Source: http://thefederalregister.com/2012/09/11/2012-21984.html
Timestamp: 2018-09-21 18:01:51
Document Index: 560382325

Matched Legal Cases: ['art 95', 'art 95', 'art 95', 'art 95', 'art 15', 'art 18', 'art 15', 'art 95', 'art 95', '§ 95', '§ 95', '§ 95', '§ 95', '§ 95', '§ 95', '§ 2', '§ 95', '§ 95', '§ 95', '§ 95', 'art 95', '§ 95', '§ 95', '§ 2', '§ 1', '§ 95', '§ 2']

Federal Register | Medical Area Body Network
[ET Docket No. 08-59; FCC 12-54]
SUMMARY: This document expands the Commission's Medical Device Radiocommunications Service (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 connect sensors to essential monitoring equipment by cables and wires. This decision is the latest in a series of actions to expand the spectrum available for wireless medical use. The Commission finds that the risk of increased interference is minimal and is greatly outweighed by the benefits of the MBAN rules.
DATES: Effective October 11, 2012, except for SSSS 95.1215(c), 95.1217(a)(3), 95.1223, and 95.1225, which contain information collection requirements thatare not effective until approved by the Office of Management and Budget. The Commission will publish a document in theFederal Registerannouncing the effective dates for those amendments. The Director of the Federal Register will approve the incorporation by reference in SS 95.1223 concurrently with the published Office of Management and Budget approval of this section.
FOR FURTHER INFORMATION CONTACT: Brian Butler, Office of Engineering and Technology, 202-418-2702,Brian.Butler@fcc.gov.
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:www.fcc.gov.People with Disabilities: To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty).
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.
2. TheReport and Orderadopts rules for MBAN operations on a secondary, non-interference basis under our “license-by-rule” framework. To address spectrum compatibility concerns with respect to incumbent operations under this approach, the Commission is establishing a process by which MBAN users will register and coordinate the use of certain equipment. In a concurrent Further Notice of Proposed Rulemaking, the Commission proposes the criteria for designating the frequency coordinator who will manage these activities. Notably, the Commission bases many of these procedures on a joint proposal (hereinafter the “Joint Proposal”) submitted by representatives of incumbent Aeronautical Mobile Telemetry (AMT) licensees and the MBAN proponents—parties that, when the Commission issued theNotice of Proposed Rulemaking(NPRM) in this proceeding, strongly disagreed as to whether MBAN and AMT operations could successfully coexist in the same frequency band. Cooperative efforts such as this are beneficial in helping us realize the vital goal of promoting robust and efficient use of our limited spectrum resources.
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 theJoint Proposalbut differ from them in certain respects. TheJoint Proposalis a comprehensive plan that draws from both the existing MedRadio and WMTS rules to specify MBAN operational requirements for body-worn sensors and hubs, but is drafted as a new subpart under part 95 of our Rules. It expands upon these rules, however, to include a detailed set of requirements for MBAN management within a health care facility. It also proposes that MBAN use in the 2360-2390 MHz band be limited mostly to indoor use and subject to specific coordination procedures and processes to protect AMT users in that band, whereas MBAN use in the 2390-2400 MHz band could occur at any location and without coordination. TheJoint Proposaldescribes an MBAN as consisting of a master transmitter (hereinafter referred to as a “hub”), which is included in a device close to the patient, and one or more client transmitters (hereinafter referred to as “body-worn sensors” or “sensors”), which are worn on the body and only transmit while maintaining communication with the hub that controls its transmissions. The hub would convey data messages to the body-worn sensors to specify, for example, the transmit frequency that should be used. The hub and sensor devices would transmit in the 2360-2400 MHz band. The hub would aggregate patient data from the body-worn sensors under its control and, using the health care facility's local area network (LAN) (which could be, for example, Ethernet, WMTS or Wi-Fi links), transmit that information to locations where health care professionals monitor patient data. The hub also would be connected via the facility's LAN to a central control point that would be used to manage all MBAN operations within the health care facility. To protect AMT operationsfrom harmful interference, theJoint Proposalwould have the Commission designate an MBAN frequency coordinator who would coordinate MBAN operations in the 2360-2390 MHz band with the AMT frequency coordinator. The control point would serve as the interface between the MBAN coordinator and the MBAN hub control operation in the 2360-2390 MHz band. The control point would receive an electronic key, which is a data message that specifies and enables use of specific frequencies by the MBAN devices. The control point, in turn, would generate a beacon or control message to convey a data message to the hub via the facility's LAN that specifies the authorized frequencies and other operational conditions for that MBAN.
5. The Commission's rules are based on the basic framework set forth in theJoint Proposal,particularly that an MBAN is comprised of two component devices—one that is worn on the body (sensor) and another that is located either on the body or in close proximity to it (hub)—that are used to monitor a patient's physiological functions and to communicate the data back to a monitoring station. Thus, the Commission will specify an MBAN to be a low power network of body sensors controlled on a localized basis by a single hub device, and use this framework as the context for our discussions. An MBAN shares many characteristics with other established medical radio services and applications. For example, MBAN devices would operate consistent with the definitions for body-worn devices in the MedRadio rules. Also, the data transmitted over the wireless link from the body-worn sensors to the nearby controlling hub would consist of physiological readings and other patient-related information that is transmitted via radiated electromagnetic signals, which follows the definition of medical telemetry in the WMTS rules. The Commission is therefore authorizing MBAN operations under our existing part 95 MedRadio rules, and the requirements adopted are limited to the operation of MBAN devices within the 2360-2400 MHz band.
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 theJoint Proposal'srecommendations to codify certain aspects of their vision—for example, requiring a health care facility to designate a central control point and specific communication procedures between the control point and the MBAN frequency coordinator or the hub. Instead, it expects that MBAN users, the frequency coordinators, and equipment manufacturers will work together cooperatively to utilize the technologies and procedures that will permit MBAN and AMT services to share spectrum while fully protecting AMT licensees' operations and while fully integrating MBAN use into the health care ecosystem.
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 theJoint Proposalhas been endorsed by parties that had previously objected to the original GEHC Petition, and that the record of this proceeding now contains conflicting pleadings by the same parties. In such cases, the Commission looked to those pleadings associated with theJoint Proposaland will not address any earlier, inconsistent submissions by the same party, based on our assumption that the earlier filings have been superseded by the more recent filings.
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 theNPRMfor MBAN use, on a secondary basis. The Commission does so by adding a new footnote to our Table of Frequency Allocations (Table) as proposed. It concludes that the 2360-2400 MHz band is particularly well suited for MBAN use, given the ability of MBAN devices to be able to share the band with incumbent users. The Commission is also persuaded that the ready availability of chipsets and technology that can be applied to this band will promote quick development of low-cost MBAN equipment. This, in turn, will reduce developmental expenses, encourage multiple parties to develop MBAN applications, and will promote the widespread use of beneficial MBAN technologies. Such deployment will reduce health care expenses, improve the quality of patient care, and could ultimately save lives.
9. The Commission also concludes that the 40 megahertz of spectrum in the 2360-2400 MHz band it proposed to allocate in theNPRMis an appropriate allocation for MBAN use. Both General Electric Healthcare (GEHC) and Philips Healthcare Systems (Philips) discuss how peak MBAN deployments would require as much as 20 megahertz of spectrum to be available if on an exclusive basis, and assert that a full 40 megahertz allocation would maximize the opportunity for MBAN devices that operate on a secondary basis to avoid interference to and from primary users. The Commission finds these arguments persuasive. Any MBAN device designed to operate in the 2360-2400 MHz band will also have to be designed to operate in a manner that will protect incumbent licensees, and a 40-megahertz allocation will provide sufficient spectrum flexibility to serve this goal. In addition, this allocation will enable greater frequency diversity and promote reliable MBAN performance. This is particularly true given the Commission's decision, to allow an MBAN device to operate with an emission bandwidth up to 5 megahertz. Additionally, the Commission finds that the 40-megahertz allocation is appropriate because it will allow for reliable MBAN operations in high-density settings, such as waiting rooms, elevator lobbies, and preparatory areas, where multiple MBAN-equipped patients will congregate. For example, AdvaMed notes that a smaller spectrum allocation might not allow for the use of devices by multiple vendors in the same hospital and thereby drive up costs, and also claims that more limited spectrum access would not support all of the currently conceived MBAN device applications. It is clear that such a scenario would increase costs byreducing competition and effectively limiting the use of multiple MBAN devices; this, in turn, could deprive many patients of the health care and cost-saving benefits that MBAN operations are poised to deliver. For all of these reasons, the Commission agree that the 40 MHz of spectrum proposed in theNPRM“will maximize opportunities to avoid interference through frequency separation, support the coexistence of multiple and competitive MBAN networks, and provide the spectrum needed for future innovation.”
10. The Commission further concludes that an MBAN will be able to share the 2360-2400 MHz band with incumbent users. TheJoint Proposaloffers a way for MBAN devices to operate in a manner compatible with incumbent AMT licensees. By proposing unrestricted use of the 2390-2400 MHz band segment and a coordination process for MBAN users in the 2360-2390 MHz portion of the band along with suggesting the use of established engineering guidelines to determine if MBAN use can occur within line-of-sight of an AMT site without causing interference, theJoint Proposaldescribes how MBAN users could successfully operate in the band on a secondary basis. The commission concludes that it is necessary for us to establish a coordination process and related procedures and guidelines to ensure that the primary AMT operations in the band are adequately protected from MBAN users.
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 theJoint Proposal,both GEHC and Philips suggested using an exclusion zone to protect the Arecibo site. Subsequently, the Joint Parties suggested that MBAN users simply notify theArecibo facility prior to operation in accordance with our existing rules. The Commission finds that the existing MedRadio Rules, which provide a prior notification requirement, are sufficient to ensure protection of radio astronomy operations at the Arecibo site.
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 willhave a large swath of spectrum in which to place their operations. Moreover, the record indicates that GEHC has already anticipated designing MBAN devices that use contention-based protocols and frequency agility to account for potential out of band emissions into the 2360-2400 MHz band. For these reasons, and notwithstanding filings made by the Wireless Communications Association, International (“WCAI”), the Commission finds no reason to adopt specific rules relating to adjacent-band WCS operations.
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.
17. TheJoint Proposalwas based on secondary MBAN use of the 2360-2400 MHz band, and no commenters supporting either the 2360-2400 MHz band or any alternate spectrum proposals endorse giving MBAN operations primary status. The Commission's decision to provide 40 megahertz of spectrum in the 2360-2400 MHz band for MBAN use is based on our decision to require MBAN users to share the spectrum with incumbent users, as well as among different MBAN devices, and that, therefore MBAN devices require a larger spectrum block than would be the case if spectrum were allocated to MBAN use on an exclusive basis. A secondary allocation is consistent with our approach. The Commission is also confident that its decision to authorize MBAN service on a secondary basis will not adversely affect the usefulness of MBAN devices. The Commission notes that the supportive comments filed by numerous manufacturers indicate a readiness to produce devices capable of relaying essential patient data in a reliable manner within this regulatory framework.
18. This action affirms the tentative conclusion from theNPRMthat the Commission should allocate spectrum not currently used by existing medical radio services to support new MBAN operations. Although ARRL suggests that MBAN devices could make use of spectrum currently used by the WMTS, the Commission agrees with Philips that the WMTS bands are not suitable for MBAN devices because of the existing widespread use of WMTS applications in hospitals. The Commission does not believe that WMTS and MBAN devices would be able to successfully co-exist on the same frequencies simultaneously within the same facilities, leaving health care facilities with the dilemma of choosing between two valuable health care tools. A better course is to accommodate MBAN users in other frequencies. The Commission further notes that all of the other frequency bands identified in this proceeding for possible MBAN use have limitations that make them less desirable than the 2360-2400 MHz band. For example, Philips claims that the alternative bands are “substantially inferior to the 2360-2400 MHz band” for MBAN use, and predicts that “devices would be unlikely to succeed for both cost and technical reasons, and the opportunity to benefit from better healthcare using these devices likely would be substantially delayed or lost.” The Commission agrees, and briefly discusses each of the alternate band proposals.
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.
A. Licensing Framework
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 distinguishbetween each of the various types of MedRadio devices when necessary by, for example, setting forth particular operational rules and authorized frequencies, we will still be able to add MBAN-specific rules when and where appropriate.
22. TheNPRMsought comment on the definitions the Commission should apply to an MBAN and its components, and proposed four terms that it could codify in our final rules. Because the Commission has decided to authorize MBAN operations under our MedRadio rules, it is not necessary to adopt such a comprehensive set of definitions. The Commission instead modified the Appendix to Subpart E of Part 95 of our Rules to add a single new definition—Medical body area network (MBAN) to read as follows:
This definition is slightly different from that proposed in theNPRM.It reflects appropriate MedRadio terminology and includes a description of the telemetry functions of an MBAN that were originally part of the separate definition the Commission proposed for the term “Medical body area device.” The other terms it had proposed to define are already encompassed within the existing MedRadio definitions. The existing definition for a MedRadio programmer/control transmitter is a transmitter that is designed to operate outside the human body for the purpose of communicating with a receiver connected to a body-worn device in the MedRadio Service. Because this definition already describes how an MBAN control transmitter functions, it is not necessary for us to adopt a separate definition for an “MBAN control transmitter.” Although the MedRadio programmer/control transmitter definition is broadly written to permit other functions—such as communicating with implanted devices or acting as a programmer—the Commission recognizes that such features will not be necessary for MBAN operations and observe that a device that does not include them could still conform to the definition. In a similar vein, it finds that the existing definition for a Medical body-worn device already describes how an MBAN sensor operates and can be used in lieu of the proposed “Medical body area device.” Finally, the existing “MedRadio transmitter” definition is analogous to our proposed “MBAN transmitter” term. The Commission finds that this overall approach to the MBAN definitions shares the same advantages as, and is consistent with, the decision to provide for MBAN operations as part of the existing MedRadio rules. It also notes that while the Joint Parties proposed numerous definitions in conjunction with their draft rules, their focus was on specific technical and operational definitions. The Commission will not adopt these terms, as we agree with AdvaMed that it is not necessary to define other components of an MBAN because there will be different ways to meet the overall MBAN definition and the Commission should afford manufacturers flexibility for innovation. Service and Technical Rules
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.
24.Operator Eligibility.In theNPRM,the Commission proposed that MBAN use be subject to the same operator eligibility requirements that are in place for the MedRadio Service. Section 95.1201 of our rules permits operation of MedRadio transmitters by duly authorized health care professionals, by persons using MedRadio transmitters at the direction of a duly authorized health care professional, and by manufacturers and their representatives for the purpose of demonstrating such equipment to duly authorized health care professionals. The Commission concludes that this rule should be applied to MBAN operations without 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.
26.Permissible Communications.In theNPRM,the Commission observed that the existing rules allow a MedRadio device to be used for diagnostic and therapeutic purposes to relay non-voice data, and asked whether such requirements would be appropriate for MBAN operations. TheNPRMalso asked how communications should be structured within a particular MBAN. Specifically, the Commission asked whether communications between body-worn MBAN devices or communications between MBAN devices within one network with those in another should be allowed, and whether a single programmer/controller should be permitted to control body-worn devices associated with multiple MBAN networks simultaneously or those associated with more than one patient. The Commission adopted communications rules that are generally consistent with the existing MedRadio provisions and modified § 95.1209 of its rules accordingly.
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 arepart of a proven framework in which to base MBAN operations, and note that AT&T's suggestion relates to general speculation about potential future MBAN functionality as opposed to a specific application it intends to deploy.
28. The Commission will require an MBAN to consist of a single programmer/control transmitter (or hub) that controls multiple (i.e.,non-implanted) sensor devices. The intent of defining an MBAN in this way is to prevent direct communications between programmer/controllers which would facilitate mesh type networks using MBAN controllers to potentially extend the range of an MBAN beyond the confines of the medical facility. Consequently, it will not permit direct communications between body-worn sensors or direct communication between programmer/control transmitters. Under the existing § 95.1209(c), programmer/control transmitters will be able to interconnect with other telecommunications systems. This will allow backhaul from a single patient-based MBAN control transmitter to a monitoring station that receives and processes MBAN body sensor data from multiple patients using frequencies other than the 2360-2400 MHz band. The Commission recognizes that some commenters would have us allow one programmer/control transmitter to be controlled by a separate programmer/control transmitter or permit direct communications between body-worn sensor devices. It does not adopt these proposals. The Commission believes that the rules it adopted provide more certainty that an MBAN will operate in compliance with it rules or a coordination agreement because each programmer/control transmitter and its associated body-worn sensors will operate in response to a control message received over the facility's LAN. As the Commission gain further experience with MBAN operations, it may revisit these restrictions.
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.
30.Authorized Locations.The Commission sought comment on whether it would be appropriate to restrict the use of MBAN transmitting antennas to indoor locations in certain frequency bands, and noted that its WMTS rules restrict antennas to indoor use only, while the MedRadio rules provide for the use of temporary outdoor antennas. The Commission modified §§ 95.1203 and 95.1213 of the MedRadio rules to provide for indoor-only MBAN operation in the 2360-2390 MHz band and MBAN operation at any location in the 2390-2400 MHz band.
31. The Commission's decision on this issue is consistent with the approach suggested in theJoint Proposal.It finds that limiting MBAN operation in the 2360-2390 MHz band to indoor locations within health care facilities is a reasonable and effective way to limit potential interference and promote sharing between MBAN and AMT users. It is also consistent with the coordination procedures being adopted. Although AT&T suggests that any rule restricting use to indoors would limit the usefulness of an MBAN, the Commission disagrees and notes that GEHC and other likely equipment developers have not been deterred by the prospect of indoor-only operation. Moreover, in the 2390-2400 MHz band, where there are fewer AMT interference concerns, the Commission is able to provide MBAN users with the added flexibility of operating in any location. The Commission rejected the suggestion by the Joint Parties that it modify the rules to permit outdoor operation in the 2360-2390 MHz band in cases of a “medical emergency declared by duly authorized governmental authorities after emergency coordination with the AMT coordinator.” The Commission finds that the suggested exception does not clearly define “medical emergency” or “authorized governmental authorities” and would essentially delegate authority to unnamed third parties to determine when outdoor MBAN operation is permitted. Instead, the Commission observed that there are other approaches that would as readily address this issue. Health care facilities can consider using MBAN devices that are capable of shifting to the 2390-2400 MHz band—where it is not necessary to receive prior approval to operate outdoors—in anticipation of situations where there may not be time to perform a quick coordination, such as an emergency in a part of the health care facility that requires some patients to be temporarily moved outdoors. For extraordinary circumstances involving outdoor use of the 2360-2390 MHz band, MBAN licensees will have to follow the same course of action as other licensees when emergencies occur, and ask the applicable licensing bureau (in this case, the Wireless Telecommunications Bureau) for a temporary waiver to permit such operation. The Commission expects that, inbona fideemergency situations, the MBAN and AMT licensees and the frequency coordinators will all cooperate to identify frequencies that can be made available for emergency MBAN operations as quickly as possible while ensuring flight safety.
32.Equipment Authorization.In theNPRM,the Commission asked if each MBAN transmitter authorized to operate in the 2360-2400 MHz band should be required to be certificated, if manufacturers of MBAN transmitters should be subject to disclosure statement and labeling requirements that are analogous to those in the existing MedRadio rules (including the identification of MBAN transmitters with a serial number), and if MBAN transmitters should be required to be marketed and sold only for the permissible communications the Commission allows for the service. These provisions allow for the deployment and operation of existing MedRadio devices in a consistent and predictable manner, and the Commission concludes that they will do the same for MBAN equipment. The Commission therefore will apply the existing MedRadio provisions in §§ 95.603(f), 95.605, 95.1215, 95.1217, and 95.1219 of the Commission's rules to MBAN operations, modified as necessary to refer to MBAN devices and their associated frequency bands.
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 theJoint Proposal,are based on requirements that have been in placesince 1999. Although WCAI had expressed concern that similar labeling rules originally suggested by GEHC might be inadequate to notify MBAN users of their responsibilities as secondary licensees, the Commission concludes that the proposed labeling rules are appropriate. The Commission has analyzed the potential for interference to and from MBAN devices—including in the adjacent-band scenarios of interest to WCAI—and determined that its rules will support MBAN operation on a secondary basis. Moreover, because MBAN devices are similar to other MedRadio devices in that they will operate at low power and under the direction of a duly authorized health care professional, it is appropriate for us to apply the existing MedRadio labeling language for the programmer/controller transmitter that has served us well for many years. However, the Commission will modify the requirement for labeling a MedRadio transmitter with a serial number. The current rule requires that all MedRadio transmitters shall be identified with a serial number. GEHC has stated that “* * * It would not be appropriate to require that individual MBAN transmitters be equipped with a unique serial number, given the fact that individual sensor nodes may be disposable.” Although the Commission is not aware that this requirement has presented any problems for the manufacture and use of existing body-worn MedRadio devices, it will only require individual MBAN programmer/controller transmitters to be labeled with a unique serial number but not require individual MBAN body-worn sensor devices to be labeled this way due to their expected low-cost and disposable nature. Finally, as proposed in theNPRM,the Commission will allow the FCC ID number associated with the transmitter and the information required by § 2.925 of the FCC rules to be placed in the instruction manual for the transmitter in lieu of being placed directly on the transmitter. The size and placement of MBAN equipment may make it impractical to place this information directly on the transmitter, and the personnel responsible for overall MBAN operations within a health care facility are not likely to be physically located in patient care areas where MBAN transmitters will be used.
34.Other Service Issues.The Commission will also adopt the proposals in theNPRMthat MBAN devices will not be required to transmit a station identification announcement, and that all MBAN transmitters are made available for inspection upon request by an authorized FCC representative. These requirements are the same as the existing MedRadio rules, and no commenters objected to applying these provisions to MBAN users. The Commission also updated § 95.1211 of its rules (“Channel Use Policy”) to reference the 2360-2400 MHz band.
35.Authorized Bandwidth and ChannelAggregation. In theNPRM,the Commission sought comment on whether to apply the MedRadio approach of specifying only the maximum permitted bandwidth, but not any particular channel plan, with respect to MBAN devices in their authorized frequency band(s). The record reflects broad support for this approach, and the Commission modified § 95.633 to specify a 5-megahertz maximum authorized bandwidth for MBAN devices. This approach is consistent with the existing MedRadio rules.
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 theNPRMsuggested a 1 megahertz limit, the Commission agrees with the Joint Parties and other commenters that 5 megahertz is a more appropriate limit. By allowing the larger authorized bandwidth, we can still accommodate MBAN devices that use a 1 megahertz bandwidth, while also providing flexibility for the development of MBAN devices that can use higher data rates and that have higher throughput for applications that require larger amounts of data. The Commission will also permit device manufacturers to aggregate multiple transmission channels in a single device, so long as the total emission bandwidth used by all devices in any single patient MBAN communication session does not exceed the maximum authorized bandwidth of 5 megahertz. This, too, is consistent with the existing channel use provisions of the MedRadio Service.
37.Transmitter Operation and Power Limits.In theNPRM,the Commission sought comment on the appropriate maximum transmitter power for MBAN devices. It proposed to limit individual MBAN devices to a maximum transmit power of 1 mW equivalent isotropic radiated power (EIRP) measured in a 1 megahertz bandwidth, which followed GEHC's proposal. TheJoint Proposalsuggested use of a maximum EIRP of 20 mW measured in a 5 megahertz bandwidth for the 2390-2400 MHz band, but maintained the original 1 mW EIRP maximum for the 2360-90 MHz band. Based on the information provided in the record and the Commission's decision to adopt a maximum bandwidth of 5 megahertz, the Commission will modify § 95.639 of its rules to specify the power limits in theJoint Proposal.
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 infrastructureand physical layout will present unique capabilities and challenges, it will not establish any requirements for how control messages are distributed within a health care facility. The Commission revised § 95.628 of the rules, which specifies the technical requirements for MedRadio transmitters, so that the MBAN programmer/controller transmitters must be capable of receiving and complying with a control message specifying its particular operating parameters within the band. Specifically, an MBAN programmer/control transmitter may not commence operation and must automatically cease operating in the 2360-2390 MHz band if it does not receive a control message. It must also comply with a control message that directs it to limit its transmissions to segments of the band or to cease operation in the band. The Commission notes that the Joint Parties did not propose a specific period of time within which the MBAN transmitter must receive a control message to begin or continue operating. The proposal also did not prescribe a specific format or protocol for the control message. It will require applicants for equipment certification to attest that they comply with the requirement that MBAN equipment receive the control message by describing the protocols that the devices employ including the expected periodicity for reception of control messages that will allow the MBAN transmitter to begin or continue operating in the band. Additionally, the Commission expects that the control message will be an electronic message since it is expected to be sent using the health care facility's LAN. This helps to ensure that the MBAN meets the requirement for operating indoors on the 2360-2390 MHz band, since it will have to be tethered to a wireline network or within signal range of a wireless network within the facility.
41.Unwanted Emissions.In theNPRM,the Commission noted that the part 95 MedRadio rules set forth limits on unwanted emissions from medical transmitting devices operating in the 401-406 MHz band and sought comment on the appropriateness of applying the same general limits to MBAN operations in the 2360-2400 MHz bands. The Commission finds that the provisions in § 95.635(d) of its rules, which specify limits on unwanted emissions, are appropriate. Accordingly, the Commission modified this rule to reflect the use of the 2360-2400 MHz band by MBAN devices. It notes that the Joint Parties' proposal supports using the proposed limits on unwanted radiation and no party objected to the use of these figures. In addition, use of the MedRadio limits is consistent with our approach of accommodating MBAN operations under the existing MedRadio rules where practical.
42.Frequency Stability.In theNPRM,the proposed to require that MBAN transmitters comply with the MedRadio rules and maintain a frequency stability of +/− 100 ppm of the operating frequency over the ambient environmental temperature range: (1) 25 °C to 45 °C in the case of MBAN transmitters; and (2) 0 °C to 55 °C in the case of MBAN control transmitters. GEHC states that +/− 100 ppm is an acceptable limit for MBAN devices, but does not discuss the temperature range over which that stability should be required. The Commission is using the existing MedRadio definitions to regulate the MBAN sensor and hub devices. Under this construction, the existing temperature range for MedRadio programmer/control transmitters set forth in § 95.628(d)(2) of the rules will apply to MBAN hub devices without modification. Because no MBAN sensor will be implanted, the Commission further concludes that the 25 °C to 45 °C range it has for implanted devices should not apply to sensors. Instead it will use the broader 0 °C to 55 °C specification.
43.RF Safety.In theNPRM,the Commission noted that portable radiofrequency (RF) transmitting devices are subject to § 2.1093 of the rules, pursuant to which an environmental assessment concerning human exposure to RF electromagnetic fields must be prepared under § 1.1307, and that these rule sections also govern existing MedRadio devices. The Commission also has an open RF safety proceeding (ET Docket No. 03-137) in which it proposed to conduct a comprehensive review of its rules regarding human exposure to RF electromagnetic fields. Thus, theNPRMonly sought comment on whether MBAN transmitters should be deemed portable devices. The Commission will apply existing § 95.1221 of its rules to MBAN devices, which will classify them as portable devices that are subject to §§ 2.1093 and 1.1307 of the rules. The record reflects support for treating MBAN devices in this manner. The Commission sees no reason to treat MBAN devices differently than existing MedRadio devices with respect to RF safety matters.
44.Frequency Monitoring.In theNPRM,the Commission sought comment on whether a frequency monitoring requirement should be required for MBAN devices to promote inter- and intra-service sharing and, if so, how it should develop such a protocol. The Commission encouraged commenters supporting implementation of a contention based protocol to discuss what kinds of contention protocols (i.e.,listen-before-talk (LBT) frequency monitoring, time slot synchronization, and frequency hopping) should or should not be utilized, and to explain in detail why or why not.
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.
46.Duty Cycle.In theNPRM,the Commission sought comment on whether it should adopt specific duty cycle limits for MBAN transmitters in our rules and whether such limits would be needed to allow the functioning of a contention-based protocol for achieving reliable MBAN system performance, or for otherreasons. The Commission finds that it is not necessary to specify a duty cycle in its rules. The record indicates that manufacturers are likely to employ duty cycles even without a specific requirement to do so because it will allow them to achieve important operational goals. The Commission believes that the ongoing efforts of standards setting bodies to address MBAN use are adequate to address any relevant duty cycle considerations.
Registration and Coordination for the 2360-2390 MHz Band
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.