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U.S. Department of Health and Human Services

Medical Devices

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Public Meeting: Converged Communications and Health Care Devices Impact on Regulation, July 26-27, 2010

The purpose of this meeting is 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. This meeting marks the beginning of a process through which the agencies will provide appropriate clarifications in the future based on the input gathered.

Date, Time and Location

The public meeting was scheduled for July 26 and 27, 2010, from 8 a.m. to 5:30 p.m. at the following location:

FCC Commission Meeting Room
445 12th St., SW
Washington, DC 20554

Webcast & Presentations

Agenda

Meeting information and agenda are also available as a printable handout, in Adobe PDF format.

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 & 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 WigginsChief Technology Officer, Philips
Charles S. FarlowSenior Program Manager, Medtronic
Jorge ValdesChief Technical Officer, DexCom
Elliot B. SloaneProfessor and Director of Health Systems Engineering, Drexel University School of Biomedical Engineering

Round Table Discussion


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

Sessions 2 – 4 focus on Emerging Trends in Wireless Health

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 ChenGlobal Health Advisor to the Deputy Director (White House OSTP)
Don JonesVP Business Development, Health & Life Sciences, Qualcomm Inc.
Tim KottakExecutive, 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, MDMedical 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 HitePrincipal, Aberdare
Joseph Smith, MD, PhDChief Medical and Science Officer, West Wireless Health Institute
Kaveh Safavi, MDVice 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

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 KooVice President, Strategic Business Development, Ericsson
Neal Seidl Design Controls Manager, GE Healthcare
Tom WatlingtonCEO, 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
    • To be announced - 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

July 27, 2010

  • Session 5
    • David Hankin - Alfred Mann Foundation
    • Jake Leach - DexCom
    • Audie Atienza, PhD - National Institutes of Health
    • Dale 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
    • Ted Osiniski - MET Labs

Supplementary Information

Background

There have been significant developments in recent years in medical and healthcare devices using radio technology to monitor various body functions and conditions, including critical elements, and to deliver treatment and therapy. There has also been an increasing proliferation of devices using established commercial communications networks such as Internet connectivity to communicate with care providers. Mobile devices like smartphones and personal digital assistants (PDAs) are transforming the transmission of information used by physicians to help manage patient care, including  communication networks to relay information for patient health monitoring and decision support.

At one end, general-purpose communications devices such as smartphones, wireless routers and certain video-conferencing equipment are regulated by FCC. At the other end, medical devices that critically monitor patient health or provide treatment or therapy are regulated by FDA. Devices that do provide critical care and also use communications, such as life-critical wireless devices like remotely controlled drug-release mechanisms, are regulated by both agencies. In addition, device applications that would not be governed by FCC but transmit over wireless networks might warrant FDA oversight, while FCC might have better capability to assess the reliability of their communications capability.

Public Meeting

The objective of this meeting is to gather information and to better understand issues and perspectives from various stakeholders so the agencies can identify potential areas where each agency’s jurisdiction can be identified and clarified for affected parties, collection and assessment of each agency’s respectively appropriate information can be improved, expertise can be shared, and regulatory approval can be coordinated and simplified. These concerns relate both to devices operating on designated frequencies and to convergent medical device and information technology. This includes challenges faced by manufacturers and innovators in ensuring compliance with various regulatory requirements and risks associated with medical device systems using spectrum shared by other medical devices, using spectrum shared by other types of devices and services, and using broadband communication capabilities.

The information gathered during the meeting will be used to enhance the coordination between FDA and FCC for such devices and applications, and clarify and delineate the respective areas of expertise and jurisdiction between the agencies.

 

Questions for Comment

FDA and FCC are planning to focus the public meeting on the following topics:

  1. Data integrity and reliability issues arising from the use of allocated spectrum, the use of unlicensed devices, and the use of commercial networks and applications, and n eeds, uses, and risks for ‘medical-grade’ wireless technology and communications.
  2. Medical device and system security issues – inadvertent and intentional intrusion – nonfunction and malfunction.
  3. Trends in medical devices using allocated spectrum and using unlicensed operation, and medical devices and applications using commercial networks. Consideration of various wireless networking scenarios and use cases.
  4. Risks Management:
    1. The need to define levels of “criticality” of device function that can be used for determining reliability requirements.
    2. Environmental factors and delivery setting – hospitals, users, clinics, home, travel, etc.
  5. Views on current FDA and FCC regulatory requirements:
    1. Relationship between FDA approval/clearance and FCC certification of applications, post market and compliance requirements.

Each of the above topics will cover

  1. Defining topics and scope
  2. Identifying the needs, goals and stakeholders
  3. Recommendations

In advance of the meeting, additional information, including a meeting agenda with a speakers’ schedule for each session, will be made available on the Internet. This information will be placed on file in the public docket FDA-2010-N-0291, which is available at http://www.regulations.gov and in the FDA and FCC public reference rooms listed below.

Transcripts

Transcripts of the public meeting may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857 or at the Federal Communications Commission, Reference Information Center, 445 12th Street SW, rm. CY-A257, Washington, DC 20554 , Monday through Thursday, between the hours of 8 a.m. and 4:30 p.m. and on Fridays between the hours of 8 a.m. and 12:00 noon, approximately 15 working days after the public meeting at a cost of 10 cents per page. A transcript of the public meeting will be available on the Internet at http://www.regulations.gov.

Public Comments

Refer to the Federal Register Notice for instructions on how to submit comments about the topics discussed at this meeting

To view the comments go to http://www.regulations.gov and search by the key word: "FDA-2010-N-0291." If you have questions about the posted comments please call the Dockets Management Public Room at (301) 827-6860.

Contact Us

For further information about this meeting, contact:

Bakul Patel
Food and Drug Administration
Center for Devices and Radiological Health
10903 New Hampshire Avenue, Bldg. 66, rm. 3543
Silver Spring, MD 20993
301-796-5528
e-mail: bakul.patel@fda.hhs.gov