HL7 vMR for CDS Project Update HL Atlanta – September 2007 Robert Dunlop, MD Director, Clinical Development InferMed UK +44-20-7291-7410 [email protected].

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]

mailto:[email protected]

http://www.infermed.com/

mailto:[email protected]

vMR Project:

HL7 Project Approval

Business Use Cases:- Breast Cancer with Genetic Extension- BUC Issues

Next Steps

Discussion Topics

HL7 Atlanta – 9/07 Virtual Medical Record (vMR) for Clinical Decision Support (CDS) 2

- 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


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


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


vMR Project Deliverables & Timeline


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


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


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


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


HL7 Project Management Office (PMO).

HL7 Architectural Review Board (ARB).

vMR Business Use Cases


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.


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).


HL7 vMR for CDS Project Update HL Atlanta – September 2007 Robert Dunlop, MD Director, Clinical Development InferMed UK +44-20-7291-7410 [email protected].

Documents

vmr project scope hl7

vmr project goal hl7

vmr project alignments

vmr recommendation

hl7 rcrimcdisc

yellow hl7 atlanta

date hl7 atlanta

reminders vmr project