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Medical Device P atient R ecord I ntegration (MDPRI) Project

Medical Device P atient R ecord I ntegration (MDPRI) Project. January 20, 2014. Agenda. The Story: Health Care Communities The Challenge and Scope Goals and Objectives The Project’s Approach MDPRI Project Structure MDPRI Technical Solution Intensive Care Unit (ICU) Use Case

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Medical Device P atient R ecord I ntegration (MDPRI) Project

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

  2. Agenda • The Story: Health Care Communities • The Challenge and Scope • Goals and Objectives • The Project’s Approach • MDPRI Project Structure • MDPRI Technical Solution • Intensive Care Unit (ICU) Use Case • Proposed MU3 Language and Key Points • The Project’s Potential Benefits and Savings • Accomplishments To-Date • Next Steps • Pre- and Post- Funding Planning

  3. The Patient Data is Here....

  4. But Not Here...............

  5. 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) project’s 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 patient’s electronic health record (EHR).

  6. 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. 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. Project History – ParticipantsTo 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. Partner SEARCH Project and Government Relationship Management Kearney & Company, HIMSS? Development / Testing / Deployment Management Development / Testing / Deployment Management Development / Testing / Deployment Management • EHR / Clinical Monitoring • Application Development • Testing • Pilot Execution • Health System • Interface Engine • EHR Vendor(s) • Health Device • Testing • Pilot Execution • Health System • Medical Device Vendors • Medical Device Middleware Vendors • 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

  10. MDPRI Technical Solution Device Observation Consumers (DOC) Enterprise EMR, EHR, … Device Observation Reporters (DOR) Network Gateways Device Integration Engines Individual Devices 1 2 ISO/IEEE 11073 mapping to SNOMED and/or LOINC for vital sign numerics IHE PCD DEC 3 IHE PCD DEC WCM, EC, ACM, … 4

  11. MDPRI Technical Solution • 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. • 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. • Device-centric data (waveforms, events, alerts, configuration and commands) would use the ISO/IEEE 11073 nomenclature. • 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. ICU Use Case (all standards based IHE Profiles)

  13. ICU Use Case Pilot (Scoping) • 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

  14. Proposed MU Stage 3 Language & Key Points Rule Key Components 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 • 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

  15. 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. 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 HL7 • Identified stakeholders – IHE, IEEE, FDA, EHRA and HIMSS • Developed preliminary timeline

  17. 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. Pre-Funding WORK (Target – May 31, 2014) ONC Sponsorship Partner Estimates and Agreements Unsolicited Proposal Stakeholder Support – Non - Government Stakeholder Support – Government Leadership, Standards, GA and Metrics Team Build

  19. 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. 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

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