Project: IEEE P802.15 Working Group for Wireless Personal Area Networks (WPANs)

1. Project: IEEE P802.15 Working Group for Wireless Personal Area Networks (WPANs) Submission Title: [Wireless and Wired Networks for Medical Devices: 21st Century Issues and Opportunities] Date Submitted: [10 July 2008] Source: [Elliot B Sloane] Company [Villanova University] Address [800 Lancaster Avenue, Villanova, PA 19085 USA] Voice:[610-519-6442], E-Mail:[ebsloane@ieee.org] Re: [If this is a proposed revision, cite the original document.] [If this is a response to a Call for Contributions, cite the name and date of the Call for Contributions to which this document responds, as well as the relevant item number in the Call for Contributions.] [Note: Contributions that are not responsive to this section of the template, and contributions which do not address the topic under which they are submitted, may be refused or consigned to the “General Contributions” area.] Abstract: [Description of document contents.] Purpose: [Description of what the author wants P802.15 to do with the information in the document.] Notice: This document has been prepared to assist the IEEE P802.15. It is offered as a basis for discussion and is not binding on the contributing individual(s) or organization(s). The material in this document is subject to change in form and content after further study. The contributor(s) reserve(s) the right to add, amend or withdraw material contained herein. Release: The contributor acknowledges and accepts that this contribution becomes the property of IEEE and may be made publicly available by P802.15.

2. Wireless and Wired Networks for Medical Devices: 21st Century Issues and Opportunities Elliot B. Sloane, PhD, CCE Villanova University EMBS AdCom IEEE SA 11073 Standards Sponsor Chair, IEEE’s Healthcare Industry Segment Initiative (’03-’05)

3. BioBrief: Elliot Sloane, PhD, CCEDual Clinical Engineering and Information Technology “Citizenship!” • 32+ Years of CE and IT/IS Industry and Academic Expertise • Initially, Vice President, ECRI Institute – 15 years, CIO & COO • World’s largest medical device research, testing, standards, and education agency • Then, Vice President, MEDIQ/PRN – 10 Years, COO & CTO • Medical device & drug distribution, service, and manufacturing • Since 2000, Information Systems faculty at Villanova University School of Business, near of Philadelphia. • Teaching, research and publishing in health informatics. • #12 undergraduate Business School in US (Business Week) • Member and Officer in CE/IT/MIS Societies since 1980 • IEEE EMBS AdCom since 2003; Member of IEEE SA • Senior Member IEEE, member since 1974. • Board of Directors ANSI HITSP committee • Co-chair International IHE Board of directors representing HIMSS, and co-chair of the IHE Patient Care Device Domain. • Past-President, American College of Clinical Engineering

4. What is a medical device? • According to FDA, it is “any product (or portion of a product) that affects a patient’s diagnosis or therapy of”

5. Important Update for IEEE In a recent 2008 FDA proposed ruling data communication or storage devices or networks that merely transmit or storepatient data will become“medical devices.” • This might well threaten future widespread 802.x deployment in life-critical healthcare applications.

6. What standards govern medical devices in the US? • Unlike Europe the FDA has NO standards for medical devices! • FDA chooses to regulate quality and safety by pre-market screening and post-market surveillance. • The furthest FDA goes is to provide a few “guidance documents” for manufacturers.

7. What standards really govern medical devices in the US? • AAMI, an industry association, develops consensus clinical, technical, and safety standards for specific medical devices like IV Pumps. • Now “importing” European standards from IEC and other sources. • IEC 60601 and some ISO standards cover European medical devices • Some of those standards include “smart” functions such as intelligent alarms, but not the transmission of data.

8. What standards really govern medical devices? • IEEE 11073 committees develop most of the medical information (a.k.a. medical informatics) standards related to the nomenclature, structure, and transmission of data between medical devices and computer systems used for medical care. • Medical image data standards are handled by DICOM. • Following approval, IEEE 11073 standards are presented for ISO balloting and approval, to make them visible for widespread global adoption.

9. What else is a “medical device?” • Strong movement now occurring inside/outside government to include “consumer health/medical devices” such as heart monitors used with treadmills as non-regulated, but still partially valid, sources of medical data. • Low cost products suit Medicare plans to reduce costs • Allows people to purchase many products for their medical care at Costco, BJs, and Wal-Mart for own “basic” medical care at home. • HHS plans use “telemedicine” to leverage these low cost devices. • IEEE 802.x (Zigbee, Bluetooth, Wi-Fi, Wi-Max), USB devices, laptops, disk drives, PDAs, etc, will acquire new liabilities when used in such applications.

10. “Industry” (e.g., Intel, Microsoft, Sharp, etc) is leading this effort to create standards for this new class of “consumer health/medical devices” and associated communication, storage, and computing accessories. ContinuaAlliance.org is the group leading that effort. • Continua Alliance is beginning to build out their standards as a subcommittee within IEEE 11073. • Continua is NOT specifically IEEE 802-friendly

11. How big is the healthcare market in the US? • Roughly $2 trillion/year in 2006 • Projected to reach $4 trillion, or 25% GDP, by 2015. • IOM/National Academies of Engineering report in 2005 gave these facts: • Waste is estimated by government at 30-40% • Errors are running at 2-3 Sigma levels • Medical errors are killing 70-100,000 patients each year

12. The IOM/NAE’s solution for spiraling medical costs? Medical Informatics, espec. “telemedicine” Since the current trends are unsustainable; US and worldwide governments are “changing the game” by building National Healthcare Information Networks (NHINs), essentially bring eCommerce and automated manufacturing tools and techniques to healthcare. • The US NHIN Program launched in 2004 • Second pilot projects under way in 2008 • Funding to physicians and hospitals in tax incentives and payment bonuses will begin in late 2008 • Participation will remain voluntary, BUT, all payments for non-NHIN-participants will be cut off in 4-5 years AND data-mining will be used to cull out (i.e., fire) underperformers

13. How is the US NHIN being created? • The ANSI Healthcare Technology Standards Panel (HITSP) is given a portfolio of annual informatics projects at the beginning of each year. • HITSP has over 350 associations now, spanning government, vendor, SDO, and other stakeholders. • The HITSP Board has about 15 elected members. • Todd Cooper (an IEEE SA delegate) was elected to the Board by the SDOs because of his medical device and informatics expertise. • Because of my own medical device, informatics, and patient safety background, and the fact that I co-chair the International Integrating the Healthcare Enterprise (IHE) organization, I was elected to the Board by the SDOs as well.

14. Chairman of the ANSI/HITSP Board: Dr. John Halamka, CMIO of Harvard

15. How many IEEE standards have been incorporated in the US NHIN so far? • NONE – • Medical device-related tasks were deferred by the HHS until 2008, and • Despite the fact that the meetings are open, free, and are mostly conducted by teleconference, despite repeated requests from to IEEE, nobody from any IEEE standards activities except medical device informatics has participated since the 2005 launch of NHIN!

16. Will that change? • Yes, for the 11073 standards • Maybe for the huge battery of relevant IEEE standards that SHOULD be considered. • Paul Croll has finally stepped forward to at least consider bringing the library of software engineering and verification and validation standards into the HITSP discussion • THIS tutorial is intended to mobilize IEEE 802.x to become THE data communication standard leaders in healthcare!

17. HITSP 2008 TC Project Plan OverviewRED indicates potential IEEE Standards Opportunities

18. The intention for this tutorial? • To introduce the medical device networking domain issues to you, the IEEE 802 experts. • Our Agenda: • Rick Hampton, Partners HealthCare: "A day in the life: wireless risks in the hospital environment" • Phil Raymond, Philips: "802.11 wireless configuration options for medical uses“ • Monroe Patillo, Emergin Philips: "Medical alarms issues and opportunities" • Leanne Cordisco, GE: "Configuring and maintaining safe medical device networks" • Elliot Sloane: Q&A, "Actionable Next Steps!

19. "The young do not know enough to be prudent, and therefore they attempt the impossible -- and achieve it, generation after generation." - Pearl S. Buck

20. THANK YOU! ??? QUESTIONS? Elliot B. Sloane, PhD, CCE ebsloane@villanova.edu, & @ieee.org, @gmail.com, @aol.com, @yahoo.com, @hotmail.com, etc. www.homepage.villanova.edu/ebsloane or just Google me!