Before the FEDERAL COMMUNICATIONS COMMISSION Washington, D.C. ) ) ) ) )

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1 Before the FEDERAL COMMUNICATIONS COMMISSION Washington, D.C. In the Matter of Amendment of Part 90 of the Commission s Rules ) ) ) ) ) WP Docket No To: The Commission COMMENTS OF THE AMERICAN SOCIETY FOR HEALTHCARE ENGINEERING OF THE AMERICAN HOSPITAL ASSOCIATION The American Society for Healthcare Engineering of the American Hospital Association ( ASHE ), pursuant to Section of the FCC s rules, hereby submits comments on the Wireless Medical Telemetry Service ( WMTS ) issues raised in the Notice of Proposed Rulemaking ( NPRM ) in the above-captioned proceeding. 1 In the NPRM, the Commission seeks comment on miscellaneous proposed changes to Part 90 of its rules, as well as proposed changes to the Part 95 rules governing WMTS, which shares spectrum with Part 90 operations. ASHE welcomes the opportunity to participate in this proceeding and commends the Commission for moving forward with rule changes intended to promote efficient WMTS operations and transparent regulatory procedures. 2 By these comments, ASHE generally 1 Amendment of Part 90 of the Commission s Rules, WP Docket No , FCC 07-85, 22 FCC Rcd 9595 (2007) (rel. May 14, 2007) ( NPRM ). 2 ASHE has a significant interest in this proceeding. ASHE was designated by the FCC as the first WMTS frequency coordinator and, as such, was assigned the responsibility to create and maintain a database of WMTS licensees and deployments as the primary source of information concerning each licensee s location and technical parameters. Amendment of Parts 2 and 95 of the Commission s Rules to Create a Wireless Medical Telemetry Service, 16 FCC Rcd 4543 (2001). ASHE s initial term as WMTS frequency coordinator was renewed by Memorandum of Understanding with the FCC effective June 19, 2006, renewable automatically for a one year term, unless terminated.

2 supports the rule changes proposed in the NPRM that affect WMTS. Specifically, ASHE supports the Commission s proposal to adopt, by cross-reference in the FCC rules, the frequency coordination protocol submitted by ASHE and the Land Mobile Communications Council ( LMCC ) (representing Part 90 frequency coordinators). 3 Such an approach will provide the relevant frequency coordinators the flexibility to modify their procedures, subject to mutual agreement, to accommodate future developments in technology and interference analysis. Additionally, ASHE supports the proposal to clarify the FCC s intent that WMTS devices should be permitted to operate on a secondary basis within the portions of the MHz band in which WMTS is not primary. ASHE also strongly supports the proposed requirements that any such use should be subject to user warnings from the WMTS frequency coordinator. 4 Finally, ASHE proposes various clean-up changes to the Part 95 rules to update references to authorized WMTS frequency bands and to make more explicit that health care facilities must register their equipment in the WMTS database before lawful operation. ASHE submits as an appendix the rule changes it proposes that differ from either existing FCC rules or the FCC s proposed rule changes set forth in Appendix C of the NPRM. I. BACKGROUND For many years the Commission allowed hospitals and other health care facilities to use wireless biomedical telemetry devices to monitor patient parameters such as ECG, oxygen saturation, blood pressure, and respiration by sharing channels on a secondary basis in the VHF and UHF TV bands (subject to Part 15 of its rules) and in the Public Land Mobile Radio Service ( PLMRS ) MHz band (subject to Part 90 of its rules). 3 NPRM at Id. at 29. 2

3 In response to an increasing number of incidents of interference to medical telemetry devices, in June 2000 the Commission established WMTS as a new Part 95 service to enhance the ability of healthcare providers to offer high quality and cost-effective care to patients with acute and chronic healthcare needs and to address concerns that [pre-wmts] medical telemetry devices are increasingly at risk of harmful interference due to more extensive use of spectrum resources by [TV and PLMRS] applications. 5 On the basis of the record compiled in that proceeding, the Commission initially allocated the following frequency bands to WMTS: MHz, MHz and the MHz portion of the MHz band. The Commission subsequently re-examined the latter allocation, in part to provide WMTS more compatible spectrum neighbors (radio astronomy and non-medical telemetry), and to accommodate incumbent utility telemetry operations in certain areas of the country that utilized frequencies at MHz. To facilitate use of the MHz band for both WMTS and non-medical telemetry, the Commission adopted a band flip proposal by which it afforded WMTS operations primary status in the MHz portion of the band and nonmedical telemetry primary status in the MHz portion of the band. However, in seven defined geographic areas the Commission made WMTS primary in the MHz portion of the band and non-medical telemetry primary in the MHz and MHz portions of the band. 6 Because WMTS transmitters operate with very low effective 5 Amendment of Parts 2 and 95 of the Commission s Rules to Create a Wireless Medical Telemetry Service, 15 FCC Rcd (2000) at 1. 6 See Amendments to Parts 1, 2, 27, and 90 of the Commission s Rules to License Services in the MHz, MHz, MHz, MHz, MHz, MHz, and MHz Government Transfer Bands, Report and Order, WT Docket No. 02-8, 17 FCC Rcd 9980, (2003) (27 MHz Report and Order); see also Amendments to Parts 1, 2, 27, and 90 of the Commission s Rules to License Services in the MHz, MHz, MHz, MHz, MHz, MHz, and MHz Government Transfer Bands, Notice of Proposed Rule Making, WT 3

4 isotropic radiated power ( EIRP ), the Commission also limited non-medical telemetry licensees to a measured or predicted field strength of no more than 150 µv/m into the WMTS portion of the band at the site of any WMTS operation to protect the WMTS licensee from interference. 7 In order to expedite the implementation of WMTS systems while maintaining an efficient licensing scheme for these low-power devices, the FCC chose not to license each WMTS system individually but rather provided for licensing by rule, requiring only a health care facility s registration of its deployments in a WMTS database maintained by the designated WMTS frequency coordinator (ASHE). This approach alleviates the need for public notice of individual deployments, prior approval by the FCC, or even registration in the FCC s own licensing system. The Commission, however, clearly wanted to assure that a medical facility installing a new WMTS system could be made aware of existing WMTS installations and to provide a method by which any adjacent-channel Part 90 licensee wishing to operate facilities in range of a WMTS installation could be mindful of the location and frequency assignments of the WMTS installed base. 8 Thus, to protect patient safety, registration of equipment with the WMTS frequency coordinator was a prerequisite for the commencement of operations in a health care facility. 9 Docket No. 02-8, 17 FCC Rcd 2500, (2002). The seven carve-out areas are Pittsburgh, Pennsylvania; Washington, D.C.; Richmond/Norfolk, Virginia; Austin/Georgetown, Texas; Battle Creek, Michigan; Detroit, Michigan; and Spokane, Washington. 27 MHz Report and Order at 9993 n.78; see 47 C.F.R (b)(4). 7 See 27 MHz Report and Order, 17 FCC Rcd at Accordingly, ASHE designed and developed a web-based registration system that allows practically instantaneous device registration and authorization, while also providing relevant deployment information to coordinators of private land mobile services that operate on nearby spectrum. 9 See 47 C.F.R (a) ( Prior to operation, authorized health care providers who desire to use wireless medical telemetry devices must register all devices with a designated frequency coordinator. ) 4

5 II. DISCUSSION ASHE commends the Commission for its proposals that would clarify the WMTS rules with respect to (a) the sharing of frequency coordination information between the WMTS frequency coordinator and those for adjacent bands and (b) permitting WMTS systems to operate on a secondary basis in the portion of the MHz band where non-medical telemetry is primary. These matters are not currently expressly or fully covered by the existing rules; and ASHE, as the WMTS frequency coordinator charged with administering the implementation of the WMTS rules, very much appreciates the Commission s efforts to provide clarity and transparency. ASHE strongly supports, and urges the Commission to adopt, the tentative conclusion that the public interest will be served by implementing the joint ASHE-LMCC coordination plan submitted August 18, 2004, in WT Docket No Representatives of ASHE and LMCC worked for many months to work out a mutually agreeable protocol for the sharing of frequency coordination information, and ASHE is appreciative of LMCC s cooperation in this process. The agreed upon protocol addresses the concerns of WMTS licensees while also minimizing the burden on Part 90 frequency coordinators. Rather than codifying the details of the multi-page frequency coordination plan agreed upon by ASHE and LMCC into its rules, however, the Commission instead should -- as the NPRM proposes in the alternative simply cross-reference the coordination plan in the rules. Such cross-reference should also allow the plan to be amended from time to time by the mutual agreement of the then-authorized WMTS frequency coordinator and the then-authorized Part 90 coordinators for the relevant frequency bands. This approach will avoid the need for lengthy 10 NPRM at 27. 5

6 rulemaking processes when the coordination process must, by the agreement of all affected coordinators, be changed to reflect then-current technologies and/or then-effective coordination processes. By requiring the consent of all affected coordinators, the same cooperative effort that let to the current protocol can be utilized to make appropriate changes. Of course, in the case of a dispute, the FCC would act as the sole arbiter. In the attached appendix, ASHE proposes specific language to add to the NPRM s proposed Section (d). ASHE also supports clarifying the Commission s rules to make express in Part 95 that WMTS devices may operate on a secondary basis in the portions of the MHz band where non-medical telemetry is primary. This relief would apply not only in the so-called band flip parts of the band, but also in other parts of the band that have been designated for non- WMTS telemetry. In fact, the FCC s Table of Allocations recognizes the possibility of such use, 11 but Part 95 does not contain specific provisions to accommodate secondary operations. While there is an implication that WMTS uses would be allowed throughout the band (since WMTS is, in fact, a form of telemetry), the current rules create unduly cumbersome burdens in those instances where the manufacturer of the WMTS system and the hospital believe that secondary operations can be effective. With such rules in place, ASHE strongly supports the Commission s proposal that WMTS users should be cautioned that WMTS operations in the portion of the MHz band where WMTS is secondary should not be relied upon for functions that are critical to patient safety, because secondary WMTS operations are not protected from interference from 11 See footnote US350 to 47 C.F.R See also Amendment of Parts 2, 25, and 73 of the Commission s Rules to Implement Decisions from the World Radiocommunication Conference (Geneva, 2003) (WRC-03) Concerning Frequency Bands Between 5900 khz and 27.5 GHz and to Otherwise Update the Rules in this Frequency Range, 20 FCC Rcd, 6570 at 155 (2005). 6

7 Part 90 operations. 12 To assure that medical facilities operating on a secondary basis are fully informed about the potential interference that could occur in such circumstances, ASHE has proposed two new rules that impose separate requirements on both the manufacturer of such devices and the frequency coordinators. Specifically, ASHE proposes a new Section (d)(5) which requires the manufacturer of any WMTS device that is intended for use on a secondary basis in the band to include in its user manual or other written information provided to the WMTS licensee at the time of installation, a conspicuous notice that the operation of the WMTS equipment on a secondary basis may be subject to harmful interference which could affect its reliability for its intended purpose. Separately, both as an additional safeguard where devices are intended by the manufacturer for secondary operations and to warn users where devices not so intended are, nevertheless, installed for secondary operation, ASHE also proposes in the attached appendix a new Section (b)(2) that places an obligation on the WMTS frequency coordinator to provide this notification to those WMTS registrants seeking to operate on a secondary basis in the MHz band. With both warnings provided to medical facilities choosing to operate on a secondary basis, ASHE believes that the likelihood of use where the potential for interference would jeopardize patient health will be minimized. Finally, ASHE proposes various clean-up changes to the Part 95 rules to correct or more accurately express the Commission s intent. First, several of the Part 95 rules need to be updated to reflect the fact that, depending on the geographic area, WMTS may operate on a primary basis not only in the MHz band but in some portion of the entire MHz band. Second, ASHE proposes language changes in Sections and (a) to make even more express that authorized health care providers become licensed (and therefore 12 See NPRM at 29. 7

8 authorized to operate transmitters in the WMTS frequency bands) only after the registration requirements of Section (a) have been met. To facilitate satisfaction of this obligation, ASHE also proposes in the attached appendix additional language for Section (d)(4) strongly encouraging manufacturers of WMTS equipment or their representatives to assist authorized health care providers in seeking registration with the WMTS frequency coordinator. III. CONCLUSION ASHE applauds the Commission for initiating this rulemaking proceeding that will provide further clarity and transparency for affected WMTS and Part 90 users. ASHE requests that the Commission adopt final rules consistent with the modifications proposed in the text of these comments and as set forth in the attached appendix. Respectfully submitted, August 13, 2007 /s/ Dale L. Woodin Executive Director American Society for Healthcare Engineering (ASHE) One North Franklin Chicago, IL

9 APPENDIX PROPOSED RULE CHANGES

10 Coordinator notification requirements on frequencies below 512 MHz, at / MHz, or at MHz. (d) Frequencies in the MHz band. Within one business day of making a frequency recommendation, each frequency coordinator must notify and provide the information indicated in paragraph (g) of this section to the WMTS frequency coordinator designated in and to all other frequency coordinators who are also certified to coordinate that frequency. In addition, the frequency coordinator must ensure compliance with all coordination requirements incorporated in the joint WMTS-Part 90 coordination plan filed in WT Docket No on August 18, 2004, as such coordination plan may be amended from time to time by the agreement of the then-authorized WMTS frequency coordinator and the then-authorized Part 90 coordinators for the relevant frequency bands.. Part 95, Subpart H - Wireless Medical Telemetry Service (WMTS) General Provisions Scope. This part sets out the regulations governing the operation of Wireless Medical Telemetry Devices in the MHz, MHz and MHz frequency bands Definitions. (c) Wireless medical telemetry. The measurement and recording of physiological parameters and other patient-related information via radiated bi-or unidirectional electromagnetic signals in the MHz, MHz, and MHz frequency bands Eligibility. Authorized health care providers are authorized by rule to operate transmitters in the Wireless Medical Telemetry Service without an individual license issued by the Commission, provided but only after the coordination requirements in have been met. Prior to completion of the coordination requirements in , only Mmanufacturers of wireless medical telemetry devices and their representatives are authorized to operated wireless medical telemetry transmitters in this service and solely for the purpose of demonstrating such equipment to, or installing and maintaining such equipment for, duly authorized health care providers. No entity that is a foreign government or which is active in the capacity as a representative of a foreign government is eligible to operate a WMTS transmitter Frequency coordination. (a) Prior to operation, authorized health care providers who desire to use wireless medical telemetry devices must register all devices with a designated frequency coordinator. Except as

11 specified in , operation of WMTS equipment prior to registration is not authorized under this Part. The registration must include the following information: Frequency coordinator. (b) (1) Review and process registration requests submitted by authorized health cares providers as required in ; (5) Upon receipt of a registration request for WMTS equipment operating in the MHz band, notify all Part 90 frequency coordinators of the intended activation in accordance with the joint WMTS-Part 90 coordination plan filed in WT Docket No on August 18, 2004, as such coordination plan may be amended from time to time by the agreement of the then-authorized WMTS frequency coordinator and the then-authorized Part 90 coordinators for the relevant frequency bands. As to WMTS registrants operating on a primary basis, tthe Part 90 frequency coordinators shall, in turn, determine potentially affected Part 90 licensees and notify those Part 90 licensees operating in the MHz band in accordance with (b) of their obligation to ensure compliance with the field strength limit of (b)(11), as measured at the WMTS site. (7) For any WMTS registrant seeking to operate on a secondary basis in the MHz band, notify such registrant that secondary operations are not protected from interference from, and may not cause interference, to licensees, including WMTS registrants, who are authorized to operate on a primary basis in the band. (a) General technical requirements. (2) In the MHz and ,532 MHz bands, the maximum allowable field strength is 740 mv/m, as measured at a distance of 3 meters, using measuring equipment with an averaging detector and a 1 MHz measurement bandwidth. (d) (1) In the MHz and MHz bands, no specific channels are specified. Wireless medical telemetry devices may operate on any channel within the bands authorized for wireless medical telemetry use in this part.

12 (3) Channel usage on frequencies where WMTS is primary is on a co-primary shared basis only, and channels will not be assigned for the exclusive use of any entity. (4) Authorized health care providers, in conjunction with the equipment manufacturers, must cooperate in the selection and use of frequencies in order to reduce the potential for interference with other wireless medical telemetry devices, or other co-primary users. Equipment manufacturers or their representatives shall assist authorized health care providers in seeking registration with the WMTS frequency coordinator. Operations in the MHz band (television channel 37) are not protected from adjacent band interference from broadcast television operating on channels 36 and 38. (5) Because secondary operations by WMTS devices in the MHz band are not protected from interference from, and may not cause interference to, primary licensees operating in the band, the manufacturer of any WMTS equipment intended to be used for secondary operation in this band shall include in its user manual or other written information provided to the WMTS licensee at the time of installation, a conspicuous notice that the operation of the WMTS equipment on a secondary basis may be subject to harmful interference which could affect its reliability for its intended purpose Specific requirements for wireless medical telemetry devices operating in the MHz and MHz bands. Due to the critical nature of communications transmitted under this part, the frequency coordinator in consultation with the National Telecommunications and Information Administration shall determine whether there are any Federal Government systems whose operations could affect, or could be affected by, proposed wireless medical telemetry operations in the MHz and MHz bands. The locations of government systems in these bands are specified in footnotes US351 and US352 of of this chapter.

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