1. Overview of FCC FDASIA Workgroup: Regulations Workgroup June 20 th 2013 Note: The views expressed in this presentation are those of the author and may not necessarily represent the views of the Federal Communications Commission

2. FCC 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 Group Photo - Oct. 2009 -Commissioner Baker has since left the FCC 2

3. Overview 3 Overview of FCC Regulation of Radio Services & Devices

4. FCC Jurisdiction FCC manages non-federal spectrum National Telecommunications & Information Administration (NTIA) manages federal spectrum -Advised by Interdepartmental Radio Advisory Committee (IRAC) -Federal Agencies participate in IRAC: DoE, DoD, DoT, NASA, State Dept., etc. FCC works closely with federal agencies on a wide variety of issues 4

5. Licensed Radio Services Broadcasting Satellite Private Wireless -Public Safety -Industrial -Aviation -Marine -Amateur Commercial Mobile -Cellular -Personal Communications -Advanced Wireless -700 MHz -Broadband Radio Service Fixed Wireless -Private -Common Carrier 5

6. Standards For Licensed Radio Services Primarily focus on interference control -Frequency -Power Output -Bandwidth/Channels -Spurious Emissions Other: -RF Exposure -Hearing aid compatibility -E-911 Rules strive to be technology neutral FCC generally has not regulated: -Protocols (i.e. LTE, WiMAX) -Performance -Reliability -Compatibility -Safety -Efficacy 6

7. NBP 7 National Broadband Plan

8. National Broadband Plan (NBP) – Published in March 2010 Comprehensive plan to facilitate broadband deployment NBP called for making 500 MHz available for wireless broadband within 10 yrs, 300 MHz of which to be made available within 5 yrs FCC has taken actions over the past year to implement NBP : -Opened 25 MHz of WCS spectrum for mobile broadband -Issued proposal to repurpose portion of TV spectrum -Provided flexibility for terrestrial in the mobile satellite service -Finalized rules for TV white space -Proposed to revamp experimental licensing -Began inquiry on dynamic spectrum access -Adopted rules to increase efficiency for backhaul spectrum 8

9. 9 Why it matters for health care: Spectrum is the “oxygen” that wireless broadband needs to thrive 9 Hungry Devices National Purposes Telemedicine Smart Grid Civic Engagement Consumer Apps Public Safety

10. Healthcare 10 Healthcare

11. 11 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

12. 12 Wireless Medical Devices and Applications are Emerging Healthcare Source: AirStrip Technologies, Intel, Medtronic, CardioNet, Corventis

13. From Plan to Action 13 From Plan to Action

14. 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 Ongoing consultation among FCC and FDA staff: -Guidance for wireless medical apps -Guidance for EMC -Guidance for RF safety 14

15. FCC – FDA Joint Public Meeting - July 26, 2010 “Enabling the Convergence of Communications and Medical Systems” First-Ever Agency Partnership to Improve Health Care Quality, Reduce Costs, Spur Private Investment Included wide range of top technologists, doctors and health care experts, along with White House and other executive branch officials More than 20 participants in Showcase Event agenda: http://reboot.fcc.gov/workshops/fcc-fda-joint- meeting-on-life-saving-wireless-medical-technologyhttp://reboot.fcc.gov/workshops/fcc-fda-joint- meeting-on-life-saving-wireless-medical-technology Read the FDA/FCC Joint Statement of Principles: http://hraunfoss.fcc.gov/edocs_public/attachmatch/DOC- 300200A1.pdf http://hraunfoss.fcc.gov/edocs_public/attachmatch/DOC- 300200A1.pdf Read the FDA/FCC Memorandum of Understanding: http://hraunfoss.fcc.gov/edocs_public/attachmatch/DOC- 300200A2.pdf http://hraunfoss.fcc.gov/edocs_public/attachmatch/DOC- 300200A2.pdf 15

16. Joint Statement on Wireless Medical Devices U.S. Food and Drug Administration Federal Communications Commission July 26, 2010 Innovation in broadband and wireless-enabled medical devices holds significant promise for enhancing health and reducing the costs of health care for all Americans. Examples include wireless sensors that remotely monitor heart rhythm and portable glucose monitoring systems. All Americans should be afforded the opportunity to benefit from medical technology advances with improved broadband and wireless technology. Developing and integrating wireless and broadband communications technology with medical devices and applications requires agencies to assure that such devices operate in a safe, reliable and secure manner. It is important for the federal government to provide leadership and encourage innovation and investment in new health care technologies that enable patients, doctors, and other health professionals to access the highest quality care. The American public -- including industry, providers, patients, and other interested stakeholders -- should have clear regulatory pathways, processes, and standards to bring broadband and wireless-enabled medical devices to market. This includes clarity regarding each agency’s scope of authority with respect to these devices, predictability regarding regulatory pathways, and streamlining the application process, as appropriate, to facilitate innovation while protecting patients. The FDA and the FCC agree to build upon this initiative launched today to proactively serve the national interest in finding innovative solutions to America’s health care challenges. Food and Drug Administration (FDA) Federal Communications Commission (FCC) Commissioner Dr. Margaret Hamburg Chairman Julius Genachowski 16