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[STDS-802-16] Fwd: Workshop on Wireless Healthcare



Begin forwarded message:

Date: 24 November 2008 2:02:49 PM MST
Subject: Fw: Workshop on Wireless Healthcare

This may be an opportunity for interested members of your committees.  Please pass along.  Thank you!

Kathryn M. Cush, Program Manager, Technical Program Development
IEEE Standards Activities - Piscataway, NJ - Ph: +1 732 465 5867
Email:  K.Cush@ieee.org  ~  Web:  
http://standards.ieee.org/
**************************************************************************************************
IEEE...Fostering technological innovation and excellence for the benefit of humanity.

----- Forwarded by Kathryn Cush/STDS/STAFF/US/IEEE on 11/24/2008 03:06 PM -----
From: "Witters Jr., Donald M." <donald.witters@fda.hhs.gov>
To: <K.Cush@ieee.org>
Date: 11/24/2008 02:07 PM
Subject: Workshop on Wireless Healthcare





Katherine,

As I mentioned, Elliot Sloane, Todd Cooper, Rick Hampton and myself are organizing a workshop on wireless in healthcare.  Please let me know if you or someone from IEEE EMBS, Computer Society, or other IEEE groups would be interested in participating in a workshop on Wireless Technology in Healthcare at Villanova University (outside Philadelphia) on Dec. 19, (see attached draft outline).  The purpose of the meeting is to formulate plans to develop pathways and tools for the safe, effective, secure, and reliable deployment and maintenance of wireless in healthcare.  We hope to have all the major stakeholders participate: academia, manufacturers, wireless industry, clinicians, hospitals, regulators, and government agencies.  Thank you.

Don Witters
FDA, CDRH, OSEL

Div. of Physics

10903 New Hampshire Ave.

Silver Spring, MD 20993-0002

301/796-2483

donald.witters@fda.hhs.gov

<<PrelimOutlineForRoundtable-11-19-08-draft (2).doc>>


Workshop on Wireless Technology in Healthcare:

“What is needed for safe, secure, and reliable deployment?”

December 19, 2008

 

Hosted by the Villanova Center for Enterprise Excellence in Technology, with participation by

US Food and Drug Administration, the IEEE Systems Council and Partners Healthcare

 

Locations: Villanova University, Villanova, PA (Suburban Philadelphia)

and real time simultaneous participation at

the Software Engineering Institute, Carnegie Mellon University (Pittsburgh)

 

Introduction:

While wireless technologies have been used for decades in medical devices, it has only been recently with the advent of wireless broadband technologies that adaptation of wireless for mobile medical devices and applications has skyrocketed.  However, most of the wireless protocol and systems now being used were not originally designed with remote home care and health monitoring or high-reliability, secure, life-critical medical applications in mind.

Problem:

More than any other technology employed in modern medicine, wireless connectivity calls upon the resources of numerous industry groups: medical devices, information technology, RFID, telecommunications and cellular telephone to mention but a few.  The disparate nature of these groups leaves several unresolved gaps in the implementation of most wireless medical devices and systems. If these gaps remain unaddressed they could result in undesired behaviors and potential safety risks.  These gaps include:

-       quality of service (QoS) needed for medical functions

-       data integrity, latency, through-put, lost or corrupted data

-       wireless coexistence

-       security of wireless signals

-       electromagnetic compatibility (EMC) of the wireless and surrounding medical devices

Goals:

The goals of the roundtable are:

-       Identify stakeholders from different industries, stimulate dialog, and develop collaborative efforts

-       Raise awareness of the unique characteristics and risks for wireless in healthcare

-       Develop pathways to ensure the safe, secure and reliable use of wireless technology in healthcare

-       Identify needed tools such as standards and guidance information and make plans to develop them

-       Devise strategies for present and future technologies

-       Develop mechanisms linking design, testing, deployment, maintenance and regulatory considerations for the safe and secure use of wireless technology in healthcare.

Agenda:

-       8:00 – 8:30 Registration, continental breakfast  

-       8:30 – 9:30 Short presentations/talks from key stakeholder’s perspectives (1 hr)

-       9:30 – 9:45 Coffee Break

-       9:45 – 11:30 Breakout session 1, groups to discuss present and future needs (1.75 hrs)

o   A. Identifying Stakeholders, benefits, challenges, risks

o   B. Identifying/categorizing critical wireless medical device/network security dimensions/factors for CIA&S (Confidentiality, Integrity, Availability & Safety)

-       11:30 – 12:30 Brief report-out from morning breakouts

-       12:00 – 1:00 “Working Lunch” – birds of a feather discussions

-       1:00 – 2:00 Breakout group session 2 – strategies for future work (1 hr)

o   C. CIA&S Performance metrics for that could/should be cataloged (e.g, QoS, Bandwidth, etc)

o   D. System design and life-cycle maintenance Verification and Validation strategies, and sources for to assure CIA&S in future applications

-       2:00 – 2:15 Coffee break

-       2:15 – 3:30 Discussion, consensus, responsibilities (1.25 hrs)

-       3:30 – 4:00 Take home action items, schedule follow-up meetings; Plans/opportunities for ongoing forums, workshops, discussions, coordination (1/2 hr)

 

 

 

Questions to consider:

-       Who are key stakeholders?

-       What are the benefits and challenges for safe use of wireless in healthcare?

-       Who is responsible for safe, secure, reliable use of wireless?

-       How can QoS, coexistence, security, EMC, etc. be addressed?

-       How can the stakeholders come together?

-       Are there clear pathways to deployment and use?

-       Are there clear tools and are they adequate?

-       If not, what needs to be developed?

-       Who should be involved in the development?

-       How should these issues be approached?

-       What schedule is needed?

-       Who will take on leadership and work?

Registration, Directions, and Lodging:

-       To Be Announced