Friday, July 30, 2010

FCC and FDA Joint Meeting on Life Saving Wireless Medical Technology

The Food and Drug Administration (FDA) and the Federal Communications Commission (FCC) signed a memorandum of understanding committing the agencies to coordinated oversight of medical devices in view of the rapid convergence of network and healthcare technologies.

They two agencies released a joint statement stating:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.

They held an unprecedented joint meeting on "Life Saving Wireless Medical Technology" on July 26-27, 2010 (video for both days is below). The purpose of these meetings was for the FDA and FCC to gain a better understanding of the convergence of communications technologies and medical devices, the future of wireless health technologies, and the challenges they face. Our goal is to enhance coordination between FDA and FCC for future devices and applications, and to clarify and delineate the respective areas of expertise and jurisdiction between the agencies. The meetings marked the beginning of a process through which the agencies will provide appropriate clarifications in the future based on the input gathered.
"This joint initiative reflects a shared commitment on behalf of the FCC and FDA to promote investment and innovation in the health technologies that will save lives and help address some of our nation’s health care challenges,” said FCC Chairman Julius Genachowski. “I enthusiastically support this effort and applaud the teams in place at the FCC and the FDA working diligently to ensure that these medical innovations can safely and swiftly be brought to market."

Day 1 - July 26, 2010
8:00 a.m. Check In & Vendor Showcase Opens
Chairman Genachowski and Commissioner Hamburg will be joined by Aneesh Chopra, Chief Technology Officer, to tour the showcase
9:00 a.m. Welcome
Julius Knapp
Chief, Office of Engineering and Technology, FCC
9:15 a.m. Opening Remarks
Julius Genachowski, JD
Chairman, Federal Communications Commission

Margaret Hamburg, MD
Commissioner, Food and Drug Administration
Each session will begin with a brief presentation made by three to four round table members followed by a round table discussion led by moderators.

9:35 a.m. Session 1: Current State of Wireless Health and Lessons Learned (45 min)
Understanding the variety of existing wireless medical technologies, their uses, and lessons learned.
Moderators: Jeffrey Shuren, MD and Julius Knapp

Presentations: (5 minutes each)

Dale Wiggins Chief Technology Officer, Philips
Charles S. Farlow Senior Program Manager, Medtronic
Jorge Valdes Chief Technical Officer, DexCom
Elliot B. Sloane Professor and Director of Health Systems Engineering, Drexel University School of Biomedical Engineering
Round Table Discussion

10:20 a.m. Break & Visit Showcase (40 min)


The objective of these sessions is to better understand the landscape of emerging wireless medical technologies and trends, their potential benefits, potential risks, and challenges from various stakeholder perspectives.

11:00 a.m. Session 2: Innovator Perspective (1 hour 15 min)
Moderators: Steve Pollack and Julius Knapp

Presentations: (5 minutes each)

Hillary Chen Global Health Advisor to the Deputy Director (White House OSTP)
Don Jones VP Business Development, Health & Life Sciences, Qualcomm Inc.
Tim Kottak Executive, Design Controls, GE Healthcare
David L. Hankin CEO, Alfred E. Mann Foundation for Scientific Research
Round Table Discussion

12:15 p.m. Lunch & Visit Showcase (1 hour 30 min)
1:45 p.m. Session 3: Healthcare Provider, Clinician & Patient Perspective (1 hour 15 min)
Moderators: Bakul Patel and Kerry McDermott

Presentations: (5 minutes each)

Adam Darkins, MD Chief Consultant for Care Coordination, Veterans Affairs
Col. Ron Poropatich, MD Deputy Director, TATRC, USAMRMC
Julian Goldman, MD Medical Director, Biomedical Engineering, Partners HealthCare; Attending Anesthesiologist, Massachusetts General Hospital
Round Table Discussion

3:00 p.m. Break (15 min)
3:15 p.m. Session 4: Investor and Research & Development Perspective (1 hour 15 min)
Moderators: Jonathan Sackner-Bernstein, MD and Phoebe Yang

Presentations: (5 minutes each)

Darren Hite Principal, Aberdare
Joseph Smith, MD, PhD Chief Medical and Science Officer, West Wireless Health Institute
Kaveh Safavi, MD Vice President and Global Lead, Cisco Internet Business Solutions Group - Healthcare Practice
Round Table Discussion

4:30 p.m. Public Comments (45 min)
Attendees will be allowed to make a statement based on advance sign-up. Preference will be given to those individuals that indicated a desire to speak during the registration process. Each speaker will be allowed a maximum of two minutes.
5:15 p.m. Wrap Up – Summarize Day 1 and Preview Day 2
5:30 p.m. Adjourn

Day 2 - July 27, 2010
8:30 a.m. Doors open
9:00 a.m. Welcome and Opening Remarks
Julius Knapp
Chief, Office of Engineering and Technology, FCC
9:10 a.m. Session 5: Reliability – How to Define Quality of Service (1 hour 15 min)
Better understanding the issues raised by use of commercial networks and unlicensed spectrum for health purposes.

Moderators: Abiy Desta and Tom Peters

Presentations: (5 minutes each)

Peter Koo Vice President, Strategic Business Development, Ericsson
Neal Seidl Design Controls Manager, GE Healthcare
Tom Watlington CEO, Sotera Wireless
Round Table Discussion

10:25 p.m. Break (15 min)
10:40 a.m. Session 6: Electromagnetic Compatibility – How to Promote EMC (1 hour 15 min)
Better understanding how wireless health devices interact and how to ensure that such devices function properly.

Moderators: Brian Beard and Rashmi Doshi

Presentations: (5 minutes each)

Jim McCoy Chief Technology Officer, InnerWireless
Rick Hampton Wireless Communications Manager, Partners Healthcare System
Terry Mahn Managing Principal, Fish & Richardson
Round Table Discussion

11:55 a.m. Public Comments (45 min)
Attendees will be allowed to make a statement based on advance sign-up. Preference will be given to those individuals that indicated a desire to speak during the registration process. Each speaker will be allowed a maximum of two minutes.
12:40 p.m. Wrap Up – Summarize Learnings, Areas for Focus & Next Steps
1:00 p.m. Adjourn

Round Table Discussion Participants – July 26, 2010
Session 1
Bernie Liebler – AdvaMed
Bonnie Norman – Intel
Kent Dicks – MedApps
Tom Watlington – Sotera Wireless
Session 2
Bernie Liebler – AdvaMed
Jorge Valdes – DexCom
Elliot Sloane, PhD – Drexel University
Bonnie Norman – Intel
Kent Dicks – MedApps
Dale Wiggins – Philips
Tom Watlington – Sotera Wireless
Session 3
Mike Tilkin – American College of Radiology
Chantal Worzala, PhD – American Hospital Association
Neal Sikka, MD – George Washington University Medical Center
Campell Hutton – Juvenile Diabetes Research Foundation (JDRF)
Bill Riley, PhD – National Heart, Lung, and Blood Institute
Stephanie Bruce, MD – Washington Hospital Center
Session 4
Jeffrey Dygert – AT&T
Blair Levin – Aspen Institute
Nancy Kamei – Intel
Philip Low, PhD – NeuroVigil, Inc.
John Maschenic – Verizon
Round Table Discussion Participants – July 27, 2010
Session 5
David Hankin – Alfred Mann Foundation
Jake Leach – DexCom
Audie Atienza, PhD – National Institutes of Health
PDale Wiggins – Philips
Dean Brenner – Qualcomm
Kevin Fu – University of Massachusetts
Session 6
John Collins – American Society for Healthcare Engineering (ASHE) of the AHA
Troy Nagle, MD, PhD – NC State U. & UNC Chapel Hill
Ken Fuchs – Draeger Medical Systems
PDale Wiggins – Philips
Ted Osiniski – MET Labs


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