC acknowledges that “medical device manufacturers seeking to develop equipment consistent with the MBAN rules would need to build robust products in order to satisfy FDA requirements and to ensure customer acceptance,” but does not view that as a barrier to its efforts to develop and deploy MBAN devices. The Commission finds that factors such as the incorporation of established techniques to avoid interference into MBAN devices, the use of low duty cycles, and the separation distances between MBAN devices and amateur operations that are likely to occur in real world situations will minimize any potential for interference to MBAN devices from amateur users. Nevertheless, MBAN operations will occur on a secondary basis and MBAN operators will thus be required to accept any interference they receive from primary amateur licensees operating in accordance with the rules.
13. The 2370-2390 MHz band is used for radio astronomy operations in Arecibo, Puerto Rico. Prior to the filing of the
14. Lastly, the Commission observes that, because MBAN operations will be permitted adjacent to other bands that host a variety of different services, MBAN users will have to take into account the operating characteristics of those adjacent-band services. The upper end of the band, 2400 MHz, is immediately adjacent to the spectrum used by unlicensed devices—such as Wi-Fi and wireless local area network (WLAN) devices—as well as industrial, scientific and medical (ISM) equipment operating under Part 18 of our Rules, both of which are widely used in health care settings. As MBAN users manage their facilities, they will need to consider the potential for adverse interaction between their MBAN, Wi-Fi, and ISM resources.
15. MBAN equipment will also operate immediately adjacent to the Wireless Communications Service (WCS) at 2360 MHz. As with any new service, it is incumbent on MBAN developers to evaluate and account for the operational characteristics of adjacent band services—in this case, WCS—when designing receivers and associated equipment. The Commission finds that it is unlikely WCS operations would preclude effective MBAN use given that MBAN operations near 2360 MHz will be in institutional settings under the control of a health care provider and because MBAN users will
16. The Commission will add a new footnote US101 to the Table of Allocations to provide a secondary mobile, except aeronautical mobile, allocation in the 2360-2400 MHz band for use by the MedRadio Service. It is making this allocation through a unique footnote rather than a direct entry in the Table, or modification of the existing US276, in order to provide consistency across the entire band and to emphasize the limited nature of this allocation. It will place footnote US101 in both the Federal Table and non-Federal Table to facilitate MBAN use in a variety of settings such as in health care facilities operated by the Department of Veterans Affairs or the United States military, as well as non-Federal health care facilities. Because use of these frequencies will be on a secondary basis, MBAN stations will not be allowed to cause interference to and must accept interference from primary services, including AMT licensees operating under the primary mobile allocation in the 2360-2390 MHz and 2390-2395 MHz bands and Amateur Radio service licensees that operate on a primary basis in the 2390-2395 MHz and 2395-2400 MHz bands.
18. This action affirms the tentative conclusion from the
19. The 2400-2483.5 MHz band is also unsuitable for widespread MBAN use, given the ISM equipment and unlicensed devices that operate in the band. While GEHC and Philips discussed the benefits of employing low-power technology and chipsets that have been widely deployed in the 2.4 GHz band and which can be readily modified to use the adjacent 2360-2400 MHz spectrum, they emphatically rejected the possibility of deploying MBAN operations above 2400 MHz. GEHC notes that the 2.4 GHz band is heavily populated by unlicensed intentional radiators and ISM devices deployed by hospitals and carried by patients, visitors, doctors and staff. The 5150-5250 MHz band which used by unlicensed national information infrastructure (U-NII) devices operating under Subpart E of the Commission's part 15 rules, is even less desirable. As with the 2.4 GHz band, many unlicensed devices already intensively use the 5150-5250 MHz band in health care settings. Moreover, as GEHC notes, use of 5150-5250 MHz band would require a higher transmit power and result in shorter battery life and it is not aware of readily available chipsets that could be incorporated into MBAN devices.
20. The Commission concludes that authorizing MBAN use on a license-by-rule basis within its part 95 rules is the best approach. These devices share many characteristics with medical radiocommunications technologies that are already authorized under a license-by-rule approach, and the Commission finds that this framework can promote the rapid and robust development of MBAN devices without subjecting users to an unnecessarily burdensome individual licensing process. Moreover, the Commission is adopting appropriate technical rules and coordination procedures to ensure that MBAN devices can successfully operated on a secondary basis in the 2.3 GHz band without the need for individual licenses.
21. While an MBAN may be similar to WMTS in purpose—both involve the measurement and recording of physiological parameters and other patient-related information—the Commission finds that they are closer to MedRadio devices in their implementation. Like MedRadio devices, MBAN devices will be designed to operate at low power levels. Moreover, the two MBAN components—the body-worn sensor and the nearby hub—are functionally analogous to the medical body-worn device and associated MedRadio programmer/control transmitter that are provided for in our MedRadio rules. Although the Commission recognizes that it could codify the MBAN rules as a separate rule subpart, it concludes that the best course is to modify the existing MedRadio rules. This is the same approach the Commission recently took when providing for the development of new ultra-low power wideband networks consisting of multiple transmitters implanted in the body that use electric currents to activate and monitor nerves and muscles. Moreover this approach avoids duplicating existing rules that logically apply to both MBAN and existing MedRadio devices. This, in turn, will ensure that any future rules that affect MBAN and other MedRadio applications will be updated in a comprehensive and consistent manner. Also, because the MedRadio rules already distinguish
Medical Body Area Network (MBAN). An MBAN is a low power network consisting of a MedRadio programmer/control transmitter and multiple medical body-worn devices all of which transmit or receive non-voice data or related device control commands for the purpose of measuring and recording physiological parameters and other patient information or performing diagnostic or therapeutic functions via radiated bi- or uni-directional electromagnetic signals
23. The Commission now sets forth the specific service and technical parameters that will define an MBAN. Because it has chosen to regulate MBAN devices under the MedRadio rules, the Commission has analyzed those rules to determine which need to be modified for MBAN devices and which are already suitable for MBAN use. The Commission focuses primarily on those service and technical rules that require further modification.
25. The Joint Parties ask that the Commission expand MBAN eligibility to permit manufacturers and vendors (and their representatives) to operate MBAN transmitters for developing, demonstrating and testing purposes. Although the Joint Parties state that this would mirror analogous provisions in the WMTS rules, in fact the WMTS rules permit manufacturers and their representatives to operate such equipment only for purposes of “demonstrating” such equipment. There is similar language in the current MedRadio rules that permits operation of MedRadio equipment by manufacturers “and their representatives.” This language permits vendors to demonstrate MBAN equipment as representatives of a manufacturer. Thus, the Commission is not modifying the current rule to state this specifically. It further notes that the current rule would not preclude authorized healthcare professionals from contracting for the services of third parties to operate an MBAN. Additionally, for the reasons discussed regarding the frequency coordinators' roles, the Commission did not modify this rule to include frequency coordinators as eligible operators of MBAN equipment. With respect to expanding the MedRadio rule to permit equipment operation by manufacturers for developing and testing purposes, it is not persuaded that such a rule revision is necessary. The Commission's experimental licensing rules provide the appropriate process for granting non-licensees operational authority for developing and testing MedRadio devices, including MBAN devices.
27. As an initial matter, no commenter objected to allowing an MBAN to communicate both diagnostic and therapeutic information. The Commission will apply § 95.1209(a) of its rules, as written, to MBAN operations. While this rule provides considerable flexibility to provide data and visual information, it does not allow voice data, as requested by AT&T. The Commission believes that the current MedRadio and WMTS prohibitions regarding voice data are
28. The Commission will require an MBAN to consist of a single programmer/control transmitter (or hub) that controls multiple (
29. The Commission believes that there is no need to specify that each MBAN control transmitter be limited to controlling the body sensor transmitters for a single patient, nor that specific protocols should be associated with such transmissions. The low power levels permitted for MBAN transmitters will already limit the effective range for communications to a small number of patients, and thus such use does not raise any unique interference concerns. Consistent with the approach it has taken in the MedRadio proceeding, the Commission also declines to restrict an MBAN from performing functions that are “life-critical” or “time-sensitive.” The Commission continues to believe that these types of determinations are best made by health care professionals in concert with FDA-required risk management processes. Operators of MBAN systems and health care facilities are reminded that even the “life-critical” operation permitted on a secondary basis must accept interference from the primary spectrum users in the 2360-2400 MHz band.
31. The Commission's decision on this issue is consistent with the approach suggested in the
33. Although no commenter specifically addressed this issue, the Commission notes that the certification requirement in § 95.603(f) of the rules does not apply to transmitters that are not marketed for use in the United States, but are being used in the United States by individuals who have traveled to the United States from abroad and comply with the applicable technical requirements. This provision will apply to MBAN devices. The disclosure statement and labeling requirements, which are similar to those suggested in the
36. The Commission's decision to specify a 5 megahertz authorized bandwidth is also consistent with recommendations from the Joint Parties and other commenters. Although the
38. The need for a different power limit in the upper portion of the MBAN band was addressed by Philips. The 2390-2400 MHz portion of the MBAN spectrum will have no restrictions regarding location or mobile use, and thus all in-home MBAN use will occur in this band. Philips provides a detailed discussion of the differences between home and hospital MBAN use, and contends that there are unique circumstances—such as the possibility that an adverse health event could result in the patient falling on the MBAN transmitter and the need to provide patients with full mobility within their homes—that warrant a higher power level for this 10 megahertz band. It also notes that the upper band's proximity to the ISM band means that the MBAN may have to overcome excess noise in some instances to ensure a reliable link budget. AdvaMed echoes Philips in support of a 20 mW maximum EIRP in the 2390-2400 MHz band. The Commission finds that there is good reason to make a distinction in the maximum power it authorizes in the lower 2360-2390 MHz and in the upper 2390-2400 MHz bands.
39. The Commission is adopting additional transmitter operation rules for MBAN devices to implement other MBAN requirements. MBAN devices may not operate outside the confines of a health care facility in the 2360-2390 MHz band. MBAN devices that operate in the 2360-2390 MHz band must comply with registration and coordination requirements, and operate in the band consistent with the terms of any coordination agreement. The Joint Parties proposed that these dual requirements—no outdoor use and compliance with a coordination agreement—could be met by requiring that the MBAN master transmitter receive a “beacon” signal or control message that conveyed the permitted scope of operation in the band and that the device cease operating in the band automatically if it could not receive the signal. In their proposal, the control point in the health care facility would transmit this beacon or control message to the MBAN master transmitter using the facility's LAN.
40. Although the Commission generally agrees with the Joint Parties' suggestions, because each health care facility's communications infrastructure
45. The Commission, citing an evolving record, finds that it is not necessary to specify protocols to ensure spectrum sharing among MBAN systems. Initial filings by GEHC as well as the Joint Parties indicated a desire to codify a sharing protocol requirement. Several parties that support contention protocols nevertheless have urged us to avoid adopting specific rules. In more recent pleadings, the Joint Parties state that, while manufacturers believe that MBAN devices are likely to incorporate a mechanism to avoid interference when operating in close proximity (such as within medical facilities), they do not wish for us to adopt detailed procedures that might inadvertently inhibit the development of innovative methods that would allow them to make more intensive use of the spectrum. The Commission believes that the best course is to refrain from mandating a sharing protocol requirement, particularly because it appears that these matters are already being addressed within the standards setting process. In addition, it believes that the relatively low power levels used by MBAN transmitters make it possible that the use of sharing protocols might be unnecessary in many situations. The Commission further concludes that MBAN manufacturers will determine the appropriate level of communications reliability through the risk management activities involved with medical device design that is subject to oversight by the Food and Drug Administration (FDA), and that they should be given the flexibility to meet that level of communications reliability through whatever means they find appropriate. The Commission also finds that because it is requiring frequency coordination for MBAN and AMT sharing, it is not necessary to adopt frequency monitoring rules to promote spectrum sharing between these services.
47. The Commission adopted registration and coordination rules for MBAN operations in the 2360-2390 MHz band. Registration and coordination are two separate but related processes. A health care facility that intends to operate an MBAN in the 2360-2390 MHz band must register the MBAN with a frequency coordinator (“the MBAN coordinator”) that the Commission will designate. The registration requirement will ensure that the locations of all MBAN operations in the 2360-2390 MHz band are recorded in a database. As part of the coordination process, the MBAN coordinator will first determine if a proposed MBAN in the 2360-2390 MHz band will be within line-of-sight of an AMT receiver. If the MBAN transmitter is within line-of-sight of an AMT receive site, the MBAN and AMT coordinators will work cooperatively to assess the risk of interference between the two operations and determine the measures that may be needed to mitigate interference risk. The MBAN coordinator will notify the health care facility when coordination is complete and the MBAN must operate consistent with the terms of any agreement reached by the coordinators. If no agreement is reached, the MBAN will not be permitted to operate in the band. The health care facility may not operate the MBAN in the band until it receives the appropriate operating parameters from the MBAN coordinator. The Commission also adopted procedures to accommodate new AMT receive sites as well as changes to MBAN deployment and operations.
48. The registration and coordination requirements adopted accomplish several key principles of the Joint Parties' proposal to protect AMT receive sites. First, an MBAN will not be allowed to operate in the 2360-2390 MHz band until the frequency coordinators determine the risk of interference between the two services and the MBAN coordinator notifies the health care facility whether the device can operate in the band and the terms and conditions of operation. Second, the parties agree that MBAN operation within the line-of-sight of an AMT receive facility should serve as the baseline criteria that would trigger an analysis of interference risk and mitigation techniques. The importance of this baseline is underscored in the Joint Parties' proposed rules which include an expectation that both MBAN and AMT licensees will avoid line-of-sight operations whenever possible. Finally, the Commission expects that the MBAN and AMT coordinators will work cooperatively to evaluate potential interference situations and thus the Commission will require that they reach mutually satisfactory coordination agreements before MBAN operation is allowed at any specific location. Nevertheless, the Commission recognizes that AMT operates under a primary allocation and is entitled to protection from MBAN operations that will occur on a secondary basis. The Commission anticipates that the AMT coordinator will only enter into agreements that ensure an appropriate level of protection for the primary AMT operations.
49. The Commission concludes that the use of frequency coordination procedures is an efficient and effective way for MBAN and AMT services to successfully share the 2360-2390 MHz band. Unlike exclusion zones, which would prohibit any MBAN operation within a specified distance of an AMT receive site, coordination provides the parties flexibility to determine whether and under what conditions both services could operate in the band at a given location. Because all MBAN operations in the band will be required to register and the information will be maintained in a database, a coordinator can readily identify those locations that are within line-of-sight of an AMT receive site and thus will require a coordination agreement with incumbent or new AMT receive sites.
50. The rules that the Commission is adopting incorporate many, but not all, of the suggestions made by the Joint Parties, including their determination that the rules governing MBAN use of the 2360-2390 MHz band will be sufficient to protect AMT operations. The rules adopted provide the flexibility manufacturers, licensees and coordinators need to accommodate changes in both AMT and MBAN operations and assurance to AMT users that their future access to the spectrum will not be hampered.