1. ONC FACA HIT Standards Committee Clinical Operations Workgroup Hearing on Barriers & Enablers for Medical Device Interoperability March 28, 2011 ~ Washington, D.C. Todd Cooper Testimony Copyright © 2011, 80001 Experts, LLC. All rights reserved.

2. 2 Background Todd Cooper Principal, 80001Experts, LLC Convenor, ISO TC215 Health Informatics – Devices Co-Chair, ISO/IEC Joint Working Group 7 “80001” Co-Chair, HL7 Health Care Devices Working Group Chair, IEEE 11073 Medical Device Communication Working Group Board of Directors, Integrating the Healthcare Enterprise (IHE) International, Chicago, IL Co-Founder IHE Patient Care Device Domain Former Board of Directors, ANSI Healthcare Information Technology Standards Panel (HITSP) Co-Editor, HITSP Technical Note 905 – Common Device Connectivity ONC HIT Standards Committee ~ Hearing on Barriers & Enablers for Medical Device Interoperability ~ 2011.03.28 ~ Washington D.C.

3. 3 Blockers for EHR Integration #1 Blocker of widespread integration of medical device information and services into EHRs and other clinical applications: Lack of sustained market demand Decades old Chicken-and-Egg Business Issue … Technology suppliers require significant market demand to justify capital outlays for bringing new devices and capabilities to market Technology users may require open standards-based interoperability in RFPs, but it is often dropped down, even off the priority list The ONC can play a pivotal role in addressing this issue and fostering medical device interoperability ONC HIT Standards Committee ~ Hearing on Barriers & Enablers for Medical Device Interoperability ~ 2011.03.28 ~ Washington D.C.

4. 4 Enablers for EHR Integration Standards and standards profiles exist today to enable widespread integration of medical device information into EHRs and other clinical applications: Standards and standards profiles/frameworks leverage mature technologies from HL7, ISO, IEEE, IHE and other organizations. Profiles have been extensively tested using NIST tooling for 5+ years, engaging all major medical device manufacturers Products based on these interoperability specifications are now starting to enter the marketplace Stage II & III meaningful use criteria should include direct recognition of device integration in clinical care contexts (not only remote monitoring or consumer acquired) ONC HIT Standards Committee ~ Hearing on Barriers & Enablers for Medical Device Interoperability ~ 2011.03.28 ~ Washington D.C.

5. 5 Semantic Interoperability #1 enabler for meaningful use of medical device information in EHR systems is consistent semantics - across all device “makes and models”: Specialized device terminologies exist today, including the ISO/IEEE 11073 terminology and information model IHE Rosetta Terminology Mapping (RTM) project provides mappings from proprietary semantics to standardized 11073 terminology, providing a path forward for true semantic interoperability Mapping and harmonization projects are underway for 11073, SNOMED-CT and LOINC. All IHE PCD communication requires use of the harmonized Rosetta semantics, validated by NIST tooling. ONC HIT Standards Committee ~ Hearing on Barriers & Enablers for Medical Device Interoperability ~ 2011.03.28 ~ Washington D.C.

6. 6 Safe, Secure & Effective In order to achieve and maintain safe, effective and secure networked medical technologies – supporting meaningful use objectives – a comprehensive multi-stakeholder risk management program must be established, such as defined by IEC 80001-1: Potential hazards must be understood for both the device technologies being integrated and the shared networking infrastructure Risks associated with these integrated systems of systems must be analyzed, mitigated effectively, and monitored This will support FDA MDDS requirements Without such a risk management program, meaningful use achievements resulting from HIT deployment will fall victim to major patient safety incidents, service failures, and compromised security ONC HIT Standards Committee ~ Hearing on Barriers & Enablers for Medical Device Interoperability ~ 2011.03.28 ~ Washington D.C.

7. 7 Safe, Secure & Effective Identify Hazards  Loss of data  Incorrect data  Incorrect timing of data  Degraded function of devices  Unauthorized access to private data  Etc… Identify Causes  Overloaded link  Network configuration error  Wireless dropout  Network hardware failure  IP Addressing conflict  Security too aggressive  Faulty cabling  User/procedural error  Etc… Identify Risk Control Measures  Network design, best practices  Pre-go-live testing  Redundancy  IT procedures, Clinical procedures  Etc… ONC HIT Standards Committee ~ Hearing on Barriers & Enablers for Medical Device Interoperability ~ 2011.03.28 ~ Washington D.C. Go Live!

8. 8 Security: Disclosure & Dialog HIT Security is a mature field of study, and its application to networked medical technologies does not require new standards or specialized technologies, but as a 3 rd key risk management property: An understanding of the unique patient safety and clinical effectiveness requirements presented by medical systems Disclosure by technology suppliers to end users and integrators of security needs, risks and control measures Dialog with technology users regarding the needed security framework of policies, guidance, infrastructure, and services IEC 80001-2-2 Security Guidance Technical Report provides the context and semantic basis for this dialog NEMA’s MDS 2 form is a good example of how this disclosure might be initiated. ONC HIT Standards Committee ~ Hearing on Barriers & Enablers for Medical Device Interoperability ~ 2011.03.28 ~ Washington D.C.

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