The FCC Waiver Process for Medical Telemetry

The discovery that life-critical medical telemetry systems were negatively impacted by Smart Grid services in TerreStar’s adjacent band spectrum was a commercially catastrophic event, which halted network deployment and compromised hundreds of millions of dollars in capital investment. Despite the fact that TerreStar’s network infrastructure and device ecosystem was fully compliant with FCC rules, the vulnerability of sensitive patient monitoring systems made conventional commercial service deployment impossible. This vulnerability is the result of non-public technology limitations within patient monitoring system receivers, and could not have been anticipated.

Given the unique safety of life issues associated with this interference problem, TerreStar worked diligently with both the FCC and the medical telemetry community. However, with thousands of medical telemetry deployments across the United States, there was no technically viable way of making TerreStar’s Smart Grid network safe. Medical interests provided compelling data that negative clinical consequences, including fatalities, were an inevitable result of medical monitoring system interference.

TerreStar arrived at the only solution to the interference problem at its disposal - the application of the 1.4 GHz commercial spectrum for medical telemetry use. Such an application would permanently protect WMTS, while giving patient monitoring networks much needed new capacity and capability. All that was required was FCC approval of a construction waiver, granting sufficient time for medical telemetry vendors to safely convert and re-certify their hospital networks for the expanded frequency band.


Timeline of Commercial Medical Telemetry Process

After discussions with FCC staff and the wireless medical telemetry community, TerreStar halted commercial Smart Grid deployment at 1.4 GHz. Following an extensive multi-year collaborative effort with both the FCC and the medical industry, an anticipated and unopposed construction waiver was unexpectedly denied by the regulator. As a result, guaranteed deployment at 2,000 hospitals across the United States, including immediate integration at VA hospitals, cannot occur.

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Healthcare Consequences of FCC Medical Telemetry Denial

The FCC denial of the medical telemetry service waiver will have significant long-term clinical consequences across the General, Federal / VA, and Rural Healthcare Systems. Beyond concerns over interference to sensitive patient monitoring networks, a lack of commercial medical telemetry spectrum will inhibit the ability of existing systems to add critically needed capacity and functionality.

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Advocacy for the TerreStar Waiver in the Public Record

The major medical telemetry interests have all contributed to the FCC record and universally support the simple construction waiver that TerreStar requires to provide commercial medical telemetry spectrum to thousands of hospitals and rural healthcare facilities across the United States. Pillars of the medical community like the American Hospital Association, GE Healthcare, and Philips Healthcare underscore that Smart Grid operations were a significant danger to patient safety, that WMTS systems can readily integrate TerreStar’s commercial spectrum, and that the need for additional spectrum capacity is acute.

Summaries of key filings (including links to full documents) in the FCC record are provided below.

 
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December 2018 - American Telemedicine Association Letter of Support

In a letter of support to the FCC, the American Telemedicine Association said that “Leading providers of WMTS technology have told the Commission in no uncertain terms that the available spectrum is insufficient, and that action is needed in the 1.4 GHz band to enable continued expansion of life-saving WMTS. Indeed, Chairman Pai has recognized that ‘introducing Wireless Medical Telemetry Services in the 1.4 GHz band is an innovative opportunity.’  The opportunity exists to facilitate deployment of commercial WMTS spectrum in the 1.4 GHz band, thereby promoting the deployment of remote monitoring in currently underserved rural communities and expand the number of patients that can benefit from this life-saving technology. We urge the FCC to act quickly on the pending petitions for reconsideration that would free up spectrum to be deployed for WMTS.”

Read the American Telemedicine Association Filing

 
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December 2018 - Letter of Support from 28 Members of Congress

In their letter of support to Chairman Pai, 28 members of the U.S. House of Representatives note that “One of the most striking examples of the crucial benefits of WMTS is that the odds of surviving an in-hospital cardiac arrest are twice as high for patients being monitored by a WMTS device.

Positive patient outcomes aided by WMTS are not just limited to patients residing in hospitals and healthcare facilities. Remote patient monitoring is truly changing the lives of rural Americans. The Commission recently stated that ‘it's becoming harder to recruit doctors to serve rural communities. It's becoming harder to keep rural hospitals afloat. And so it's becoming harder for many rural patients to get health care.’ Remote patient monitoring is already facilitating better patient outcomes in rural communities by allowing patients to stay in their homes while simultaneously being connected to their primary care doctor. And data shows that by giving patients more mobility and keeping them out of emergency rooms, WMTS is also helping to lower the healthcare costs of those patients.

Today, there are hundreds of thousands of patients in hospitals, healthcare facilities across the country being monitored by devices that only operate properly if the 1.4 GHz spectrum is free of interference. Making additional spectrum available will ensure this is the case, while also unlocking additional monitoring capacity and driving innovation in health care.”

Read the Congressional Letter of Support

 
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February 2018 - Letter of Support from Sen. Roger Wicker

In his letter of support to Chairman Pai, Sen. Wicker noted that “The benefits of this technology are significant. WMTS has helped increase survival rates among patients by assisting clinicians' efforts to address health conditions before they worsen. Moreover, WMTS provides patients with more mobility and allows doctors and nurses to monitor multiple patients at one time, increasing the overall efficiency of medical care. The availability of this technology in rural areas is particularly important in Mississippi, given our shortage of doctors and the significant distances that many residents must travel to receive care.

TerreStar Corporation's WMTS proposal promises to provide access to many innovative medical services for small rural health facilities. It has committed to servicing 2,000 hospitals in the U.S. by 2020 using this life-saving technology. This will help rural Mississippians and thousands of other rural Americans receive unprecedented access to essential health-care services.”

Read Senator Wicker’s Letter of Support

 
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February 2018 - American Hospital Associate (AHA) Advocacy for Waiver

To advocate for critically needed medical telemetry protection and expansion, the American Hospital Association met with a number of FCC officials and Commissioners. Their presentation included the following points regarding the 1.4 GHz medical telemetry waiver:

1.4 GHz WMTS band is extensively used and spectrum congestion at some locations is occurring

  • Additional spectrum would support the demand for encryption at VA hospitals and elsewhere while retaining current capabilities and coverage

  • Meeting WMTS data security (encryption) requirements roughly doubles the amount of spectrum necessary per patient

  • Significant opportunity to expand 1.4 GHz WMTS spectrum by permitting WMTS use in adjacent TerreStar spectrum

  • Wireless Bureau should reconsider its recent denial of the TerreStar waiver, which would bring significant benefits to hospitals/patients

  • WMTS manufacturers are ready to immediately put the spectrum to use for WMTS

  • Absent reconsideration in WT Docket 16-290, the spectrum will likely lie fallow for years with no clear alternative high-value use that will not cause interference to current WMTS operations

Read the American Hospital Association Filing - Part 1

Read the American Hospital Association Filing - Part 2

 
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January 2018 - TerreStar Legal Analysis of FCC Waiver Denial

In an extensive legal analysis submitted to the FCC, TerreStar notes “When TerreStar realized that the initial planned use for its licenses was fundamentally incompatible with already deployed WMTS devices, it took immediate steps to solve the problem. TerreStar worked closely with staff from the Bureau, as well as licensees of the adjacent WMTS spectrum, to pursue a different use - one that promises to deliver better medical care to millions of patients across America - even though TerreStar was legally entitled to proceed with its original smart grid plan. Recognizing that this change would delay TerreStar’s build out, the company expressly and conscientiously informed the Bureau that it would need regulatory relief from the substantial service deadline. For its part, the Bureau consistently encouraged TerreStar’s plan to use its spectrum to expand WMTS and certainly never raised any objections to that plan or expressed concerns about the fact that the company would be unable to meet its substantial-service obligations within the originally allotted time. When TerreStar formally requested a temporary waiver or extension of the substantial-service requirements, however, the Bureau abruptly rejected TerreStar’s request. That denial was both unjust and unlawful.”

Read the TerreStar Medical Filing

 
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November 2017 - Philips Healthcare Petition to the FCC

Following the FCC’s denial of TerreStar’s medical telemetry service waiver, the American Hospital Association, GE Healthcare, and Philips Healthcare took the extraordinary steps of filing their own independent Petitions for Reconsideration. In its petition, Philips notes “the Bureau denied the TerreStar Request for Temporary Waiver notwithstanding TerreStar’s demonstrated diligent and good faith efforts to meet the substantial service requirements applicable to its 1.4 GHz licenses and its having worked over multiple years to resolve difficult interference issues that threatened the WMTS systems that operate on the immediately adjacent spectrum.

The underlying purpose of construction requirements such as those at issue in this proceeding is to ensure that spectrum is put to use for the benefit of the American people. In the case presented, complex interference issues exist because the WMTS and TerreStar spectrum blocks are immediately adjacent. All concerned parties actively discussed the technical issues involved, came to identical conclusions, and strongly support TerreStar’s Request as being the manner in which the spectrum can be put to use rapidly in the service of improving healthcare. To deny the waiver at this juncture is to oppose the underlying purpose of the construction requirements themselves and impede much-needed capabilities and improvements to wireless monitoring systems in hospitals that otherwise would be available but for the lack of spectrum.

From Philip Healthcare’s perspective and interest in this proceeding, the result of the Order is to prevent critically needed improvements and expansion of Wireless Medical Telemetry Service (WMTS) to better care for critically ill patients. Instead of putting the subject spectrum to almost immediate use, the practical effect of the Order instead is to relegate the spectrum at issue to continued vacancy for multiple more years, if not decades, before a new licensee can acquire it. Then, after years of wasting this valuable resource, the new licensee will have to start from scratch to find solutions to the difficult adjacent spectrum compatibility problems discussed at length in the record.”

Read the Philips Healthcare Filing

 
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November 2017 - GE Healthcare Petition to the FCC

Following the FCC’s denial of TerreStar’s medical telemetry service waiver, the American Hospital Association, GE Healthcare, and Philips Healthcare took the extraordinary steps of filing their own independent Petitions for Reconsideration. In its petition, GE notes that “the WTB materially erred in denying TerreStar’s waiver request, notably by failing to consider the nation’s growing need for wireless medical telemetry capacity and the grave interference threat posed to safety-of-life Wireless Medical Telemetry Service (“WMTS”) systems by TerreStar’s original business plan.

…Despite input from GEHC and others, the Order failed to acknowledge hospitals’ growing need for wireless medical telemetry capacity. Instead, the Order avoided the issue altogether, expressly ‘declining to address . . . whether, as a general matter, WMTS operators require access to additional spectrum.’ That maneuver allowed the WTB to ignore a critical way in which granting TerreStar’s request would have furthered the public interest and is difficult to square with the Commission’s longstanding recognition of ‘the importance of the WMTS to patient care’ and the ‘significant benefits’ it offers to patients and healthcare.

…The record in this proceeding also demonstrates that TerreStar’s previously envisioned 1.4 GHz WiMAX Smart Grid network posed a significant interference threat to existing and future WMTS systems. GEHC, for example, cautioned that this system posed ‘an unacceptable risk’ to WMTS systems even though it was arguably permitted under the FCC’s rules.”

Read the GE Healthcare Filing

 
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November 2017 - TerreStar Petition to the FCC

In response to the FCC’s denial of its medical telemetry waiver, TerreStar filed a Petition for Reconsideration. The company notes that “The WMTS interference concerns identified by the Commission when it developed its service rules for the 1.4 GHz band in 2002 are distinct from and independent of the interference concerns discovered by TerreStar in 2014. The FCC’s authorization of sensitive WMTS operations in the 1.4 GHz spectrum and the mass deployment of these life-saving devices were also outside of TerreStar’s control. Further, unique factual circumstances make application of the buildout obligations inequitable - the Bureau must recognize that it is unique for two fully compliant services to cause harmful interference, particularly when one service is critical to safety of life.

TerreStar has also demonstrated a number of reasons why grant of its waiver would serve the public interest: it would protect existing and future WMTS operations in the adjacent band from potential interference; it would lead to expanded use of the 1.4 GHz band for WMTS, which would generate public interest benefits far greater than those from any other presently feasible use of this band; it would relieve congestion and increase the amount of medical telemetry spectrum at hospitals; the additional channel capacity would be critical to increasing the number of monitored patients and the types of patient metrics that may be monitored; it would result in the use of licensed medical telemetry service outside of major healthcare facilities for the first time; and it would further cybersecurity efforts at medical institutions.”

Read the TerreStar Medical Filing

 
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November 2017 - American Hospital Association (AHA) Petition to the FCC

Following the FCC’s denial of TerreStar’s medical telemetry service waiver, the American Hospital Association, GE Healthcare, and Philips Healthcare took the extraordinary steps of filing their own independent Petitions for Reconsideration. In their petition, the AHA noted that “The Division should reconsider its denial because it erroneously concluded that there is insufficient support in the record to determine that additional spectrum is necessary to meet the WMTS needs of hospitals and that TerreStar’s earlier plans to operate a WiMAX Smart Grid service would cause harmful interference to WMTS. In addition, the Division failed to appropriately consider the substantial public interest benefits of granting the waiver and allowing the TerreStar spectrum to be used to expand the amount of spectrum available for wireless medical telemetry services. ASHE had discussed in multiple filings that additional protected spectrum for WMTS is needed to meet the growing demands of hospitals, as did the major providers of WMTS. The TerreStar spectrum is a unique opportunity because it is adjacent to existing Part 95 WMTS spectrum in the 1.4 GHz band, thereby potentially providing a larger continuous block of spectrum available for wireless medical telemetry. This larger block would allow hospitals to support the growing demand for encryption security while maintaining range and/or the number of devices supported. For example, hospitals could increase the power of their systems slightly without interfering with adjacent bands because of the larger continuous block. This increased capability potentially would lower costs for hospitals. Still another benefit of spectrum adjacency is that existing WMTS equipment more easily could be tuned to use the TerreStar spectrum, in order to facilitate rapid build-out.”

Read the American Hospital Association Filing

 
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August 2017 - GE Healthcare Letter of Support

In a letter of support to FCC Chairman Pai, Philips wrote “Several years ago we became aware of TerreStar’s plan to deploy WiMAX Smart Grid systems on adjacent spectrum. After study, it was clear that such a system would present a significant danger of interference to already-deployed WMTS systems throughout the country because of the very low power and high sensitivity required of WMTS patient-worn devices. We appreciate that upon learning of the likelihood for interference, and after its own study, TerreStar worked with the WMTS community to protect WMTS hospital systems and devices from interference that otherwise could have been destructive.”

Read the Philips Healthcare Filing

 
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August 2017 - GE Healthcare Letter of Support

In a letter of support to FCC Chairman Pai, GE Healthcare wrote “…1.4 GHz WiMax Smart Grid network posed an unacceptable interference risk to hospitals’ L Band Wireless Medical Telemetry Service (WMTS) systems, representing a significant danger to patient safety… The American Society for Healthcare Engineering of the American Hospital Association estimates that WMTS systems are deployed in over 3,700 unique locations. The number of locations that use WMTS is expected to increase significantly in the future as hospitals seek to better address the problems raised by an aging U.S. patient population and increased patient acuities. The Commission can help address this growing need by granting TerreStar’s waiver request.”

Read the GE Healthcare Filing

 
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July 2017 - American Hospital Association (AHA) Letter of Support

In a letter of support to FCC Chairman Pai, the American Hospital Association wrote “As a result of such innovations and hospitals’ increasing reliance on WMTS, ASHE understands that some areas with a concentration of health care facilities are experiencing WMTS saturation due to a lack of 1.4 GHz spectrum… TerreStar’s aggressive proposed milestones demonstrate its motivation to work quickly with manufacturers, hospitals and ASHE (AHA) to deploy wireless monitoring devices in its spectrum. Because of the proximity of the TerreStar spectrum to existing 1.4 GHz WMTS spectrum, we understand that WMTS manufacturers may be able to modify their equipment relatively easily to access the additional spectrum.”

Read the American Hospital Association Filing

 
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July 2017 - Steward Health Care System Letter of Support

In a letter of support to FCC Chairman Pai, the Steward Health Care System wrote “we believe that an FCC grant of that waiver will be enormously beneficial to our patients… This greater capacity will enable Steward to avoid interference between its remote monitoring systems, increase the number of patients using these devices, and take advantage of new telemetry technologies as they are developed. In this way, TerreStar’s medical telemetry operations will ensure the reliability of our patient monitoring systems for years to come.”

Read the Steward Health Care Filing

 
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November 2016 - American Hospital Association (AHA) Letter of Support

In a letter of support to the FCC, the American Society for Healthcare Engineering (ASHE) of the American Hospital noted that they “urge the Bureau to grant the relief requested by TerreStar in its request for Temporary Waiver.”

Read the American Hospital Association Filing

 
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October 2016 - Philips Healthcare Reply Comments

In response to the FCC’s Public Notice, Philips noted that “over the past year we explored with TerreStar in lengthy discussions both the interference potential of WiMAX 802.16-type systems and possible extension of WMTS-like services to TerreStar’s commercial spectrum. The interference potential of deploying WiMAX 802.16 systems adjacent to WMTS spectrum is very real and of significant concern to the WMTS community.”

Read the Philips Healthcare Filing

 
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October 2016 - Philips Healthcare Letter of Support

In a letter of support to the FCC, Philips wrote that “The Commission’s grant of TerreStar’s request for a temporary waiver will address the need for additional WMTS spectrum in a realistic and timely fashion. The waiver and TerreStar’s work would significantly increase the supply of spectrum for 1.4 GHz medical telemetry and allow a substantial expansion of WMTS capacity that today is foreclosed by spectrum restraints.”

Read the Philips Healthcare Filing

 
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October 2016 - GE Healthcare Reply Comments

In response to the FCC’s Public Notice, GE wrote that “the Commission should grant TerreStar’s request because it will help meet the nation’s growing demand for spectrum to support safety-of-life wireless medical telemetry operations, such as heart rate and oxygen saturation monitoring.”

Read the GE Healthcare Filing

 

Lend Your Voice: Contact TerreStar Medical to discuss how your organization can participate in the regulatory effort to enable commercial medical telemetry spectrum.