February 2015

Federal Communications Commission and the Food and Drug Administration
Tuesday, March 31, 2015
9 am - 4:30 pm
http://transition.fcc.gov/Daily_Releases/Daily_Business/2015/db0220/DA-1...

A public workshop on the role of wireless medical test beds and their influence on the development of converged medical technology for clinical and non-clinical settings. A wireless test bed is an environment where devices can be evaluated across a range of interference scenarios.

TENTATIVE AGENDA

9:00-9:15 a.m. Welcome, Greetings from FCC and FDA

9:15-9:30 a.m. Overview of FCC and FDA Ongoing Collaborative Efforts and Interest in Wireless Test Beds for Converged Medical Devices

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

9:30-10:45 a.m. Session One: Defining the Need for and Scope of Wireless Medical Device Test Beds

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; CoChair, 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

10:45-11:00 a.m. Break

11:00-12:00 p.m. Session Two: Overview of Current Public and Private Wireless Medical Device Test Bed Programs and Initiatives

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.
  • Dr. Hazem Refai, Associate Professor, University of Oklahoma; Founder and Director of the Wireless Electromagnetic Compliance and Design Center
  • Daria Stehling, Consultant; Member of CTIA M2M sub-working group, the ANSI C63 SC7, and contributor to ANSI C63.27 working group on coexistence standards
  • Dr. William Young, Senior Engineer, National Institute of Standards and Technology

12:00-1:00 p.m. Lunch Break

1:00-1:30 p.m. Spotlight Session — Future of Healthcare and Medical Device Innovations

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

1:30-2:45 p.m. Session Three: Identifying and Prioritizing Key Features, Functions and Gaps in Wireless Medical Device Test Beds

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.

2:45-3:00 p.m. Break

3:00-4:15 p.m. Session Four: Driving Innovation and Safe Coexistence of Wireless Medical Technologies

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

4:15-4:30 p.m. Closing

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The event is free and open to the public. An agenda, providing additional details about the workshop, including participants and issues to be discussed, will be released at a later date. Details also will be posted on http://www.fcc.gov/health

*Registration is strongly encouraged. To register and get on an e-mail list for the event, please e-mail testbeds@fcc.gov with “Registration” in the subject line and provide your name, organization affiliation and contact information.

A free webcast of the live event, with open captioning over the Internet, will be available at FCC.gov/live.

For additional registration or logistical information, please contact Shannon Hyatt by e-mail at testbeds@fcc.gov or by phone at (202) 418-1887.

Please direct press inquiries to Katie Gorscak, Connect2HealthFCC Task Force, FCC, at (202) 418-2156 or katie.gorscak@fcc.gov; and to Andrea Fischer, Office of Media Affairs, FDA, at (301) 796-0393 or andrea.fischer@fda.hhs.gov.



Senate Commerce Committee
Thursday, February 26, 2015
10 am

The Committee will markup nine bills and nominations for six agencies. On the agenda -- S. 253, Federal Communications Commission Consolidated Reporting Act of 2015, Sponsor: Sen. Dean Heller (R-NV)



Rep Chaffetz (R-UT) wants unredacted emails from FCC

House Oversight Committee Chairman Jason Chaffetz (R-UT) fired off his third letter in February in his probe into whether the White House had an improper role in the Federal Communications Commission's development of network neutrality rules. Chairman Chaffetz requested a set of unredacted emails that date back to April 2014, shorty before FCC Chairman Tom Wheeler unveiled his initial draft net neutrality plan.

The heavily redacted April emails show an unnamed official alerting the White House about an upcoming New York Times article. John Podesta, an adviser to President Barack Obama at the time, described it as a “brutal story” and asked if someone planned to respond on the record. The Times article reference an increased lobbying push by advocates who were disappointed that Chairman Wheeler’s plan was not stronger. Chairman Chaffetz wants a copy of the unredacted emails by Feb 23.

Minnesota Gains 10-Gigabit Broadband for Schools from Telecommunications Group

Schools throughout a large part of northwestern Minnesota will be getting 10 gigabit broadband as the result of a cooperative effort between a school district consortium and a consortium of 18 small local telecom service providers. The initiative builds on a 13-year relationship between the telecommunications company consortium, known as Northwest Minnesota Special Access (NMSA), and NWLINKS, the school district consortium.

In 2009, NMSA made the decision to bring fiber to all of the NWLINKS schools. E-Rate funding helped cover schools’ monthly service charges but each telecommunications company in the NMSA consortium was responsible for the cost of deploying fiber where needed. At that time some companies already had made fiber deployments and even offered fiber-to-the-home, while others had not. Some other small telecommunications companies in various parts of the country have found that once they bring fiber to anchor institutions such as schools, it is easier to make a business case for broader Fiber-to-the-Home or fiber to the node deployments.

ACA, NCTA Push Pole Position

The National Cable & Telecommunications Association and the American Cable Association have both called on the Federal Communications Commission to act on a petition on pole attachment rates before the Feb. 26 vote to reclassify Internet service providers as telecommunications services under Title II. Cable operators argue that if the FCC does reclassify broadband access under Title II regulations, as FCC Chairman Tom Wheeler has said it will do, that could translate into higher pole-attachment rates, especially for smaller and medium-sized operators. The telecommunications rate was traditionally higher than the cable rate. The FCC voted in 2011 to harmonize the rates, but the opportunity remained for pole owners to charge higher rates under some circumstances. The NCTA, Comptel and others sought to resolve that situation in a petition for reconsideration filed back in 2011, asking the FCC to insure that broadband providers can attach at the lowest rate available under FCC rules.

Your City Is Going To Be Able To Build Its Own Broadband And Blow Evil Cable Companies Away

Comcast, Verizon, AT&T: Watch out. In order to increase competition and expand high-speed Internet access to areas without, the Federal Communications Commission is set to vote to support the rights of cities to create their own fiber networks. "The number of municipal networks is really poised to explode," says Christopher Mitchell, director of community broadband networks at the Institute for Local Self-Reliance.

"There’s not one model that we’re expecting to see, but as a result of this, we’re expecting cities to take a larger role." In addition to government actions, he credits Google Fiber -- which although a private service and only available in a few cities -- for showing other communities what is possible and giving them leverage to demand better from their providers or build their own networks.

Broadband is better as a public-private partnership

[Commentary] Waiting for the incumbent Internet service providers to do something on their own or even providing substantial incentives to motivate them is not working. There must be a better way. A simple solution is to encourage municipalities to build out this so-called “last-mile” connection to individual homes and businesses by installing publicly owned fiber. This “dark fiber” would not necessarily have any service on it provided by the municipality. Instead, it would function as a “road” to one or more centralized publicly owned “meet-me” locations.

This model addresses many of the concerns with municipal broadband -- such as a lack of choice and poor customer service, or concerns about filtering, privacy and tracking -- while retaining the true need and competitive advantage of offering very high-speed connections critical to future growth and prosperity. By separating the true infrastructure from the services that can ride on top of it we have, in effect, created something much more analogous to the road network that is provided publicly but utilized by many people and businesses in many different ways.

[Ben Franske, Ph.D., is a Professor of Information Technology and Security at Inver Hills Community College]

The Right to Be Forgotten, the Privilege to Be Remembered

[Commentary] What does it mean to be “forgotten”? So many people are, whether they have a right to it or not. But being easily linked, forever, to certain search engine results -- is that the opposite of being forgotten? Is that being “remembered”? Privacy scholars Woodrow Hartzog and Evan Selinger have written about information obscurity as “a protective state that can further a number of goals, such as autonomy, self-fulfillment, socialization, and relative freedom from the abuse of power.”

Can we find the balance that allows for both obscurity and preservation -- even proclamation -- of the past? Do we want to be identified, and remembered? That depends: By whom, and for what purpose? The European Union decision on delisting gives people some level of control over the information that can be easily found about them. Forgetting, and remembering, are about a lot more.

[Irina Raicu, is the Director of the Internet Ethics Program at Santa Clara University]

Bringing the FCC's Contest Rule Up to Date

[Commentary] It is an unusual occasion indeed when the Federal Communications Commission offers to revise its rules to provide regulatory relief to both television and radio stations. Yet that is precisely what the FCC proposed in a Notice of Proposed Rulemaking to update its station-conducted contest rule to allow broadcasters to post contest rules online rather than broadcast them.

As the proposal now stands, stations would no longer need to broadcast the contest rules if they instead announce the full website address where the rules can be found each time they discuss the contest on-air. In short, the FCC has an opportunity to ease the burden on both broadcasters and their audiences by allowing stations the flexibility to elect to make their contest rule disclosures online. The FCC shouldn't diminish the benefit to be gained by reflexively imposing unnecessary restrictions on that flexibility.

Frontier's President and COO: We won't expand U-verse

Frontier Communications enhanced its video service capabilities when it purchased AT&T's Connecticut operations, a deal that gave it AT&T's U-verse platform, but for now Frontier has no immediate plans to expand it into new markets anytime soon. Daniel McCarthy, President and COO for Frontier, told investors that the service provider plans to see how it can leverage elements of the U-verse systems, including the operational support system, while conducting trials of U-verse in some markets.

"We have no major plans to expand U-verse widely across the country but we do think that there [are] low cost alternatives in ways to leverage this system, the OSS, the content ingestion, the TV Everywhere, all of those components of it, to take advantage of all the broadband expansion and all the next-gen equipment that we've installed around the country, quite frankly," McCarthy said. "So you'll see us probably take a look at selectively trials in different markets but there is no wholesale expansion plans at this point."