[Federal Register Volume 74, Number 150 (Thursday, August 6, 2009)]
[Proposed Rules]
[Pages 39249-39259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-18859]


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FEDERAL COMMUNICATIONS COMMISSION

47 CFR Parts 2 and 95

[ET Docket No. 08-59; FCC 09-57]


Medical Body Area Network (MBAN)

AGENCY: Federal Communications Commission.

ACTION: Proposed rule.

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SUMMARY: 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, patient-attached 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 well-being of the American 
public.

DATES: Comments must be filed on or before October 5, 2009, and reply 
comments must be filed on or before November 4, 2009.

ADDRESSES: You may submit comments, identified by ET Docket No. 08-59, 
by any of the following methods:
    [squf] Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
    [squf] Federal Communications Commission's Web Site: http://www.fcc.gov/cgb/ecfs/. Follow the instructions for submitting comments.
    [squf] E-mail: [Optional: Include the E-mail address only if you 
plan to accept comments from the general public.] Include the docket 
number(s) in the subject line of the message.
    [squf] Mail: [Optional: Include the mailing address for paper, disk 
or CD-ROM submissions needed/requested by your Bureau or Office. Do not 
include the Office of the Secretary's mailing address here.]

[[Page 39250]]

    [squf] People with Disabilities: Contact the FCC to request 
reasonable accommodations (accessible format documents, sign language 
interpreters, CART, etc.) by e-mail: <a href="/cdn-cgi/l/email-protection#8accc9c9bfbabecaece9e9a4ede5fc"><span class="__cf_email__" data-cfemail="aceaefef999c98eccacfcf82cbc3da">[email protected]</span></a> or phone: 202-418-
0530 or TTY: 202-418-0432.

For detailed instructions for submitting comments and additional 
information on the rulemaking process, see the SUPPLEMENTARY 
INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Gary Thayer, Office of Engineering and 
Technology, (202) 418-2290, e-mail: <a href="/cdn-cgi/l/email-protection#a4e3c5d6dd8af0ccc5ddc1d6e4c2c7c78ac3cbd2"><span class="__cf_email__" data-cfemail="b2f5d3c0cb9ce6dad3cbd7c0f2d4d1d19cd5ddc4">[email protected]</span></a>, TTY (202) 418-
2989.

SUPPLEMENTARY INFORMATION: This is a summary of the Commission's Notice 
of Proposed Rule Making, ET Docket No. 08-59, FCC 09-57, 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 CY-A257), 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 CY-B402, Washington, DC 20554, telephone (202) 488-5300, 
facsimile (202) 488-5563 or via e-mail <a href="/cdn-cgi/l/email-protection#de989d9d9e9c9d8e97899b9cf0bdb1b3"><span class="__cf_email__" data-cfemail="d2949191929091829b859790fcb1bdbf">[email protected]</span></a>. 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 e-mail. To get filing instructions, 
filers should send an e-mail to <a href="/cdn-cgi/l/email-protection#482d2b2e3b082e2b2b662f273e"><span class="__cf_email__" data-cfemail="badfd9dcc9fadcd9d994ddd5cc">[email protected]</span></a>, 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.
    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.
    [squf] 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 before entering the building.
    [squf] Commercial overnight mail (other than U.S. Postal Service 
Express Mail and Priority Mail) must be sent to 9300 East Hampton 
Drive, Capitol Heights, MD 20743.
    [squf] U.S. Postal Service first-class, Express, and Priority mail 
should be addressed to 445 12th Street, SW., Washington, DC 20554.
    People with Disabilities: To request materials in accessible 
formats for people with disabilities (Braille, large print, electronic 
files, audio format), send an e-mail to <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="88eeebebbdb8bcc8eeebeba6efe7fe">[email protected]</a> or call the 
Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-
418-0432 (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 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 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 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

[[Page 39251]]

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. 2300-2305 MHz and 2360-2400 MHz Frequency Bands
    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.
2. 2400-2483.5 MHz Frequency Band
    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

[[Page 39252]]

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 
2360-2400 MHz band be applicable for MBAN operation in the 2400-2483.5 
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 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 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 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.
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 license-by-rule operation pursuant to Section 307(e) of 
the Communications Act (Act). Under this approach, medical devices 
would operate in the band on a shared, non-exclusive 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 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 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 non-exclusive licensing under part 90. Under that approach, MBAN 
operations would be licensed on a non-exclusive 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 3650-3700 MHz band, i.e., eligible 
entities would apply for non-exclusive 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 license-by-rule 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    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 non-voice 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 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--i.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 life-critical and time-sensitive 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 time-sensitive 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 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.
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

[[Page 39254]]

within the MBAN band so long as the maximum emission bandwidth, out-of-
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 ad-hoc 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 2360-2390 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 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.
    36. Frequency Coordination. With respect to protecting AMT 
operations from MBAN interference in portions of the 2360-2400 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 contention-based 
protocol as discussed below to promote intra-service sharing. Regarding 
coordination of MBAN operations with incumbent

[[Page 39255]]

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 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.
    41. Frequency Monitoring (Contention-based 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 contention-based 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 
contention-based protocol, it invites comment as to whether it should 
rely upon the general definition of contention-based 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.

    ``Contention-based 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 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?
    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 gateway-hub 
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 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,

[[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 
contention-based 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., one-half 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 401-406 MHz band. Those provisions include limits on 
both in-band and out-of-band 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 30-88 MHz, 100 [mu]V/m, (b) between 88-216 MHz, 150 
[mu]V/m, (c) between 216-960 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 2300-2305 
MHz and 2360-2400 MHz bands. If parties suggest other out-of-band 
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 2360-2390 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. 
03-137) 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. 03-137, 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 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

[[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 
2360-2400 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. 104-121, 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).
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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, patient-attached 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 not-for-profit 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

[[Page 39258]]

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 now-superseded 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, pre-2007 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 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.
    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 2300-2305 MHz and 2390-2400 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 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.
    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 interference that may be caused by such stations, including 
interference that may cause undesired operation. Such 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.
---------------------------------------------------------------------------

    \21\ For example, under the MedRadio rules, each transmitter 
must include a statement that ``This transmitter is authorized by 
rule under the MedRadio Service. This transmitter must not cause 
harmful interference to stations authorized to operate on a primary 
basis in the 2360-2400 MHz band, and must accept interference that 
may be caused by such stations, including interference that may 
cause undesired operation. This transmitter shall be used only in 
accordance with the FCC Rules governing the MedRadio Service. Analog 
and digital voice communications are prohibited. Although this 
transmitter has been approved by the Federal Communications 
Commission, there is no guarantee that it will not receive 
interference or that any particular transmission from this 
transmitter will be free from interference.''
---------------------------------------------------------------------------

    70. The Commission further seeks comment on whether to require that 
MBAN control transmitters (if allocated on a secondary basis) be 
labeled and shall 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, it 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.
    71. Finally, with respect to marketing limitations, the Commission 
seeks comment on requiring that MBAN transmitters intended for 
operation in any portions of the 2360-2400 MHz band may be marketed and 
sold only for those permissible uses.
    72. Licensing. The Commission seeks comment on whether medical 
device operations in any portion of the frequency bands under 
consideration should be authorized under the MedRadio Service in part 
95 of our Rules, thus providing for license-by-rule

[[Page 39259]]

operation \22\ pursuant to section 307(e) of the Communications Act 
(Act).\23\ Under this approach, medical devices would operate in the 
band on a shared, non-exclusive 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.
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    \22\ See 47 CFR 95.401 (d).
    \23\ Under Section 307(e) of the Act, the Commission may 
authorize the operation of radio stations by rule without individual 
licenses in certain specified radio services when the Commission 
determines that such authorization serves the public interest, 
convenience, and necessity. The services set forth in this provision 
for which the Commission may authorize operation by rule include: 
(1) The Citizens Band Radio Service, (2) the Radio Control Service, 
(3) the Aviation Radio Service, and (4) the Maritime Radio Service. 
See 47 USC 307(e)(1).
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    73. Alternatively, the Commission also seeks comment on whether 
MBAN operations should be licensed on a non-exclusive basis under part 
90. Under that approach, MBAN operations would be licensed on a non-
exclusive 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 we do with wireless broadband services in the 
3650-3700 MHz band, i.e., eligible entities would apply for non-
exclusive nationwide licenses and subsequently register individual 
stations with the Commission.\24\ If this approach were to be adopted, 
the Commission also seeks comment on whether it should 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. In this 
regard, the Commission seeks comment on what type of licensing and 
registration information for MBAN operations would facilitate 
coordination with incumbent services; and what would be the relative 
benefits and disadvantages of licensing under part 90 compared with the 
license-by-rule approach under part 95.
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    \24\ See 47 CFR 90.1307.
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E. Steps Taken To Minimize Significant Economic Impact on Small 
Entities, and Significant Alternatives Considered

    74. The RFA requires an agency to describe any significant 
alternatives that it has considered in reaching its proposed approach, 
which may include the following four alternatives (among others): (1) 
The establishment of differing compliance or reporting requirements or 
timetables that take into account the resources available to small 
entities; (2) the clarification, consolidation, or simplification of 
compliance or reporting requirements under the rule for small entities; 
(3) the use of performance, rather than design, standards; and (4) an 
exemption from coverage of the rule, or any part thereof, for small 
entities.\25\
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    \25\ See 5 U.S.C. 603(c).
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    75. The Commission also invites commenters to address the validity 
of the competing interference modeling studies that have already been 
placed into the record by GEHC and AFTRCC. Each party reaches opposite, 
alternative conclusions concerning whether MBAN operation would pose an 
undue interference risk to AMT operations in the 2360-2395 MHz band. 
The Commission asks commenters to address which aspects of these 
interference models would be appropriate, or not, to be relied upon 
under the particular factual circumstances herein. For example, should 
interference potential be evaluated in this instance by reference to 
worst-case static models or by other statistical simulations such as 
the Monte Carlo approach type relied upon by GEHC? Why or why not? 
Would some other interference modeling approaches give results 
providing a greater degree of confidence in their merit?

F. Federal Rules That May Duplicate, Overlap, or Conflict With the 
Proposed Rules

    76. None.

Ordering Clauses

    77. Pursuant to Sections 4(i), 301, 302, 303(e), 303(f) and 303(r) 
of the Communications Act of 1934, as amended, 47 USC Sections 154(i), 
301, 302, 303(e), 303(f) and 303(r), this Notice of Proposed Rule 
Making is adopted.
    78. The Commission's Consumer and Governmental Affairs Bureau, 
Reference Information Center, SHALL SEND a copy of this Notice of 
Proposed Rule Making, including the Initial Regulatory Flexibility 
Analysis to the Chief Counsel for Advocacy of the Small Business 
Administration.

Federal Communications Commission.
Marlene H. Dortch,
Secretary.
[FR Doc. E9-18859 Filed 8-5-09; 8:45 am]
BILLING CODE 6712-01-P


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