Daily Rules, Proposed Rules, and Notices of the Federal Government
This is a summary of the Commission's
Pursuant to §§ 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed using: (1) The Commission's Electronic Comment Filing System (ECFS), (2) the Federal Government's eRulemaking Portal, or (3) by filing paper copies.
▪ For ECFS filers, if multiple docket or rulemaking numbers appear in the caption of this proceeding, filers must transmit one electronic copy of the comments for each docket or rulemaking number referenced in the caption. In completing the transmittal screen, filers should include their full name, U.S. Postal Service mailing address, and the applicable docket or rulemaking number. Parties may also submit an electronic comment by Internet e-mail. To get filing instructions, filers should send an e-mail to
Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail (although we continue to experience delays in receiving U.S. Postal Service mail). All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.
▪ The Commission's contractor will receive hand-delivered or messenger-delivered paper filings for the Commission's Secretary at 236 Massachusetts Avenue, NE., Suite 110, Washington, DC 20002. The filing hours at this location are 8 a.m. to 7 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes must be disposed of
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Filings and comments are also available for public inspection and copying during regular business hours at the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC 20554. They may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone: (202) 488-5300, fax: (202) 488-5563, or via e-mail
1. In the Notice of Proposed Rulemaking (NPRM), the Commission seeks comment on allocating spectrum and establishing service and technical rules for the operation of Medical Body Area Network (or MBAN) systems using body sensor devices. The NPRM reflects the Commission's continuing efforts to foster the availability and use of advanced medical devices using wireless technologies which, in turn, should help to improve the health and well-being of the American public.
2. MBAN systems, as contemplated by the NPRM, could provide a flexible platform for the wireless networking of multiple body sensors used for monitoring a patient's physiological data, primarily in health care facilities as well as in other health care monitoring situations. Use of MBAN systems hold the promise of improved safety, quality, and efficiency of patient care by reducing or eliminating a wide array of hardwired, patient-attached cables used by present monitoring technologies.
3. Given these significant health care benefits offered by MBAN systems, the Commission tentatively concludes that providing spectrum for MBAN operations would serve the public interest.
4. Against this backdrop, the Commission addresses a petition filed by GE Healthcare (hereinafter the “GEHC petition”) to allocate up to 40 megahertz of spectrum in the 2360-2400 MHz band, which is used on a primary basis by Federal and non-Federal Aeronautical Mobile Telemetry (AMT), Federal Radiolocation, and non-Federal Amateur services. In addition, the Commission seeks comment on an alternative recommendation by the Aerospace and Flight Test Radio Coordinating Council (AFTRCC) to accommodate MBAN operations in the 2300-2305 MHz and 2395-2400 MHz bands. Finally, the Commission seeks comment on whether other bands such as the 2400-2483.5 MHz or 5150-5250 MHz bands could be used to support MBAN operations.
5. The Commission also addresses several spectrum compatibility concerns with respect to incumbent operations in accommodating MBAN operations. Thus, the Commission seeks comment on the potential for interference caused either to incumbents, or to MBAN systems, and how any such concerns might be mitigated. In addition, the Commission seeks comment more generally on whether allocating spectrum and establishing rules to allow
6. Finally, the Commission seeks comment on what licensing approaches would be appropriate for MBAN operations in the various frequency bands under consideration, as well as service and technical rules for MBAN operation. This includes a discussion of whether MBANs should be authorized on a licensed basis under part 95, a “licensing-lite” approach under part 90, or an unlicensed basis under part 15. The tentative service and technical rules discussed in the NPRM follow the general framework of the recently adopted rules for the MedRadio Service.
7. The Commission seeks comment on whether to allow MBAN operations on up to 40 megahertz of spectrum in the 2360-2400 MHz band on a secondary basis. This option reflects the initial recommendation set forth in the GEHC petition. In this context, the Commission recognizes the necessity of affording interference protection to incumbent primary users, particularly AMT operations. In addition, the NPRM considers the potential for interference to MBAN devices and the attendant risk to patients using MBAN systems.
8. The Commission also seeks additional comment on the amount of spectrum required to support MBAN operations, and what factors (including the number and types of incumbent users) should be taken into account in determining the amount of spectrum required.
9. Regarding the potential for interference from MBAN devices to incumbent operations, the Commission seeks comment on whether the potential for sharing between MBAN systems and incumbent AMT and radiolocation operations could be facilitated if geographic exclusion zones were to be established around AMT test flight sites in the 2360-2395 MHz band to protect those sites from harmful interference. In addition to or in lieu of exclusion zones, MBAN operators and AMT licensees may be able to coordinate their operations. The Commission further observes in the NPRM that sharing between MBAN systems and incumbents AMT and radiolocation operations could be facilitated if MBAN operations in the 2360-2390 MHz band, which is allocated for AMT operations, are limited to indoor use within health care facilities as defined in the WMTS. The Commission believes that this requirement would limit the incidence of MBAN operations and effectively reduce the likelihood that they would occur near AMT flight test sites. Because MBAN systems would be used indoors, building structures would attenuate MBAN signals and further reduce the likelihood of interference to AMT. Thus, the Commission seeks comment on whether permitting MBAN systems to operate in the 2360-2395 MHz band under the limitations proposed would provide interference protection to incumbent users.
10. Regarding interference from AMT to MBAN operations, the Commission seeks comment on whether MBAN devices could avoid receiving interference from AMT or other incumbent users by employing a contention-based protocol or some other techniques. In this regard, the Commission seeks comment on whether transmissions from incumbent stations, as well as flight test stations using future technologies (which might include the use of high-power, omnidirectional uplink and downlink transmissions) could adversely affect the operation of MBAN devices—possibly resulting in adverse effects to patients.
11. To address recommendations made in comments filed by AFTRCC, the Commission seeks comment on limiting MBAN operations to the 2300-2305 MHz and 2395-2400 MHz bands. It specifically seeks comment on the ability of MBAN devices to utilize these two blocks of spectrum that are separated by 90 megahertz. The Commission also seeks comment on whether it should consider a secondary allocation for MBAN operations in these two bands, or if allocating these bands on a primary basis would allow MBAN devices to more effectively use the spectrum since they would not have to avoid AMT users. The Commission seeks comment as to whether MBAN operations can exist compatibly with the incumbent Amateur service users in the 2300-2305 MHz and 2390-2400 MHz bands. The Commission further seeks comment as to whether, in the 2390-2395 MHz band it should consider allowing MBAN and AMT operations to operate on a co-primary basis and what the sharing rules between them should be. Additionally, the Commission seeks comment on whether any additional MBAN spectrum would be needed if it were to reallocate the 2390-2395 MHz band to remove the AMT allocation in order to provide a total of up to 15 megahertz of spectrum for use by MBAN operations on a primary basis.
12. To the extent that MBAN operation might ultimately be authorized in any portion of the 2300-2305 MHz or 2360-2400 MHz bands, the Commission proposes including a new U.S. footnote to the Table of Allocations in part 2 of the rules for the specific band. The Commission would also require that MBANs not cause harmful interference to and accept interference from Federal and non-Federal stations operating in accordance with the Table of Frequency Allocations. The Commission seeks comment on this approach.
13. The Commission seeks comment on whether MBAN devices could operate in the 2400-2483.5 MHz band. The 2400-2483.5 MHz band is used by Industrial, Scientific and Medical (ISM) equipment operating under part 18 of the Commission's rules. Any equipment or services operating in ISM bands are obliged to accept interference from ISM equipment. In its petition, GEHC has asserted that manufacturers could leverage available technology used for ISM equipment in this band to develop low-cost MBAN devices.
14. In addition to present use by ISM, the Commission observes that various radio services are also allocated in this band. Among these, the 2400-2417 MHz band is allocated to the Amateur service on a primary basis. The 2417-2450 MHz band is allocated to the Amateur service on a secondary basis, and to the Federal radiolocation service on a secondary basis. Such Federal operations may be authorized on a non-interference basis, but may not constrain the implementation of any non-Federal operations. The 2450-2483.5 MHz band is allocated to the non-Federal fixed and mobile services on a primary basis, and to the non-Federal radiolocation service on a secondary basis. The Federal radiolocation service is also permitted in this band on condition that harmful interference is not caused to non-Federal services. The 2400-2483.5 MHz band is also used by unlicensed devices operating under Part 15 of the Commission's Rules. These unlicensed devices include WiFi, cordless phones, and Bluetooth, among various other types of uses.
15. The Commission seeks comment on whether the widespread success of the unlicensed devices described in the preceding paragraph would provide manufacturers the opportunity to leverage these technologies for the development of low cost MBAN devices within the 2400-2483.5 MHz band. More particularly, the Commission seeks comment as to whether MBAN devices could be certified and operate under the current part 15 rules, whether
16. The Commission also cautions that any MBAN equipment operating in these bands would have no protection from interference from ISM equipment operating under part 18 of the rules or other low power transmitters operating under part 15 of the rules. The Commission seeks information as to whether the ISM bands are still used by medical telemetry devices, and comment as to whether MBAN operations would fit within this category of use.
17. The Commission seeks comment on whether there are other frequency bands where MBAN manufacturers could leverage existing technologies to implement such devices and achieve economies of scale. For example, the Commission seeks comment on whether the 5150-5250 MHz band offers similar opportunities for MBAN operation as may be achievable in or near the 2400 MHz band as described. The 5150-5250 MHz band is allocated to the Federal and non-Federal aeronautical radionavigation service. The band is also allocated to the non-Federal fixed-satellite service. In addition to these allocated services, the band is also used by unlicensed national information infrastructure (U-NII) devices operating under subpart E of the Commission's part 15 rules.
18. U-NII devices use digital modulation techniques and provide a wide array of high data rate mobile and fixed communications applications. U-NII devices operating in the 5250-5350 MHz and 5470-5725 MHz bands must employ Dynamic Frequency Selection (DFS) to avoid operating on the same channels as radars. However, the 5150-5250 MHz band does not require DFS and is limited to indoor operation only, which would appear to be consistent with GEHC's proposed MBAN devices.
19. With respect to the 5150-5250 MHz band, the Commission seeks comment as to whether MBAN devices could be certified and operate under the current part 15 rules, whether a new subpart under part 15 might be required, or whether it should consider licensed operation of MBAN devices under part 95 of the Commission's rules. If it is determined that licensed operation is appropriate, would the technical and service rules discussed below for the 2360-2400 MHz band be applicable for MBAN operation in the 5150-5250 MHz band? If not, what technical and service rules would apply? What amount of bandwidth would MBAN devices require to operate in this band and in what portion of the band would they operate? Can MBAN devices operate compatibly with the incumbent services in the 5150-5250 MHz band? Should MBAN operations be limited to indoor locations, similar to the indoor restriction to U-NII devices in § 15.407(e)?
20. The tentative rules discussed in the NPRM focus upon the overall framework of the MedRadio Service in part 95, but with modified power and emission bandwidth requirements to accommodate the anticipated bandwidth and EIRP needs of MBAN operations that might apply in the 2360-2400 MHz band. At the same time, the Commission seeks comment on other approaches, such as under part 90 or part 15, that might be feasible. The Commission takes this approach in the NPRM because the 2360-2400 MHz band was specifically addressed in the GEHC petition and in both the comments and reply comments, The Commission notes that, in any event, similar rules would also be required if MBAN operations were to be authorized in either the 2400-2483.5 MHz or the 5150-5250 MHz bands under consideration.
22. Alternatively, the Commission seeks comment on whether MBAN operations should be licensed on a non-exclusive basis under part 90. In this context, the Commission also seeks comment on whether it would be feasible to establish geographic exclusion zones around AMT operational areas as an interference avoidance mechanism. At the same time, the Commission seeks comment on whether the use of such exclusion zones could frustrate the widespread use of MBAN devices—particularly, for example, if such exclusion zones were so large as to encompass major metropolitan areas where MBAN operations might be prohibited. As discussed elsewhere in the
• Medical body area device—a medical sensing device that is placed on or in close proximity to the human body for the purpose of measuring and recording physiological parameters and other patient information or performing diagnostic or therapeutic functions via radiated bi- or unidirectional electromagnetic signals. These devices may only communicate as part of a medical body area network.
• Medical body area network (MBAN)—a low-power independent network comprised of multiple medical body area devices that transmit or receive either non-voice medical data of a patient or related device control commands. Transmissions to and from these multiple medical body area devices are routed through a hub, which is placed on or in close proximity to the patient's body, and which may communicate with a remote monitoring location.
• MBAN transmitter—A transmitter that operates as part of a Medical Body Area Network, and is located either on the human body or in close proximity to it.
• MBAN control transmitter—A MBAN transmitter, which is designed to be placed on or in close proximity to the patient's body, that serves as a hub to control and coordinate communications with body area devices, and which may also communicate with a remote monitoring location.
24. The Commission requests comment as to whether these definitions would be too broad or too narrow and whether alternative definitions should be used. The Commission asks whether other components of wireless MBAN systems should also be identified and defined. The Commission is not proposing to include medical implant devices as part of MBAN systems, although it recognizes that such devices could be used for monitoring, diagnostic or therapeutic purposes. Parties that believe medical implant devices should be allowed as part of MBAN operations should address how such devices would co-exist with body sensor devices and the technical rules that would apply to their operation. The Commission also seeks comment on whether any other current definitions included in the MedRadio Service rules need to be modified to accommodate wireless MBAN devices.
26. In the MedRadio proceeding, the Commission declined to explicitly limit the use of some frequencies to life-critical and time-sensitive applications, as the comments of some parties suggested, while allowing other frequencies to be used for non-life-critical, non-time sensitive applications. The Commission concluded that the ultimate decision on which frequency band to use for each type of application was best left to health care professionals and medical device manufacturers, in concert with FDA-required risk management processes, as it would result in better and more flexible use of this scarce spectrum resource. The Commission seeks comment on whether a similar approach is appropriate for MBAN devices—
27. The Commission also notes that the current MedRadio Service rules do not allow programmer/control transmitters to relay information to a receiver that is not included with a MedRadio implant or body-worn device. However, the MedRadio Service rules do allow programmer/control transmitters to be interconnected with other telecommunications systems including the public switched telephone network. The Commission seeks comment on whether, and if so why, similar requirements should also apply here. The Commission also seeks comment on how spectrum might be used to perform backhaul from a single patient-based MBAN control transmitter to a monitoring station that receives and processes MBAN body sensor data from multiple patients and what spectrum should be used for that purpose.
28. The Commission seeks comment on whether communications between MBAN body sensors, or other intra-MBAN network communications, should be allowed, and whether there should be a requirement that each external MBAN control transmitter be limited to controlling the body sensor transmitters for a single patient. Alternatively, the Commission asks whether it should permit groups of MBAN body sensors for multiple patients to be coordinated by one central MBAN control transmitter and if so, whether any special protocols or other requirements should be applied to such communications.
30. One benefit of this approach would be that networked MBAN devices could transmit on any center frequency
31. Alternatively, the Commission seeks comment on whether a specific channeling plan would be needed. If so, what form might it take and what are the advantages that it would obtain over the proposed approach?
33. The Commission also seeks comment on whether exclusion zones could always preclude operation of MBAN devices at some locations. If so, would it be in the public interest to preclude these technologies from certain health care facilities based on their location? Or should health care facilities located within an exclusion zone be permitted to coordinate MBAN use with AMT operations in that zone?
34. If exclusion zones were to be established, what criteria should be used to identify those AMT sites in need of protection? Should only AMT test sites that now actually use the 2360-2390 MHz band be protected, or also those test sites that do not presently use the band but might prospectively do so? If protection were to be required of sites that AFTRCC claims are “entitled” to, but do not currently use the 2360-2390 MHz band, how would the sites which are “entitled” to be protected be determined? Once existing test sites were determined, how would future test sites be protected if MBAN devices are already operating within the area that will be designated as a new exclusion zone? With respect to making these determinations, the NPRM notes that the Commission (for non-Federal users) and NTIA (for Federal users) maintain separate data bases containing geographic location and frequency information on users authorized to operate transmitters throughout the radio spectrum. Thus, if an exclusion zone approach permitting MBAN operation were to be adopted, the Commission would anticipate relying, to the extent possible, upon the information contained in the relevant Commission and NTIA data bases as a baseline for identifying facilities that require protection. If the Commission ultimately decides to protect sites that are not currently licensed to use the 2360-2390 MHz band, how would information on exclusion zones be accurately maintained and timely updated in the Commission's rules? The Commission seeks comment on these matters.
35. The NPRM seeks comment on whether the distance for MBAN operations should be measured from the specified center point that establishes the incumbent's area of operation or whether it should be measured from the edge of that area? How should incumbent sites be accounted for that are in close proximity to each other such that their areas of operation may overlap each other? Should further information be collected about incumbent operational locations and how should it be gathered? Regarding information about Federal sites, the Commission notes that it would intend to consult with NTIA about how to identify this information and make it available. The Commission also seeks comment on how it should account for future installations if a healthcare facility that is using MBANs is located in an area that would become part of an exclusion zone for the new site.
37. For example, the Commission acknowledges the suggestion made in the GEHC petition that the Commission could require frequency coordination and device registration for MBAN operations such as is used for coordination of WMTS operation. There, the Commission designated a private entity to serve as the WMTS frequency coordinator and that entity maintains a database of all WMTS equipment in operation.
38. However, in the case of MBAN systems, users may not need to coordinate their operations among themselves as do WMTS users, particularly if MBAN devices ultimately rely on a contention-based protocol as discussed below to promote intra-service sharing. Regarding coordination of MBAN operations with incumbent
39. Alternatively, the Commission could license MBAN operations on a non-exclusive basis under part 90, and would be responsible for facilitating coordination. For example, licensees in the Wireless Broadband Service in the 3650-3700 MHz band are permitted to operate anywhere outside of specified 150 km protection zones around incumbent non-Federal primary earth station facilities. Those wishing to operate within the protection zones must negotiate with the affected incumbents directly. To ensure compatibility with Federal stations, the Commission coordinates operations with NTIA through the Frequency Assignment Subcommittee of the Interdepartment Radio Advisory Committee for any station that requests registration of a site closer than 80 km from three specified radio location sites. The Commission further notes that our Universal Licensing System has the capability of screening for any terrestrial applications that might propose site coordinates located within the 80 km coordination zone and flag that application for any necessary coordination.
40. The Commission notes that, in the present case proposed by GEHC, the circumstances under which Federal and non-Federal AMT spectrum use is coordinated is substantially different than those at 3650-3700 MHz. AFTRCC is the designated coordinator of all non-Federal AMT use, and is recognized as such by both the Commission and NTIA. Consequently, any Federal and non-Federal use of the 2360-2395 MHz band is referred to AFTRCC and coordination with them must be completed prior to operation. In addition, the Commission coordinates non-Federal use of this spectrum with NTIA. If the Commission were to follow this approach, any MBAN operation in the 2360-2395 MHz band segment would be referred to AFTRCC and to NTIA, which might delay deployment. At the same time, because the Commission would have the licensing and coordination information readily available, it could intercede in resolving disagreements more easily, as needed. Regarding spectrum sharing among MBAN operations, coordination under a non-exclusive licensing scheme does not appear to provide any additional benefits compared to the WMTS model. The Commission seeks comment on whether such an approach would be feasible here. Commenters should address the relative advantages and disadvantages of the approaches they support.
42. The Commission encourages commenters supporting implementation of a contention-based protocol to discuss what kinds of contention protocols should or should not be utilized, and to explain in detail why or why not. How should such protocols be defined? Should the protocol be open-source or proprietary? Should more than one protocol be permitted? Should the same protocol be required for all devices, and how would this be accomplished? How should such protocols be established—by rule, by industry standard setting procedures, or other approaches? Would any of these protocols be expected to interact either favorably or adversely with incumbent users?
44. While GEHC emphasizes the use of MBAN systems for monitoring patient physiological data, the Commission recognizes that the definition that it proposed for MBAN systems would also allow the operation of two or more networked medical devices to perform diagnostic and therapeutic functions. The Commission seeks comment on whether the power/bandwidth limits proposed above—which reflect GEHC's recommendations—would be appropriate for such other purposes. The Commission specifically asks whether another combination of power and duty cycle limits would provide a better balance between affording interference protection to incumbent users and achieving sufficiently reliable MBAN system performance. The Commission requests that commenters suggesting other bandwidths should fully discuss their relative benefits and potential disadvantages in light of the considerations discussed herein. With respect to transmitter duty cycles, the Commission seeks comment on whether GEHC's assumption of a 25 percent factor adequately characterizes operations that would be expected from real-world devices. For example, would the duty factor of MBAN transmitters used for diagnostic or therapeutic purposes, instead of patient monitoring, be more likely to require higher, lower,
51. First, the Commission seeks comment on whether it should require that each authorized MBAN transmitter be certificated, except for such transmitters that are not marketed for use in the United States, but which otherwise comply with the applicable technical requirements and are operated in the United States by individuals who have traveled to the United States from abroad.
52. The Commission also seeks comment on whether to specifically require that all non-implanted MBAN transmitter apparatus be made available for inspection upon request by an authorized FCC representative. Under such a provision, persons operating MBAN transmitters would be required to cooperate reasonably with duly authorized FCC representatives in the resolution of interference.
53. The Commission request comment on requiring that manufacturers of MBAN transmitters include an appropriate disclosure statement analogous to that for MedRadio transmitters with each MBAN transmitting device. Such a statement would disclose the provision of the rules under which the device is authorized, along with a statement that the transmitter must not cause harmful interference to stations authorized to operate on a primary basis in the band, and must accept interference that may be caused by such stations, including interference that may cause undesired operation. Such a statement would also indicate that the transmitter shall be used only in accordance with the FCC rules, and that analog and digital voice communications are prohibited. The
54. The Commission further seeks comment on whether to require that MBAN control transmitters (if allocated on a secondary basis) be labeled and bear the following statement in a conspicuous location on the device: “This device may not interfere with stations authorized to operate on a primary basis and must accept any interference received, including interference that may cause undesired operation.” Where a MBAN control transmitter is constructed in two or more sections connected by wire and marketed together, the statement specified in this section would be required to be affixed only to the main control unit. The Commission also seeks comment on whether to require that MBAN transmitters be identified with a serial number. Under that plan, the Commission would 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.
55. Finally, with respect to marketing limitations, the Commission seeks comment on whether it should specify that MBAN transmitters may be marketed and sold only for those permissible uses described in the NPRM.
56. As noted in the
57. The Commission seeks comment on all of the matters discussed in this NPRM, and encourages commenters to address any other relevant matters of concern that might serve to illuminate the record in this proceeding.
58. As required by the Regulatory Flexibility Act (RFA),
59. The Commission seeks comment on the feasibility of allocating spectrum for the operation of Medical Body Area Network (or MBAN) systems using body sensor devices. Under the service and technical rules proposed herein, the Commission envisions that MBAN systems could provide a flexible platform for the wireless networking of multiple body sensors used for monitoring physiological patient data in health care facilities. Use of MBAN systems should result in improved safety, quality, and efficiency of patient care by reducing or eliminating a wide array of hardwired, patient-attached cables used by present monitoring technologies.
60. The proposed action is authorized under Sections 4(i), 301, 302, 303(e), 303(f), 303(r), 304 and 307 of the Communications Act of 1934, as amended, 47 U.S.C. Sections 154(i), 301, 302, 303(e), 303(f), 303(r), 304 and 307.
61. The RFA directs agencies to provide a description of and, where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted.
62. Nationwide, there are a total of approximately 27.2 million small businesses, according to the SBA.
64. The 2300-2305 MHz, 2360-2400 MHz, 2400-2500 MHz and 5150-5250 MHz bands are used by various Federal and non-Federal radiocommunication services. Thus, the Commission seeks comment related to the potential for interference caused either to incumbents, or to MBAN systems, and how any such concerns might be mitigated.