[Federal Register Volume 65, Number 137 (Monday, July 17, 2000)]
[Rules and Regulations]
[Pages 43995-44010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17970]
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FEDERAL COMMUNICATIONS COMMISSION
47 CFR Parts 1, 2, 15, 90 and 95
[ET Docket No. 99-255; PR Docket No. 92-235; FCC 00-211]
Wireless Medical Telemetry Service
AGENCY: Federal Communications Commission.
ACTION: Final rule.
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SUMMARY: This document allocates new spectrum and establishes rules for
a Wireless Medical Telemetry Service (WMTS) that allows potentially
life-critical equipment to operate on an interference-protected basis.
Medical telemetry equipment is used in hospitals and health care
facilities to transmit patient measurement data, such as pulse and
respiration rates to a nearby receiver, permitting greater patient
mobility and increased comfort. This action will increase the
reliability of medical telemetry equipment.
DATES EFFECTIVE: October 16, 2000.
FOR FURTHER INFORMATION CONTACT: Hugh Van Tuyl, Office of Engineering
and Technology, (202) 418-7506.
SUPPLEMENTARY INFORMATION: This is a summary of the Commission's Report
and Order, ET Docket 99-255 and PR Docket 92-235, FCC 00-211, adopted
June 8, 2000, and released June 12, 2000. The full text of this
Commission decision is available for inspection and copying during
normal business hours in the FCC Reference Information Center, Room CY-
A257, 445 12th Street, SW, Washington, DC, and also may be purchased
from the Commission's duplication contractor, International
Transcription Service, (202) 857-3800, 1231 20th Street, NW,
Washington, DC 20036.
Summary of the Report and Order
1. The Report and Order establishes a new Wireless Medical
Telemetry Service (WMTS) which will enhance the ability of health care
providers to offer high quality and cost-effective care to patients
with acute and chronic health care needs. This action addresses
consumer concerns that medical telemetry devices are increasingly at
risk of harmful interference due to more extensive use of spectrum
resources by other applications. The Commission allocates 14 Megahertz
(MHz) to WMTS on a primary basis, which will allow potentially life-
critical medical telemetry equipment to operate on an interference-
protected basis. The Commission also adopts service rules for WMTS that
``license by rule'' to minimize regulatory procedures to facilitate
rapid deployment. Medical telemetry equipment is used in hospitals and
health care facilities to transmit patient measurement data, such as
pulse and respiration rates to a nearby receiver, permitting greater
patient mobility and increased comfort. As this service permits remote
monitoring of several patients simultaneously it could also potentially
decrease health care costs. The Commission's action will improve the
reliability of this vital service.
2. In the Notice of Proposed Rule Making (NPRM), 64 FR 41891,
August 2, 1999, in this proceeding, we proposed to allocate spectrum
where medical telemetry equipment could operate on a primary basis. We
also proposed to establish a new Wireless Medical Telemetry Service
(WMTS) under part
[[Page 43996]]
95 of the rules. The Commission's proposal was based on recommendations
provided by the American Hospital Association's (AHA) Medical Telemetry
Task Force, which was established in coordination with the FDA, in
response to the incidence of interference to medical telemetry
equipment from a DTV station.
Spectrum Allocation
3. We are making available 14 MHz of spectrum in three blocks
located at 608-614 MHz, 1395-1400 MHz, and 1429-1432 MHz for wireless
medical telemetry. In making available 14 MHz of spectrum, we note that
these bands each have significant constraints, such that the entire
allocation is unlikely to be available in any individual market. The
608-614 MHz band is constrained as a result of radio astronomy quiet
zones, including some sites in large markets, and interference from
adjacent TV channels. The remaining 8 MHz that we are allocating is
constrained by adjacent band interference from high power radars
located below 1390 MHz and grandfathered protected Federal sites.
However, this allocation ensures that at least 6 MHz is available for
WMTS in all locations, consistent with the AHA needs assessment, with
at least some additional spectrum available to accommodate long term
needs. We note that this is in fact significantly less than the amount
of spectrum that is currently available to medical telemetry on an
unprotected basis. However, we find that the benefits of a primary
allocation dedicated to this service compensates for the reduced
availability of spectrum. We wish to underscore that we do not
anticipate any further allocations for medical telemetry devices and
expect manufacturers and the health care community to ensure that this
spectrum is used efficiently to meet long term needs. We also wish to
note that this medical telemetry allocation is an exception to the
approach we have been taking toward more flexible allocations that are
not service specific. A specific allocation is necessary in this case
to protect the public safety by providing spectrum where medical
telemetry equipment can operate without interference. Further, it will
resolve conflicts that have delayed the land mobile refarming and that
are affecting the deployment of DTV.
Frequency Bands
4. The Notice proposed the following two options for frequency
bands to be allocated to the WMTS:
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Option 1 Option 2
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608-614 MHz............................... 608-614 MHz
1395-1400 MHz............................. 1391-1400 MHz
1429-1432 MHz.............................
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The 608-614 MHz band corresponds to TV channel 37, which is not used
for TV stations and is currently reserved for radio astronomy. It is
available for medical telemetry under part 15 of the rules on an
unlicensed basis. The other proposed bands are former government bands
that were reallocated for non-government use under the Omnibus Budget
Reconciliation Act of 1993. Government operations in those bands may
continue at certain sites around the country for a number of years.
5. We conclude that it is necessary to allocate spectrum where
medical telemetry equipment can operate on a primary basis. Based on
the record, we also conclude that WMTS's planned use is best
accommodated by making three blocks of spectrum available in the 608-
614 MHz, 1395-1400 MHz, and 1429-1432 MHz bands. We will coordinate the
frequency allocations with Canadian and Mexican governments as
appropriate. Given the low-power nature of this equipment, we do not
anticipate any interference issues in border areas.
6. 608-614 MHz. We find the 608-614 MHz band to be suitable for
WMTS because, other than radio astronomy, it is only used for medical
telemetry under part 15 of the rules. We also note that no commenters
opposed the use of this band. Accordingly, we allocate this band to
medical telemetry equipment on a co-primary basis with radio astronomy.
Operation of medical telemetry equipment in this band must not cause
interference to sensitive radio astronomy operations, and users will be
required to coordinate their operation with radio astronomy facilities.
We note that medical telemetry service providers operating on 608-614
MHz (television channel 37) currently must accept adjacent channel
interference from broadcast television stations operating on channels
36 and 38. With this allocation, we are not requiring television
broadcasters to protect WMTS from adjacent band interference. We
believe that the multi-band approach that we are adopting provides
sufficient flexibility to WMTS. WMTS providers can operate on one of
the other bands that we are making available in situations where a
hospital is in close proximity to a television station operating on
channels 36 or 38. Furthermore, WMTS providers can design equipment to
provide sufficient protection from adjacent channel interference as is
current practice.
7. 1395-1400 MHz and 1429-1432 MHz. In addition to the 608-614 MHz
band, we are allocating the 1395-1400 MHz and 1429-1432 MHz bands for
medical telemetry. Allocating the 1395-1400 MHz band instead of the
alternative band we proposed will result in a 4 MHz greater frequency
separation between medical telemetry and government radars operating
below 1385 MHz, thereby reducing the risk of interference to medical
telemetry equipment. We find that the frequency separation between the
1395-1400 MHz and the 1429-1432 MHz bands will give greater flexibility
for medical telemetry by making the bands more useful for two-way
communications than a single contiguous band at 1391-1400 MHz.
Service Rules
8. We adopt service rules for the new Wireless Medical Telemetry
Service (WMTS). These service rules only apply to the WMTS that will
operate at 608-614 MHz, 1395-1400 MHz, and 1429-1432 MHz, and not to
the current medical telemetry operations permitted under parts 15 and
90. The rules include licensing requirements and technical standards
for the equipment, as well as a frequency coordination procedure.
9. Definition. In the NPRM, 64 FR 41892, August 2, 1999, we
proposed the following definition for medical telemetry:
Wireless medical telemetry is defined as the measurement and
recording of physiological parameters and other patient-related
information via radiated bi- or unidirectional electromagnetic signals.
10. We agree that allowing bi-directional transmissions could
promote the development of more advanced medical telemetry equipment
and encourage more efficient use of the spectrum. The split frequency
allocation we are adopting in this item was selected in part to
facilitate two-way communications. Accordingly, we are adopting a
definition of medical telemetry that will allow bi-directional
transmissions. We find it unnecessary to exclude voice and video
transmissions in the definition for medical telemetry.
11. Licensing. There were no comments opposing our proposal that
WMTS equipment be ``licensed by rule'', rather than requiring
individual operators'' licenses. Individual licensing is generally
designed to give a licensee a protected service area, and thus
establishes rights among competing entities in the same service.
Operators in the WMTS will not be in competition
[[Page 43997]]
with each other as are parties in other radio services. The WMTS
spectrum will be shared among medical telemetry users, and there will
be no mutual exclusivity between users. In addition, ``licensing by
rule'' will minimize regulatory procedures and thus facilitate
deployment. We are therefore adopting our proposal that the WMTS exist
as one of the Citizen's Band services contained in part 95 of the rules
and that the equipment used in this service be ``licensed by rule''.
The Commission has authority under Section 307(e) of the Communications
Act to define the citizen's band radio services and to license them by
rule.
12. Eligibility. We proposed that only authorized health care
providers be eligible to operate transmitters in the WMTS. For the
purpose of this service, an ``authorized health care provider'' would
be defined as (1) a physician or other individual authorized under
state or federal law to provide health care services; (2) a health care
facility operated by or employing individuals authorized under state or
federal law to provide health care services; or (3) any trained
technician under the supervision and control of an individual or health
care facility authorized under state or federal law to provide health
care services. We proposed to define a ``health care provider
facility'' as a hospital or other establishment that offers services,
facilities and beds for use beyond a 24 hour period in rendering
medical treatment, 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. Health care facilities on tribal
lands would also be included under our proposed definition. A health
care facility would not include an ambulance or other moving vehicle,
and this definition would also not allow home use of WMTS equipment. We
are adopting these eligibility definitions as proposed.
13. Frequency coordination. The comments supported our proposal to
designate a frequency coordinator to maintain a database of all WMTS
equipment identified by location, operating frequency, emission type
and output power. NTIA notes that a frequency coordinator would
facilitate band sharing between hospitals and the remaining government
operations at protected sites. Accordingly, we are adopting the
proposal to designate a frequency coordinator to maintain a database of
WMTS equipment. Without a database, there would be no record of WMTS
usage because WMTS transmitters will not be individually licensed. The
database will provide a record of the frequencies used by each facility
or device to assist parties in selecting frequencies to avoid
interference. The database will be used by eligible users and
manufacturers to plan for specific frequency use within a geographic
area, especially where numerous WMTS operations may occur.
14. The frequency coordinator will not be a decision maker as to
which frequency should be used. Rather, the coordinator will notify
users of potential frequency conflicts, and users should be able to
resolve any conflicts among themselves. We expect that there will be
few conflicts between users of WMTS equipment due to its low operating
power, but the Commission will make the final decision on a case-by-
case basis in disputes between users, if necessary. The coordinator
must be familiar with the medical telemetry user community, and must
make its services available to all parties on a first-come, first-
served and non-discriminatory basis. The frequency coordinator must be
willing to serve a five-year term, which could be renewed by the
Commission. In the event that a frequency coordinator does not wish to
continue at the end of its term, it will have to transfer its database
to another designated entity.
15. The NPRM, 64 FR 41892, August 2, 1999, asked for comments on
the following questions about the frequency coordinator: (1) any other
qualifications that a frequency coordinator must have, (2) whether a
single entity or multiple entities should be designated as frequency
coordinator(s), (3) how the frequency records could be maintained with
multiple coordinators, and (4) whether we should limit the fees the
frequency coordinator(s) can charge.
16. Several entities expressed an interest in being a frequency
coordinator for WMTS. In the past the Commission has tried, where
appropriate, to introduce market forces into the frequency coordination
process. Therefore, rather than adopt a Commission rule restricting
database management of WMTS spectrum to a single coordinator, we will
leave the ultimate decision on the number of coordinators up to the
Commission's Wireless Telecommunications Bureau (WTB). WTB already has
delegated authority to select frequency coordinators in the services it
administers. WTB will announce its coordination selection procedures in
a Public Notice in the near future. We have not found it necessary to
set limits on the fees charged by coordinators in other services, and
we have no reason to believe that fee limits will be necessary in the
WMTS. Accordingly, we will allow the designated coordinator to set the
fee structure as necessary to recoup costs.
17. The NPRM, 64 FR 41892, August 2, 1999, proposed that certain
information be submitted to the frequency coordinator for inclusion on
the database, including:
(1) Frequency range(s) used
(2) Modulation scheme used
(3) Effective radiated power
(4) Number of transmitters in use at the health care facility at
the time of registration
(5) Legal name of the authorized health care provider
(6) Location of transmitter (coordinates, street address, building)
(7) Point of contact for the authorized health care provider.
We find that including the equipment manufacturer and model number in
the database could be useful for helping the frequency coordinator and
users in determining the interference potential of WMTS equipment. This
information could also assist the Commission or the FDA in locating
certain devices in the event a question of compliance with the rules
arose. Accordingly, we will specify that the equipment manufacturer and
model number be submitted to the frequency coordinator for inclusion on
the database. Much of the other information (fax numbers, e-mail
addresses, assigned frequencies and occupied bandwidth) simply
represents a more detailed description of the information we proposed.
We agree with these recommendations and are including them in the final
rules. We recognize that including the name of the health care provider
and point of contact in the database could possibly make that
information available to commercial entities. However, we find that
this information is necessary to allow the coordinator and parties
using the WMTS to contact other users to verify information and resolve
potential conflicts. Thus, we will require the name of the health care
provider and a point of contact to be included on the database.
Including this information should not raise issues of privacy of
patient information, because the database will not contain the patient
names or other patient identification information.
18. We find that requiring periodic equipment registration renewals
from health care providers to be an unnecessary burden. Most hospitals
would find it difficult to remember to renew their registrations after
five years have passed, and requiring coordinators
[[Page 43998]]
to send out periodic renewal notices and process renewal applications
could significantly increase their workload. However, we will not
preclude coordinators from verifying the continued use of registered
equipment on an ``as needed'' basis, such as when the database shows a
conflict between a registered user and a new user. Accordingly, we are
adopting our proposal that equipment registrations will remain valid
until the health care provider requests cancellation. Restricting
access to the database to certain parties would be difficult and
burdensome for the coordinator because the coordinator would have to
verify that each and every party accessing the database has a need for
the information that is related to health care. Such restrictions could
make it difficult for parties with legitimate needs for information to
view the database. We therefore find that the database should be open
to all parties.
19. Permissible communications. We proposed that the WMTS could be
used for all types of communications, except for voice or video
transmissions. We proposed to exclude these types of transmissions
because we were concerned that video could occupy a significant portion
of the spectrum allocated to the WMTS, and that allowing voice
transmissions could encourage the equipment to be used as a form of
wireless intercom.
20. We find that the transmission of waveform information such as
electrocardiograms (ECGs) is within the intended purpose of the WMTS,
which is to transmit vital patient data. Accordingly, we will permit
the transmission of waveform information in the WMTS. However, allowing
the general purpose use of video in the WMTS could potentially result
in video occupying a large portion of the available spectrum. This is a
greater concern initially because portions of the WMTS spectrum will be
unavailable for a number of years in parts of the country due to
grandfathered government operations. We are not persuaded that there is
currently a need for voice capabilities in telemetry equipment, and we
reiterate our concern that allowing such capabilities could encourage
use of the equipment for other than its intended purpose of
transmitting patient data. Accordingly, we will prohibit voice and
video transmissions in the WMTS at this time, but we may revisit the
issue at a later date after government operations cease in the WMTS
bands.
21. Technical Standards. We proposed only minimal technical
standards for WMTS equipment to give manufacturers the flexibility to
develop different applications for medical telemetry. We did not
propose a specific channelization scheme for the 1395-1400 MHz and
1429-1432 MHz bands. However, to prevent users from monopolizing the
608-614 MHz band, we proposed that equipment using broadband
technologies, such as spread spectrum, be capable of operating on
channels of 1.5 MHz each, up to a maximum of 6 MHz. Such equipment
would operate on the minimum number of channels necessary, and must
have the capability of being ``throttled back'' so it will occupy as
little as one 1.5 MHz channel, if necessary, to allow multiple users to
share that band. There were no objections to the proposed requirement
on maximum channel usage in the 608-614 MHz band, so we are adopting
this requirement which will allow the WMTS spectrum to be used more
efficiently.
22. We proposed the following field strength limits for
transmitters in the WMTS.
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Maximum field Measurement Measurement
Frequency band strength distance bandwidth Detector function
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608-614 MHz 200 mV/m 3 meters 120 +/-20 kHz CISPR QP.
1395-1400 MHz 740 mV/m 3 meters 1 MHz Average.
1429-1432 MHz 740 mV/m 3 meters 1 MHz Average.
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23. We proposed the same out-of-band field strength limits for
transmitters in the WMTS bands that are used for most intentional
radiators under part 15 of the rules. We have found those limits to be
effective at controlling interference. There were no objections to
applying the part 15 out-of-band emission limits to WMTS equipment, and
we are adopting them.
24. Protection of other existing services. The WMTS must not cause
interference to radio astronomy operations, and to certain
grandfathered government operations. We are therefore adopting rules
requiring the coordination of WMTS operations in the 608-614 MHz band
with radio astronomy operations, which are the same as the coordination
requirements currently found in part 15. The rules also require
operators in the 1395-1400 MHz and 1429-1432 MHz bands to protect
certain government operations. Finally, parties using WMTS equipment
should be aware that the operation of transmitters in close proximity
to medical equipment could cause interference to the operation of the
medical equipment. The rules provide a warning to this effect, which is
the same warning found in part 15.
25. RF Safety. We do not currently require the routine evaluation
of medical telemetry equipment for compliance with the radiofrequency
(RF) radiation safety guidelines in our rules due to the low power of
the equipment. The NPRM, 64 FR 41892, August 2, 1999 did not propose to
require RF safety measurements for WMTS equipment because such
equipment would also operate at relatively low power levels.
26. Our rules for RF safety classify equipment into two categories:
(1) mobile devices, which normally operate with at least a 20
centimeter separation from the radiating element to the body of the
user or a nearby person , and (2) portable devices, which normally
operate with less than a 20 centimeter separation from the radiating
element to the body of the user. Based upon our analysis, we agree that
portable WMTS equipment could possibly exceed the RF safety guidelines
in our rules. Accordingly, we will require routine environmental
evaluation for RF exposure of portable WMTS equipment prior to
equipment authorization or use. We expect that the majority of WMTS
equipment will be classified as ``portable'' because medical telemetry
transmitters are typically worn on the body. However, we realize that
there may be some applications where the transmitter is separated from
the body by more than 20 centimeters, such as a unit mounted on a bed
or incorporated within a separate device. Consistent with the RF safety
requirements for other services, mobile WMTS equipment will be
categorically excluded from routine environmental evaluation because
WMTS equipment complying with the technical requirements we are
adopting will operate with an effective radiated power (ERP) of less
than 1.5 watts, which is the threshold for the exclusion of equipment
operating below 1.5 GHz.
27. Equipment authorization requirement. The NPRM, 64 FR 41892,
[[Page 43999]]
August 2, 1999 proposed authorizing WMTS transmitters through the
Declaration of Conformity (DoC) procedure in part 2 of the rules. DoC
is a manufacturer's self-approval procedure where the equipment is
tested to ensure it complies with the Commission's technical standards,
and may then be marketed without an approval by the Commission.
28. The certification procedure requires the manufacturer to file
electronically a test report showing the equipment complies with the
rules along with other supporting documentation to the Commission or to
a designated Telecommunication Certification Body (TCB). The equipment
may not be marketed until an approval has been received from the
Commission or a TCB. Upon further consideration, we agree that
certification is the appropriate authorization procedure for WMTS
equipment. WMTS equipment involves new technologies, and the majority
will be subject to routine environmental evaluation for RF safety.
Requiring certification is consistent with the actions we have taken in
similar cases, such as the Medical Implant Communication Service (MICS)
in part 95. However, we note that procedures for making the RF exposure
measurements are currently under development. When such procedures are
developed, we may consider relaxing the certification requirement for
medical telemetry equipment.
Transition Provisions
29. Equipment authorization. We proposed that all new medical
telemetry equipment that receives an equipment authorization starting
two years after the adoption of final rules must operate in the newly
authorized frequency bands. Two years is a reasonable timetable for
requiring manufacturers to produce equipment to operate in the new
bands. Based on the comments received, we are confident that
manufacturers will be able to meet this deadline. We decline to allow
equipment approved after that deadline to have the capability of
operating in the current part 15 and part 90 bands. Our goal in this
proceeding is to not only provide spectrum where medical telemetry he
Commission has taken, such as the freeze in the 450-470 MHz band and
the requirement for DTV stations to notify nearby health care
facilities, affect other parties. We therefore wish to encourage
medical telemetry users to migrate out of the current frequency bands
and into the new frequency bands. Allowing the development of new
equipment that can operate in the old bands after the transition date
would discourage the eventual migration to the new bands.
30. Grandfathering. Requiring the replacement of functional medical
telemetry systems that are not subject to interference would be an
unnecessary financial burden on hospitals. Accordingly, we will permit
medical telemetry equipment that has received an equipment
authorization to operate in current part 15 and part 90 bands prior to
the two year transition date to be manufactured, imported, marketed and
operated without a cutoff date. This action will ensure that
manufacturers will be able to make replacement parts for systems
operating in the old bands, and that hospitals will be permitted to
operate their existing systems as long as possible until replacement is
necessary due to age or interference concerns.
31. Existing equipment registration. We find it unlikely that a
complete database of all part 15 and part 90 medical telemetry
transmitters could be developed prior to the transition to the new
frequency bands. However, placing even some transmitters in a database
could possibly assist parties in avoiding cases of interference. We
therefore have no objection to allowing the voluntary registration of
existing part 15 and part 90 medical telemetry devices. The rules we
are adopting allow frequency coordinators to process voluntary requests
to register equipment operating under parts 15 and 90.
450-470 MHz Freeze
32. In 1995, the Commission adopted changes to part 90 of the rules
to allow more efficient use of the spectrum for land mobile services.
These changes permitted high power operations on channels in the 450-
470 MHz band. However, under the new channeling scheme, high-power
primary users of the band would be able to operate on the same
frequencies used for medical telemetry equipment. This could possibly
result in interference to medical telemetry equipment. For this reason,
on August 11, 1995, the Commission placed a freeze on the filing of
applications for high power operation in the 450-470 MHz band on the
12.5 kHz offset channels.
33. 450-460 MHz band freeze. On October 20, 1999, the Commission
issued a public notice asking parties operating medical telemetry
equipment in the 450-460 MHz band to provide certain information to the
Commission. We received responses from 25 parties around the country
operating in this band. The majority of these users were operating a
small number of devices on a limited number of frequencies around 457
and 458 MHz. Based on the limited usage of the 450-460 MHz band for
medical telemetry, we find that the freeze on high-power land mobile
applications in the 450-460 MHz band can be lifted. Accordingly, the
Wireless Telecommunications Bureau will issue a public notice
announcing the lifting of the freeze in this band in the near future.
34. 460-470 band freeze. We find that a five-year transition period
is longer than is necessary to prepare for the lifting of the freeze in
the 460-470 MHz band. The freeze was announced almost five years ago,
so hospitals have been on notice that they may eventually have to
change frequencies. Equipment is already available to operate in the
608-614 MHz band we are allocating in this proceeding, and equipment to
operate in the other bands allocated in this proceeding should become
available over the next two years. Five more years should not be
required for hospitals to make the transition. We will therefore lift
the freeze on high power land mobile application in the 460-470 MHz
band within three years from the effective date of final rules in this
proceeding.
35. The NPRM, 64 FR 41892, August 2, 1999, did not propose to
preclude medical telemetry equipment from operating in the ISM bands
under part 15 because only a small number of devices operate under
these provisions. Therefore, there is not the same potential for a
large number of cases of interference to medical telemetry equipment in
these bands as there is for medical telemetry equipment operating in
the TV and PLMR bands. We expect that the majority of medical telemetry
equipment manufacturers will design equipment for the new bands
allocated in this proceeding, and that only a small number of devices
will continue to use the ISM bands. There, we will continue to allow
medical telemetry equipment to operate in the ISM bands under part 15.
While such operation will be permissible, manufacturers and users are
cautioned that equipment operating in these bands has no protection
from interference from ISM equipment operating under part 18 of the
rules or other low power transmitters operating under part 15 of the
rules.
36. Pursuant to sections 4(I), 11, 301, 302, 303(e), 303(f), 303(r)
304, 307 and 332(b) of the Communications Act of 1934, as amended, 47
U.S.C. 154(i), 161, 301, 302, 303(3), 303(f), 303(r), 304, 307 and
332(b).
[[Page 44000]]
Final Regulatory Flexibility Analysis
37. As required by the Regulatory Flexibility Act (RFA), \1\ an
Initial Regulatory Flexibility Analysis (IRFA) was incorporated in the
Notice of Proposed Rule Making, Amendment of parts 2 and 95 of the
Commission's Rules to Establish a Wireless Medical Telemetry Service.
\2\ The Commission sought written public comment on the proposals in
the Notice, including comment on the IRFA. The comments received are
discussed below. This present Final Regulatory Flexibility Analysis
(FRFA) conforms to the RFA. \3\
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\1\ See 5 U.S.C. 603. The RFA, see 5 U.S.C. 601 et seq., has
been amended by the Contract With America Advancement Act of 1996,
Public Law 104-121, 110 Stat. 847 (1996) (CWAAA). Title II of the
CWAAA is the Small Business Regulatory Enforcement Fairness Act of
1996 (SBREFA).
\2\ See Notice of Proposed Rule Making in ET Docket 99-255, 64
FR 41891, 41896 (August 2, 1999).
\3\ See 5 U.S.C. 604.
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A. Need for, and Objectives of, the Report and Order
38. Medical telemetry equipment currently operates on an unlicensed
basis on certain unused TV channels under part 15 of the rules, and on
a secondary basis to private land mobile services in the 450-470 MHz
band under part 90 of the rules. With the transition to digital TV
service, both full power and low-power TV stations may begin operating
on some of the vacant channels used by medical telemetry equipment. In
addition, the new channelization scheme being implemented in the 450-
470 MHz band will allow high-power operation on the channels currently
reserved for low-power use where medical telemetry equipment operates.
Both of these changes could result in severe interference to medical
telemetry equipment. The rules adopted in the Report and Order allocate
new frequency bands where medical telemetry equipment can operate on a
primary basis without receiving interference.
B. Summary of Significant Issues Raised by Public Comments in Response
to the IRFA
39. There were no timely filed comments in response to the IRFA.
The Office of Advocacy, U.S. Small Business Administration (SBA) filed
``reply comments'' after the comment deadline, but prior to the reply
comment deadline. Because they do not respond to comments on the IRFA,
they are in fact untimely filed comments. Nevertheless, we will address
the issues raised by the SBA.
40. The SBA claims two deficiencies on the part of the Commission
in this proceeding. First, SBA states that the NPRM did not consider
the impact of the proposed rules on small businesses. \4\ Second, SBA
states that the IRFA does not describe the impact of the rules on small
businesses and does not provide significant alternatives designed to
minimize this impact. \5\
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\4\ See SBA comments at 1-2.
\5\ See SBA comments at 2-3.
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41. We believe SBA is clearly in error on the first point. The RFA
only requires agencies to provide an analysis of the impact of the
proposed rules on small businesses in the IRFA. \6\ There is no
requirement in the RFA to provide such an analysis in the NPRM, which
would unnecessarily duplicate the analysis in the IRFA. Thus we reject
SBA's first claim.
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\6\ See 5 U.S.C. 603(a).
---------------------------------------------------------------------------
42. We disagree with SBA on the second point as well. The RFA
requires the Commission to provide an analysis that discusses
significant alternatives such as (1) the establishment of differing
compliance or reporting requirements or timetables that take into
account the resources available to small entities; (2) the
clarification, consolidation, or simplification of compliance and
reporting requirements under the rule for such small entities; (3) the
use of performance rather than design standards; and (4) an exemption
from coverage of the rule, or any part thereof, for such small
entities. \7\ These are merely examples of the type of information that
should be included; this list is not a rigid checklist. The IRFA
included with the NPRM in this proceeding did in fact include an
analysis of the type required by the RFA. Specifically, it discussed
the simplified compliance and reporting requirements we considered to
minimize the impact of the rules on small businesses. We considered the
effect on small business from the outset and made the rules apply
equally to all parties. Thus, we consider the IRFA in this proceeding
to be adequate. We further note that no other parties had any
objections to the IRFA or considered it to be inadequate.
---------------------------------------------------------------------------
\7\ See 5 U.S.C. 603(c).
---------------------------------------------------------------------------
C. Description and Estimate of the Number of Small Entities To Which
the Proposed Rules Will Apply
43. The RFA directs agencies to provide a description of, and,
where feasible, an estimate of the number of small entities that may be
affected by the proposed rules, if adopted.\8\ Under the RFA, small
entities may include small organizations, small businesses, and small
governmental jurisdictions. 5 U.S.C. 601(6). The RFA, 5 U.S.C. 601(3),
generally defines the term ``small business'' as having the same
meaning as the term ``small business concern'' under the Small Business
Act, 15 U.S.C. 632. A small business concern is one which: (1) Is
independently owned and operated; (2) is not dominant in its field of
operation; and (3) satisfies any additional criteria established by the
SBA. This standard also applies in determining whether an entity is a
small business for purposes of the RFA.
---------------------------------------------------------------------------
\8\ See 5 U.S.C. 603(b)(3).
---------------------------------------------------------------------------
44. The Commission has not developed a definition of small entities
applicable to RF Equipment Manufacturers. Therefore, the applicable
definition of small entity is the definition under the SBA rules
applicable to manufacturers of ``Radio and Television Broadcasting and
Communications Equipment.'' According to the SBA's regulation, an RF
manufacturer must have 750 or fewer employees in order to qualify as a
small business.\9\ Census Bureau data indicates that there are 858
companies in the United States that manufacture radio and television
broadcasting and communications equipment, and that 778 of these firms
have fewer than 750 employees and would be classified as small
entities.\10\ Therefore, we believe that many of the companies that
manufacture RF equipment would qualify as small entities.
---------------------------------------------------------------------------
\9\ See 13 CFR 121.201, Standard Industrial Classification (SIC)
Code 3663.
\10\ See U.S. Department of Commerce, 1992 Census of
Transportation, Communications and Utilities (issued May 1995), SIC
category 3663.
---------------------------------------------------------------------------
45. According to the SBA's regulations, nursing homes and hospitals
must have annual gross receipts of $5 million or less in order to
qualify as a small business concern. 13 CFR 121.201. There are
approximately 11,471 nursing care firms in the nation, of which 7,953
have annual gross receipts of $5 million or less.\11\ There are
approximately 3,856 hospital firms in the nation, of which 294 have
gross receipts of $5 million or less. Thus, the approximate number of
small confined setting entities to which the Commission's new rules
will apply is 8,247.
---------------------------------------------------------------------------
\11\ See Small Business Administration Tabulation File, SBA Size
Standards Table 2C, January 23, 1996, SBA, Standard Industrial Code
(SIC) categories 8050 (Nursing and Personal Care Facilities) and
8060 (Hospitals). (SBA Tabulation File)
---------------------------------------------------------------------------
[[Page 44001]]
D. Description of Projected Reporting, Recordkeeping, and Other
Compliance Requirements
46. WMTS equipment will be authorized through the certification
procedure. The certification procedure requires the manufacturer to
file electronically a test report showing the equipment complies with
the rules along with other supporting documentation to the Commission
or to a designated Telecommunication Certification Body (TCB). The
equipment may not be marketed or operated until an approval has been
received from the Commission or TCB. This is the same process adopted
by the Commission for the Medical Implant Communication Service
(MICS).\12\ We are requiring that all parties including small
businesses have their equipment approved though the certification
procedure because of concerns over radiofrequency radiation safety.
---------------------------------------------------------------------------
\12\ See para. 53, supra.
---------------------------------------------------------------------------
47. Parties operating the equipment will not be required to obtain
an individual operator's license from the Commission, but they will
have to register with a frequency coordinator designated by the
Commission. The Commission may designate multiple coordinators to
provide competition to keep costs at a minimum. The information
submitted to the frequency coordinator will be:
(1) Specific frequencies or frequency range(s) used;
(2) Modulation scheme used (including occupied bandwidth);
(3) Effective radiated power;
(4) Number of transmitters in use at the health care facility as of
the date of registration (including manufacturer name(s) and model
numbers);
(5) Legal name of the authorized health care provider;
(6) Location of transmitter (coordinates, street address,
building);
(7) Point of contact for the authorized health care provider (name,
title, office, phone number, fax number, e-mail address).
E. Steps Taken to Minimize Significant Economic Impact on Small
Entities, and Significant Alternatives Considered.
48. We are not requiring individual operators' licenses for
equipment in the WMTS. Instead, the equipment will be ``licensed by
rule'', meaning that users are permitted to operate WMTS equipment that
complies with rules without the need to apply for a license from the
Commission. Licensing by rule benefits small businesses by eliminating
the expense and delays that would result if parties were required to
obtain individual operators' licenses.
49. New equipment for the WMTS will not have to operate in the
newly allocated frequency bands until two years after the effective
date of the new rules. This will allow sufficient time for
manufacturers to develop equipment for the new bands, thus reducing the
development costs for small businesses. We are also allowing equipment
in the old frequency bands that has received an equipment authorization
before the two year transition date to be manufactured, imported,
marketed and operated without a cutoff date. This will ensure that
replacement parts are available for existing telemetry systems and that
hospitals will be able to use their existing systems as long as
possible before replacement is required, thus reducing expenses for
small businesses.
50. There is currently a freeze on high-power land mobile
operations in the 450-470 MHz band. The freeze was put in effect in
1995 to protect medical telemetry in that band from interference. We
are providing a three-year transition period before lifting the freeze
in the 460-470 MHz band. This will assist small businesses by providing
adequate time for medical telemetry users to begin migration to the new
frequency bands, if necessary. The freeze in the 450-460 MHz band will
be lifted shortly after release of this Order because we have
determined that little medical telemetry equipment operates in this
portion of the band. Therefore, there will be little impact on small
businesses.
Report to Congress: The Commission will send a copy of the Report
and Order, Amendment of parts 2 and 95 of the Commission's Rules to
Establish a Wireless Medical Telemetry Service, including this FRFA, in
a report to be sent to Congress pursuant to the SBREFA, see 5 U.S.C.
801(a)(1)(A). In addition, the Commission will send a copy of the
Report and Order, including FRFA, to the Chief Counsel for Advocacy of
the SBA.
List of Subjects
47 CFR Part 1
Reporting and recordkeeping requirements
47 CFR Part 2 and 95
Communications equipment, Reporting and recordkeeping requirement.
47 CFR Part 15
Communications equipment.
47 CFR Part 90
Communications equipment, Emergency medical services.
Federal Communications Commission.
William F. Caton,
Deputy Secretary.
Rules Changes
For the reasons discussed in the preamble, the Federal
Communications Commission amends 47 CFR parts 1, 2, 15, 90, and 95 as
follows:
PART 1--PRACTICE AND PROCEDURE
1. The authority citation for part 1 continues to read as follows:
Authority: 47 U.S.C. 151, 154(i), 154(j), 155, 225, 303(r), 309
and 325(e).
2. Section 1.1307 is amended by revising paragraph (b)(2) to read
as follows:
Sec. 1.1307 Actions that may have a significant environmental effect,
for which Environmental Assessments (EAs) must be prepared.
* * * * *
(b) * * *
(2) Mobile and portable transmitting devices that operate in the
Cellular Radiotelephone Service, the Personal Communications Services
(PCS), the Satellite Communications Services, the General Wireless
Communications Service, the Wireless Communications Service, the
Maritime Services (ship earth stations only) and the Specialized Mobile
Radio Service authorized under Subpart H of parts 22, 24, 25, 26, 27,
80, and 90 of this chapter are subject to routine environmental
evaluation for RF exposure prior to equipment authorization or use, as
specified in Secs. 2.1091 and 2.1093 of this chapter. Unlicensed PCS,
unlicensed NII and millimeter wave devices are also subject to routine
environmental evaluation for RF exposure prior to equipment
authorization or use, as specified in Secs. 15.253(f), 15.255(g),
15.319(i), and 15.407(f) of this chapter. Portable transmitting
equipment for use in the Wireless Medical Telemetry Service (WMTS) is
subject to routine environment evaluation as specified in Secs. 2.1093
and 95.1125 of this chapter. Equipment authorized for use in the
Medical Implant Communications Service (MICS) as a medical implant
transmitter (as defined in Appendix 1 to Subpart E of part 95 of this
chapter) is subject to routine environmental evaluation for RF exposure
prior to equipment authorization, as specified in Sec. 2.1093 of this
chapter by finite difference time domain computational
[[Page 44002]]
modeling or laboratory measurement techniques. Where a showing is based
on computational modeling, the Commission retains the discretion to
request that specific absorption rate measurement data be submitted.
All other mobile, portable, and unlicensed transmitting devices are
categorically excluded from routine environmental evaluation for RF
exposure under Secs. 2.1091, 2.1093 of this chapter except as specified
in paragraphs (c) and (d) of this section.
* * * * *
PART 2--FREQUENCY ALLOCATIONS AND RADIO TREATY MATTERS; GENERAL
RULES AND REGULATIONS
3. The authority citation for part 2 continues to read as follows:
Authority: 47 U.S.C. 154, 302, 303, 307, 336, and 337, unless
otherwise noted.
4. Section 2.106 is amended as follows:
a. Revise the entries for the MHz bands of the Table of Frequency
Allocations to read as follows.
b. In the United States (US) footnotes, revise footnote US246 and
add footnotes US350, US351, and US352.
c. In the Government (G) footnotes, revise footnotes G27, G30, and
G114.
The revisions and additions read as follows:
Sec. 2.106 Table of frequency allocations.
* * * * *
BILLING CODE 6712-01-W
[[Page 44003]]
[GRAPHIC] [TIFF OMITTED] TR17JY00.033
[[Page 44004]]
[GRAPHIC] [TIFF OMITTED] TR17JY00.034
[[Page 44005]]
[GRAPHIC] [TIFF OMITTED] TR17JY00.035
[[Page 44006]]
[GRAPHIC] [TIFF OMITTED] TR17JY00.036
BILLING CODE 6712-01-C
* * * * *
[[Page 44007]]
United States (US) Footnotes
* * * * *
US246 Except for medical telemetry equipment operating in the band
608-614 MHz, no stations shall be authorized to transmit in the
following bands: 608-614 MHz, 1400-1427 MHz, 1660.5-1668.4 MHz, 2690-
2700 MHz, 4990-5000 MHz, 10.68-10.70 GHz, 15.35-15.40 GHz, 23.6-24.0
GHz, 31.3-31.8 GHz, 51.4-54.25 GHz, 58.2-59.0 GHz, 64-65 GHz, 86-92
GHz, 100-102 GHz, 105-116 GHz, 164-168 GHz, 182-185 GHz and 217-231
GHz. Medical telemetry equipment shall not cause harmful interference
to radio astronomy operations in the band 608-614 MHz and shall be
coordinated under the requirements found in 47 CFR 95.1119.
* * * * *
US350 In the bands 608-614 MHz, 1395-1400 MHz, and 1429-1432, the
land mobile service is limited to medical telemetry and telecommand
operations. Additionally, the band 1429-1432 MHz may be used on
secondary basis for non-Government land mobile telemetry and
telecommand and fixed telemetry.
US351 In the band 1390-1400 MHz, Government operations, except for
medical telemetry operations in the sub-band 1395-1400 MHz, are on a
non-interference basis to authorized non-Government operations and
shall not hinder implementation of any non-Government operations.
However, Government operations authorized as of March 22, 1995 at 17
sites identified below will be continued on a fully protected basis
until January 1, 2009.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Radius Radius
Sites Lat/Long (km) Sites Lat/Long (km)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Eglin AFB, FL....................... 30 deg.28'N/086 deg.31'W....... 80 Ft. Greely, AK........ 63 deg.47'N/145 deg.52'W 80
Dugway PG, UT....................... 40 deg.11'N/112 deg.53'W....... 80 Ft. Rucker, AL........ 31 deg.13'N/085 deg.49'W 80
China Lake, CA...................... 35 deg.41'N/117 deg.41'W....... 80 Redstone, AL.......... 34 deg.35'N/086 deg.35'W 80
Ft. Huachuca, AZ.................... 31 deg.33'N/110 deg.18'W....... 80 Utah Test Range, UT... 40 deg.57'N/113 deg.05'W 80
Cherry Point, NC.................... 34 deg.57'N/076 deg.56'W....... 80 WSM Range, NM......... 32 deg.10'N/106 deg.21'W 80
Patuxent River, MD.................. 38 deg.17'N/076 deg.25'W....... 80 Holloman AFB, NM...... 33 deg.29'N/106 deg.50'W 80
Aberdeen PG, MD..................... 39 deg.29'N/076 deg.08'W....... 80 Yuma, AZ.............. 32 deg.29'N/114 deg.20'W 80
Wright-Patterson AFB, OH............ 39 deg.50'N/084 deg.03'W....... 80 Pacific Missile Range, 34 deg.07'N/119 deg.30'W 80
CA.
Edwards AFB, CA..................... 34 deg.54'N/117 deg.53'W....... 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
US352 In the band 1429-1432 MHz, Government operations, except for
medical telemetry operations, are on a non-interference basis to
authorized non-Government operations and shall not hinder the
implementation of any non-Government operations. However, Government
operations authorized as of March 22, 1995 at 14 sites identified below
will be continued on a fully protected basis until January 1, 2004.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Radius Radius
Sites Lat/Long (km) Sites Lat/Long (km)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Patuxent River, MD.................. 38 deg.17'N/076 deg.25'W 70 Mountain Home AFB, ID. 43 deg.01'N/115 deg.50'W 160
NAS Oceana, VA...................... 36 deg.49'N/076 deg.02'W 100 NAS Fallon, NV........ 39 deg.24'N/118 deg.43'W 100
MCAS Cherry Point, NC............... 34 deg.54'N/076 deg.52'W 100 Nellis AFB, NV........ 36 deg.14'N/115 deg.02'W 100
Beaufort MCAS, SC................... 32 deg.26'N/080 deg.40'W 160 NAS Lemore, CA........ 36 deg.18'N/119 deg.47'W 120
NAS Cecil Field, FL................. 30 deg.13'N/081 deg.52'W 160 Yuma MCAS, AZ......... 32 deg.39'N/114 deg.35'W 160
NAS Whidbey IS., WA................. 48 deg.19'N/122 deg.24'W 70 China Lake, CA........ 35 deg.29'N/117 deg.16'W 80
Yakima Firing Ctr AAF, WA........... 46 deg.40'N/120 deg.15'W 70 MCAS Twenty Nine 34 deg.15'N/116 deg.03'W 80
Palms, CA.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
G27 In the bands 225-328.6, 335.4-399.9, and 1350-1395 MHz, the
fixed and mobile services are limited to the military services.
G30 In the bands 138-144, 148-149.9, 150.05-150.8, 1427-1429, and
1432-1435 MHz, the fixed and mobile services are limited primarily to
operations by the military services.
* * * * *
G114 In the band 1350-1395 MHz, the frequency 1381.05 MHz with
emissions limited to 12 MHz is also allocated to fixed and
mobile satellite services (space-to-earth) for the relay of nuclear
burst data.
* * * * *
5. Section 2.1093 is amended by revising paragraph (c) to read as
follows:
Sec. 2.1093 Radiofrequency radiation exposure evaluation: portable
devices.
* * * * *
(c) Portable devices that operate in the Cellular Radiotelephone
Service, the Personal Communications Service (PCS), the Satellite
Communications Services, the General Wireless Communications Service,
the Wireless Communications Service, the Maritime Services, the
Specialized Mobile Radio Service, the Wireless Medical Telemetry
Service (WMTS) and the Medical Implant Communications Service (MICS),
authorized under subpart H of part 22 of this chapter, part 24 of this
chapter, part 25 of this chapter, part 26 of this chapter, part 27 of
this chapter, part 80 of this chapter (ship earth station devices
only), part 90 of this chapter, subparts H and I of part 95, and
unlicensed personal communication service, unlicensed NII devices and
millimeter wave devices authorized under subparts D and E, Sec. 15.253
and Sec. 15.255 of part 15 of this chapter are subject to routine
environmental evaluation for RF exposure prior to equipment
authorization or use. All other portable transmitting devices are
categorically excluded from routine environmental evaluation for RF
exposure prior to equipment authorization or use, except as specified
in Secs. 1.1307(c) and 1.1307(d) of this chapter. Applications for
equipment authorization of portable transmitting devices subject to
routine environmental evaluation must contain a statement confirming
compliance with the limits specified in paragraph (d) of this section
as part of their application. Technical information showing the basis
for this statement must be
[[Page 44008]]
submitted to the Commission upon request.
* * * * *
PART 15--RADIO FREQUENCY DEVICES
6. The authority citation for Part 15 continues to read as follows:
Authority: 47 U.S.C. 154, 302, 303, 304, 307 and 544A.
7. Section 15.37 is amended by adding a new paragraph (i).
Sec. 15.37 Transition provisions for compliance with the rules.
* * * * *
(i) Effective October 16, 2002, an equipment approval may no longer
be obtained for medical telemetry equipment operating under the
provisions of Sec. 15.241 or Sec. 15.242. The requirements for
obtaining an approval for medical telemetry equipment after this date
are found in Subpart H of Part 95 of this chapter.
PART 90--PRIVATE LAND MOBILE RADIO SERVICES
8. The authority citation for Part 90 continues to read as follows:
Authority: Sections 4(i), 11, 303(g), 303(r), and 332(c)(7) of
the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 161,
303(g), 303(r), 332(c)(7).
9. Section 90.203 is amended by revising paragraph (a)(1) to read
as follows:
Sec. 90.203 Certification required.
(a) * * *
(1) Effective October 16, 2002, an equipment approval may no longer
be obtained for in-hospital medical telemetry equipment operating under
the provisions of this part. The requirements for obtaining an approval
for medical telemetry equipment after this date are found in Subpart H
of Part 95 of this chapter.
PART 95--PERSONAL RADIO SERVICES
10. The authority citation for Part 95 continues to read as
follows:
Authority: Sections 4, 303, 48 Stat. 1066, 1082, as amended; 47
U.S.C. 154, 303.
11. Section 95.401 is amended by adding a new paragraph (d) to read
as follows:
Sec. 95.401 (CB Rule 1) What are the Citizens Band Radio Services?
* * * * *
(d) The Wireless Medical Telemetry Service (WMTS)--a private, short
distance data communication service for the transmission of patient
medical information to a central monitoring location in a hospital or
other medical facility. Voice and video communications are prohibited.
Waveforms such as electrocardiograms (ECGs) are not considered video.
The rules for this service are contained in subpart H of this part.
12. Section 95.601 is amended by revising the last sentence of the
introductory text to read as follows:
Sec. 95.601 Basis and purpose.
* * * The Personal Radio Services are the GMRS (General Mobile
Radio Service)-subpart A, the Family Radio Service (FRS)-subpart B, the
R/C (Radio Control Radio Service)-subpart C, the CB (Citizens Band
Radio Service)-subpart D, the Low Power Radio Service (LPRS)-subpart G,
the Wireless Medical Telemetry Service (WMTS)-subpart H, and the
Medical Implants Communication Service (MICS)-subpart I.
13. Section 95.630 is added to read as follows:
Sec. 95.630 WMTS transmitter frequencies.
WMTS transmitters may operate in the frequency bands specified
below:
608-614 MHz
1395-1400 MHz
1429-1432 MHz
14. Section 95.631 is amended by adding a new paragraph (h) to read
as follows:
Sec. 95.631 Emission types.
* * * * *
(h) A WMTS station may transmit any emission type appropriate for
communications in this service, except for video and voice. Waveforms
such as electrocardiograms (ECGs) are not considered video.
15. Section 95.639 is amended by adding a new paragraph (f) to read
as follows:
Sec. 95.639 Maximum transmitter power.
* * * * *
(f) The maximum field strength authorized for WMTS stations in the
608-614 MHz band is 200 mV/m, measured at 3 meters. For stations in the
1395-1400 MHz and 1429-1432 MHz bands, the maximum field strength is
740 mV/m, measured at 3 meters.
16. Section 95.649 is revised to read as follows:
Sec. 95.649 Power capability.
No CB, R/C, LPRS, FRS, MICS or WMTS unit shall incorporate
provisions for increasing its transmitter power to any level in excess
of the limits specified in Sec. 95.639.
17. Section 95.651 is revised to read as follows:
Sec. 95.651 Crystal control required.
All transmitters used in the Personal Radio Services must be
crystal controlled, except an R/C station that transmits in the 26-27
MHz frequency band, a FRS unit, a LPRS unit, a MICS transmitter, or a
WMTS unit.
18. Appendix 1 to Subpart E to Part 95--Glossary of Terms is
revised to add the term ``WMTS. Wireless Medical Telemetry Service.''
at the end of the list.
19. A new Subpart H is added to Part 95 to read as follows:
Subpart H--Wireless Medical Telemetry Service (WMTS)
General Provisions
Sec.
95.1101 Scope.
95.1103 Definitions.
95.1105 Eligibility.
95.1107 Authorized locations.
95.1109 Equipment authorization requirement.
95.1111 Frequency coordination.
95.1113 Frequency coordinator.
95.1115 General technical requirements.
95.1117 Types of communications.
95.1119 Specific requirements for wireless medical telemetry
devices operating in the 608-614 MHz band.
95.1121 Specific requirements for wireless medical telemetry
devices operating in the 1395-1400 MHz and 1429-1432 MHz bands.
95.1123 Protection of medical equipment.
95.1125 RF Safety.
95.1127 Station identification.
95.1129 Station inspection.
* * * * *
Subpart H--Wireless Medical Telemetry Service (WMTS)
General Provisions
Sec. 95.1101 Scope.
This part sets out the regulations governing the operation of
Wireless Medical Telemetry Devices in the 608-614 MHz, 1395-1400 MHz
and 1429-1432 MHz frequency bands.
Sec. 95.1103 Definitions.
(a) Authorized health care provider. A physician or other
individual authorized under state or federal law to provide health care
services, or any other health care facility operated by or employing
individuals authorized under state or federal law to provide health
care services, or any trained technician operating under the
supervision and control of an individual or health care facility
authorized under state or federal law to provide health care services.
[[Page 44009]]
(b) Health care facility. A health care facility includes hospitals
and other establishments that offer services, facilities and beds for
use beyond a 24 hour period in rendering medical treatment, and
institutions and organizations regularly engaged in providing medical
services through clinics, public health facilities, and similar
establishments, including government entities and agencies such as
Veterans Administration hospitals; except the term health care facility
does not include an ambulance or other moving vehicle.
(c) Wireless medical telemetry. The measurement and recording of
physiological parameters and other patient-related information via
radiated bi-or unidirectional electromagnetic signals in the 608-614
MHz, 1395-1400 MHz, and 1429-1432 MHz frequency bands.
Sec. 95.1105 Eligibility.
Authorized health care providers are authorized by rule to operate
transmitters in the Wireless Medical Telemetry Service without an
individual license issued by the Commission provided the coordination
requirements in Sec. 95.1111 have been met. Manufacturers of wireless
medical telemetry devices and their representatives are authorized to
operated wireless medical telemetry transmitters in this service solely
for the purpose of demonstrating such equipment to, or installing and
maintaining such equipment for, duly authorized health care providers.
No entity that is a foreign government or which is active in the
capacity as a representative of a foreign government is eligible to
operate a WMTS transmitter.
Sec. 95.1107 Authorized locations.
The operation of a wireless medical telemetry transmitter under
this part is authorized anywhere within a health care facility provided
the facility is located anywhere a CB station operation is permitted
under Sec. 95.405. This authority does not extend to mobile vehicles,
such as ambulances, even if those vehicles are associated with a health
care facility.
Sec. 95.1109 Equipment authorization requirement.
(a) Wireless medical telemetry devices operating under this part
must be authorized under the certification procedure prior to marketing
or use in accordance with the provisions of Part 2, Subpart J of this
chapter.
(b) Each device shall be labeled with the following statement:
Operation of this equipment requires the prior coordination with a
frequency coordinator designated by the FCC for the Wireless Medical
Telemetry Service.
Sec. 95.1111 Frequency coordination.
(a) Prior to operation, authorized health care providers who desire
to use wireless medical telemetry devices must register all devices
with a designated frequency coordinator. The registration must include
the following information:
(1) Specific frequencies or frequency range(s) used;
(2) Modulation scheme used (including occupied bandwidth);
(3) Effective radiated power;
(4) Number of transmitters in use at the health care facility as of
the date of registration including manufacturer name(s) and model
numbers);
(5) Legal name of the authorized health care provider;
(6) Location of transmitter (coordinates, street address,
building);
(7) Point of contact for the authorized health care provider (name,
title, office, phone number, fax number, e-mail address).
(b) An authorized health care provider shall notify the frequency
coordinator whenever a medical telemetry device is permanently taken
out of service, unless the device is replaced with another transmitter
utilizing the same technical characteristics as those reported on the
effective registration. An authorized health care provider shall
maintain the information contained in each registration current in all
material respects, and shall notify the frequency coordinator when any
change is made in the location or operating parameters previously
reported which is material.
Sec. 95.1113 Frequency coordinator.
(a) The Commission will designate a frequency coordinator(s) to
manage the usage of the frequency bands for the operation of medical
telemetry devices.
(b) The frequency coordinator shall (1) Review and process
coordination requests submitted by authorized health care providers as
required in Sec. 95.1111; (2) maintain a database of WMTS use; (3)
notify users of potential conflicts; and (4) coordinate WMTS operation
with radio astronomy observatories and Federal Government radar systems
as specified in Secs. 95.1119 and 95.1121.
Sec. 95.1115 General technical requirements.
(a) Field strength limits. (1) In the 608-614 MHz band, the maximum
allowable field strength is 200 mV/m, as measured at a distance of 3
meters, using measuring instrumentation with a CISPR quasi-peak
detector.
(2) In the 1395-1400 MHz and 1429-1432 MHz bands, the maximum
allowable field strength is 740 mV/m, as measured at a distance of 3
meters, using measuring equipment with an averaging detector and a 1
MHz measurement bandwidth.
(b) Undesired emissions. (1) Out-of-band emissions below 960 MHz
are limited to 200 /m, as measured at a distance of 3 meters,
using measuring instrumentation with a CISPR quasi-peak detector.
(2) Out-of-band emissions above 960 MHz are limited to 500
m as measured at a distance of 3 meters using measuring
equipment with an averaging detector and a 1 MHz measurement bandwidth.
(c) Emission types. A wireless medical telemetry device may
transmit any emission type appropriate for communications in this
service, except for video and voice. Waveforms such as
electrocardiograms (ECGs) are not considered video.
(d) Channel use. (1) In the 1395-1400 MHz and 1429-1432 MHz bands,
no specific channels are specified. Wireless medical telemetry devices
may operate on any channel within the bands authorized for wireless
medical telemetry use in this part.
(2) In the 608-614 MHz band, wireless medical telemetry devices
utilizing broadband technologies such as spread spectrum shall be
capable of operating within one or more of the following channels of
1.5 MHz each, up to a maximum of 6 MHz, and shall operate on the
minimum number of channels necessary to avoid harmful interference to
any other wireless medical telemetry devices.
608.0-609.5 MHz
609.5-611.0 MHz
611.0-612.5 MHz
612.5-614.0 MHz
(3) Channel usage is on a co-primary shared basis only, and
channels will not be assigned for the exclusive use of any entity.
(4) Authorized health care providers, in conjunction with the
equipment manufacturers, must cooperate in the selection and use of
frequencies in order to reduce the potential for interference with
other wireless medical telemetry devices, or other co-primary users.
Operations in the 608-614 MHz band (television channel 37) are not
protected from adjacent band interference from broadcast television
operating on channels 36 and 38.
(e) Frequency stability. Manufacturers of wireless medical
telemetry devices are responsible for ensuring frequency stability such
that an emission is maintained within the band of operation under all
of the manufacturer's specified conditions.
[[Page 44010]]
Sec. 95.1117 Types of communications.
(a) All types of communications except voice and video are
permitted, on both a unidirectional and bidirectional basis, provided
that all such communications are related to the provision of medical
care. Waveforms such as electrocardiograms (ECGs) are not considered
video.
(b) Operations that comply with the requirements of this part may
be conducted under manual or automatic control, and on a continuous
basis.
Sec. 95.1119 Specific requirements for wireless medical telemetry
devices operating in the 608-614 MHz band.
For a wireless medical telemetry device operating within the
frequency range 608-614 MHz and that will be located near the radio
astronomy observatories listed below, operation is not permitted until
a WMTS frequency coordinator specified in Sec. 95.1113 has coordinated
with, and obtain the written concurrence of, the director of the
affected radio astronomy observatory before the equipment can be
installed or operated
(a) Within 80 kilometers of:
(1) National Astronomy and Ionosphere Center, Arecibo, Puerto Rico:
18 deg.20'38.28" North Latitude, 66 deg. 45'09.42" West Longitude.
(2) National Radio Astronomy Observatory, Socorro, New Mexico:
34 deg. 04'43" North Latitude, 107 deg.37'04" West Longitude.
(3) National Radio Astronomy Observatory, Green Bank, West
Virginia: 38 deg.26'08" North Latitude, 79 deg.49'42" West Longitude.
(b) Within 32 kilometers of the National Radio Astronomy
Observatory centered on:
------------------------------------------------------------------------
Very long baseline array stations Latitude (north) Longitude (west)
------------------------------------------------------------------------
Pie Town, NM...................... 34 deg. 18' 108 deg. 07'
Kitt Peak, AZ..................... 31 deg. 57' 111 deg. 37'
Los Alamos, NM.................... 35 deg. 47' 106 deg. 15'
Fort Davis, TX.................... 30 deg. 38' 103 deg. 57'
North Liberty, IA................. 41 deg. 46' 91 deg. 34'
Brewster, WA...................... 48 deg. 08' 119 deg. 41'
Owens Valley, CA.................. 37 deg. 14' 118 deg. 17'
Saint Croix, VI................... 17 deg. 46' 64 deg. 35'
Mauna Kea, HI..................... 19 deg. 49' 155 deg. 28'
Hancock, NH....................... 42 deg. 56' 71 deg. 59'
------------------------------------------------------------------------
The National Science Foundation point of contact for coordination
is: Spectrum Manager, Division of Astronomical Sciences, NSF Room 1045,
4201 Wilson Blvd., Arlington, VA 22230, telephone: 703-306-1823.
Sec. 95.1121 Specific requirements for wireless medical telemetry
devices operating in the 1395-1400 MHz and 1429-1432 MHz bands.
Due to the critical nature of communications transmitted under this
part, the frequency coordinator in consultation with the National
Telecommunications and Information Administration shall determine
whether there are any federal government radar systems whose operations
could affect, or could be affected by, proposed wireless medical
telemetry operations in the 1395-1400 MHz and 1429-1432 MHz bands. The
locations of government radar systems in these bands are specified in
footnotes US351 and US352 of Sec. 2.106 of this chapter.
Sec. 95.1123 Protection of medical equipment.
The manufacturers, installers and users of WMTS equipment are
cautioned that the operation of this equipment could result in harmful
interference to other nearby medical devices.
Sec. 95.1125 RF safety.
Portable devices as defined in Sec. 2.1093(b) of this chapter
operating in the WMTS are subject to radio frequency radiation exposure
requirements as specified in Secs. 1.1307(b) and 2.1093 of this
chapter. Applications for equipment authorization of WMTS devices must
contain a statement confirming compliance with these requirements.
Technical information showing the basis for this statement must be
submitted to the Commission upon request.
Sec. 95.1127 Station identification.
A WMTS station is not required to transmit a station identification
announcement.
Sec. 95.1129 Station inspection.
All WMTS transmitters must be available for inspection upon request
by an authorized FCC representative.
[FR Doc. 00-17970 Filed 7-14-00; 8:45 am]
BILLING CODE 6712-01-U