Federal Register: August 6, 2009 (Volume 74, Number 150)
DOCID: fr06au09-16 FR Doc E9-18859
FEDERAL COMMUNICATIONS COMMISSION
Federal Communications Commission
CFR Citation: 47 CFR Parts 2 and 95
Docket ID: [ET Docket No. 08-59; FCC 09-57]
NOTICE: PROPOSED RULES
DOCUMENT ACTION: Proposed rule.
Medical Body Area Network (MBAN)
DATES: Comments must be filed on or before October 5, 2009, and reply comments must be filed on or before November 4, 2009.
In this document 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. MBAN systems would 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. 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, patientattached cables used by present monitoring technologies. This Notice of Proposed Rulemaking reflects the Commission's continuing desire to foster the availability and use of advanced medical devices using wireless technologies, which, in turn, should help to improve the health and wellbeing of the American public.
Medical Body Area Network (MBAN)
This is a summary of the Commission's Notice of Proposed Rule Making, ET Docket No. 0859, FCC 0957, adopted June 29, 2009, and released June 29, 2009. The full text of this document is available for public inspection and copying during regular business hours in the Commission's Reference Information Center, Portals II, 445 12th Street, SW., (Room CYA257), Washington, DC 20554. The complete text of this document also may be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., Portals II, 445 12th Street, SW., Room CYB402, Washington, DC 20554, telephone (202) 4885300, facsimile (202) 4885563 or via email FCC@BCPIWEB.com. The full text may also be downloaded at: http://www.fcc.gov.
Pursuant to Sec. Sec. 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. See Electronic Filing of Documents in Rulemaking Proceedings, 63 FR 24121 (1998).
[squf] Electronic Filers: Comments may be filed electronically using the Internet by accessing the ECFS: http://www.fcc.gov/cgb/ecfs/ or the Federal eRulemaking Portal: http://www.regulations.gov. Filers should follow the instructions provided on the Web site for submitting comments.
[squf] 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 email. To get filing instructions, filers should send an email to firstname.lastname@example.org, and include the following words in the body of the message, ``get form.'' A sample form and directions will be sent in response.
[squf] Paper Filers: Parties who choose to file by paper must file an original and four copies of each filing. If more than one docket or rulemaking number appears in the caption of this proceeding, filers must submit two additional copies for each additional docket or rulemaking number.
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overnight courier, or by firstclass or overnight U.S. Postal Service
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Secretary, Office of the Secretary, Federal Communications Commission.
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People with Disabilities: To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to email@example.com or call the Consumer & Governmental Affairs Bureau at 2024180530 (voice), 202 4180432 (tty).
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 CYA257, 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 CYB402, Washington, DC 20554, telephone: (202) 4885300, fax: (202) 4885563, or via email http://www.bcpiweb.com. Summary of Notice of Proposed Rulemaking
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 wellbeing 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, patientattached 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 23602400 MHz band, which is used on a primary basis by Federal and nonFederal Aeronautical Mobile Telemetry (AMT), Federal Radiolocation, and nonFederal 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 23002305 MHz and 23952400 MHz bands. Finally, the Commission seeks comment on whether other bands such as the 24002483.5 MHz or 51505250 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
the operation of MBAN systems for the purposes described herein would serve the public interest.
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.
A. Frequency Allocation
1. 23002305 MHz and 23602400 MHz Frequency Bands
7. The Commission seeks comment on whether to allow MBAN operations on up to 40 megahertz of spectrum in the 23602400 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 23602390 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 23602395 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 contentionbased 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 highpower, omnidirectional uplink and downlink transmissions) could adversely affect the operation of MBAN devicespossibly 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 23952400 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 23002305 MHz and 23902400 MHz bands. The Commission further seeks comment as to whether, in the 23902395 MHz band it should consider allowing MBAN and AMT operations to operate on a coprimary 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 23902395 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 23002305 MHz or 23602400 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 nonFederal stations operating in accordance with the Table of Frequency Allocations. The Commission seeks comment on this approach.
2. 24002483.5 MHz Frequency Band
13. The Commission seeks comment on whether MBAN devices could operate in the 24002483.5 MHz band. The 24002483.5 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 lowcost 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 24002417 MHz band is allocated to the Amateur service on a primary basis. The 24172450 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 nonFederal operations. The 24502483.5 MHz band is allocated to the nonFederal fixed and mobile services on a primary basis, and to the nonFederal 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 nonFederal 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 24002483.5 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
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 for the 23602400 MHz band be applicable for MBAN operation in the 24002483.5 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? The Commission also seeks comment regarding whether MBAN operations can exist compatibly with the incumbent Amateur service users who operate in this band.
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.
3. Other Frequency Bands
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 51505250 MHz band offers similar opportunities for MBAN operation as may be achievable in or near the 2400 MHz band as described. The 51505250 MHz band is allocated to the Federal and nonFederal aeronautical radionavigation service. The band is also allocated to the nonFederal fixedsatellite 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. UNII devices use digital modulation techniques and provide a wide array of high data rate mobile and fixed communications applications. UNII devices operating in the 52505350 MHz and 5470 5725 MHz bands must employ Dynamic Frequency Selection (DFS) to avoid operating on the same channels as radars. However, the 51505250 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 51505250 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 23602400 MHz band be applicable for MBAN operation in the 51505250 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 51505250 MHz band? Should MBAN operations be limited to indoor locations, similar to the indoor restriction to UNII devices in Sec. 15.407(e)?
B. Service and Technical Rules
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 23602400 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 23602400 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 24002483.5 MHz or the 51505250 MHz bands under consideration.
1. Service Rules
21. Licensing. The Commission seeks comment on whether medical device operations should be authorized in part 95 of our rules, thus providing for licensebyrule operation pursuant to Section 307(e) of the Communications Act (Act). Under this approach, medical devices would operate in the band on a shared, nonexclusive basis with respect to each other and without the need for MBAN systems to be individually licensed. As the Commission determined when it adopted the MedRadio Service rules, this approach minimizes regulatory burdens and facilitates the expeditious deployment of new generations of beneficial wireless medical devices that can improve the quality of life for countless Americans, thus serving the public interest, convenience and necessity. The Commission seeks comment on whether the rules for MBANs should be included in subpart I of part 95, which authorizes the MedRadio Service, or whether the rules for MBANs should be included in a new subpart under part 95.
22. Alternatively, the Commission seeks comment on whether MBAN operations should be licensed on a nonexclusive 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 devicesparticularly, 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 NPRM, frequency coordination also could facilitate sharing between the incumbent operations and MBAN devices. Frequency coordination is required for WMTS operations authorized under part 95, but does not involve as many sites as could be required for MBAN and AMT coordination. Another licensing approach that the Commission would consider for MBAN operation that includes coordination is nonexclusive licensing under part 90. Under that approach, MBAN operations would be licensed on a nonexclusive basis with respect to each other for ten year license terms. The Commission seeks comment on whether it should consider using the same approach here as it does with wireless broadband services in the 36503700 MHz band, i.e., eligible entities would apply for nonexclusive nationwide licenses and subsequently register individual stations with the Commission. If the Commission were to adopt this approach, should it require that licensees register each individual MBAN system or, alternatively, require them to register the individual health care facility at which the licensee would be allowed to operate multiple MBAN systems? What type of licensing and registration information for MBAN operations would facilitate coordination with incumbent services? What would be the relative benefits and disadvantages of licensing under part 90 [[Page 39253]]
compared with the licensebyrule approach under part 95?
23. Definitions. The Commission seeks comment on the definitions to
apply to MBAN systems and body sensor devices. Because MBAN systems may
be comprised of sensors that perform not only monitoring functions but
also diagnostic and therapeutic functions, definitions for MBAN and
body sensor networks should be consistent with definitions already in
the Commission's part 95 rules for wireless medical telemetry and body
worn devices. The Commission seeks comment on the following proposed definitions:
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 coexist 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.
25. Permissible Communications and Operator Eligibility. The Commission proposes to establish requirements for permissible communications and operator eligibility that are generally the same as those in place for the MedRadio Service. The MedRadio rules provide that a MedRadio device may be used by persons for diagnostic and therapeutic purposes, but only to the extent that such devices have been provided to a human patient under the direction of a duly authorized health care professional. Furthermore, transmissions are limited to nonvoice data signals. The Commission expects, based on representations made in the GEHC petition, that wireless body sensor devices configured as a MBAN would be used primarily for monitoring patient data. The Commission believes it would be prudent to provide flexibility so that MBAN systems can also be used for performing diagnostic or therapeutic functions. The Commission seeks comment on whether these requirements would be appropriate for MBAN operations.
26. In the MedRadio proceeding, the Commission declined to explicitly limit the use of some frequencies to lifecritical and time sensitive applications, as the comments of some parties suggested, while allowing other frequencies to be used for nonlifecritical, 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 FDArequired 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 devicesi.e., permitting health care professionals and medical device manufacturers, in concert with FDA required risk management processes, to decide whether MBAN devices should be used for lifecritical and timesensitive applications even though these devices would not receive interference protection from radiocommunication services with a higher allocation status. Commenters who believe that the Commission should not allow MBAN devices for life critical and timesensitive applications should suggest how the Commission should define these terms and types of applications.
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 bodyworn 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 patientbased 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 intraMBAN 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.
2. Technical Rules
29. Channelization. The Commission seeks comment on adopting rules for MBAN operations that do not specify a particular channeling plan, thereby following the general approach used with the MedRadio Service. Under this approach, the ``channel'' occupied by a MBAN transmitter or transmission would be loosely defined as any continuous segment of spectrum that is equal to the largest bandwidth used by any MBAN transmitter that participates in a given single patient MBAN communications session. In this context, a MBAN ``communication session'' would be defined (analogous to the definition of a MedRadio communication session) as a collection of transmissions that may or may not be continuous and that take place between two or more MBAN devices in a single patient network.
30. One benefit of this approach would be that networked MBAN devices could transmit on any center frequency
within the MBAN band so long as the maximum emission bandwidth, outof band, and spurious emission limits adopted herein are met. This approach would also afford the flexibility for MBAN devices to subdivide the authorized frequency band(s) into adhoc device ``channels'' that could be tailored by manufacturers to meet device specific spectrum requirements for a variety of medical monitoring, diagnostic and therapeutic functions. The Commission seeks 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). In particular, the Commission seeks comment on whether the potential benefits described above might be outweighed by an increased risk of adverse mutual interactions between multiple MBAN devices or MBAN devices and incumbent users using differing center frequencies and bandwidths and whether there are other factors that should be considered under this option.
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?
32. Exclusion Zones. The Commission recognizes that the current record contains conflicting information relating to the appropriate models to be used for evaluating the potential for interference to AMT operations from MBAN devices and establishing the size of exclusion zones to protect those operations. Therefore, the Commission seeks comment on the feasibility of using exclusion zones as a means to prevent interference to incumbent operations in the 23602390 MHz band and, if exclusion zones are to be used, the appropriate radius to use for such exclusion zones. The Commission states that it is not convinced at this time that either the GEHC or AFTRCC analysis is appropriate for determining interference potential and the utility or size of exclusion zones. Thus, the Commission seeks comment on the analytic methodology that should be used and the assumptions that should be employed, including the methodologies and analyses used by AFTRCC and GEHC for determining an exclusion zone radius. The Commission also invites comment on other methodologies and analyses, including assumptions on which they rely, that could be used. The Commission also seeks comment on whether it is appropriate to use either interference criteria described herein, which are primarily intended for satellite and terrestrial sharing in the adjacent frequency band, for AMT and MBAN operations and invite suggestions for alternative approaches for determining the radius of potential exclusion zones. The Commission provides in Appendix A of the NPRM additional parameters for MBAN and AMT systems that parties should address, as appropriate, to support further technical analyses.
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 23602390 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 23602390 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 nonFederal 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 23602390 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.
36. Frequency Coordination. With respect to protecting AMT operations from MBAN interference in portions of the 23602400 MHz band, the Commission recognizes that coordination may be useful because MBAN operations might otherwise be excluded from large geographic areas that encompass medical facilities. In such cases coordination would provide a means for the parties to work together on some type of sharing arrangement for given locations. Thus, the Commission seeks comment on whether coordination of MBAN systems is needed and should be required and, if so, under what circumstances. The Commission also seeks comment on whether it should require AMT or other incumbent licensees to participate in frequency coordination with operators of MBAN systems in any portions of the band. If so, what approaches would be feasible, and what parties would be responsible for ensuring that such coordination takes place?
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 contentionbased
protocol as discussed below to promote intraservice sharing. Regarding coordination of MBAN operations with incumbent
users, the Commission also notes that MBAN devices would operate on a secondary basis, and a significantly large number of primary users must be accorded interference protection. Thus, the Commission seeks comment on whether the WMTS model would be feasible here. Parties supporting this approach should address what criteria would be used to determine if a MBAN system could operate without causing interference, what type of information should be contained in a database, who would have access to the database and on what terms, and how the Commission would designate a database administrator.
39. Alternatively, the Commission could license MBAN operations on a nonexclusive basis under part 90, and would be responsible for facilitating coordination. For example, licensees in the Wireless Broadband Service in the 36503700 MHz band are permitted to operate anywhere outside of specified 150 km protection zones around incumbent nonFederal 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 nonFederal AMT spectrum use is coordinated is substantially different than those at 36503700 MHz. AFTRCC is the designated coordinator of all nonFederal AMT use, and is recognized as such by both the Commission and NTIA. Consequently, any Federal and nonFederal use of the 23602395 MHz band is referred to AFTRCC and coordination with them must be completed prior to operation. In addition, the Commission coordinates nonFederal use of this spectrum with NTIA. If the Commission were to follow this approach, any MBAN operation in the 23602395 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 nonexclusive 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.
41. Frequency Monitoring (Contentionbased Spectrum Access Protocols). The Commission recognizes that low power operation and spread spectrum or similar technology may enable MBAN devices to operate in very close proximity to one another without any mutual interference and mitigate the potential for one body sensor network to block another's access to the spectrum. The Commission also notes that GEHC claims that contention protocols could be applied as a way for MBAN devices to successfully coexist within the band, and also as a way to protect MBAN devices from interference from the primary AMT systems. The Commission invites comment on these observations and whether any rules should be adopted to ensure such sharing. In particular, it seeks comment on whether a contentionbased protocol should be applied to MBAN transmitting devices, and if so, how such a protocol might be developed. If the Commission were to adopt a requirement for a contentionbased protocol, it invites comment as to whether it should rely upon the general definition of contentionbased protocol recently adopted by the Commission for the operation of wireless devices under part 90 of the rules in the 3650 MHz band, which reads as follows. ``Contentionbased protocol. A protocol that allows multiple users to share the same spectrum by defining the events that must occur when two or more transmitters attempt to simultaneously access the same channel and establishing rules by which a transmitter provides reasonable opportunities for other transmitters to operate. Such a protocol may consist of procedures for initiating new transmissions, procedures for determining the state of the channel (available or unavailable), and procedures for managing
retransmissions in the event of a busy channel.''
42. The Commission encourages commenters supporting implementation of a contentionbased 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 opensource 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 establishedby 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?
43. Transmitter Power, Emission Bandwidth, and Duty Cycle. As recommended by GEHC, the Commission would limit individual MBAN devices to a maximum transmit power of 1 mW equivalent isotropic radiated power (EIRP) measured in a 1 megahertz bandwidth, and a maximum emission bandwidth of 1 megahertz. In explaining this recommendation, GEHC indicates that, as presently conceived, a typical MBAN system would be comprised of a single network per patient/person with a gatewayhub device coordinating transmissions from multiple body worn sensors. It estimates that the suggested power and bandwidth limits would be sufficient to allow short burst messaging, which in turn would facilitate low power consumption from duty cycles less than 25 percent.
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 abovewhich reflect GEHC's
recommendationswould 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 realworld 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, [[Page 39256]]
or the approximately the same duty cycles and, if so, should this be accounted for in the maximum duty cycle specification? What would be the relative advantages or disadvantages of specifying versus not specifying specific duty cycle limits for MBAN transmitters in the rules? Is a duty cycle limit needed to allow the functioning of a contentionbased spectrum access protocol and, if so, what is the maximum duty cycle that should be allowed in order to support such a protocol? Should the duty cycle apply to individual MBAN transmitters, whether located in a medical body area device or the MBAN control transmitter, or to the aggregate duty cycle of all transmitters comprising an MBAN, as the terms are proposed to be defined above?
45. Channel aggregation. To the extent that device manufacturers might wish to aggregate multiple transmission channels in a single device, the Commission seeks comment on requiring only that the total emission bandwidth used by all devices in any single patient MBAN communication session not exceed the maximum authorized bandwidth of 1 megahertz. Thus, for example, a single MBAN body sensor could be designed to operate nominally on two channels, each occupying up to 500 kHz (i.e., onehalf the maximum authorized emission). In essence, this would also carry forward the existing channel use provisions of the MedRadio Service. As an additional example, the Commission further notes that this provision would not preclude full duplex or half duplex communications; provided that the total amount of bandwidth utilized by all of the channels employed by collection of a single patient, networked MBAN devices during a communications session does not exceed the maximum authorized 1 megahertz emission bandwidth. The Commission also requests comment on allowing any lesser emission bandwidths to be employed so long as the device complies with all other EIRP and unwanted emission limits. The Commission seeks comment on all of these issues.
46. Unwanted emissions. The MedRadio rules under part 95 set forth limits on unwanted emissions from medical transmitting devices operating in the 401406 MHz band. Those provisions include limits on both inband and outofband radiation. Specifically, emissions on frequencies 500 kHz or less above or below any particular authorized bandwidth [are] required to be attenuated by at least 20 dB below the transmitter output power. In addition, emissions more than 500 kHz above or below any particular authorized bandwidth [are] required to be attenuated to a level no greater than the following signal strengths at 3 m: (a) between 3088 MHz, 100 [mu]V/m, (b) between 88216 MHz, 150 [mu]V/m, (c) between 216960 MHz, 200 [mu]V/m, and (d) 960 MHz and above, 500 [mu]V/m. The Commission seeks comment on the appropriateness of applying the same general limits on MBAN operations in the 23002305 MHz and 23602400 MHz bands. If parties suggest other outofband emission limits for devices operating in this band, they should provide sufficient technical justification to support those limits. Under any approach, the Commission seeks to provide an RF environment that would be adequate to protect incumbent operations while fostering efficient spectrum use by MBAN devices.
47. Frequency stability. Following the MedRadio rules, the Commission would require that MBAN transmitters maintain a frequency stability of +/ 100 ppm of the operating frequency over the range: (1) 25 [deg]C to 45 [deg]C in the case of MBAN transmitters; and (2) 0 [deg]C to 55 [deg]C in the case of MBAN control transmitters. The Commission seeks comment on these stability criteria.
48. Antenna locations. The Commission seeks comment on whether it would be appropriate to restrict the use of MBAN transmitting antennas to indoor locations in certain frequency bands. For example, in light of the concerns discussed above regarding the interference potential between AMT and MBAN systems, should MBAN operations that might be permitted in the 23602390 MHz band be limited to indoor use (within healthcare facilities)? This would be similar to the WMTS approach noted herein, where transmitting antennas are restricted to indoor locations only. Alternatively, would it be more practical in other frequency bands to follow the approach of the present MedRadio rules by which temporary outdoor antennas are permitted? The Commission invites commenters to address the relative advantages and disadvantages of either approach for MBAN use in any of the frequency bands under consideration in this proceeding.
49. RF safety. The Commission notes that portable devices are subject to Sec. 2.1093 of the rules, pursuant to which an environmental assessment must be prepared under Sec. 1.1307. These rule sections also govern existing MedRadio devices. Devices covered by these rules are subject to routine environmental evaluation for RF exposure prior to equipment authorization. The Commission further notes, however, that in our ongoing RF safety proceeding (ET Docket No. 03137) it anticipates dealing with proposed changes in our rules regarding human exposure to RF electromagnetic fields in a more comprehensive fashion. Thus, for the purposes of the instant proceeding and the Commission's pending action in the RF safety proceeding in ET Docket No. 03137, the Commission only seeks comment here on whether MBAN transmitters should be deemed as portable devices subject to Sec. Sec. 2.1093 and 1.1307 of the Commission's existing rules. To the extent that MBAN devices are deemed portable devices, they would then be subject to our RF exposure rules for such devices.
50. Miscellaneous provisions. The Commission also seeks comment on various rule provisions regarding equipment certification, authorized locations, station identification, station inspection, disclosure policy, labeling requirements and marketing limitations that mirror the existing MedRadio rules.
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 nonimplanted 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 [[Page 39257]]
Commission seeks comment on this proposal.
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 Sec. 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.
C. Other Matters and Conclusion
56. As noted in the Background discussion of the NPRM, BSI (Broadcast Sports, Inc.) filed comments in which it proposes an ``Event Radio Service'' as an alternative to the GEHC proposal for use of the 23602400 MHz band. The Commission finds that BSI has not provided sufficient clarity to consider such an allocation or related service rules. On its face, the BSI proposal appears to be intended to preserve the ability to obtain access to additional spectrum for video coverage of sports events that can already be obtained under STAs. There is no evidence, however, to support the proposition that an allocation for MBANS would constrain the ability to obtain STAs for video coverage of sports events. Moreover, special temporary authority is precisely the proper instrument for authorizing temporary operations at specific locations. Furthermore, the Commission is not persuaded that an allocation of spectrum and service rules limited to video coverage of sports events represents the most efficient use of this spectrum nor best serves the public interest as compared with devices that may have significant benefits for health care. Accordingly, the Commission declines to propose BSI's alternative allocation for an Event Radio service.
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.
Initial Regulatory Flexibility Analysis
58. As required by the Regulatory Flexibility Act (RFA),\1\ the
Commission has prepared this present Initial Regulatory Flexibility
Analysis (IRFA) of the possible significant economic impact on small
entities by the policies and rules proposed in this Notice of Proposed
Rule Making (NPRM). Written public comments are requested on this IRFA.
Comments must be identified as responses to the IRFA and must be filed
by the deadlines for comments provided in this NPRM. The Commission
will send a copy of this NPRM, including this IRFA, to the Chief
Counsel for Advocacy of the Small Business Administration (SBA).\2\
\1\ See 5 U.S.C. 603. The RFA, see 5 U.S.C. 601 et seq., has
been amended by the Contract With America Advancement Act of 1996,
Public Law No. 104121, 110 Stat. 847 (1996) (CWAAA). Title II of
the CWAAA is the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA).
\2\ See 5 U.S.C. 603(a).
A. Need for, and Objectives of, the Proposed Rules
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, patientattached cables used by present monitoring technologies.
B. Legal Basis
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.
C. Description and Estimate of the Number of Small Entities to Which the Proposed Rules Would Apply
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.\3\ The RFA generally
defines the term ``small entity'' as having the same meaning as the
terms ``small business,'' ``small organization,'' and ``small
governmental jurisdiction.'' \4\ In addition, the term ``small
business'' has the same meaning as the term ``small business concern''
under the Small Business Act.\5\ A small business concern is one which:
(1) Is independently owned and operated; (2) is not dominant in its
field of operation; and (3) satisfies any additional criteria established by the SBA.\6\
\3\ 5 U.S.C. 603(b)(3).
\4\ 5 U.S.C. 601(6).
\5\ 5 U.S.C. 601(3) (incorporating by reference the definition of ``small business concern'' in 15 U.S.C. 632). Pursuant to the RFA, the statutory definition of a small business applies ``unless an agency, after consultation with the Office of Advocacy of the Small Business Administration and after opportunity for public comment, establishes one or more definitions of such term which are appropriate to the activities of the agency and publishes such definition(s) in the Federal Register.'' 5 U.S.C. 601(3).
\6\ Small Business Act, 15 U.S.C. 632 (1996).
62. Nationwide, there are a total of approximately 27.2 million
small businesses, according to the SBA.\7\ A ``small organization'' is
generally ``any notforprofit enterprise which is independently owned
and operated and is not dominant in its field.'' \8\ Nationwide, as of
2002, there were approximately 1.6 million small organizations.\9\ The
term ``small governmental jurisdiction'' is defined generally as
``governments of cities, towns, townships, villages, school districts,
or special districts, with a population of less than fifty thousand.''
\10\ Census Bureau data for 2002 indicate that there were 87,525 local
governmental jurisdictions in the United States.\11\ The Commission
estimates that, of this total, 84,377 entities were ``small governmental jurisdictions.'' \12\ Thus, it estimates that
most governmental jurisdictions are small.
\7\ See SBA, Office of Advocacy, ``Frequently Asked Questions,'' http://web.sba.gov/faqs (accessed Jan. 2009). \8\ 5 U.S.C. 601(4).
\9\ Independent Sector, The New Nonprofit Almanac & Desk Reference (2002).
\10\ 5 U.S.C. 601(5).
\11\ U.S. Census Bureau, Statistical Abstract of the United States: 2006, Section 8, page 272, Table 415.
\12\ We assume that the villages, school districts, and special districts are small, and total 48,558. See U.S. Census Bureau, Statistical Abstract of the United States: 2006, section 8, page 273, Table 417. For 2002, Census Bureau data indicate that the total number of county, municipal, and township governments nationwide was 38,967, of which 35,819 were small. Id.
63. Wireless Telecommunications Carriers (except Satellite). Since
2007, the Census Bureau has placed wireless firms within this new,
broad, economic census category.\13\ Prior to that time, such firms
were within the nowsuperseded categories of ``Paging'' and ``Cellular
and Other Wireless Telecommunications.'' \14\ Under the present and
prior categories, the SBA has deemed a wireless business to be small if
it has 1,500 or fewer employees.\15\ Because Census Bureau data are not
yet available for the new category, we will estimate small business
prevalence using the prior categories and associated data. For the
category of Paging, data for 2002 show that there were 807 firms that
operated for the entire year.\16\ Of this total, 804 firms had
employment of 999 or fewer employees, and three firms had employment of
1,000 employees or more.\17\ For the category of Cellular and Other
Wireless Telecommunications, data for 2002 show that there were 1,397
firms that operated for the entire year.\18\ Of this total, 1,378 firms
had employment of 999 or fewer employees, and 19 firms had employment
of 1,000 employees or more.\19\ Thus, we estimate that the majority of wireless firms are small.
\13\ U.S. Census Bureau, 2007 NAICS Definitions, ``517210 Wireless Telecommunications Categories (Except Satellite)''; http:// www.census.gov/naics/2007/def/ND517210.HTM#N517210.
\14\ U.S. Census Bureau, 2002 NAICS Definitions, ``517211 Paging''; http://www.census.gov/epcd/naics02/def/NDEF517.HTM.; U.S. Census Bureau, 2002 NAICS Definitions, ``517212 Cellular and Other Wireless Telecommunications''; http://www.census.gov/epcd/naics02/ def/NDEF517.HTM.
\15\ 13 CFR 121.201, NAICS code 517210 (2007 NAICS). The now superseded, pre2007 CFR citations were 13 CFR 121.201, NAICS codes 517211 and 517212 (referring to the 2002 NAICS).
\16\ U.S. Census Bureau, 2002 Economic Census, Subject Series: Information, ``Establishment and Firm Size (Including Legal Form of Organization,'' Table 5, NAICS code 517211 (issued Nov. 2005). \17\ Id. The census data do not provide a more precise estimate of the number of firms that have employment of 1,500 or fewer employees; the largest category provided is for firms with ``1000 employees or more.''
\18\ U.S. Census Bureau, 2002 Economic Census, Subject Series: Information, ``Establishment and Firm Size (Including Legal Form of Organization,'' Table 5, NAICS code 517212 (issued Nov. 2005). \19\ Id. The census data do not provide a more precise estimate of the number of firms that have employment of 1,500 or fewer employees; the largest category provided is for firms with ``1000 employees or more.''
D. Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements
64. The 23002305 MHz, 23602400 MHz, 24002500 MHz and 51505250 MHz bands are used by various Federal and nonFederal
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.
65. The Commission thus seeks comment on allowing MBAN operations in any of the bands on a secondary basis, subject to the further condition that harmful interference is not caused to primary services allocated in the bands, or on allowing MBAN operations on a primary basis in the 23002305 MHz and 23902400 MHz bands. We would further propose to provide for such use by including a U.S. footnote to the Table of Allocations in Part 2 of the Rules for the specific band segments.\20\
\20\ See 47 CFR 2.106.
66. The Commission also seeks comment on various provisions regarding equipment certification, authorized locations, station identification, station inspection, disclosure policy, labeling requirements and marketing limitations that mirror the existing MedRadio rules.
67. First, the Commission seeks comment on whether it should require that each MBAN transmitter must 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.
68. The Commission also seeks comment on whether to provide that all nonimplanted 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.
69. The Commission seeks comment on whether to require that manufacturers of MBAN transmitters include with each transmitting device (if allocated on a secondary basis) an appropriate disclosure statement analogous to that for MedRadio transmitters with each MBAN transmitting device.\21\ 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
FOR FURTHER INFORMATION CONTACT
Gary Thayer, Office of Engineering and Technology, (202) 4182290, email: Gary.Thayer@fcc.gov, TTY (202) 418 2989.