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HL7 EHR System Functional Model andStandard (ISO/HL7 10781), Release 2Health Information Management Systems Society (HIMSS)Las Vegas, NV20 Feb 2012Presented by:Mark G. Janczewski, MD, MPHDeloitte Consulting, LLP 2011 Health Level Seven International. All Rights Reserved.HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
Agenda1. Introduction2. Release 2 Background3. Conformance Clause / Functional Profiles4. Glossary / Verb Hierarchy5. Function List 2011 Health Level Seven International. All Rights Reserved.HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
Brief History of HL7Functional Model (FM) In the Spring of 2003 HL7 began efforts to develop astandardized functional specification for Electronic HealthRecords Systems (EHR-S) Approved July 2004 as a Draft Standard for Trial UseApproved February 2007 as a fully accredited standard by theAmerican National Standards Institute (ANSI)Approved mid-2009 as an International (ISO) StandardCCHIT referenced the EHR-S FM (Release 1) and domainspecific Functional Profiles in developing its productcertification criteria5 2011 Health Level Seven International. All Rights Reserved.HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
Electronic Health Record (EHR)vs. EHR-System EHR: Underlying single, logical patient recordRecord is structuredServes as Provider legal recordEHR System: Software that provides functionality to: Manage and maintain the recordAccomplish various clinical, research, and businessrequirementsMay be: Monolithic system; orSystem of systems 2011 Health Level Seven International. All Rights Reserved.HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
Functional Model (FM)Scope SummaryIs Not A messaging specificationAn EHR design specificationAn implementationspecification (not the “how”) Does not prescribetechnologyDoes not dictate howfunctions must beimplemented (e.g., via theuser interface, databasedesign) 2011 Health Level Seven International. All Rights Reserved.HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.Is A system specificationAn EHR system specificationA reference list of functions thatmay be present in an EHR-S (the“what” and “why”) Enables consistent expression offunctionalityProvides flexibility for innovationand product differentiationGold standard, sensitive to whatcan practically be done by asystem yet guides future systemdevelopment
A Way to Specifythe Complete s beyondcertification criteria arespecified by the EHR-SFM and more “domainspecific” FunctionalProfiles (e.g. EmergencyDept., Behav. Health)Certification is a necessary, but not sufficient, description of what functions asystem can perform. The Functional Model provides a more comprehensiveset of EHR-S functional requirements 2011 Health Level Seven International. All Rights Reserved.HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
Continued Development 2007: FM passes HL7 Full Normative Ballot, Release 12007: FM published as HL7/ANSI Standard2009: FM passes Joint Ballot with HL7, ISO and CEN,Release 1.1November 2009: FM published as ISO/HL7 107812010-2011: FM Release 2 Development2012: FM Release 2 joint balloting HL7, ISO, CEN, IHTSDO and CDISC 2011 Health Level Seven International. All Rights Reserved.HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
Inputs to EHR-S FM Release 2UC Alignment . .EHR LifecycleProvider BasedSOAVital Rptg.RM & ESBeh. HealthPHR-SFM HR-S FMRelease 2InternationalStandardsOther Industry hInfoExchange 2011 Health Level Seven International. All Rights Reserved.HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.Data Use Fraud Mgt Quality Rev Cycle(ISO TC215,ISO 20514,ISO DISCEN 18308,13606)Others?
201320122011Release 2 TimelineWhen/TargetEHR-S FM Release 2 ActivityMayDraft for CommentJuly – SeptemberComment Reconciliation and Continued Chapter UpdatesSeptember 12-15EHR Working Group (WG) Meeting – San Diego, CaliforniaSeptember – NovemberContinued content development and quality assuranceDecember 6thBallot Draft ReadyJanuary 16-19EHR WG Meeting – San Antonio, TexasApril 2ndHL7 Ballot OpensMay 7thJoint (HL7, ISO, CEN, CDISC and IHTSDO) Ballot ClosesMay 14-17EHR WG Meeting – Vancouver, BC, CanadaMay – NovemberBallot reconciliation and material updatesDecember 12nd Ballot Draft Ready for Submission to ISO, CEN, CDISC andIHTSDO for Ballot preparationJanuary 13 - 18HL7 WG MeetingAprilBallotSubmission to ISO, CEN, CDISC and IHTSDO for Ballot preparation 2011 Health Level Seven International. All Rights Reserved.HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
Significant R2 Changesfrom R1/R1.1 Introduction of Overarching Criteria ChapterEnhancement and enforcement of Glossary – specifically the“Action-Verb Hierarchy”Reorganization of ChaptersSubstantial increase in number and granularity ofconformance criteriaSubstantial increase in number of functions Implicit functions are now made more explicit.Incorporation of EHR Interoperability Model and EHRLifecycle Model (previous independent Draft Standard forTrial Use [DSTU] documents)Substantial improvements to Conformance Clause chapter 2011 Health Level Seven International. All Rights Reserved.HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
Conformance Clause andStatement The Conformance Clause defines the minimumrequirements for functional profiles claimingconformance to the EHR-S FM.The value of the Conformance Clause – A vendorcan provide a Conformance Statement thatshows how well it conforms to relevant FunctionalProfiles 2011 Health Level Seven International. All Rights Reserved.HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
Conformance to ProfilesConforms toEHR-SDerivedDomainProfileConforms toConforms nsConformanceCriteriaRules Cancer ResearchImplementationsFunctional Profiles 2011 Health Level Seven International. All Rights Reserved.HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.EHR-S FunctionalModel
Glossary - Introduction Glossary clearly defines terms in the Functional Modeland Profiles Includes a specific Action Verb hierarchy Goal is to promote clarity and consistency wheninterpreting and applying the text of the HL7 ElectronicHealth Record System Functional Model (EHR-S FM). Release 2 Glossary has undergone a complete reviewand is more comprehensive including all terms used in theModel. Glossary includes 238 active terms. 2011 Health Level Seven International. All Rights Reserved.HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
Release 2 Action-Verb Hierarchy Data Management Category Action-Verbs for the full range of datahandling actions by a system.Release 1.1CreateAdd, inputDefine, Tailor, Specify,SetGenerateCite, IncludeExportFind, IdentifySpecifyPromptManage inkTagDeletePurgeExtract 2011 Health Level Seven International. All Rights Reserved.HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM e-IdentifyHideMaskRe-IdentifyUnhideUnmask
Secure (System) Category Action Verbs Action-Verbs for controlling access(authenticating and authorizing users),tracking activities (logging and auditing), andsustaining operations.Secure (System)Control AccessAuthenticateAuthorize 2011 Health Level Seven International. All Rights Reserved.HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.TrackLogAuditSustain (Operations)
Extension of Function List The number of conformance criteria increasedfrom 972 in R1.0, 983 in R1.1 and 2,310 in R2.0Summary Breakdown of Functions and Conformance CriteriaHL7 EHR-S Functional Model, Release 2ChapterFunctionsOVOverarching CriteriaCPConformanceCriteria233Care Provision41494CPSCare Provision Support76559POPPopulation Health Support18108ASAdministration Support55249RIRecords Infrastructure37186TITrust Infrastructure936813222,310TOTALS: 2011 Health Level Seven International. All Rights Reserved.HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.Release 1.1Release 1ConformanceCriteriaConformanceCriteria983972
Chapter ReorganizationDirect Care (DC)Supportive (S)Information Infrastructure (IN)Overarching (O)Care Provision (CP)Care Provision Support(CP)Population HealthSupport (POP)Record Infrastructure (RI)Trust Infrastructure (TI) 2011 Health Level Seven International. All Rights Reserved.HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.Administrative Support(AS)
EHR-S Functional Model –Components Function ID Function Name Function Statement Function Description Examples See Also Conformance Criteria 2011 Health Level Seven International. All Rights Reserved.HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
Overarching Criteria Chapter Criteria that apply to all EHR Systems andconsequently must be included in all EHR-S FMcompliant profilesExamples:OV.1The system SHALL conform to function TI.1.1 (Entity Authentication).The system SHALL conform to function TI.1.2 (Entity Authorization).OverarchingThe system SHALL conform to function TI.1.3 (Entity Access Control).IF the system receives or transmits data for which jurisdictionally establishedinterchange standards exist, THEN the system SHALL conform to function IN.5.1(Interchange Standards) to support interoperability.The system SHOULD conform to function IN.6 (Business Rules Management).The system SHOULD conform to function IN.7 (Workflow Management).OV.2Manage User Help 2011 Health Level Seven International. All Rights Reserved.HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
Care Provision Care Provision Focus on functions required to provide care to a specific patientand enable hands-on delivery of healthcareOrganized in general order of an e Clinical HistoryRender Externally-sourced InformationManage Clinical DocumentationManage OrdersCP.1Manage ResultsCP.1.1Manage Treatment AdministrationManage Future CareCP.1.2Manage Patient Education & CommunicationCP.1.3Manage Care Coordination & ReportingCP.1.4CP.1.5CP.1.6CP.1.7CP.1.8 2011 Health Level Seven International. All Rights Reserved.HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.Example child functions:Manage Clinical HistoryManage Patient HistoryManage Allergy, Intolerance and Adverse ReactionListManage Medication ListManage Problem ListManage Strengths ListManage Immunization ListManage Medical Equipment, Prosthetic/Orthotic,Device ListManage Patient and Family Preferences
Care Provision Support Care Provision Support Focus on functions required to support the provision of care to aspecific patient to enable hands-on delivery of healthcareOrganized in alignment with Care Provision .9Record ManagementSupport Externally-sourced InformationExample child functions:Support Clinical DocumentationCPS.4Support OrdersSupport OrdersCPS.4.1Manage Order Set TemplatesSupport ResultsCPS.4.2Support Medication & Immunization OrdersSupport Treatment AdministrationCPS.4.2.1Support for Medication Interaction & Allergy CheckingSupport Future CareCPS.4.2.2Support for Patient Specific Dosing and WarningsSupport Patient Education &CommunicationSupport Care Coordination CPS.4.2.3& Reporting Support for Medication Ordering EfficienciesCPS.4.2.4Support for Medication RecommendationsCPS.4.3Support for Non-Medication OrderingCPS.4.4Support Orders for Diagnostic TestsCPS.4.5Support Orders for Blood Products and Other Biologics 2011 Health Level Seven International. All Rights Reserved.HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
Population Health SupportPopulation Health Support Focus on input to systems that perform medical research, promotepublic health, & improve the quality of care at a multi-patientlevelPOP.1POP.2POP.3Support for Health Maintenance, Preventive Care and WellnessSupport for Epidemiological Investigations of Clinical Health Within a PopulationSupport for Notification and t for Monitoring Response Notifications Regarding a Specific Patient’s HealthDonor Management SupportMeasurement, Analysis, Research and ReportsPublic Health Related UpdatesDe-Identified Data Request ManagementSupport Consistent Healthcare Management of Patient Groups or PopulationsManage Population Health Study-Related IdentifiersExample child ment, Analysis, Research and ReportsOutcome Measures and AnalysisPerformance and Accountability MeasuresSupport for Process ImprovementSupport for Care System Performance Indicators (Dashboards) 2011 Health Level Seven International. All Rights Reserved.HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
Administration SupportAdministration support Focus on functions to assist with the administrative and financialrequirementsAS.1Manage Provider InformationAS.2AS.3AS.4AS.5AS.6Manage Patient Demographics, Location and SynchronizationAS.7AS.8AS.9Manage Personal Health Record InteractionManage CommunicationManage Clinical Workflow TaskingManage Resource AvailabilityManage Encounter/Episode of Care ManagementManage Information Access for Supplemental UseManage Provider InformationAS.1Manage Administrative Transaction ProcessingManage Provider Registry or DirectoryAS.1.1Manage Provider's Location Within FacilityAS.1.2Example child functions: 2011 Health Level Seven International. All Rights Reserved.HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.AS.1.3Provider's On Call LocationAS.1.4Manage Provider's Location(s) or Office(s)AS.1.5Team/Group of Providers Registry or DirectoryAS.1.6Provider Caseload/PanelAS.1.7Manage Practitioner/Patient Relationships
Record Infrastructure Focus on records, record entries and record management,including R1.1 functions/criteria and key provisions of the RM-ESFunctional Profile, EHR Interoperability and Lifecycle Model DSTUs.Consists of Release1.1’s : IN.2 (Record Management, except Audit),IN.8 (Record Archive/Restore) andIN.10 (Record Lifecycle -RecordInfrastructurepreviously EHR Lifecycle Model DSTU).RI.1.1RI.1Record Lifecycle and Lifespan RI.1.1.1RI.2Record SynchronizationRI.3Record Archive and RestoreExample child functions: 2011 Health Level Seven International. All Rights Reserved.HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM 1.1.7RI.1.1.8RI.1.1.9RI.1.1.10RI.1.1.11Record LifecycleOriginate and Retain Record EntryAmend Record Entry ContentTranslate Record Entry ContentAttest Record Entry ContentView/Access Record Entry ContentTransmit and/or Disclose Record EntriesReceive and Retain Record EntriesDe-identify Record EntriesPseudomynize Record EntriesRe-identify Record EntriesExtract Record Entry Content
Trust InfrastructureTrust Infrastructure Contains the remaining Release 1.1 Infrastructure functions,including AuditRegistry and Directory ServicesStandard Terminology and Terminology ServicesStandards-Based InteroperabilityBusiness Rules ManagementTI.1SecurityWorkflow ManagementTI.1.1 Entity AuthenticationDatabase Backup and RecoveryTI.1.2 Entity AuthorizationSystem Management Operations and PerformanceExample child functions: 2011 Health Level Seven International. All Rights Reserved.HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM ntity Access ControlPatient Access ManagementNon-RepudiationSecure Data ExchangeSecure Data RoutingInformation AttestationPatient Privacy and Confidentiality
Want to Know More? Join HL7, review the HL7 web site Subscribe to HL7 EHR WG list serve http://www.HL7.org/special/committees/list sub.cfm?list ehrDownload and review Functional ProfilesAttend open public sessions www.HL7.org ; Work Groups; Electronic Health ndex.cfmNo HL7 membership requiredRequest an “HL7 Ambassador Briefing” 2011 Health Level Seven International. All Rights Reserved.HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
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Electronic Health Record (EHR) vs. EHR-System EHR: Underlying single, logical patient record Record is structured Serves as Provider legal record EHR System: Software that provides functionality to: Manage and maintain the record Accomplish various clinical, research, and business requirements May be: Monolithic system; or
