Kensaku Kawamoto, MD, PhDInitiative Coordinator, Health eDecisions

Associate Chief Medical Information Officer, Univ. of Utah Health Sciences Center

Tonya Hongsermeier, MD, MBAChief Medical Information Officer, Lahey Health

Aziz Boxwala, MD, PhD, FACMIPresident, Meliorix, Inc.

Victor C. Lee, MDVice President of Clinical Informatics, Zynx Health

Jacob Reider, MDActing National Coordinator for Health IT

Health eDecisions: A Public-Private Partnership to Enable Standards-

Based Clinical Decision Support at Scale

1

Introductions and Lineup

Panelist Title Initiative Role

Jacob Reider, MD Acting National Coordinator for Health IT

Executive Sponsor

Tonya Hongsermeier, MD, MBA

CMIOLahey Health

Past Initiative Coordinator

Kensaku Kawamoto, MD, PhD

Associate CMIO University of Utah

Initiative Coordinator

Aziz Boxwala, MD, PhD

PresidentMeliorix, Inc.

Subject Matter Expert

Victor Lee, MD VP of Clinical InformaticsZynx Health

Key Community Contributor

2

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

Kawamoto

Pilots overview and vendor perspective Lee

Panel discussion, and questions from audience Reider

3

Jacob Reider, MDActing National Coordinator for Health IT

Executive Sponsor, Health eDecisions

ONC Perspective on Motivation for Initiating HeD

4

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;295:1351-5.Ref 2. Kawamoto K et al. BMJ. 2005;330:765.

5

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;14:141-145.

6

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;14:141-145.

7

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

8

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

9

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 (2011-2012): data capture and sharing– Stage II (2014): advance clinical processes– Stage III (2016): improved outcomes, with CDS as a key

component

10

Tonya Hongsermeier, MD, MBAChief Medical Information Officer, Lahey Health

Past Initiative Coordinator, Health eDecisions (Jun-Dec 2012)

Overview of HeD and its Methodology

11

Health eDecisions (HeD)

• ONC-sponsored, public-private initiative to develop and validate standards to enable CDS at scale (www.healthedecisions.org)– 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

12

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 13

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

14

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

15

Standards & Interoperability (S&I) Framework Methodology

• Structured framework for defining and validating standards for consideration in MU

Tools and ServicesTools and Services

Use Case Development

and Functional Requirements

Use Case Development

and Functional Requirements

Standards DevelopmentSupport

Standards DevelopmentSupport

Harmonization ofCore Concepts

Harmonization ofCore Concepts

Implementation Specifications

Implementation Specifications

Pilot Demonstration Projects

Pilot Demonstration Projects

Reference Implementation

Reference Implementation

Architecture Refinement and ManagementArchitecture Refinement and Management

Certificationand TestingCertificationand Testing

16

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.

Ref. Kawamoto K et al. Open Medical Informatics Journal. 2010, 4:235-44. 17

Health eDecisions TimelineMarch MayFeb Apr June July Aug Dec

Consensus Reached on UC 2

UC Harmonization Begins

Pilot Work Begins Pilot Activities Completed

18

June 12

NovSept Aug Dec Jan 13

Kickoff

Consensus on Project Charter Reached

Consensus Reached

Consensus Standards Reached

HL7 Ballot Submitted

Presented at HL7 – Affirmative Vote Received

Pre-Discovery

Discovery Implementation Pilot

Use

Cas

e O

ne

Use

Cas

e Tw

o

Discovery Implementation

Present 5 UC 2 Artifacts to Sept Hl7 Ballot

Sept Oct Nov

Reconcile all ballot comments and submit UC 2 Artifacts to HL7 for Jan 2014 Ballot

18

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

19

Kensaku Kawamoto, MD, PhDAssociate Chief Medical Information Officer, University of Utah

Initiative Coordinator, Health eDecisions

HeD Key Deliverable 1: Foundational CDS Information Model

20

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

21

Office of the National Coordinator for Health IT (ONC)

Partners HealthCare RAND Corporation ARUP Laboratories

McKesson InterQual ESAC, Inc. Inflexxion, Inc. Intelligent Automation, Inc.

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

22

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

23

Example Challenge without VMR

ObservationCode = BPValue = 120/80 mmHg

Blood PressureSystolic = 120 mmHgDiastolic = 80 mmHgCode = BPValue = 120/80 mmHg

Observation Code = BP

ObservationCode =

SBPValue =

120 mmHGObservation

Code = DSP

Value = 80 mmHg

Vital SignsType = BPValue = 120/80Units = mmHg

24

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

25

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 (www.opencds.org) and HeD pilots

– Initial ballot in 2010; Sept. 2013 = 4th round of balloting

26

Why Not Just Use C-CDA as the vMR?

<entry typeCode="DRIV"> <act classCode="ACT" moodCode="EVN"> <templateId root="2.16.840.1.113883.10.20.22.4.3"/> <id root="ec8a6ff8-ed4b-4f7e-82c3-e98e58b45de7"/> <code code="CONC" codeSystem="2.16.840.1.113883.5.6" displayName="Concern"/> <statusCode code="completed"/> <effectiveTime><low value="20070103"/></effectiveTime> <entryRelationship typeCode="SUBJ"> <observation classCode="OBS" moodCode="EVN">

<templateId root="2.16.840.1.113883.10.20.22.4.4"/> <id root="ab1791b0-5c71-11db-b0de-0800200c9a66"/> <code code="409586006" codeSystem="2.16.840.1.113883.6.96" displayName="Complaint"/> <statusCode code="completed"/> <effectiveTime><low value="19500101"/></effectiveTime> <value xsi:type="CD" code="195967001" codeSystem="2.16.840.1.113883.6.96" displayName="Asthma"/> <entryRelationship typeCode="REFR"> <observation classCode="OBS" moodCode="EVN">

<templateId root="2.16.840.1.113883.10.20.22.4.6"/> <code xsi:type="CE" code="33999-4" codeSystem="2.16.840.1.113883.6.1" codeSystemName="LOINC" displayName="Status"/> <statusCode code="completed"/> <value xsi:type="CD" code="55561003" codeSystem="2.16.840.1.113883.6.96" codeSystemName="SNOMED CT" displayName="Active"/> </observation> </entryRelationship> </observation> </entryRelationship> </act> </entry>

CCDA 1.1 representation of “Patient has had asthma since 1950”

27

Why Not Just Use C-CDA as the vMR?

entry[typeCode=“DRIV” and act[classCode=“ACT” and moodCode=“EVN” and /templateId[root=“2.16.840.1.113883.10.20.22.4.3”] and /code[codeSystem=“2.16.840.1.113883.5.6” and code=“CONC”] and /statusCode[code=“completed”] and /entryRelationship[typeCode=“SUBJ” and /observation[classCode=“OBS” and moodCode=“EVN” and /templateId[root=“2.16.840.1.113883.10.20.22.4.4”] and /code[codeSystem=“2.16.840.1.113883.6.96” and code=“409586006”] and /statusCode[code=“completed”] and /effectiveTime[/low[value<=“20130814”]] and

/value[xsi:type=“CD” and codeSystem=“2.16.840.1.113883.6.96” and code=“95967001”] and /entryRelationship[typeCode=“REFR” and /observation[classCode=“OBS” and moodCode=“EVN” and /templateId[root=“2.16.840.1.113883.10.20.22.4.6”] and /code[xsi:type=“CE” and codeSystem=“2.16.840.1.113883.6.1” and code=“33999-4” ] and /statusCode[code=“completed”] and /value [xsi:type=“CD” and codeSystem=“2.16.840.1.113883.6.96” and code=“55561003” ] ] ] ] ] ]

Sample CDS expression that“Patient currently has active asthma” using CCDA 1.1 Data Model

28

vMR Representation of Equivalent Content

<clinicalStatement xsi:type="vmr:Problem"> <templateId root="2.16.840.1.113883.3.1829.11.7.2.5"/> <problemCode codeSystem="2.16.840.1.113883.6.96" code="195967001"><displayName value="Asthma"/></problemCode> <problemEffectiveTime><low value="19500101"/><problemEffectiveTime> <problemStatus codeSystem="2.16.840.1.113883.6.96" code="55561003"><displayName value="Active"/></problemStatus></clinicalStatement>

Sample CDS expression for “Patient currently has active asthma” using vMR

clinicalstatement[xsi:type=“vmr:Problem” and /templateId[root=“2.16.840.1.113883.3.1829.11.7.2.5”] and /problemCode[codeSystem=“2.16.840.1.113883.6.96” and code=“195967001”] and /problemEffectiveTime[/low[value<=“20130814”]] and /problemStatus[codeSystem=“2.16.840.1.113883.6.96” and code=“55561003”] ]

vMR representation of “Patient has had asthma since 1950”

29

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

30

Example vMR Template

Example:<clinicalStatement xsi:type="vmr:Problem"> <templateId root="2.16.840.1.113883.3.1829.11.7.2.5“ identifierName=“ActiveProblemListEntryCodeOnly”/> <problemCode codeSystem="2.16.840.1.113883.6.96" code="195967001"><displayName value="Asthma"/></problemCode></clinicalStatement>

31

Aziz Boxwala, MD, PhDPresident, Meliorix, Inc.

Subject Matter Expert, Health eDecisions

HeD Key Deliverable 2: HL7 CDS Knowledge Artifact Implementation

Guide (IG)

(HeD Use Case 1 IG)

32

Goal

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

33

Use Case Overview

34

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

35

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, …

36

CDS Artifact Sharing Use Case

FR & Data Elements

VMR GEM

eRECS CDSC L3

HL7 Order

Set Model

SHARP ARDEN

Inputs

HeD Knowledge

Artifact Schema

Harmonization and ModelingHarmonization and Modeling

CREF

Knowledge artifact schema

• Modular, component based solution• Specifies key components of any CDS

intervention– Metadata– Expression language– Action– Trigger– Data model (by reference)

• vMR

37

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

39

Expressions• External Data

– Specifies the data required to evaluate the artifact

• Logic– Criteria used within CDS

• Calculations– Dosing, risk

40

External Data Example

<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="2.16.840.1.114222.4.11.7005" version="1"/> </expression></def>

41

Addressing the curly braces issue using HeD expression language and the VMR

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> <operand xsi:type="Or"> <!-- Necessary clinical conditions --> <operand xsi:type="ExpressionRef" name="HasActivePertussisProblems"/> <operand xsi:type="ExpressionRef" name="DeathWasCausedByPertussis"/> <operand xsi:type="ExpressionRef" name="HasPositivePertussisCulture"/> </operand> </logic> <conditionRole value="ApplicableScenario"/></condition>

42

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>

44

Kensaku Kawamoto, MD, PhDAssociate Chief Medical Information Officer, University of Utah

Initiative Coordinator, Health eDecisions

HeD Key Deliverable 3: HL7 Decision Support Service IG

(HeD Use Case 2 IG)

45

Goal

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

46

Use Case Overview

CDS Guidance Requestor

CDS Guidance(care guidance)

CDS Guidance Supplier

CDS Request (patient data)

47

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

48

CDS Guidance Service – Example

Decision Support Service

Decision Support Service EHR SystemEHR System

vMRvMR

Eval. ResultEval.

Result

49

Sample CDS Guidance ServicesEvaluation Input Evaluation Output

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

Patient age, gender, past health maintenance procedures

List of health maintenance procedures due or almost due

50

Sample Current Implementers• OpenCDS (www.opencds.org)

– 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

51

OpenCDS Knowledge Editor

52

www.OpenCDS.org

53

Standards Status

54

Standard Description HL7 Status

Comments

HL7 vMR Logical Model

Base UML specification

Passed HL7 ballot Sept. 2013

HL7 vMR XML Specification

XML specification Passed HL7 ballot Sept. 2013

HL7 vMR Templates

Includes terminology binding

Passed HL7 ballot Sept. 2013Developing 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. 2013 with 100% affirmative vote

HL7 DSS IG Use Case 2 IG Passed HL7 ballot Sept. 2013 with 100% affirmative vote

Ref: http://wiki.hl7.org/index.php?title=HL7_CDS_Standards

Victor Lee, MDVice President of Clinical Informatics, Zynx Health

Community Contributor, Health eDecisions

Pilots and Vendor Perspective

55

56

57

Do the right thing

58

59

Pilot Partnerships – HeD Use Case 1EHR Pilot Content SupplierDesign Clinicals

Order Set – Heart Failure

Zynx Health

Allscripts Rule – NQF 068 (Million Hearts)

newMentor

Allscripts Rule – San Diego Pertussis

CDC

VA Documentation Template – UTI

Wolters Kluwer Health

60

Order Set Exchange Pilot

61

WKH Doc. Template in VA CPRS

© 2013, Kensaku Kawamoto 62

63

“People who say it can’t be done

should get out of the way

of people who are doing it.”

64

Jacob Reider, MDActing National Coordinator for Health IT

Executive Sponsor, Health eDecisions

Conclusions and Panel Discussion

65

Conclusions

• True community effort• Remarkable achievements in limited timeframe• Unique opportunity to realize the promise of CDS

and make Meaningful Use of EHRs

66

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?

67

Thank You!

Kensaku Kawamoto, MD, PhDAssociate Chief Medical Information Officer, Univ. of Utah Health Sciences CenterInitiative Coordinator, Health eDecisions

Tonya Hongsermeier, MD, MBAChief Medical Information Officer, Lahey Health

Aziz Boxwala, MD, PhDPresident, Meliorix, Inc.

Victor C. Lee, MDVice President of Clinical Informatics, Zynx Health

Jacob Reider, MDActing National Coordinator for Health IT

68