HL7 vMR for CDSProject Update
HL Atlanta – September 2007
Robert Dunlop, MDDirector, Clinical DevelopmentInferMed UK
[email protected]://www.infermed.com
Barbara McKinnonMcKinnon Associates Inc.Project Lead: HL7 GELLO & Virtual Medical Record (vMR) Projects
(O) 610-644-5245(M) [email protected]
vMR Project:
HL7 Project Approval
Business Use Cases:- Breast Cancer with Genetic Extension- BUC Issues
Next Steps
Discussion Topics
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- Scope - Timeline- Goal - Outreach- Deliverables - Alignments
A Virtual Medical Record (vMR) is a data model, based on the HL7 RIM format, for representing
clinical information inputs and outputs to/from
clinical decision support services.
Data is exchanged with local clinical informationsystems at the point of care, through a softwaremiddleware layer that translates the data into astandardized vMR format.
vMR Project Scope
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OMG
Business
Use
Cases
Point
of
Care
HL7
Clinical Decision Support Clinical
Guidelines
Interoperable with
HL7 Service Functional Model
Align to
HL7 Data Models
Clinical Information
Systems
Export
vMR Data via System Export
Capabilities
@neurist Project
Brain Aneurisms
&
Cocoon Project
Breast Cancer
Hypertension
Type 2 Diabetes
Others TBD
Physician
Interacts
with
EHR
CDS-Enabled Clinical Guidelines & Protocols
SOAWeb
Services
vMR
for Chronic Disease
Management
Inputs &
Outputs
Clinical Assessments, Decisions, Goals, Alerts, Reminders
vMR Project Scope – Highlighted in Yellow
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The goal of this project is to create an HL7 vMR
data model recommendation and implementation
guide, based on the HL7 V. 3 RIM, which is
capable of supporting clinical decision support(CDS) for “chronic disease management” at thepoint of care.
vMR Project Goal
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vMR Project Deliverables & Timeline
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Deliverables Timeline
Clinical Decision Support (CDS) Storyboards for:
1. Breast Cancer screening and treatment, including family history and genomics.
2. Type 2 Diabetes.3. Asymptomatic Unruptured Cerebral Aneurysms, Risk Assessment &
Management.4. Hypertension. Others TBD
Summer-Winter 2007
For each of the above storyboards, develop a set of HL7 Project technical materials, including:- Activity Diagrams.- Use Case Models. - Specification models.- Gap analysis between existing HL7 standards specifications and
requirements for CDS use cases.
vMR Project Timeline
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Deliverables Timeline
Recommendations to other HL7 Technical Committee’s for revisions to existing HL7 data models and identification of new elementsrequired for computer-enabled clinical decision support.
Spring – Summer 2008
CDS recommendation on an HL7 vMR (V.3) meta-model for clinicaldecision support representation and information exchange.
Testing of this recommendation within two European Union projects – the @neurist and Cocoon Projects. Both projects requiring the vMR recommendation to be comprehensive enough to support computer-enabled clinical decision support.
HL7 vMR (V.3) Implementation Guide to enable implementers todevelop the infrastructure necessary for using computer-enabled clinical decision support.
vMR Project Outreach
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Extensive outreach done prior to finalizing project scope.
HL7 Board Members, Technical Steering Committee, Infrastructure & Modeling, RCRIM, UK Affiliate, Patient Care.
AHRQ, CDISC, DoD, NCI, VA.
Will continue to provide periodic updates to interested parties who cannot attend HL7.
vMR Project AlignmentsIdentified to Date
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HL7 TC’s & SIG’s Projects
Clinical Decision Support TC
• TC Sponsor
Clinical Genomics SIG
Template SIG
EHR TC
Patient Care TC
Clinical Interoperability
Clinical Documents
European Union – @neurist & Cocoon projects to deliver computer-enabled CDS to PoC.
Harvard/Partners – Clinical Genomics Patient Profile for EHR.
US HITSP ONC – Personalized Healthcare.
HL7 RCRIM/CDISC – Aspire Project to deliver clinical trial patient eligibility criteria.
HL7 vMR Project Approvals
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HL7 Project Management Office (PMO).
HL7 Architectural Review Board (ARB).
vMR Business Use Cases
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The project team will define 4 initial business usecases, including storyboard, activity diagram, andspecification model:
1. Breast Cancer with Genetic Extension (in progress)
2. Diabetes Type 2 (in progress)
3. Asymptomatic Brain Aneurism
4. Hypertension
Other business use cases will be developed with approvalof CDS work group and if resources are available todevelop required HL7 project materials.
vMR Breast Cancer BUC
Summary of Multiple CDS Step Inputs & Outputs
CDS Step Data Inputs CDS Step Data Outputs
Patient Identifier Patient Identifier (for audit purposes)
Patient - Gender Male; Female
Patient - Date of Birth Calculated Age
Patient - Race Caucasian; etc.
Patient - Ethnic Origins Ashkenazi Jewish – unknown; true; false
Patient - Symptoms Breast Cancer Symptoms – unknown; true; false
Patient - Diagnoses Breast Cancer Diagnosis – unknown; true; false
Patient - Laboratory Genetic Tests BRCA 1 & BRCA 2
Patient - Radiology Tests Mammographies - unknown; true; false
Patient - Surgeries Mastectomies – unknown; true; false
Patient - Family History Specified Diseases; Relationship Id; Relationship Type; Diagnosis; Age at Diagnosis; Age at Death
Breast/Ovarian Cancer – unknown; true; false
Relative 1 – Maternal Aunt – Age at Dx=39; Age at Death = 42.
Data Items: type; values; selected data item value; default data item value; validation expressions (ranges)
Summary of Multiple CDS Step Inputs & OutputsCDS Step Data Inputs CDS Step Data Outputs
Request for Genetic Testing Test Id; Test Name; Variant/SourceCode
Results of Genetic Testing Test Id: LOINC 21636-6
Test Name: BRCA1 Gene Mutation Anal Bid/T
Variant/Source Code: Germline
GeneticLocus.Name: BRCA1
GeneticLocus.ID: BRCA1
Gene.Region: Exon
Gene.Region_Sequence: 2
Sequence.Variation: c.187delAG
Interpretation Code: Pathogenic
Zygosity: Heterozygous
Request for CDS Assessment CDS Risk Calculation
Confirmation of Recommendation Completion CDS Determinations: Genetic Predisposition to High Breast Cancer Risk = High
CDS Recommendations: Regular Mammography; Ovarian Screening; Specialist Consultation
CDS Recommendation Pros & Cons (Argumentation)
State File of Executable Guideline - audit trail of inputs & outputs.
vMR Breast Cancer BUC
vMR BUC Issues
How to represent CDS Service Determination “pros” and “cons”; both encoded and narrative text.
Re-interpretation of patient genetic profile as data elements are updated in EHR, including how re-interpretation will be initiated: auto-generated via EHR or CDS Service, or person-initiated via EHR; and how patient consent will be obtained.
Need for knowledge databases of:
• DNA variations (or variant combinations).
• Coded clinical significance: Unknown Significance to Pathogenic or Benign. The system receiving notification of the change might then propagate this information, flagging records for re-evaluation.
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vMR Project - Next Steps
Set up more formal lines of communication to aligned HL7 TC’s and SIG’s.
Evaluate alignment to other projects. i.e. US HIT ONC Personalized Health & HL7 RCRIM/CDISC ASPIRE Project.
Evaluate alignment to CEN vMR.
Continue business use case development.
Project update at HL7 San Antonio, TX (1/07).
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