1. © 2006 Canada Health Infoway Inc. 1 April 26, 2006 Dennis Giokas Chief Technology Officer Canada Health Infoway Inc. Standards at Infoway Overview for HITSP

2. Outline 2 Introducing Infoway Key Definitions Key Clinical and Business Requirements Solution Architecture Standards for Interoperability Standards Landscape Infoway Standards Collaborative Standards Projects Challenges and Lessons Learned

3. © 2006 Canada Health Infoway Inc. 3 Canada Health Infoway Mission To foster and accelerate the development and adoption of electronic health information systems with compatible standards and communications technologies on a pan-Canadian basis, with tangible benefits to Canadians. To build on existing initiatives and pursue collaborative relationships in pursuit of its mission. Vision A high-quality, sustainable and effective Canadian health care system supported by an infostructure that provides residents of Canada and their healthcare providers timely, appropriate and secure access to the right information when and where they enter into the healthcare system. Respect for privacy is fundamental to this vision. Goal Infoway’s plan is to have an interoperable electronic health record in place across 50 percent of Canada (by population) by the end of 2009. Shared Governance Facilitates Collaboration Canada Health Infoway is an independent not-for-profit organization, whose Members are Canada’s 14 federal, provincial and territorial Deputy Ministers of Health.

4. © 2006 Canada Health Infoway Inc. 4 Infoway’s Role – Strategic Investor Infoway focuses on initial investment in a solution & its deployment. Our unique role is in providing strategic leadership. Funder Intervener Developer “Invest, advise & monitor”  Invests with Partners  Involved in project planning  Monitors progress of projects and quality of deliverables Gated funding manages risk “Work alongside & take over if needed” “Write code & build modules” “Fund & ignore” Strategic Investor Leadership in setting strategic direction and standards for EHR deployment across Canada Infoway is Not  A Granting Agency  A Venture Capital Fund  A builder, direct implementer or holder of proprietary solutions An active partner, contributing to all aspects of the projects, while establishing a broad knowledge & experience base across Canada

5. EHR An Electronic Health Record (EHR) provides each individual in Canada with a secure and private lifetime record of their key health history and care within the health system. The record is available electronically to authorized health providers and the individual anywhere, anytime in support of high quality care. This record is designed to facilitate the sharing of data – across the continuum of care, across healthcare delivery organizations and across geographies. 5 © 2006 Canada Health Infoway Inc.

6. 6 EHR Key Clinical & Business Requirements Patient centric, life-long longitudinal record of clinical data Support for accurate, complete, timely delivery of information Allowing private and secured access to data made available in the EHR Focused on clinically relevant data shared beyond organizational boundaries Shared across multiple organizations, jurisdictions Scalable to allow continuous, extensive growth of clinical information with a ROI More POS applications sourcing data to EHR More users accessing and using data from EHR Towards more physician order entry and decision support Interoperable, integrated Standards based

7. 7 High Level View of the Solution Architecture © 2006 Canada Health Infoway Inc.

8. EHR Infostructure 8 The EHR Infostructure is a collection of common and reusable components in the support of a diverse set of health information management applications. It consists of software solutions to support integration with the EHR, data definitions for the EHR and messaging standards for integration and interoperability. © 2006 Canada Health Infoway Inc.

9. 9 Key EHRS Architecture Concepts EHR SOLUTION (EHRS) EHR INFOSTRUCTURE (EHRi) EHR Viewer Point of Service Application EHRS Locator Longitudinal Record Services Health Information Access Layer (HIAL) Ancillary Data & Services Health Information Data Warehouse EHR Data & Services Registries Data & Services

10. © 2006 Canada Health Infoway Inc. 10 EHRS EHRS In Canada Federated Databases, Peer-to-Peer, Message Based EHR SOLUTION (EHRS) EHR INFOSTRUCTURE (EHRi) EHR Viewer Point of Service Application Ancillary Data & Services Health Information Data Warehouse EHR Data & Services Registries Data & Services Longitudinal Record Services Health Information Access Layer (HIAL) EHR SOLUTION (EHRS) EHR INFOSTRUCTURE (EHRi) EHR Viewer Point of Service Application Ancillary Data & Services Health Information Data Warehouse EHR Data & Services Registries Data & Services Longitudinal Record Services Health Information Access Layer (HIAL)

11. Standards-based Solutions Standardized Architecture Standardized Interfaces Standardized Data Structures Standardized Data Vocabularies Standardized Functional Behaviour 11 © 2006 Canada Health Infoway Inc.

12. 12 Standards-based Solutions Why Standards? They facilitate information exchange; are a critical foundation for EHR They create opportunity for future cost reduction as vendors and systems converge on pan-Canadian and international standards They ease effort required for systems integration Mandatory Investment Eligibility Requirements Compliance to standards (infostructure, architecture) Initiatives must comply with existing guidelines or standards adopted by Infoway Where standards or guidelines do not exist, projects must support longer-term interoperability and congruence of solutions Infoway’s role is to set standards and requirements for robust, interoperable products and outcomes Standards

13. © 2006 Canada Health Infoway Inc. 13 EHR Infostructure: Standards Based Connectivity JURISDICTIONAL INFOSTRUCTURE Ancillary Data & Services Registries Data & Services EHR Data & Services Data Warehouse Outbreak Mgmt PHS Reporting Shared Health Record Drug Information Diagnostic Imaging Laboratory Health Information Client Registry Provider Registry Location Registry Terminology Registry POINT OF SERVICE Business Rules EHR Index Message Structures Normalization Rules Security Mgmt Privacy Data Configuration Longitudinal Record Services Hospital, LTC, CCC, EPR Physician Office EMR EHR Viewer Physician/ Provider Lab System (LIS) Lab Clinician Radiology Center PACS/RIS Radiologist Pharmacy System Pharmacist Public Health Services Public Health Provider HIAL Communication Bus Common Services EHR IP HIAL EHR IP EHR IP Standards EHR SCP Standards

14. © 2006 Canada Health Infoway Inc. 14 Principles for Establishing Pan-Canadian EHRS Standards Infoway has created Principles for Establishing pan-Canadian EHRS Standards to provide guidance in the adoption of standards-based solutions 11 Principles – accessible via the Infoway Knowledge Way Business-driven Adoption of existing standards where ever possible HL7 V3 for all new message development Establishment of pan-Canadian EHR standards is coordinated via an open, transparent and inclusive Stakeholder Collaboration Process as defined by our stakeholders International collaboration and balloting of standards work http://knowledge.infoway-inforoute.ca

15. © 2006 Canada Health Infoway Inc. 15 Canadian Standards Community Standards Organizations Standards Development Organizations (SDOs) Licensing and Maintenance Certification and Conformance Approval and Endorsement Integrators Funders & Investors Complexity of the Standards Landscape

16. © 2006 Canada Health Infoway Inc. 16 Infoway Standards Projects 1- Need Identification & Business Definition 2- Options Analysis & Selection Decision 3- Development & Stable for Use Decision 4- Test/Pilot & Approval 5- Training/Education 6- Implementation 7- Conformance 8- Maintenance & Support Standards Selection Decision Point (e.g. Use existing, adapt, develop) Stable for Use decision point (optional) 1 2 3 4 5 6 7 8 Final Approval decision point Standards Collaborative Program Projects Note: Process is not linear

17. © 2006 Canada Health Infoway Inc. 17 Infoway Standards Collaborative Scope Infoway will be home for development, ongoing operations, SDO liaisons, and pan-Canadian collaboration and coordination of standards Includes collaboration and coordination functions of HL7 Canada, Partnership, ISO (as shared with Canadian Standards Association), DICOM Liaison Scope is standards within Infoway’s mandate for the EHR and eClaims standard (NeCST) Type of standards include: Messaging, Vocabulary and Interoperability Profiles

18. © 2006 Canada Health Infoway Inc. 18 Conformance for pan-Canadian Standards Definition of Conformance Conformance includes the development of pan-Canadian standards business requirements, the conformance testing against these business requirements, and certification. Scope Functional, message level interoperability, privacy and security, usability Infoway and the eHealth Collaboratory will share responsibilities for conformance on pan-Canadian Standards Infoway (Standards Collaborative) will undertake the development of business requirements, including the development of conformance statements, for the pan-Canadian approved standards; The eHealth Collaboratory (Collaboratory) will undertake the building of the conformance testing environment, the development of the testing processes and will undertake the actual conformance testing against the established business requirements.

19. © 2006 Canada Health Infoway Inc. 19 Infoway Standards Collaborative Functional Model Group Director Governance Standards Collaboration Process Support, Conformance, Maintenance Education, Training, Events Standards Development SDO Secretariat & Liaison Complete to approval Test/pilot Stds. Maintenance Implementation support Conformance/Certification Change Management SNOMED LOINC Others terminologies Structural codes for iEHR OIDs Artifacts repository Training artifacts Training services Train-the-trainer Marketing/Communications Partnership HL7 Canada education IHE Canada education HL7 Inc. IHE ISO SNOMED LOINC DICOM HL7 Canada IHE Canada CAC/Z295 Distribution and Rights Management HISCs Example – not meant to represent any organizational model CTO Strategy Development Investment oversight Approvals – Investment deliverables Compliance (gated funding) Benefits Evaluation Adoption

20. © 2006 Canada Health Infoway Inc. 20 Standards Collaboration Process (SCP) The EHR Standards Steering Committee which leads and approves pan-Canadian EHR information standards within the context of Infoway investment programs The EHR Standards Advisory Committee which recommends information standards for approval by the EHR Standards Steering Committee and coordinates and guides the activities of pan-Canadian Standards Groups A number of pan-Canadian Standards Groups that guide the standards requirements of individual Infoway programs An expert group of resources available to provide cross-program technical and subject matter expertise in standards

21. © 2006 Canada Health Infoway Inc. 21 Standards Portfolio Architecture Standards EHRS Blueprint EHR Use Cases EHR Data Model EHR Services Model EHR Interoperability Profiles Data & Messaging Standards eClaims (Primary Care, Oral, Vision, Chiro/Physio) HL7 v3 (complete) Client Registry HL7 v2.4 & HL7 v3 (complete) Provider Registry HL7 v3 (in ballot) Drug Information Systems HL7 v3 (in ballot) Laboratory HL7 v3 (in development) Diagnostic Imaging/Teleradiology DICOM, IHE (complete) iEHR Clinical Messaging HL7 v3 (in development) iEHR Technical Standards (in planning) Public Health Standards HL7 v3 (in development) Clinical Terminology Strategy (complete) Terminology Standards (SNOMED, LOINC, ICD10-CA, CCI)

22. © 2006 Canada Health Infoway Inc. 22 Standards Projects – Typical Deliverables Business Requirements Use Cases Standards Specifications Messaging schemas Codesets IHE Profiles Implementation Guide Training, Marketing Materials; White Papers; Project Governance Artifacts (project reports, decision criteria)

23. © 2006 Canada Health Infoway Inc. 23 Lessons Learned & Key Challenges Standards Collaboration Process is a success! Stable for Use Standards and Selected Standards Strategies in 1 year Active engagement and collaboration across the country and internationally Needed additional decision points along the Standards Life Cycle Appropriate level of detail and amount of information to make decisions is different for different committees Translating between technical and business “speak” Stakeholder and expert overburden Being very clear and specific on what decisions and words mean E.g. select vs adopt vs mandate Standards readiness – for test/pilot, for implementation projects Policy and EHR implementation issues versus standards issues One strategy or one development methodology doesn’t fit all

24. © 2006 Canada Health Infoway Inc. 24 Website:www.infoway-inforoute.ca E-mail:dgiokas@infoway-inforoute.ca Thank you!

25. © 2006 Canada Health Infoway Inc. 25 Client Registry StandardBusiness FunctionsKey Dates Messaging : HL7 v2.4 & v3.0 Vocab: HL7 Domain Tables EIP: Currently Available at: 1.Messaging Package Overview 2. Implementation Guide, 3.V2.4 Conformance Profiles, 4.Client Registry Schemas http://forums.infoway- inforoute.ca/RC502/C RPCSG/CR- pCSG_Materials/?14@ 350.H1QfatHDaqq.5@ 1.Add Client – to a registry 2.Update Client – to data in a registry 3.Delete Client – to delete a client record added in error to a registry 4.Link Client – linking of two records (both records remain active) 5.Unlink Client – the unlinking of two records in a registry 6.Merge Client – merging of two records 7.Unmerge Client – unmerging of two records 8.Get Client Demographics Query Request – to request demographic data when the client identification is known 9.Get Client Demographics Query Response 10.Query Client – list of clients matching query parameters 11.Query Client Response International HL7 PATC Committee Ballot – passed Sept 2005 HL7 Membership Ballot – due Jan06 ISO-TC215 “Subjects of Care” – harmonized IHE Integration Profiles (PIX/PDQ) being re-purposed for HL7v3 – approved for 2006 Roadmap National HL7 Canada – Realm localization ballot reconciliation March 2006 Stable for Use approval by SSC March 2006. SAC Approved as Stable for Use January 2006 All Review cycle documents: http://forums.infoway- inforoute.ca/RC502/SCP%20Review%20C ycle%20for%20CR/?14@395.31XEatitaCw. 1@

26. © 2006 Canada Health Infoway Inc. 26 Provider Registry StandardBusiness FunctionsKey Dates Messaging: HL7 v3.0 Vocab: Provider Role Types, HL7 Domain Tables EIP: Currently Available at: 1.Messaging Package Overview 2. Implementation Guide, 3.Provider Registry Schemas http://forums.infoway- inforoute.ca/RP502/PR PCSGG/PR- pCSG_Materials/?14@ 494.X1Izatw1a1u.3@ 1.Add Provider/Request Confirmation Response 2.Add Provider Notification (Broadcast) 3.Revise Provider Notification (Broadcast) 4.Revise Provider Request/Confirmation Response 5.Provider Details Query/Provider Detail Response 6.Find Associated Identifiers Query/Response International HL7 PMTC Membership Ballot – passed Sept 2005 National HL7 Canada – Realm localization ballot reconciliation March 2006 Stable for Use approval by SSC March 2006. SAC Approved as Stable for Use January 2006 All Review cycle documents: http://forums.infoway- inforoute.ca/RP502/SCP%20Review%20Cy cle%20for%20PR/?14@538.v1nrauvQawj.1 0@ http://forums.infoway- inforoute.ca/RP502/SCP%20Review%20Cy cle%20for%20PR/?14@538.v1nrauvQawj.1 0@

27. © 2006 Canada Health Infoway Inc. 27 CeRx (Drug) StandardBusiness FunctionsKey Dates Messaging: HL7 v3.0 Vocab: Investigating HL7 Domain Tables, CCI, DIN, Encode FM, LOINC, Anatomical Therapeutic Classification, Investigating SNOMED CT, Uniform Codes for Unit of Measure, IETF RFC 1766, Mime Media Types, URLSchema, Active Ingredient Code EIP: Currently Available at: Sept 2005 Version – 4 zip files – 1.Messaging Overview 2. Implementation Guide, 3.Schemas 4.Vocabulary 5.Technical & Business artefacts http://forums.infoway- inforoute.ca/CeRx/CeRx_Discuss/Ce Rx_Materials/Specs/V01_20050921/? 14@538.v1nrauvQawj.27@ Core Prescribing and Dispensing Functions 1.Prescribing 2.Dispensing 3.Patient Medication Queries 4.Prescription Status Management 5.Support (Generic Undo) 6.Updates (Notes) 7.Clinical Access Control Related EHR Data with Drug Domain Significance 8.Allergy/Intolerance 9.Medical Conditions 10.Basic patient Observations 11.Immunization Leverage Drug Knowledge Bases 12.Drug Queries 13.Contraindications Related Functions 14.ADR 15.Professional Service 16.Infrastructure International HL7 Pharmacy SIG – Committee Ballot for core CeRx items - Jan 2006 National Implementable Specifications Published Dec 2005 Approval as Stable for Use Spring 2006

28. © 2006 Canada Health Infoway Inc. 28 Cross Enterprise Document Sharing for Imaging EHR Interoperability Profile (XDS-I) StandardBusiness FunctionsKey Dates Interoperability Profile: XDS-I EIP: Currently Available at: 1.XDS-I White Paper Final 2. DI-TR pCSG Use Case Scenarios v4 Final 3.2 Technical Review artefacts http://forums.infoway- inforoute.ca/DI/SCP%20Review%20P eriod%20for%20XDS- I/?14@325.w2bqaoGpaox.1@http://forums.infoway- inforoute.ca/DI/SCP%20Review%20P eriod%20for%20XDS- I/?14@325.w2bqaoGpaox.1@ XDS-I Interoperability Profile specifies a solution for sharing imaging documents, specifically  Medical Images in DICOM format  Medical Images in JPEG format  Radiology reports in plain text and PDF format  All other DICOM objects The objective of this interoperability profile is to address the technical challenges of sharing images and reports between operational Picture Archiving and Communications Systems (PACS) and Radiology Information Systems (RIS). The interoperability profile standardizes the format, transactions and protocols for communcationg imaging information between systems as well as defines the interoperability expectations with client registries. International IHE International Approval August 2005 IHE Vendor Connectathon – Jan 2006 National Implementable Interoperability Profile XDS-I Published Nov 2005 SCP Review – SSC Approval as Stable for Use March 2006

29. © 2006 Canada Health Infoway Inc. 29 Laboratory StandardBusiness FunctionsKey Dates Messaging: HL7 v3.0 Interoperability Profiles Vocab: HL7 Domain Tables, LOINC, SNOMED CT, SI Units and others that will be identified as the project progresses EIP: Blueprint EIPs supported will be identified during the project Will be Available at: http://forums.infoway- inforoute.ca/Labs/?14@337.k2oVaoal aAS.3@ For the exchange of lab information between LIS-JLIS-EHR:  Order Requests, Referral of Orders, Redirect of Orders, Revise Orders, Cancel Orders, Order Promises, Order Status, Filler Orders, Unsolicited Results, Query Results, Result Query Response, Result Status International HL7 Balloting Mid 2006- Spring 2007 National Implementable Specifications Published Fall 2006 SCP Review – SSC Approval as Standard Selection Strategy March 2006 Stable for Use approval of specification – Fall 2006

30. © 2006 Canada Health Infoway Inc. 30 Public Health Surveillance StandardBusiness FunctionsKey Dates Messaging: HL7 v3.0 Interoperability Profiles Vocab: HL7 Domain Tables, SNOMED CT, CCI, ICD10-CA, Free Text, and others that will be identified as the project progresses EIP: Blueprint EIPs supported will be identified during the project Will be Available at: Infoway Knowledgeway http://knowledge.infoway- inforoute.ca/CHIPortal/Home/ 58 Transactions in 5 packages:  Package 1: Case & Outbreak Management  Package 2: Immunization Management  Package 3: Vaccine & Materials Management  Package 4: Alert Management  Package 5: Other International HL7 Balloting Mid 2006- Early 2007 National Specifications Published December 2006 Stable for Use approval of specification – Early 2007

31. © 2006 Canada Health Infoway Inc. 31 iEHR Standards Project StandardBusiness FunctionsKey Dates Messaging: HL7 v3.0 Vocab: HL7 Domain Tables, SNOMED CT, CCI, ICD10-CA, Free Text, and others that will be identified as the project progresses EIP: Blueprint EIPs supported will be identified during the project Will be Available at: Infoway Knowledgeway http://knowledge.infoway- inforoute.ca/CHIPortal/Home/ Package 1 Encounter History Discharge Summary Package 2 Clinical Summary Service Delivery Location Package 3 Observations Referral Notes Health Conditions International HL7 Balloting Mid 2006- March 2006 National Implementable Specifications Published Summer 2006 Stable for Use approval of specification – Fall 2006

32. © 2006 Canada Health Infoway Inc. 32 Clinical Terminology Integration Project StandardBusiness FunctionsKey Dates Messaging: none Interoperability Profiles Vocab: SNOMED CT, CCI, ICD10-CA, Free Text EIP: Information Currently Available at: http://forums.infoway- inforoute.ca/CTI/?14@286.P3naa3toa rf.4@ Selected Terminologies for:  Diagnosis, State of Diagnosis, Family History, Genetic Condition, Non-Drug Agent Adverse Reaction., Non-Drug Offending Agent Type, Non- Drug Offending Agent Description, Severity relating to Non-Drug related Severities of Adverse Reactions, Allergy: Non-medication Allergy, Risk Factor, Exposure, Intervention, Clinical Symptom / Health Problem (Clinical Finding), Physical Assessment Finding, Psychological/Mental Assessment, External Cause, Place of Occurrence, Anatomical Site, Episodicity, Course, Occurrence, Number, Onset, Patient Health Problem International National SCP Review – SSC Approval as Standard Selection Strategy March 2006