1. FCC Healthcare and mHealth Initiatives DoD/VA mHealth Nov 18, 2013 Matt Quinn, Director of Healthcare Initiatives Federal Communications Commission (FCC)

2. Agenda About FCC and its Role in Healthcare Rural Healthcare Program Regulatory Domain Spectrum for Medical Devices Equipment Authorization MBANs FCC-FDA Cooperation Wireless Test beds and Experimental Licensing

3. Mission The FCC was established by the Communications Act of 1934 and is charged with regulating interstate and international communications by radio, television, wire, satellite and cable. The FCC's jurisdiction covers the 50 states, the District of Columbia, and U.S. possessions. Federal Communications Commission www.fcc.gov Staff & Offices Approx. 1700 Attorneys, Engineers, Economists, et al HQ at 445 12 th St, SW, Wash., DC Lab in Columbia, MD Field Offices: 3 Regional, 16 District, 8 Resident Agent

4. FCC Areas of Responsibility Rural Health Care Program: Supports broadband for health care providers, which promotes telemedicine adoption to expand patient access to specialists and drive down costs. Broadband: Advances both wireline and wireless communications services and technologies, thus enabling many medical and medical-associated applications. Spectrum: Provides access to the airwaves for wireless medical devices and various radio services that support Health IT applications, while preventing harmful interference. National Broadband Plan: Engages in a variety of actions and activities to facilitate Health IT under NBP recommendations. 4

5. The Promise of Broadband-Enabled Health Technology Expanding connectivity for health technology can: Increase access to health care and medical expertise, especially in hard to serve areas –Telemedicine and video conferencing allow rural health care providers to take advantage of specialists, training, and resources in urban centers Improve patient care by utilizing data to improve health care strategies –Patients who used a mobile tracking system for diabetes care received regular, tailored self-care messages and were able to achieve significant reduction in blood sugar levels over a year long study Reduce health care costs by using information to improve efficiency of care delivery –Telehealth can reduce the costs of medical care among the elderly by 25%, because it reduces the number of face to-face consultations needed –Costs related to data collection can be reduced by allowing patients and doctors to access health records remotely, increase efficiency, avoid duplication, and save between 20% and 30% in administrative costs 5

6. 6 As a platform for innovation and information exchange, broadband can help improve health outcomes and lower the cost of care Create incentives for broader health IT adoption and innovation Drive innovative applications and advanced analytics Ensure all providers have access to affordable broadband Modernize regulations to increase access to care and enable health IT adoption Revise credentialing, privileging and state licensing requirements to enable e-care Clarify regulatory requirements and the approval process for converged communications and healthcare devices Create next-generation interoperability across clinical, research and administrative data Ensure patients have access to and control over their health data Transform the Rural Health Care Program -Subsidize ongoing costs -Subsidize network deployment -Expand eligibility -Require institutions to meet outcomes-based measures Upgrade Indian Health Service broadband service Track and publish progress on broadband connectivity in healthcare facilities 1 2 3 4 Increase e-care pilots that evaluate cost savings & clinical outcomes Expand reimbursement for e- care under current fee-for- service model where outcomes are proven Provide Congress with a plan to realize the value of e-care

7. mHealth Task Force Task Force sparked via FCC held mHealth Summit (June 2012) bringing together academia, industry, and government to accelerate adoption of wireless health technologies. –Participants included senior executives and leaders from health technology companies, including established companies, startups, non-profits, hospital leaders, and government experts –The Co-chairs of this working group were Julian Goldman from Partners HealthCare, Robert Jarrin from Qualcomm, and Douglas Trauner from Health Analytic Services. In September 2012, the mHealth Task Force released its report and recommendations to the public. –The Report set the following five year goal: For mHealth technology to become a rou tine medical best practice within five years.

8. mHealth Task Force The FCC has taken action on 85% of the mHealth Task Force recommendations, including: 8  Enable wireless test beds  Create the Health Care Connect Fund  Broadband Adoption Lifeline Pilot  Promote international spectrum usage for MBANs  Enhance FCC coordination with CMS  Hired Director of Health Care Initiatives  Improve interagency alignment, data sharing, and cooperation  Launch FCC.gov/health

9. Director of Healthcare Initiatives A new position to coordinate the FCC’s numerous initiatives related to expanding access to healthcare applications through wired and wireless broadband Lead the agency’s efforts in promoting communications technologies and services that: –Improve the quality of health care for all citizens and help reduce health care costs; –Facilitating the availability of medical devices that use spectrum; –Ensuring hospitals and other health care facilities have required connectivity Collaboration, coordination, communication

10. Current FCC Rural Health Care Programs Telecommunications Program –Funds urban/rural rate difference for telecommunications services for rural HCPs –Remains in place after Healthcare Connect Fund is implemented Internet Access Program –Provides 25 percent discount on Internet access services for rural HCPs –Ends June 30, 2014, as participants transition to Healthcare Connect Fund Pilot Program –Supports 50 state-wide and regional broadband HCP networks –Participants transition to Healthcare Connect Fund as Pilot funds are exhausted 10

11. Key Features of New Healthcare Connect Fund Support for broadband connectivity and broadband networks for eligible health care providers (HCPs) Both consortium and individual HCPs may apply 35% HCP contribution required Funding begins January 1, 2014 (July 1, 2013, for existing Pilot projects) Covers both broadband services and HCP-owned infrastructure Non-rural HCPs can participate if in majority-rural consortia Multi-year funding commitments available to consortia Connections to off-site administrative offices and data centers covered 11

12. Benefits of Consortium Approach Creation and growth of broadband HCP networks Lower administrative costs Sharing of medical, administrative, and technical expertise Lower prices, higher bandwidth, and better quality connections Access by rural HCPs to medical specialists at larger HCPs through telemedicine Enhanced exchange of electronic health records and coordination of patient care Remote training of medical personnel Improved quality and lower cost of health care 12

13. Who is eligible to participate? To be eligible, an HCP must be public or not-for-profit and belong to one of these statutory categories: hospitals, rural health clinics, community health centers, health centers serving migrants, community mental health centers, local health departments or agencies, post- secondary educational institutions/teaching hospitals/medical schools, or a consortia of the above. 47 U.S.C. § 254(h)(7)(B) Non-rural HCPs may participate in Healthcare Connect Fund if they belong to a consortium that has a majority rural HCPs The largest HCPs (400 + patient beds) are eligible, but support is capped if non-rural. 13

14. What is supported? For all applicants: –Broadband services –Reasonable and customary installation charges –Equipment necessary to make service functional –Connections to off-site administrative offices and data centers –Connections to research & education networks Consortium applicants also may receive support for: –Equipment necessary for network –Upfront charges for deployment of new or upgraded facilities, including dark fiber HCP constructed and owned facilities, if shown to be most cost-effective option 14

15. Application Process – Usual Steps Assess technical requirements Organize consortium and design network (consortia) Obtain and submit letters of agency and network plan (consortia) Submit request for services (or RFP) for competitive bidding (unless exempt from competitive bidding) Review bids and select most cost-effective bid Submit request for funding commitment Begin receiving services Receive vendor invoice and pay HCP portion (35 %) Submit invoice for payment by Administrator to vendor 15

16. Skilled Nursing Facilities Pilot Program Purpose is to test how to support broadband connections for skilled nursing facilities Pilot will get underway in 2014 Funding will be up to $50 million total over a three-year period FCC will solicit input regarding design of the pilot program Participants will be required to collect data and submit reports 16

17. Funding Caps Cap on total funding for FCC Rural Health Care Programs, including Healthcare Connect Fund and Skilled Nursing Facilities Pilot, is $400 million annually Cap for upfront payments in Healthcare Connect Fund is $150 million annually 17

18. Questions? For more information: –Healthcare Connect Fund order, at http://hraunfoss.fcc.gov/edocs_public/attachmatch/FCC-12-150A1.doc http://hraunfoss.fcc.gov/edocs_public/attachmatch/FCC-12-150A1.doc –FCC website, http://www.fcc.gov/encyclopedia/rural-health-carehttp://www.fcc.gov/encyclopedia/rural-health-care –Healthcare Connect Fund FAQs, http://www.fcc.gov/encyclopedia/healthcare-connect-fund-frequently-asked- questions http://www.fcc.gov/encyclopedia/healthcare-connect-fund-frequently-asked- questions –USAC website, www.usac.org/rhcwww.usac.org/rhc –Pilot Program map, http://www.fcc.gov/maps/rural-health-care-pilot-programhttp://www.fcc.gov/maps/rural-health-care-pilot-program –Pilot Program Staff Evaluation, http://hraunfoss.fcc.gov/edocs_public/attachmatch/DA-12-1332A1.pdf http://hraunfoss.fcc.gov/edocs_public/attachmatch/DA-12-1332A1.pdf –Questions: rhc-assist@usac.orgrhc-assist@usac.org 18

19. = + FCC as Enabler of Wireless Technologies in Medical Care

20. FCC Regulations Federal Communications Commission (FCC) manages use of the radio spectrum by the private sector: –First, the Commission establishes technical regulations (frequency allocation, emission, etc.) for transmitters and other equipment to minimize their potential for causing interference to radio services. –Second, the Commission administers an authorization program to ensure that equipment reaching the market complies with the technical requirements. (Part 2 J)

21. Broadband for Medical Applications Cellular, PCS, AWS Bands 21 Hungry Devices National Purposes Telemedicine Smart Grid Civic Engagement Consumer Apps Public Safety

22. Spectrum for Medical Devices Medical Radiocommunications Service 4706146081395 WMTS UHF-TV 140014271432 WMTS UHF-TV Wireless Medical Telemetry Service ISM & UNII Bands (Unlicensed Devices) 2400 902 928 2483.5 5150 5350 5470 57255825 401 406419413 Implants and Body Worn MMNs 432426 MMNs 444 438 MMNs 457451 MMNs 24002360 MBANs 22 Indoor Only 5250 DFS

23. Unlicensed Devices Many medical devices operate under rules for unlicensed devices –Part 15 – Unlicensed devices Low power No interference protection –Part 18 – Industrial, Scientific, Medical devices Interference protection within ISM allocated frequency bands –Examples Assistive listening devices Boston Scientific - Implantable pacemakers, cardioverter defibrillators and cardiac resynchronization therapy devices that use inductive coupling –Currently use 90-110 kHz, but moving to 902-928 MHz Enteromedics – Implantable devices to treat gastro-intestinal disorders –Uses 6.765 ‑ 6.795 MHz ISM band Second Sight - Retinal Prosthesis System –Power transmission on 3.156 MHz (ISM) / Data on 481.5 kHz (Part 15) –Healthcare institutions also extensively use wi-fi, bluetooth, zigbee and RFID 23

24. Equipment Authorization Required Multi-tiered equipment authorization program - - many devices self-declared Most transmitters must be certificated by FCC or telecommunications certification body Equipment may not be imported or marketed until certificated Check label for FCC ID Grants of certification available on FCC web site http://www.fcc.gov/oet/ea/ See FCC Id: XXXYYYY

25. 25 Wireless Medical Devices and Applications are Emerging Source: AirStrip Technologies, Intel, Medtronic, CardioNet, Corventis

26. What is an MBAN? A Medical Body Area Network (MBAN) consists of body-worn sensors placed on a patient in order to monitor physiological data (such as heart rate, respiration, and blood pressure) and perform diagnostic and therapeutic functions, that, in turn, are wirelessly linked to a nearby external control unit. –The control unit aggregates the data and then sends it to a monitoring point (such as to a nurse’s station) via existing or readily available communication infrastructure (Ethernet, WiFi, Wireless Medical Telemetry Service, etc.). –Primary application is in a health care facility but we anticipate other opportunities for use – even at a patient’s residence.

27. Recent FCC Actions Retinal Implants, November 2011: OET granted a waiver to Second Sight Medical Products, Inc. of Section 15.209(a) of the Commission’s rules to allow it to obtain FCC certification for and market its Argus II Retinal Prosthesis System which is a medical implant system designed to treat profoundly blind people. 27 Medical Body Area Networks (MBANs), May 2012: Order to allocate spectrum for Medical Body Area Networks, making the U.S. the first country in the world to make spectrum available for this specific usage. MBANs are networks of wireless sensors which transmit data on a patient’s vital health indicators to their doctor or hospital. Experimental Licensing Order, January 2013: Order to promote expanded opportunities for radio experimentation and market trials, including for medical devices

28. Medical Body Area Networks (MBANs) Commission adopted rules in May, 2012 allowing MBANS to share 2360 – 2400 MHz with aeronautical telemetry and amateurs –Based largely on joint industry agreement and coordination Very short-range networks of multiple body-worn sensors (e.g., chest, back, arms, etc.) and a nearby hub station: –Sensors take readings of key patient-specific information (e.g., temperature, pulse, blood glucose level, etc.) –Antennas embedded in sensors wirelessly transmit data to body-worn or closely located hub devices –Hub devices may process data locally and/or transmit it wirelessly for centralized processing, display, and storage MBANS can reduce infection risk, increase patient mobility & improve caregiver effectiveness 28

29. FCC – FDA Cooperation FCC and FDA have worked together for many years: –FCC: Office of Engineering and Technology and Wireless Telecommunications Bureau –FDA: Center for Devices and Radiological Health –Meet regularly to discuss topics of mutual interest Past and ongoing topics: –Managing interference to telemetry systems from DTV –Managing transition of telemetry in 450 MHz band –Identifying new spectrum for telemetry systems –Electromagnetic Compatibility (EMC) –Hearing aid compatibility of wireless phones –Radio frequency Exposure –FDASIA Ongoing consultation among FCC and FDA staff: –Guidance for wireless medical apps –Guidance for EMC –Guidance for RF safety 29

30. FCC-FDA Joint Public Meeting - July 26, 2010 First-Ever Agency Partnership to Improve Health Care Quality, Reduce Costs, Spur Private Investment –Agencies entered into MOU Agencies agree to work together to promote initiatives related to the review and use of FDA-regulated medical devices that utilize radiofrequency emissions –Goals Further enhance information sharing efforts in order to further ensure the safety and efficacy of medical devices Improve the efficiency of the agencies’ regulatory processes in areas where their jurisdiction overlaps, such as with respect to various medical devices that utilize broadband and wireless technology Promote efficient utilization of tools and expertise for product analysis, validation, and risk identification Build infrastructure and processes that meet the common needs for evaluating broadband and wireless enabled medical devices 30

31. Recent FDA Final Guidance on Wireless Medical Devices (Aug 13, 2013) Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff Addresses considerations that may affect the safe and effective use of medical devices that incorporate RF wireless technology (wireless medical devices), including: –Selection of wireless technology, quality of service, coexistence, security, and EMC. Such RF wireless technologies operate under a grant of certification and/or issuance of a license from the Federal Communications Commission (FCC ). http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077210.htm

32. Wireless Test beds – Experimental License Program FCC has adopted (January 31, 2013) new Experimental Licensing rules to expand existing Experimental Radio Service rules to promote cutting-edge research and foster development of new wireless technologies. Through a “medical testing license,” qualified healthcare facilities would have broad authority to conduct research without the need to seek new approval for each individual experiment. This will help facilities, and industry more broadly, better evaluate how wireless technologies and other electronic devices coexist in a hospital environment. –For example, how might a medical body area network react with others sensitive medical monitoring equipment, such as infusion pumps or fetal monitoring devices? –How might it affect diagnostic equipment in the OR and vice versa? –What happens when multiple patients in a waiting room are being simultaneously monitored by MBANS?

33. Thank You! Matt Quinn Director of Healthcare Initiatives Federal Communications Commission (FCC) Email: matthew.quinn@fcc.govmatthew.quinn@fcc.gov