1J A N U A RY 2 0 , 2 0 1 4

Medical Device Patient Record Integration (MDPRI) Project

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

THE PATIENT DATA IS HERE....

3

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

4

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) 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).

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

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

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

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

Development / Testing / Deployment Management

Development / Testing / Deployment Management

Project and Government Relationship ManagementKearney & Company, HIMSS?

MDPRI TECHNICAL SOLUTION

11

NumericsWaveformsAnnotationsEventsAlertsConfigurationCommands

ISO/IEEE 11073 mapping to SNOMED and/or LOINCfor vital sign numerics

IHE PCD DEC

IHE PCD DECWCM, EC, ACM, …

Device Observation Reporters (DOR)

Network GatewaysDevice Integration Engines

Individual Devices

Device Observation Consumers (DOC)

Enterprise EMR, EHR, …1

3

2

4

12

MDPRI TECHNICAL SOLUTION1. 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.

ICU USE CASE (ALL STANDARDS BASED IHE PROFILES)

Device Clinical Data (Typical)Arrives In or Is Placed in Smart Bed Weight, Variety of Alarms, Advisories

Physiologic MonitoringVital 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 PumpDelivers 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

Ventilator Provides oxygenated airPulse Oximeter May be part of the physiologic monitorTransferred to Local Community Hospital Discharge Summary (future)

13

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

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 HL7• Identified stakeholders – IHE, IEEE, FDA, EHRA

and HIMSS • Developed preliminary timeline

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 effortsProject Support & Endorsement

• ONC Guidance & Sponsorship• Interagency Agreement for “Champions” (NLM,

NIST, and ONC) • New Meaningful Use Stage 3 Rule Approval• Project Funding

19

PRE-FUNDING WORK (TARGET – MAY 31, 2014)

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

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