[Federal Register Volume 64, Number 147 (Monday, August 2, 1999)]
[Proposed Rules]
[Pages 41891-41897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19707]
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FEDERAL COMMUNICATIONS COMMISSION
47 CFR Parts 2 and 95
[ET Docket 99-255; FCC 99-182]
Wireless Medical Telemetry Service
AGENCY: Federal Communications Commission.
ACTION: Proposed rule.
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SUMMARY: This document proposes to amend the Commission's rules to
allocate spectrum and to establish rules for a Wireless Medical
Telemetry Service. This action is intended to allow potentially life-
critical medical telemetry equipment, which currently operates on a
secondary basis, unprotected from interference, to operate on a blanket
licensed, interference protected basis. We believe our action will
improve the reliability of this critical service.
DATES: Comments must be filed on or before September 16, 1999, and
reply comments must be filed on or before October 18, 1999.
ADDRESSES: Address all comments concerning this proposed rule to the
Commission's Secretary, Magalie Roman Salas, Office of the Secretary,
FCC, 445 12th Street SW, Washington, DC 20554.
FOR FURTHER INFORMATION CONTACT: Hugh L. Van Tuyl, Office of
Engineering and Technology, (202) 418-7506, TTY (202) 418-2989, e-mail:
hvantuyl@fcc.gov.
SUPPLEMENTARY INFORMATION: This is a summary of the Commission's Notice
of Proposed Rule Making, ET Docket 99-255, FCC 99-182, adopted July 14,
1999 and released July 16, 1999. The full text of this document is
available for inspection and copying during regular business hours in
the FCC Reference Information Center, Room CY-A257, 445 12th Street,
SW, Washington, DC, and is available on the FCC's Internet site at
http://www.fcc.gov/oet/dockets/et99-255/. The complete text of this
document may also be purchased from the Commission's duplication
contractor, International Transcription Service, Inc., (202) 857-3800,
1231 20th Street, NW, Washington, DC 20036.
Summary of Notice of Proposed Rule Making
1. The Commission proposes to amend parts 2 and 95 of the rules to
allocate spectrum and to establish service rules for a Wireless Medical
Telemetry Service. It proposes to allocate frequencies for medical
telemetry equipment to operate on a primary basis. Two possible options
for frequencies are proposed; (1) 608-614 MHz, 1395-1400 MHz and 1429-
1432 MHz, or (2) 608-614 MHz and 1391-1400 MHz. This action is intended
to allow potentially life-critical medical telemetry equipment, which
currently operates on a secondary basis, unprotected from interference,
to operate on a blanket licensed, interference protected basis. We
believe our action will improve the reliability of this critical
service.
2. Medical telemetry equipment is used in hospitals and health care
facilities to transmit patient measurement data to a nearby receiver,
permitting greater patient mobility and increased comfort. Examples of
medical telemetry equipment include heart, blood pressure and
respiration monitors. The use of these devices allows patients to move
around early in their recovery while still being monitored for adverse
symptoms. With such devices, one health care worker can monitor several
patients remotely, thus decreasing health care costs.
3. Currently, medical telemetry devices are allowed to operate
under either part 15 or part 90 of the Commission's rules. Part 15 of
the rules permits medical telemetry equipment to operate on an
unlicensed basis on TV channels 7-13 and 14-46 (174-216 MHz and 470-668
MHz). Part 90 of the rules permits medical telemetry equipment to
operate on a secondary basis to land mobile users in the 450-470 MHz
band.
4. There have been recent changes to the Commission's rules that
could result in harmful interference to medical telemetry equipment
operating under part 15. At the direction of Congress, the Commission
has provided for the introduction of digital television (DTV) stations
in the TV broadcast bands. In order to accomplish this, the Commission
has provided each local TV station with an additional channel that will
be used to broadcast DTV during the transition. This means that there
will be fewer vacant channels in every market, and that in some areas,
channels that were once unused for TV broadcasting may now be used for
DTV.
5. To reduce the possibility of DTV causing interference to medical
telemetry equipment, the Commission adopted changes to part 15 of the
rules in 1997 to increase the number of TV frequencies where medical
telemetry devices could operate on an unlicensed basis. These changes
allow operation on TV channels 14-46 in addition to channels 7-13,
which were the only channels where medical telemetry equipment was
previously allowed to operate. The Commission also increased the
maximum allowable operating
[[Page 41892]]
power for these devices to improve reliability.
6. The transition from analog to digital television is currently
under way, with the first stations commencing regular DTV broadcasting
in November 1998. The Commission has created over 1600 allotments for
DTV stations, a large percentage of which are on TV channels 7-46,
which are also used for medical telemetry equipment operating under
part 15 of the rules. All television stations are required to commence
DTV broadcasting no later than May 1, 2003. As existing stations begin
DTV operation on their new channels, some low-power television stations
currently operating on or adjacent to those channels may be forced to
switch frequency to avoid causing harmful interference to DTV, thereby
further crowding the spectrum used by medical telemetry equipment.
7. Concerns about possible interference to medical telemetry
equipment by DTV operations were recently heightened. In March 1998, a
TV station in Texas began test transmissions on a previously unused
channel that had been assigned to it for DTV operation. The
transmissions caused severe interference to the operation of medical
telemetry equipment at a nearby hospital, rendering the equipment
temporarily unusable. The station immediately ceased operation upon
learning of the interference, and the medical telemetry equipment was
changed to operate on another frequency. The Commission and the Food
and Drug Administration have since taken steps to help ensure that
hospitals are notified before new DTV stations come on the air to
provide them with time to modify any medical telemetry equipment that
operates on the same frequency.
8. The American Hospital Association's (AHA) Medical Telemetry Task
Force recently submitted recommendations to the Commission for
addressing the potential critical safety risks to patients from harmful
interference caused to wireless medical telemetry equipment. The task
force was established in response to the incidence of interference to
medical telemetry equipment from a DTV station. Among the AHA
recommendations are that specific frequencies be allocated for a
medical telemetry service, and that the service be given primary status
on those frequencies.
9. Medical telemetry equipment is increasingly relied upon in
hospitals to improve health care and reduce costs. Patients that
require the monitoring and treatment capabilities that were formerly
available only in intensive care units can be moved to general nursing
units. Patient recovery is also improved because the general nursing
unit offers a less stressful environment. The number of patients with
chronic medical conditions is rising due to the growth in the elderly
population. For these reasons, the need for monitoring patients outside
of intensive care is rapidly increasing, and this need can be fulfilled
with medical telemetry equipment. As we noted, it may be difficult for
this equipment to continue to operate in the bands used for DTV and the
PLMR services without receiving interference. Given the importance of
this equipment, we tentatively conclude that it is necessary to find
additional spectrum for medical telemetry equipment. We further
tentatively conclude that the spectrum should be allocated on a primary
basis to ensure that medical telemetry equipment is able to function
without interference from other sources. We seek comment on these
tentative conclusions.
10. The AHA performed a survey of 14 hospitals of various sizes in
both metropolitan and suburban/rural areas to determine the amount of
spectrum needed for medical telemetry equipment. The survey results
identify six categories of patient medical parameters that may be
measured, and indicate that up to 600 patients may need to be monitored
concurrently at a single facility. In order to calculate the required
spectrum, AHA assumed the transmitters would operate with a spectral
efficiency of 0.8 bits per second per Hertz, which is approximately the
same spectral efficiency the Commission requires in part 90 of the
rules. AHA then calculated the required spectrum for each of the six
categories of parameters and determined that a total of 6.125 MHz is
required to meet current patient needs. The AHA survey also indicated
that the spectrum requirements for medical telemetry equipment would
likely double within ten years. Therefore, AHA believes that in the
long term, at least 12 MHz of spectrum is needed for medical telemetry
equipment. We invite comment on this analysis, including whether the
assumed spectral efficiency is reasonable, and whether more spectrally
efficient technologies could be employed to reduce the amount of
spectrum required.
11. The AHA performed an analysis of the suitability of various
frequency bands, based on such factors as equipment costs, data
reliability, amount of spectrum in each band and equipment power
consumption. Based on its study, the AHA recommends that the following
frequency bands be used for the medical telemetry service: 608-614 MHz,
1385-1390 MHz and 1432-1435 MHz.
12. We note that other parties have expressed an interest in
operating in portions of the 1300 MHz and 1400 MHz bands adjacent to
the frequencies recommended by AHA. For example the Land Mobile
Communications Council (LMCC) has filed a petition for rule making to
allocate the 1390-1400 MHz and 1427-1432 MHz bands for private land
mobile services under part 90 of the rules. In addition, several
licensees of low earth orbit (``Little Leo'') satellite systems have
been performing studies on the feasibility of operating satellite
feeder uplinks in the 1390-1393 MHz band and downlinks in the 1429-1432
MHz band in an effort to obtain an international frequency allocation
for this purpose. A discussion of the frequency bands recommended by
AHA and the adjacent bands noted above follows. We request comment on
the impact that a frequency allocation for medical telemetry would have
on other prospective users of these bands.
13. We tentatively conclude that it is necessary to allocate
spectrum where medical telemetry equipment can operate on a primary
basis. The 608-614 MHz band appears to be suitable, because, other than
radio astronomy, it is only used for medical telemetry under part 15 of
the rules. Accordingly, we propose to allocate this band to medical
telemetry equipment on a co-primary basis with radio astronomy. Under
this proposal, operation in this band must not cause interference to
radio astronomy operations, and users will be required to coordinate
their operation with radio astronomy facilities.
14. While we make no finding regarding NTIA's assertion that the
1385-1390 and 1432-1435 MHz bands must be made available through
auction, in order to expedite this proceeding we propose to identify
spectrum in the 1390-1400 MHz and 1427-1432 MHz bands for medical
telemetry equipment. The medical telemetry allocation would be primary
to provide protection from interference, but would be non-exclusive. If
an international allocation for Little Leo feeder links were made in
the future, we could initiate a proceeding to domestically allocate
medical telemetry on a co-primary basis with Little Leo feeder links,
although medical telemetry equipment would continue to receive
protection from interference. We have devised two possible options for
a medical telemetry frequency allocation, which are discussed below. We
seek comment on which option is more suitable, or
[[Page 41893]]
whether any other alternative frequencies would be more suitable.
15 Option 1: 608-614 MHz/1395-1400 MHz/1429-1432 MHz. The 1395-1400
MHz band could be allocated for medical telemetry equipment as an
alternative to the 1385-1390 band recommended by AHA. Allocating this
band would provide the same amount of spectrum AHA requested in the
adjacent band, and would increase the frequency separation from
government radars operating below 1385 MHz, thereby reducing the risk
of interference to medical telemetry equipment. Also, the 1429-1432 MHz
band could be allocated as an alternative to the 1432-1435 MHz band
recommended by AHA. This would provide the same amount of spectrum as
requested by AHA in the adjacent band, and the frequency separation
between it and the 1395-1400 MHz band could make them more useful for
two-way communications. However, this option would use the 1429-1432
MHz band that the Little Leo satellite operators are investigating for
satellite feeder downlinks, as well as parts of the frequency bands
requested by LMCC in their petition. Commenters should address the
sharing possibilities and criteria for sharing between Little LEOs and
medical telemetry under this option.
16. Option 2: 608-614 MHz/1391-1400 MHz. A single band at 1391-1400
MHz could be allocated to medical telemetry equipment as an alternative
to the upper two bands recommended by AHA. This would provide an
additional 1 MHz of spectrum for medical telemetry. The larger
contiguous band could provide a greater opportunity for broadband
transmissions, although it may be less useful for two-way
communications than two separate bands. This option would resolve the
potential conflict with satellite downlinks in the 1429-1432 MHz band,
but would result in 2 MHz of overlap between the proposed medical
telemetry band and a possible 1390-1393 MHz satellite feeder uplink
band. This option would also use parts of the frequency bands requested
by LMCC in their petition. Commenters should address the sharing
possibilities and criteria for sharing between Little LEOs and medical
telemetry under this option.
17. We propose service rules for the new Wireless Medical Telemetry
Service (WMTS). These proposed service rules only apply to the WMTS and
not to the current medical telemetry operations under parts 15 and 90.
The proposed rules include licensing requirements and technical
standards for the equipment, as well as a frequency coordination
procedure. Our proposals are based primarily upon recommendations in
the AHA report submitted to the Commission. We request comment on all
aspects of these proposed rules.
18. AHA proposes 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.
19. Our intention is to create a Wireless Medical Telemetry Service
(WMTS) that will allow medical telemetry equipment to operate in
hospitals and medical facilities in much the same manner as the part 15
and part 90 rules allow, but without the potential for interference.
Because the definition proposed by AHA appears to encompass our
intention in creating this service, we propose it as the definition of
the medical telemetry, and request comment.
20. Licensing. Medical telemetry equipment operating under part 15
of the rules does not require an individual operator's license.
Similarly, medical telemetry equipment operating pursuant to part 90
does not require an individual operator's license. AHA states that,
given the number and nature of devices that could be operated in a new
medical telemetry service and the number of separate licenses that
could co-exist in a given area, there is no basis for the
administrative burden of individual licenses. AHA suggests that
equipment in the WMTS could be ``licensed by rule'', such as is done in
the Family Radio Service. We tentatively concur in AHA's assessment
that there is no need to require individual operators licenses in the
new WMTS. Individual licensing is generally designed to give a licensee
a protected service area, and thus establishes rights among competing
entities in the same service. We do not envision that operators in the
WMTS will be in competition with each other as are parties in other
radio services. Under our proposal, the WMTS spectrum would be shared,
and there would be no mutual exclusivity between users. We therefore
propose that the WMTS exist as one of the Citizen's Band services
contained in part 95 of the rules. The Commission has authority under
Section 307(e) of the Communications Act to license the Citizen's Band
services by rule and to define ``citizen's band radio service'' by
rule. We seek comment on our tentative conclusion.
Eligibility. AHA proposes that only authorized health care
professionals be eligible to operate transmitters in the WMTS. For the
purpose of this service, an ``authorized health care professional''
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. AHA suggests that we define a ``health
care facility'' as a hospital or other establishment that offers
services, facilities and beds for use beyond 24 hours 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 for their
own medical activities. A health care facility would not include an
ambulance or other moving vehicle. We propose the eligibility
restrictions recommended by AHA to ensure that use of the allocated
spectrum is limited to medical telemetry equipment. However, for the
sake of clarity, we will change the term ``authorized health care
professional'' to ``authorized health care provider'', and change
``beyond 24 hours'' to ``beyond a 24 hour period''. We seek comment on
this proposed eligibility requirement, including whether it should be
expanded to cover in-home medical uses and how it can be enforced
without individual licensing.
22. Frequency Coordination. AHA notes that if the WMTS were
``licensed-by-rule'', there would be no record of which frequencies are
used by each facility or device. This could result in interference if
multiple parties located close together attempt to use the same
frequencies. Accordingly, AHA recommends the appointment of a frequency
coordinator, who will maintain a database of all WMTS equipment in
operation. The database would be used by eligible users and
manufacturers to plan for specific frequency use within a geographic
area, especially where numerous WMTS operations may occur. Equipment
registered first in a geographic area would be entitled to protection
over later-registered equipment. We preliminarily agree that AHA's
proposal would assist WMTS users in avoiding interference. Accordingly,
we propose that all parties using equipment in the WMTS be required to
coordinate their operating frequency and other relevant technical
operating parameters with a
[[Page 41894]]
coordinator designated by the Commission. We seek comment on this
proposal.
23. Specifically, we propose that the designated frequency
coordinator would have responsibility to maintain an accurate
engineering database of all WMTS transmitters, identified by location,
operating frequency, emission type and output power. The frequency
coordinator, though, would not be a decision maker as to which
frequency should be used. The coordinator would notify users of
potential frequency conflicts. We expect that there will be few
conflicts between users of WMTS equipment due to its low operating
power, and that users will be able to resolve any conflicts among
themselves. The Commission would make the final decision, as necessary,
in disputes between users. We propose that a single frequency
coordinator be designated to handle all requests nationwide. 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 did not wish
to continue at the end of its term, it would have to transfer its
database to another designated entity. The Wireless Telecommunications
Bureau would have delegated authority to select the coordinator, and
would announce this selection by public notice. We seek comments on
this proposal, including: (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. We also invite parties interested in becoming a frequency
coordinator for the WMTS to file a written statement describing their
qualifications.
24. The frequency coordinator would be required to maintain a
database of the operating parameters submitted to it by users of the
WMTS. We propose to require that the frequency coordinator make the
database available to WMTS users, equipment manufacturers and the
public. AHA recommends that the information submitted to the
coordinator include:
(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 seek comment on these and any other possible information
requirements.
25. AHA recommends that equipment registrations be effective for a
term of five years, and may be renewed for additional five year terms.
Health care providers would have to notify the frequency coordinator
when a device is permanently taken out of service, unless it is
replaced with one with the same technical characteristics. Health care
providers would also be expected to notify the frequency coordinator of
any change in location or other operating parameters. We propose to
adopt these requirements, except for the more burdensome requirement
that equipment registrations be renewed every five years. We seek
comment on these proposals, in particular, whether an expiration date
for equipment registration is necessary to ensure the database does not
become ``cluttered'' with entries for equipment that is no longer in
service if users fail to notify the coordinator of the cessation of
operation. We also seek comment on who should have access to the
database.
26. Permissible communications. AHA recommends that all types of
information flows should be permissible in the service, including
voice, data, video and telecommand, on both a unidirectional and
bidirectional basis. We are concerned, however, about AHA's
recommendation to allow voice and video transmissions in the WMTS.
Allowing voice transmissions could encourage equipment in this service
to be used as a form of wireless intercom, rather than for its intended
purpose of transmitting vital patient data. Further, video
transmissions could occupy a significant portion of the available
spectrum for this service. Accordingly, we propose that the WMTS be
used for all types of communication, except voice or video
transmissions, on either a uni-or bi-directional basis. We seek
comments on these proposals.
27. Technical Standards. AHA recommends that the Commission adopt
only minimal technical standards for WMTS equipment. AHA states that
this flexibility will encourage manufacturers to develop different
applications for medical telemetry. AHA does not believe that the lack
of standards will lead to inefficient uses of the band. On the
contrary, it believes that allowing the industry to move forward
without government standards will result in a high degree of
innovation. We seek comment on this general approach, and whether the
Commission should adopt more specific requirements for certain
parameters (e.g.--spectral efficiency.)
28. AHA generally does not recommend a specific channelization
scheme for these bands. However, it is concerned that the use of
broadband technologies, such as spread spectrum, could allow a single
user to monopolize a band, which could inhibit the ability of other
health care facilities within an area to utilize narrowband
technologies. To facilitate sharing of the spectrum, it recommends that
broadband equipment operating in the 608-614 MHz band be capable of
operating within one or more 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. We are proposing
these requirements, which we believe will allow the WMTS spectrum to be
used efficiently. We seek comment on these proposals.
29. AHA recommends the following field strength limits for WMTS
transmitters.
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Maximum field Measurement Measurement Detector
Frequency band strength distance bandwidth function
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608-614 MHz..................... 370 mV/m........... 3 meters........... 12020 CISPR QP.
kHz.
1385-1390 MHz................... 740 mV/m........... 3 meters........... 1 MHz............. Average.
1432-1435 MHz................... 740 mV/m........... 3 meters........... 1 MHz............. Average.
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[[Page 41895]]
We note that the proposed limit in the 608-614 MHz band is
approximately 5 dB higher than the current part 15 limit for equipment
operating in this band. AHA does not provide a justification as to why
the limit should be increased, and we are concerned that a higher limit
could result in interference to radio astronomy. Accordingly, we
propose to maintain the current part 15 limit in the 608-614 MHz band.
We propose the higher limits recommended by AHA in the 1395-1400 MHz
and 1429-1432 MHz bands (or in the alternatively proposed 1391-1400 MHz
band) to offset the increased propagation losses at those frequencies.
We request comment on the appropriateness of these proposed limits.
Commenters who suggest alternatives to the frequency bands proposed in
this Notice should address the issue of appropriate limits in those
alternative bands.
30. AHA recommends the following out-of-band emission limits for
transmitters in the WMTS.
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Maximum field Measurement Measurement Detector
Frequency band strength distance bandwidth function
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608-614 MHz..................... 200 V/m... 3 meters........... 120 20 CISPR QP.
kHz.
1385-1390 MHz................... 500 V/m... 3 meters........... 1 MHz............. Average.
1432-1435 MHz................... 500 V/m... 3 meters........... 1 MHz............. Average.
----------------------------------------------------------------------------------------------------------------
These are the same as the current part 15 limits for out-of-band
emissions from most intentional radiators, which we believe to be
effective at controlling interference. Accordingly, we are proposing
AHA's recommended limits for the 608-614 MHz band, and for the 1395-
1400 MHz and 1429-1432 MHz bands (or the alternatively proposed 1391-
1400 MHz band). We request comment on the appropriateness of these
limits. Commenters who suggest alternatives to the frequency bands
proposed in this Notice should address the issue of appropriate limits
in those alternative bands.
31. Protection of other existing services. The WMTS must not cause
interference to radio astronomy operations, and to certain
``grandfathered'' government operations. We therefore propose rules
requiring the coordination of WMTS operations in the 608-614 MHz band
with radio astronomy operations, similar to the requirements in part
15. The proposed rules would also require that operation in the 1395-
1400 MHz and 1429-1432 MHz bands (or the alternatively proposed 1391-
1400 MHz band) must protect certain government operations. Finally,
parties using WMTS equipment would need to be aware that the operation
of transmitters in close proximity to medical equipment could cause
interference to the operation of the medical equipment. The proposed
rules would provide a warning to this effect, similar to the warning
found in the part 15 rules for medical telemetry equipment. Commenters
who suggest alternatives to the frequency bands proposed in this Notice
should address the need to protect other existing services.
32. Equipment authorization requirement. AHA recommends that WMTS
transmitters be authorized through the Declaration of Conformity (DoC)
procedure in part 2 of the rules. AHA also recommends that the
manufacturer be required to provide certain technical information to
the user in addition to the other information required as part of the
DoC process. DoC is a manufacturer's self-approval procedure where the
equipment is tested to ensure it complies with the Commission's
specified technical standards, and may then be marketed without an
approval by the Commission. We believe that DoC is an appropriate
authorization for WMTS equipment. The equipment is relatively low
powered, and will operate in a band reserved exclusively for medical
telemetry equipment, with the exception of a limited number of fixed
government operations. There is therefore less concern about the
equipment causing interference than would be the case if the band were
shared with other services. Accordingly, we propose that medical
telemetry equipment operating under the new WMTS be authorized through
the DoC procedure. We also propose that laboratories accredited to
perform DoC testing under part 15 of the rules be permitted to perform
DoC testing for equipment in the new WMTS, since the measurement
procedures are essentially the same for both types of equipment.
However, we would decline to require manufacturers to provide users
certain technical information AHA recommends as part of the DoC
process. We believe manufacturers would already provide this
information as a routine matter, so a requirement on our part is
unnecessary. We seek comments on these proposals, and whether
certification would be appropriate due to the fact that new types of
equipment may be developed for this service.
33. Transition Provisions. AHA believes that eventually all medical
telemetry equipment should be designed to operate in the new frequency
bands. AHA estimates it will take manufacturers approximately three to
four years to develop and market devices for these bands. Therefore,
they recommend that all equipment approved, beginning four years after
adoption of final rules, should be designed to operate in the new
frequency bands. AHA further recommends that equipment approved prior
to that date can continue to be manufactured, marketed and operated
indefinitely so that health care facilities are not forced to replace
devices that are still useful.
34. While our primary goal in this proceeding is to protect the
operation of medical telemetry equipment from harmful interference, we
need to balance that with the goal of allowing DTV and PLMR to grow and
develop without unnecessary delays. In that regard, we believe that
four years is a longer transition period than necessary for requiring
new equipment to operate in the new frequency bands. Equipment
operating in the 608-614 MHz band is already available under the
provisions of part 15, and AHA has indicated that equipment can be
rapidly developed for the other proposed bands. In order to encourage
users to migrate out of the DTV and PLMR bands as quickly as possible,
we propose that, beginning two years from the effective date of final
rules in this proceeding, all medical telemetry equipment authorized
must operate in the new frequency bands. Equipment that is already in
operation in the DTV and PLMR bands as of that date may continue to be
operated, but at the users' own risk. We seek comment on these
proposals, including whether we should place a cutoff date on the
manufacturing and importation of equipment authorized under parts 15
and 90.
35. AHA also is concerned that the Commission may lift the freeze
on high-power operation on the 12.5 kHz offset channels in the 450-470
MHz band. It
[[Page 41896]]
states that a five-year transition period starting from the adoption of
rules allocating spectrum for medical telemetry equipment is necessary
to avoid disastrous consequences to existing users. AHA states that a
shorter transition time may be possible in parts of the band, either by
relocating existing users or identifying channels which are not used by
medical telemetry devices. We seek comment on AHA's 5-year proposal,
and on what steps may be taken to allow an earlier lifting of the
freeze in the 450-470 MHz band without causing interference to medical
telemetry equipment.
Initial Regulatory Flexibility Analysis
36. As required by Section 603 of the Regulatory Flexibility Act, 5
U.S.C. 603, the Commission has prepared this present Initial Regulatory
Flexibility Analysis (IRFA) of the possible significant economic impact
on small entities by the policies and rules proposed in this Notice of
Proposed Rule Making (``NPRM''). Written public comments are requested
on this IRFA. Comments must be identified as responses to the IRFA and
must be filed by the deadlines for comments on the NPRM provided above.
The Commission will send a copy of this NPRM, including this IRFA, to
the Chief Counsel for Advocacy of the Small Business Administration in
accordance with paragraph 603(a) of the Regulatory Flexibility Act.
A. Need for, and Objectives of, the Proposed Rules
37. 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 with medical
telemetry equipment. The proposed rules are intended to allocate new
frequency bands where medical telemetry equipment can operate on a
primary basis without receiving interference.
B. Legal Basis
38. The proposed action is authorized under Sections 4(i), 301,
302, 303(e), 303(f), 303(r), 304 and 307 of the Communications Act of
1934, as amended, 47 U.S.C. Sections 154(i), 301, 302, 303(e), 303(f),
303(r), 304 and 307.
C. Description and Estimate of the Number of Small Entities to Which
the Proposed Rules Will Apply
39. 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 Small Business Administration
(``SBA''). This standard also applies in determining whether an entity
is a small business for purposes of the RFA.
40. 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.1 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.2 We believe that many of the companies that
manufacture RF equipment may qualify as small entities.
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\1\ See 13 CFR 121.201, Standard Industrial Classification (SIC)
Code 3663.
\2\ See U.S. Department of Commerce, 1992 Census of
Transportation, Communications and Utilities (issued May 1995), SIC
category 3663.
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41. 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.3 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.
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\3\ 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)
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D. Description of Projected Reporting, Recordkeeping, and Other
Compliance Requirements
42. We are proposing that equipment operating in the new frequency
bands be authorized through the Declaration of Conformity (DoC)
procedure. DoC is a manufacturer's self-approval procedure, in which
the manufacturer has the equipment tested at an accredited laboratory,
and is then permitted to market the equipment without a Commission
approval provided the equipment complies with the applicable technical
requirements. The DoC procedure requires the manufacturer to supply a
compliance statement with each product, and to retain test records.
43. 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 information submitted to the frequency coordinator will
be:
(1) Frequency range(s) used;
(2) Modulation scheme used;
(3) Effective radiated power;
(4) Number of transmitters in use at the health care facility as of
the date of coordination;
(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).
E. Steps Taken To Minimize Significant Economic Impact on Small
Entities, and Significant Alternatives Considered
44. We are proposing to allow equipment in this service to be
``licensed by rule''. This will eliminate the expense and delays that
would result if parties were required to obtain individual operators'
licenses. We are also proposing that equipment in this service be
authorized through the Declaration of Conformity procedure. This will
eliminate the delays in getting equipment to market that would result
if manufacturers were required to obtain certification through the
Commission or a designated Telecommunication Certification Body.
[[Page 41897]]
F. Federal Rules That May Duplicate, Overlap, or Conflict With the
Proposed Rule
45. None.
List of Subjects in 47 CFR Parts 2 and 95
Communications equipment.
Federal Communications Commission.
William F. Caton,
Deputy Secretary.
[FR Doc. 99-19707 Filed 7-30-99; 8:45 am]
BILLING CODE 6712-01-P
