Medical Body Area Network, 60092-60100 [2014-23519]
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60092
Federal Register / Vol. 79, No. 193 / Monday, October 6, 2014 / Rules and Regulations
Commission amends 47 CFR part 73 as
follows:
PART 73—RADIO BROADCAST
SERVICES
1. The authority citation for part 73
continues to read as follows:
■
Authority: 47 U.S.C. 154, 303, 334, 336.
§ 73.202
[Amended]
2. Section 73.202(b), the Table of FM
Allotments under Mississippi, is
amended by adding Bruce, Channel
233A.
■
[FR Doc. 2014–23779 Filed 10–3–14; 8:45 am]
BILLING CODE 6712–01–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 95
[ET Docket No. 08–59; FCC 14–124]
Medical Body Area Network
Federal Communications
Commission.
ACTION: Final rule.
AGENCY:
This document addresses an
Order on Reconsideration and Second
Report and Order in which the
Commission takes further actions to
foster the development and deployment
of new and innovative Medical Body
Area Network (MBAN) devices. In
addressing petitions for reconsideration
of the First Report and Order in this
proceeding, the Commission provides
MBAN users with additional flexibility
to enable the implementation of
technical standards being developed for
MBAN devices, and clarify and modify
portions of its rules to facilitate the
coordination, deployment, and use of
MBAN systems. In the Second Report
and Order portion in this proceeding,
the Commission finalizes the process for
selecting a MBAN Coordinator. This
coordinator will facilitate use of the
MBAN frequencies, which operate in
shared-use bands. Collectively, our
actions will allow the development of
new and innovative health care
applications.
SUMMARY:
Effective November 5, 2014,
except for § 95.1225(c), which contains
information collection requirements that
have not been approved by the Office of
Management and Budget (OMB). The
Commission will publish a document in
the Federal Register announcing the
effective date of § 95.1225(c).
FOR FURTHER INFORMATION CONTACT:
Jamison Prime, (202) 418–7474,
Jamison.Prime@fcc.gov or Brian Butler
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DATES:
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(202) 418–2702, Brian.Butler@fcc.gov,
Office of Engineering and Technology.
SUPPLEMENTARY INFORMATION: This is a
summary of the Commission’s Order on
Reconsideration and Second Report and
Order, ET Docket No. 08–59, FCC 14–
124, adopted August 20, 2014 and
released August 21, 2014. 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 fcc504@
fcc.gov or call the Consumer &
Governmental Affairs Bureau at 202–
418–0530 (voice), 202–418–0432 (tty).
Summary of Order on Reconsideration
1. In the Order on Reconsideration
and Second Report and Order, the
Commission took further actions to
foster the development and deployment
of new and innovative Medical Body
Area Network (MBAN) devices. MBAN
technology provides a platform for the
wireless networking of multiple bodyworn sensors used for measuring and
recording physiological parameters and
other patient information or for
performing diagnostic or therapeutic
functions, primarily in health care
facilities. By addressing petitions for
reconsideration of the First Report and
Order in this proceeding, we provided
MBAN users with additional flexibility
to enable the implementation of
technical standards being developed for
MBAN devices, and clarified and
modified portions of our rules to
facilitate the coordination, deployment,
and use of MBAN systems.
Authorized Locations
2. Health Care Facilities. The
Commission revised § 95.1203 of its
rules to limit use of the 2360–2390 MHz
band to hospitals and other
establishments that offer services,
facilities and beds for use beyond a 24hour period in rendering medical
treatment. It eliminated a portion of the
definition that included 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.
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By limiting the types (and, thus, the
numbers) of medical institutions in the
2360–2390 MHz band, the Commission
intended to make it easier for both the
MBAN and AMT coordinators to
establish, implement and enforce
efficient and effective coordination
procedures. Further, it found that
limiting potential locations would
simplify their efforts to identify and
remedy any harmful interference in the
extremely unlikely event it occurs.
3. Although GE Healthcare, Phillips
Healthcare, and the Aerospace and
Flight Test Radio Coordinating Council
(AFTRCC) (the’’ Joint Parties’’) had
suggested this approach as part of their
comprehensive set of proposed rules,
they had not discussed the rationale for
this limitation until the filing of their
Petition for Reconsideration. Because
the Petition for Reconsideration stated
with particularity the reasons why the
Commission should adopt their
proposed authorized locations
definition, it found that the public
interest would be it served by taking the
Joint Parties’ facts and arguments into
consideration.
4. As part of this decision, the
Commission determined that, because
the existing MBAN standard will
support numerous patients in the 2390–
2400 MHz band, and because frequency
reuse techniques can augment that
capacity in many situations, no health
care facilities—including those that do
not qualify for use of the 2360–2390
MHz band—will be precluded from
operating MBAN systems. For this
reason, the Commission disagreed with
SmartEdgeNet that health care providers
will be ‘‘denied the benefits of MBAN’’
if the Commission limited the
authorized locations as requested.
5. Antenna Locations. In their Petition
for Reconsideration, the Joint Parties
claimed that § 95.1213, titled
‘‘Antennas,’’ appeared to exclude the
installation of outdoor antennas for the
2390–2400 MHz band at locations above
a building’s first floor, such as balconies
and roof terraces, and that this was not
the intent of the rule. Upon
reconsideration, the Commission agreed
and expressly found that it was not
necessary to apply antenna height
restrictions—which were originally
intended as a constraint on temporary
outdoor use of MedRadio antennas
regardless of the band in which the
transmitter operated—to antennas used
for MedRadio transmitters operating in
the 2390–2400 MHz band.
6. The Commission concluded that,
based on the permissible outdoor use in
this band and the relatively low power
operations of MBAN transmitters
(which effectively limits any gain in
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coverage that is often associated with
increased antenna height), there is no
need to prescribe a specific antenna
height limit (for either permanent or
temporary outdoor antennas used for
this band) and revised § 95.1213 as set
forth in the rules.
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MBAN Definition and Permissible
Communications
7. MBAN Configurations with a Single
Body-Worn Device. The Commission
amended Appendix 1 to subpart E of
part 95 (‘‘Glossary of Terms’’) to define
an MBAN as a low power network
consisting of a MedRadio programmer/
control transmitter and one or more
medical body-worn devices. The
Commission found the argument of the
Joint Parties that the pairing of a
programmer/control transmitter with a
single body-worn device ‘‘will likely be
common’’ was plausible, concluding
that there could be times where best
treatment practices could require the
use of only a single body-worn device.
8. Use of Bedside Devices. Under the
Commission’s rules as adopted in the
First Report and Order, a medical bodyworn device is defined as an apparatus
that is placed on or in close proximity
to the human body (e.g., within a few
centimeters) for the purpose of
performing diagnostic or therapeutic
functions. The Commission clarified
that bedside devices, which would
require a physical attachment to the
patient (e.g. by wire or tube), would
meet the definition even though there
are other parts of the apparatus that are
located away from the body. The
Commission further clarified that the
‘‘few centimeters’’ language in the rule
should be read as a general example and
not the codification of a specific
distance requirement. Based on this
clarification, the Commission did not
grant the Joint Parties request to modify
the rule to remove the ‘‘few
centimeters’’ language.
9. Allowing Greater Flexibility in
Designing MBAN Systems. Together
§ 95.1209(g) (‘‘Permissible
Communications’’) and the MBAN
definition contained in Appendix 1,
subpart E of the part 95 Rules (‘‘Glossary
of Terms’’) established the MedRadio
programmer/control transmitter and the
medical body-worn device as distinct
elements that must be present in every
MBAN; allow body-worn transmitters to
relay information in the 2360–2400
MHz band only to a programmer/control
transmitter that is part of the same
MBAN; and prohibit a programmer/
control transmitter from using the 2360–
2400 MHz band to relay information to
another programmer/control transmitter.
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10. The Commission modified
existing rule § 95.1209(g) to provide an
exception to permit communications
between programmer/control
transmitters of different MBAN systems
for the sole purpose of avoiding
interference to each other, based on the
text of the existing MedRadio rules for
Medical Micropower Networks. It
recognized that allowing MBAN systems
in the 2360–2390 MHz band (as well as
the 2390–2400 MHz band) to coordinate
use among themselves of the available
MBAN frequencies could promote
efficient spectrum use. The Commission
emphasized that it considered the
modified requirement to be a limited
exception to the general rule and, in
agreement with the Joint Parties, noted
that programmer/control transmitters
would continue to be barred from
relaying the control message to each
other. It retained the prohibition on
programmer/control transmitters
relaying other information (such as
medical data) to each other.
11. The Commission amended
§ 95.1209 of the rules to eliminate the
language that precludes body-worn
devices from communicating with other
body-worn devices in the 2360–2400
MHz band. It recognized that doing so
could potentially enhance patient
welfare by preserving battery life and
enhancing signal strength in situations
that may adversely affect the reception
of data. Further, the Commission noted
that the adoption of industry standards,
it may have made it both feasible and
practical to produce such equipment.
12. Additionally, the Joint Parties
asked that the Commission allow either
a programmer/control transmitter or a
body-worn device to perform as a
‘‘coordinator node’’ in an MBAN
system. According to the Joint Parties,
coordinator node is the ‘‘. . . term used
in IEEE 802.15.6 for the node
responsible for coordinating the MAC
function (e.g., assigning TDMA slots to
other nodes) and being the main routing
hub for communication with all other
nodes in the MBAN star topology.’’ As
an example, the Joint Parties described
a scenario in which a body-worn device
serves as a coordinator node to transmit
information related to the technical
operation of the network (e.g., what
communication protocols to use) to
other body-worn devices within the
MBAN system and aggregate the patient
data that it receives from other bodyworn devices. Because the Commission
decided to permit a body-worn device
within an MBAN system to
communicate with another body-worn
device, it concluded that the Joint
Parties would be able to design MBAN
systems consistent with their request
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under the existing rules and that no rule
modifications were necessary.
13. 2390–2400 MHz band. The
Commission denied the Joint Parties’
request to eliminate all restrictions on
MBAN systems that operate in the
2390–2400 MHz band. Such a change
would have allowed networks that
consist of multiple programmer/control
transmitters, networks that do not
include any programmer/control
transmitters, and networks in which
different groups of programmer/control
transmitters and body-worn devices
communicate between and among each
other. The Commission disagreed with
the Joint Parties’ assertion that the
rationale for the MBAN system design
requirements in § 95.1209(g) related
exclusively to concerns in the 2360–
2390 MHz band and applying the
restriction to the 2390–2400 MHz band
served no purpose. Instead, it noted that
entities operating in the 2360–2390
MHz band may need to default to the
2390–2400 MHz band and found that it
would be unwise to further complicate
such transitions by allowing the band to
be populated by medical devices
operating under many different system
designs. Nevertheless, the Commission
did note that the First Report and Order
left open the potential to revisit the
permissible use restrictions after gaining
further experience with MBAN
operations and it deemed continuing
this approach to be reasonable and
appropriate to the circumstances.
Device Operation
14. In the First Report and Order, the
Commission adopted transmission
requirements for the component parts of
an MBAN—the programmer/control
transmitters and body-worn devices.
The Commission applied much of the
existing MedRadio rule on ‘‘Permissible
Communications,’’ 47 CFR 95.1209, to
MBAN operation. Among these
requirements, § 95.1209(b), in pertinent
part, addresses the operation of bodyworn devices by stating that no
MedRadio implant or body-worn
transmitter shall transmit except in
response to a transmission from a
MedRadio programmer/control
transmitter or in response to a non-radio
frequency actuation signal generated by
a device external to the body with
respect to which the MedRadio implant
or body-worn transmitter is used.
Additionally, with regard to
programmer/control transmitters,
§ 95.628(c) states that 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
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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.
15. The Joint Parties asserted that
§ 95.1209 as adopted in the First Report
and Order permitted only a polled
media access control (MAC) protocol—
that is, that the only time a body-worn
device can operate is immediately after
the receipt of a transmission from the
programmer/control transmitter. The
Commission found that this assertion
was based upon an overly narrow
reading of the rule and was inconsistent
with the language of the First Report
and Order. It stated that while a polled
access scenario would comply with the
rules, other access modes are
permissible provided that the bodyworn devices operate in response to
whatever instructions are transmitted by
their associated programmer/control
transmitter. The Commission thus
determined that the rules allow
sufficient flexibility to account for the
Joint Parties’ concerns and made no
changes to the rule.
16. The Commission modified
§ 95.628(c) of the rules, as shown below,
to clearly state that body-worn
transmitters must be capable of ceasing
transmissions when necessary to avoid
interference in the 2360–2390 MHz
band. It agreed that it is ‘‘critical that all
MBAN devices . . . cease operation in
2360–2390 MHz in the absence of a
control message,’’ and noted that,
because the rules adopted in the First
Report and Order require a programmer/
control transmitter operating in the
2360–2390 MHz that fails to receive a
control message to cease operation and
allow body-worn transmitters to
transmit only in response to a
transmission from the programmer/
control transmitter, such a requirement
was already implicit.
Coordination and Registration
17. Registration Requirement for the
2390–2400 MHz Band. In the First
Report and Order, the Commission
adopted a registration requirement for
the 2360–2390 MHz band to facilitate
coordination with AMT operations in
that band, but it did not adopt a
registration requirement for the 2390–
2400 MHz band. On reconsideration, the
Commission amended its rules to
require that entities preparing to use the
2390–2400 MHz band with equipment
that is capable of also operating in the
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2360–2390 MHz band and who are
eligible to operate MBAN systems in the
2360–2390 MHz band register the
MBAN system—regardless of whether
they have any current intent to
eventually use the 2360–2390 MHz
band capacity of their equipment. The
Commission agreed with ASHE that
such a requirement will give the
coordinator and health care facilities a
more complete understanding of the
current and potential local spectrum
environment for MBANs and will allow
qualifying health care facilities (and
their equipment vendors and installers)
to better plan their facilities with
respect to appropriate efficient network
architecture and systems planning and
implementation. The Commission
further noted that the modified
registration requirement is more limited
and less burdensome than a more
comprehensive requirement that the
Commission rejected in the First Report
and Order, and concluded that the
benefits of providing the MBAN
coordinator with this important
additional information outweigh the
fairly slight increase in registration costs
for the limited number of MBAN
operators discussed.
18. Registration Requirement for the
2360–2390 MHz Band. In the First
Report and Order, the Commission
required all MBAN devices operating in
the 2360–2390 MHz band to be
registered with a frequency coordinator,
and adopted § 95.1223 addressing
MBAN registration and coordination.
Upon reconsideration, the Commission
agreed with the Joint Parties that the
language in § 95.1223(a) that required
registration of all MBAN devices a
health care facility proposes to operate
in the 2360–2390 MHz band was
broader than necessary. It also noted
that, while the introductory text in
§ 95.1223(a) suggests that all MBAN
devices should be registered, the
registration information specified in
subparts (1) through (7) of the rule does
not address body-worn devices.
Furthermore, subparts (3) and (5)
specifically speak to ‘‘control
transmitter[s]’’ (which we are updating
to read ‘‘MedRadio programmer/control
transmitter’’ to provide clarity and
consistency). Because the existing rule
construction may create confusion in
that it could appear to be inconsistent
or ambiguous, the Commission
amended the introductory text of
§ 95.1223(a) as shown below. Under the
revision, the Commission did not
require that the MBAN user provide the
coordinator with unique identifying
data (e.g., a serial number) for each
programmer/control transmitter. The
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Commission agreed with the Joint
Parties that it will be sufficient to
provide the quantity and type (i.e.
equipment that may have different
technical characteristics) of
programmer/control transmitters at each
MBAN installation. The Commission
accomplished this objective by retaining
the requirement in § 95.1223(a)(3) that
programmer/control transmitter
information include the manufacturer
name, model number and FCC
identification number. The practical
effect of the revised rules is that health
care facilities will be able to account for
large groups of devices under a single
filing.
19. Finally, the Commission clarified
that replacement of programmer/control
transmitters having the same technical
characteristics as those reported on the
health care facility’s registration (i.e.,
the manufacturer name, model number
and FCC identification number) will not
trigger additional notification
requirements under § 95.1223(b) of the
rules.
20. Interaction between MBAN and
AMT Coordinators. Under
§ 95.1225(b)(2) of the Commission’s
rules, the MBAN Coordinator is
required to 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.
Additionally, the MBAN coordinator
must approve any changes made to an
authorized MBAN installation before
operation could begin with the altered
parameters. Accordingly, § 95.1223(b)
states, in pertinent part, that a health
care facility must notify the MBAN
coordinator of any material change to
the MBAN’s location or operating
parameters, and that it may not operate
under changed operating parameters
until the frequency coordinator
determines whether such changes
require coordination with the AMT
coordinator. The Joint Parties had
suggested edits to the coordinator duties
listed in § 95.1225 of the rules. The
Commission concluded that the Joint
Parties’ proposed edits to § 95.1225(b)
were already addressed in § 95.1223(c)
and concluded that it would be
unnecessarily repetitive to make the
requested edits.
21. The Commission determined that
it would be beneficial to further clarify
the procedures for how the AMT
coordinator is consulted before an
MBAN location or operation is changed.
Specifically, the Commission found the
need to provide clarification as to
whether coordination with or
notification to the AMT coordinator
would be required if the modified
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MBAN facility would operate beyond
line-of-sight of an AMT receive facility.
It determined that the best course in
such cases is to apply the existing
procedures outlined in § 95.1223(c)(1),
which requires the MBAN coordinator
to approve operation without prior
coordination with the AMT coordinator,
but also requires the MBAN coordinator
to notify the AMT coordinator and
provide the AMT coordinator with the
opportunity to concur that the MBAN
facility is beyond line of sight.
Accordingly, the Commission revised
§ 95.1223(b) of the rules to state that the
MBAN coordinator must evaluate the
proposed changes and comply with
either (c)(1) or (c)(2), as appropriate,
prior to authorizing a modified MBAN
operation. Such a change satisfies the
Joint Parties’ request that the
Commission clarify the advance
consultation requirement for the AMT
coordinator, and does so in a way that
complements our existing rules for
coordinating MBAN operations.
22. Notification of Interference. The
Commission did not adopt a request by
the Joint Parties to amend § 95.1223(a)
of the rules to include a specific
requirement that, if a health care facility
or the MBAN coordinator is notified of
MBAN interference to an AMT receive
antenna, the MBAN user must cease
transmissions on the frequencies
causing interference. The Commission
pointed out that § 95.1211(c) of the rules
plainly states that MBAN devices may
not cause harmful interference to
authorized stations operating in the
2360–2400 MHz band which places the
onus of avoiding such interference
squarely on the operator of these
devices. Accordingly, it is the MBAN
user’s responsibility to respond to
interference complaints, and to be
prepared to cease operation as necessary
to avoid causing harmful interference.
The Commission also emphasized that
failure to abide by this rule will subject
an MBAN user to appropriate
Commission enforcement action. The
existing rules give the MBAN
coordinator the responsibility to
identify the MBAN that is the source of
interference and the authority to notify
the registered health care facility to
cease operation as may be appropriate to
the circumstances. Moreover, any health
care facility planning to operate MBAN
devices in the 2360–2390 MHz band
will have provided to the MBAN
coordinator, pursuant to the rules, a
point of contact in the event the MBAN
user is directed to cease operation.
Thus, the Commission concluded that,
together, the rule defining the MBAN
user responsibilities and the rule
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describing the functions of the 2360–
2390 MHz band MBAN coordinator
should provide for the prompt
identification and resolution of any
harmful interference caused by an
MBAN to AMT operations.
23. Testing of Installed MBAN
Equipment. The Joint Parties and ASHE
requested the Commission to require
hospitals or equipment vendors to
certify to the MBAN coordinator that
testing of the relevant 2360–2390 MHz
MBAN equipment was conducted in
situ and confirmed that the equipment
does not operate outdoors. The
Commission found that its existing rules
and processes are sufficient to address
such concerns. It noted that all MBAN
equipment capable of operating in the
2360–2390 MHz band is certified to be
under the equipment authorization
process to demonstrate compliance with
the indoor operation restrictions and
that, under the existing rules, MBAN
users must acknowledge when
registering with an MBAN coordinator
the need to comply with these
requirements. In this regard, the
Commission noted that it has given
MBAN coordinators broad discretion to
implement coordination procedures to
ensure that MBAN operations are
permitted only when and where they
will not interfere with AMT operations.
Thus, if an MBAN coordinator
determines that the type of testing and
certification the Joint Parties and ASHE
seeks is warranted, it may ask a hospital
or equipment vendor to provide such
information as part of the coordination
process.
Equipment Authorization
24. Attached Antennas and Operation
in the 2360–2390 MHz Band. The
Commission did not adopt the Joint
Parties’ request that § 95.1213 of the
rules, which describes MBAN antenna
placement, be modified ‘‘to clarify that
an antenna must be permanently affixed
to its MBAN transmitter’’ for devices
operating in the 2360–2390 MHz
portion of the band. The Commission
determined that there was little risk that
MBAN users will make post-market
device modifications, noting that it was
not aware of any issues with
unauthorized modification of the
existing base of MedRadio devices, nor
had the Joint Parties provided any
supporting evidence that this is a
common occurrence that would support
additional rules tailored to MBAN
operation in the 2360–2390 MHz band.
It also found that the existing rules
already protect against the potential
harm described by the Joint Parties.
Specifically, § 95.639(f)(5) of the rules
states that the antenna associated with
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any MedRadio transmitter must be
supplied with the transmitter and shall
be considered part of the transmitter
subject to equipment authorization.
25. Equipment Labeling Requirement.
The labeling requirement for MBAN
devices states that MedRadio
programmer/control transmitters
operating in the 2360–2400 MHz band
shall be labeled as provided in part 2 of
the 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.
26. The Commission denied the Joint
Parties’ request that, in the event that
the warning is not included on the
device label, the Commission should
require that the warning be placed on
the front page of the instruction manual
in capital letters. On reconsideration,
the Commission found that the Joint
Parties had not offered any reason for it
to question this analysis the
Commission undertook in the First
Report and Order, or to convince it that
additional steps were needed to ensure
that ‘‘all personnel are fully aware’’ of
the status of MBAN devices.
27. Publication of Equipment
Authorization Requirements. The Joint
Parties asked that the Commission take
steps to ensure that the requirements for
equipment authorization of MBAN
devices be ‘‘clear for all to follow.’’ They
did not propose any specific rule
modifications, but instead submitted a
list of ‘‘expected attestation and
certification requirements for MBAN
equipment. While the Commission
declined to codify the Joint Parties’
specific requirements, it indicated that
it will draw on existing resources (for
example, the OET Laboratory Division’s
Knowledge Database (KDB)) and staff
will continue to be available to ensure
that information regarding authorization
procedures for MBAN equipment is
published in a readily accessible
manner, and that MBAN equipment is
authorized in compliance with
Commission rules.
Second Report And Order
28. The Commission’s rules require
that MBAN operations in the 2360–2390
MHz be registered and coordinated to
ensure that AMT operations in this band
are protected from harmful interference.
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The registration and coordination
functions are to be performed by a
frequency coordinator to be designated
by the Commission. An MBAN
coordinator will be required to maintain
a database of MBAN registrations that
includes the locations of MBAN systems
that operate in the 2360–2390 MHz
band, determine when MBAN
transmitters are within line-of-sight of
AMT receive facilities, coordinate
MBAN operations with the coordinator
for AMT services, notify registered
MBAN users when they must change
frequencies or cease operations
consistent with a coordination
agreement between the MBAN and AMT
coordinator, and develop procedures to
ensure that MBAN users operate
consistent with the coordination
requirements.
29. In the Second Report and Order,
the Commission determined that it will
select only one MBAN coordinator for a
ten-year term. After the ten-year term,
the coordinator will serve until either it
elects not to continue as coordinator or
is removed by the Commission. The
MBAN coordinator may rely on a thirdparty consultant for technical services
necessary to fulfill its responsibilities,
but will be required to disclose
information about the technical
qualifications of the third-party
consultant and the contractual
arrangement it has with the consultant.
The MBAN coordinator will be required
to provide service on a nondiscriminatory basis to all eligible
health care institutions and will be
permitted to charge reasonable fees that
reflect only its actual costs (including
the costs associated with coordination,
such as the AMT coordinator’s cost and
the expense of any third-party technical
consultant). The Wireless
Telecommunications Bureau (Bureau),
acting under delegated authority as
provided in the Commission’s rules,
will select the MBAN coordinator. The
Bureau will execute a Memorandum of
Understanding (MOU) with the selected
coordinator, which will describe the
duties and responsibilities of the
coordinator and provide for removal of
the coordinator if circumstances
warrant. These requirements are
described in further detail in the
following paragraphs.
30. Single Coordinator. The
Commission found it appropriate to
select only one MBAN coordinator at
this time given the characteristics of the
MBAN service. The health care
community represents a small part of
the radiofrequency user ecosystem and
the number of MBAN registrants is
likely to be proportionally small. A
single coordinator will simplify MBAN
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registration for health care institutions
because there will be a single point of
contact and the registration process will
be analogous to the Wireless Medical
Telemetry Service (WMTS) registration
process that is familiar to many entities
in this specialized group, and will make
coordination with AMT coordinator
simpler. The Commission noted that the
authority already delegated to the
Bureau to certify frequency coordinators
for the services it administers allows it
to introduce competitive coordination
into a service with an exclusive
coordinator, and noted that the Bureau
will consider, in the future, whether to
certify one or more additional
coordinators if it determines that such
an action would serve the public
interest.
31. Term of Service. The Commission
required that the MBAN coordinator
agree to serve a ten-year term. After the
initial ten-year term, the MBAN
coordinator will continue to serve until
the coordinator acts to vacate the role or
the Commission acts to remove the
coordinator under the procedures
discussed. The Commission also
adopted the proposal in the Further
Notice to require that the MBAN
coordinator transfer the MBAN
registration data to another entity
designated by the Commission if the
coordinator cannot or chooses not to
continue as coordinator. The
Commission directed the Bureau to
incorporate this requirement into the
MOU that it will execute with the
MBAN coordinator. As part of the MOU,
the Bureau should also address what
notice the MBAN coordinator must give
the Commission to provide adequate
time to select a replacement
coordinator, in the event that the
coordinator intends to vacate the
coordinator role. This notice will have
to provide sufficient time for the Bureau
to select a replacement coordinator, for
the replacement coordinator to establish
a registration and coordination system,
and for the incumbent MBAN
coordinator to transfer the registration
data to the replacement coordinator.
The Commission also recognized that it
is possible that the coordinator would
not continue in its role at some point.
In such a case, these notice and transfer
requirements will be necessary to
ensure an effective transition of
coordinators. The provisions will help
avoid having a period of time during
which there would be no functioning
MBAN registration and coordination
regime or creating a re-registration
burden on MBAN licensees.
32. Because the role of the MBAN
coordinator is essential to prevent
harmful interference to a primary
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service, the Commission indicated that
it is important to allow the MBAN
coordinator to be replaced by the
Commission if necessary. Consistent
with the existing procedures for the
WMTS coordinator, the Commission
delegated to the Bureau the authority to
remove the MBAN coordinator after
giving adequate notice if it determines
that such an action would serve the
public interest. The Bureau can include
specific provisions in the MOU,
including the notice it will give the
coordinator.
33. Qualifying Criteria. In the Further
Notice, the Commission sought
comment on the minimum qualifying
criteria that should be established for
selecting an MBAN coordinator and
proposed that parties interested in being
designated an MBAN coordinator must,
at a minimum, demonstrate that they
meet the following criteria:
• Ability to register and maintain a
database of MBAN transmitter locations
and operational parameters;
• Knowledge of or experience with
medical wireless systems in health care
facilities (e.g., WMTS);
• Knowledge of or experience with
AMT operations;
• Ability to calculate and measure
interference potential between MBAN
and AMT operations and to enter into
mutually satisfactory coordination
agreements with the AMT coordinator
based on the requirements in
§ 95.1223(c);
• Ability to develop procedures to
ensure that registered health care
facilities operate an MBAN consistent
with the requirements in § 95.1223.
34. In the Second Report and Order,
the Commission required applicants
applying to become the MBAN
coordinator to demonstrate that they
meet these five criteria. It determined
that these criteria ‘‘ensure that the
designated coordinator can successfully
accomplish the functions required by
our rules.’’ The Commission declined to
add the additional criteria suggested by
ASHE and Philips/GE to the core
criteria that it adopted, noting that some
of these elements are already addressed
by the five criteria it adopted and
determining that other elements of the
proposed criteria described qualities
that would likely be useful for an
MBAN coordinator to possess but did
not appear essential for performing the
coordination obligations required by the
rules that it adopted, were insufficiently
concrete to warrant certification, or
would be expected to attend compliance
with the criteria it has specified.
35. The Commission also found that
the MBAN coordinator should be able to
rely on a contract with a third party for
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technical expertise, and it will consider
such arrangements as part of a
candidate’s demonstration that it
satisfies the core qualifying criteria. The
Commission recognized that it may be
difficult to identify a single entity that
satisfies all the minimum qualifying
criteria that it has adopted, and stated
that a candidate that lacks expertise in
the core criteria may choose to rely on
a third party for technical support to
demonstrate that it would be able to
provide all of the MBAN registration
and coordination functions with
minimal delay. The Commission noted
that the Bureau may exercise its
authority to terminate the tenure of the
MBAN coordinator if the third-party
technical consultant stops providing
service to the MBAN coordinator and
the Bureau is not persuaded that either
the MBAN coordinator can perform
these necessary duties without
assistance of a third-party consultant or
use of a replacement consultant will
allow the coordinator to meet its
obligations under our rules.
36. The Commission found that
MBAN coordinator candidates that rely
on third party contracts to demonstrate
compliance with the core qualifying
criteria will need to disclose certain
information about such contracts. The
Commission found that demonstration
of the core qualifying criteria will
require the disclosure of more detailed
information because the relationship
between the MBAN coordinator and a
third-party technical expert will affect
both the coordinator’s ability to carry
out its responsibilities and the
program’s ability to continue if either
the coordinator or the third-party expert
must relinquish its role. The
Commission therefore directed the
Bureau to require that applicants for the
MBAN coordinator role relying on a
third party consultant make a number of
attestations regarding the consultant and
the contract between the consultant and
the applicant, and to take this
information into account when judging
the suitability of applicants for the
MBAN coordinator position. This
information must include the identity
and qualifications of any third-party
technical consultant the MBAN
coordinator will rely on, the length of
time that the contract between the
MBAN coordinator and the third-party
consultant would be in effect, and under
what circumstances that contract could
terminate.
37. The Commission also indicated
that the MOU should also recognize the
possibility that the technical consultant
would stop providing service to the
MBAN coordinator. Upon such an
occurrence, the MBAN coordinator
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would need time to employ a
replacement consultant who meets the
Commission’s high standards and, if
such a coordinator is not found, the
Commission needs time to replace the
MBAN coordinator. The Commission
provided the Bureau with the discretion
to include such requirements in the
MOU it executes with the MBAN
coordinator.
38. Fees for Service. The Commission
decided to permit the MBAN
coordinator to set fees for MBAN
registration and coordination (as
opposed to having the Commission or
the Bureau prescribe fees. The
Commission required that the fees
charged for MBAN registration and
coordination be reasonable and reflect
only the MBAN coordinator’s actual
costs of providing the coordination and
registration functions. The MBAN
coordinator will be required to provide
the coordination and registration
functions on a not-for-profit basis. The
Commission determined that requiring
that the MBAN coordinator provide
services on a not-for-profit basis was
necessary because, with likely only one
MBAN coordinator, it cannot rely on
competitive market forces to serve as a
check on the fees associated with
MBAN registration and coordination. If
competitive forces are introduced and
more than one coordinator is selected,
however, the Commission recognized
that the need for such regulations may
no longer exist and may need to be
reconsidered. The Commission also
required that the MBAN coordinator
must provide services on a nondiscriminatory basis to all eligible
health care institutions.
39. The Commission concluded that
the MBAN coordinator should establish
MBAN user fees that include all costs
associated with MBAN registration and
coordination, including the cost of any
third-party technical consultant
employed by the MBAN coordinator
and the fees of the AMT coordinator.
This approach establishes a single pay
point for MBAN users and will simplify
the registration and coordination
process for them, and is supported by
the record. As with the other costs for
which the MBAN user is responsible,
the cost of any third-party technical
consultant must be reasonable. This cost
can include only the MBAN
coordinator’s actual costs for such
consultation services. The amount of the
payment to the AMT coordinator should
be determined by agreement between
the AMT and MBAN coordinators, and
would be incorporated into the overall
coordination fee that an MBAN user
incurs. The Commission indicated that
it expects the AMT coordinator to pass
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60097
on only its actual coordination costs, on
a not-for-profit basis, to the MBAN
coordinator. This cost may include the
actual cost to the AMT coordinator of
coordinating Federal AMT operations,
but may not include charges for work
performed by Federal employees such
as the Federal Government Area
Frequency Coordinators. Because the
costs incurred by the AMT coordinator
will be charged to the MBAN user as
part of the registration and coordination
fees paid to the MBAN coordinator, the
Commission found that there is no need
to place a requirement in our rules that
the MBAN user bear direct
responsibility for the AMT coordinator’s
cost.
40. On the matter of how reasonable
costs should be evaluated and what
oversight the Commission should
exercise over AMT–MBAN coordination
fees, the Commission observed that the
Bureau has the authority to investigate
the reasonableness of the MBAN
registration and coordination fees, and it
will do so as appropriate, either in
response to complaints or on its own
motion. The MBAN coordinator will be
required to provide the Bureau with any
information it requests in the course of
conducting such an investigation. In
judging the reasonableness of MBAN
registration and coordination fees the
Bureau should consider the customary
practices in other bands where
registration or coordination is required
under the Commission’s rules. The
Commission also required the MBAN
coordinator to provide the Bureau with
its fee schedule upon request. This fee
notification requirement coupled with
the ability to investigate the
reasonableness of fees will provide a
necessary incentive for the MBAN and
AMT coordinators to maintain the fee
structure for MBAN registration and
coordination at a reasonable level.
41. MBAN Coordinator Selection. The
Commission directed the Bureau, acting
under its existing delegated authority, to
select the MBAN coordinator. Because
the procedures the Bureau used in
selecting the WMTS coordinator were
successful, it directed it to employ a
similar process to select the MBAN
coordinator, including releasing a
Public Notice to announce procedures
for interested parties to submit
applications for consideration as an
MBAN coordinator, issuing an Order to
designate the MBAN coordinator, and
executing a MOU on behalf of the
Commission with the selected
coordinator that will set forth the
coordinator’s authority and
responsibilities. The Commission
anticipated that the MBAN coordinator
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would assume its duties upon the
execution of this MOU.
42. The Commission agreed with
Philips/GE that the MBAN coordinator
and AMT coordinator should quickly
reach agreement on mutually agreeable
procedures to create coordination
agreements. Until such procedures are
in place, no registered MBAN system
can be deployed. Hence, the
Commission required the selected
MBAN coordinator to report to the
Commission when it has procedures in
place with the AMT coordinator
allowing coordination agreements for
MBAN systems to be made. If no such
report is made within six months of
selection of the MBAN coordinator, the
Commission directed the Bureau to take
all necessary action to promote such an
agreement.
43. The Commission declined to
adopt AFTRCC’s suggestion that
selection of the MBAN coordinator be
contingent on executing a coordination
agreement with AFTRCC. The
Commission emphasized that it is the
responsibility of both the selected
MBAN coordinator and AFTRCC to
cooperate in good faith in developing
procedures for MBAN coordination.
44. Petition for Rulemaking. Ben
Bartlett, who identifies himself as a law
student at the University of California
Hastings College of Law, filed a Petition
for Rulemaking requesting that the
Commission allocate spectrum for
MBAN use in an unused portion of the
television frequency bands. Bartlett
claimed that the 2360–2400 MHz band
is unsuitable for MBAN use because
interference between MBAN systems
and the AMT and amateur services
would put patients at risk and interfere
with the operation of these services, that
the amount of spectrum available for
MBAN operations was not sufficient to
meet the future demand for medical
applications, and that the current
MBAN frequencies have limited
propagation characteristics compared to
the TV bands. He envisioned an
expanded role for MBAN devices where
patients will not be tied to a hub
because the wireless link will be able to
traverse long distances and pass through
buildings and other obstacles.
45. The Commission concluded that
the petition does not warrant further
consideration at this time and dismissed
it without prejudice. First, the
Commission pointed out that MBAN
systems are designed to provide
wireless monitoring of patients over
short distances to provide patients with
mobility in hospitals and other health
care facilities. In the First Report and
Order, the Commission concluded that
the 2360–2400 MHz band is well suited
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for this purpose given the ability of
MBAN devices to share with spectrum
with the incumbent users. Nothing in
the petition gave the Commission reason
to question this conclusion. Second, the
petition asserted that the amount of
spectrum the Commission has allocated
for MBAN use would not be sufficient
to meet future demand. The
Commission found this claim to be
speculative at best, particularly given
that no MBAN devices have been
deployed. Finally, the petition did not
provide the technical details necessary
to draw conclusions as to the feasibility
of the long-range medical wireless
devices that Bartlett envisions. The
Commission concluded that deployment
of these types of devices may be
possible under its existing rules in other
frequency bands.
Procedural Matters
46. Final Regulatory Flexibility
Certification. The Regulatory Flexibility
Act of 1980, as amended (RFA) 1
requires that a regulatory flexibility
analysis be prepared for rulemaking
proceedings, unless the agency certifies
that ‘‘the rule will not have a significant
economic impact on a substantial
number of small entities.’’ 2 The RFA
generally defines ‘‘small entity’’ as
having the same meaning as the terms
‘‘small business,’’ ‘‘small organization,’’
and ‘‘small governmental jurisdiction.’’ 3
In addition, the term ‘‘small business’’
has the same meaning as the term
‘‘small business concern’’ under the
Small Business Act.4 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 Small Business
Administration (SBA).5
47. In the Order on Reconsideration
and Second Report and Order, the
Commission addressed a number of
issues related to designating the MBAN
coordinator for the 2360–2390 MHz
1 The RFA, see section 5 U.S.C. S 601 et. seq., has
been amended by the Contract With America
Advancement Act of 1996, Public Law 104–121,
110 Stat. 847 (1996) (CWAAA). Title II of the
CWAAA is the Small Business Regulatory
Enforcement Fairness Act of 1996 (SBREFA).
2 5 U.S.C. 605(b).
3 5 U.S.C. 601(6).
4 5 U.S.C. 601(3) (incorporating by reference the
definition of ‘‘small business concern’’ in Small
Business Act, 15 U.S.C. S 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.’’
5 Small Business Act, section 15 U.S.C. S 632.
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band. Among other actions, the
Commission concludes to only
designate one MBAN coordinator, but
delegates to the Wireless
Telecommunication Bureau (Bureau)
the authority to possibly designate more
than one coordinator at a later date. The
Commission adopts a number of
qualifying criteria to guide the Bureau
in selecting the coordinator, such as the
ability to register and maintain a
database of MBAN transmitter locations,
knowledge of wireless systems in
healthcare facilities and of AMT
operations, and the ability to calculate
and measure interference potential
between MBAN and AMT operations.
The Commission also adopts a rule
requiring that the MBAN coordinator
provide registration and coordination to
all eligible healthcare facilities on a
non-discriminatory basis, provide the
registration and coordination services
on a not-for-profit basis, notify the
Commission six months prior to ceasing
to perform the functions of frequency
coordinator, and transmit the MBAN
registration data in a usable form to
another coordinator designated by the
Commission if it ceases to be the
frequency coordinator. While the
decisions made and rules adopted in the
Order on Reconsideration and Second
Report and Order could have a
significant economic impact on the
MBAN coordinator, the Commission has
decided to designate only one MBAN
coordinator. Although the Commission
does allow the Bureau to possibly
designate multiple coordinators at a
later date, it does not foresee there ever
being more than a couple of MBAN
coordinators.
48. The Commission also addresses
several issues related to MBAN users.
First, the revisions to the authorized
location rule will not increase the
number of health care facilities that can
use the 2360–2390 MHz band, and
therefore will not impose regulatory
burdens on any new small entities.
Second, in the Report and Order, the
Commission originally declined to
require registration for the 2390–2400
MHz band users because it concluded
that such a requirement ‘‘would
unnecessarily burden hospitals that do
not need assistance from the MBAN
coordination.’’ Under the revised
registration requirement we are
adopting, the scope is narrower and it
targets only those hospitals that may
eventually need to interact with MBAN
coordinator. We find that the benefit of
providing the MBAN coordinator with
this additional information outweighs
the slight increase in registration costs
for this limited number of MBAN
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operators. In addition, we find that the
increase in registration costs is minor,
and therefore will not have a significant
economic impact on a substantial
number of small entities. Lastly, the
remaining revisions to § 95.1223 do not
change the regulatory burden on small
business health care facilities; they
merely clarify the rules and do not have
a significant economic impact on any
new small entities.
49. Therefore, the Commission
certifies that the requirements of this
Order on Reconsideration and Second
Report and Order will not have a
significant economic impact on a
substantial number of small entities.
The Commission will send a copy of the
Order on Reconsideration and Second
Report and Order including a copy of
this final certification, in a report to
Congress pursuant to the Small Business
Regulatory Enforcement Fairness Act of
1996, see 5 U.S.C. 801(a)(1)(A). In
addition, the Order on Reconsideration
and Second Report and Order and this
certification will be sent to the Chief
Counsel for Advocacy of the Small
Business Administration, and will be
published in the Federal Register. See
5 U.S.C. 605(b).
50. Congressional Review Act. The
Commission will send a copy of this
Order on Reconsideration and Second
Report and Order to Congress and the
Government Accountability Office
pursuant to the Congressional Review
Act, see 5 U.S.C. 801(a)(1)(A).
51. Paperwork Reduction Act. This
document contains new and modified
information collection requirements
subject to the Paperwork Reduction Act
of 1995 (PRA), Public Law 104–13. The
requirements will be submitted to the
Office of Management and Budget
(OMB) for review under section 3507(d)
of the PRA. The Commission will
publish a separate notice in the Federal
Register inviting comment on the
revised information collection
requirements adopted in this document.
The requirements will not go into effect
until OMB has approved them and the
Commission has published a notice
announcing the effective date of the
information collection requirements.
Ordering Clauses
52. 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. 154(i), 301, 302a,
303(e), 303(f), 303(r), and 307(e), this
Order on Reconsideration and Second
Report and Order is adopted.
53. The rules and requirements
adopted herein will become effective
November 5, 2014, except for 47 CFR
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95.1225(c), which includes new or
modified information collection
requirements that require approval by
Office of Management and Budget under
the PRA and will become effective after
such approval, on the effective date
specified in a notice that the
Commission publishes in the Federal
Register announcing such approval and
effective date.
54. Pursuant to the authority of
section 5(c) of the Communications Act
of 1934, as amended, 47 U.S.C. 155(c),
the Commission delegate authority to
the Wireless Telecommunications
Bureau as set forth in this Second
Report and Order.
55. The Petition for Rulemaking filed
by Ben Bartlett in ET Docket Nos. 08–
59 and 04–186 is denied.
56. The Joint Petition for
Reconsideration of GE Healthcare,
Phillips Healthcare, and the Aerospace
and the Flight Test Radio Coordinating
Council is granted in part and denied in
part.
57. The Petition for Reconsideration
of The American Society for Healthcare
Engineering of the American Hospital
Association is granted.
58. The Commission’s Consumer and
Governmental Affairs Bureau, Reference
Information Center, shall send a copy of
this Order on Reconsideration and
Second Report and Order, including the
Final Regulatory Certification, to the
Chief Counsel for Advocacy of the Small
Business Administration.
60099
§ 95.628 MedRadio transmitters in the
413–419 MHz, 426–432 MHz, 438–444 MHz,
and 451–457 MHz and 2360–2400 MHz
bands.
*
*
*
*
*
(c) Requirements for Medical Body
Area Networks. A MedRadio
programmer/control transmitter and its
associated medical body-worn
transmitters shall not commence
operating in, and shall automatically
cease operating in, the 2360–2390 MHz
band if the programmer/control
transmitter does not receive, in
accordance with the protocols specified
by the manufacturer, a control message
permitting such operation. Medical
body-worn transmitters shall cease
operating in 2360–2390 MHz if they lose
communication with their associated
programmer/control transmitter.
Additionally, a MedRadio programmer/
control transmitter and its associated
medical body-worn transmitters
operating in the 2360–2390 MHz band
shall comply with a control message
that notifies the devices to limit
transmissions to segments of the 2360–
2390 MHz band or to cease operation in
the band.
*
*
*
*
*
■ 3. Appendix 1 to Subpart E is
amended by revising the definition of
‘‘Medical Body Network’’ to read as
follows:
Appendix 1 to Subpart E of Part 95—
Glossary of Terms
*
*
*
*
*
Federal Communications Commission.
Marlene H. Dortch,
Secretary.
Medical Body Area Network (MBAN). An
MBAN is a low power network consisting of
a MedRadio programmer/control transmitter
and one or more multiple medical body-worn
devices all of which transmit or receive nonvoice 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.
Final Rules
*
For the reasons discussed in the
preamble, the Federal Communications
Commission amends 47 CFR part 95 as
follows:
Subpart I—Medical Device
Radiocommunications Service
(MedRadio)
List of Subjects in 47 CFR Part 95
Communications equipment, Medical
devices, Reporting and recordkeeping
requirements.
PART 95—PERSONAL RADIO
SERVICES
1. The authority citation for part 95 is
revised to read as follows:
■
Authority: 47 U.S.C. 154, 301, 302(a), 303,
and 307(e).
Subpart E—Technical Regulations
2. Section 95.628 is amended by
revising paragraph (c) to read as follows:
■
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*
*
*
*
4. Section 95.1203 is revised to read
as follows:
■
§ 95.1203
Authorized locations.
MedRadio operation is authorized
anywhere CB station operation is
authorized under § 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 § 95.1225. For
the purposes of this subpart, health care
facilities are limited to hospitals and
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other establishments, both Federal and
non-Federal, that offer services,
facilities and beds for use beyond a 24
hour period in rendering medical
treatment.
■ 5. Section 95.1209 is amended by
revising paragraph (g) to read as follows:
§ 95.1209
Permissible communications.
*
*
*
*
*
(g) Medical body-worn transmitters
may relay only information in the 2360–
2400 MHz band to a MedRadio
programmer/control transmitter or
another medical body-worn transmitter
device 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 other MedRadio programmer/
controller transmitters. Wireless
retransmission of all other information
from an MBAN transmitter 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. Notwithstanding
the above restriction, a MedRadio
programmer/control transmitter in the
2360–2400 MHz band may
communicate with another MedRadio
programmer/control transmitter in the
2360–2400 MHz band to coordinate
transmissions so as to avoid interference
between the two Medical Body Area
Networks.
*
*
*
*
*
■ 6. Section 95.1213 is revised to read
as follows:
§ 95.1213
Antennas.
(a) An antenna for a MedRadio
transmitter shall not be configured for
permanent outdoor use.
(b) 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.
(c) Paragraphs (a) and (b) of this
section do not apply to MedRadio
operations in the 2390–2400 MHz band.
■ 7. Section 95.1223 is amended by
revising the section heading, paragraph
(a) introductory text, and paragraphs
(a)(3), (a)(5), and (b) to read as follows:
tkelley on DSK3SPTVN1PROD with RULES
§ 95.1223 Registration and frequency
coordination.
(a) Registration. Prior to operating
MBAN devices that are capable of
operation in the 2360–2390 MHz band,
a health care facility, as defined by
§ 95.1203, must register with a
frequency coordinator designated under
§ 95.1225. Operation of MBAN devices
in the 2360–2390 MHz band is
prohibited prior to the MBAN
VerDate Sep<11>2014
16:42 Oct 03, 2014
Jkt 235001
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:
*
*
*
*
*
(3) Number of MedRadio programmer/
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;
*
*
*
*
*
(5) Location of MedRadio
programmer/control transmitters (e.g.,
geographic coordinates, street address,
building);
*
*
*
*
*
(b) Notification. A health care facility
shall notify the frequency coordinator
whenever an MBAN programmer/
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 and locations as those
reported on the health care facility’s
registration which will cover the
replacement transmitter(s). A health
care facility shall keep the information
contained in each registration current
and shall notify the frequency
coordinator of any material change to
the MBAN’s location or operating
parameters. In the event that the health
care facility proposes to change the
MBAN’s location or operating
parameters, the MBAN coordinator must
first evaluate the proposed changes and
comply with paragraph (c) of this
section, as appropriate, before the health
care facility may operate the MBAN in
the 2360–2390 MHz band under
changed operating parameters.
*
*
*
*
*
■ 8. Section 95.1225 is amended by
revising paragraphs (a) and (b)(1) and
adding paragraph (c) to read as follows:
§ 95.1225
Frequency coordinator.
(a) The Commission will designate a
frequency coordinator(s) to manage the
operation of medical body area
networks by eligible health care
facilities.
(b) * * *
(1) Register health care facilities that
operate MBAN transmitters, maintain a
database of these MBAN transmitter
locations and operational parameters,
and provide the Commission with
information contained in the database
upon request;
*
*
*
*
*
(c) The frequency coordinator shall:
(1) Provide registration and
coordination of MBAN operations to all
PO 00000
Frm 00044
Fmt 4700
Sfmt 4700
eligible health care facilities on a nondiscriminatory basis;
(2) Provide MBAN registration and
coordination services on a not-for-profit
basis;
(3) Notify the Commission of its intent
to no longer serve as frequency
coordinator six months prior to ceasing
to perform these functions; and
(4) Transfer the MBAN registration
data in usable form to a frequency
coordinator designated by the
Commission if it ceases to be the
frequency coordinator.
[FR Doc. 2014–23519 Filed 10–3–14; 8:45 am]
BILLING CODE 6712–01–P
DEPARTMENT OF TRANSPORTATION
Federal Highway Administration
23 CFR Part 771
Federal Transit Administration
49 CFR Part 622
[Docket No. FHWA–2013–0049]
FHWA RIN 2125–AF59]
FTA RIN 2132–AB14
Environmental Impact and Related
Procedures—Programmatic
Agreements and Additional
Categorical Exclusions
Federal Highway
Administration (FHWA), Federal
Transit Administration (FTA),
Department of Transportation (DOT).
ACTION: Final rule.
AGENCY:
This final rule amends the
FHWA and FTA joint procedures that
implement the National Environmental
Policy Act (NEPA) by adding new
categorical exclusions (CE) for FHWA
and FTA; allowing State departments of
transportation (State DOT) to process
certain CEs without FHWA’s detailed
project-by-project review and approval
as long as the action meets specific
constraints; and adding a new section
on programmatic agreements between
FHWA and State DOTs that allow State
DOTs to apply FHWA CEs on FHWA’s
behalf, as described in section 1318 of
the Moving Ahead for Progress in the
21st Century Act (MAP–21).
DATES: Effective on November 5, 2014.
FOR FURTHER INFORMATION CONTACT: For
the FHWA: Owen Lindauer, Ph.D.,
Office of Project Delivery and
Environmental Review (HEPE), (202)
366–2655, or Jomar Maldonado, Office
of the Chief Counsel (HCC), (202) 366–
1373, Federal Highway Administration,
SUMMARY:
E:\FR\FM\06OCR1.SGM
06OCR1
Agencies
[Federal Register Volume 79, Number 193 (Monday, October 6, 2014)]
[Rules and Regulations]
[Pages 60092-60100]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-23519]
-----------------------------------------------------------------------
FEDERAL COMMUNICATIONS COMMISSION
47 CFR Part 95
[ET Docket No. 08-59; FCC 14-124]
Medical Body Area Network
AGENCY: Federal Communications Commission.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This document addresses an Order on Reconsideration and Second
Report and Order in which the Commission takes further actions to
foster the development and deployment of new and innovative Medical
Body Area Network (MBAN) devices. In addressing petitions for
reconsideration of the First Report and Order in this proceeding, the
Commission provides MBAN users with additional flexibility to enable
the implementation of technical standards being developed for MBAN
devices, and clarify and modify portions of its rules to facilitate the
coordination, deployment, and use of MBAN systems. In the Second Report
and Order portion in this proceeding, the Commission finalizes the
process for selecting a MBAN Coordinator. This coordinator will
facilitate use of the MBAN frequencies, which operate in shared-use
bands. Collectively, our actions will allow the development of new and
innovative health care applications.
DATES: Effective November 5, 2014, except for Sec. 95.1225(c), which
contains information collection requirements that have not been
approved by the Office of Management and Budget (OMB). The Commission
will publish a document in the Federal Register announcing the
effective date of Sec. 95.1225(c).
FOR FURTHER INFORMATION CONTACT: Jamison Prime, (202) 418-7474,
Jamison.Prime@fcc.gov or Brian Butler (202) 418-2702,
Brian.Butler@fcc.gov, Office of Engineering and Technology.
SUPPLEMENTARY INFORMATION: This is a summary of the Commission's Order
on Reconsideration and Second Report and Order, ET Docket No. 08-59,
FCC 14-124, adopted August 20, 2014 and released August 21, 2014. 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 fcc504@fcc.gov or
call the Consumer & Governmental Affairs Bureau at 202-418-0530
(voice), 202-418-0432 (tty).
Summary of Order on Reconsideration
1. In the Order on Reconsideration and Second Report and Order, the
Commission took further actions to foster the development and
deployment of new and innovative Medical Body Area Network (MBAN)
devices. MBAN technology provides a platform for the wireless
networking of multiple body-worn sensors used for measuring and
recording physiological parameters and other patient information or for
performing diagnostic or therapeutic functions, primarily in health
care facilities. By addressing petitions for reconsideration of the
First Report and Order in this proceeding, we provided MBAN users with
additional flexibility to enable the implementation of technical
standards being developed for MBAN devices, and clarified and modified
portions of our rules to facilitate the coordination, deployment, and
use of MBAN systems.
Authorized Locations
2. Health Care Facilities. The Commission revised Sec. 95.1203 of
its rules to limit use of the 2360-2390 MHz band to hospitals and other
establishments that offer services, facilities and beds for use beyond
a 24-hour period in rendering medical treatment. It eliminated a
portion of the definition that included 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. By
limiting the types (and, thus, the numbers) of medical institutions in
the 2360-2390 MHz band, the Commission intended to make it easier for
both the MBAN and AMT coordinators to establish, implement and enforce
efficient and effective coordination procedures. Further, it found that
limiting potential locations would simplify their efforts to identify
and remedy any harmful interference in the extremely unlikely event it
occurs.
3. Although GE Healthcare, Phillips Healthcare, and the Aerospace
and Flight Test Radio Coordinating Council (AFTRCC) (the'' Joint
Parties'') had suggested this approach as part of their comprehensive
set of proposed rules, they had not discussed the rationale for this
limitation until the filing of their Petition for Reconsideration.
Because the Petition for Reconsideration stated with particularity the
reasons why the Commission should adopt their proposed authorized
locations definition, it found that the public interest would be it
served by taking the Joint Parties' facts and arguments into
consideration.
4. As part of this decision, the Commission determined that,
because the existing MBAN standard will support numerous patients in
the 2390-2400 MHz band, and because frequency reuse techniques can
augment that capacity in many situations, no health care facilities--
including those that do not qualify for use of the 2360-2390 MHz band--
will be precluded from operating MBAN systems. For this reason, the
Commission disagreed with SmartEdgeNet that health care providers will
be ``denied the benefits of MBAN'' if the Commission limited the
authorized locations as requested.
5. Antenna Locations. In their Petition for Reconsideration, the
Joint Parties claimed that Sec. 95.1213, titled ``Antennas,'' appeared
to exclude the installation of outdoor antennas for the 2390-2400 MHz
band at locations above a building's first floor, such as balconies and
roof terraces, and that this was not the intent of the rule. Upon
reconsideration, the Commission agreed and expressly found that it was
not necessary to apply antenna height restrictions--which were
originally intended as a constraint on temporary outdoor use of
MedRadio antennas regardless of the band in which the transmitter
operated--to antennas used for MedRadio transmitters operating in the
2390-2400 MHz band.
6. The Commission concluded that, based on the permissible outdoor
use in this band and the relatively low power operations of MBAN
transmitters (which effectively limits any gain in
[[Page 60093]]
coverage that is often associated with increased antenna height), there
is no need to prescribe a specific antenna height limit (for either
permanent or temporary outdoor antennas used for this band) and revised
Sec. 95.1213 as set forth in the rules.
MBAN Definition and Permissible Communications
7. MBAN Configurations with a Single Body-Worn Device. The
Commission amended Appendix 1 to subpart E of part 95 (``Glossary of
Terms'') to define an MBAN as a low power network consisting of a
MedRadio programmer/control transmitter and one or more medical body-
worn devices. The Commission found the argument of the Joint Parties
that the pairing of a programmer/control transmitter with a single
body-worn device ``will likely be common'' was plausible, concluding
that there could be times where best treatment practices could require
the use of only a single body-worn device.
8. Use of Bedside Devices. Under the Commission's rules as adopted
in the First Report and Order, a medical body-worn device is defined as
an apparatus that is placed on or in close proximity to the human body
(e.g., within a few centimeters) for the purpose of performing
diagnostic or therapeutic functions. The Commission clarified that
bedside devices, which would require a physical attachment to the
patient (e.g. by wire or tube), would meet the definition even though
there are other parts of the apparatus that are located away from the
body. The Commission further clarified that the ``few centimeters''
language in the rule should be read as a general example and not the
codification of a specific distance requirement. Based on this
clarification, the Commission did not grant the Joint Parties request
to modify the rule to remove the ``few centimeters'' language.
9. Allowing Greater Flexibility in Designing MBAN Systems. Together
Sec. 95.1209(g) (``Permissible Communications'') and the MBAN
definition contained in Appendix 1, subpart E of the part 95 Rules
(``Glossary of Terms'') established the MedRadio programmer/control
transmitter and the medical body-worn device as distinct elements that
must be present in every MBAN; allow body-worn transmitters to relay
information in the 2360-2400 MHz band only to a programmer/control
transmitter that is part of the same MBAN; and prohibit a programmer/
control transmitter from using the 2360-2400 MHz band to relay
information to another programmer/control transmitter.
10. The Commission modified existing rule Sec. 95.1209(g) to
provide an exception to permit communications between programmer/
control transmitters of different MBAN systems for the sole purpose of
avoiding interference to each other, based on the text of the existing
MedRadio rules for Medical Micropower Networks. It recognized that
allowing MBAN systems in the 2360-2390 MHz band (as well as the 2390-
2400 MHz band) to coordinate use among themselves of the available MBAN
frequencies could promote efficient spectrum use. The Commission
emphasized that it considered the modified requirement to be a limited
exception to the general rule and, in agreement with the Joint Parties,
noted that programmer/control transmitters would continue to be barred
from relaying the control message to each other. It retained the
prohibition on programmer/control transmitters relaying other
information (such as medical data) to each other.
11. The Commission amended Sec. 95.1209 of the rules to eliminate
the language that precludes body-worn devices from communicating with
other body-worn devices in the 2360-2400 MHz band. It recognized that
doing so could potentially enhance patient welfare by preserving
battery life and enhancing signal strength in situations that may
adversely affect the reception of data. Further, the Commission noted
that the adoption of industry standards, it may have made it both
feasible and practical to produce such equipment.
12. Additionally, the Joint Parties asked that the Commission allow
either a programmer/control transmitter or a body-worn device to
perform as a ``coordinator node'' in an MBAN system. According to the
Joint Parties, coordinator node is the ``. . . term used in IEEE
802.15.6 for the node responsible for coordinating the MAC function
(e.g., assigning TDMA slots to other nodes) and being the main routing
hub for communication with all other nodes in the MBAN star topology.''
As an example, the Joint Parties described a scenario in which a body-
worn device serves as a coordinator node to transmit information
related to the technical operation of the network (e.g., what
communication protocols to use) to other body-worn devices within the
MBAN system and aggregate the patient data that it receives from other
body-worn devices. Because the Commission decided to permit a body-worn
device within an MBAN system to communicate with another body-worn
device, it concluded that the Joint Parties would be able to design
MBAN systems consistent with their request under the existing rules and
that no rule modifications were necessary.
13. 2390-2400 MHz band. The Commission denied the Joint Parties'
request to eliminate all restrictions on MBAN systems that operate in
the 2390-2400 MHz band. Such a change would have allowed networks that
consist of multiple programmer/control transmitters, networks that do
not include any programmer/control transmitters, and networks in which
different groups of programmer/control transmitters and body-worn
devices communicate between and among each other. The Commission
disagreed with the Joint Parties' assertion that the rationale for the
MBAN system design requirements in Sec. 95.1209(g) related exclusively
to concerns in the 2360-2390 MHz band and applying the restriction to
the 2390-2400 MHz band served no purpose. Instead, it noted that
entities operating in the 2360-2390 MHz band may need to default to the
2390-2400 MHz band and found that it would be unwise to further
complicate such transitions by allowing the band to be populated by
medical devices operating under many different system designs.
Nevertheless, the Commission did note that the First Report and Order
left open the potential to revisit the permissible use restrictions
after gaining further experience with MBAN operations and it deemed
continuing this approach to be reasonable and appropriate to the
circumstances.
Device Operation
14. In the First Report and Order, the Commission adopted
transmission requirements for the component parts of an MBAN--the
programmer/control transmitters and body-worn devices. The Commission
applied much of the existing MedRadio rule on ``Permissible
Communications,'' 47 CFR 95.1209, to MBAN operation. Among these
requirements, Sec. 95.1209(b), in pertinent part, addresses the
operation of body-worn devices by stating that no MedRadio implant or
body-worn transmitter shall transmit except in response to a
transmission from a MedRadio programmer/control transmitter or in
response to a non-radio frequency actuation signal generated by a
device external to the body with respect to which the MedRadio implant
or body-worn transmitter is used.
Additionally, with regard to programmer/control transmitters, Sec.
95.628(c) states that 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
[[Page 60094]]
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.
15. The Joint Parties asserted that Sec. 95.1209 as adopted in the
First Report and Order permitted only a polled media access control
(MAC) protocol--that is, that the only time a body-worn device can
operate is immediately after the receipt of a transmission from the
programmer/control transmitter. The Commission found that this
assertion was based upon an overly narrow reading of the rule and was
inconsistent with the language of the First Report and Order. It stated
that while a polled access scenario would comply with the rules, other
access modes are permissible provided that the body-worn devices
operate in response to whatever instructions are transmitted by their
associated programmer/control transmitter. The Commission thus
determined that the rules allow sufficient flexibility to account for
the Joint Parties' concerns and made no changes to the rule.
16. The Commission modified Sec. 95.628(c) of the rules, as shown
below, to clearly state that body-worn transmitters must be capable of
ceasing transmissions when necessary to avoid interference in the 2360-
2390 MHz band. It agreed that it is ``critical that all MBAN devices .
. . cease operation in 2360-2390 MHz in the absence of a control
message,'' and noted that, because the rules adopted in the First
Report and Order require a programmer/control transmitter operating in
the 2360-2390 MHz that fails to receive a control message to cease
operation and allow body-worn transmitters to transmit only in response
to a transmission from the programmer/control transmitter, such a
requirement was already implicit.
Coordination and Registration
17. Registration Requirement for the 2390-2400 MHz Band. In the
First Report and Order, the Commission adopted a registration
requirement for the 2360-2390 MHz band to facilitate coordination with
AMT operations in that band, but it did not adopt a registration
requirement for the 2390-2400 MHz band. On reconsideration, the
Commission amended its rules to require that entities preparing to use
the 2390-2400 MHz band with equipment that is capable of also operating
in the 2360-2390 MHz band and who are eligible to operate MBAN systems
in the 2360-2390 MHz band register the MBAN system--regardless of
whether they have any current intent to eventually use the 2360-2390
MHz band capacity of their equipment. The Commission agreed with ASHE
that such a requirement will give the coordinator and health care
facilities a more complete understanding of the current and potential
local spectrum environment for MBANs and will allow qualifying health
care facilities (and their equipment vendors and installers) to better
plan their facilities with respect to appropriate efficient network
architecture and systems planning and implementation. The Commission
further noted that the modified registration requirement is more
limited and less burdensome than a more comprehensive requirement that
the Commission rejected in the First Report and Order, and concluded
that the benefits of providing the MBAN coordinator with this important
additional information outweigh the fairly slight increase in
registration costs for the limited number of MBAN operators discussed.
18. Registration Requirement for the 2360-2390 MHz Band. In the
First Report and Order, the Commission required all MBAN devices
operating in the 2360-2390 MHz band to be registered with a frequency
coordinator, and adopted Sec. 95.1223 addressing MBAN registration and
coordination. Upon reconsideration, the Commission agreed with the
Joint Parties that the language in Sec. 95.1223(a) that required
registration of all MBAN devices a health care facility proposes to
operate in the 2360-2390 MHz band was broader than necessary. It also
noted that, while the introductory text in Sec. 95.1223(a) suggests
that all MBAN devices should be registered, the registration
information specified in subparts (1) through (7) of the rule does not
address body-worn devices. Furthermore, subparts (3) and (5)
specifically speak to ``control transmitter[s]'' (which we are updating
to read ``MedRadio programmer/control transmitter'' to provide clarity
and consistency). Because the existing rule construction may create
confusion in that it could appear to be inconsistent or ambiguous, the
Commission amended the introductory text of Sec. 95.1223(a) as shown
below. Under the revision, the Commission did not require that the MBAN
user provide the coordinator with unique identifying data (e.g., a
serial number) for each programmer/control transmitter. The Commission
agreed with the Joint Parties that it will be sufficient to provide the
quantity and type (i.e. equipment that may have different technical
characteristics) of programmer/control transmitters at each MBAN
installation. The Commission accomplished this objective by retaining
the requirement in Sec. 95.1223(a)(3) that programmer/control
transmitter information include the manufacturer name, model number and
FCC identification number. The practical effect of the revised rules is
that health care facilities will be able to account for large groups of
devices under a single filing.
19. Finally, the Commission clarified that replacement of
programmer/control transmitters having the same technical
characteristics as those reported on the health care facility's
registration (i.e., the manufacturer name, model number and FCC
identification number) will not trigger additional notification
requirements under Sec. 95.1223(b) of the rules.
20. Interaction between MBAN and AMT Coordinators. Under Sec.
95.1225(b)(2) of the Commission's rules, the MBAN Coordinator is
required to 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. Additionally, the MBAN
coordinator must approve any changes made to an authorized MBAN
installation before operation could begin with the altered parameters.
Accordingly, Sec. 95.1223(b) states, in pertinent part, that a health
care facility must notify the MBAN coordinator of any material change
to the MBAN's location or operating parameters, and that it may not
operate under changed operating parameters until the frequency
coordinator determines whether such changes require coordination with
the AMT coordinator. The Joint Parties had suggested edits to the
coordinator duties listed in Sec. 95.1225 of the rules. The Commission
concluded that the Joint Parties' proposed edits to Sec. 95.1225(b)
were already addressed in Sec. 95.1223(c) and concluded that it would
be unnecessarily repetitive to make the requested edits.
21. The Commission determined that it would be beneficial to
further clarify the procedures for how the AMT coordinator is consulted
before an MBAN location or operation is changed. Specifically, the
Commission found the need to provide clarification as to whether
coordination with or notification to the AMT coordinator would be
required if the modified
[[Page 60095]]
MBAN facility would operate beyond line-of-sight of an AMT receive
facility. It determined that the best course in such cases is to apply
the existing procedures outlined in Sec. 95.1223(c)(1), which requires
the MBAN coordinator to approve operation without prior coordination
with the AMT coordinator, but also requires the MBAN coordinator to
notify the AMT coordinator and provide the AMT coordinator with the
opportunity to concur that the MBAN facility is beyond line of sight.
Accordingly, the Commission revised Sec. 95.1223(b) of the rules to
state that the MBAN coordinator must evaluate the proposed changes and
comply with either (c)(1) or (c)(2), as appropriate, prior to
authorizing a modified MBAN operation. Such a change satisfies the
Joint Parties' request that the Commission clarify the advance
consultation requirement for the AMT coordinator, and does so in a way
that complements our existing rules for coordinating MBAN operations.
22. Notification of Interference. The Commission did not adopt a
request by the Joint Parties to amend Sec. 95.1223(a) of the rules to
include a specific requirement that, if a health care facility or the
MBAN coordinator is notified of MBAN interference to an AMT receive
antenna, the MBAN user must cease transmissions on the frequencies
causing interference. The Commission pointed out that Sec. 95.1211(c)
of the rules plainly states that MBAN devices may not cause harmful
interference to authorized stations operating in the 2360-2400 MHz band
which places the onus of avoiding such interference squarely on the
operator of these devices. Accordingly, it is the MBAN user's
responsibility to respond to interference complaints, and to be
prepared to cease operation as necessary to avoid causing harmful
interference. The Commission also emphasized that failure to abide by
this rule will subject an MBAN user to appropriate Commission
enforcement action. The existing rules give the MBAN coordinator the
responsibility to identify the MBAN that is the source of interference
and the authority to notify the registered health care facility to
cease operation as may be appropriate to the circumstances. Moreover,
any health care facility planning to operate MBAN devices in the 2360-
2390 MHz band will have provided to the MBAN coordinator, pursuant to
the rules, a point of contact in the event the MBAN user is directed to
cease operation. Thus, the Commission concluded that, together, the
rule defining the MBAN user responsibilities and the rule describing
the functions of the 2360-2390 MHz band MBAN coordinator should provide
for the prompt identification and resolution of any harmful
interference caused by an MBAN to AMT operations.
23. Testing of Installed MBAN Equipment. The Joint Parties and ASHE
requested the Commission to require hospitals or equipment vendors to
certify to the MBAN coordinator that testing of the relevant 2360-2390
MHz MBAN equipment was conducted in situ and confirmed that the
equipment does not operate outdoors. The Commission found that its
existing rules and processes are sufficient to address such concerns.
It noted that all MBAN equipment capable of operating in the 2360-2390
MHz band is certified to be under the equipment authorization process
to demonstrate compliance with the indoor operation restrictions and
that, under the existing rules, MBAN users must acknowledge when
registering with an MBAN coordinator the need to comply with these
requirements. In this regard, the Commission noted that it has given
MBAN coordinators broad discretion to implement coordination procedures
to ensure that MBAN operations are permitted only when and where they
will not interfere with AMT operations. Thus, if an MBAN coordinator
determines that the type of testing and certification the Joint Parties
and ASHE seeks is warranted, it may ask a hospital or equipment vendor
to provide such information as part of the coordination process.
Equipment Authorization
24. Attached Antennas and Operation in the 2360-2390 MHz Band. The
Commission did not adopt the Joint Parties' request that Sec. 95.1213
of the rules, which describes MBAN antenna placement, be modified ``to
clarify that an antenna must be permanently affixed to its MBAN
transmitter'' for devices operating in the 2360-2390 MHz portion of the
band. The Commission determined that there was little risk that MBAN
users will make post-market device modifications, noting that it was
not aware of any issues with unauthorized modification of the existing
base of MedRadio devices, nor had the Joint Parties provided any
supporting evidence that this is a common occurrence that would support
additional rules tailored to MBAN operation in the 2360-2390 MHz band.
It also found that the existing rules already protect against the
potential harm described by the Joint Parties. Specifically, Sec.
95.639(f)(5) of the rules states that the antenna associated with any
MedRadio transmitter must be supplied with the transmitter and shall be
considered part of the transmitter subject to equipment authorization.
25. Equipment Labeling Requirement. The labeling requirement for
MBAN devices states that MedRadio programmer/control transmitters
operating in the 2360-2400 MHz band shall be labeled as provided in
part 2 of the 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.
26. The Commission denied the Joint Parties' request that, in the
event that the warning is not included on the device label, the
Commission should require that the warning be placed on the front page
of the instruction manual in capital letters. On reconsideration, the
Commission found that the Joint Parties had not offered any reason for
it to question this analysis the Commission undertook in the First
Report and Order, or to convince it that additional steps were needed
to ensure that ``all personnel are fully aware'' of the status of MBAN
devices.
27. Publication of Equipment Authorization Requirements. The Joint
Parties asked that the Commission take steps to ensure that the
requirements for equipment authorization of MBAN devices be ``clear for
all to follow.'' They did not propose any specific rule modifications,
but instead submitted a list of ``expected attestation and
certification requirements for MBAN equipment. While the Commission
declined to codify the Joint Parties' specific requirements, it
indicated that it will draw on existing resources (for example, the OET
Laboratory Division's Knowledge Database (KDB)) and staff will continue
to be available to ensure that information regarding authorization
procedures for MBAN equipment is published in a readily accessible
manner, and that MBAN equipment is authorized in compliance with
Commission rules.
Second Report And Order
28. The Commission's rules require that MBAN operations in the
2360-2390 MHz be registered and coordinated to ensure that AMT
operations in this band are protected from harmful interference.
[[Page 60096]]
The registration and coordination functions are to be performed by a
frequency coordinator to be designated by the Commission. An MBAN
coordinator will be required to maintain a database of MBAN
registrations that includes the locations of MBAN systems that operate
in the 2360-2390 MHz band, determine when MBAN transmitters are within
line-of-sight of AMT receive facilities, coordinate MBAN operations
with the coordinator for AMT services, notify registered MBAN users
when they must change frequencies or cease operations consistent with a
coordination agreement between the MBAN and AMT coordinator, and
develop procedures to ensure that MBAN users operate consistent with
the coordination requirements.
29. In the Second Report and Order, the Commission determined that
it will select only one MBAN coordinator for a ten-year term. After the
ten-year term, the coordinator will serve until either it elects not to
continue as coordinator or is removed by the Commission. The MBAN
coordinator may rely on a third-party consultant for technical services
necessary to fulfill its responsibilities, but will be required to
disclose information about the technical qualifications of the third-
party consultant and the contractual arrangement it has with the
consultant. The MBAN coordinator will be required to provide service on
a non-discriminatory basis to all eligible health care institutions and
will be permitted to charge reasonable fees that reflect only its
actual costs (including the costs associated with coordination, such as
the AMT coordinator's cost and the expense of any third-party technical
consultant). The Wireless Telecommunications Bureau (Bureau), acting
under delegated authority as provided in the Commission's rules, will
select the MBAN coordinator. The Bureau will execute a Memorandum of
Understanding (MOU) with the selected coordinator, which will describe
the duties and responsibilities of the coordinator and provide for
removal of the coordinator if circumstances warrant. These requirements
are described in further detail in the following paragraphs.
30. Single Coordinator. The Commission found it appropriate to
select only one MBAN coordinator at this time given the characteristics
of the MBAN service. The health care community represents a small part
of the radiofrequency user ecosystem and the number of MBAN registrants
is likely to be proportionally small. A single coordinator will
simplify MBAN registration for health care institutions because there
will be a single point of contact and the registration process will be
analogous to the Wireless Medical Telemetry Service (WMTS) registration
process that is familiar to many entities in this specialized group,
and will make coordination with AMT coordinator simpler. The Commission
noted that the authority already delegated to the Bureau to certify
frequency coordinators for the services it administers allows it to
introduce competitive coordination into a service with an exclusive
coordinator, and noted that the Bureau will consider, in the future,
whether to certify one or more additional coordinators if it determines
that such an action would serve the public interest.
31. Term of Service. The Commission required that the MBAN
coordinator agree to serve a ten-year term. After the initial ten-year
term, the MBAN coordinator will continue to serve until the coordinator
acts to vacate the role or the Commission acts to remove the
coordinator under the procedures discussed. The Commission also adopted
the proposal in the Further Notice to require that the MBAN coordinator
transfer the MBAN registration data to another entity designated by the
Commission if the coordinator cannot or chooses not to continue as
coordinator. The Commission directed the Bureau to incorporate this
requirement into the MOU that it will execute with the MBAN
coordinator. As part of the MOU, the Bureau should also address what
notice the MBAN coordinator must give the Commission to provide
adequate time to select a replacement coordinator, in the event that
the coordinator intends to vacate the coordinator role. This notice
will have to provide sufficient time for the Bureau to select a
replacement coordinator, for the replacement coordinator to establish a
registration and coordination system, and for the incumbent MBAN
coordinator to transfer the registration data to the replacement
coordinator. The Commission also recognized that it is possible that
the coordinator would not continue in its role at some point. In such a
case, these notice and transfer requirements will be necessary to
ensure an effective transition of coordinators. The provisions will
help avoid having a period of time during which there would be no
functioning MBAN registration and coordination regime or creating a re-
registration burden on MBAN licensees.
32. Because the role of the MBAN coordinator is essential to
prevent harmful interference to a primary service, the Commission
indicated that it is important to allow the MBAN coordinator to be
replaced by the Commission if necessary. Consistent with the existing
procedures for the WMTS coordinator, the Commission delegated to the
Bureau the authority to remove the MBAN coordinator after giving
adequate notice if it determines that such an action would serve the
public interest. The Bureau can include specific provisions in the MOU,
including the notice it will give the coordinator.
33. Qualifying Criteria. In the Further Notice, the Commission
sought comment on the minimum qualifying criteria that should be
established for selecting an MBAN coordinator and proposed that parties
interested in being designated an MBAN coordinator must, at a minimum,
demonstrate that they meet the following criteria:
Ability to register and maintain a database of MBAN
transmitter locations and operational parameters;
Knowledge of or experience with medical wireless systems
in health care facilities (e.g., WMTS);
Knowledge of or experience with AMT operations;
Ability to calculate and measure interference potential
between MBAN and AMT operations and to enter into mutually satisfactory
coordination agreements with the AMT coordinator based on the
requirements in Sec. 95.1223(c);
Ability to develop procedures to ensure that registered
health care facilities operate an MBAN consistent with the requirements
in Sec. 95.1223.
34. In the Second Report and Order, the Commission required
applicants applying to become the MBAN coordinator to demonstrate that
they meet these five criteria. It determined that these criteria
``ensure that the designated coordinator can successfully accomplish
the functions required by our rules.'' The Commission declined to add
the additional criteria suggested by ASHE and Philips/GE to the core
criteria that it adopted, noting that some of these elements are
already addressed by the five criteria it adopted and determining that
other elements of the proposed criteria described qualities that would
likely be useful for an MBAN coordinator to possess but did not appear
essential for performing the coordination obligations required by the
rules that it adopted, were insufficiently concrete to warrant
certification, or would be expected to attend compliance with the
criteria it has specified.
35. The Commission also found that the MBAN coordinator should be
able to rely on a contract with a third party for
[[Page 60097]]
technical expertise, and it will consider such arrangements as part of
a candidate's demonstration that it satisfies the core qualifying
criteria. The Commission recognized that it may be difficult to
identify a single entity that satisfies all the minimum qualifying
criteria that it has adopted, and stated that a candidate that lacks
expertise in the core criteria may choose to rely on a third party for
technical support to demonstrate that it would be able to provide all
of the MBAN registration and coordination functions with minimal delay.
The Commission noted that the Bureau may exercise its authority to
terminate the tenure of the MBAN coordinator if the third-party
technical consultant stops providing service to the MBAN coordinator
and the Bureau is not persuaded that either the MBAN coordinator can
perform these necessary duties without assistance of a third-party
consultant or use of a replacement consultant will allow the
coordinator to meet its obligations under our rules.
36. The Commission found that MBAN coordinator candidates that rely
on third party contracts to demonstrate compliance with the core
qualifying criteria will need to disclose certain information about
such contracts. The Commission found that demonstration of the core
qualifying criteria will require the disclosure of more detailed
information because the relationship between the MBAN coordinator and a
third-party technical expert will affect both the coordinator's ability
to carry out its responsibilities and the program's ability to continue
if either the coordinator or the third-party expert must relinquish its
role. The Commission therefore directed the Bureau to require that
applicants for the MBAN coordinator role relying on a third party
consultant make a number of attestations regarding the consultant and
the contract between the consultant and the applicant, and to take this
information into account when judging the suitability of applicants for
the MBAN coordinator position. This information must include the
identity and qualifications of any third-party technical consultant the
MBAN coordinator will rely on, the length of time that the contract
between the MBAN coordinator and the third-party consultant would be in
effect, and under what circumstances that contract could terminate.
37. The Commission also indicated that the MOU should also
recognize the possibility that the technical consultant would stop
providing service to the MBAN coordinator. Upon such an occurrence, the
MBAN coordinator would need time to employ a replacement consultant who
meets the Commission's high standards and, if such a coordinator is not
found, the Commission needs time to replace the MBAN coordinator. The
Commission provided the Bureau with the discretion to include such
requirements in the MOU it executes with the MBAN coordinator.
38. Fees for Service. The Commission decided to permit the MBAN
coordinator to set fees for MBAN registration and coordination (as
opposed to having the Commission or the Bureau prescribe fees. The
Commission required that the fees charged for MBAN registration and
coordination be reasonable and reflect only the MBAN coordinator's
actual costs of providing the coordination and registration functions.
The MBAN coordinator will be required to provide the coordination and
registration functions on a not-for-profit basis. The Commission
determined that requiring that the MBAN coordinator provide services on
a not-for-profit basis was necessary because, with likely only one MBAN
coordinator, it cannot rely on competitive market forces to serve as a
check on the fees associated with MBAN registration and coordination.
If competitive forces are introduced and more than one coordinator is
selected, however, the Commission recognized that the need for such
regulations may no longer exist and may need to be reconsidered. The
Commission also required that the MBAN coordinator must provide
services on a non-discriminatory basis to all eligible health care
institutions.
39. The Commission concluded that the MBAN coordinator should
establish MBAN user fees that include all costs associated with MBAN
registration and coordination, including the cost of any third-party
technical consultant employed by the MBAN coordinator and the fees of
the AMT coordinator. This approach establishes a single pay point for
MBAN users and will simplify the registration and coordination process
for them, and is supported by the record. As with the other costs for
which the MBAN user is responsible, the cost of any third-party
technical consultant must be reasonable. This cost can include only the
MBAN coordinator's actual costs for such consultation services. The
amount of the payment to the AMT coordinator should be determined by
agreement between the AMT and MBAN coordinators, and would be
incorporated into the overall coordination fee that an MBAN user
incurs. The Commission indicated that it expects the AMT coordinator to
pass on only its actual coordination costs, on a not-for-profit basis,
to the MBAN coordinator. This cost may include the actual cost to the
AMT coordinator of coordinating Federal AMT operations, but may not
include charges for work performed by Federal employees such as the
Federal Government Area Frequency Coordinators. Because the costs
incurred by the AMT coordinator will be charged to the MBAN user as
part of the registration and coordination fees paid to the MBAN
coordinator, the Commission found that there is no need to place a
requirement in our rules that the MBAN user bear direct responsibility
for the AMT coordinator's cost.
40. On the matter of how reasonable costs should be evaluated and
what oversight the Commission should exercise over AMT-MBAN
coordination fees, the Commission observed that the Bureau has the
authority to investigate the reasonableness of the MBAN registration
and coordination fees, and it will do so as appropriate, either in
response to complaints or on its own motion. The MBAN coordinator will
be required to provide the Bureau with any information it requests in
the course of conducting such an investigation. In judging the
reasonableness of MBAN registration and coordination fees the Bureau
should consider the customary practices in other bands where
registration or coordination is required under the Commission's rules.
The Commission also required the MBAN coordinator to provide the Bureau
with its fee schedule upon request. This fee notification requirement
coupled with the ability to investigate the reasonableness of fees will
provide a necessary incentive for the MBAN and AMT coordinators to
maintain the fee structure for MBAN registration and coordination at a
reasonable level.
41. MBAN Coordinator Selection. The Commission directed the Bureau,
acting under its existing delegated authority, to select the MBAN
coordinator. Because the procedures the Bureau used in selecting the
WMTS coordinator were successful, it directed it to employ a similar
process to select the MBAN coordinator, including releasing a Public
Notice to announce procedures for interested parties to submit
applications for consideration as an MBAN coordinator, issuing an Order
to designate the MBAN coordinator, and executing a MOU on behalf of the
Commission with the selected coordinator that will set forth the
coordinator's authority and responsibilities. The Commission
anticipated that the MBAN coordinator
[[Page 60098]]
would assume its duties upon the execution of this MOU.
42. The Commission agreed with Philips/GE that the MBAN coordinator
and AMT coordinator should quickly reach agreement on mutually
agreeable procedures to create coordination agreements. Until such
procedures are in place, no registered MBAN system can be deployed.
Hence, the Commission required the selected MBAN coordinator to report
to the Commission when it has procedures in place with the AMT
coordinator allowing coordination agreements for MBAN systems to be
made. If no such report is made within six months of selection of the
MBAN coordinator, the Commission directed the Bureau to take all
necessary action to promote such an agreement.
43. The Commission declined to adopt AFTRCC's suggestion that
selection of the MBAN coordinator be contingent on executing a
coordination agreement with AFTRCC. The Commission emphasized that it
is the responsibility of both the selected MBAN coordinator and AFTRCC
to cooperate in good faith in developing procedures for MBAN
coordination.
44. Petition for Rulemaking. Ben Bartlett, who identifies himself
as a law student at the University of California Hastings College of
Law, filed a Petition for Rulemaking requesting that the Commission
allocate spectrum for MBAN use in an unused portion of the television
frequency bands. Bartlett claimed that the 2360-2400 MHz band is
unsuitable for MBAN use because interference between MBAN systems and
the AMT and amateur services would put patients at risk and interfere
with the operation of these services, that the amount of spectrum
available for MBAN operations was not sufficient to meet the future
demand for medical applications, and that the current MBAN frequencies
have limited propagation characteristics compared to the TV bands. He
envisioned an expanded role for MBAN devices where patients will not be
tied to a hub because the wireless link will be able to traverse long
distances and pass through buildings and other obstacles.
45. The Commission concluded that the petition does not warrant
further consideration at this time and dismissed it without prejudice.
First, the Commission pointed out that MBAN systems are designed to
provide wireless monitoring of patients over short distances to provide
patients with mobility in hospitals and other health care facilities.
In the First Report and Order, the Commission concluded that the 2360-
2400 MHz band is well suited for this purpose given the ability of MBAN
devices to share with spectrum with the incumbent users. Nothing in the
petition gave the Commission reason to question this conclusion.
Second, the petition asserted that the amount of spectrum the
Commission has allocated for MBAN use would not be sufficient to meet
future demand. The Commission found this claim to be speculative at
best, particularly given that no MBAN devices have been deployed.
Finally, the petition did not provide the technical details necessary
to draw conclusions as to the feasibility of the long-range medical
wireless devices that Bartlett envisions. The Commission concluded that
deployment of these types of devices may be possible under its existing
rules in other frequency bands.
Procedural Matters
46. Final Regulatory Flexibility Certification. The Regulatory
Flexibility Act of 1980, as amended (RFA) \1\ requires that a
regulatory flexibility analysis be prepared for rulemaking proceedings,
unless the agency certifies that ``the rule will not have a significant
economic impact on a substantial number of small entities.'' \2\ The
RFA generally defines ``small entity'' as having the same meaning as
the terms ``small business,'' ``small organization,'' and ``small
governmental jurisdiction.'' \3\ In addition, the term ``small
business'' has the same meaning as the term ``small business concern''
under the Small Business Act.\4\ 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 Small Business Administration (SBA).\5\
---------------------------------------------------------------------------
\1\ The RFA, see section 5 U.S.C. S 601 et. seq., has been
amended by the Contract With America Advancement Act of 1996, Public
Law 104-121, 110 Stat. 847 (1996) (CWAAA). Title II of the CWAAA is
the Small Business Regulatory Enforcement Fairness Act of 1996
(SBREFA).
\2\ 5 U.S.C. 605(b).
\3\ 5 U.S.C. 601(6).
\4\ 5 U.S.C. 601(3) (incorporating by reference the definition
of ``small business concern'' in Small Business Act, 15 U.S.C. S
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.''
\5\ Small Business Act, section 15 U.S.C. S 632.
---------------------------------------------------------------------------
47. In the Order on Reconsideration and Second Report and Order,
the Commission addressed a number of issues related to designating the
MBAN coordinator for the 2360-2390 MHz band. Among other actions, the
Commission concludes to only designate one MBAN coordinator, but
delegates to the Wireless Telecommunication Bureau (Bureau) the
authority to possibly designate more than one coordinator at a later
date. The Commission adopts a number of qualifying criteria to guide
the Bureau in selecting the coordinator, such as the ability to
register and maintain a database of MBAN transmitter locations,
knowledge of wireless systems in healthcare facilities and of AMT
operations, and the ability to calculate and measure interference
potential between MBAN and AMT operations. The Commission also adopts a
rule requiring that the MBAN coordinator provide registration and
coordination to all eligible healthcare facilities on a non-
discriminatory basis, provide the registration and coordination
services on a not-for-profit basis, notify the Commission six months
prior to ceasing to perform the functions of frequency coordinator, and
transmit the MBAN registration data in a usable form to another
coordinator designated by the Commission if it ceases to be the
frequency coordinator. While the decisions made and rules adopted in
the Order on Reconsideration and Second Report and Order could have a
significant economic impact on the MBAN coordinator, the Commission has
decided to designate only one MBAN coordinator. Although the Commission
does allow the Bureau to possibly designate multiple coordinators at a
later date, it does not foresee there ever being more than a couple of
MBAN coordinators.
48. The Commission also addresses several issues related to MBAN
users. First, the revisions to the authorized location rule will not
increase the number of health care facilities that can use the 2360-
2390 MHz band, and therefore will not impose regulatory burdens on any
new small entities. Second, in the Report and Order, the Commission
originally declined to require registration for the 2390-2400 MHz band
users because it concluded that such a requirement ``would
unnecessarily burden hospitals that do not need assistance from the
MBAN coordination.'' Under the revised registration requirement we are
adopting, the scope is narrower and it targets only those hospitals
that may eventually need to interact with MBAN coordinator. We find
that the benefit of providing the MBAN coordinator with this additional
information outweighs the slight increase in registration costs for
this limited number of MBAN
[[Page 60099]]
operators. In addition, we find that the increase in registration costs
is minor, and therefore will not have a significant economic impact on
a substantial number of small entities. Lastly, the remaining revisions
to Sec. 95.1223 do not change the regulatory burden on small business
health care facilities; they merely clarify the rules and do not have a
significant economic impact on any new small entities.
49. Therefore, the Commission certifies that the requirements of
this Order on Reconsideration and Second Report and Order will not have
a significant economic impact on a substantial number of small
entities. The Commission will send a copy of the Order on
Reconsideration and Second Report and Order including a copy of this
final certification, in a report to Congress pursuant to the Small
Business Regulatory Enforcement Fairness Act of 1996, see 5 U.S.C.
801(a)(1)(A). In addition, the Order on Reconsideration and Second
Report and Order and this certification will be sent to the Chief
Counsel for Advocacy of the Small Business Administration, and will be
published in the Federal Register. See 5 U.S.C. 605(b).
50. Congressional Review Act. The Commission will send a copy of
this Order on Reconsideration and Second Report and Order to Congress
and the Government Accountability Office pursuant to the Congressional
Review Act, see 5 U.S.C. 801(a)(1)(A).
51. Paperwork Reduction Act. This document contains new and
modified information collection requirements subject to the Paperwork
Reduction Act of 1995 (PRA), Public Law 104-13. The requirements will
be submitted to the Office of Management and Budget (OMB) for review
under section 3507(d) of the PRA. The Commission will publish a
separate notice in the Federal Register inviting comment on the revised
information collection requirements adopted in this document. The
requirements will not go into effect until OMB has approved them and
the Commission has published a notice announcing the effective date of
the information collection requirements.
Ordering Clauses
52. 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. 154(i), 301, 302a, 303(e), 303(f), 303(r), and
307(e), this Order on Reconsideration and Second Report and Order is
adopted.
53. The rules and requirements adopted herein will become effective
November 5, 2014, except for 47 CFR 95.1225(c), which includes new or
modified information collection requirements that require approval by
Office of Management and Budget under the PRA and will become effective
after such approval, on the effective date specified in a notice that
the Commission publishes in the Federal Register announcing such
approval and effective date.
54. Pursuant to the authority of section 5(c) of the Communications
Act of 1934, as amended, 47 U.S.C. 155(c), the Commission delegate
authority to the Wireless Telecommunications Bureau as set forth in
this Second Report and Order.
55. The Petition for Rulemaking filed by Ben Bartlett in ET Docket
Nos. 08-59 and 04-186 is denied.
56. The Joint Petition for Reconsideration of GE Healthcare,
Phillips Healthcare, and the Aerospace and the Flight Test Radio
Coordinating Council is granted in part and denied in part.
57. The Petition for Reconsideration of The American Society for
Healthcare Engineering of the American Hospital Association is granted.
58. The Commission's Consumer and Governmental Affairs Bureau,
Reference Information Center, shall send a copy of this Order on
Reconsideration and Second Report and Order, including the Final
Regulatory Certification, to the Chief Counsel for Advocacy of the
Small Business Administration.
List of Subjects in 47 CFR Part 95
Communications equipment, Medical devices, Reporting and
recordkeeping requirements.
Federal Communications Commission.
Marlene H. Dortch,
Secretary.
Final Rules
For the reasons discussed in the preamble, the Federal
Communications Commission amends 47 CFR part 95 as follows:
PART 95--PERSONAL RADIO SERVICES
0
1. The authority citation for part 95 is revised to read as follows:
Authority: 47 U.S.C. 154, 301, 302(a), 303, and 307(e).
Subpart E--Technical Regulations
0
2. Section 95.628 is amended by revising paragraph (c) 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.
* * * * *
(c) Requirements for Medical Body Area Networks. A MedRadio
programmer/control transmitter and its associated medical body-worn
transmitters shall not commence operating in, and shall automatically
cease operating in, the 2360-2390 MHz band if the programmer/control
transmitter does not receive, in accordance with the protocols
specified by the manufacturer, a control message permitting such
operation. Medical body-worn transmitters shall cease operating in
2360-2390 MHz if they lose communication with their associated
programmer/control transmitter. Additionally, a MedRadio programmer/
control transmitter and its associated medical body-worn transmitters
operating in the 2360-2390 MHz band shall comply with a control message
that notifies the devices to limit transmissions to segments of the
2360-2390 MHz band or to cease operation in the band.
* * * * *
0
3. Appendix 1 to Subpart E is amended by revising the definition of
``Medical Body Network'' to read as follows:
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 one or
more 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
4. 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. For the purposes of this subpart,
health care facilities are limited to hospitals and
[[Page 60100]]
other establishments, both Federal and non-Federal, that offer
services, facilities and beds for use beyond a 24 hour period in
rendering medical treatment.
0
5. Section 95.1209 is amended by revising paragraph (g) to read as
follows:
Sec. 95.1209 Permissible communications.
* * * * *
(g) Medical body-worn transmitters may relay only information in
the 2360-2400 MHz band to a MedRadio programmer/control transmitter or
another medical body-worn transmitter device 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 other MedRadio programmer/controller transmitters. Wireless
retransmission of all other information from an MBAN transmitter 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. Notwithstanding the above restriction, a MedRadio programmer/
control transmitter in the 2360-2400 MHz band may communicate with
another MedRadio programmer/control transmitter in the 2360-2400 MHz
band to coordinate transmissions so as to avoid interference between
the two Medical Body Area Networks.
* * * * *
0
6. Section 95.1213 is revised to read as follows:
Sec. 95.1213 Antennas.
(a) An antenna for a MedRadio transmitter shall not be configured
for permanent outdoor use.
(b) 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.
(c) Paragraphs (a) and (b) of this section do not apply to MedRadio
operations in the 2390-2400 MHz band.
0
7. Section 95.1223 is amended by revising the section heading,
paragraph (a) introductory text, and paragraphs (a)(3), (a)(5), and (b)
to read as follows:
Sec. 95.1223 Registration and frequency coordination.
(a) Registration. Prior to operating MBAN devices that are capable
of operation in the 2360-2390 MHz band, a health care facility, as
defined by Sec. 95.1203, must register with a frequency coordinator
designated under Sec. 95.1225. Operation of MBAN 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:
* * * * *
(3) Number of MedRadio programmer/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;
* * * * *
(5) Location of MedRadio programmer/control transmitters (e.g.,
geographic coordinates, street address, building);
* * * * *
(b) Notification. A health care facility shall notify the frequency
coordinator whenever an MBAN programmer/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
and locations as those reported on the health care facility's
registration which will cover the replacement transmitter(s). A health
care facility shall keep the information contained in each registration
current and shall notify the frequency coordinator of any material
change to the MBAN's location or operating parameters. In the event
that the health care facility proposes to change the MBAN's location or
operating parameters, the MBAN coordinator must first evaluate the
proposed changes and comply with paragraph (c) of this section, as
appropriate, before the health care facility may operate the MBAN in
the 2360-2390 MHz band under changed operating parameters.
* * * * *
0
8. Section 95.1225 is amended by revising paragraphs (a) and (b)(1) and
adding paragraph (c) 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 by eligible health
care facilities.
(b) * * *
(1) Register health care facilities that operate MBAN transmitters,
maintain a database of these MBAN transmitter locations and operational
parameters, and provide the Commission with information contained in
the database upon request;
* * * * *
(c) The frequency coordinator shall:
(1) Provide registration and coordination of MBAN operations to all
eligible health care facilities on a non-discriminatory basis;
(2) Provide MBAN registration and coordination services on a not-
for-profit basis;
(3) Notify the Commission of its intent to no longer serve as
frequency coordinator six months prior to ceasing to perform these
functions; and
(4) Transfer the MBAN registration data in usable form to a
frequency coordinator designated by the Commission if it ceases to be
the frequency coordinator.
[FR Doc. 2014-23519 Filed 10-3-14; 8:45 am]
BILLING CODE 6712-01-P