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

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Presentation on theme: "HL7 vMR for CDS Project Update HL Atlanta – September 2007 Robert Dunlop, MD Director, Clinical Development InferMed UK +44-20-7291-7410"— Presentation transcript:

1 HL7 vMR for CDS Project Update HL Atlanta – September 2007 Robert Dunlop, MD Director, Clinical Development InferMed UK +44-20-7291-7410 robert.dunlop@infermed.com http://www.infermed.com Barbara McKinnon McKinnon Associates Inc. Project Lead: HL7 GELLO & Virtual Medical Record (vMR) Projects (O) 610-644-5245 (M) 484-883-6927 bmm15@comcast.net

2 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

3 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 information systems at the point of care, through a software middleware layer that translates the data into a standardized vMR format. vMR Project Scope HL7 Atlanta – 9/07 Virtual Medical Record (vMR) for Clinical Decision Support (CDS) 3

4 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 SOA Web Services vMR for Chronic Disease Management Inputs & Outputs Clinical Assessments, Decisions, Goals, Alerts, Reminders vMR Project Scope – Highlighted in Yellow HL7 Atlanta – 9/07 Virtual Medical Record (vMR) for Clinical Decision Support (CDS) 4

5 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 the point of care. vMR Project Goal HL7 Atlanta – 9/07 Virtual Medical Record (vMR) for Clinical Decision Support (CDS) 5

6 vMR Project Deliverables & Timeline HL7 Atlanta – 9/07 Virtual Medical Record (vMR) for Clinical Decision Support (CDS) 6 DeliverablesTimeline 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.

7 vMR Project Timeline HL7 Atlanta – 9/07 Virtual Medical Record (vMR) for Clinical Decision Support (CDS) 7 DeliverablesTimeline Recommendations to other HL7 Technical Committees for revisions to existing HL7 data models and identification of new elements required for computer-enabled clinical decision support. Spring – Summer 2008 CDS recommendation on an HL7 vMR (V.3) meta-model for clinical decision 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 to develop the infrastructure necessary for using computer-enabled clinical decision support.

8 vMR Project Outreach HL7 Atlanta – 9/07 Virtual Medical Record (vMR) for Clinical Decision Support (CDS) 8 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.

9 vMR Project Alignments Identified to Date HL7 Atlanta – 9/07 Virtual Medical Record (vMR) for Clinical Decision Support (CDS) 9 HL7 TCs & SIGsProjects 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.

10 HL7 vMR Project Approvals HL7 Atlanta – 9/07 Virtual Medical Record (vMR) for Clinical Decision Support (CDS) 10 HL7 Project Management Office (PMO). HL7 Architectural Review Board (ARB).

11 vMR Business Use Cases HL7 Atlanta – 9/07 Virtual Medical Record (vMR) for Clinical Decision Support (CDS) 11 The project team will define 4 initial business use cases, including storyboard, activity diagram, and specification 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 approval of CDS work group and if resources are available to develop required HL7 project materials.

12 vMR Breast Cancer BUC Summary of Multiple CDS Step Inputs & Outputs CDS Step Data InputsCDS Step Data Outputs Patient IdentifierPatient Identifier (for audit purposes) Patient - GenderMale; Female Patient - Date of BirthCalculated Age Patient - RaceCaucasian; etc. Patient - Ethnic OriginsAshkenazi Jewish – unknown; true; false Patient - SymptomsBreast Cancer Symptoms – unknown; true; false Patient - DiagnosesBreast Cancer Diagnosis – unknown; true; false Patient - Laboratory Genetic TestsBRCA 1 & BRCA 2 Patient - Radiology TestsMammographies - unknown; true; false Patient - SurgeriesMastectomies – 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)

13 Summary of Multiple CDS Step Inputs & Outputs CDS Step Data InputsCDS Step Data Outputs Request for Genetic TestingTest Id; Test Name; Variant/SourceCode Results of Genetic TestingTest 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 AssessmentCDS Risk Calculation Confirmation of Recommendation CompletionCDS 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

14 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. HL7 Atlanta – 9/07 Virtual Medical Record (vMR) for Clinical Decision Support (CDS) 14

15 vMR Project - Next Steps Set up more formal lines of communication to aligned HL7 TCs and SIGs. 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 Atlanta – 9/07 Virtual Medical Record (vMR) for Clinical Decision Support (CDS) 15


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