[Federal Register Volume 62, Number 210 (Thursday, October 30, 1997)]
[Rules and Regulations]
[Pages 58656-58659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-28761]


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FEDERAL COMMUNICATIONS COMMISSION

47 CFR Part 15

[ET Docket No. 95-177; FCC 97-379]


Biomedical Telemetry Transmitters

AGENCY: Federal Communications Commission.

ACTION: Final rule.

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SUMMARY: By this Report and Order, the Commission amends its 
regulations regarding the unlicensed operation of biomedical telemetry 
transmitters in the 174-216 MHz (TV channels 7-13) and 470-668 MHz (TV 
channels 14-46) bands, as proposed in the Notice of Proposed Rule 
Making (``Notice'') in this proceeding, 61 FR 3367, January 31, 1996. 
These amendments will provide patients in health care facilities the 
ability to move about in a limited area while being continually 
monitored, speeding patient recovery times, shortening lengths of stay, 
and reducing health care costs. The standards being adopted for these 
devices should protect the licensed services operating in the TV bands. 
Further, a coordination procedure has been implemented to protect radio 
astronomy observatories from potential interference from biomedical 
telemetry systems operating on 608-614 MHz (TV channel 37).

DATES: Effective December 1, 1997.

ADDRESSES: Federal Communications Commission, 1919 M Street, N.W., 
Washington, D.C. 20554.

FOR FURTHER INFORMATION CONTACT: John A. Reed, Office of Engineering 
and Technology, (202) 418-2455.

SUPPLEMENTARY INFORMATION: This is a summary of the Commission's Report 
and Order in ET Docket No. 95-177, FCC 97-379, adopted October 9, 1997, 
and released October 20, 1997. The complete text of this Report and 
Order is available for inspection and copying during normal business 
hours in the FCC Reference Center (Room 239), 1919 M Street, N.W., 
Washington, D.C., and also may be purchased from the Commission's copy 
contractor, International Transcription Services, Inc., (202) 857-3800, 
1231 20th Street, NW, Washington, D.C. 20036.

Summary of the Report and Order

    1. In the Report and Order (``Order''), the Commission amended Part 
15 of its regulations to permit unlicensed biomedical telemetry 
transmission

[[Page 58657]]

systems operating on TV channels 7-46 in the 174-216 MHz and 470-668 
MHz frequency bands to be used in health care facilities. Biomedical 
telemetry transmitters are used in hospitals to transmit patient 
measurement data to a nearby receiver, permitting patient mobility and 
improved comfort. Typical devices include heart, blood pressure and 
respiration monitors.
    2. While the Commission proposed in the Notice to permit the 
operation of biomedical telemetry devices over TV channels 7-69, it 
noted that it was now proposing to reallocate TV channels 52-69 to 
other services. Further, it is undecided at this time whether the 
Commission will reallocate TV channels 2-6 or 47-51. Thus, the 
Commission amended its rules to permit unlicensed biomedical telemetry 
devices only on TV channels 7-46. The Commission believes that these 
products can share the spectrum with licensed services. Biomedical 
telemetry devices are expensive, complex products that are generally 
installed by the manufacturer or by a third party working with the 
manufacturer. In most cases, individual systems must be specifically 
engineered for each location. Further, biomedical telemetry devices are 
sensitive to interference. Because interference to these products could 
endanger the health and safety of patients using this equipment, it is 
expected that health care facilities, in combination with the 
manufacturers and installers, would expend considerable effort to avoid 
operating on occupied broadcast channels. Operators of unlicensed 
biomedical telemetry devices are reminded that they must accept 
whatever level of interference is received from other radio operations 
and are responsible for resolving any interference problems caused by 
the operation of their equipment, even if resolving that interference 
requires that the biomedical telemetry device cease operations.
    3. Protection from potential harmful interference from biomedical 
telemetry devices must be provided to all authorized operations within 
the TV bands, including TV broadcast stations operating under Part 73 
of the rules, Low Power TV, TV Translator and TV Booster Stations 
operation under Subpart G of Part 74 of the rules, Low Power Auxiliary 
Stations operating under Subpart H of Part 74 of the rules, and Private 
Land Mobile Radio Services operating under Part 90 of the rules. The 
minimum separation distances employed to avoid inference need to be 
established based on the protection criteria for the individual radio 
services. The interference analysis should not generally rely on 
assumptions about the attenuation of intervening walls and other 
objects since biomedical telemetry devices are designed to be used on 
ambulatory patients who could be near windows or immediately outside of 
the hospital walls, such as on an attached patio. Also, the 
interference analyses should not rely on assumptions about body 
shielding as manufacturers often request that measurement of body-worn 
transmitters be made while the transmitter is worn on a person. Based 
on these criteria, the Commission recalculated minimum co-channel 
separation distances that must be observed by the operators and 
installers of biomedical telemetry transmitters, as shown in the 
attached regulations. Parties wishing to operate biomedical telemetry 
transmitters on TV channel 37 should note that they first must obtain 
written concurrence from the director of the affected radio astronomy 
observatory if they are located closer than the specified minimum 
distance. The Commission declined to establish separation distances for 
adjacent channel operations, noting that the limits on unwanted 
emissions should prevent this type of interference problem.
    4. In the Order, the Commission established a maximum field 
strength limit of 200 mV/m, as measured at a distance of three meters. 
Further, the fundamental signal may not be wider than the 6 MHz 
bandwidth of a single TV channel, and the signal must be contained 
within a single TV channel. Emissions outside of the TV channel within 
which the fundamental emission from the biomedical telemetry 
transmitter is located must be attenuated to the general emission 
limits in 47 CFR Sec. 15.209.
    5. Accordingly, It is ordered that Part 15 of the Commission's 
Rules and Regulations is amended. This action is taken pursuant to 
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.

Final Regulatory Flexibility Analysis

    6. As required by Section 603 of the Regulatory Flexibility Act, 5 
U.S.C. Sec. 603 (RFA), Initial Regulatory Flexibility Analysis (IRFA) 
was incorporated into the Notice of Proposed Rule Making (``Notice'') 
in ET Docket No. 95-177.1 The Commission sought written 
public comments on the proposals in the Notice including the IRFA. The 
Commission's Regulatory Flexibility Analysis (FRFA) in this Report and 
Order conforms to the RFA, as amended by the Contract with America 
Advancement Act of 1996 (CWAAA), Public Law 104-121, 110 Stat. 847 
(1996).
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    \1\ Amendment of Part 15 of the Commission's Rules to permit 
operation of biomedical telemetry devices on VHF TV channels 7-13 
and on UHF TV channels, 11 FCC Rcd 1063 (1996).
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    7. Need for and Objective of the Rule. In this Order, the 
Commission amends Part 15 of its rules to expand the availability of 
frequencies and to increase the permitted power for unlicensed 
biomedical telemetry devices operating on VHF and UHF television 
channels 7-46 within health care facilities. These devices will provide 
patients the freedom to move about in a limited area while being 
continually monitored, speeding patient recovery times, shortening 
lengths of stay, and reducing health care costs. The changes to the 
regulations support spectrum efficiency by facilitating the sharing of 
scarce radio spectrum between two services and providing cost-efficient 
and needed medical technologies to health care communities.
    8. Summary of Significant Issues Raised by the Public Comments in 
Response to the Initial Regulatory Flexibility Analysis. No comments 
were received in direct response to the Initial Regulatory Flexibility 
Analysis. However, commenters expressed considerable concern regarding 
the potential impact of biomedical telemetry devices sharing spectrum 
with the TV broadcast frequencies, especially in light of the 
forthcoming introduction of DTV. Many of the commenters requested that 
dedicated spectrum, outside of the TV bands, should be set aside for 
biomedical telemetry devices. For example, the Society of Broadcast 
Engineers (SBE) states that potentially life-critical biomedical 
telemetry has no place as a ``bottom-of-the-food-chain'' Part 15 
device; if CCTG needs more spectrum, it should explore bands where such 
use can occur on a licensed, and therefore protected, basis. The Public 
Broadcasting Service and the Association of America's Public Television 
Stations (PBS/APTS) add that it would be a mistake for the Commission 
to establish a new system in the TV broadcasting spectrum where 
substantial changes are planned. The Community Broadcasters Association 
(CBA) states that TV spectrum is a poor environment into which to 
launch more intensive and higher powered use of critical medical 
devices on which health and lives will depend. Even CCTG states that 
the Commission should consider dedicating spectrum to the exclusive use 
of medical telemetry after the DTV

[[Page 58658]]

transition. Other commenters, such as the Leesburg Regional Medical 
Center and Texas Children's Hospital, are concerned that interference 
will be caused to biomedical devices from TV signals rather than 
interference from biomedical devices to TV signals.
    9. The Critical Care Telemetry Group that petitioned the Commission 
to implement these rule changes and filed comments in this proceeding 
consists of Hewlett-Packard Company Medical Products Group, Marquette 
Electronics, Inc., Pacific Communications, Siemens Medical Systems, 
Inc., and SpaceLabs Medical, Inc.
    10. Description and Estimate of the Number of Small Entities 
Subject to Which the Rules Apply. For purposes of the Report and Order, 
the RFA 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. Sec. 632, unless the Commission has developed 
one or more definitions that are appropriate to its 
activities.2 Under the Small Business Act, a small business 
concern is one that: (1) Is independently owned and operated; (2) is 
not dominant in its field of operation; and (3) meets any additional 
criteria established by the Small Business Administration (SBA). Since 
the Regulatory Flexibility Act amendments were not in effect until the 
record in this proceeding was closed, the Commission was unable to 
request information regarding the number of small businesses that would 
be affected by this action. The rules adopted in this Report and Order 
apply to the operation of unlicensed biomedical telemetry transmitter 
devices for medical care facilities. These devices are used to transmit 
data, including heart, blood pressure and respiration monitors, to a 
nearby receiver.
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    \2\ See 5 U.S.C. Sec. 601(3).
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    11. The Commission has not developed a definition of small entities 
applicable to biomedical telemetry transmitter devices. Therefore, the 
applicable definition of small entity is the definition under the Small 
Business Administration (SBA) rules applicable to Communications 
Services ``Not Elsewhere Classified.'' This definition provides that a 
small entity is one with $11.0 million or less in annual 
receipts.3 According to Census Bureau data, there are 848 
firms that fall under the category of Communications Services, Not 
Elsewhere Classified. Of those approximately 775 reported annual 
receipts of $11 million or less and qualify as small 
entities.4 This category is very broad, and we are unable to 
determine how many operators of unlicensed biomedical telemetry devices 
will qualify as small entities.
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    \3\ 13 CFR 121.201, Standard Industrial Classification (SIC) 
Code 4899.
    \4\ U.S. Bureau of the Census, U.S. Department of Commerce, 1992 
Census of Transportation, Communications, and Utilities, UC92-S-1, 
Subject Series, Establishment and Firm Size, Table 2D, Employment 
Size of Firms: 1992, SIC Code 4899 (issued May 1995).
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    12. Description of Projected Reporting, Recordkeeping and Other 
Compliance Requirements. The rule change will not alter current 
reporting, recordkeeping or other requirements. To receive equipment 
authorization to operate on the television channels, applicants would 
have to demonstrate that their biomedical telemetry devices comply with 
the equipment standards and obtain an authorization from the 
Commission.
    13. Significant Alternatives and Steps Taken by Agency to Minimize 
Significant Economic Impact on a Substantial Number of Small Entities 
Consistent with Stated Objectives. While the Notice proposed to permit 
biomedical telemetry operation over the frequency ranges of 174-216 MHz 
and 470-806 MHz (TV channels 7-69), we no longer believe that this 
entire frequency range can be made available. In the DTV Sixth Report 
and Order in MM Docket No. 87-268 the Commission indicated that it 
plans to reallocate TV channels 52-69 (698 MHz to 806 MHz) to other 
services and will reallocate either TV channels 2-6 (54-88 MHz) or 47-
51 (668-698 MHz).5 Thus, this spectrum no longer appears 
suitable for assignment to unlicensed biomedical telemetry operation. 
Accordingly, we are amending the rules to permit the operation of 
biomedical telemetry devices only over the frequency bands of 174-216 
MHz and 470-668 MHz (TV channels 7-46).
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    \5\ See the Sixth Report and Order in MM Docket No. 87-268, 62 
FR 26684, May 14, 1997. See also the Notice of Proposed Rule Making 
in ET Docket No. 97-157, 62 FR 41012, July 31, 1997, proposing to 
reallocate TV channels 60-69 for public safety use and for other 
services. In addition, see Balanced Budget Act of 1997, Public Law 
105-33, 111 Stat. 251 (1997), requiring the Commission to reallocate 
TV channels 52-69 for other services.
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    14. Report to Congress. The Commission shall send a copy of this 
Final Regulatory Flexibility Analysis, along with this Report and 
Order, in a report to Congress pursuant to the Small Business 
Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 
Sec. 801(a)(1)(A).

List of Subjects

47 CFR Part 15

    Communications equipment, Radio, Reporting and recordkeeping 
requirements.

Federal Communications Commission.
William F. Caton,
Acting Secretary.

Rule Changes

    Title 47 of the Code of Federal Regulations, Part 15, is amended as 
follows:

PART 15--RADIO FREQUENCY DEVICES

    1. The authority citation for part 15 continues to read as follows:

    Authority: Secs. 4, 302, 303, 304, 307 and 624A of the 
Communications Act of 1934, as amended, 47 U.S.C. 154, 302, 303, 
304, 307 and 544A.

    2. Section 15.205 is amended by adding a new paragraph (d)(5), to 
read as follows:


Sec. 15.205  Restricted bands of operation.

* * * * *
    (d) * * *
    (5) Biomedical telemetry devices operating under the provisions of 
Sec. 15.242 of this part are not subject to the restricted band 608-614 
MHz but are subject to compliance within the other restricted bands.
* * * * *
    3. Section 15.209 is amended by revising paragraph (g) to read as 
follows:


Sec. 15.209  Radiated emission limits; general requirements.

* * * * *
    (g) Perimeter protection systems may operate in the 54-72 MHz and 
76-88 MHz bands under the provisions of this section. The use of such 
perimeter protection systems is limited to industrial, business and 
commercial applications.
    4. A new Sec. 15.242 is added to read as follows:


Sec. 15.242  Operation in the bands 174-216 MHz and 470-668 MHz.

    (a) The marketing and operation of intentional radiators under the 
provisions of this section is restricted to biomedical telemetry 
devices employed solely on the premises of health care facilities.
    (1) A health care facility includes hospitals and other 
establishments that offer services, facilities, and beds for use beyond 
24 hours in rendering medical treatment and institutions and 
organizations regularly engaged in providing medical services through

[[Page 58659]]

clinics, public health facilities, and similar establishments, 
including governmental entities and agencies for their own medical 
activities.
    (2) This authority to operate does not extend to mobile vehicles, 
such as ambulances, even if those vehicles are associated with a health 
care facility.
    (b) The fundamental emissions from a biomedical telemetry device 
operating under the provisions of this section shall be contained 
within a single television broadcast channel, as defined in part 73 of 
this chapter, under all conditions of operation and shall lie wholly 
within the frequency ranges of 174-216 MHz and 470-668 MHz.
    (c) The field strength of the fundamental emissions shall not 
exceed 200 mV/m, as measured at a distance of 3 meters using a quasi-
peak detector. Manufacturers should note that a quasi-peak detector 
function indicates field strength per 120 kHz of bandwidth 
20 kHz. Accordingly, the total signal level over the band 
of operation may be higher than 200 mV/m. The field strength of 
emissions radiated on any frequency outside of the television broadcast 
channel within which the fundamental is contained shall not exceed the 
general limits in Sec. 15.209.
    (d) The user and the installer of a biomedical telemetry device 
operating within the frequency range 174-216 MHz, 470-608 MHz or 614-
668 MHz shall ensure that the following minimum separation distances 
are maintained between the biomedical telemetry device and the 
authorized radio services operating on the same frequencies:
    (1) At least 10.3 km outside of the Grade B field strength contour 
(56 dBuV/m) of a TV broadcast station or an associated TV booster 
station operating within the band 174-216 MHz.
    (2) At least 5.5 km outside of the Grade B field strength contour 
(64 dBuV/m) of a TV broadcast station or an associated TV booster 
station operating within the bands 470-608 MHz or 614-668 MHz.
    (3) At least 5.1 km outside of the 68 dBuV/m field strength contour 
of a low power TV or a TV translator station operating within the band 
174-216 MHz.
    (4) At least 3.1 km outside of the 74 dBuV/m field strength contour 
of a low power TV or a TV translator station operating within the bands 
470-608 MHz or 614-668 MHz.
    (5) Whatever distance is necessary to protect other authorized 
users within these bands.
    (e) The user and the installer of a biomedical telemetry device 
operating within the frequency range 608-614 MHz and that will be 
located within 32 km of the very long baseline array (VLBA) stations or 
within 80 km of any of the other radio astronomy observatories noted in 
footnote US 311 of Section 2.106 of this chapter must coordinate with, 
and obtain the written concurrence of, the director of the affected 
radio astronomy observatory before the equipment can be installed or 
operated. The National Science Foundation point of contact for 
coordination is: Spectrum Manager, Division of Astronomical Sciences, 
NSF Rm 1045, 4201 Wilson Blvd., Arlington, VA 22230; tel: (703) 306-
1823.
    (f) Biomedical telemetry devices must not cause harmful 
interference to licensed TV broadcast stations or to other authorized 
radio services, such as operations on the broadcast frequencies under 
subparts G and H of part 74 of this chapter, land mobile stations 
operating under part 90 of this chapter in the 470-512 MHz band, and 
radio astronomy operation in the 608-614 MHz band. (See Sec. 15.5.) If 
harmful interference occurs, the interference must either be corrected 
or the device must immediately cease operation on the occupied 
frequency. Further, the operator of the biomedical telemetry device 
must accept whatever level of interference is received from other radio 
operations. The operator, i.e., the health care facility, is 
responsible for resolving any interference that occurs subsequent to 
the installation of these devices.
    (g) The manufacturers, installers, and users of biomedical 
telemetry devices are reminded that they must ensure that biomedical 
telemetry transmitters operating under the provisions of this section 
avoid operating in close proximity to authorized services using this 
spectrum. Sufficient separation distance, necessary to avoid causing or 
receiving harmful interference, must be maintained from co-channel 
operations. These parties are reminded that the frequencies of the 
authorized services are subject to change, especially during the 
implementation of the digital television services. The operating 
frequencies of the part 15 devices may need to be changed, as necessary 
and in accordance with the permissive change requirements of this 
chapter, to accommodate changes in the operating frequencies of the 
authorized services.
    (h) The manufacturers, installers and users of biomedical telemetry 
devices are cautioned that the operation of this equipment could result 
in harmful interference to other nearby medical devices.

[FR Doc. 97-28761 Filed 10-29-97; 8:45 am]
BILLING CODE 6712-01-P