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Aziz Boxwala, MD, PhD, FACMI

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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

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