[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: 
[email protected].

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.

----------------------------------------------------------------------------------------------------------------
                                     Maximum field         Measurement          Measurement         Detector
         Frequency band                 strength             distance            bandwidth          function
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------


[[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.

----------------------------------------------------------------------------------------------------------------
                                     Maximum field         Measurement          Measurement         Detector
         Frequency band                 strength             distance            bandwidth          function
----------------------------------------------------------------------------------------------------------------
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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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)
---------------------------------------------------------------------------

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