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mHealth Alert FCC Proposes Rules for MBAN

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mHealth Alert: FCC Proposes Rules for
mHealth Alert: FCC Proposes Rules for


MBAN
MBAN



7/2/2009

The Federal Communications Commission (FCC) has proposed to allocate radiofrequency
The Federal Communications Commission (FCC) has proposed to allocate radiofrequency
spectrum and establish service and technical rules for the operation of Medical Body Area
           and establish service and technical rules for the operation of Medical Body
          (MBAN) systems. The              envisions that MBANs
Network (MBAN) systems. The FCC envisions that MBANs would provide a platform for the      for the
                       of multiple body sensors used for                         physiological data,
wireless networking of multiple body sensors used for monitoring a patient’s physiological data,
primarily in health care facilities. The use of MBANs would help eliminate the need for
primarily in health care facilities. The       of MBANs would help eliminate the need
            patient-attached cables used by current monitoring                             proposal
hardwired, patient-attached cables used by current monitoring technologies. The FCC’s proposal
                     its efforts to satisfy the spectrum
is a continuation of its efforts to satisfy the spectrum requirements of wireless medical
technologies, and is responsive to a request submitted by GE Healthcare (GEHC). The deadlines
technologies, and is responsive to a request submitted by GE Healthcare (GEHC). The deadlines
for submitting comments and reply comments on the FCC’s proposal are 60 and 90 days,
for submitting comments and reply comments on the FCC’s proposal are 60 and 90 days,
respectively, from the time the proposal is published in the Federal Register, which has not yet
respectively, from the time the proposal is published in the Federal Register, which has not yet
occurred.

                             MBAN could be created through attaching multiple wireless sensors
The FCC envisions that an MBANcould be created through attaching multiple wireless sensors
on the patient. The patient-attached devices would take readings of key information, such as
on  the patient. The patient-attached devices would take readings of key information, such as
temperature, pulse, blood glucose level, blood pressure, respiratory function, and a variety of
temperature, pulse, blood glucose level, blood pressure, respiratory function, and a variety
other physiological metrics. Antenna components in the sensors would then transmit the data
other physiological metrics. Antenna components in the sensors would then transmit the data
wirelessly a short distance to a              which would then relay the data or processed
wirelessly a short distance to a hub device, which would then relay the data or processed
information to another                facility for further centralized processing, display, and
information to another station in the facilityfor further centralized processing, display, and
storage.
storage.


Frequency Allocation
Frequency Allocation


The FCC is considering several possible frequency bands for use by MBANs.
                               possible frequency bands for use by MBANs.

2300-2305 MHz and 2360-2395 MHz Band
2300-2305 MHz and 2360-2395 MHz Band

GEHC’s request targeted the use of this band for MBANs. However, this band is currently used
GEHC’s request targeted the use of this band for MBANs. However, this band currently used
    several other services, including Aeronautical Mobile Telemetry (AMT),
by several other services, including Aeronautical Mobile Telemetry (AMT), federal
radiolocation, and amateur radio users. Nevertheless, the FCC seeks comment on the potential
radiolocation, and amateur radio users. Nevertheless, the FCC seeks comment on the potential
use of these bands by MBANs on a secondary (non-interference) basis. The FCC states
use of these bands by MBANs on a secondary (non-interference) basis. The FCC states that
         between MBAN systems and AMT and radiolocation operations could be facilitated if
sharing between MBAN systems and AMT and radiolocation operations could be facilitated if it
                                                                           limited to indoor use.
established exclusion zones around AMT test flight sites and MBANs were limited to indoor use.
established exclusion zones around AMT test flight sites and MBANs
The FCC also suggests that MBAN users may be able to coordinate their operations with AMT
                suggests that MBAN users may be able to coordinate their operations with AMT
licensees. According to GEHC, MBAN operations                                    AMT licensees
licensees. According to GEHC, MBAN operations could avoid interference from AMTlicensees
              with a                               detects AMT operations.
by operating with a contention-based protocol that detects AMT operations.

2400-2483.5 MHz Band
2400-2483.5 MHz Band
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             used by Industrial, Scientific and Medical (ISM) equipment on a non-licensed basis
This band is used by Industrial, Scientific and Medical (ISM) equipment on a non-licensed basis
                           addition to ISM devices, a portion of the band is allocated to amateur
under the FCC’s rules. In addition to ISM devices, a portion of the band is allocated to amateur
       the FCC’s
      operators,                           service and                        such as Wi-Fi routers
radio operators, the federal radiolocation service and unlicensed equipment such as Wi-Fi routers
and cordless phones. The FCC seeks comment on whether MBANs could operate in this band
and cordless phones. The FCC seeks comment on whether MBANs could operate in this band
              rules or whether new rules would be required to regulate MBANs using this band.
under current rules or whether new rules would be required to regulate MBANs using this band.

Other Frequency Bands
Other Frequency Bands


          seeks comment on whether other frequency bands may be appropriate for MBANs,
The FCC seeks comment on whether other frequency bands may be appropriate for MBANs,
including the 5150-5250 MHz band, which is now allocated for federal and non-federal
including the             MHz band, which is now allocated for federal and
aeronautical navigation and non-federal fixed-satellite use and unlicensed national information
                         and non-federal fixed-satellite    and unlicensed national information
               (U-NII) devices.
infrastructure (U-NII) devices.

Service and Technical
Service and Technical Rules               Rules
Service Rules
Service Rules

        seeks comments on the following potential attributes of MBAN systems:
The FCC seeks comments on the following potential attributes of MBAN systems:

       Licensing - Whether MBANs should operate without individual licenses (and instead, be
       Licensing - Whether MBANs should operate without individual licenses (and instead, be
       “licensed-by-rule”). Alternatively, the FCC asks whether MBANs should be licensed on a non-
       “licensed-by-rule”). Alternatively, the FCC asks whether MBANs should be licensed on a non-
       exclusive basis.
       exclusive basis.
       Definitions The FCC seeks comment on the definitions of “medical body area device,” “medical
       Definitions --The FCCseeks comment on the definitions of “medical body area device,” “medical
              area network,” “MBAN transmitter”         “MBAN control transmitter.”
       body area network,” “MBAN transmitter” and “MBAN control transmitter.”
       Permissible Communications and Operator Eligibility The FCC proposes requirements for
       Permissible Communications and Operator Eligibility - -The FCC proposes requirements for
       permissible communications and operator eligibility that are generally the same as those in
       permissible communications and operator eligibility that are generally the same as those in
       place for the MedRadio Service (which generally provide that devices may be used by persons
       place for the MedRadio Service (which generally provide that devices may be used by persons
       for diagnostic and therapeutic purposes, but only to the extent that such devices have been
       for diagnostic and therapeutic purposes, but only to the extent that such devices have been
       provided to a human patient under the direction of a duly authorized health care professional).
       provided to a human patient under the direction of a duly authorized health care professional).
       The FCC seeks comment on how spectrum may be used to perform backhaul from a single
       The FCC seeks comment on how spectrum may be used to perform backhaul from a single
       patient-based MBAN control transmitter to a monitoring station that receives and processes
       patient-based                  transmitter to a monitoring station that receives and processes
             from multiple patients. Today’s MedRadio rules do not allow transmitters to be
       data from multiple patients. Today’s MedRadio rules do not allow transmitters to be
       data
                                                                            the telephone
       interconnected with other telecommunications systems, including the telephone network.
                        with other telecommunications systems,

Technical Rules
Technical Rules

        seeks comments on the following potential technical attributes of MBAN systems:
The FCC seeks comments on the following potential technical attributes of MBAN systems:

       Channelization The FCC proposes not to adopt a channelization plan.
       Channelization -- The FCCproposes not to adopt a channelization plan.
       Exclusion Zones - As noted above, the FCC seeks comment on the feasibility of using exclusion
       Exclusion Zones - As noted above, the FCCseeks comment on the feasibility of using exclusion
       zones (and the technical parameters that would apply to those zones) as a means to prevent
       zones (and the technical parameters that would apply to those zones) as a means to prevent
       interference to incumbent operations in the 2360-2390 MHz band.
       interference to incumbent operations in the 2360-2390 MHz band.
       Frequency Coordination The FCC asks whether coordination should be required by MBANs
       Frequency Coordination--The FCCasks whether coordination should be required by MBANs
       with AMT and other incumbent users and, if so, how that coordination should be conducted.
       with AMT and other incumbent users and, if so, how that coordination should be conducted.
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       Alternatively, the FCC seeks comment on whether it should license MBANs on a non-exclusive
       Alternatively, the FCC seeks comment on whether it should license MBANs on a non-exclusive
       basis, similar to its regulation of the 3650-3700 MHz band.
       basis, similar to its regulation of the 3650-3700 MHz band.
       Frequency Monitoring (Spectrum-based Spectrum Access Protocols) The FCC invites comment
       Frequency Monitoring(Spectrum-based Spectrum Access Protocols) --The FCC invites comment
       on whether these techniques              be used to protect MBANs from interference from
       on whether these techniques should be used to protect MBANs from interference from entities
                               spectrum.
       that share the same spectrum.
       that share the same
       Transmitter Power, Emission Bandwidth, and Duty Cycle The FCC proposes to limit individual
       Transmitter Power, Emission Bandwidth, and Duty Cycle --The FCCproposes to limit individual
       MBAN devices to a maximum transmit power of 1 mW equivalent isotropic
       MBAN devices to a maximum transmit power of 1 mW equivalent isotropic radiated power
       (EIRP) measured in         megahertz bandwidth, and a maximum emission bandwidth of 1
       (EIRP)measured in aa11megahertz bandwidth, and a maximum emission bandwidth of 1
       megahertz. asks whether a duty cycle limit is needed to allow the functioning of contention-
       megahertz. It asks whether a duty cycle limit is needed to allow the functioning of contention-
       based spectrum access (and if so, what that duty cycle should be).
       based spectrum access(and if so, what that duty cycle should be).
       Channel Aggregation - The FCC proposes that the total emission bandwidth used by all devices
       Channel Aggregation - The FCC proposes that the total emission bandwidth used by all devices
       in any single patient MBAN communication session not exceed the maximum authorized
       in any single patient MBAN communication session not exceed the maximum authorized
       bandwidth of 1 megahertz.
       bandwidth of 1 megahertz.
       Unwanted Emissions - The MedRadio rules require that emissions on frequencies 500 kHz or
       Unwanted Emissions - The MedRadio rules require that emissions on frequencies 500 kHz or
       less above or below authorized bandwidth be attenuated by at least 20 dB below the
       less above or below authorized bandwidth be attenuated by at least 20 dB below the
       transmitter output power, and that frequencies more than 500 kHz above or below authorized
       transmitter output power, and that frequencies more than 500 kHz above
       bandwidth require attenuation based on varying signal strengths. The FCC asks whether the
       bandwidth require attenuation based on varying signal strengths. The FCC asks whether the
       same limits should apply for MBANs.
       same limits should apply for MBANs.
       Frequency Stability The FCC proposes that MBANs maintain a frequency stability of +/- 100
       Frequency Stability -- The FCCproposes that MBANs maintain a frequency stability of +/- 100
       ppm of the operating frequency over the range: 25 degrees centigrade to 45 degrees centigrade
       ppm of the operating frequency over the range: 25 degrees centigrade to 45 degrees centigrade
       in the case of MBAN transmitters, and 0 degrees centigrade to 55 degrees centigrade in the case
       in the case of MBAN transmitters, and 0 degrees centigrade to 55 degrees centigrade in the case
       of control transmitters.
       Antenna Locations - The FCC asks whether would be appropriate to restrict the use of MBAN
       Antenna Locations - The FCC asks whether ititwould be appropriate to restrict the use of MBAN
       transmitting antennas to indoor locations in certain frequency bands.
       transmitting antennas to indoor locations in certain frequency bands.
       Radiofrequency Safety The FCC seeks comment on whether MBANs should be classified as
       Radiofrequency Safety --The FCC seeks comment on whether MBANs should be classified as
       portable devices under its radiofrequency safety rules.
       portable devices under its radiofrequency safety rules.
       Miscellaneous Provisions The FCC seeks comment on whether: 1) each MBAN transmitter
       Miscellaneous Provisions -- The FCCseeks comment on whether: 1) each MBAN transmitter
       should be certified, except for transmitters not marketed in the United States; 2) all non-
       should be certified, except for transmitters not marketed in the United States; 2) all non-
       implanted MBANs should be available for inspection upon request of an authorized FCC
       implanted MBANs should be available for inspection upon request of an authorized FCC
       representative; 3) it should require manufacturers to disclose that devices must not cause
       representative; 3) it should require manufacturers to disclose that devices must not cause
       harmful interference to others; 4) devices should be labeled with such information; and 5) it
       harmful interference to others; 4) devices should be labeled with such information; and 5) it
       should specify that MBANs may be marketed and sold only for permissible uses.
       should specify that MBANs may be marketed and sold only for permissible uses.




For assistance this area, please            one                         below or any member of
For assistance in this area, please contact one of the attorneys listed below or any member of
     Mintz Levin client service team.
your Mintz Levin client service team.

Russell H. Fox
(202) 434-7483
RFox@mintz.com

Howard J. Symons
Howard J. Symons
(202) 434-7305
HJSymons@mintz.com
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Susan W. Berson
       W.
(202) 661-8715
SBerson@mintz.com

Heather L. Westphal
(202) 585-3538
HLWestphal@mintz.com

								
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