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Certification and Conformance Approaches for Canada’s EHR Elaine Sawatsky, Senior Management Consultant, Privacy & Security, Canada

Certification and Conformance Approaches for Canada’s EHR Elaine Sawatsky, Senior Management Consultant, Privacy & Security, Canada

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  • Certification and Conformance Approaches for Canadas EHRElaine Sawatsky, Senior Management Consultant, Privacy & Security, Canada

  • Conformance: Canadas EHRInfoway Conformance Services in Canada

    Supporting the Implementation of pan-Canadian Standards

    Provincial/Territorial work

    On the ground experiences

  • Conformance: Canadas EHRSharing information requires a quality assessment of products to ensure interoperability, to reduce risk to patients, purchasers and the system. Standards support sharing data and bringing it togetherImproves comparability and harmonisation between products.Certification: a process of validation of products in a given context against specific validation criteria.Certification criteria are even regarding the same functionality up to a certain degree similar but also different between jurisdictions in:The way they are formulated & validatedThe importance given to each of themCertification should be unambiguous, fair and trustworthy

  • Conformance Services Vision

    To support the successful implementation of pan-Canadian Standards within projects through the provision of conformance testing artefacts and tooling.To improve the consistent implementation of pan-Canadian StandardsTo reduce the effort required to implement pan-Canadian StandardsTo reduce the cost of implementing pan-Canadian StandardsStrategic Intent of Conformance Services:Ensure that there is a national service to support the vendor conformance and certification of iEHR, public health and EMR solutions.

  • SK EHR Blueprint and Concepts

    Provincial Infostructure

    Point-of-Service (POS) Infostructure

    Registries Data & Services

    Data Warehouse

    EHR Data & Services

    Ancillary Data & Services

    Client Registry (SCI)

    Provider Registry (PRS)

    Location Registry


    Outbreak Management

    Shared Health Record

    Drug InformationPIP

    Diagnostic Reports & Imaging PACS

    Lab RepositorySLRR

    PHS Reporting

    Health Information

    Surgical Care Registry

    POS Infostructure will continue to evolve as future needs are identified





    Modified: October 2, 2006


    User Registry

    SecurityManagement Data





    Organizational Infrastructure

    Access Systems

    Long Term Care (MDS)

    SK Cancer Agency

    Clinical Management Service (Varian)

    Prov Lab

    Lab (LIMS)


    Regional Systems

    Drug (WinPharm, RxTFC, PCSI)

    Lab (TriWin, SCC)

    Clinical Information System (SCM)

    Regional ADT(WinCIS, Enovation)

    Health Records (WinRecs, 3M)

    Home Care(Procura)

    Surgical (SIS)

    Transcription (WinCIS, HealthSuite,...)





    Radiology (RIS)

    Public HealthImmunizationPublic Health Surveillance

    RHA Integration Hub (Cloverleaf)

    Primary Health CareChronic Disease Mgmt. (CDM)

    Clinical Viewer (SCM)Provincial Medication ProfileProvincial PACSProvincial Lab Results

    Vendor PoS

    Community PharmaciesMedication Profile

    Clinical EMRsPrimary Health Care (PHC)LABMedication ProfileShared Health Record (SHR)

    eHealth Portal

    EHR DesktopLab Results (SLRR)Medication Profile (PIP)DI Image & ReportsShared Health Record (SHR)Public Health Surveillance (PHS)Client Id. (SCI)Health Insurance (PHRS)Provider Id. (PRS)Wait List (Surgical Care)

    Individual Viewers

    Client ID Viewer (SCI)

    Health Insurance Viewer (PHRS)

    Medication Profile (PIP)

    Diagnostic Imaging Viewer (PACS)



  • The need: Bridging The GapThe challenge is to bridge the gap that exists between the health informatician (modeler) and the clinical integration specialist (solution developer). EHR in OperationHealth InformaticsModelerIntegration SpecialistModeling CultureDelivering SpecificationsProject and Product CultureDelivers Production SolutionsStandards DevelopmentStandards Implementation, Conformance & MaintenanceTooling*

  • Conformance: Canadas EHR

  • Conformance: Canadas EHRApproachThere is recognition that there is a need for conformance testing to ensure alignmentThe approach is founded on international standards

    Prototype & Learn conformance testing is not well understood yetBuild Methods & Processes with stakeholder input Build tooling & leverage : Standards HL7 v3, LOINC, SNOMED, XDSIToolingComponent model integration is key!Sharing of testing artefacts huge value to stakeholders

  • Conformance: Canadas EHR

    Key Messages

    There is recognition that we all need to do end to end and integrated testingWe are committed to leveraging work of others We are making good progress in developing processes and tooling to assist our jurisdictions in implementing Conformant solutions

  • Conformance ContinuumConformance includes:Message content and structureVocabulary and terminologyInteroperability profiles and message sequencingSending and receiving applications and intermediaries

    Conformance Testing includes:Functionality of applicationBasic privacy and security services related to the functionalityWorkflow (to an optimal level determined by conformance continuum)*

  • Our ApproachFirst, develop Profiles for all pan-Canadian standardsDevelop a process & mechanisms linking the pan-Canadian Profiles through to conformance test Develop, deploy, continuously improve quick-hit toolsProvide business and technical support for Investment Projects to set up and execute conformance testingDocument & refine requirements for long-term solutionHarvest artefacts for sharing with other jurisdictionsRationalize jurisdiction artefacts to create pan-Canadian versionsEstablish a pan-Canadian Working Group of early participant jurisdictions and their vendor partners to provide guidance and assistance in the development of Conformance Testing artefacts

  • EvaluationAdoptionStrategiesTools andTemplatesStandardsKnowledgeManagementLiaisonPromotion & CommunicationLicensesChange ManagementStandards Selection StrategyStable for UseFinal ApprovalOur Approach

  • Conformance: Canadas EHRBenefits:Financial savings through reduced duplication of efforts in test authoringProvinces leverage other provinces Business RulesFinancial savings though tools based test message developmentProvinces use Infoway tools and other provinces messagesBreadth of testing improved through increased quantity and quality of test casesProvinces are committed to sharing test artefacts.

  • Conformance: Canadas EHRBenefits:Depth of testing improved through consistent test rules and toolingProvinces use of tooling has improved UAT testing Too early to accrue benefitsQuality and consistency of conformance testing improved between Investment Projects Too early to accrue benefits

    Improved consistency in Investment Project implementations of pan-Canadian standards Too early to accrue benefits

  • BenefitsProviding Implementation support for the development of Test Authoring and Test Execution will enable jurisdictions to leverage and share Conformance Profiles and testing artefacts, leading to:Improved quality of testingFinancial savings through reduced duplication of effortsBreadth of testing improved through increased quantity and quality of test cases Improved quality and consistency of conformance testing Financial savings though tools based test message developmentDepth of testing improved through consistent test rules and toolingImproved consistency in implementations of pan-Canadian standards

  • Conformance: Canadas EHRConformance Services OverviewMain elements influencing content of test criteria:Legal, national, cultural (business and social)Sophistication of the industry areaEnvironmentCertification is the processConformance is the resultMust be good enough, not best or everyone will failArea subject matter experts what will the medical professional need?

  • Stakeholder EngagementGovernanceCollaboration on Test Authoring componentsCollaboration on supporting tools development and implementationRegistry of vendor systems & certification status Registry of implementation projectsOngoing liaison/communication with jurisdictions and vendorsPromotion and Education around Conformance ServicesOverview of Conformance Services *

  • Strategic Direction Analysis ProjectProject Objective:Develop a preferred option for the future delivery of Conformance Services. Define and identify existing conformance services models;Develop a shared vision for the delivery of Conformance Services for the Canadian healthcare sectorDevelop conformance services delivery options for the Canadian healthcare sector; and detail the preferred option. Defined Strategic Intent of Conformance Services:Ensure that there is a national service to support the vendor conformance and certification of iEHR, public health and EMR solutions. *

    RFP ReleaseFebruary 15 08Project StartMarch 15 08Draft recommendationsJune 30 08Final Recommendations AvailableAugust 30 08

  • Investment Project Support Overview Project Objective:Provide immediate Standards Implementation Support for Test Authoring & Test Execution to key Infoway Investment projectsProject Approach: Develop a process & mechanisms linking the pan-Canadian Profiles through to conformance testDevelop, deploy, continuously improve quick-hit toolsRollout to qualified projects (if proof of concept successful)Harvest artefacts for sharing with other jurisdictionsProvide lessons learned and input into CS Strategic Direction ProjectProvide transition and support to recommended Strategic Direction*

    Project Kick-offNovember 1 07Proof of concept (2-3 projects)March 31 08Proposed Project Extension:Limited rollout (4-6 projects)September 08

  • Investment Project Support ActivitiesThe specific services that Infoway is offering to assist projectsAssistance in developing test strategiesSort out overlap between conformance testing vs. UAT Education on development of business rules & test casesTechnical education on development of message instances and test dataSharing of testing artefactsQuality review of artefacts developed by investment projectsFull set of tools to assist getting to Conformance Testing Assistance to jurisdiction in rationalizing and integrating their testing tools with Infoway conformance toolsHarvesting of testing artefacts for sharing with jurisdictionsSharing of Lessons LearnedFacilitating inter-jurisdiction collaboration on conformance testing *

  • *Engagement Process to ConformanceTest case Examples

    HarvestedartefactsEnd to EndTest AuthoringExamplesJurisdiction Test ArtefactsToolsEnd to EndTest ExecutionExamplesJurisdiction Test Authoring ArtefactsJurisdiction still needto complete, but ready to perform ConformanceTestingOngoing Harvesting

  • *Conformance Constructs End-to-End ProcessJurisdictionInputBestPractice

  • Conformance: Canadas EHRMajor Tooling ComponentsBusiness Rules Manager- Maintains Business RulesConformance Profile Manager - browse pan-Canadian Conformance ProfilesImplementation Conformance Profile Manager - browse profiles and create/maintain ICPsStatic Model Constraint Tool - captures changes to models, and traceability informationInstance Editor - creates Conformance Test Scenario Files, Message Fragments and Parameter Files as XML output. Test Case Author - Maintains Test CasesTest Authoring Manager - The main user interfaceTest Execution Manager - links the Test Authoring Manager to control the test executionTest Authoring Reports Manager - run reports

  • Conformance: Canadas EHRConformance Test Execution ScenariosThere are different ways to perform Conformance Test Execution. This process uses the pCCT Test Execution manager and / or the HL7 Test Harness to allow the user to test both POS and iEHR systems as real or simulated applications under test.

    Scenario 001 - Real POS with Simulated iEHR Application Scenario 002 - Simulated POS with Simulated iEHR Application Scenario 003 - Simulated POS with Real iEHR Application Scenario 004 - Real POS with Real iEHR Application

  • Lessons Learned Considerations for AB

    Testing artefact reuse is seen to be a big winOne province has 100 business rules & 300 test cases target is 500-700 test casesAnother target will be significantly higher (~2,500 test cases)Others will leverage oand likely add moreToolset are not all or nothingOne province using blend of Infoway tools and home grownUses Infoway tools and processes first to perform testing then conformance testing of PoSOne province using Infoway tools for go forward & PoS testingSpecific initiatives will likely use blend

    Infoway is investing in tools so jurisdictions dont have to!

  • Conformance: Canadas EHRTooling VisionCreate a suite of integrated Conformance Test tools based on Open Source principles and accepted pan-Canadian standards that allows jurisdictions, and vendors to perform conformance testingIncludes:Well documented processes and proceduresA repository of structured conformance profiles, test cases, test data and business rules that can be reusedA suite of re-usable conformance testing solution components able to easily exchange structured data between each component and projectsAn Enhanced Web Based Presence to allow remote administration, self registration, shared resources management, self testing / monitoring and publication of results

  • Lessons Learned Considerations for ABMany jurisdiction projects have left UAT & Conformance Testing until very late in their project lifecycleThere is not a clear understanding of the continuum of conformance testing Profile Business rules Test cases Messaging Conformance testTraceability is key to conformance testProfile Business rules Test cases Messaging Conformance testUsing Profiles to help them define user rolesWhat does a physician do vs. project focusTools can and are providing immediate benefit to jurisdiction projects for publishingConsolidated view of all business rulesPublication of specification for vendor*

  • Conformance ProfilesPan-CanadianConformance Profile (pCCP)ImplementationConformance Profile (ICP)pCCPExtensionConstraintExample:BC ICP #84#84BC ExtensionsBCConstraintLikelyInitial StateDesiredState

  • Conformance: Canadas EHRTooling for Test Authoring Components (TAC)Use prototyping methodology to conduct staged development Test with jurisdictional review and input Document processes, requirements and changesGarner feedback and experience to inform the refinement of detailed specifications for long-term open source tooling development Address immediate jurisdictional needs & provide tangible benefitsAll test artefacts exportableWork with jurisdictions to rationalize and integrate tooling Align test cases, business rules across jurisdictionsPromote early sharing and leveraging of work by jurisdictions

  • Conformance: Canadas EHRTooling for Test ExecutionLeverage an existing open source test harness (previous Infoway investment), adding ability for jurisdictions to easily configure to reflect local technology solutions such as transport and securityLeverage Eclipse Instance Editor for message and vocabulary creation Use data exported from test authoring toolsKey is to ensure tools export into a format that can be consumed by HL7 Test HarnessInvest in documenting processes, requirements, integrationRationalize and integrate toolsDevelop guidelines for local Test Execution prototyping environments including a reference implementationDevelop processes to ensure data integrity between different groups of users during prototyping phase

  • Conformance: Canadas EHRIts not easy:In order to get to a conformance test, you need to start with the Profile, know what the business rules are and create test data and message instances that will then test a scenario

    Once you have done this for every business and technical scenario, only then can you think about performing a conformance test

    By our simple calculations, this will be thousands and thousands of test cases!

  • 0 Step 0 Engagement1 Step 1 Workshop2 Step 2 Activities3 Step 3 Workshop4 Step 4 Activities5 Step 5 WorkshopPlannedScheduled/UnderwayCompleted 0,1004,50,1,2,3Panorama00,100,10*13-Mar-08Conformance Services Activity in Canada

  • Conformance: Canadas EHRProvinces have done functional Certification for EMRs specifically. Other certification means defining differences in function, scope, perspective (e.g. Social interaction between users, staff and patients), Legal requirements are different between provinces, policies are different: Infoway cannot set policy but provinces must Provinces must work in collaboration with Health Authorities and professional bodies. Conformance criteria will be different from one business environment to another.

  • Conformance: Canadas EHRWork is based on existing provincial modelsEstablish business rules to support policy set by Ministries of Health, College of Physicians and Surgeons and College of PharmacistsPublish compliance specifications that include all the transactions needed at the point-of-service (e.g. pharmacy claims, pharmacy prescriptions, Client Registry, Provider Registry, Common, Lab, Immunization, etc.)Provide support to vendors during their developmentConduct compliance testing of vendor software once they pass a pre-testSupport change agents (chain stores, vendors, etc.) during their training and deployment activities

  • Conformance: Canadas EHRPOS Software Compliance PrinciplesPOS systemsMust enhance patient safety & Supportclinician workflowMust be secure and ensure privacy of patient medical recordsMust support interoperability standardsAre integral in creating and maintaining quality data for use throughout the health care systemPOS vendors must be able to differentiate their productsCompliance documentsAre referred to in some provinces legislationCommunicate what rules need to be followed, not how the rules are implemented in vendor softwareProvide one place to house Ministry policy, College rules and application capabilitiesProvide a level playing field for all vendors regardless of size

  • Conformance: Canadas EHRPOS Conformance SpecificationsDefine Business rulesBased on existing business rules from compliance documents and input from Clinical Working GroupIdentify items that need further clarificationDevelop Compliance specificationsBased on existing compliance documents and published message specifications from InfowayBuilds on Infoway Conformance Profile definitionsLeverage, where possible, work from other jurisdictionsMaterials include:POS Software Vendor Compliance specifications;Vendor registration and development support processes;Compliance testing process;Process for approving vendors with compliant softwareStakeholders included in joint review of material prior to publishing

  • Conformance: Canadas EHRCompliance Lessons LearnedIt takes time for the vendors to develop code to the level that warrants compliance testingVendors may present software that was not stable enough to warrant compliance testingVendors can require multiple attempts at compliance testingThorough compliance testing takes time, especially on the very first test of new software or a major release changeGood rules are needed on what constitutes an initial test and a follow-up test for each version of the vendor softwareGood rules are needed on when penalty and charges are applied to the test

  • Conformance: Canadas EHRSample tests were provided for vendorsFocus needed to ensure that the vendors could prove they ran the tests and the tests worked before scheduling a compliance testingNeed mechanisms to ensure compliance team provided consistent responses to all vendors throughout the compliance support processGood rules are needed around mandatory training that a vendor must provide e.g. training plans, training outcomes, etc.Good test facilities are needed for vendors and for compliance testingMultiple training environments are needed for each vendorGood tools are needed for the compliance testers that assist them in developing the test cases and support them during the testing

  • Conformance: Canadas EHRClinical guidance was critical during vendor development and compliance testing to clarify options and workflowRequires ongoing clinical involvementSpecifications, clinical guidance and support needs to include detailsCompliance team requires good communication and negotiation skills and need to be able to stand their ground under pressureCompliance documentation needs to be targeted to specific audiences and also clearly identify elements common across audiencesA tool that enables easy linking and/or packaging of modules is highly desirable. Documents that are difficult to maintain dont get maintainedBusiness context for the compliance material is just as important as the rules themselves

  • Conformance: Canadas EHRConformance includes:Message content and structureVocabulary and terminologyInteroperability profiles and message sequencingSending and receiving applications and intermediaries

    Conformance Testing includes:Functionality of applicationBasic privacy and security services related to the functionalityWorkflow (to an optimal level determined by conformance continuum)

  • Contact

    Standards Collaborative Information Desk Bureau d'information de l'Unit collaborative de normalisation dInforoute 1-877-595-3417 or 416-595-3417 [email protected] or [email protected]

    [email protected] and Security, SME

  • Holding slide

    *I will not spend a lot of time on this, just to point out that within each of these boxes, tubes and lines there is a need for decision points that have rules and consequences. When integrating information from multiple sources it will be necessary to normalize the data in such a way as not to change the meaning but to reflect it in standardized format. These require Business/clinical input and agreement. Those who create the data and those who are consumers of the data will need to agree on this common platform for presentation of the data.Within the context of this slide, our project is focused on trying to bridge the gap!Our project is focused on working with jurisdictions to understand how to bridge the gap********Introduction Workshop on project, approach and tools why we always do things the way we do things (Done for SK, NL Dec 12th)Two day Workshop Test Authoring Component (TAC) FocusedHow to create a test case end to end Business process focusedHow to use Quick-hit tools to create testing artefacts note: you dont get the tools unless there is commitment on both sides to success!Jurisdiction Test Authoring Development (time boxed to 15-20 days develop for breadth and depth, not 100%)Jurisdiction development of test casesInfoway business and technical supportRegular bi-weekly checkpoint meetings/progress reviewScheduling of Test Execution Component (TEC) WorkshopTwo day Workshop TEC FocusedHow to import TAC artefacts into PEI Test HarnessHow to use PEI Test Harness to execute a conformance testJurisdiction TEC set up & testing (time boxed to 15-20 days develop for breadth and depth, not 100%)Jurisdiction set up; import of test cases into TECJurisdiction set up of vendor test environment & testingInfoway business and technical supportRegular bi-weekly checkpoint meetings/progress reviewJurisdiction Pilot testing of vendorJurisdiction execution of pilot of conformance testing with vendorInfoway business and technical support (3-5 days)

    Rationale for tooling approachTools to demonstrate and refine requirements quicklyLeverage existing tools (PEI HL7 Test Harness, Eclipse Instance Editor)Meets immediate needs of implementations Content easily imported, exported & migrated Allows integration with jurisdiction UAT, or other automated testing toolsInform long-term tools development approach & requirements

    *Conformance ProfilesThe initial set of pCCPs have been developed by Infoways Subject Matter Experts (SMEs) based on the Conformance Framework Principles as well as knowledge of existing jurisdictional development projects pCCPs are defined at the level of building blocks to facilitate the bundling or grouping of one or more Conformance Profiles in an application pCCPs to be reviewed with jurisdictions and through SCWGs over the next weeks/month