HIMSS Electronic HealthRecord Vendor Association

EHR Clinical Research Integration Project

Spring AMIAInformatics Across the Spectrum

May 24, 2007

Charlene Underwood, MBA, SiemensDirector, Government and Industry AffairsPast Chair, HIMSS EHRVA

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Discussion Points

• HIMSS EHRVA Background• Collaboration with PhRMA

– PhMRA Education - 2006– HIMSS EHRVA / PhRMA / Life Sciences / Clinical

Research Meeting – February 25, 2007– HIMSS EHRVA Pharmaceutical Industry Workgroup

• Future Opportunities

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EHRVA Mission

Promote the rapid adoption of electronic health records that advance cost effective healthcare

Provide a unified voice and a forum for cooperation for the EHR vendor community

Strategic Plan focuses on these areas• Certification• Interoperability• Advocacy / Public Policy • Quality

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EHRVA members

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EHRVA members

EHRVA Interoperability Roadmap• Five communication services building blocks• Framework that supports incremental evolution• Transparency between Edge Systems & Edge-Core interface

Five communication services building blocksFramework that supports incremental evolutionTransparency between Edge Systems & Edge to NHIN Core Interface

andProvider

Access

Edge-System to Edge-System Communication ServicesEdge-System to Edge-System Communication Services

Clinical ContentMe

dical

Summ

aries

Lab R

esult

s

Radio

logy

Medic

ation

s

Aller

gies

Prob

lems

Quality &PublicHealth

Reporting

Lab R

esult

s

Edge-System to NHIN Core Communication ServicesEdge-System to NHIN Core Communication Services

Patient

ID Mgmt

AccessControl

Patient

ID Mgmt

AccessControl

Internet

Document Sharing Dynamic InformationManagement

Transactions

Resource Locator Services

PersistentInformation

Management

DynamicInformation

Access Workflow / Quality

Internet

Document Sharing Dynamic InformationManagement

Transactions

Resource Locator Services

Internet

Document Sharing Dynamic InformationManagement

Transactions

Resource Locator Services

PersistentInformation

Management

DynamicInformation

Access Workflow / Quality Persistent

InformationManagement

DynamicInformation

Access Workflow / Quality

PatientID Mgmt

AccessControl

PatientID Mgmt

AccessControl

Security & Access Control

PatientIdentificationManagement

Security & Access Control

PatientIdentificationManagement

Notifications

RequestsResponses

ePrescribing,Lab Ordering

etc.)

Notifications

RequestsResponses

ePrescribing,Lab Ordering

etc.)

RequestsResponses

ePrescribing,Lab Ordering

etc.)

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EHRVA Pharmaceutical Industry Workgroup Members

Shelley Fichtner, PhRMADaijin Kim, PfizerKraig Kinchen, Eli LillyTanuj Gupta, AstraZenecaHima Kher, Bristol-Myers SquibbMitra Rocca, NovartisKim Slocum, KDS Consulting (Facilitator)Justin Barnes, NoteworthyCharlie Jarvis, NextGenDon Schoen, MedinotesCharlene Underwood, Siemens Medical SolutionsHugh Zettel, GE Healthcare

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Education Topics –Potential “use cases”

• Electronic Health Records and Outcomes Research

• Matching Investigators and/or Patients to Clinical Trials

• EHR/EDC (Electronic Data Capture)• Drug Safety and Surveillance• Coordination of Care for Chronic Disease

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Using EHRs to Support Research

Establish Common Understanding of

HIT / EHR Systems

Understand Business Area Capabilities &

Priorities

EHR-CR Requirements Development

Envision How EHR Systems Could

Impact Business Area

Identify EHR CR Requirements

– NHIN Slipstream Project – AstraZeneca, Bristol-Myers Squibb, Pfizer, Wyeth

– Electronic Health Records and Clinical Research – Pfizer– Implications of Electronic Health Records for the Pharmaceutical

Industry – Astra Zeneca

Use CasesClinical Trial Data Collection

Clinical Trial Recruitment

Understand Disease Progression

Understanding Disease Mechanism

Epidemiology (Study disease prevalence in populations)

Document Management for Clinical Trials

Drug Safety Surveillance

Outcomes Research

Support Regulatory Approval

Audit Medication Workflow

Trial Subject Compliance

Virtual Phase IV trials

Study Drug Use Post-Launch

Remote Site Monitoring

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Clinical Research RequirementsRequirements are grouped by category and can be filtered by use case or system type.

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Use cases from IHE/CDISC Demo (HIMSS 2007)

Drug SafetySponsored byPfizerPowered bySentrx/RelsysAllscriptsAccentureSAS

Clinical Trial: Lab and Image DataSponsored byNovartisPowered byNovartisSiemensSAS

Clinical Trial: Visit WorkflowSponsored by Eli Lilly and Company Powered byCerner Corporation

Phase ForwardIBM

Disease Registry

Sponsored byGenzymePowered by•Outcome•Allscripts•Digital Infuzion•SAS•Assero/IPL

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Collaboration OpportunitiesHelp private sector develop a roadmap to shared value• Mutual understanding of business processes, use case

and priorities• Leverage Use Case DevelopmentContinue to invest in EHR/EDC initiatives• Standards, IHE & CDISC • Controlled Medical VocabularyInteroperable EHRs to be certified; work to make sure that what is certified meets your needs• Clinical Labs• E-prescribing• Quality (i.e., Adverse Events)• Population Health