1. JANUARY 20, 2014 Medical Device Patient Record Integration (MDPRI) Project 1

2. AGENDA The Story: Health Care Communities The Challenge and Scope Goals and Objectives The Projects Approach MDPRI Project Structure MDPRI Technical Solution Intensive Care Unit (ICU) Use Case Proposed MU 3 Language and Key Points The Projects Potential Benefits and Savings Accomplishments To-Date Next Steps Pre- and Post- Funding Planning 2

3. THE PATIENT DATA IS HERE.... 3

4. BUT NOT HERE............... 4

5. 5

6. CHALLENGE AND SCOPE Challenge: Health care is supposed to be about the patient. Technology is supposed to be about simplifying our lives. But the lack of interoperable devices, systems and software can make health care technology a challenge for both the patient and care-giver. Project Scope: The Medical Device Patient Record Integration (MDPRI) projects initial focus will be on an Intensive Care Unit (ICU) in one hospital utilizing 6 to 12 discrete device manufacturers and model combinations that will translate device data into a patients electronic health record (EHR). 6

7. GOALS AND OBJECTIVES Goals To achieve improved patient safety and care delivery through medical device and clinical system semantic interoperability Implement this project within scope, within budget, and meet development planned deadlines Objectives Build a working framework that is extensible across medical devices that facilitates the use of structured data from clinical devices into EHRs Appropriate streams / snapshots of data provided to the EHR electronically, without error, without clinician time, and immediately available to all who need the data for care and decision support and provided by the EHR in tabular, graphical and other views 7

8. PROJECT APPROACH Highly Experienced, Structured Project Management Team – Kearney & Company Combine Project Management PMBOK and PMP Best Practices in conjunction with the ONC S&I Framework Manage deliverables, partner integration, risk, communication, relationships.... Meaningful stakeholder involvement throughout the project A nimble but highly disciplined methodology A 3-Pillar Technical Approach Standards Leadership Foundation (IHE, HL7, IEEE, IHTSDO, LOINC) Appropriate combination of agile, waterfall and PDSA using PDSA (Plan / Do / Study / Act) methodologies High end NIST / IHE ISO 17025 test tools utilization IHE USA ISO 17065 Integration Profile Certification –UL like product stamp of approval (building block for potential Meaningful Use) Scenario Testing Certification with provider organizations – either IHE USA Projectathons or IWG certification Demonstration of success in HIMSS Interoperability Showcase Implementation in two separate cycles to reach high level of confidence in widespread adoptions : Pilot and General Release 8

9. PROJECT HISTORY – PARTICIPANTS TO DATE IHE International PCD Domain IHE PCD Leadership Manny Furst Paul Schluter Paul Garguilo John Rhoads HIMSS Lisa Gallagher Tom Leary Stephanie Jamison Jeff Coughlin HIMSS and IHE USA Alex Lippitt Joyce Sensmeier Kearney & Co Jackie Hunt Kim Douglas Karla Chryar HL7 – Todd Cooper IEEE – Bill Ash CAP Debbie Klieman Paloma Hawry EHRA (HIMSS) Angie Gorden Charles Parisot FDA – Jackie Reed Pew Charitable Trusts – Ben Moscovitch 9

10. PARTNER SEARCH 10 Health Device Testing Pilot Execution Health System Medical Device Vendors Medical Device Middleware Vendors EHR / Clinical Monitoring Application Development Testing Pilot Execution Health System Interface Engine EHR Vendor(s) Semantic Harmonization Terminology Baseline Terminology Mapping Mapping Application Maintenance and Support NIST NLM Semantic Domain Consultants Leadership, Standards, Quality Assurance and Metrics - IHE USA / ONC S&I Frameworks Charter, Business Case, Use Case Development Requirements, Specifications, Implementation Guides Measurement, Sustainability Test Management and Quality Assurance Development / Testing / Deployment Management Project and Government Relationship Management Kearney & Company, HIMSS?

11. MDPRI TECHNICAL SOLUTION 11 Numerics Waveforms Annotations Events Alerts Configuration Commands ISO/IEEE 11073 mapping to SNOMED and/or LOINC for vital sign numerics IHE PCD DEC WCM, EC, ACM, … Device Observation Reporters (DOR) Network Gateways Device Integration Engines Individual Devices Device Observation Consumers (DOC) Enterprise EMR, EHR, … 1 3 2 4

12. MDPRI TECHNICAL SOLUTION 1.Enterprise gateways, device integration engines (e.g. Capsule, iSiron, Nuvon) and possibly individual devices send near real-time medical device data using the IHE PCD DEC Profiles (HL7 V2.6 messaging and ISO/IEEE 11073 nomenclatures. 2.For numeric vital signs observations, a normative mapping from ISO/IEEE 11073 to SNOMED and/or LOINC are developed (by organizations representing SNOMED and/or LOINC) and are made available on the NIST RTMMS and other nomenclature repositories. Enterprise Device Observation Consumers would use the normative mapping table to translate the ISO/IEEE 11073 nomenclature to SNOMED and/or LOINC. 3.Device-centric data (waveforms, events, alerts, configuration and commands) would use the ISO/IEEE 11073 nomenclature. 4.The IHE PCD DEC (Device Enterprise Communication) Technical Framework and ISO/IEEE 11073 nomenclature are recognized as Meaningful Use profiles and standards for medical device data transfer to and from enterprise entities. 12

13. ICU USE CASE (ALL STANDARDS BASED IHE PROFILES) DeviceClinical Data (Typical) Arrives In or Is Placed in Smart BedWeight, Variety of Alarms, Advisories Physiologic Monitoring Vital Signs with Alarms, Advisories Question: Do we include Events (work in process)? Medication Admin. (PIV IOP) Bedside (or Bar-Code) Medication Administration system communicates physician orders to pump system for clinician's review and initiation IV Pump Delivers medication as prescribed and reports drug therapy delivery, progress, alarms, advisories and events PCA Pump Delivers pain meds in response to patient's needs. Reports drug therapy delivery, progress, alarms, advisories and events VentilatorProvides oxygenated air Pulse OximeterMay be part of the physiologic monitor Transferred to Local Community HospitalDischarge Summary (future) 13

14. ICU USE CASE PILOT (SCOPING) 14 One Pilot: limited scope and one health system - or would 2 or 3 required? Health System ICU 6 – 12 Devices, 3 – 12 Vendors 1 EHR Vendor (Epic?) Filtering – No Flooding Sample at specified intervals – EHR maintains sample data : all devices Continuous (example – PCA pump overdose, endangering patient: oxygen saturation ): limited devices (may add or replace) Intermittent – noninvasive blood pressure – clinician initiated

15. PROPOSED MU STAGE 3 LANGUAGE & KEY POINTS Rule Key Components EHR acceptance of IEEE 11073 nomenclature from devices (vital signs & other data) Requirement by use case availability for EHRs and other clinical data systems to translate IEEE nomenclature to appropriate clinical nomenclature and store appropriately for access (physiologic data included) 100% adoption by use case. Each use case will define classes of devices, discrete data to be included, frequency, sampling and filtering mechanisms, required consumer utilization scenarios Positioning Companion to UDI – real teeth device and mobile lab functionality Addresses Meaningful Use Stage 3 Themes: Quality, Safety, and Efficiency Improvements – this is the key focus (direct) Patient Access to Self- Management Tools (enabler) Access to Comprehensive Patient Data Through Patient-Centered HIE ( enabler 15

16. POTENTIAL BENEFITS AND SAVINGS The benefits of this project are: Improves patient safety through reduction in errors manually transcribed into EHR Provides near- real time patient health data from various ICU devices to the full care team as appropriate Simplifies the workflow of patient data from health devices into the EHR resulting in significant cost savings in time expended and better patient care through the added feasibility to bring medical device clinical data into the EHR and clinical Potential $30 Billion in annual savings for medical device interoperability West Health Institute testimony before the House Energy and Commerce Subcommittee March 20, 2013 Not a big leap - Solid standards foundation for medical device communication to patient records - IHE DEC (Device Enterprise Communication) Clinical and patient medical device interoperability game changer in conjunction with UDI (Universal Device ID) and Patient Matching initiatives 16

17. ACCOMPLISHMENTS TO DATE Identified the problem and the solution Established project management around the ONC S&I Framework – Kearney & Company Developed the technical architecture – NIST and IHE Reviewed the Health Care Device Interoperability Project brief with HL 7 Identified stakeholders – IHE, IEEE, FDA, EHRA and HIMSS Developed preliminary timeline 17

18. NEXT STEPS Next Steps Recruit development team leadership and get level of effort (LOE) from each Find out where Federal Agencies are in relationship to medical device semantic interoperability efforts Project Support & Endorsement ONC Guidance & Sponsorship Interagency Agreement for Champions (NLM, NIST, and ONC) New Meaningful Use Stage 3 Rule Approval Project Funding 18

19. PRE-FUNDING WORK (TARGET – MAY 31, 2014) 19 ONC Sponsorship Stakeholder Support – Government Partner Estimates and Agreements Unsolicited Proposal Leadership, Standards, GA and Metrics Team Build Stakeholder Support – Non - Government

20. PRE-FUNDING PROPOSED MILESTONES Stakeholder Support – Non Governmental Presentations Support Letters IHE USA Project Formation Stakeholder Support – Governmental Stakeholder Co-Lead MOU Presentations Support Letters Quality Assurance Steering Group Formation Milestone Reviews ONC Sponsorship Concept Meeting Proposal Presentation Standards Committee Track Unsolicited Proposal S+I Framework Charter NLM Alignment Full Draft Proposal CO-Lead Approvals: Kearney, HIMSS, IHE USA Partner Agreements eMail Team Management Commitments Hours Estimates Support Letters 20

21. POST-FUNDING PROPOSED MILESTONES Calendar 2014 End of Second Quarter Project Organization Baseline Data and Refined Metrics End of Third Quarter Detailed Specs Semantic Mapping – Phase 1 IHE Integration Profile Proposal – EHR End Detailed Use Case End of Fourth Quarter Construction of Mapping Tables as NIST Coded Applications and Unit Testing Accepted IHE Proposal Calendar 2015 End of First Quarter Successful Testing at Connectathon Draft IHE Documentation Pilot Phase Plan IHE Approval for Trial Implementation End of Second Quarter Pilot Execution Himss showcase End of third Quarter Pilot Study Standards Update - Act Limited Rollout Plan End of Fourth Quarter Limited Release Execution Pilot Site Phase 2 21