UPDATED: Public Meeting on Impact on Regulation of Converged Communications and Health Care Devices
Public Meeting on Impact on Regulation of Converged Communications and Health Care Devices
Federal Communications Commission and the Food and Drug Administration
July 26-27
See Public Notice:
http://hraunfoss.fcc.gov/edocs_public/attachmatch/DA-10-1071A1.doc
Pre-registration: Email registration by 5 p.m., July 19, to fcc-fdameeting@fcc.gov
Following up on the National Broadband Plan's recommendation to use the power of broadband to improve health care, the nation's lead agencies overseeing communications and medical devices have scheduled a joint meeting to discuss ways to promote investment and innovation in health technology by streamlining government processes.
The joint public meeting on July 26-27 between the Federal Communications Commission and the Food and Drug Administration reflects a commitment by the two agencies to work even more closely to ensure the safety and reliability of wireless broadband-enabled medical devices while increasing their availability to consumers and health care providers. This collaboration is a critical step in the development and approval of new wireless medical devices and applications that hold great promise for improving the quality of health care and reducing costs.
Agenda
MONDAY, JULY 26, 2010
8:00 a.m. Check In & Vendor Showcase Begins
9:00 a.m. Welcome
Julius Knapp, Chief, Office of Engineering and Technology, Federal Communications Commission
9:15 a.m. Opening Remarks
- Chairman Julius Genachowski, FCC
- Commissioner Margaret Hamburg, Food and Drug Administration
9:35 a.m. Session 1: Current State of Wireless Health & Lessons Learned
Panelists
- Dale Wiggins, Philips
- Charles S. Farlow, Medtronic
- Jorge Valdes, DexCom
- Elliot B. Sloane, Drexel University School of Biomedical Engineering
Roundtable
- Jeffrey Shuren, FDA
- Julius Knapp, FCC
- Bernie Liebler, AdvaMed
- Bonnie Norman, Intel
- Kent Dicks, MedApps
- Tom Watlington, Sotera Wireless
10:20 a.m. Break
11:00 a.m. Session 2: Innovator Perspective
Panelists
- Hillary Chen, Office of Science and Technology Policy, White House
- Don Jones, Qualcomm Inc.
- Tim Kottak, GE Healthcare
- David L. Hankin, Alfred E. Mann Foundation for Scientific Research
Roundtable
- Steve Pollack, FDA
- Julius Knapp, FCC
- Bernie Liebler, AdvaMed
- Jorge Valdes, DexCom
- Elliot Sloane, Drexel University
- Bonnie Norman, Intel
- Kent Dicks, MedApps
- Dale Wiggins, Philips
- Tom Watlington, Sotera Wireless
12:15 p.m. Lunch
1:45 p.m. Session 3: Healthcare Provider, Clinician & Patient Perspective
Panelists
- Adam Darkins, Veterans Affairs
- Col. Ron Poropatich, TATRC, USAMRMC
- Julian Goldman, Partners HealthCare and Massachusetts General Hospital
Roundtable
- Bakul Patel, FDA
- Kerry McDermott, FCC
- Mike Tilkin, American College of Radiology
- Chantal Worzala, American Hospital Association
- Neal Sikka, George Washington University Medical Center
- TBD, Juvenile Diabetes Research Foundation
- Bill Riley, National Institutes of Mental Health
- Stephanie Bruce, Washington Hospital Center
3:00 p.m. Break
3:15 p.m. Session 4: Investor and Research & Development Perspective
Panelists
- Darren Hite, Aberdare
- Joseph Smith, West Wireless Health Institute
- Kaveh Safavi, Cisco Internet Business Solutions Group - Healthcare Practice
Roundtable
- Jonathan Sackner-Bernstein
- Phoebe Yang
- Jeffrey Dygert, AT&T
- Blair Levin, Aspen Institute
- Nancy Kamei, Intel
- Phillip Low, NeuroVigil, Inc.
- John Maschenic, Verizon
4:30 p.m. Public Comments
5:15 p.m. Summary of Day 1 & Preview of Day 2
5:30 p.m. Adjournment
TUESDAY, JULY 27, 2010
9:00 a.m. Welcome and Opening Remarks
Julius Knapp, FCC
9:10 a.m. Session 5: Reliability - How to Define Quality of Service
Panelists
- Peter Koo, Ericsson
- Neal Seidl, GE Healthcare
- Tom Watlington, Sotera Wireless
Roundtable
- Abiy Desta, FDA
- Tom Peters, FCC
- David Hankin, Alfred Mann Foundation
- Jake Leach, DexCom
- Audie Atienza, National Institutes of Health
- Dale Wiggins, Philips
- Dean Brenner, Qualcomm
- Kevin Fu, University of Massachusetts
10:25 p.m. Break
10:40 a.m. Session 6: Electromagnetic Compatibility - How to Promote EMC
Panelists
- Jim McCoy, InnerWireless
- Rick Hampton, Partners Healthcare System
- Terry Mahn, Fish & Richardson
Roundtable
- Brian Beard, FDA
- Rashmi Doshi, FCC
- John Collin, American Society for Healthcare Engineering of the AHA
- Troy Nagle, NC State U. & UNC Chapel Hill
- Ken Fuchs, Draeger Medical Systems
- Ted Osiniski, MET Labs
11:55 a.m. Public Comments
12:40 p.m. Summary, Areas for Focus & Next Steps
1:00 p.m. Adjournment
FDA and FCC are planning to focus the public meeting on the following topics:
A. 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 needs, uses, and risks for 'medical-grade' wireless technology and communications.
B. Medical device and system security issues - inadvertent and intentional intrusion - nonfunction and malfunction.
C. 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.
D. Risks Management:
a. The need to define levels of "criticality" of device function that can be used for determining reliability requirements.
b. Environmental factors and delivery setting - hospitals, users, clinics, home, travel, etc.
E. Views on current FDA and FCC regulatory requirements:
a. Relationship between FDA approval/clearance and FCC certification of applications, post market and compliance requirements.
Each of the previous topics will cover
1. Defining topics and scope;
2. Identifying the needs, goals and stakeholders; and
3. Recommendations.
FCC and FDA are seeking comments on the topics and soliciting suggestions on alternate or additional topics that commenters deem closely related. All comments and suggestions will be considered with the constraint of completing the workshop in no more than two days. To be considered, topics proposed must be relevant to the objective and intent of the workshop.