Wireless Medical Telemetry Service

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

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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.

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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