1. 1 ISO/IEEE 11073 IEEE, EMB, S2E Standards Opportunities for Medical Devices and Healthcare Informatics Presentation to IEEE S2E ExCom, 31 July 2008: The 21 st Century Healthcare Informatics Industry & IEEE’s leadership roles and opportunities Elliot B. Sloane Villanova University EMBS AdCom, IEEE 11073 Sponsor Chair, IEEE’s Healthcare Industry Segment Initiative (’03-’05) Presentation developed with input and permission from Todd Cooper, President of Breakthrough Solutions, IEEE 11073 Chair, and ISO TC 215 Chair

2. 2 ISO/IEEE 11073 BioBrief: Elliot Sloane, PhD, CCE Dual 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 Board of Directors 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

3. 3 ISO/IEEE 11073 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”

4. 4 ISO/IEEE 11073 Important Update for IEEE standards activities/opportunities In a recent 2008 FDA proposed ruling data communication or storage devices or networks that merely transmit or store patient data will become “medical devices” e.g., This might be an opportunity to introduce IEEE S2E standards into life-critical healthcare applications, because formal validation is required.

5. 5 ISO/IEEE 11073 What standards govern medical devices in the US? Unlike Europe the FDA has NO written federal/state 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.

6. 6 ISO/IEEE 11073 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.

7. 7 ISO/IEEE 11073 What standards really govern medical devices? IEEE 11073 committees develop most of the medical information standards(a.k.a. medical informatics standards) related to nomenclature, structure, and transmission of data between medical devices and/lr computer systems used for medical care. –Medical image data standards are handled by DICOM, but realtime waveform data like heart rhythms are not yet addressed there. Following approval, IEEE 11073 standards are presented for ISO balloting and approval, to make them visible for widespread global adoption.

8. 8 ISO/IEEE 11073 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.

9. 9 ISO/IEEE 11073 “Industry” (e.g., Intel, Microsoft, 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. –Intel HAS achieved FDA 510K approval for one consumer product this July! (http://www.healthnewsdirect.com/?p=372)

10. 10 ISO/IEEE 11073 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

11. 11 ISO/IEEE 11073 The global solution perceived for spiraling medical costs? Medical Informatics 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

12. 12 ISO/IEEE 11073 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.

13. 13 Chairman of the ANSI/HITSP Board: Dr. John Halamka, CMIO of Harvard

14. 14 ISO/IEEE 11073 How many IEEE standards have been incorporated in the US NHIN so far? The first are being added to this year’s drafts –Medical device-related tasks were deferred by the HHS until 2008, which delayed IEEE 11073, and –Despite the fact that the meetings are open, free, and are mostly conducted by teleconference, and despite repeated requests from Todd Cooper and myself, nobody from any IEEE standards committees except 11073 has participated since 2004

15. 15 ISO/IEEE 11073 Will IEEE’s involvement change? Yes, for the 11073 standards Maybe for the huge battery of relevant IEEE standards that SHOULD be considered. –S2E has finally stepped forward to at least consider bringing the library of software engineering and verification and validation standards into the ANSI/HITSP discussion –We are trying to mobilize IEEE 802.x or various quality, genomics, security/encryption, and other IEEE standards leaders…

16. 16 ISO/IEEE 11073 What’s involved? HITSP panels do not write primary standards. HITSP committees do their best to identify all relevant potential standards HITSP committees do their best to interpret the advantages and disadvantages of all available standards –They post their findings and recommendations for internal and then public review The bottom line: whoever shows up or speaks up gets to vote, and the earlier, the better! –Committee and subcommittee leaders are volunteers who are voted in mostly due to their willingness to do the work.

17. 17 HITSP TC Existing Constructs C35 - Lab Result Terminology C36 - Lab Result Message C37 - Lab Report Document T18 - View Lab Result From Web App C39 - Encounter Message C41 - Radiology Result Message TP49 - Sharing Radiology Results C48 - Encounter Document C32 - Summary Docs Using CCD C28 - Emergency Care Summary Document C34 - Patient Level Quality Data Message C38 - Patient Level Quality Data Document T42 - Medication Dispensing Status TP43 - Medication Orders C19 - Entity Identity Assertion C25 - Anonymize C26 - Nonrepudiation of Origin T15 - Collect and Comm Security Audit Trail T16 - Consistent Time T17 - Secured Communication Channel T24 - Pseudonymize TP20 - Access Control TP30 - Manage Consent Directives C44 - Secure Web Connection T29 - Notification of Document Availability T31 - Document Reliable Interchange T23 - Patient Demographics Query T33 - Transfer of Documents on Media TP13 - Manage Sharing of Documents TP14 - Send Lab Result Message TP21 - Query for Existing Data TP22 - Patient ID Cross-Referencing TP50 - Retrieve Form for Data Capture C47 - Resource Utilization T40 - Patient Eligibility Verification TP46 - Medication Formulary and Benefits Information Security Privacy & Infrastructure Care Management & Health Records Administrative & Finance

18. 18 HITSP 2008 TC Project Plan Overview RED indicates potential IEEE Standards Opportunities TC2008 Use Case Work2006/2007 Carry-over Work ProviderConsultations and Transfer of Care Personalized Healthcare IS01 Lab EHR IS04 Emergency Responder EHR IS07 Medication Management Consumer Remote Monitoring (11073) Patient Provider Secure Messaging IS03 Consumer Access via Media IS05 Consumer Access via Network PopulationPublic Health Case Reporting Immunization and Response Management IS02 Biosurveillance IS06 Quality Security, Privacy & Infrastructure Remote Monitoring Patient Provider Secure Messaging IS03 Consumer Access via Media IS05 Consumer Access via Network IS06 Quality TN900 Security and Privacy and 19 existing constructs Care Mgmnt & Health Records TBD15 existing constructs Administrative and FinanceTBD3 existing constructs NOTE: 11073 is stretched to cover soley the medical device issues!

19. 19 ISO/IEEE 11073 ISO/IEEE 11073 Tutorial for IEEE EMBS - 2003-09-17 The 11073 standards are pretty simple, and constitute a Medical Device Data Language (MDDL): i.e., the Semantics needed to communicate a device’s application status and control information. Consists of three main components:  Nomenclature (1073.1.1.1)  Domain Information Model (DIM) (1073.1.2.1)  Device Specializations (1073.1.3.x)

20. 20 ISO/IEEE 11073 Major vendors, including Draeger/Siemens, GE, and Philips are already well advanced in a “Rosetta Project” that maps each vendor’s proprietary data standards to the IEEE 11073 standard “Reference ID,” as shown below:

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23. 23 “IHE International” is a major underlying NHIN framework, with global governance processes Scope of IHE International Governance Nations/regions establish separate but consistent governance models Board Operations Committee IHE International Board Liaison Organizations Liaison Organizations Operations Committee Marketing and Communications Committee Marketing and Communications Committee Testing and Tools Committee Testing and Tools Committee Domain Planning & Technical Committees Domain Planning & Technical Committees Domain Planning & Technical Committees Domain Planning & Technical Committees Domain Planning & Technical Committees Domain Planning & Technical Committees Domain Coordination Committee Domain Coordination Committee Domains Development Activities National Deployment Committee National Deployment Committee National Deployment Committee National Deployment Committee National Deployment Committee National Deployment Committee National Deployment Committee National Deployment Committee Regional Deployment Committee National Deployment Committee National Deployment Committee National Deployment Committee National Deployment Committee National Deployment Committee National Deployment Committee Regional Deployment Committee Regional Deployment Activities Advisory Panel Empowerment IEEE SHOULD play a role in IHE’s Infrastructure Committees in order to have GLOBAL impact.

24. 24 International Adoption of IHE FranceUSAGermanyItalyJapanUKCanadaKoreaTaiwan Norway HollandSpainChina Year 1 (1999) Year 2 (2000) Year 3 (2001) Year 4 (2002) Year 5 (2003) Year 6 (2004) Year 7 (2005) Year 8 (2006)

25. 25 Growth in IHE Domains Radiology (18) IT Infrastructure for Healthcare (17) Cardiology (7) Laboratory (6) Radiation Oncology (1) Patient Care Coordination (5) Patient Care Devices (1) Quality Eye Care (3) Veterinary Endoscopy Pathology Pharmacy Year 1 (1999) Year 2 (2000) Year 3 (2001) Year 4 (2002) Year 5 (2003) Year 6 (2004) Year 7 (2005) Year 8 (2006) Year 9 (2007) Over 250 vendors involved world-wide Over 250 vendors involved world-wide 12 Technical Frameworks 12 Technical Frameworks 48 Integration Profiles 48 Integration Profiles Testing at “Connectathons” world-wideTesting at “Connectathons” world-wide Demonstrations at major conferences world-wide Demonstrations at major conferences world-wide

26. 26 IHE Interoperability Showcases demonstrate working systems by leading COMPETING companies:

27. 27 IHE PCD in the HIMSS 2007 and 2008 Interoperability Showcase

28. 28 GE Aware Gateway Patient Monitor, Ventilator Philips Intellivue InformationCenter Patient Monitor Intensive Care Philips Intellivue Clinical InformationPortfolio Draeger Innovian ® Solution Suite Capsule Welch Allyn Connex TM Data Mgmt System Vital Signs Monitor Emergency Care LiveData OR – DashBoard GE Centricity ® Periop Anesthesia Draeger Infinity Gateway Patient Monitor, Anesthesia Sys Perioperative Care Spacelabs Intesys Clinical Suite Patient Monitor Epic Epic InPatient Enterprise PDQ/PAM Server Time Server Patient Care Devices HIMSS IHE ShowCase 2008, February 23-28 Infusion Devices B. Braun DoseTrac TM Infusion Mgmt SW

29. 29 ISO/IEEE 11073 Is IEEE represented in IHE International? I am co-chair of the International Board of Directors IEEE 11073 members Todd Cooper, Jack Harrington, and have all been co-chairs of the IHE Patient Care Device Domain since its founding in 2002. –The Technical and Planning Committees are also full of IEEE 11073 subcommittee members

30. 30 ISO/IEEE 11073 Progress? –Worldwide, IEEE 11073 standards are becoming integral to all IHE International Patient Care Device “integration profiles” The entire IHE family of integration profiles are the largest single resource selected globally by “Ministry of Health” task forces who have been building national electronic healthcare information networks and systems since 2002 or so. In the US, since 2005, most of the ANSI HITSP panel members and leaders are drawn from the same pool of volunteers who have been drafting the IHE integration profiles since 1998. –Virtually all HITSP standards recommendations since 2005 have therefore been based on the IHE integration profiles.

31. 31 ISO/IEEE 11073 Where is this headed in the US? All of the State and Federal Medicare agencies, and then all private insurers, will use the next generation of communicating, interoperable medical devices to install telemedicine as the standard of care for chronic disease and wellness care and to automate data capture for electronic health records. –Eventually, most homes will have multiple products that we, today, categorize as “medical devices” –Unless we really mess this up, all state, federal, and home medical devices, systems, and accessories will interoperable with the NHIN via IEEE 11073 standards. FDA-regulated devices for hospitals and acute will follow suit because, frankly, that makes more economic sense than inventing a separate system than the IEEE 11073 that the vendors, themselves, created!

32. 32 ISO/IEEE 11073 HUGE GAPS exist? None of the State or Federal healthcare informatics initiatives in the US related to bootstrapping our National Healthcare Information Network have formal S2E concepts incorporated (e.g., no V&V, no formal system development processes, etc.) –Medical devices themselves have general constraints, I do not believe that NO IEEE Standards are identified as exemplars, nor are courses offered to mfrs to expedite the adoption.

33. 33 ISO/IEEE 11073 Three basic questions we have in front of us: How large does IEEE want its role to be in 21 st Century Healthcare? How, or is, IEEE going to make that happen? Can IEEE even afford to consider sitting on the sidelines in healthcare any longer (e.g., what if IEEE 802.x is displaced in healthcare, or IEEE Software and Systems Engineering Standards are simply overlooked?)

34. 34 ISO/IEEE 11073 One proposal: Get the 11073 and S2E experts together to consider formulating a presentation to ANSI/HITSP and IHE leadership. –This will have to be a high-level “gloss” that excites and invites them to welcome the S2E expertise quickly in order to create a “fast path” to infuse the concepts into their cultures. –Fortunately, there is a lot of overlap between ANSI/HITSP and IHE membership, though by no means complete…

35. 35 ISO/IEEE 11073 “The young do not know enough to be prudent, and therefore they attempt the impossible -- and achieve it, generation after generation.” - Pearl S. Buck They said it couldn’t be done….

36. 36 ISO/IEEE 11073 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!