Medical Area Body Network, 55715-55735 [2012-21984]

Agencies

• FEDERAL COMMUNICATIONS COMMISSION

[Federal Register Volume 77, Number 176 (Tuesday, September 11, 2012)]
[Rules and Regulations]
[Pages 55715-55735]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-21984]


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FEDERAL COMMUNICATIONS COMMISSION

47 CFR Parts 2 and 95

[ET Docket No. 08-59; FCC 12-54]


Medical Area Body Network

AGENCY: Federal Communications Commission.

ACTION: Final rule.

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SUMMARY: This document expands the Commission's Medical Device 
Radiocommunications Service (MedRadio) rules to permit the development 
of new Medical Body Area Network (MBAN) devices in the 2360-2400 MHz 
band. The MBAN technology will provide a flexible platform for the 
wireless networking of multiple body transmitters used for the purpose 
of measuring and recording physiological parameters and other patient 
information or for performing diagnostic or therapeutic functions, 
primarily in health care facilities. This platform will enhance patient 
safety, care and comfort by reducing the need to physically connect 
sensors to essential monitoring equipment by cables and wires. This 
decision is the latest in a series of actions to expand the spectrum 
available for wireless medical use. The Commission finds that the risk 
of increased interference is minimal and is greatly outweighed by the 
benefits of the MBAN rules.

DATES: Effective October 11, 2012, except for Sec. Sec.  95.1215(c), 
95.1217(a)(3), 95.1223, and 95.1225, which contain information 
collection requirements that

[[Page 55716]]

are not effective until approved by the Office of Management and 
Budget. The Commission will publish a document in the Federal Register 
announcing the effective dates for those amendments. The Director of 
the Federal Register will approve the incorporation by reference in 
Sec.  95.1223 concurrently with the published Office of Management and 
Budget approval of this section.

FOR FURTHER INFORMATION CONTACT: Brian Butler, Office of Engineering 
and Technology, 202-418-2702, Brian.Butler@fcc.gov.

SUPPLEMENTARY INFORMATION: This is a summary of the Commission's First 
Report and Order, ET Docket No. 08-59, FCC 12-54, adopted May 24, 2012 
and released May 24, 2012. The full text of this document is available 
for inspection and copying during normal business hours in the FCC 
Reference Center (Room CY-A257), 445 12th Street SW., Washington, DC 
20554. The complete text of this document also may be purchased from 
the Commission's copy contractor, Best Copy and Printing, Inc., 445 
12th Street SW., Room, CY-B402, Washington, DC 20554. The full text may 
also be downloaded at: www.fcc.gov. People with Disabilities: To 
request materials in accessible formats for people with disabilities 
(braille, large print, electronic files, audio format), send an email 
to or call the Consumer & Governmental Affairs Bureau at 202-418-0530 
(voice), 202-418-0432 (tty).

Summary of the First Report and Order

    1. This First Report and Order (R&O) expands the Commission's part 
95 MedRadio rules to permit the development of new Medical Body Area 
Network (MBAN) devices in the 2360-2400 MHz band. The MBAN technology 
will provide a flexible platform for the wireless networking of 
multiple body transmitters used for the purpose of measuring and 
recording physiological parameters and other patient information or for 
performing diagnostic or therapeutic functions, primarily in health 
care facilities. This platform will enhance patient safety, care and 
comfort by reducing the need to physically wire sensors to essential 
monitoring equipment. As the numbers and types of medical radio devices 
continue to expand, these technologies offer tremendous power to 
improve the state of health care in the United States. The specific 
MBAN technology that can be deployed under our revised rules promises 
to enhance patient care as well as to achieve efficiencies that can 
reduce overall health care costs.
    2. The Report and Order adopts rules for MBAN operations on a 
secondary, non-interference basis under our ``license-by-rule'' 
framework. To address spectrum compatibility concerns with respect to 
incumbent operations under this approach, the Commission is 
establishing a process by which MBAN users will register and coordinate 
the use of certain equipment. In a concurrent Further Notice of 
Proposed Rulemaking, the Commission proposes the criteria for 
designating the frequency coordinator who will manage these activities. 
Notably, the Commission bases many of these procedures on a joint 
proposal (hereinafter the ``Joint Proposal'') submitted by 
representatives of incumbent Aeronautical Mobile Telemetry (AMT) 
licensees and the MBAN proponents--parties that, when the Commission 
issued the Notice of Proposed Rulemaking (NPRM) in this proceeding, 
strongly disagreed as to whether MBAN and AMT operations could 
successfully coexist in the same frequency band. Cooperative efforts 
such as this are beneficial in helping us realize the vital goal of 
promoting robust and efficient use of our limited spectrum resources.
    3. The Commission concludes that there are significant public 
interest benefits associated with the development and deployment of new 
MBAN technologies. Existing wired technologies inevitably result in 
reduced patient mobility and increased difficulty and delay in 
transporting patients. Caregivers, in turn, can spend inordinate 
amounts of time managing and arranging monitor cables, as well as 
gathering patient data. The introduction of Wireless Medical Telemetry 
Service (WMTS) in health care facilities has overcome some of the 
obstacles presented by wired sensor networks. Nonetheless, the WMTS is 
restricted to in-building networks that are often used primarily for 
monitoring critical care patients in only certain patient care areas. 
The MBAN concept would allow medical professionals to place multiple 
inexpensive wireless sensors at different locations on or around a 
patient's body and to aggregate data from the sensors for backhaul to a 
monitoring station using a variety of communications media. The 
Commission concludes that an MBAN represents an improvement over 
traditional medical monitoring devices (both wired and wireless) in 
several ways, and will reduce the cost, risk and complexity associated 
with health care. The Commission also concludes that these benefits can 
be achieved with minimal cost. The only cost resulting from these new 
regulations is the risk of increased interference, and we are have 
minimizing that risk by adopting rules that permit an MBAN device to 
operate only over relatively short distances and as part of a low power 
networked system. This approach will permit us to provide frequencies 
where an MBAN can co-exist with existing spectrum users and engage in 
robust frequency re-use, which will result in greater spectral 
efficiency. As a result, the Commission believes that the risk of 
increased interference is low and is greatly outweighed by the 
substantial benefits of this new technology.
    4. The rules adopted are based on and largely reflect the 
provisions of the Joint Proposal but differ from them in certain 
respects. The Joint Proposal is a comprehensive plan that draws from 
both the existing MedRadio and WMTS rules to specify MBAN operational 
requirements for body-worn sensors and hubs, but is drafted as a new 
subpart under part 95 of our Rules. It expands upon these rules, 
however, to include a detailed set of requirements for MBAN management 
within a health care facility. It also proposes that MBAN use in the 
2360-2390 MHz band be limited mostly to indoor use and subject to 
specific coordination procedures and processes to protect AMT users in 
that band, whereas MBAN use in the 2390-2400 MHz band could occur at 
any location and without coordination. The Joint Proposal describes an 
MBAN as consisting of a master transmitter (hereinafter referred to as 
a ``hub''), which is included in a device close to the patient, and one 
or more client transmitters (hereinafter referred to as ``body-worn 
sensors'' or ``sensors''), which are worn on the body and only transmit 
while maintaining communication with the hub that controls its 
transmissions. The hub would convey data messages to the body-worn 
sensors to specify, for example, the transmit frequency that should be 
used. The hub and sensor devices would transmit in the 2360-2400 MHz 
band. The hub would aggregate patient data from the body-worn sensors 
under its control and, using the health care facility's local area 
network (LAN) (which could be, for example, Ethernet, WMTS or Wi-Fi 
links), transmit that information to locations where health care 
professionals monitor patient data. The hub also would be connected via 
the facility's LAN to a central control point that would be used to 
manage all MBAN operations within the health care facility. To protect 
AMT operations

[[Page 55717]]

from harmful interference, the Joint Proposal would have the Commission 
designate an MBAN frequency coordinator who would coordinate MBAN 
operations in the 2360-2390 MHz band with the AMT frequency 
coordinator. The control point would serve as the interface between the 
MBAN coordinator and the MBAN hub control operation in the 2360-2390 
MHz band. The control point would receive an electronic key, which is a 
data message that specifies and enables use of specific frequencies by 
the MBAN devices. The control point, in turn, would generate a beacon 
or control message to convey a data message to the hub via the 
facility's LAN that specifies the authorized frequencies and other 
operational conditions for that MBAN.
    5. The Commission's rules are based on the basic framework set 
forth in the Joint Proposal, particularly that an MBAN is comprised of 
two component devices--one that is worn on the body (sensor) and 
another that is located either on the body or in close proximity to it 
(hub)--that are used to monitor a patient's physiological functions and 
to communicate the data back to a monitoring station. Thus, the 
Commission will specify an MBAN to be a low power network of body 
sensors controlled on a localized basis by a single hub device, and use 
this framework as the context for our discussions. An MBAN shares many 
characteristics with other established medical radio services and 
applications. For example, MBAN devices would operate consistent with 
the definitions for body-worn devices in the MedRadio rules. Also, the 
data transmitted over the wireless link from the body-worn sensors to 
the nearby controlling hub would consist of physiological readings and 
other patient-related information that is transmitted via radiated 
electromagnetic signals, which follows the definition of medical 
telemetry in the WMTS rules. The Commission is therefore authorizing 
MBAN operations under our existing part 95 MedRadio rules, and the 
requirements adopted are limited to the operation of MBAN devices 
within the 2360-2400 MHz band.
    6. The Commission adopted rules that focus primarily on the service 
and technical rules for operating MBAN sensors and hubs, as well as the 
registration and coordination requirements to protect primary AMT 
operations in the 2360-2390 MHz band. The adopted rules do not extend 
to the communications links between the hubs and central control points 
and the MBAN hubs and the MBAN frequency coordinator. The Commission 
recognizes that MBAN users will have to consider additional factors 
when they deploy their systems--such as how to relay the data collected 
at the MBAN hubs to control points at remote locations by technologies 
that do not use the 2360-2400 MHz band, and what method the users will 
use to establish communication links to an MBAN coordinator. However, 
the Commission also recognizes that each health care facility is unique 
and needs flexibility to decide how best to accomplish these backhaul/
interface functions. Thus, the Commission does not include here the 
Joint Proposal's recommendations to codify certain aspects of their 
vision--for example, requiring a health care facility to designate a 
central control point and specific communication procedures between the 
control point and the MBAN frequency coordinator or the hub. Instead, 
it expects that MBAN users, the frequency coordinators, and equipment 
manufacturers will work together cooperatively to utilize the 
technologies and procedures that will permit MBAN and AMT services to 
share spectrum while fully protecting AMT licensees' operations and 
while fully integrating MBAN use into the health care ecosystem.
    7. In the Report and Order, the Commission first discussed MBAN 
spectrum requirements and determined that a secondary allocation in the 
2360-2400 MHz band is best suited to support MBAN operations. Second, 
it concludes that MBAN operations would be most efficiently implemented 
by modifying our existing part 95 MedRadio rules. Third, the Commission 
discusses the service and technical rules that will apply to MBAN 
operations. Finally, it discusses the registration and coordination 
requirements for MBAN operation in the 2360-2390 MHz band. As part of 
our analysis, the Commission recognizes that the Joint Proposal has 
been endorsed by parties that had previously objected to the original 
GEHC Petition, and that the record of this proceeding now contains 
conflicting pleadings by the same parties. In such cases, the 
Commission looked to those pleadings associated with the Joint Proposal 
and will not address any earlier, inconsistent submissions by the same 
party, based on our assumption that the earlier filings have been 
superseded by the more recent filings.

Spectrum for MBAN Operation

    8. The Commission finds that the best way to promote MBAN 
development is by allocating the entire 40 megahertz of spectrum in the 
2360-2400 MHz band proposed in the NPRM for MBAN use, on a secondary 
basis. The Commission does so by adding a new footnote to our Table of 
Frequency Allocations (Table) as proposed. It concludes that the 2360-
2400 MHz band is particularly well suited for MBAN use, given the 
ability of MBAN devices to be able to share the band with incumbent 
users. The Commission is also persuaded that the ready availability of 
chipsets and technology that can be applied to this band will promote 
quick development of low-cost MBAN equipment. This, in turn, will 
reduce developmental expenses, encourage multiple parties to develop 
MBAN applications, and will promote the widespread use of beneficial 
MBAN technologies. Such deployment will reduce health care expenses, 
improve the quality of patient care, and could ultimately save lives.
    9. The Commission also concludes that the 40 megahertz of spectrum 
in the 2360-2400 MHz band it proposed to allocate in the NPRM is an 
appropriate allocation for MBAN use. Both General Electric Healthcare 
(GEHC) and Philips Healthcare Systems (Philips) discuss how peak MBAN 
deployments would require as much as 20 megahertz of spectrum to be 
available if on an exclusive basis, and assert that a full 40 megahertz 
allocation would maximize the opportunity for MBAN devices that operate 
on a secondary basis to avoid interference to and from primary users. 
The Commission finds these arguments persuasive. Any MBAN device 
designed to operate in the 2360-2400 MHz band will also have to be 
designed to operate in a manner that will protect incumbent licensees, 
and a 40-megahertz allocation will provide sufficient spectrum 
flexibility to serve this goal. In addition, this allocation will 
enable greater frequency diversity and promote reliable MBAN 
performance. This is particularly true given the Commission's decision, 
to allow an MBAN device to operate with an emission bandwidth up to 5 
megahertz. Additionally, the Commission finds that the 40-megahertz 
allocation is appropriate because it will allow for reliable MBAN 
operations in high-density settings, such as waiting rooms, elevator 
lobbies, and preparatory areas, where multiple MBAN-equipped patients 
will congregate. For example, AdvaMed notes that a smaller spectrum 
allocation might not allow for the use of devices by multiple vendors 
in the same hospital and thereby drive up costs, and also claims that 
more limited spectrum access would not support all of the currently 
conceived MBAN device applications. It is clear that such a scenario 
would increase costs by

[[Page 55718]]

reducing competition and effectively limiting the use of multiple MBAN 
devices; this, in turn, could deprive many patients of the health care 
and cost-saving benefits that MBAN operations are poised to deliver. 
For all of these reasons, the Commission agree that the 40 MHz of 
spectrum proposed in the NPRM ``will maximize opportunities to avoid 
interference through frequency separation, support the coexistence of 
multiple and competitive MBAN networks, and provide the spectrum needed 
for future innovation.''
    10. The Commission further concludes that an MBAN will be able to 
share the 2360-2400 MHz band with incumbent users. The Joint Proposal 
offers a way for MBAN devices to operate in a manner compatible with 
incumbent AMT licensees. By proposing unrestricted use of the 2390-2400 
MHz band segment and a coordination process for MBAN users in the 2360-
2390 MHz portion of the band along with suggesting the use of 
established engineering guidelines to determine if MBAN use can occur 
within line-of-sight of an AMT site without causing interference, the 
Joint Proposal describes how MBAN users could successfully operate in 
the band on a secondary basis. The commission concludes that it is 
necessary for us to establish a coordination process and related 
procedures and guidelines to ensure that the primary AMT operations in 
the band are adequately protected from MBAN users.
    11. MBAN operators in the 2390-2400 MHz band will also have to 
account for amateur radio users, which are authorized on a primary 
basis in this spectrum. Both Philips and GEHC assert that interference 
from MBAN devices to amateur radio is unlikely, citing factors such as 
the low transmission power and low duty cycle proposed for MBAN 
devices, as well as geographic separation and the frequency agility of 
MBAN devices. ARRL, The National Association for Amateur Radio, (ARRL) 
does not anticipate that an MBAN would cause ``a significant amount of 
harmful interference'' to amateur users, but it cautions that some 
amateur operations--such as weak signal communications, that occur on a 
``completely unpredictable basis''- could receive interference. The 
Commission believes that MBAN devices can successfully share the band 
with the amateur service. These frequencies are part of the larger ``13 
cm band'' in which amateur radio operators already share the adjacent 
2400-2450 MHz portion of the band with low-powered equipment authorized 
under part 15 of our rules. The Commission expects that the amateur 
service will likewise be able to share the 2390-2400 MHz portion of the 
band with MBAN devices because the power limits for MBAN operations 
will be even lower than that allowed for the unlicensed equipment that 
operates in the 2400-2450 MHz range. It further believes that MBAN and 
amateur operations are highly unlikely to occur in close proximity to 
each other. An MBAN, which will use very low transmitted power levels 
compared to the amateur service, is not intended for mass market types 
of deployment and instead will be used only under the direction of 
health care professionals. The Commission also believes that the 
majority of MBAN operations in the 2390-2400 MHz band will be located 
indoors. It envisions that the most likely outdoor use will occur in 
ambulances or while patients are otherwise in transit, thus we do not 
believe that prolonged outdoor use in a single location is likely. In 
such a situation, any interference that might occur would likely be 
transitory in nature and would not seriously degrade, obstruct or 
repeatedly interrupt amateur operations and thus would not be 
considered harmful under our definition of harmful interference. In the 
unlikely event that an atypical scenario occurs where amateur operators 
do receive harmful interference from MBAN operations, the Commission 
notes that amateur operators would be entitled to protection from MBAN 
interference.
    12. The Commission also addressed the potential for interference 
from licensed amateur operations to MBAN operations. ARRL states that 
amateur operation in the band is unpredictable. The ``substantial power 
levels and exceptionally high antenna gain figures used by radio 
Amateurs in the 2390-2400 MHz band will provide no reliability of MBANs 
in this segment whatsoever,'' it observes, calling the results of such 
interference ``potentially disastrous.'' MBAN proponents assert that 
MBAN devices will have built-in capabilities such as spectrum sensing 
techniques to detect in-band amateur signals and frequency agility 
capability to move MBAN transmissions to other available channels. As 
to ARRL's concerns about MBAN's reliability and the risk presented by 
interference caused by amateur operation, GEHC acknowledges that 
``medical device manufacturers seeking to develop equipment consistent 
with the MBAN rules would need to build robust products in order to 
satisfy FDA requirements and to ensure customer acceptance,'' but does 
not view that as a barrier to its efforts to develop and deploy MBAN 
devices. The Commission finds that factors such as the incorporation of 
established techniques to avoid interference into MBAN devices, the use 
of low duty cycles, and the separation distances between MBAN devices 
and amateur operations that are likely to occur in real world 
situations will minimize any potential for interference to MBAN devices 
from amateur users. Nevertheless, MBAN operations will occur on a 
secondary basis and MBAN operators will thus be required to accept any 
interference they receive from primary amateur licensees operating in 
accordance with the rules.
    13. The 2370-2390 MHz band is used for radio astronomy operations 
in Arecibo, Puerto Rico. Prior to the filing of the Joint Proposal, 
both GEHC and Philips suggested using an exclusion zone to protect the 
Arecibo site. Subsequently, the Joint Parties suggested that MBAN users 
simply notify the Arecibo facility prior to operation in accordance 
with our existing rules. The Commission finds that the existing 
MedRadio Rules, which provide a prior notification requirement, are 
sufficient to ensure protection of radio astronomy operations at the 
Arecibo site.
    14. Lastly, the Commission observes that, because MBAN operations 
will be permitted adjacent to other bands that host a variety of 
different services, MBAN users will have to take into account the 
operating characteristics of those adjacent-band services. The upper 
end of the band, 2400 MHz, is immediately adjacent to the spectrum used 
by unlicensed devices--such as Wi-Fi and wireless local area network 
(WLAN) devices--as well as industrial, scientific and medical (ISM) 
equipment operating under Part 18 of our Rules, both of which are 
widely used in health care settings. As MBAN users manage their 
facilities, they will need to consider the potential for adverse 
interaction between their MBAN, Wi-Fi, and ISM resources.
    15. MBAN equipment will also operate immediately adjacent to the 
Wireless Communications Service (WCS) at 2360 MHz. As with any new 
service, it is incumbent on MBAN developers to evaluate and account for 
the operational characteristics of adjacent band services--in this 
case, WCS--when designing receivers and associated equipment. The 
Commission finds that it is unlikely WCS operations would preclude 
effective MBAN use given that MBAN operations near 2360 MHz will be in 
institutional settings under the control of a health care provider and 
because MBAN users will

[[Page 55719]]

have a large swath of spectrum in which to place their operations. 
Moreover, the record indicates that GEHC has already anticipated 
designing MBAN devices that use contention-based protocols and 
frequency agility to account for potential out of band emissions into 
the 2360-2400 MHz band. For these reasons, and notwithstanding filings 
made by the Wireless Communications Association, International 
(``WCAI''), the Commission finds no reason to adopt specific rules 
relating to adjacent-band WCS operations.
    16. The Commission will add a new footnote US101 to the Table of 
Allocations to provide a secondary mobile, except aeronautical mobile, 
allocation in the 2360-2400 MHz band for use by the MedRadio Service. 
It is making this allocation through a unique footnote rather than a 
direct entry in the Table, or modification of the existing US276, in 
order to provide consistency across the entire band and to emphasize 
the limited nature of this allocation. It will place footnote US101 in 
both the Federal Table and non-Federal Table to facilitate MBAN use in 
a variety of settings such as in health care facilities operated by the 
Department of Veterans Affairs or the United States military, as well 
as non-Federal health care facilities. Because use of these frequencies 
will be on a secondary basis, MBAN stations will not be allowed to 
cause interference to and must accept interference from primary 
services, including AMT licensees operating under the primary mobile 
allocation in the 2360-2390 MHz and 2390-2395 MHz bands and Amateur 
Radio service licensees that operate on a primary basis in the 2390-
2395 MHz and 2395-2400 MHz bands.
    17. The Joint Proposal was based on secondary MBAN use of the 2360-
2400 MHz band, and no commenters supporting either the 2360-2400 MHz 
band or any alternate spectrum proposals endorse giving MBAN operations 
primary status. The Commission's decision to provide 40 megahertz of 
spectrum in the 2360-2400 MHz band for MBAN use is based on our 
decision to require MBAN users to share the spectrum with incumbent 
users, as well as among different MBAN devices, and that, therefore 
MBAN devices require a larger spectrum block than would be the case if 
spectrum were allocated to MBAN use on an exclusive basis. A secondary 
allocation is consistent with our approach. The Commission is also 
confident that its decision to authorize MBAN service on a secondary 
basis will not adversely affect the usefulness of MBAN devices. The 
Commission notes that the supportive comments filed by numerous 
manufacturers indicate a readiness to produce devices capable of 
relaying essential patient data in a reliable manner within this 
regulatory framework.
    18. This action affirms the tentative conclusion from the NPRM that 
the Commission should allocate spectrum not currently used by existing 
medical radio services to support new MBAN operations. Although ARRL 
suggests that MBAN devices could make use of spectrum currently used by 
the WMTS, the Commission agrees with Philips that the WMTS bands are 
not suitable for MBAN devices because of the existing widespread use of 
WMTS applications in hospitals. The Commission does not believe that 
WMTS and MBAN devices would be able to successfully co-exist on the 
same frequencies simultaneously within the same facilities, leaving 
health care facilities with the dilemma of choosing between two 
valuable health care tools. A better course is to accommodate MBAN 
users in other frequencies. The Commission further notes that all of 
the other frequency bands identified in this proceeding for possible 
MBAN use have limitations that make them less desirable than the 2360-
2400 MHz band. For example, Philips claims that the alternative bands 
are ``substantially inferior to the 2360-2400 MHz band'' for MBAN use, 
and predicts that ``devices would be unlikely to succeed for both cost 
and technical reasons, and the opportunity to benefit from better 
healthcare using these devices likely would be substantially delayed or 
lost.'' The Commission agrees, and briefly discusses each of the 
alternate band proposals.
    19. The 2400-2483.5 MHz band is also unsuitable for widespread MBAN 
use, given the ISM equipment and unlicensed devices that operate in the 
band. While GEHC and Philips discussed the benefits of employing low-
power technology and chipsets that have been widely deployed in the 2.4 
GHz band and which can be readily modified to use the adjacent 2360-
2400 MHz spectrum, they emphatically rejected the possibility of 
deploying MBAN operations above 2400 MHz. GEHC notes that the 2.4 GHz 
band is heavily populated by unlicensed intentional radiators and ISM 
devices deployed by hospitals and carried by patients, visitors, 
doctors and staff. The 5150-5250 MHz band which used by unlicensed 
national information infrastructure (U-NII) devices operating under 
Subpart E of the Commission's part 15 rules, is even less desirable. As 
with the 2.4 GHz band, many unlicensed devices already intensively use 
the 5150-5250 MHz band in health care settings. Moreover, as GEHC 
notes, use of 5150-5250 MHz band would require a higher transmit power 
and result in shorter battery life and it is not aware of readily 
available chipsets that could be incorporated into MBAN devices.

A. Licensing Framework

    20. The Commission concludes that authorizing MBAN use on a 
license-by-rule basis within its part 95 rules is the best approach. 
These devices share many characteristics with medical 
radiocommunications technologies that are already authorized under a 
license-by-rule approach, and the Commission finds that this framework 
can promote the rapid and robust development of MBAN devices without 
subjecting users to an unnecessarily burdensome individual licensing 
process. Moreover, the Commission is adopting appropriate technical 
rules and coordination procedures to ensure that MBAN devices can 
successfully operated on a secondary basis in the 2.3 GHz band without 
the need for individual licenses.
    21. While an MBAN may be similar to WMTS in purpose--both involve 
the measurement and recording of physiological parameters and other 
patient-related information--the Commission finds that they are closer 
to MedRadio devices in their implementation. Like MedRadio devices, 
MBAN devices will be designed to operate at low power levels. Moreover, 
the two MBAN components--the body-worn sensor and the nearby hub--are 
functionally analogous to the medical body-worn device and associated 
MedRadio programmer/control transmitter that are provided for in our 
MedRadio rules. Although the Commission recognizes that it could codify 
the MBAN rules as a separate rule subpart, it concludes that the best 
course is to modify the existing MedRadio rules. This is the same 
approach the Commission recently took when providing for the 
development of new ultra-low power wideband networks consisting of 
multiple transmitters implanted in the body that use electric currents 
to activate and monitor nerves and muscles. Moreover this approach 
avoids duplicating existing rules that logically apply to both MBAN and 
existing MedRadio devices. This, in turn, will ensure that any future 
rules that affect MBAN and other MedRadio applications will be updated 
in a comprehensive and consistent manner. Also, because the MedRadio 
rules already distinguish

[[Page 55720]]

between each of the various types of MedRadio devices when necessary 
by, for example, setting forth particular operational rules and 
authorized frequencies, we will still be able to add MBAN-specific 
rules when and where appropriate.
    22. The NPRM sought comment on the definitions the Commission 
should apply to an MBAN and its components, and proposed four terms 
that it could codify in our final rules. Because the Commission has 
decided to authorize MBAN operations under our MedRadio rules, it is 
not necessary to adopt such a comprehensive set of definitions. The 
Commission instead modified the Appendix to Subpart E of Part 95 of our 
Rules to add a single new definition--Medical body area network (MBAN) 
to read as follows:

    Medical Body Area Network (MBAN). An MBAN is a low power network 
consisting of a MedRadio programmer/control transmitter and multiple 
medical body-worn devices all of which transmit or receive non-voice 
data or related device control commands for the purpose of measuring 
and recording physiological parameters and other patient information 
or performing diagnostic or therapeutic functions via radiated bi- 
or uni-directional electromagnetic signals

This definition is slightly different from that proposed in the NPRM. 
It reflects appropriate MedRadio terminology and includes a description 
of the telemetry functions of an MBAN that were originally part of the 
separate definition the Commission proposed for the term ``Medical body 
area device.'' The other terms it had proposed to define are already 
encompassed within the existing MedRadio definitions. The existing 
definition for a MedRadio programmer/control transmitter is a 
transmitter that is designed to operate outside the human body for the 
purpose of communicating with a receiver connected to a body-worn 
device in the MedRadio Service. Because this definition already 
describes how an MBAN control transmitter functions, it is not 
necessary for us to adopt a separate definition for an ``MBAN control 
transmitter.'' Although the MedRadio programmer/control transmitter 
definition is broadly written to permit other functions--such as 
communicating with implanted devices or acting as a programmer--the 
Commission recognizes that such features will not be necessary for MBAN 
operations and observe that a device that does not include them could 
still conform to the definition. In a similar vein, it finds that the 
existing definition for a Medical body-worn device already describes 
how an MBAN sensor operates and can be used in lieu of the proposed 
``Medical body area device.'' Finally, the existing ``MedRadio 
transmitter'' definition is analogous to our proposed ``MBAN 
transmitter'' term. The Commission finds that this overall approach to 
the MBAN definitions shares the same advantages as, and is consistent 
with, the decision to provide for MBAN operations as part of the 
existing MedRadio rules. It also notes that while the Joint Parties 
proposed numerous definitions in conjunction with their draft rules, 
their focus was on specific technical and operational definitions. The 
Commission will not adopt these terms, as we agree with AdvaMed that it 
is not necessary to define other components of an MBAN because there 
will be different ways to meet the overall MBAN definition and the 
Commission should afford manufacturers flexibility for innovation.

Service and Technical Rules

    23. The Commission now sets forth the specific service and 
technical parameters that will define an MBAN. Because it has chosen to 
regulate MBAN devices under the MedRadio rules, the Commission has 
analyzed those rules to determine which need to be modified for MBAN 
devices and which are already suitable for MBAN use. The Commission 
focuses primarily on those service and technical rules that require 
further modification.

Service Rules

    24. Operator Eligibility. In the NPRM, the Commission proposed that 
MBAN use be subject to the same operator eligibility requirements that 
are in place for the MedRadio Service. Section 95.1201 of our rules 
permits operation of MedRadio transmitters by duly authorized health 
care professionals, by persons using MedRadio transmitters at the 
direction of a duly authorized health care professional, and by 
manufacturers and their representatives for the purpose of 
demonstrating such equipment to duly authorized health care 
professionals. The Commission concludes that this rule should be 
applied to MBAN operations without further modification.
    25. The Joint Parties ask that the Commission expand MBAN 
eligibility to permit manufacturers and vendors (and their 
representatives) to operate MBAN transmitters for developing, 
demonstrating and testing purposes. Although the Joint Parties state 
that this would mirror analogous provisions in the WMTS rules, in fact 
the WMTS rules permit manufacturers and their representatives to 
operate such equipment only for purposes of ``demonstrating'' such 
equipment. There is similar language in the current MedRadio rules that 
permits operation of MedRadio equipment by manufacturers ``and their 
representatives.'' This language permits vendors to demonstrate MBAN 
equipment as representatives of a manufacturer. Thus, the Commission is 
not modifying the current rule to state this specifically. It further 
notes that the current rule would not preclude authorized healthcare 
professionals from contracting for the services of third parties to 
operate an MBAN. Additionally, for the reasons discussed regarding the 
frequency coordinators' roles, the Commission did not modify this rule 
to include frequency coordinators as eligible operators of MBAN 
equipment. With respect to expanding the MedRadio rule to permit 
equipment operation by manufacturers for developing and testing 
purposes, it is not persuaded that such a rule revision is necessary. 
The Commission's experimental licensing rules provide the appropriate 
process for granting non-licensees operational authority for developing 
and testing MedRadio devices, including MBAN devices.
    26. Permissible Communications. In the NPRM, the Commission 
observed that the existing rules allow a MedRadio device to be used for 
diagnostic and therapeutic purposes to relay non-voice data, and asked 
whether such requirements would be appropriate for MBAN operations. The 
NPRM also asked how communications should be structured within a 
particular MBAN. Specifically, the Commission asked whether 
communications between body-worn MBAN devices or communications between 
MBAN devices within one network with those in another should be 
allowed, and whether a single programmer/controller should be permitted 
to control body-worn devices associated with multiple MBAN networks 
simultaneously or those associated with more than one patient. The 
Commission adopted communications rules that are generally consistent 
with the existing MedRadio provisions and modified Sec.  95.1209 of its 
rules accordingly.
    27. As an initial matter, no commenter objected to allowing an MBAN 
to communicate both diagnostic and therapeutic information. The 
Commission will apply Sec.  95.1209(a) of its rules, as written, to 
MBAN operations. While this rule provides considerable flexibility to 
provide data and visual information, it does not allow voice data, as 
requested by AT&T. The Commission believes that the current MedRadio 
and WMTS prohibitions regarding voice data are

[[Page 55721]]

part of a proven framework in which to base MBAN operations, and note 
that AT&T's suggestion relates to general speculation about potential 
future MBAN functionality as opposed to a specific application it 
intends to deploy.
    28. The Commission will require an MBAN to consist of a single 
programmer/control transmitter (or hub) that controls multiple (i.e., 
non-implanted) sensor devices. The intent of defining an MBAN in this 
way is to prevent direct communications between programmer/controllers 
which would facilitate mesh type networks using MBAN controllers to 
potentially extend the range of an MBAN beyond the confines of the 
medical facility. Consequently, it will not permit direct 
communications between body-worn sensors or direct communication 
between programmer/control transmitters. Under the existing Sec.  
95.1209(c), programmer/control transmitters will be able to 
interconnect with other telecommunications systems. This will allow 
backhaul from a single patient-based MBAN control transmitter to a 
monitoring station that receives and processes MBAN body sensor data 
from multiple patients using frequencies other than the 2360-2400 MHz 
band. The Commission recognizes that some commenters would have us 
allow one programmer/control transmitter to be controlled by a separate 
programmer/control transmitter or permit direct communications between 
body-worn sensor devices. It does not adopt these proposals. The 
Commission believes that the rules it adopted provide more certainty 
that an MBAN will operate in compliance with it rules or a coordination 
agreement because each programmer/control transmitter and its 
associated body-worn sensors will operate in response to a control 
message received over the facility's LAN. As the Commission gain 
further experience with MBAN operations, it may revisit these 
restrictions.
    29. The Commission believes that there is no need to specify that 
each MBAN control transmitter be limited to controlling the body sensor 
transmitters for a single patient, nor that specific protocols should 
be associated with such transmissions. The low power levels permitted 
for MBAN transmitters will already limit the effective range for 
communications to a small number of patients, and thus such use does 
not raise any unique interference concerns. Consistent with the 
approach it has taken in the MedRadio proceeding, the Commission also 
declines to restrict an MBAN from performing functions that are ``life-
critical'' or ``time-sensitive.'' The Commission continues to believe 
that these types of determinations are best made by health care 
professionals in concert with FDA-required risk management processes. 
Operators of MBAN systems and health care facilities are reminded that 
even the ``life-critical'' operation permitted on a secondary basis 
must accept interference from the primary spectrum users in the 2360-
2400 MHz band.
    30. Authorized Locations. The Commission sought comment on whether 
it would be appropriate to restrict the use of MBAN transmitting 
antennas to indoor locations in certain frequency bands, and noted that 
its WMTS rules restrict antennas to indoor use only, while the MedRadio 
rules provide for the use of temporary outdoor antennas. The Commission 
modified Sec. Sec.  95.1203 and 95.1213 of the MedRadio rules to 
provide for indoor-only MBAN operation in the 2360-2390 MHz band and 
MBAN operation at any location in the 2390-2400 MHz band.
    31. The Commission's decision on this issue is consistent with the 
approach suggested in the Joint Proposal. It finds that limiting MBAN 
operation in the 2360-2390 MHz band to indoor locations within health 
care facilities is a reasonable and effective way to limit potential 
interference and promote sharing between MBAN and AMT users. It is also 
consistent with the coordination procedures being adopted. Although 
AT&T suggests that any rule restricting use to indoors would limit the 
usefulness of an MBAN, the Commission disagrees and notes that GEHC and 
other likely equipment developers have not been deterred by the 
prospect of indoor-only operation. Moreover, in the 2390-2400 MHz band, 
where there are fewer AMT interference concerns, the Commission is able 
to provide MBAN users with the added flexibility of operating in any 
location. The Commission rejected the suggestion by the Joint Parties 
that it modify the rules to permit outdoor operation in the 2360-2390 
MHz band in cases of a ``medical emergency declared by duly authorized 
governmental authorities after emergency coordination with the AMT 
coordinator.'' The Commission finds that the suggested exception does 
not clearly define ``medical emergency'' or ``authorized governmental 
authorities'' and would essentially delegate authority to unnamed third 
parties to determine when outdoor MBAN operation is permitted. Instead, 
the Commission observed that there are other approaches that would as 
readily address this issue. Health care facilities can consider using 
MBAN devices that are capable of shifting to the 2390-2400 MHz band--
where it is not necessary to receive prior approval to operate 
outdoors--in anticipation of situations where there may not be time to 
perform a quick coordination, such as an emergency in a part of the 
health care facility that requires some patients to be temporarily 
moved outdoors. For extraordinary circumstances involving outdoor use 
of the 2360-2390 MHz band, MBAN licensees will have to follow the same 
course of action as other licensees when emergencies occur, and ask the 
applicable licensing bureau (in this case, the Wireless 
Telecommunications Bureau) for a temporary waiver to permit such 
operation. The Commission expects that, in bona fide emergency 
situations, the MBAN and AMT licensees and the frequency coordinators 
will all cooperate to identify frequencies that can be made available 
for emergency MBAN operations as quickly as possible while ensuring 
flight safety.
    32. Equipment Authorization. In the NPRM, the Commission asked if 
each MBAN transmitter authorized to operate in the 2360-2400 MHz band 
should be required to be certificated, if manufacturers of MBAN 
transmitters should be subject to disclosure statement and labeling 
requirements that are analogous to those in the existing MedRadio rules 
(including the identification of MBAN transmitters with a serial 
number), and if MBAN transmitters should be required to be marketed and 
sold only for the permissible communications the Commission allows for 
the service. These provisions allow for the deployment and operation of 
existing MedRadio devices in a consistent and predictable manner, and 
the Commission concludes that they will do the same for MBAN equipment. 
The Commission therefore will apply the existing MedRadio provisions in 
Sec. Sec.  95.603(f), 95.605, 95.1215, 95.1217, and 95.1219 of the 
Commission's rules to MBAN operations, modified as necessary to refer 
to MBAN devices and their associated frequency bands.
    33. Although no commenter specifically addressed this issue, the 
Commission notes that the certification requirement in Sec.  95.603(f) 
of the rules does not apply to transmitters that are not marketed for 
use in the United States, but are being used in the United States by 
individuals who have traveled to the United States from abroad and 
comply with the applicable technical requirements. This provision will 
apply to MBAN devices. The disclosure statement and labeling 
requirements, which are similar to those suggested in the Joint 
Proposal, are based on requirements that have been in place

[[Page 55722]]

since 1999. Although WCAI had expressed concern that similar labeling 
rules originally suggested by GEHC might be inadequate to notify MBAN 
users of their responsibilities as secondary licensees, the Commission 
concludes that the proposed labeling rules are appropriate. The 
Commission has analyzed the potential for interference to and from MBAN 
devices--including in the adjacent-band scenarios of interest to WCAI--
and determined that its rules will support MBAN operation on a 
secondary basis. Moreover, because MBAN devices are similar to other 
MedRadio devices in that they will operate at low power and under the 
direction of a duly authorized health care professional, it is 
appropriate for us to apply the existing MedRadio labeling language for 
the programmer/controller transmitter that has served us well for many 
years. However, the Commission will modify the requirement for labeling 
a MedRadio transmitter with a serial number. The current rule requires 
that all MedRadio transmitters shall be identified with a serial 
number. GEHC has stated that ``* * * It would not be appropriate to 
require that individual MBAN transmitters be equipped with a unique 
serial number, given the fact that individual sensor nodes may be 
disposable.'' Although the Commission is not aware that this 
requirement has presented any problems for the manufacture and use of 
existing body-worn MedRadio devices, it will only require individual 
MBAN programmer/controller transmitters to be labeled with a unique 
serial number but not require individual MBAN body-worn sensor devices 
to be labeled this way due to their expected low-cost and disposable 
nature. Finally, as proposed in the NPRM, the Commission will 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. The size and placement of MBAN equipment may make 
it impractical to place this information directly on the transmitter, 
and the personnel responsible for overall MBAN operations within a 
health care facility are not likely to be physically located in patient 
care areas where MBAN transmitters will be used.
    34. Other Service Issues. The Commission will also adopt the 
proposals in the NPRM that MBAN devices will not be required to 
transmit a station identification announcement, and that all MBAN 
transmitters are made available for inspection upon request by an 
authorized FCC representative. These requirements are the same as the 
existing MedRadio rules, and no commenters objected to applying these 
provisions to MBAN users. The Commission also updated Sec.  95.1211 of 
its rules (``Channel Use Policy'') to reference the 2360-2400 MHz band.

Technical Rules

    35. Authorized Bandwidth and Channel Aggregation. In the NPRM, the 
Commission sought comment on whether to apply the MedRadio approach of 
specifying only the maximum permitted bandwidth, but not any particular 
channel plan, with respect to MBAN devices in their authorized 
frequency band(s). The record reflects broad support for this approach, 
and the Commission modified Sec.  95.633 to specify a 5-megahertz 
maximum authorized bandwidth for MBAN devices. This approach is 
consistent with the existing MedRadio rules.
    36. The Commission's decision to specify a 5 megahertz authorized 
bandwidth is also consistent with recommendations from the Joint 
Parties and other commenters. Although the NPRM suggested a 1 megahertz 
limit, the Commission agrees with the Joint Parties and other 
commenters that 5 megahertz is a more appropriate limit. By allowing 
the larger authorized bandwidth, we can still accommodate MBAN devices 
that use a 1 megahertz bandwidth, while also providing flexibility for 
the development of MBAN devices that can use higher data rates and that 
have higher throughput for applications that require larger amounts of 
data. The Commission will also permit device manufacturers to aggregate 
multiple transmission channels in a single device, so long as the total 
emission bandwidth used by all devices in any single patient MBAN 
communication session does not exceed the maximum authorized bandwidth 
of 5 megahertz. This, too, is consistent with the existing channel use 
provisions of the MedRadio Service.
    37. Transmitter Operation and Power Limits. In the NPRM, the 
Commission sought comment on the appropriate maximum transmitter power 
for MBAN devices. It proposed to limit individual MBAN devices to a 
maximum transmit power of 1 mW equivalent isotropic radiated power 
(EIRP) measured in a 1 megahertz bandwidth, which followed GEHC's 
proposal. The Joint Proposal suggested use of a maximum EIRP of 20 mW 
measured in a 5 megahertz bandwidth for the 2390-2400 MHz band, but 
maintained the original 1 mW EIRP maximum for the 2360-90 MHz band. 
Based on the information provided in the record and the Commission's 
decision to adopt a maximum bandwidth of 5 megahertz, the Commission 
will modify Sec.  95.639 of its rules to specify the power limits in 
the Joint Proposal.
    38. The need for a different power limit in the upper portion of 
the MBAN band was addressed by Philips. The 2390-2400 MHz portion of 
the MBAN spectrum will have no restrictions regarding location or 
mobile use, and thus all in-home MBAN use will occur in this band. 
Philips provides a detailed discussion of the differences between home 
and hospital MBAN use, and contends that there are unique 
circumstances--such as the possibility that an adverse health event 
could result in the patient falling on the MBAN transmitter and the 
need to provide patients with full mobility within their homes--that 
warrant a higher power level for this 10 megahertz band. It also notes 
that the upper band's proximity to the ISM band means that the MBAN may 
have to overcome excess noise in some instances to ensure a reliable 
link budget. AdvaMed echoes Philips in support of a 20 mW maximum EIRP 
in the 2390-2400 MHz band. The Commission finds that there is good 
reason to make a distinction in the maximum power it authorizes in the 
lower 2360-2390 MHz and in the upper 2390-2400 MHz bands.
    39. The Commission is adopting additional transmitter operation 
rules for MBAN devices to implement other MBAN requirements. MBAN 
devices may not operate outside the confines of a health care facility 
in the 2360-2390 MHz band. MBAN devices that operate in the 2360-2390 
MHz band must comply with registration and coordination requirements, 
and operate in the band consistent with the terms of any coordination 
agreement. The Joint Parties proposed that these dual requirements--no 
outdoor use and compliance with a coordination agreement--could be met 
by requiring that the MBAN master transmitter receive a ``beacon'' 
signal or control message that conveyed the permitted scope of 
operation in the band and that the device cease operating in the band 
automatically if it could not receive the signal. In their proposal, 
the control point in the health care facility would transmit this 
beacon or control message to the MBAN master transmitter using the 
facility's LAN.
    40. Although the Commission generally agrees with the Joint 
Parties' suggestions, because each health care facility's 
communications infrastructure

[[Page 55723]]

and physical layout will present unique capabilities and challenges, it 
will not establish any requirements for how control messages are 
distributed within a health care facility. The Commission revised Sec.  
95.628 of the rules, which specifies the technical requirements for 
MedRadio transmitters, so that the MBAN programmer/controller 
transmitters must be capable of receiving and complying with a control 
message specifying its particular operating parameters within the band. 
Specifically, an MBAN programmer/control transmitter may not commence 
operation and must automatically cease operating in the 2360-2390 MHz 
band if it does not receive a control message. It must also comply with 
a control message that directs it to limit its transmissions to 
segments of the band or to cease operation in the band. The Commission 
notes that the Joint Parties did not propose a specific period of time 
within which the MBAN transmitter must receive a control message to 
begin or continue operating. The proposal also did not prescribe a 
specific format or protocol for the control message. It will require 
applicants for equipment certification to attest that they comply with 
the requirement that MBAN equipment receive the control message by 
describing the protocols that the devices employ including the expected 
periodicity for reception of control messages that will allow the MBAN 
transmitter to begin or continue operating in the band. Additionally, 
the Commission expects that the control message will be an electronic 
message since it is expected to be sent using the health care 
facility's LAN. This helps to ensure that the MBAN meets the 
requirement for operating indoors on the 2360-2390 MHz band, since it 
will have to be tethered to a wireline network or within signal range 
of a wireless network within the facility.
    41. Unwanted Emissions. In the NPRM, the Commission noted that the 
part 95 MedRadio rules set forth limits on unwanted emissions from 
medical transmitting devices operating in the 401-406 MHz band and 
sought comment on the appropriateness of applying the same general 
limits to MBAN operations in the 2360-2400 MHz bands. The Commission 
finds that the provisions in Sec.  95.635(d) of its rules, which 
specify limits on unwanted emissions, are appropriate. Accordingly, the 
Commission modified this rule to reflect the use of the 2360-2400 MHz 
band by MBAN devices. It notes that the Joint Parties' proposal 
supports using the proposed limits on unwanted radiation and no party 
objected to the use of these figures. In addition, use of the MedRadio 
limits is consistent with our approach of accommodating MBAN operations 
under the existing MedRadio rules where practical.
    42. Frequency Stability. In the NPRM, the proposed to require that 
MBAN transmitters comply with the MedRadio rules and maintain a 
frequency stability of +/- 100 ppm of the operating frequency over the 
ambient environmental temperature range: (1) 25 [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. GEHC states that +/- 100 ppm is an 
acceptable limit for MBAN devices, but does not discuss the temperature 
range over which that stability should be required. The Commission is 
using the existing MedRadio definitions to regulate the MBAN sensor and 
hub devices. Under this construction, the existing temperature range 
for MedRadio programmer/control transmitters set forth in Sec.  
95.628(d)(2) of the rules will apply to MBAN hub devices without 
modification. Because no MBAN sensor will be implanted, the Commission 
further concludes that the 25 [deg]C to 45 [deg]C range it has for 
implanted devices should not apply to sensors. Instead it will use the 
broader 0 [deg]C to 55 [deg]C specification.
    43. RF Safety. In the NPRM, the Commission noted that portable 
radiofrequency (RF) transmitting devices are subject to Sec.  2.1093 of 
the rules, pursuant to which an environmental assessment concerning 
human exposure to RF electromagnetic fields must be prepared under 
Sec.  1.1307, and that these rule sections also govern existing 
MedRadio devices. The Commission also has an open RF safety proceeding 
(ET Docket No. 03-137) in which it proposed to conduct a comprehensive 
review of its rules regarding human exposure to RF electromagnetic 
fields. Thus, the NPRM only sought comment on whether MBAN transmitters 
should be deemed portable devices. The Commission will apply existing 
Sec.  95.1221 of its rules to MBAN devices, which will classify them as 
portable devices that are subject to Sec. Sec.  2.1093 and 1.1307 of 
the rules. The record reflects support for treating MBAN devices in 
this manner. The Commission sees no reason to treat MBAN devices 
differently than existing MedRadio devices with respect to RF safety 
matters.
    44. Frequency Monitoring. In the NPRM, the Commission sought 
comment on whether a frequency monitoring requirement should be 
required for MBAN devices to promote inter- and intra-service sharing 
and, if so, how it should develop such a protocol. The Commission 
encouraged commenters supporting implementation of a contention based 
protocol to discuss what kinds of contention protocols (i.e., listen-
before-talk (LBT) frequency monitoring, time slot synchronization, and 
frequency hopping) should or should not be utilized, and to explain in 
detail why or why not.
    45. The Commission, citing an evolving record, finds that it is not 
necessary to specify protocols to ensure spectrum sharing among MBAN 
systems. Initial filings by GEHC as well as the Joint Parties indicated 
a desire to codify a sharing protocol requirement. Several parties that 
support contention protocols nevertheless have urged us to avoid 
adopting specific rules. In more recent pleadings, the Joint Parties 
state that, while manufacturers believe that MBAN devices are likely to 
incorporate a mechanism to avoid interference when operating in close 
proximity (such as within medical facilities), they do not wish for us 
to adopt detailed procedures that might inadvertently inhibit the 
development of innovative methods that would allow them to make more 
intensive use of the spectrum. The Commission believes that the best 
course is to refrain from mandating a sharing protocol requirement, 
particularly because it appears that these matters are already being 
addressed within the standards setting process. In addition, it 
believes that the relatively low power levels used by MBAN transmitters 
make it possible that the use of sharing protocols might be unnecessary 
in many situations. The Commission further concludes that MBAN 
manufacturers will determine the appropriate level of communications 
reliability through the risk management activities involved with 
medical device design that is subject to oversight by the Food and Drug 
Administration (FDA), and that they should be given the flexibility to 
meet that level of communications reliability through whatever means 
they find appropriate. The Commission also finds that because it is 
requiring frequency coordination for MBAN and AMT sharing, it is not 
necessary to adopt frequency monitoring rules to promote spectrum 
sharing between these services.
    46. Duty Cycle. In the NPRM, the Commission sought comment on 
whether it should adopt specific duty cycle limits for MBAN 
transmitters in our rules and whether such limits would be needed to 
allow the functioning of a contention-based protocol for achieving 
reliable MBAN system performance, or for other

[[Page 55724]]

reasons. The Commission finds that it is not necessary to specify a 
duty cycle in its rules. The record indicates that manufacturers are 
likely to employ duty cycles even without a specific requirement to do 
so because it will allow them to achieve important operational goals. 
The Commission believes that the ongoing efforts of standards setting 
bodies to address MBAN use are adequate to address any relevant duty 
cycle considerations.

Registration and Coordination for the 2360-2390 MHz Band

    47. The Commission adopted registration and coordination rules for 
MBAN operations in the 2360-2390 MHz band. Registration and 
coordination are two separate but related processes. A health care 
facility that intends to operate an MBAN in the 2360-2390 MHz band must 
register the MBAN with a frequency coordinator (``the MBAN 
coordinator'') that the Commission will designate. The registration 
requirement will ensure that the locations of all MBAN operations in 
the 2360-2390 MHz band are recorded in a database. As part of the 
coordination process, the MBAN coordinator will first determine if a 
proposed MBAN in the 2360-2390 MHz band will be within line-of-sight of 
an AMT receiver. If the MBAN transmitter is within line-of-sight of an 
AMT receive site, the MBAN and AMT coordinators will work cooperatively 
to assess the risk of interference between the two operations and 
determine the measures that may be needed to mitigate interference 
risk. The MBAN coordinator will notify the health care facility when 
coordination is complete and the MBAN must operate consistent with the 
terms of any agreement reached by the coordinators. If no agreement is 
reached, the MBAN will not be permitted to operate in the band. The 
health care facility may not operate the MBAN in the band until it 
receives the appropriate operating parameters from the MBAN 
coordinator. The Commission also adopted procedures to accommodate new 
AMT receive sites as well as changes to MBAN deployment and operations.
    48. The registration and coordination requirements adopted 
accomplish several key principles of the Joint Parties' proposal to 
protect AMT receive sites. First, an MBAN will not be allowed to 
operate in the 2360-2390 MHz band until the frequency coordinators 
determine the risk of interference between the two services and the 
MBAN coordinator notifies the health care facility whether the device 
can operate in the band and the terms and conditions of operation. 
Second, the parties agree that MBAN operation within the line-of-sight 
of an AMT receive facility should serve as the baseline criteria that 
would trigger an analysis of interference risk and mitigation 
techniques. The importance of this baseline is underscored in the Joint 
Parties' proposed rules which include an expectation that both MBAN and 
AMT licensees will avoid line-of-sight operations whenever possible. 
Finally, the Commission expects that the MBAN and AMT coordinators will 
work cooperatively to evaluate potential interference situations and 
thus the Commission will require that they reach mutually satisfactory 
coordination agreements before MBAN operation is allowed at any 
specific location. Nevertheless, the Commission recognizes that AMT 
operates under a primary allocation and is entitled to protection from 
MBAN operations that will occur on a secondary basis. The Commission 
anticipates that the AMT coordinator will only enter into agreements 
that ensure an appropriate level of protection for the primary AMT 
operations.
    49. The Commission concludes that the use of frequency coordination 
procedures is an efficient and effective way for MBAN and AMT services 
to successfully share the 2360-2390 MHz band. Unlike exclusion zones, 
which would prohibit any MBAN operation within a specified distance of 
an AMT receive site, coordination provides the parties flexibility to 
determine whether and under what conditions both services could operate 
in the band at a given location. Because all MBAN operations in the 
band will be required to register and the information will be 
maintained in a database, a coordinator can readily identify those 
locations that are within line-of-sight of an AMT receive site and thus 
will require a coordination agreement with incumbent or new AMT receive 
sites.
    50. The rules that the Commission is adopting incorporate many, but 
not all, of the suggestions made by the Joint Parties, including their 
determination that the rules governing MBAN use of the 2360-2390 MHz 
band will be sufficient to protect AMT operations. The rules adopted 
provide the flexibility manufacturers, licensees and coordinators need 
to accommodate changes in both AMT and MBAN operations and assurance to 
AMT users that their future access to the spectrum will not be 
hampered.

Registration Requirement

    51. The Commission adopts a new rule, Sec.  95.1223, which requires 
health care facilities to register all MBAN devices they propose to 
operate in the 2360-2390 MHz band with a frequency coordinator 
designated by the Commission. MBAN operation in the 2360-2390 MHz band 
prior to registration is prohibited. The Commission believes that 
registration of all MBAN operations in the band will create a 
regulatory environment that promotes MBAN use and protects AMT 
operations. In order to register MBAN devices that operate in 2360-2390 
MHz frequency range, a health care facility must provide to the MBAN 
coordinator the following information:
     Specific frequencies or frequency range(s) within the 
2360-2390 MHz band to be used, and the capabilities of the MBAN 
equipment to use the 2390-2400 MHz band;
     Effective isotropic radiated power;
     Number of programmer/controller transmitters in use at the 
health care facility as of the date of registration including 
manufacturer name(s) and model numbers and FCC identification number;
     Legal name of the health care facility;
     Location of programmer/controller transmitters (e.g., 
geographic coordinates, street address, building);
     Point of contact for the health care facility (e.g., name, 
title, office, phone number, fax number, email address). This would 
typically be an administrator or other official who has a high level of 
authority within the facility; and
     Contact information (e.g., name, title, office, phone 
number, fax number, email address) for the party that is responsible 
for ensuring that MBAN operations within the health care facility are 
discontinued or modified in the event such devices have to cease 
operating in all or a portion of the 2360-2390 MHz band due to 
interference or because the terms of coordination have changed. This 
person would typically be an employee or contractor. The health care 
facility also must state whether, in such cases, its MBAN operation is 
capable of defaulting to the 2390-2400 MHz band and that it is 
responsible for ceasing MBAN operations in the 2360-2390 MHz band or 
defaulting traffic to other hospital systems.
    52. To ensure that the registration data maintained by the MBAN 
coordinator is accurate and up to date, the Commission is requiring 
heath care facilities to keep their registration information current 
and to notify the MBAN coordinator of any material changes to the 
location or operating parameters of a registered MBAN.

[[Page 55725]]

Because changes in MBAN location or operation could place that MBAN 
within line-of-sight of an AMT receive site, the Commission will 
prohibit the MBAN from operating under the changed parameters until the 
MBAN coordinator has determined if a new or revised coordination 
agreement with the AMT coordinator is required, and if so, coordination 
with the AMT coordinator is completed. The Commission will also require 
a health care facility to notify the MBAN coordinator whenever an MBAN 
programmer/controller transmitter in the 2360-2390 MHz band is 
permanently taken out of service, unless it is replaced with 
transmitter(s) using the same technical characteristics as those 
reported on the health care facility's registration.
    53. The Commission does not adopt a suggestion by the Joint Parties 
to require health care facilities to implement a ``transition plan'' 
that they must file with the MBAN coordinator in order to register an 
MBAN operating in the 2360-2390 MHz band. The Commission is not 
persuaded that requiring a transition plan as suggested by the Joint 
Parties is necessary to ensure that interference with AMT operations, 
if it occurs, can be quickly resolved. Instead, the Commission adopts 
other requirements that would be less burdensome and provide some 
flexibility in accomplishing the same objective. In particular, it 
requires a health care facility, as part of the registration process 
with the MBAN coordinator, to state whether its MBAN is capable of 
defaulting its operations to the 2390-2400 MHz band or to other 
hospital systems. The Commission finds that this approach effectively 
puts the facility on notice that it is responsible for taking whatever 
actions necessary to prevent or correct any harmful interference with 
AMT operations and also appropriately leaves the responsibility of 
defining and ensuring patient safety in the hands of medical 
professionals rather than the Commission or Commission designated 
frequency coordinators. Also, the Commission is requiring that an MBAN 
transmitter not operate in the 2360-2390 MHz band unless it is able to 
receive and comply with a control message that notifies the device to 
limit or cease operations in the band. This requirement should ensure 
that MBAN devices always operate in compliance with any coordination 
agreement and quickly respond to any interference situation. The 
Commission also concludes that the rules it is adopting will provide 
health care facilities with sufficient flexibility to decide how best 
to manage its communication and medical networks because each situation 
is unique in terms of network capability and management capability.
    54. The Commission does not believe that a frequency coordinator 
should be responsible for approving a health care facility's plans for 
complying with the rules or its plans for managing its internal systems 
for communications or patient care. The transition plan as described by 
the Joint Parties goes beyond the scope of the registration and 
coordination functions the Commission is requiring to ensure 
interference protection to AMT licensees, and those plans might overlap 
the risk assessment that is within the FDA's purview. The Commission 
does not believe that a frequency coordinator is an appropriate party 
for approving such plans or that the Commission should confer such 
approval authority on a frequency coordinator. The approach it adopts 
will allow health care facilities to manage their own MBAN systems or 
enter agreements as they determine to be appropriate for their 
individual situation, rather than adopting an approach that would 
require a health care facility to enter into service agreements with 
MBAN vendors. Finally, while the Commission does not require health 
care facilities to file a transition plan with the MBAN coordinator, it 
anticipates that health care facilities will create such plans in 
routine practice. The Commission encourages them to share such 
information with the MBAN coordinator to facilitate the coordination 
process.
    55. The Commission has adopted a registration requirement for the 
2360-2390 MHz band because it will facilitate coordination with AMT 
operations in that band; coordination is not needed and will not be 
required for an MBAN to operate in the 2390-2400 MHz band. The 
Commission's rules recognize that some MBAN equipment may operate 
across the whole 2360-2400 MHz band, but some equipment may be designed 
to operate only in the 2390-2400 MHz band which can be used for indoor 
or outdoor use without coordination. In the latter case, a registration 
requirement would unnecessarily burden hospitals that do not need 
assistance from the MBAN coordinator. Even if the Commission was 
persuaded that a registration requirement in the upper band would serve 
some useful purpose, the Commission's rules should not discriminate as 
to which facilities should be required to register. The rules require 
that any facility that registers MBAN equipment that operates in the 
2360-2390 MHz specify whether its equipment can default to the 2390-
2400 MHz band since this information will enable the coordinator to 
help the facility manage its MBAN operations consistent with any 
coordination agreements.

Coordination Requirement

    56. The Commission finds that use of a coordination framework that 
is based on the Joint Parties' proposal will allow for the operation of 
MBAN devices in the 2360-2390 MHz band while also providing adequate 
interference protection for AMT receivers, and the Commission will 
codify these coordination procedures in new Sec.  95.1223(c) of our 
rules. As the first step in the coordination process, the MBAN 
coordinator will determine whether a proposed MBAN location is within 
line-of-sight of AMT operations. The Commission will require that the 
MBAN coordinator provide the AMT coordinator with the MBAN registration 
information and obtain the AMT coordinator's concurrence that the MBAN 
is beyond line-of-sight prior to the MBAN beginning operations in the 
band. If the MBAN is within line-of-sight, the MBAN and AMT 
coordinators will assess the risk of interference between the two 
operations and determine the measures that may be needed to mitigate 
interference risk. In determining compatibility between proposed line-
of-sight MBAN and AMT operations, the coordinators will use ITU-R 
M.1459, subject to accepted engineering practices and standards that 
are mutually agreeable to both coordinators and that take into account 
the local conditions and operating characteristics of the AMT and 
proposed MBAN facilities. The Joint Parties have proposed specific 
analytical techniques for determining whether proposed MBAN locations 
are within line-of-sight and how to determine actual path loss. The 
Commission declines to specify these procedures in our rules. It 
recognizes that the MBAN and AMT coordinators will have to agree to the 
procedures they will use to determine when coordination is required and 
how it is done, but the Commission is also confident that the 
coordinators will be technically competent and will fully cooperate to 
develop mutually agreeable procedures to create coordination 
agreements. The Commission is also convinced that codifying specific 
procedures would potentially reduce flexibility on the part of both 
coordinators to adapt the coordination procedures as MBAN technologies 
mature.
    57. The Joint Parties have suggested procedures to follow when AMT 
users

[[Page 55726]]

need to expand their operations beyond existing receiver locations. 
Since they are authorized on a primary basis in the 2360-2390 MHz band, 
AMT users are entitled to expand as necessary to provide for 
aeronautical testing purposes. Because health care facilities need to 
be certain of their ability to rely on MBAN devices and also need time 
to adapt to the increased AMT requirements, the Joint Parties propose 
that an AMT licensee planning to expand its operations would first 
consider using locations that are not within line-of-sight to existing 
MBAN locations. If locations outside the line-of-sight to MBAN 
operations are not available, the AMT coordinator would give the MBAN 
coordinator at least seven days notice that MBAN users would have to 
cease or modify their operations. Under this proposal, the MBAN 
operator would still be eligible to enter into a new or modified 
coordination agreement with the new AMT operator, but the MBAN operator 
would nevertheless be required to vacate its operations at the end of 
the seven-day period if no coordination agreement is reached. The 
Commission adopts this proposal because it finds that it provides for 
the continuing requirements of the AMT community and preserves their 
growth potential, while also providing adequate notice to MBAN 
operators to adapt to any new AMT requirements.
    58. The Joint Parties have also suggested procedures to follow when 
AMT users experience interference from MBAN operations. The Commission 
agrees that it is important to consider the possibility that unexpected 
interference situations may occur, and it adopted rules that will aid 
MBAN users in identifying and resolving interference complaints. The 
channel use policy rule the Commission adopted conditions MBAN use on 
not causing harmful interference to and accepting interference from 
authorized stations operating in the 2360-2400 MHz band. As part of the 
registration process for operating MBAN devices in the 2360-2390 MHz 
band, the Commission will also require an MBAN user to provide an MBAN 
coordinator with a point of contact for the health care facility that 
is responsible for making changes to MBAN operating parameters (such as 
discontinuing operations or changing frequencies), to state whether its 
MBAN operation is capable of defaulting to the 2390-2400 MHz band, and 
to acknowledge that it, in the event of interference, it is responsible 
for ceasing MBAN operations in the 2360-2390 MHz band or defaulting 
traffic to other hospital systems. The Commission requires the MBAN 
coordinator, as part of its duties, to work with the health care 
facility to identify an interference source in response to a complaint 
from the AMT coordinator. Together, these rules give MBAN users clear 
notice that they must be prepared to cease use of the 2360-2390 MHz 
band in the event of interference, require them to disclose the person 
who is able to modify or cut off MBAN use within a health care 
facility, and obligate the MBAN coordinator--the party who has a record 
of MBAN use and who will logically be contacted by the AMT coordinator 
about interference--to identify alternative frequencies for MBAN use or 
to direct the MBAN to cease operation. Under the procedures suggested 
by the Joint Parties, if a health care facility is notified of MBAN 
interference to an AMT receive antenna, the MBAN system should be 
required to immediately cease transmission. The Commission concludes 
that the rules it is implementing describes can accomplish the same 
overall goal of identifying and resolving interference to AMT from MBAN 
users in a way that also clearly sets forth the roles and 
responsibilities of the parties. The Commission fully expects that 
licensees will work together to resolve any instances of harmful 
interference under the rules it adopted and the procedures described.

Coordinator Functions

    59. To implement the registration and coordination requirements, 
the Commission will designate an MBAN coordinator(s) after resolution 
of the proceedings addressed in the Further Notice. The Commission has 
directed the staff to act expeditiously to prepare a decision in 
response to the Further Notice and to initiate the selection of an MBAN 
coordinator(s), with a target of completing the process by June 2013. 
The Commission adopts a new rule, Sec.  95.1225, which sets forth the 
specific functions that the MBAN coordinator will perform. The MBAN 
coordinator must:
     Register health care facilities that operate an MBAN in 
the 2360-2390 MHz band, maintain a database of these MBAN transmitter 
locations and operational parameters, and provide the Commission with 
information contained in the database upon request;
     Determine if an MBAN is within line-of-sight of an AMT 
receive facility in the 2360-2390 MHz band and coordinate MBAN 
operations with the designated AMT coordinator;
     Notify a registered health care facility when an MBAN has 
to change frequency within the 2360-2390 MHz band or to cease operating 
in the band consistent with a coordination agreement between the MBAN 
and the AMT coordinators; and
     Develop procedures to ensure that registered health care 
facilities operate an MBAN consistent with the coordination 
requirements.
     Regarding the AMT coordinator functions, in 1969 the 
Commission designated Aerospace & Flight Test Radio Coordinating 
Council (AFTRCC) as the AMT coordinator under its rules. AFTRCC 
performs coordination for non-Federal Government licensees and 
coordinates with the Federal Government Area Frequency Coordinators for 
day-to-day scheduling of missions. In the NPRM, the Commission 
acknowledged AFTRCC's role as AMT coordinator and sought comment on the 
organization's involvement in MBAN and AMT spectrum-sharing. The 
Commission expects that AFTRCC will represent both Federal and non-
Federal AMT interests when coordinating with the MBAN coordinator, 
thereby eliminating the need for MBAN licensees to separately 
coordinate with Federal AMT systems. This should significantly reduce 
the time needed to complete coordination and should facilitate timely 
deployment of MBAN operations.

Final Regulatory Flexibility Analysis

    60. As required by the Regulatory Flexibility Act of 1980, as 
amended (RFA),\1\ an Initial Regulatory Flexibility Analysis (IRFA) was 
incorporated in the Notice of Proposed Rulemaking (NPRM).\2\ The 
Commission sought written public comment on the proposals in the NPRM, 
including comment on the IRFA. No comments were received addressing the 
IRFA. This present Final Regulatory Flexibility Analysis (FRFA) 
conforms to the RFA.\3\
---------------------------------------------------------------------------

    \1\ See 5 U.S.C. 603. The RFA, see 5 U.S.C. 601-612, has been 
amended by the Small Business Regulatory Enforcement Fairness Act of 
1996 (SBREFA), Public Law 104-121, Title II, 110 Stat. 857 (1996).
    \2\ See Amendment of the Commission's Rules to Provide Spectrum 
for the Operation of Medical Body Area Networks, ET Docket No. 08-
59, Notice of Proposed Rulemaking (NPRM), 24 FCC Rcd 9589, 9615-18 
(2009).
    \3\ See 5 U.S.C. 604.
---------------------------------------------------------------------------

A. Need for and Objective of the Report and Order

    61. The Report and Order (R&O) expands our part 95 Medical Device 
Radiocommunication Service (MedRadio) rules to permit the development 
of new Medical Body Area Network (MBAN) devices. MBAN

[[Page 55727]]

devices will be linked into wireless networks of multiple body 
transmitters used for measuring and recording physiological parameters 
and other patient information or for performing diagnostic or 
therapeutic functions, primarily in health care facilities. By reducing 
the need to physically connect sensors to essential monitoring 
equipment by cables and wires, MBAN technology will enhance patient 
care and promote efficiencies that can in turn reduce overall health 
care costs.
    62. The R&O concludes that the 2360-2400 MHz band is particularly 
well suited for MBAN use, given the propagation characteristics of 
these frequencies, the ability of MBAN devices to be able to share the 
band with incumbent users, and the ready availability of chipsets and 
technology that can be leveraged for MBAN development. The R&O 
establishes a 40 megahertz secondary allocation for MedRadio, with use 
limited to MBAN operations, through the addition of a footnote to the 
Table of Frequency Allocations (Table). Because MBAN operation is 
authorized on a secondary basis, an MBAN must accept interference from 
and not cause interference to primary services that share the 2360-2400 
MHz band. The R&O adopts technical and service rules to govern MBAN 
operation. MBAN devices will operate under existing part 95 MedRadio 
rules, as modified to account for device networking, wider bandwidth, 
and higher transmission power. The R&O adopts new registration and 
coordination rules to ensure protection of Aeronautical Mobile 
Telemetry (AMT) operations in the 2360-2390 MHz band.

B. Summary of Significant Issues Raised by Public Comments in Response 
to the IRFA

    63. No comments were filed in response to the IFRA in this 
proceeding. In addition no comments were submitted concerning small 
business issues.

C. Response to Comments by the Chief Counsel for Advocacy of the Small 
Business Administration

    64. Pursuant to the Small Business Jobs Act of 2010, the Commission 
is required to respond to any comments filed by the Chief Counsel for 
Advocacy of the Small Business Administration (SBA), and to provide a 
detailed statement of any change made to the proposed rules as a result 
of those comments. The Chief Counsel did not file any comments in 
response to the proposed rules in this proceeding.

D. Description and Estimate of the Number of Small Entities to Which 
the Adopted Rules Will Apply

    65. 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 rules and policies adopted herein.\4\ The RFA generally 
defines the term ``small entity'' as having the same meaning as the 
terms ``small business,'' ``small organization,'' and ``small 
governmental jurisdiction.'' \5\ In addition, the term ``small 
business'' has the same meaning as the term ``small business concern'' 
under the Small Business Act.\6\ 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.\7\ Nationwide, there are a total of 
approximately 27.5 million small businesses, according to the SBA. As 
an initial matter, the Commission notes that its decision will permit 
MBAN use of the 2390-2400 MHz band, which is also allocated to the 
Amateur Radio Service on a primary basis. Individuals who are the 
control operators of amateur radio stations are not ``small entities,'' 
as defined in the RFA.
---------------------------------------------------------------------------

    \4\ 5 U.S.C. 603(b)(3).
    \5\ 5 U.S.C. 601(6).
    \6\ 5 U.S.C. 601(3) (incorporating by reference the definition 
of ``small-business concern'' in the Small Business Act, 15 U.S.C. 
632). Pursuant to 5 U.S.C. 601(3), 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.''
    \7\ 15 U.S.C. 632 (1996).
---------------------------------------------------------------------------

    66. Personal Radio Services. The MBAN devices will be subject to 
part 95 of our rules (``Personal Radio Services''). The Commission has 
not developed a small business size standard specifically applicable to 
these services. Therefore, for purposes of this analysis, the 
Commission uses the SBA small business size standard for the category 
Wireless Telecommunications Carriers (except Satellite), which is 1,500 
or fewer employees.\8\ Census data for 2007 show that there were 1,383 
firms that operated that year.\9\ Of those, 1,368 had fewer than 100 
employees. Personal radio services provide short-range, low power radio 
for personal communications, radio signaling, and business 
communications not provided for in other services. The Personal Radio 
Services include spectrum licensed under part 95 of our rules and cover 
a broad range of uses.\10\ Many of the licensees in these services are 
individuals and thus are not small entities. In addition, due to the 
fact that licensing of operation under part 95 is accomplished by rule 
(rather than by issuance of individual license), and due to the shared 
nature of the spectrum utilized by some of these services, the 
Commission lacks direct information other than the census data above 
upon which to base an estimation of the number of small entities under 
an SBA definition that might be directly affected by the proposed rules 
adopted.
---------------------------------------------------------------------------

    \8\ See 13 CFR 121.201, NAICS code 517210.
    \9\ U.S. Census Bureau, 2007 Economic Census, Sector 51, 2007 
NAICS code 517210 (rel. Oct. 20, 2009), https://factfinder.census.gov/servlet/IBQTable?_bm=y&-geo_id=&-fds_name=EC0700A1&-_skip=700&-ds_name=EC0751SSSZ5&-_lang=en.
    \10\ 47 CFR part 90.
---------------------------------------------------------------------------

    67. Wireless Communications Equipment Manufacturers. The Census 
Bureau does not have a category specific to medical device 
radiocommunication manufacturing. The appropriate category is that for 
wireless communications equipment manufacturers. The Census Bureau 
defines this category as follows: ``This industry comprises 
establishments primarily engaged in manufacturing radio and television 
broadcast and wireless communications equipment. Examples of products 
made by these establishments are: Transmitting and receiving antennas, 
cable television equipment, GPS equipment, pagers, cellular phones, 
mobile communications equipment, and radio and television studio and 
broadcasting equipment.'' The SBA has developed a small business size 
standard for Radio and Television Broadcasting and Wireless 
Communications Equipment Manufacturing, which is: All such firms having 
750 or fewer employees.\11\ According to Census bureau data for 2007, 
there were a total of 919 firms in this category that operated for the 
entire year. Of this total, 771 had fewer than 100 employees and 148 
had more than 100 employees.\12\ Thus, under this size standard, the 
majority of firms can be considered small.
---------------------------------------------------------------------------

    \11\ 13 CFR 121.201 NAICS code 334220.
    \12\ See https://factfinder.census.gov/servlet/IBQTable?_bm=y&-geo_id=&-fds_name=EC0700A1&-_skip=4500&-ds_name=EC0731SG3&-_lang=en.
---------------------------------------------------------------------------

    68. Aeronautical Mobile Telemetry (AMT). Currently there are 9 AMT 
licensees in the 2360-2395 MHz band. It is unclear how many of these 
will be affected by our new rules. The Commission has not yet defined a 
small business with respect to aeronautical mobile telemetry services. 
Therefore, for purposes of this analysis, the

[[Page 55728]]

Commission uses the SBA small business size standard for the category 
Wireless Telecommunications Carriers (except Satellite), which is 1,500 
or fewer employees.\13\ Census data for 2007 show that there were 1,383 
firms that operated that year.\14\ Of those 1,368 had fewer than 100 
employees. Thus, under this size standard, the majority of firms can be 
considered small. The rules we adopt provide the flexibility 
manufacturers, licensees and coordinators need to accommodate changes 
in both AMT and MBAN operations and assurance to AMT users that their 
future access to the spectrum will not be hampered.
---------------------------------------------------------------------------

    \13\ See 13 CFR 121.201, NAICS code 517210.
    \14\ U.S. Census Bureau, 2007 Economic Census, Sector 51, 2007 
NAICS code 517210 (rel. Oct. 20, 2009), https://factfinder.census.gov/servlet/IBQTable?_bm=y&-geo_id=&-fds_name=EC0700A1&-_skip=700&-ds_name=EC0751SSSZ5&-_lang=en.
---------------------------------------------------------------------------

E. Description of Projected Reporting, Recordkeeping and Other 
Compliance Requirements

    69. Under the adopted rules, MBAN operators will not require 
individual licenses but instead will qualify for license-by-rule 
operation \15\ pursuant to Section 307(e) of the Communications Act 
(Act).\16\ While there is no requirement to file with the Commission, 
parties seeking to utilize the 2360-2390 MHz band must register with a 
frequency coordinator. The Commission will designate the MBAN frequency 
coordinator(s). The frequency coordinator will require the following 
information from an entity that seeks to operate an MBAN in the 2360-
2390 MHz band:
---------------------------------------------------------------------------

    \15\ See 47 CFR 95.1201.
    \16\ 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 U.S.C. 307(e)(1).
---------------------------------------------------------------------------

     Specific frequencies or frequency range(s) within the 
2360-2390 MHz band to be used, and the capabilities of the MBAN 
equipment to use the 2390-2400 MHz band;
     Effective isotropic radiated power;
     Number of programmer/controller transmitters in use at the 
health care facility as of the date of registration including 
manufacturer name(s) and model numbers and FCC identification number;
     Legal name of the health care facility;
     Location of programmer/controller transmitters;
     Point of contact for the health care facility; and
     Contact information for the party that is responsible for 
ensuring that MBAN operations within the health care facility are 
discontinued or modified in the event such devices have to cease 
operating in all or a portion of the 2360-2390 MHz band due to 
interference or because the terms of coordination have changed. The 
health care facility also must state whether, in such cases, its MBAN 
operation is capable of defaulting to the 2390-2400 MHz band and that 
it is responsible for ceasing MBAN operations in the 2360-2390 MHz band 
or defaulting traffic to other hospital systems.
    70. The Commission imposes these notification requirements in 
recognition that MBAN device operations have the potential to interfere 
with the sensitive receivers and high gain antennas used by the primary 
AMT licensees. The Report and Order also establishes a coordination 
procedure that will be used when the MBAN coordinator determines that 
MBAN devices in the 2360-2390 MHz band would be operating under 
conditions where such interference might occur--specifically, within 
the line-of-sight of AMT operations. The coordination process would 
allow the MBAN coordinator and the AMT coordinator to determine whether 
and under what circumstances MBAN equipment could be used without 
interfering with the primary AMT operations. The Report and Order 
concludes that the adoption of reasonable coordination requirements 
will adequately protect AMT operations while enabling MBAN devices to 
be widely deployed in health care facilities. The Commission concludes 
that the registration and coordination requirements effectively balance 
the interests of the interested parties and are preferable to other 
options, such as using alternate frequency bands or establishing large 
exclusion zones around AMT locations.
    71. The R&O adopts service and technical rules that apply to all 
entities that manufacture and use MBAN devices. The rules generally 
require that MBAN devices be able to operate in the presence of other 
primary and secondary users in these frequency bands. MBAN operations 
in the 2360-2390 MHz are restricted to indoor locations to protect AMT 
operations. The MBAN programmer/controller must ensure that its network 
operates in the 2360-2390 MHz band only if it is in receipt of a 
control message. As directed by a control message, the MBAN programmer/
controller must be capable of: (1) Redirecting the MBAN to newly 
specified spectrum in the 2360-2390 MHz band; or (2) redirecting the 
MBAN to spectrum in the 2390-2400 MHz band. An MBAN programmer/
controller that does not receive a control message within the timeframe 
programmed into the device by the manufacturer must ensure that its 
MBAN ceases operation in the 2360-2390 MHz band.\17\
---------------------------------------------------------------------------

    \17\ Paras. 48-49, supra.
---------------------------------------------------------------------------

    72. MBAN use shall be restricted for use by persons only for 
diagnostic and therapeutic purposes and only to the extent that such 
devices have been provided to a human patient under the direction of a 
duly authorized health care professional.\18\ An MBAN consists of only 
body-worn devices. A single MBAN programmer/controller may direct more 
than one MBAN. MBAN programmer/controller devices may not directly 
communicate with each other and MBAN component devices may not directly 
communicate with each other.\19\
---------------------------------------------------------------------------

    \18\ Paras. 33-34, supra.
    \19\ Paras. 35-38, supra.
---------------------------------------------------------------------------

    73. An MBAN may transmit in an authorized bandwidth of 5 
megahertz.\20\ MBAN transmitters may transmit in the 2360-2390 MHz 
band, the maximum EIRP over the frequency bands of operation shall not 
exceed the lesser of 1 mW or 10*log (B) dBm, where B is the 20 dB 
emission bandwidth in MHz. MBAN transmitters may transmit in the 2390-
2400 MHz band, the maximum EIRP over the frequency bands of operation 
shall not exceed the lesser of 20 mW or 16+10*log (B) dBm, where B is 
the 20 dB emission bandwidth in MHz. The MBAN must meet specific limits 
on unwanted emissions.\21\ MBAN transmitters will be required to 
maintain a frequency stability as specified in the current MedRadio 
rules of  100 ppm of the operating frequency over the range 
0[deg]C to 55[deg]C.\22\
---------------------------------------------------------------------------

    \20\ Paras. 44-45, supra.
    \21\ Paras. 46-47, supra.
    \22\ Para. 51, supra.
---------------------------------------------------------------------------

    74. MBAN transmitters must be certificated except for such 
transmitters that are not marketed for use in the United States, are 
being used in the United States by individuals who have traveled to the 
United States from abroad, and comply with the applicable technical 
requirements. Manufacturers of MBAN transmitters must include with each 
transmitting device a disclosure statement and each MBAN programmer/
controller must be labeled with a statement.\23\ An MBAN may be 
operated anywhere that CB station operation is authorized under Sec.  
95.405,

[[Page 55729]]

except in the 2360-2390 MHz band MBAN use is restricted to indoor 
operation within a health care facility registered with the MBAN 
coordinator, and an MBAN is not required to transmit a station 
identification announcement. All non-MBAN transmitters must be made 
available for inspection upon request by an authorized FCC 
representative.\24\
---------------------------------------------------------------------------

    \23\ Paras 41-42, supra.
    \24\ Para. 43, supra.
---------------------------------------------------------------------------

F. Steps Taken To Minimize Significant Economic Impact on Small 
Entities, and Significant Alternatives Considered

    75. 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\
---------------------------------------------------------------------------

    \25\ See 5 U.S.C. 603(c).
---------------------------------------------------------------------------

    76. The Commission adopted a license-by-rule approach for MBAN 
operations. This decision should decrease the cost of MBAN use for 
small entities as compared to a requirement that MBAN users apply for 
and obtain individual station licenses from the Commission because it 
will eliminate application expenses associated with the traditional 
licensing process.
    77. The registration and coordination process for operation in the 
2360-2390 MHz band, as well as the requirement that MBAN devices be 
capable of receiving and complying with a control message, will 
maximize the ability of MBAN devices to share spectrum with primary AMT 
users. Alternative approaches, such as the use of exclusion zones, 
would have categorically prohibited MBAN use in certain areas, even if 
it would be technically possible to operate MBAN devices without 
interference to AMT users. Other options would have made it more 
difficult to accommodate new or modified use by the primary AMT 
licensees that can affect the ability for MBAN users to operate without 
causing interference.
    78. Permitting operation in the 2360-2400 MHz band will enable MBAN 
manufacturers to easily adapt the wide variety of equipment that is 
already produced for operation in the adjacent 2.4 GHz band, thus 
reducing MBAN equipment costs. Alternative higher spectrum bands would 
require increased power to provide adequate coverage, which would 
result in shorter battery life. This, along with the lack of readily 
available chipsets, indicates that adopting the other allocation 
options considered in the proceeding would likely have resulted in 
higher costs for MBAN users.
    79. The Commission adopted various provisions regarding equipment 
certification, authorized locations, station identification, station 
inspection, disclosure policy, labeling requirements and marketing 
limitations that mirror the existing MedRadio rules. Taken as a whole, 
these requirements will ensure that (1) MBAN operations comply with our 
technical rules, (2) MBAN users are aware of pertinent interference 
requirements, and (3) equipment manufacturers market and sell MBAN 
devices only for the types of communications permitted under the 
Commission's rules. Utilizing our existing regulatory framework, which 
is familiar to both health care providers and medical device 
manufacturers, enables us to authorize MBAN devices without 
implementing new rule subparts or codifying a significantly more 
complex system management scheme into our existing rules. Thus, we are 
able to provide for MBAN deployment in a manner that protects incumbent 
users without passing any undue costs or regulatory burdens onto 
prospective MBAN users, many of whom may be small entities.

Report to Congress

    80. The Commission will send a copy of the Report and Order, 
including this FRFA, in a report to Congress pursuant to the 
Congressional Review Act.\26\ In addition, the Commission will send a 
copy of the Report and Order, including this FRFA, to the Chief Counsel 
for Advocacy of the SBA. A copy of the Report and Order and the FRFA 
(or summaries thereof) will also be published in the Federal Register.
---------------------------------------------------------------------------

    \26\ See 5 U.S.C. 801(a)(1)(A).
---------------------------------------------------------------------------

    81. Pursuant to the authority contained in Sections 4(i), 301, 302, 
303(e), 303(f), 303(r), and 307(e) of the Communications Act of 1934, 
as amended, 47 U.S.C. Sections 154(i), 301, 302, 303(e), 303(f), 
303(r), and 307(e), this Report and Order IS ADOPTED and parts 2 and 95 
of the Commission's rules are amended as set forth in Final rules will 
become October 11, 2012, except for Sec. Sec.  95.1215(c), 
95.1217(a)(3), 95.1223 and 95.1225, which contain information 
collection requirements subject to the Paperwork Reduction Act of 1995, 
Public Law 104-13, that are not effective until approved by the Office 
of Management and Budget. The Federal Communications Commission will 
publish a document in the Federal Register announcing OMB approval and 
the effective date of these rules.
    82. The Commission's Consumer and Governmental Affairs Bureau, 
Reference Information Center, shall send a copy of this Report and 
Order, including the Final Regulatory Flexibility Analysis in Appendix 
C, to the Chief Counsel for Advocacy of the Small Business 
Administration.
    83. The Commission will send a copy of this Report & Order and 
Further Notice of Proposed Rulemaking to Congress and the Government 
Accountability Office pursuant to the Congressional Review Act, see 5 
U.S.C. 801(a)(1)(A).

List of Subjects

47 CFR Part 2

    Communications equipment, Reporting and recordkeeping.

47 CFR Part 95

    Communications equipment, Incorporation by reference, Medical 
devices, Reporting and recordkeeping.

Federal Communications Commission.
Marlene H. Dortch,
Secretary.

Final Rules

    For the reasons discussed in the preamble, the Federal 
Communications Commission amends 47 CFR parts 2 and 95 as follows:

PART 2--FREQUENCY ALLOCATIONS AND RADIO TREATY MATTERS; GENERAL 
RULES AND REGULATIONS

0
1. The authority citation for part 2 continues to read as follows:

    Authority: 47 U.S.C. 154, 302a, 303, and 336, unless otherwise 
noted.


0
2. Section 2.106, the Table of Frequency Allocations, is amended as 
follows:
0
a. Pages 37 and 38 are revised.
0
b. In the list of United States (US) Footnotes, footnote US101 is 
added.
    The revisions and addition read as follows:


Sec.  2.106  Table of Frequency Allocations.

* * * * *
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[[Page 55730]]

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[[Page 55731]]


[GRAPHIC] [TIFF OMITTED] TR11SE12.017


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United States (US) Footnotes

* * * * *
    US101 The band 2360-2400 MHz is also allocated on a secondary basis 
to the mobile, except aeronautical mobile, service. The use of this 
allocation is limited to MedRadio operations. MedRadio stations are 
authorized by rule and operate in accordance with 47 CFR part 95.
* * * * *

PART 95--PERSONAL RADIO SERVICES

0
3. The authority citation for part 95 continues to read as follows:

    Authority: Secs. 4, 303, 48 Stat, 1066, 1082, as amended; 47 
U.S.C. 154, 303.

Subpart E--Technical Regulations

0
4. Section 95.628 is revised to read as follows:


Sec.  95.628  MedRadio transmitters in the 413-419 MHz, 426-432 MHz, 
438-444 MHz, and 451-457 MHz and 2360-2400 MHz bands.

    The following provisions apply to MedRadio transmitters operating 
in the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz bands as 
part of a Medical Micropower Network (MMN) and in the 2360-2400 MHz 
band as part of a Medical Body Area Network (MBAN).
    (a) Operating frequencies. A MedRadio station authorized under this 
part must have out-of-band emissions that are attenuated in accordance 
with Sec.  95.635.
    (1) Only MedRadio stations that are part of an MMN may operate in 
the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz frequency 
bands. Each MedRadio station that is part of an MMN must be capable of 
operating in each of the following frequency bands: 413-419 MHz, 426-
432 MHz, 438-444 MHz, and 451-457 MHz. All MedRadio stations that are 
part of a single MMN must operate in the same frequency band.
    (2) Only MedRadio stations that are part of an MBAN may operate in 
the 2360-2400 MHz frequency band.
    (b) Requirements for a Medical Micropower Network. (1) Frequency 
monitoring. MedRadio programmer/control transmitters must incorporate a 
mechanism for monitoring the authorized bandwidth of the frequency band 
that the MedRadio transmitters intend to occupy. The monitoring system 
antenna shall be the antenna used by the programmer/control transmitter 
for a communications session.
    (i) The MedRadio programmer/control transmitter shall be capable of 
monitoring any occupied frequency band at least once every second and 
monitoring alternate frequency bands within two seconds prior to 
executing a change to an alternate frequency band.
    (ii) The MedRadio programmer/control transmitter shall move to 
another frequency band within one second of detecting a persistent 
(i.e., lasting more than 50 milliseconds in duration) signal level 
greater than -60 dBm as received by a 0 dBi gain antenna in any 12.5 
kHz bandwidth within the authorized bandwidth.
    (iii) The MedRadio programmer/control transmitter shall be capable 
of monitoring the authorized bandwidth of the occupied frequency band 
to determine whether either direction of the communications link is 
becoming degraded to the extent that communications is likely to be 
lost for more than 45 milliseconds. Upon making such a determination 
the MedRadio programmer/control transmitter shall move to another 
frequency band.
    (2) MedRadio transmitters. MedRadio transmitters shall incorporate 
a programmable means to implement a system shutdown process in the 
event of communication failure, on command from the MedRadio 
programmer/control transmitter, or when no frequency band is available. 
The shutdown process shall commence within 45 milliseconds after loss 
of the communication link or receipt of the shutdown command from the 
MedRadio programmer/control transmitter.
    (3) MedRadio programmer/control transmitters. MedRadio programmer/
control transmitters shall have the ability to operate in the presence 
of other primary and secondary users in the 413-419 MHz, 426-432 MHz, 
438-444 MHz, and 451-457 MHz bands.
    (4) Authorized bandwidth. The 20 dB authorized bandwidth of the 
emission from a MedRadio station operating in the 413-419 MHz, 426-432 
MHz, 438-444 MHz, and 451-457 MHz bands shall not exceed 6 MHz.
    (c) Requirements for Medical Body Area Networks. A MedRadio 
programmer/control transmitter shall not commence operating and shall 
automatically cease operating in the 2360-2390 MHz band if it does not 
receive, in accordance with the protocols specified by the 
manufacturer, a control message permitting such operation Additionally, 
a MedRadio programmer/control transmitter operating in the 2360-2390 
MHz band shall comply with a control message that notifies the device 
to limit its transmissions to segments of the 2360-2390 MHz band or to 
cease operation in the band.
    (d) Frequency stability. Each transmitter in the MedRadio service 
must 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 medical implant 
transmitters; and
    (2) 0 [deg]C to 55 [deg]C in the case of MedRadio programmer/
control transmitters and Medical body-worn transmitters.
    (e) Shared access. The provisions of this section shall not be used 
to extend the range of spectrum occupied over space or time for the 
purpose of denying fair access to spectrum for other MedRadio systems.
    (f) Measurement procedures. (1) MedRadio transmitters shall be 
tested for frequency stability, radiated emissions and EIRP limit 
compliance in accordance with paragraphs (f)(2) and (3) of this 
section.
    (2) Frequency stability testing shall be performed over the 
temperature range set forth in (d) of this section.
    (3) Radiated emissions and EIRP limit measurements may be 
determined by measuring the radiated field from the equipment under 
test at 3 meters and calculating the EIRP. The equivalent radiated 
field strength at 3 meters for 1 milliwatt, 25 microwatts, 250 
nanowatts, and 100 nanowatts EIRP is 115.1, 18.2, 1.8, or 1.2 mV/meter, 
respectively, when measured on an open area test site; or 57.55, 9.1, 
0.9, or 0.6 mV/meter, respectively, when measured on a test site 
equivalent to free space such as a fully anechoic test chamber. 
Compliance with the maximum transmitter power requirements set forth in 
Sec.  95.639(f) shall be based on measurements using a peak detector 
function and measured over an interval of time when transmission is 
continuous and at its maximum power level. In lieu of using a peak 
detector function, measurement procedures that have been found to be 
acceptable to the Commission in accordance with Sec.  2.947 of this 
chapter may be used to demonstrate compliance. For a transmitter 
intended to be implanted in a human body, radiated emissions and EIRP 
measurements for transmissions by stations authorized under this 
section may be made in accordance with a Commission-approved human body 
simulator and test technique. A formula for a suitable tissue 
substitute material is defined in OET Bulletin 65 Supplement C (01-01).

[[Page 55733]]


0
5. Section 95.633 is amended by revising paragraph (e)(1) to read as 
follows:


Sec.  95.633  Emission bandwidth.

* * * * *
    (e) * * *
    (1) For stations operating in 402-405 MHz, the maximum authorized 
emission bandwidth is 300 kHz. For stations operating in 401-401.85 MHz 
or 405-406 MHz, the maximum authorized emission bandwidth is 100 kHz. 
For stations operating in 401.85-402 MHz, the maximum authorized 
emission bandwidth is 150 kHz. For stations operating in 413-419 MHz, 
426-432 MHz, 438-444 MHz, or 451-457 MHz, the maximum authorized 
emission bandwidth is 6 megahertz. For stations operating in 2360-2400 
MHz, the maximum authorized emission bandwidth is 5 megahertz.
* * * * *

0
6. Section 95.635 is amended by adding paragraph (d)(1)(v); 
redesignating paragraph (d)(7) as paragraph (d)(8) and adding a new 
paragraph (d)(7) to read as follows:


Sec.  95.635  Unwanted radiation.

* * * * *
    (d) * * *
    (1) * * *
    (v) Are more than 2.5 MHz outside of the 2360-2400 MHz band (for 
devices designed to operate in the 2360-2400 MHz band).
* * * * *
    (7) For devices designed to operate in the 2360-2400 MHz band: In 
the first 2.5 megahertz beyond any of the frequency bands authorized 
for MBAN operation, the EIRP level associated with any unwanted 
emission must be attenuated within a 1 megahertz bandwidth by at least 
20 dB relative to the maximum EIRP level within any 1 megahertz of the 
fundamental emission.
* * * * *

0
7. Section 95.639 is amended by redesignating (f)(3) as paragraph 
(f)(5) and adding new paragraphs (f)(3) and (4) to read as follows:


Sec.  95.639  Maximum transmitter power.

* * * * *
    (f) * * *
    (3) For transmitters operating in the 2360-2390 MHz band, the 
maximum EIRP over the frequency bands of operation shall not exceed the 
lesser of 1 mW or 10*log (B) dBm, where B is the 20 dB emission 
bandwidth in MHz.
    (4) For transmitters operating in the 2390-2400 MHz band, the 
maximum EIRP over the frequency bands of operation shall not exceed the 
lesser of 20 mW or 16+10*log (B) dBm, where B is the 20 dB emission 
bandwidth in MHz.
* * * * *

0
8. Appendix 1 is amended by adding a definition for ``Medical Body Area 
Network'' to the definitions list in alphabetical order:

Appendix 1 to Subpart E of Part 95--Glossary of Terms

* * * * *
    Medical Body Area Network (MBAN). An MBAN is a low power network 
consisting of a MedRadio programmer/control transmitter and multiple 
medical body-worn devices all of which transmit or receive non-voice 
data or related device control commands for the purpose of measuring 
and recording physiological parameters and other patient information 
or performing diagnostic or therapeutic functions via radiated bi- 
or uni-directional electromagnetic signals.
* * * * *

Subpart I--Medical Device Radiocommunications Service (MedRadio)

0
9. Section 95.1203 is revised to read as follows:


Sec.  95.1203  Authorized locations.

    MedRadio operation is authorized anywhere CB station operation is 
authorized under Sec.  95.405, except that use of Medical Body Area 
Network devices in the 2360-2390 MHz band is restricted to indoor 
operation within a health care facility registered with the MBAN 
coordinator under Sec.  95.1225. A health care facility includes 
hospitals and other establishments that offer services, facilities and 
beds for use beyond a 24 hour period in rendering medical treatment, 
and institutions and organizations regularly engaged in providing 
medical services through clinics, public health facilities, and similar 
establishments, including government entities and agencies such as 
Veterans Administration hospitals.

0
10. Section 95.1209 is amended by redesignating paragraph (g) as 
paragraph (h) and adding a new paragraph (g) to read as follows:


Sec.  95.1209  Permissible communications.

* * * * *
    (g) Medical body-worn transmitters may only relay information in 
the 2360-2400 MHz band to a MedRadio programmer/control transmitter 
that is part of the same Medical Body Area Network (MBAN). A MedRadio 
programmer/control transmitter may not be used to relay information in 
the 2360-2400 MHz band to another MedRadio programmer/controller 
transmitter. Wireless retransmission of information to a receiver that 
is not part of the same MBAN shall be performed using other radio 
services that operate in spectrum outside of the 2360-2400 MHz band.
* * * * *

0
11. Section 95.1211 is amended by revising paragraph (c) to read as 
follows:


Sec.  95.1211  Channel use policy.

* * * * *
    (c) MedRadio operation is subject to the condition that no harmful 
interference is caused to stations operating in the 400.150-406.000 MHz 
band in the Meteorological Aids, Meteorological Satellite, or Earth 
Exploration Satellite Services, or to other authorized stations 
operating in the 413-419 MHz, 426-432 MHz, 438-444 MHz, 451-457, and 
2360-2400 MHz bands. MedRadio stations must accept any interference 
from stations operating in the 400.150-406.000 MHz band in the 
Meteorological Aids, Meteorological Satellite, or Earth Exploration 
Satellite Services, and from other authorized stations operating in the 
413-419 MHz, 426-432 MHz, 438-444 MHz, 451-457, and 2360-2400 MHz 
bands.

0
12. Section 95.1213 is revised to read as follows:


Sec.  95.1213  Antennas.

    Except for the 2390-2400 MHz band, no antenna for a MedRadio 
transmitter shall be configured for permanent outdoor use. In addition, 
any MedRadio antenna used outdoors shall not be affixed to any 
structure for which the height to the tip of the antenna will exceed 
three (3) meters (9.8 feet) above ground.

0
13. Section 95.1215 is amended by adding paragraph (c) to read as 
follows:


Sec.  95.1215  Disclosure policies.

* * * * *
    (c) Manufacturers of MedRadio transmitters operating in the 2360-
2400 MHz band must include with each transmitting device the following 
statement:

    ``This transmitter is authorized by rule under the MedRadio 
Service (47 CFR part 95). 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

[[Page 55734]]

transmission from this transmitter will be free from interference.''


0
14. Section 95.1217 is amended by adding paragraph (a)(3) and revising 
paragraph (c) to read as follows:


Sec.  95.1217  Labeling requirements.

* * * * *
    (a) * * *
    (3) MedRadio programmer/control transmitters operating in the 2360-
2400 MHz band shall be labeled as provided in part 2 of this chapter 
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 in the 2360-2400 MHz band, and must 
accept any interference received, including interference that may 
cause undesired operation.''


The statement may be placed in the instruction manual for the 
transmitter where it is not feasible to place the statement on the 
device.
* * * * *
    (c) MedRadio transmitters shall be identified with a serial number, 
except that in the 2360-2400 MHz band only the MedRadio programmer/
controller transmitter shall be identified with a serial number. The 
FCC ID number associated with a medical implant transmitter and the 
information required by Sec.  2.925 of this chapter may be placed in 
the instruction manual for the transmitter and on the shipping 
container for the transmitter, in lieu of being placed directly on the 
transmitter.

0
15. Section 95.1223 is added to read as follows:


Sec.  95.1223  Registration and frequency coordination in the 2360-2390 
MHz Band.

    (a) Registration. A health care facility must register all MBAN 
devices it proposes to operate in the 2360-2390 MHz band with a 
frequency coordinator designated under Sec.  95.1225 of this chapter. 
Operation of these devices in the 2360-2390 MHz band is prohibited 
prior to the MBAN coordinator notifying the health care facility that 
registration and coordination (to the extent coordination is required 
under paragraph (c) of this section), is complete. The registration 
must include the following information:
    (1) Specific frequencies or frequency range(s) within the 2360-2390 
MHz band to be used, and the capabilities of the MBAN equipment to use 
the 2390-2400 MHz band;
    (2) Effective isotropic radiated power;
    (3) Number of control transmitters in use at the health care 
facility as of the date of registration including manufacturer name(s) 
and model numbers and FCC identification number;
    (4) Legal name of the health care facility;
    (5) Location of control transmitters (e.g., geographic coordinates, 
street address, building);
    (6) Point of contact for the health care facility (e.g., name, 
title, office, phone number, fax number, email address); and
    (7) In the event an MBAN has to cease operating in all or a portion 
of the 2360-2390 MHz band due to interference under Sec.  95.1211 or 
changes in coordination under paragraph (c) of this section, a point of 
contact (including contractors) for the health care facility that is 
responsible for ensuring that this change is effected whenever it is 
required (e.g., name, title, office, phone number, fax number, email 
address). The health care facility also must state whether, in such 
cases, its MBAN operation is capable of defaulting to the 2390-2400 MHz 
band and that it is responsible for ceasing MBAN operations in the 
2360-2390 MHz band or defaulting traffic to other hospital systems.
    (b) Notification. A health care facility shall notify the frequency 
coordinator whenever an MBAN control transmitter in the 2360-2390 MHz 
band is permanently taken out of service, unless it is replaced with 
transmitter(s) using the same technical characteristics as those 
reported on the health care facility's registration. A health care 
facility shall keep the information contained in each registration 
current, shall notify the frequency coordinator of any material change 
to the MBAN's location or operating parameters, and is prohibited from 
operating the MBAN in the 2360-2390 MHz band under changed operating 
parameters until the frequency coordinator determines whether such 
changes require coordination with the AMT coordinator designated under 
Sec.  87.305 of this chapter and, if so, the coordination required 
under paragraph (c) of this section has been completed.
    (c) Coordination procedures. The frequency coordinator will 
determine if an MBAN is within the line of sight of an AMT receive 
facility in the 2360-2390 MHz band and notify the health care facility 
when it may begin MBAN operations under the applicable procedures in 
(c)(1) or (2) of this section.
    (1) If the MBAN is beyond the line of sight of an AMT receive 
facility, it may operate without prior coordination with the AMT 
coordinator, provided that the MBAN coordinator provides the AMT 
coordinator with the MBAN registration information and the AMT 
coordinator concurs that the MBAN is beyond the line of sight prior to 
the MBAN beginning operations in the band.
    (2) If the MBAN is within line of sight of an AMT receive facility, 
the MBAN frequency coordinator shall achieve a mutually satisfactory 
coordination agreement with the AMT frequency coordinator prior to the 
MBAN beginning operations in the band. Such coordination agreement 
shall provide protection to AMT receive stations consistent with 
International Telecommunication Union (ITU) Recommendation ITU-R 
M.1459, ``Protection criteria for telemetry systems in the aeronautical 
mobile service and mitigation techniques to facilitate sharing with 
geostationary broadcasting-satellite and mobile-satellite services in 
the frequency bands 1 452-1 525 and 2 310-2 360 MHz,'' May 2000, as 
adjusted using generally accepted engineering practices and standards 
that are mutually agreeable to both coordinators to take into account 
the local conditions and operating characteristics of the applicable 
AMT and MBAN facilities, and shall specify when the device shall limit 
its transmissions to segments of the 2360-2390 MHz band or shall cease 
operation in the band. This ITU document is incorporated by reference 
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 and approved by 
the Director of Federal Register. Copies of the recommendation may be 
obtained from ITU, Place des Nations, 1211 Geneva 20, Switzerland, or 
online at https://www.itu.int/en/publications/Pages/default.aspx. You 
may inspect a copy at the Federal Communications Commission, 445 12th 
Street, SW., Washington, DC 20554, or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: https://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. ``Generally accepted engineering practices and 
standards'' include, but are not limited to, engineering analyses and 
measurement data as well as limiting MBAN operations in the band by 
time or frequency.
    (3) If an AMT operator plans to operate a receive site not 
previously analyzed by the MBAN coordinator to determine line of sight 
to an MBAN facility, the AMT operator shall consider using locations 
that are beyond the line of sight of a registered health care facility. 
If the AMT operator determines that non-line of sight locations are not 
practical for its

[[Page 55735]]

purposes, the AMT coordinator shall notify the MBAN coordinator upon no 
less than 7 days' notice that the registered health care facility must 
cease MBAN operations in the 2360-2390 MHz band unless the parties can 
achieve a mutually satisfactory coordination agreement under paragraph 
(c)(2) of this section.

0
16. Section 95.1225 is added to read as follows:


Sec.  95.1225  Frequency coordinator.

    (a) The Commission will designate a frequency coordinator(s) to 
manage the operation of medical body area networks in the 2360 MHz -
2390 MHz band.
    (b) The frequency coordinator shall perform the following 
functions:
    (1) Register health care facilities that operate an MBAN in the 
2360-2390 MHz band, maintain a database of these MBAN transmitter 
locations and operational parameters, and provide the Commission with 
information contained in the database upon request;
    (2) Determine if an MBAN is within line of sight of an AMT receive 
facility in the 2360-2390 MHz band and coordinate MBAN operations with 
the designated AMT coordinator as specified in Sec.  87.305 of this 
chapter;
    (3) Notify a registered health care facility when an MBAN has to 
change frequency within the 2360-2390 MHz band or to cease operating in 
the band consistent with a coordination agreement between the MBAN and 
the AMT coordinators;
    (4) Develop procedures to ensure that registered health care 
facilities operate an MBAN consistent with the coordination 
requirements under Sec.  95.1223; and
    (5) Identify the MBAN that is the source of interference in 
response to a complaint from the AMT coordinator and notify the health 
care facility of alternative frequencies available for MBAN use or to 
cease operation consistent with the rules.
[FR Doc. 2012-21984 Filed 9-10-12; 8:45 am]
BILLING CODE 6712-01-P