FCC and FDA Joint Workshop Agenda

• FCC Chairman Tom Wheeler
• FCC Commissioner Mignon Clyburn
• Dr. William Maisel, Deputy Director, Center for Devices and Radiological Health, FDA

• Julius Knapp, Chief, Office of Engineering and Technology, FCC
• Bakul Patel, Associate Director for Digital Health, Center for Devices and Radiological Health, FDA

What issues and potential problems arise as medical devices go wireless? What are the potential implications of medical devices using unlicensed spectrum? Are there current programs examining wireless medical device coexistence in hospitals and other health care facilities? Are there different needs for pre-deployment testing and post-installation monitoring? Are medical device test beds needed, and if so, why? What is the desired output or outcome of using wireless test beds? How do they help protect patient safety? Are there any challenges and/or limitations from using a test bed? Are new issues emerging that make the need for these test beds more or less important (e.g., hospital to home; broader consumer use outside medical facilities; mBANS, more connected devices/Medical IoT)?

• Moderators:
  • H. Stephen Berger, President, TEM Consulting; Chair, ANSI ASC C63 Subcommittee 7 on Spectrum Etiquette; Chair, ANSI C63.27 Working Group on Wireless Coexistence Testing; Co-Chair, AAMI Medical Device Wireless Committee
  • Dr. Julian Goldman, Medical Director, Biomedical Engineering, Partners HealthCare System; Attending Anesthesiologist, Massachusetts General Hospital/Harvard Medical School; Director, Medical Device Interoperability Program; Co-Chair, AAMI Interoperability Working Group
• Discussants:
  • Shawn M. Jackman, Director, Strategic Planning, Network Services, Kaiser Permanente
  • Kerry McDermott, Vice President, Public Policy and Communications, Center for Medical Interoperability; former Director of Healthcare, FCC
  • Phil Raymond, Wireless Architect, Philips Healthcare; Chair, Wi-Fi Alliance, Healthcare Marketing Task Group
  • Rick Tevis, Senior Director, Clinical Engineering, Geisinger Health System
  • Donald Witters, Biomedical Engineer, Center for Devices and Radiological Health, FDA

What are some of the current, most innovative public and private wireless medical device test bed programs today, and where are they housed (e.g., hospitals, non-hospital settings, homes, universities, etc.)? What components and characteristics comprise these test beds? Are there different types of medical device test beds (e.g., hardware, software, etc.)? Where do these devices operate in the radio frequency? Is there a central repository of test results/data that the medical community and other stakeholders can access? What types of medical devices and innovations are being tested? How are tests and simulations being conducted in these settings? What testing standards, if any, are being applied for current wireless medical device test beds? Who are the primary users of wireless medical device test beds (researchers, manufacturers, doctors, innovators, entrepreneurs) and what knowledge can be gleaned from them?

• Moderators:
  • Dr. Wendy Nilsen, Health Science Administrator, National Institutes of Health; Program Director, National Science Foundation
  • Seth Seidman, Senior Electrical Engineer, Center for Devices and Radiological Health, FDA
• Discussants:
  • Greg Bowden, Senior Reliability Engineer, Medtronic, Inc.
  • Mick Conley, Development Manager Industry Programs, Underwriters Laboratories Inc.
  • Michelle Jump, Principal Regulatory Affairs Specialist, Stryker Corporation
  • Dr. Hazem Refai, Professor, University of Oklahoma; Founder and Director of the Wireless Electromagnetic Compliance and Design Center
  • Dr. William Young, Senior Engineer, National Institute of Standards and Technology

Featuring: Dr. Harry Greenspun, Director, Center for Health Solutions, Deloitte Services LP

What would a wireless medical device test bed ideally look like? What can be done to enable more efficient testing? Are there gaps in the availability of test beds, test equipment, and/or test subjects? Are there gaps in standards for wireless medical devices that inhibit testing? What are the impacts of wireless test beds on patient care? Are the necessary features and functions, and any gaps in wireless medical test beds different for small versus large players? What should the role of the federal government, and more specifically the FCC and FDA, be in promoting these test beds? What, if any, changes should be made in the regulatory process to enable more efficient testing? How can the development of wireless medical device test beds be accelerated? What are the roles of medical device manufacturers, hospital IT departments, technology developers, and networking infrastructure providers?

• Moderators:
  • Ed Cantwell, Chief Operating Officer, Center for Medical Interoperability
  • Ira Keltz, Deputy Chief, Office of Engineering and Technology, FCC
• Discussants:
  • Dr. Steven Baker, Senior Principal Engineer, Welch Allyn
  • Rick Hampton, Wireless Communications Manager, Partners Healthcare System
  • Fanny Mlinarsky, President, octoScope, Inc.
  • Chris Riha, Senior Director, Technology Services Group, Carilion Clinic Health System
  • Ed Wyatt, Senior Systems Engineer, Ruckus Wireless, Inc.

What is the future of wireless health and connected health? As care moves from the clinical setting to the retail or home setting, how is coexistence affected? How are the coexistence issues similar or dissimilar between those settings? In light of the ongoing health care transformation, how can medical devices be future-proofed? What is next on the horizon for wireless test beds in clinical and non-clinical settings? How can relevant stakeholders develop a learning environment for wireless medical technologies so that information can be shared while balancing proprietary interests? What are some strategies to evaluate, catalog, and disseminate knowledge related to intelligent integration of medical devices into wireless systems in various settings. Are there other models (beyond or in conjunction with) wireless test beds to consider?

• Moderators:
  • Dale Hatfield, Senior Fellow, Silicon Flatirons Center for Law, Technology and Entrepreneurship, University of Colorado at Boulder; former Chief, Office of Engineering and Technology, FCC
  • Robert Havasy, Vice President, Personal Connected Health Alliance; Executive Dir., Continua
• Discussants:
  • Surjit Ahluwalia, Director, Advanced Services, Cisco Systems
  • Dipankar (Dipu) Ganguly, Chief Executive Officer, AkibaH, Inc.
  • Scott Gresbach, Program Leader, GE Healthcare Global Services
  • Robert Jarrin, Senior Director, Government Affairs, Qualcomm Inc.
  • Jeffrey Tri, Section Head, Information Technology, Mayo Foundation for Education and Research