HIMSS Electronic Health Record Vendor Association

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HIMSS Electronic HealthRecord Vendor Association
EHR Clinical Research Integration
Project Clinical Research Forum IT
Roundtable April 25, 2007
Charlene Underwood, MBA, Siemens Director,
Government and Industry Affairs Past 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 three areas
• Certification
• Interoperability
• Advocacy / Public Policy

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EHRVA members
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EHRVA members
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EHRVA Interoperability Roadmap

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

• Five communication services building blocks
• Framework that supports incremental evolution
• Transparency between Edge Systems Edge to NHIN
  Core Interface

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EHRVA Pharmaceutical Industry Workgroup Members

• Shelley Fichtner, PhRMA
• Daijin Kim, Pfizer
• Kraig Tanuj Gupta, AstraZeneca Kinchen, Lilly
• Hima Kher, Bristol-Myers Squibb
• Mitra Roca, Novartis
• Kim Slocum, KDS Consulting (Facilitator)
• Justin Barnes, Noteworthy
• Charlie Jarvis, NextGen
• Don Schoen, Medinotes
• Charlene Underwood, Siemens Medical Solutions
• Hugh Zettel, GE Healthcare

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Using EHRs to Support Research
EHR-CR Requirements Development
Establish Common Understanding of HIT / EHR
Systems
Understand Business Area Capabilities Priorities
Envision How EHR Systems Could Impact Business
Area
Identify EHR CR Requirements

• NHIN Slipstream Project AstraZeneca,
  Bristol-Myers Squibb, Phizer, Wyeth
• Electronic Health Records and Clinical Research
  Phizer Healthcare Informatics
• Implications of Electronic Health Records for the
  Pharmaceutical Industry Astra Zeneca

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Use Cases
Outcomes Research Support Regulatory
Approval Audit Medication Workflow Trial Subject
Compliance Virtual Phase IV trials Study Drug Use
Post-Launch Remote Site Monitoring

• Clinical 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

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Clinical Research Requirements
Requirements are grouped by category and can be
filtered by use case or system type.
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Electronic Health Record (EHR) / Electronic Data
Capture (EDC) Initiatives

• eClinicalForum
• Clinical Forum Research Informatics Workgroup
• EFPIA, EMR Taskforce
• CDISC IHE
• HL7 EHR TC, PHR WG, Pediatric SIG, HIMSS PHIT
• HL7 RCRIM Technical Committee

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RFD Pharmacovigilance Demonstration HIMSS 2007

• Scenario
• Physician/investigator, using an EHR, discovers
  a suspected adverse drug event and summons a
  data-capture form provides information on the
  event submits form electronically to the
  manufacturer and Regulator(s)
• Team Pfizer, Sentrx, Allscripts, Relsys
• Standards XForm, CDISC ODM, HL7 ICSR /
  E2B(M/R3)
• Mapped CDISC Operational Data Model (ODM) to the
  ICH E2B format
• Enables seamless transmission of safety event
  from collection to reporting

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Collaboration Opportunities

• Help private sector develop a roadmap to shared
  value
• Mutual understanding of business processes, use
  case and priorities
• Leverage Use Case Development
• Continue to invest in EHR/EDC initiatives
• Standards, IHE
• Controlled Medical Vocabulary
• Interoperable EHRs to be certified work to make
  sure that what is certified meets your needs
• Clinical Labs
• E-prescribing
• Quality
• Population Health
• quality