Didi Davis, HIMSS Senior Director, Informatics/IHE International

1. Introduction to Integrating the Healthcare Enterprise (IHE)and IHE’s contribution to standards harmonization for the Nationwide Health Information Network Didi Davis, HIMSS Senior Director, Informatics/IHE International

2. What is Standards Harmonization? Healthcare is a complex multi-specialty multi-stakeholder system. Multiple standard development organizations are necessary. Challenge is to achieve “interoperability” while implementing multiple standards to meet a broad range of information exchange needs: Application-to-application System-to-system Setting-to-setting Coordinate adoption of standards to meet clinical and administrative Use Cases Identify the key interoperability problems they face Providers and industry work together to develop and make available standards-based solution 2

3. Standards: Necessary…Not Sufficient • Standards are • Foundational - interoperability and communications • Broad - varying interpretations and implementations • Narrow - may not consider relationships between standards domains • Plentiful - often redundant or disjointed • Focused - standards implementation guides typically focus on a single standard Need a standard process for implementing multiple standards

4. What is “Integrating the Healthcare Enterprise”? • A 9-year public-private initiative • Driven by end-users, IHE improves patient care by harmonizing electronic health information exchange • Enables approved standards to seamlessly pass health information among care providers on a local, regional and national level • IHE Frameworks are freely available to all • The IHE Global Standards Adoption process as approved by the International Standards Organization (ISO) as a Technical Report 28380 in August 2007

5. How does IHE work? • Clinicians and IT professionals identify key clinical and business workflow problems • Clinicians, IT professionals, consultants, and vendors jointly solve those problems by standardizing the way existing standards are implemented in HIT products • IT professionals follow the IHE guidelines in purchasing and integrating effective systems

6. Who’s involved in IHE? • Users - Clinicians, Staff, Administrators, CIOs, Gov’t agencies (e.g. NIST, VA, DoD, CDC, CMS) • Professional Societies representing 270,000 individual members: • HIMSS, RSNA, ACC, ACP, AAO, ACCE, ASTRO, etc • Standards Development Orgs (SDOs): • HL7, DICOM, ISO, CDISC, ASTM, W3C, IEEE, IETF, etc • Vendors & consultants (e.g., imaging, EHRs, cardiology, medical devices)

7. Integrating the Healthcare Enterprise “Achieving Interoperability through Implementation of Standards” 1997: Founded in Radiology (RSNA) and IT (HIMSS) • Many professional societies (stakeholder representation) • American Academy of Ophthalmology (AAO) • American College of Cardiology (ACC) • American College of Physicians (ACP) • American College of Clinical Engineering (ACCE) • American College of Emergency Physicians (ACEP) • American Society for Therapeutic Radiation Oncology (ASTRO) • GMSIH (IT France), JAHIS (IT Japan), SFIL (laboratory) • Healthcare Information Management Systems Society (HIMSS) • Radiological Society of North America (RSNA) • And many more….

8. Who benefits from IHE’s work? • Patients • Enhance care’s quality, safety, efficiency & effectiveness • Clinicians • Improve workflow & information reporting • Fewer error opportunities; Less repeated work • Vendors & Consultants • Satisfy customers’ interoperability demands • Decreased cost & complexity of installation & mgt • SDOs • Rapid feedback to address real-world issues • Establishment of critical mass and widespread adoption • Government • Reduced costs of implementing EHR systems • Increased patient information interoperability

9. IHE International Board Global Development Regional Deployment IHE North America IHE Asia-Oceania China Japan Radiology IT Infrastructure Laboratory Canada USA Korea Taiwan Cardiology Patient Care Coordination Pathology IHE Europe Radiation Oncology Patient Care Devices Eye Care Netherlands France Germany Italy Public Health, Quality and Research Spain UK Norway Sweden Professional Societies / Sponsors ACC ACP HIMSSRSNA Contributing & ParticipatingVendors GMSIH SFRSFIL ACCE COCIR EAR-ECR DRG SIRM BIR EuroRec ESC JAHISJIRAJRS METI-MLHW MEDIS-DCJAMI IHE Organizational Structure

10. International Growth of IHE Australia Netherlands Germany Norway Canada Austria Taiwan France Japan Korea China USA Italy UK Spain 2005 2006 2000 2007 1999 2001 2002 2003 2004 2088 • Local Deployment • National Extensions • Promotional & Live Demonstration Events • Funding Pragmatic global standards harmonization + best practices sharing 10

11. Proven Standards Adoption Process Testing at Connectathons IHE Demonstrations Develop technical specifications Products with IHE Identify available standards (e.g. HL7, DICOM, IETF, OASIS) Document Use Case Requirements Easy to integrate products Timely access to information

12. National and Regional Projects Using IHE Profiles Lower Austria Austria Netherland Amsterdam Italy (Conto Corrente Salute) UK CfH (Radiology WF) Denmark (Funen) Italy (Veneto) Spain (Aragon) FranceDMP Quebec, Ontario,Alberta, British ColumbiaCanada Health Infoway VITL-Vermont Boston Medical Center - MA Philadelphia HIE CPHIC – Pennsylvania CareSpark – TN & VA South Africa THINC- New York NCHICA – N. Carolina Malaysia CHINA-MoH Lab results sharing JAPAN-Nagoya Imaging Info Sharing CHINA-Shanghai Imaging Info Sharing 12

13. Growth in IHE Domains Veterinary Endoscopy Pharmacy • Over 200 vendors involved world-wide • 8 Technical Frameworks • 64 Integration Profiles • Testing at “Connectathons” world-wide • Demonstrations at major conferences world-wide Public Health, Quality and Research Pathology Patient Care Devices (3 profiles) Patient Care Coord. (5 profiles) Radiation Oncology (3 profiles) Eye Care (4 profiles) Laboratory (6 profiles) Cardiology (7 profiles) IT Infrastructure for Healthcare (20 profiles) Radiology (18 profiles) 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

14. IHE Integration Profiles for Health Info Nets What is available and has been added this cycle Basic Patients Privacy Consents Emergency Referrals PHR Extracts/Updates Format of the Document Content and associated coded vocabulary Establish Consents & Enable Access Control Patient Demographics Query ECG Report Document Format of the Document Content and associated coded vocabulary Lab Results Document Content Format of the Document Content and associated coded vocabulary Scanned Documents Cross-Enterprise User Attestation Format of the Document Content and associated coded vocabulary Patient Identifier Cross-referencing Imaging Information Format of the Document Content User Attributes fro Access Control Medical Summary (Meds, Allergies, Pbs) Format of the Document Content and associated coded vocabulary Map patient identifiers across independent identification domains Document Digital Signature Format of the Document Content and associated coded vocabulary Attesting “true-copy and origin Cross-Enterprise Document Sharing Audit Trail & Node Authentication Request Formfor Data Capture Registration, distribution and access across health enterprises of clinical documents forming a longitudinal record Centralized privacy audit trail and node to node authentication to create a secured domain. External form with custom import/export scripting Notification of Document Availability Cross-Enterprise Document Pt-Pt Reliable Interchange Consistent Time Notification of a remote provider/ health enterprise Coordinate time across networked systems Cross-Enterprise Document Media Interchange Cross-Community Access Security & Privacy Clinical and PHR Content Patient ID Mgmt Health Data Exchange Other

15. The Community is the Hub that Drives Interoperability The Certification Commission for Healthcare Information Technology (CCHIT) Healthcare Information Technology Standards Panel (HITSP) American Health Information Community (AHIC) The Health Information Security and Privacy Collaboration (HISPC) Nationwide Health Information Network (NHIN) Architecture Projects • AHIC, chaired by HHS Secretary provides strategic coordination. • CCHIT focuses on developing a mechanism for certification of health care IT products • HITSP brings together all relevant stakeholders to identify & harmonize appropriate standards • HISPC addresses variations in business policy and state law that affect privacy and security • NHIN is focused on interoperability pilots and implementation

16. Standards Harmonization HITSP (Healthcare Information Standards Panel)

17. US Federal Initiative for Health IT and Nationwide Health Information Network • The U.S. healthcare system is managed both at the federal level and the state-level. • Over 200 Health Information Exchange projects in the U.S. at the state level or regional communities within the states. • At the federal level, HHS has set-up a policy-level setting board (AHIC), a coordination office (ONC) and 4 supporting initiatives for standards harmonization, certification, privacy and implementation prototyping. • IHE-USA has been engaged in the organization of one of these supporting initiatives: HITSP. IHE and its sponsors (e.g. HIMSS, RSNA, ACCE, etc.) and participants contribute to those initiatives.

18. HITSP Delivers Interoperability Specs to AHIC • The Healthcare Information Technology Standards Panel (HITSP) has addressed 7 business use cases for interoperability. • HITSP has nearly 400 member organizations representing all U.S. stakeholders including Standards Development Organizations (incl. X12, DICOM, HL7, etc.). • HITSP, through its standards-based interoperability specifications, is leveraging standard-based implementation guides such as those from Integrating the Healthcare Enterprise (IHE). • The IHE Connectathon and the HIMSS Interoperability Showcase play a visible role demonstrating the HITSP/IHE synergy.

19. From Standards to Solving a Use Case Business Use Case • AHIC/ONC • HITSP Interoperability Specifications + Constructs Standards Adoption/Profiling Technical Use Case Driven • IHE • HL7, NCPDP, • X12, DICOM, ISO, etc… Base Standards Foundations

20. 18 IHE Profiles adopted byHITSP Interoperability Specifications IHE contributes to HITSP’s success 20

21. Conformance Testing & Certification • CCHIT Certification Interoperability Specifications + Constructs • IHE Conformance Testing Standards Adoption/Profiling Technical Use Case Driven Base Standards Foundations

22. HITSP GOALS and IHE • HITSP goals with respect to testing activities • Ensure 'fitness for use' of HITSP Interoperability Specifications • Has leveraged the IHE testing process to support overall collaborative testing activities • HITSP collaboration with IHE • 18 IHE Profiles are used as constructs in HITSP ISs • IHE Profiles provide globally accepted standards to HITSP • IHE Connectathon/HIMSS Showcase provide opportunity for collaboration to meet mutual goals • To access HITSP Interoperability Specifications: www.HITSP.org

23. HIMSS08 Interoperability Showcase40 out of 51 implementers demonstrated HITSP

24. Requirements for an open RHIO/HIE(1) • Bring trust and ease of use for healthcare professionals: • Care delivery organizations choose information to share: • Based on patient situation • When they see fit (discharge, end of encounter, etc.) • What information to share (pick relevant types of documents, and content elements). • Care delivery organizations access patient information through: • their own EMR (if they have one), or • through a shared portal otherwise. • When accessing patient info: • Find quickly if relevant information is available or not (single query). • May select among relevant documents, which ones to see (may be done in background) • Among those of interest, chose to import in whole or part in its own EMR Chart (responsibility).

25. Requirements for an open RHIO/HIE(2) • Bring trust and privacy to patients: • Only authorized organizations and authenticated healthcare providers may transact in the HIE: • Each node or IT system interfaced is strongly authenticated • Each user shall be authenticated on the edge system (where context is best known) • All traffic trough the infrastructure is encrypted • Patient consent needs multiple choices or levels • Unless opt-in, no data about a specific patient may be shared • Several data sharing policies offered to the patient consent • Each shared document is assigned to specific policies (or not shared) at encounter time. • Healthcare providers may only access documents compatible with their role. • Shared Document Registry does not contain patient clinical data only generic information (minimum metadata + repository reference)

26. Categories of Healthcare Communication Services HIEs and RHIOs Hospitals Patient and Provider ID Mgt e.g. access to last 6 months historical labs and encounter summaries e.g. get a current list of allergies or med list from a source e.g. order a lab test, track status and receive results Security Document Sharing Dynamic Information Access Workflow Management Source persisted and attested health records Specific info snapshot provided on demand 2 or more entities synchronize a task

27. IT Infrastructure

28. What is IHE IT Infrastructure? • IHE IT Infrastructure domain produces... • Profiles that serve the purposes of clinical workflows, regardless of IHE clinical domain Examples: Security, Records Storage, Patient Identifiers • Basic implementation-specification foundations to be extended by other IHE clinical domains Examples: Retrieve Forms for Data Capture; Cross-Enterprise Document Sharing • White Papers for current work items Examples: HIE Security and Privacy; Health Data Re-use Infrastructure; Risk Management

29. Introduced at HIMSS in 2005 : IHE-XDS Community or sub-network Hospital Record Reference to records Clinic Record Specialist Record 3-Records Returned 4-Patient data presented to Physician Aggregate Patient Info Index of patients records (Document-level) Clinical IT System Sharing System 2-Reference to Records for Inquiry Clinical Encounter Repository ofDocuments Repository ofDocuments

30. IHE-XDS Infrastructure Components • Audit Record Repository (ATNA) – Receive audit records from other actors and securely store for audit purposes. ATNA also authenticates peer-nodes and encrypt communications. • Time Server (CT) – Provides consistent definition of date/time enabling time synchronization across multiple systems. Enables events associated with patients to be sorted reliably in chronological order. • Document Registry (XDS) – Queryable index of metadata and references to all documents shared within a connected community (XDS Affinity Domain) • Document Repository (XDS) – Supports storage and retrieval of clinical information (as documents). May be centralized or distributed. • Patient Identifier Cross Reference Manager (PIX) – Reconciles information on patients from multiple domains to a single, cross referenced set of ids for each given patient. • Patient Demographics Supplier (PDQ) – Returns demographic information and identifiers for patients based on specified demographic criteria.

31. IHE IT InfrastructureComposable Integration Profiles Patient Demographics Query Patient Identifier Cross-referencing Document Digital Signature Map patient identifiers across independent identification domains Attesting “true-copy and origin Cross-Enterprise User Assertion Notice of Document Availability Audit Trail & Node Authentication User Attributes for Access Cntrl Know about new information Centralized privacy audit trail and node to node authentication to create a secured domain. Request Form for Data Capture Consistent Time Cross-Community Access Doc Sharing XDS Pt-Pt DocInterchange XDR MediaInterchange XDM Querying and Retrieving Documents across multiple communities Coordinate time across networked systems Remotely Manage Information Capture Patient Administration Management Enterprise User Authentication Personal White Pages Patient Synchronized Applications Retrieve Information for Display * Scanned Doc XDS-SD * Doc Exchange Integration Profiles * * * (Intra-Enterprise only) * Adopted by HITSP

32. XDS Scenario + use of ATNA & CT EHR System ED Application Physician Office XDS Document Repository PACS XDSDocument Repository EHR System PACS Lab Info. System Teaching Hospital Community Clinic ATNA Audit record repository CT Time server PMS XDS Document Registry Query Document Register Document Secured Messaging Retrieve Document Provide & Register Docs Maintain Time Maintain Time Record Audit Event Maintain Time Record Audit Event Record Audit Event

33. XDS Scenario + use of PIX & PDQ A87631 A87631 A87631 14355 M8354673993 M8354673993 M8354673993 M8354673993 EHR System ED Application Physician Office XDS Document Repository PACS XDS Document Repository EHR System PACS Lab Info. System L-716 L-716 L-716 Teaching Hospital Community Clinic ATNA Audit record repository CT Time server PDQ Query to Acquire Affinity Domain Patient ID Patient Identity Feed Patient Identity XRef Mgr Patient Identity Feed Affinity Domain Patient Identity Source Patient Identity Feed Patient Identity Feed PIX Query Document Registry PIX Query Query Document (using Pt Id) Register (using Pt ID) Provide & Register Docs Retrieve Document PACS

34. Patient Care Coordination

35. A content profile is… • A sharable information component that can be exchanged… • within an HIE or RHIO (XDS) • via Media or USB Device (XDM) • via Reliable Messages (XDR) • Document content using standards • CDA Release 2.0 • HL7 Care Record Summary • ASTM/HL7 Continuity of Care Document • Library of Reusable Parts

36. XDS-MS Medical Summary or PHR Extract ExchangeProfile based on HL7 CDA Rel 2 and ASTM/HL7 CCD CCHIT 08 Level 3 Text Structure Med, Problems and Allergies Entry as highly structured text. Coded Section Coded Section Coded Section Text easy to import/parse Entry Entry Entry Level 3 Med Problems a nd Text Structure Allergies have a Entry fine-grain structure with CCHIT 09 optional coding. Coding Scheme explicitly identified. Text Structure Entry Level 1 Structured and Coded Header Patient, A uthor, Authenticator, Institution, Header always structured and coded Time of Service, etc. Level 2 S t r u c t u r e d C o n t e n t w i t h c o d e d s e c t i o n s : S t r u c t u r e d C o n t e n t w i t h c o d e d s e c t i o n s : Title - coded sections with non - structured · Reason for Referral nor coded content (text, lists, tables). · · Vital Signs  Simple Viewing (XML Style sheet) · · M e d i c a t i o n M e d i c a t i o n · Studies · · A l l e r g i e s A l l e r g i e s · Social History · · P r o b l e m s P r o b l e m s XDS-MS and XPHR enable both semantic interoperability & simple viewing ! · Care Plan

37. PCC Profiles BasicPatientPrivacyConsent LabReport FunctionalStatusAssessments Medical Summaries PreprocedureHistory andPhysical EmergencyDepartmentEncounter Record AntepartumCare Summary ED Referral ExchangingPHRContent Integration Content Query for Existing Data 2005-062006-072007-08 - Among 30 Consensus Standards Recommended by HITSP and accepted by HHS Secretary Leavitt.

38. Combining IHE ProfilesDocument Content & Modes of Document Exchange Doc Content Profiles (Semantics content) Scanned Doc XDS-SD Pre-Surgery PPHP Functional Status Assesment FSA Consent BPPC Emergency EDR PHR Exchange XPHR Discharge &Referrals XDS-MS Imaging XDS-I Laboratory XD*-Lab Document Exchange Integration Profiles Document SharingXDS Reliable Pt-PtInterchange XDR MediaInterchange XDM

39. Use of a shared XDS infrastructure to access Radiology Reports and Images (XDS-I) • Between Radiology and : • Imaging specialists • Non-imaging clinicians Hospital PACS Y Radiology -to-Radiology Radiology -to-Physicians PACS Z Imaging Center Physician Practice Same XDS Infrastructure (Registry and Repositories) for medical summaries and imaging information !

40. 2008 HIMSS Interoperability Showcase

41. Featured this year in the Showcase… The 2008 Cast: • 76 connected applications, 32 IHE profiles • Secured Health Information Exchange with broad content • Clinical Scenarios, focusing on clinician and patient access and information sharing across the continuum of care • Population Health, Quality and Research • Privacy and Security • HITSP Interoperability Specifications Visit the Virtual Conference April 23 – 24, 2008 • Health information exchange with patient care devices • Personal health record solutions • Financial and administrative systems for billing and claims attachments (CAQH/CORE) • Expanded distributed demonstration in an HIE format showing connectivity with vendor booths

42. IHE: Proof of Concept – Promotion – Participation Live Public Demonstrations • Walk-Through healthcare scenarios • Simulated multi-vendor clinical settings • USA: RSNA, HIMSS • Europe: ECR, DRG, JFR, … • Asia: JRC, … Industry Participation 2008 70 Organizations 136 Systems >389 Engineers 1999 23 Vendors 47 Systems Connectathons • Proof of concept • Annual multi-vendor interoperability tests • North America, Europe, Asia

43. Health Information Exchanges Interoperability: Cross-enterprise Document Sharing • Cross-Enterprise Document Sharing simplifies clinical data management by defining interoperable infrastructure. Transparency = Ease of Evolution • Patients have guaranteed portability and providers may share information without concerns of aggregation errors.Digital Documents = Patients and providers empowerment • Supports both centralized and decentralized repository architectures. Ease of federation nationally. Flexible privacy, Flexibility of configurations • Addresses the need for a longitudinal healthcare data (health records). Complements to interactive workflow or dynamic access to data.

44. How to Use IHE As a Vendor Implementer • Participate and Implement IHE Integration Profiles • Test systems through Connectathon process • Publish an IHE Integration Statement for products As a User Implementer or Consultant • Use IHE Integration Profiles to develop interoperability strategy • Use Connectathon Results and Integration Statements to evaluate vendors • Require IHE Integration Profile compliance in RFPs

45. Providers and Vendors Working Together to Deliver Interoperable Health Information Systems in the Enterprise and Across Care Settings http://www.ihe.net