1. doc.: IEEE 802.15- Submission, Slide 1 Project: IEEE P802.15 Working Group for Wireless Personal Area Networks (WPANs) Submission Title: [Implementation issues for medical device networking with IEEE 802.x technologies] Date Submitted: [10 July 2008] Source: [Phil Raymond] Company [Philips HI] Address [] Voice:[Add telephone number], FAX: [Add FAX number], E-Mail:[Phillip.raymond@philips.com] 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. doc.: IEEE 802.15- Submission, Implementation issues for medical device networking with IEEE 802.x technologies Agenda Life Critical Networking Requirements Problem Statement Summary & Actionable Items

3. doc.: IEEE 802.15- Submission, Life Critical Requirements Overview Initial: Always allow network access –Admission control mechanism cannot deny network access to medical device Ongoing: Access to the channel must be managed and controlled –Cannot allow other devices, including Voice, to block access Compatibility: Proprietary mechanisms must not disrupt life critical data path –E.g. RF management QoS: Whereas, 802.11/LAN typical delays are acceptable, packet drops are unacceptable –Alarm doesnt need to use Voice or Video AC if packet transmission is guaranteed –802.11 lives in usec world, Clinician lives in single_digit_seconds world Spectrum and Device Management: IT must deploy and manage WLAN –SNR ~-25dBm; 802.11a preferred; channel overlap, piloted deployment of new devices

4. doc.: IEEE 802.15- Submission, Problem Statement 802.11 has no mechanism to support life critical data –WMM-AC provides no life critical data differentiation from Voice/Video/Data Compatibility across WLAN vendors does not exist –WLAN vendor proprietary mechanisms require 1-to-1 testing Majority of todays hospital Wi-Fi deployments not yet ready for medical devices –Early IT/IS concept of spectrum and wireless device management Healthcare standardization and harmonization groups cannot define the 802.11 specification –But can get involved

5. doc.: IEEE 802.15- Submission, Summary & Actionable Items No existing capability or mechanism in 802.11 specification to support life critical data, so consider a technical means of identifying a medical device and assuring network access and delivery is guaranteed Possible Solutions: 1.Expanding 802.11u e911 Emergency Services Network for life critical data support 2.Creating a life critical data identifier in a protocol frame Provide highest network access at association and packet delivery 3.Pre-configuring a medical device SSID with assured SLA –SSID provides medical device ID to WLAN for SLA support 4.Others to be discussed…

6. doc.: IEEE 802.15- Submission, Thank You For Your Time! Please contact me at any time for questions or follow-up

7. doc.: IEEE 802.15- Submission, IEEE 802 Plenary Tutorial Session Rick Hampton Wireless Manager Partners HealthCare Information Systems "A Day In The Life: Wireless Risks In The Hospital Environment" July 15, 2008

8. doc.: IEEE 802.15- Submission, Agenda The Current Environment Uses of Wireless Some Problems Experienced Regulatory Concerns The Challenges Action Agenda Recommendations

9. doc.: IEEE 802.15- Submission, Uses of Wireless Devices Voice devices –Cellular telephones, wireless VoIP, hand-held radios Data devices –Laptop computers, PDAs, two-way pagers, RFID tags/readers, wireless LAN access points (APs) Integrated devices (RIM Blackberrys ® ) Real-Time Location devices –Active/passive RFID tags Medical Telemetry –WMTS and wireless LANs Accessory devices –Cordless headsets, keyboards, mice, printers, etc.

10. doc.: IEEE 802.15- Submission, FCC Services Utilized ISM (Industrial, Scientific, Medical) WMTS (Wireless Medical Telemetry Service) PLMRS (Private Land Mobile Radio Service) –Public Safety –Bio-medical Telemetry –Industrial/Business –Private Land Mobile Paging –Radiolocation Paging MURS (Multi-Use Radio Service) FRS (Family Radio Service) GMRS (General Mobile Radio Service) MICS (Medical Implant Communications Service) Part 15 –Medical Telemetry –RFID –Spread Spectrum –U-NII (Unlicensed National Information Infrastructure) –UWB (Ultra WideBand) Medical Imaging Cellular Radio Service SMRS (Specialized Mobile Radio) AWS (3G) - Advanced Wireless Services Spectrum PCS (Personal Communications Service) Amateur Radio Private Operational Fixed Microwave

11. doc.: IEEE 802.15- Submission, Courtesy Jan Wittenber, Philips/IEEE 11073

12. doc.: IEEE 802.15- Submission, Wireless Application Map

13. doc.: IEEE 802.15- Submission, Summary - The Current and Changing Environment Many wireless/radio systems for many different purposes Placed in context as part of the hospital system (collection of devices and utilities required to care for the sick and injured) these communications systems are life-critical in nature. Failure of some could lead to injury, illness, or death of patients, healthcare staff, and visitors IT industry is marketing the unified IT w/LAN as the single best solution moving forward The IT LAN, wired and wireless, must meet high standards for availability, reliability, and manageability not seen before

14. doc.: IEEE 802.15- Submission, Some Problems Experienced: Pre-deployment –Site survey tools best guess… at best! Deployment –Too many ways IT vendors can choose to implement Standards –EVERY new wireless device is problematic Reliability –Sell it now, fix it later! mentality in IT industry –Too many bugs associated with proprietary work-arounds –Cant keep up with code revisions Maintainability –Some automated management tools dont work –Legacy support – Medical devices have MUCH longer design cycle and life-span than IT equipment 17 floors of 802.11FH still used for medical monitoring

15. doc.: IEEE 802.15- Submission, Regulatory Concerns of Wireless Medical Devices FDA does not yet regulate the IS LAN as a medical device. If connecting a medical device to the IS LAN adds functionality to the device, the LAN could become part of the device and additional regulatory requirements (510k) would likely be required. Since the device manufacturer has no control over the IS LAN, it is prudent for the IS department to begin assessing and ensuring the extra level of reliability required by the addition of medical devices.

16. doc.: IEEE 802.15- Submission, Regulatory Concerns of Wireless Medical Devices (Cont.) IEC 80001 Draft Standard – Title: Application of risk management for IT- networks incorporating medical devices –Expected to be ratified in 2010 –Addresses IT/Medical integration head on –Requires risk analysis and mitigation to be done on an ongoing basis for networked medical systems

17. doc.: IEEE 802.15- Submission, Regulatory Concerns of Wireless Medical Devices (Cont.) FDA Medical Device Data System (Proposed) is a device intended to provide one or more of the following uses: –The electronic transfer or exchange of medical device data from a medical device, without altering the function or parameters of any connected devices. –The electronic storage and retrieval of medical device data from a medical device, without altering the function or parameters of connected devices. –The electronic display of medical device data from a medical device, without altering the function or parameters of connected devices. –The electronic conversion of medical device data from one format to another format in accordance with a preset specification. Major concern is that automating systems removes transparency of error generation from end user and over-reliance upon flawed systems

18. doc.: IEEE 802.15- Submission, The Challenges (To be more fully addressed by subsequent presenters) Current standards address only the most basic requirements requiring IT vendors to create multiple proprietary work-arounds –May not be compatible between vendors –Need to work with generic devices and be transparent 802.11 QoS for medical devices (or lack thereof) Inability to segregate wireless traffic (not enough SSIDs) Some current automated wireless management systems fail miserably –Unreliable - Cause dropout of clients –Present undesirable conditions for every medical device manufacturer Ive worked with –We have 2000+ APs, all managed manually

19. doc.: IEEE 802.15- Submission, The Challenges (Cont.) Wireless systems will need NOC-level real-time spectrum management capabilities IT industry goals often do not take into account clinical/medical goals – conflicts result –VoIP, RFID, etc., may required different/conflicting wireless architecture (QoS, deployment, security, etc.) Current wireless standards are implemented for consumer environments, not enterprise healthcare –Bluetooth Version 1.0 – notorious interferer –802.11n, Zigbee, Wibree, and other standards coming and not all may be useful in hospitals

20. doc.: IEEE 802.15- Submission, Overlapping wireless technologies in the 2450 MHz ISM band

21. doc.: IEEE 802.15- Submission, Action Agenda Recommendations Understand and acknowledge that 802.11 committees have an important role in improving healthcare in hospitals, in homes, in life in general Establish formal link with IEEE 11073 and other medical device standards committees Take a leadership position in rectifying issues outlined by this group of presenters through the creation of meaningful standards for medical devices

22. doc.: IEEE 802.15- Submission, Contact Information Rick Hampton Wireless Communications Manager Partners HealthCare System One Constitution Center, OCC210 Charlestown, MA 02129 Office: 617-726-6633 Cell: 617-968-2262 RHampton@Partners.org