1. Aziz Boxwala, MD, PhD, FACMI
Health eDecisions: A Public-Private Partnership to Enable Standards-Based Clinical Decision Support at Scale
Kensaku Kawamoto, MD, PhD Initiative Coordinator, Health eDecisions
Associate Chief Medical Information Officer, Univ. of Utah Health Sciences Center
Tonya Hongsermeier, MD, MBA Chief Medical Information Officer, Lahey Health
Aziz Boxwala, MD, PhD, FACMI
President, Meliorix, Inc.
Victor C. Lee, MD
Vice President of Clinical Informatics, Zynx Health
Jacob Reider, MD
Acting National Coordinator for Health IT

2. Introductions and Lineup
Panelist
Title
Initiative Role
Jacob Reider, MD
Acting National Coordinator for Health IT
Executive Sponsor
Tonya Hongsermeier, MD, MBA
CMIO
Lahey Health
Past Initiative Coordinator
Kensaku Kawamoto, MD, PhD
Associate CMIO
University of Utah
Initiative Coordinator
Aziz Boxwala, MD, PhD
President
Meliorix, Inc.
Subject Matter Expert
Victor Lee, MD
VP of Clinical Informatics
Zynx Health
Key Community Contributor
SCT 14May

3. Agenda Topic Panelist ONC perspective on motivation for initiating HeD
Reider
Overview of HeD and its methodology
Hongsermeier
Foundational data model: HL7 Virtual Medical Record
Kawamoto
HeD Use Case 1: sharing CDS through standard knowledge artifacts
Boxwala
HeD Use Case 2: sharing CDS through CDS guidance services
Pilots overview and vendor perspective
Lee
Panel discussion, and questions from audience
SCT 14May

4. ONC Perspective on Motivation for Initiating HeD
Jacob Reider, MD
Acting National Coordinator for Health IT
Executive Sponsor, Health eDecisions

5. The Promise of CDS
RCTs demonstrating CDS effectiveness available for almost 40 years1
Actionable, computer-generated CDS provided automatically at the point of care has significantly improved care quality in >90% of RCTs2
Ref 1. McDonald C. NEJM. 1976;295:
Ref 2. Kawamoto K et al. BMJ ;330:765.
SCT 14May

6. The Reality of CDS
CDS commonly available for drug-drug interactions and drug-allergy contraindications
Robust CDS for other domains available in select healthcare systems
However, in general, CDS use is relatively limited
Ref: Osheroff JA et al. A roadmap for national action on clinical decision support. J Am Med Inform Assoc. 2007;14:
SCT 14May

7. Key Barrier: Limited CDS Portability
Most existing CDS systems and their knowledge bases have limited portability1
Ref 1: Osheroff JA et al. J Am Med Inform Assoc. 2007;14:
SCT 14May

8. Potential Solutions
Define standard, universal format(s) for CDS knowledge that can be written once and imported anywhere
Define standard, universal format for encapsulating and accessing CDS capabilities as a software service
SCT 14May

9. Why HeD?
“The nice thing about standards is that there are so many to choose from”
Andrew Tanenbaum
Relevant prior work that can be leveraged, plus need to align and harmonize
Market forces alone maybe inadequate to move CDS-enabled health and healthcare improvement forward
SCT 14May

10. The Opportunity: Alignment with MU
Meaningful Use (MU)
Federal program that incentives adoption of EHR systems fulfilling MU certification requirements
Administered by U.S. Office of the National Coordinator for Health IT (ONC)
MU Focus
Stage I ( ): data capture and sharing
Stage II (2014): advance clinical processes
Stage III (2016): improved outcomes, with CDS as a key component
SCT 14May

11. Overview of HeD and its Methodology
Tonya Hongsermeier, MD, MBA
Chief Medical Information Officer, Lahey Health
Past Initiative Coordinator, Health eDecisions (Jun-Dec 2012)

12. Health eDecisions (HeD)
ONC-sponsored, public-private initiative to develop and validate standards to enable CDS at scale (
Will inform MU Stage III EHR certification criteria
Brief timeline
April 2012: face-to-face planning discussion, DC
June 2012: initiative kickoff
Jan, May, Sept 2013: HL7 ballots
March 2013+: pilots
Late ’13/early ’14 (anticipated): draft MU criteria
SCT 14May

13. Key Contributors Wide, deep range of contributors
ONC: Jacob Reider, Alicia Morton, Joe Bormel, Amy Helwig
Initiative Coordinator: Ken Kawamoto (1/13+), Tonya Hongsermeier (6/12-12/12)
Initiative SMEs: Aziz Boxwala, Bryn Rhodes
Terminology SMEs: Robert McClure, Mark Roche
Project Management and Support: Jamie Parker, Atanu Sen, Anna Langhans, Saunya Williams, Virginia Riehl, Divya Raghavachari
Community Contributors: Zynx Health (Claude Nanjo* and Victor Lee*), Univ. of Utah (David Shields*), Intermountain Healthcare, ASU, Wolters Kluwer Health, VHA, Allscripts, newMentor, CDC, Design Clinicals, and many, many others
*Each with hundreds of hours of contribution
SCT 14May

14. HeD Goal
To define and validate standards that facilitate the emergence of systems and services whereby CDS interventions can be shared or accessed by any healthcare stakeholder via an importable format or via a CDS Web service
In short, to define and validate standards that enable CDS sharing at scale
SCT 14May

15. HeD Scope
Use Case 1: standard format for sharing CDS knowledge artifacts
Rules, order sets and documentation templates
Goal: CDS knowledge authored in standard format can be imported and used in any EHR system
Use Case 2: standard interface for accessing CDS Web services
Goal: CDS capability encapsulated using standard interface can be integrated with any EHR system
SCT 14May

16. Standards & Interoperability (S&I) Framework Methodology
Structured framework for defining and validating standards for consideration in MU
Standards Development
Support
Pilot Demonstration Projects
Use Case Development and Functional Requirements
Harmonization of Core Concepts
Certification and Testing
Implementation Specifications
Reference Implementation
Tools and Services
Architecture Refinement and Management
SCT 14May

17. Prior Work Analyzed Standard, universal format for CDS knowledge
HL7 Arden Syntax, HL7 GELLO, HL7 Order Sets, ASTM GEM, GLIF3, CDS Consortium L3 model, SAGE, Asbru, PROforma, PRODIGY, AHRQ eRecommendations, etc.
Standard interface for submitting patient data and obtaining patient-specific care guidance
HL7 Decision Support Service, IHE Request for Clinical Guidance, OpenCDS, CDS Consortium ECRS, SEBASTIAN, etc.
Standard information models
HL7 Virtual Medical Record, C-CDA, QRDA, various HL7 V3 models, FHIM, FHIR, etc.
All of these options but still not a universal adoption
Ref. Kawamoto K et al. Open Medical Informatics Journal , 4:
SCT 14May

18. Health eDecisions Timeline
Feb
March
Apr
May
June
July
Aug
Sept
Oct
Nov
Dec
June 12
Aug
Sept
Nov
Dec
Jan 13
Kickoff
Consensus on Project Charter Reached
Consensus Reached
Consensus Standards Reached
Use Case One
HL7 Ballot Submitted
Presented at HL7 – Affirmative Vote Received
Pilot Work Begins
Pilot Activities Completed
Pre-Discovery
Discovery
Implementation
Pilot
AB:added comment
Consensus Reached on UC 2
UC Harmonization Begins
Present 5 UC 2 Artifacts to Sept Hl7 Ballot
Use Case Two
Reconcile all ballot comments and submit UC 2 Artifacts to HL7 for Jan 2014 Ballot
Discovery
Implementation 18

19. Deliverables Overview
Foundational Deliverables
Functional requirements, including scope specification, use cases, and data requirements
Analysis of relevant efforts (esp. standards)
Standards
HL7 Virtual Medical Record (multiple facets)
HL7 Decision Support Service Release 2
Use Case 1 and 2 implementation guides
SCT 14May

20. HeD Key Deliverable 1: Foundational CDS Information Model
Kensaku Kawamoto, MD, PhD
Associate Chief Medical Information Officer, University of Utah
Initiative Coordinator, Health eDecisions

21. Disclaimers
I am, or have been in the recent past, a consultant on clinical decision support to the following entities:
I have no competing interests related to OpenCDS
Office of the National Coordinator for Health IT (ONC)
McKesson InterQual
ESAC, Inc.
Partners HealthCare
Inflexxion, Inc.
RAND Corporation
Intelligent Automation, Inc.
ARUP Laboratories
SCT 14May

22. Underlying Information Model
Need
Standard CDS data model that is simple and intuitive for a typical CDS knowledge engineer to understand and use
Relevant Prior Work Evaluated
HL7 Consolidated Clinical Document Architecture (C-CDA)
HL7 Quality Reporting Document Architecture (QRDA)
HL7 Fast Healthcare Interoperability Resources (FHIR)
HL7 Virtual Medical Record (vMR)
IHC Clinical Element Models, OpenEHR templates, others
Decision
HL7 vMR with templates derived from C-CDA and QRDA
SCT 14May

23. vMR Background
A “holy grail” of clinical informatics is scalable, interoperable CDS
Key requirement for interoperable CDS and re-use of CDS knowledge resources = use of a common patient data model
Referred to as a “Virtual Medical Record” or vMR (Johnson et al., AMIA Annu Symp Proc, 2001)
Needs to be easy and safe for a typical CDS knowledge engineer to understand and use
Lack of a common vMR has been a major barrier to sharing knowledge and scaling CDS
SCT 14May

24. Example Challenge without VMR
Blood Pressure
Systolic = 120 mmHg
Diastolic = 80 mmHg
Code = BP
Value = 120/80 mmHg
Observation
Code = BP
Value = 120/80 mmHg
Observation
Code = BP
Code = SBP
Value = 120 mmHG
Code = DSP
Value = 80 mmHg
Vital Signs
Type = BP
Value = 120/80
Units = mmHg
SCT 14May

25. vMR Goal
Provide standard information model for CDS that (i) can be used across CDS implementations and (ii) is simple and intuitive for a typical CDS knowledge engineer to understand, use, and implement

26. Development Methodology
Analysis of data required by 20 CDS systems from 4 countries (Kawamoto et al., AMIA 2010)
Analysis of various standard information models
HL7 CCD, C-CDA, QRDA, Pedigree model, Clinical Statement pattern, etc.
Analysis of orderables from hundreds of hospitals
Iterative refinement from pilot use
In particular, through OpenCDS ( and HeD pilots
Initial ballot in 2010; Sept = 4th round of balloting

27. Why Not Just Use C-CDA as the vMR?
<entry
typeCode="DRIV">
<act classCode="ACT" moodCode="EVN">
<templateId root=" "/>
<id root="ec8a6ff8-ed4b-4f7e-82c3-e98e58b45de7"/>
<code code="CONC" codeSystem=" " displayName="Concern"/>
<statusCode code="completed"/>
<effectiveTime><low value=" "/></effectiveTime>
<entryRelationship typeCode="SUBJ">
<observation classCode="OBS" moodCode="EVN">
<templateId root=" "/>
<id root="ab1791b0-5c71-11db-b0de c9a66"/>
<code code=" " codeSystem=" " displayName="Complaint"/>
<effectiveTime><low value=" "/></effectiveTime>
<value xsi:type="CD" code=" " codeSystem=" " displayName="Asthma"/>
<entryRelationship typeCode="REFR">
<templateId root=" "/>
<code xsi:type="CE" code=" " codeSystem=" " codeSystemName="LOINC"
displayName="Status"/>
<value xsi:type="CD" code=" " codeSystem=" "
codeSystemName="SNOMED CT" displayName="Active"/>
</observation>
</entryRelationship>
</act>
</entry>
CCDA 1.1 representation of
“Patient has had asthma since 1950”
SCT 14May

28. Why Not Just Use C-CDA as the vMR?
Sample CDS expression that
“Patient currently has active asthma”
using CCDA 1.1 Data Model
entry[typeCode=“DRIV” and
act[classCode=“ACT” and
moodCode=“EVN” and
/templateId[root=“ ”] and
/code[codeSystem=“ ” and code=“CONC”] and
/statusCode[code=“completed”] and
/entryRelationship[typeCode=“SUBJ” and
/observation[classCode=“OBS” and moodCode=“EVN” and
/templateId[root=“ ”] and
/code[codeSystem=“ ” and code=“ ”] and
/effectiveTime[/low[value<=“ ”]] and
/value[xsi:type=“CD” and codeSystem=“ ” and code=“ ”] and
/entryRelationship[typeCode=“REFR” and
/templateId[root=“ ”] and
/code[xsi:type=“CE” and
codeSystem=“ ” and
code=“ ”
] and
/value [xsi:type=“CD” and
codeSystem=“ ” and
code=“ ”
] ] ] ] ] ]
SCT 14May

29. vMR Representation of Equivalent Content
vMR representation of “Patient has had asthma since 1950”
<clinicalStatement xsi:type="vmr:Problem">
<templateId root=" "/>
<problemCode codeSystem=" " code=" "><displayName value="Asthma"/></problemCode>
<problemEffectiveTime><low value=" "/><problemEffectiveTime>
<problemStatus codeSystem=" " code=" "><displayName value="Active"/></problemStatus>
</clinicalStatement>
Sample CDS expression for “Patient currently has active asthma” using vMR
clinicalstatement[xsi:type=“vmr:Problem” and
/templateId[root=“ ”] and
/problemCode[codeSystem=“ ” and code=“ ”] and
/problemEffectiveTime[/low[value<=“ ”]] and
/problemStatus[codeSystem=“ ” and code=“ ”] ]
SCT 14May

30. Simplification – Data Types
HL7 Version 3 Release 2 Data
Type Model for Integer
Constrained HL7 Version 3 Release 2 Data Type Model for Integer used in vMR
Value of the INT
SCT 14May

31. Example vMR Template Example:
<clinicalStatement xsi:type="vmr:Problem">
<templateId root=" “ identifierName=“ActiveProblemListEntryCodeOnly”/>
<problemCode codeSystem=" " code=" "><displayName value="Asthma"/></problemCode>
</clinicalStatement>
SCT 14May

32. HeD Key Deliverable 2: HL7 CDS Knowledge Artifact Implementation Guide (IG) (HeD Use Case 1 IG)
Aziz Boxwala, MD, PhD
President, Meliorix, Inc.
Subject Matter Expert, Health eDecisions

33. Goal
CDS interventions must be made shareable and implementable so that they can be acquired and deployed by any organization

34. Use Case Overview

35. Design objectives Format for specifying computable CDS knowledge
Knowledge can be imported into existing CDS systems
Not creating a new execution format
Format must be flexible
Support different CDS intervention types
More than alerts and reminders
Knowledge must be portable

36. Approach Reviewed several existing knowledge representation formalisms
Did not meet requirements completely
Solution is a harmonization of several formats and ideas
CDSC-L3, ArdenML, CREF
HL7 Order Sets Specification, Infobutton
GEM, HQMF, eRecommendations, GELLO, research from SHARP-C, …
CREF
eRECS
CDSC L3
HL7 Order Set Model
VMR
GEM
SHARP ARDEN
Inputs
Harmonization and Modeling
CDS Artifact Sharing Use Case FR & Data Elements
HeD Knowledge
Artifact Schema

37. Knowledge artifact schema
Modular, component based solution
Specifies key components of any CDS intervention
Metadata
Expression language
Action
Trigger
Data model (by reference)
vMR

39. Knowledge artifact schema
Schemas defined by composition of components
Currently supported CDS interventions
Event-condition-action rules
Order sets
Structured documentation templates
In future, can be expanded
E.g., Plans of care, infobutton rules/knowledge, relevant data display

40. Expressions External Data
Specifies the data required to evaluate the artifact
Logic
Criteria used within CDS
Calculations
Dosing, risk

41. External Data Example
Addressing the curly braces issue using HeD expression language and the VMR
<def name="PertussisProblems">
<expression xsi:type="ClinicalRequest" dataType="vmr:Problem" cardinality="Multiple“ isInitial="true" useValueSets="true" dateProperty="diagnosticEventTime.begin" codeProperty="problemCode" triggerType="DataElementAdded">
<description>Pertussis problem</description>
<codes xsi:type="ValueSet" id=" " version="1"/>
</expression>
</def>

42. Conditions Example <condition> <logic xsi:type="And">
<description>(Patient lives in SD or Care encounter was in SD) and
(Diagnosed with Pertussis or Cause of Death was Pertussis
or culture results positive for pertussis)</description>
<operand xsi:type="Or">
<operand xsi:type="ExpressionRef" name="PatientLivesInSDCounty"/>
<operand xsi:type="ExpressionRef" name="EncounterWasInSDCounty"/>
</operand>
<!-- Necessary clinical conditions -->
<operand xsi:type="ExpressionRef" name="HasActivePertussisProblems"/>
<operand xsi:type="ExpressionRef" name="DeathWasCausedByPertussis"/>
<operand xsi:type="ExpressionRef" name="HasPositivePertussisCulture"/>
</logic>
<conditionRole value="ApplicableScenario"/>
</condition>

43. Actions Create/Modify/Remove Action
Create indicates proposal for an action as a vMR object
e.g. create a SubstanceAdministrationProposal
create a CommunicationProposal
Collect Information Action
Defines information to be collected
Action Groups
Provide structure for grouping actions

44. Communication Action <simpleAction xsi:type="CreateAction">
<actionSentence xsi:type="ObjectExpression"
objectType="vmr:CommunicationProposal">
<property name="message">
<value xsi:type="ComplexLiteral">
<value xsi:type="dt:ED" value="This patient has or is suspected of having pertussis. Patients diagnosed with or suspected of having pertussis must be reported to County of San Diego Health and Human Services Agency within one working day of identification or suspicion"/>
</value>
</property>
</actionSentence>
</simpleAction>

45. Kensaku Kawamoto, MD, PhD
HeD Key Deliverable 3: HL7 Decision Support Service IG (HeD Use Case 2 IG)
Kensaku Kawamoto, MD, PhD
Associate Chief Medical Information Officer, University of Utah
Initiative Coordinator, Health eDecisions

46. Goal
Allow any organization to easily obtain CDS guidance through a secure, standard Web service interface.

47. CDS Guidance Requestor
Use Case Overview
CDS Guidance Requestor
CDS Guidance
(care guidance)
CDS Guidance Supplier
CDS Request
(patient data)

48. Key Standards HL7 Decision Support Service (DSS)
Defines SOAP and REST Web service interfaces for CDS guidance services
HL7 Virtual Medical Record (vMR)
Provides easy-to-understand data model for CDS
HL7 Consolidated CDA (C-CDA) and Quality Reporting Document Architecture (QRDA)
Terminology bindings and value sets largely being adopted within vMR as vMR templates

49. CDS Guidance Service – Example
Eval. Result
vMR
Decision Support Service
EHR System
SCT 14May

50. Sample CDS Guidance Services
Evaluation Input
Evaluation Output
Patient age, gender, past health maintenance procedures
List of health maintenance procedures due or almost due
Medication identifier, age, gender, weight, serum creatinine level
Recommended maximum and minimum doses for medication given patient's estimated renal function
Insurance provider, data relevant to prescription
Prior authorization to prescribe medication
Patient summary
Wide range of care recommendations
SCT 14May

51. Sample Current Implementers
OpenCDS (
Multi-institutional open-source effort led by Univ. of Utah
Implements HL7 DSS and vMR; will support HeD UC 2
200+ members from 150+ organizations
Example implementation: Immunization Calculation Engine (ICE), led by HLN Consulting, & used by New York City, Alabama, eClinicalWorks
Enterprise Clinical Rules Service
Part of CDS Consortium effort
Epic EHR
Will support CDS Guidance Services in 2014 release

52. OpenCDS Knowledge Editor

54. Standards Status Standard Description HL7 Status Comments
HL7 vMR Logical Model
Base UML specification
Passed HL7 ballot Sept. 2013
HL7 vMR XML Specification
XML specification
HL7 vMR Templates
Includes terminology binding
Developing additional templates
HL7 CDS Knowl. Artifact IG
Use Case 1 IG
Passed HL7 ballot Jan. 2013
HL7 DSS Release 2
DSS base specification
Passed HL7 ballot Sept with 100% affirmative vote
HL7 DSS IG
Use Case 2 IG
Ref:

55. Pilots and Vendor Perspective
Victor Lee, MD
Vice President of Clinical Informatics, Zynx Health
Community Contributor, Health eDecisions

58. Do the right thing

60. Pilot Partnerships – HeD Use Case 1
EHR
Pilot
Content Supplier
Design Clinicals
Order Set – Heart Failure
Zynx Health
Allscripts
Rule – NQF 068 (Million Hearts)
newMentor
Rule – San Diego Pertussis
CDC VA
Documentation Template – UTI
Wolters Kluwer Health

61. Order Set Exchange Pilot

62. WKH Doc. Template in VA CPRS
© 2013, Kensaku Kawamoto

64. “People who say it can’t be done should get out of the way of people who are doing it.”

65. Conclusions and Panel Discussion
Jacob Reider, MD
Acting National Coordinator for Health IT
Executive Sponsor, Health eDecisions

66. Conclusions True community effort
Remarkable achievements in limited timeframe
Unique opportunity to realize the promise of CDS and make Meaningful Use of EHRs

67. Discussion Questions
What do you think of HeD and its potential impact?
How can we best encourage CDS sharing at scale?
How can we best align CDS with healthcare transformation?
What more can the public and private sectors do to facilitate CDS-enabled healthcare improvement?
How can we start to make progress NOW?
What kind of content would be most useful?

68. Thank You!
Kensaku Kawamoto, MD, PhD Associate Chief Medical Information Officer, Univ. of Utah Health Sciences Center
Initiative Coordinator, Health eDecisions
Tonya Hongsermeier, MD, MBA Chief Medical Information Officer, Lahey Health
Aziz Boxwala, MD, PhD
President, Meliorix, Inc.
Victor C. Lee, MD
Vice President of Clinical Informatics, Zynx Health
Jacob Reider, MD
Acting National Coordinator for Health IT

69. Backup Slides

70. S&I Framework Phases Phase Activities Pre-Discovery
Development of Initiative Charter
Definition of Initiative Goals & Outcomes
Discovery
Development of Use Cases & Functional Requirements
Review and analysis of existing standards
Implementation
Development and balloting of needed standards
Development of tools to facilitate implementation of standards
Pilot
Pilot implementation of the standards
Refinement of standards based on lessons learned
Evaluation
Measurement of initiative success against goals and outcomes
Provide recommendations to ONC for potential wider scale deployment
AB:added comment

71. Clinical Decision Support (CDS)
Definition
Provision of pertinent knowledge and person-specific information to clinical decision makers to enhance health and health care1
Examples
Alerts and reminders
Order sets, documentation templates
Infobuttons, data displays
Ref 1. Osheroff et al. JAMIA ;14:
SCT 14May

72. Metadata Identifiers Id, Title, Description, Artifact Lifecycle
Documentation
Documentation, Related Resources
Supporting Evidence
Data Models
Key Terms

73. Metadata (Example) <identifiers>
<identifier root="SDCOID_PertussisClinicanNoLabs" version="1"/>
</identifiers>
<artifactType value="Rule"/>
<schemaIdentifier root="urn:hl7-org:v3:knowledgeartifact:r1" version="1"/>
<dataModels>
<modelReference>
<description value="Virtual Medical Record model release 2"/>
<referencedModel value="urn:hl7-org:vmr:r2"/>
</modelReference>
</dataModels>
<title value="San Diego County Public Health Reporting for Pertussis - Clinicians"/>
<description value="This document describes the reporting requirements for Clinician
Reporting for Pertussis with and without Lab Data in San Diego County."/>

74. Pilots Overview HeD Use Case 1 pilots HeD Use Case 2 pilots
Completed summer 2013
Focus of discussion today
HeD Use Case 2 pilots
Various groups are using earlier versions of standards in production systems
Pilots of current versions of standards in progress

75. Pilot Partnerships – HeD Use Case 1
EHR
Pilot
Content Supplier
Design Clinicals
Order Sets – Heart Failure
Zynx Health
AllScripts
Rule –NQF 068 (Million Hearts)
NewMentor
Allscripts
Rule - San Diego Pertussis
CDC VA
Documentation Template – Urinary Tract Infection
Wolters Kluwer Health

76. General Approach CDS knowledge artifact expressed using HL7 standard
Model transformed from HeD format to EHR-specific format using model mapping tool
Bryn Rhodes: HeD Schema Framework
Robert Lario: UML Modeling Transformation Framework
Knowledge artifact consumed in EHR

77. HeD to Allscripts CREF Example

78. Order Set Exchange Pilot
CDS Supplier: Zynx Health
Claude Nanjo
Victor Lee
CDS Consumer/EHR Vendor: Design Clinicals
Dewey Howell

79. UML Modeling Transformation Framework (R. Lario)

80. Model Transformation
© 2013, Kensaku Kawamoto