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

2 What is Standards Harmonization? Healthcare is a complex multi-specialty multi-stakeholder system. Multiple standard development organizations are necessary.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: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 CasesCoordinate 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

Standards: Necessary…Not Sufficient Standards areStandards 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

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 in August 2007

How does IHE work? Clinicians and IT professionals identify key clinical and business workflow problemsClinicians 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 productsClinicians, 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 systemsIT professionals follow the IHE guidelines in purchasing and integrating effective systems

Whos involved in IHE? Users - Clinicians, Staff, Administrators, CIOs, Govt agencies (e.g. NIST, VA, DoD, CDC, CMS)Users - Clinicians, Staff, Administrators, CIOs, Govt agencies (e.g. NIST, VA, DoD, CDC, CMS) Professional Societies representing 270,000 individual members:Professional Societies representing 270,000 individual members: –HIMSS, RSNA, ACC, ACP, AAO, ACCE, ASTRO, etc Standards Development Orgs (SDOs):Standards Development Orgs (SDOs): –HL7, DICOM, ISO, CDISC, ASTM, W3C, IEEE, IETF, etc Vendors & consultants (e.g., imaging, EHRs, cardiology, medical devices)Vendors & consultants (e.g., imaging, EHRs, cardiology, medical devices)

Integrating the Healthcare Enterprise Achieving Interoperability through Implementation of Standards 1997: Founded in Radiology (RSNA) and IT (HIMSS) Many professional societies (stakeholder representation)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….

Who benefits from IHEs work? Patients –Enhance cares 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

IHE Organizational Structure ACC ACP HIMSS RSNA JAHIS JIRA JRS METI-MLHW MEDIS-DC JAMI GMSIH SFR SFIL ACCE SIRM BIR EuroRec COCIR EAR-ECR DRG ESC Professional Societies / Sponsors Contributing & Participating Vendors IHE International Board IHE Europe IHE North America France USA Canada IHE Asia-Oceania Japan KoreaTaiwan Netherlands Spain Sweden UK Italy Germany Norway Regional Deployment China Global Development Radiology Cardiology IT Infrastructure Patient Care Coordination Patient Care Devices Laboratory Pathology Eye CareRadiation Oncology Public Health, Quality and Research

10 International Growth of IHE France Local Deployment National Extensions Promotional & Live Demonstration Events Funding USAGermanyItalyJapanUKCanadaKoreaTaiwanNorway Netherlands Spain ChinaAustria Pragmatic global standards harmonization + best practices sharing Australia

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

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

Growth in IHE Domains Radiology (18 profiles) IT Infrastructure for Healthcare (20 profiles) Cardiology (7 profiles) Laboratory (6 profiles) Radiation Oncology (3 profiles) Patient Care Coord. (5 profiles) Patient Care Devices (3 profiles) Pathology Eye Care (4 profiles) 1999 Over 200 vendors involved world-wideOver 200 vendors involved world-wide 8 Technical Frameworks8 Technical Frameworks 64 Integration Profiles64 Integration Profiles Testing at Connectathons world-wideTesting at Connectathons world-wide Demonstrations at major conferences world-wideDemonstrations at major conferences world-wide Veterinary Endoscopy Pharmacy Public Health, Quality and Research

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

The Community is the Hub that Drives Interoperability 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 Healthcare Information Technology Standards Panel (HITSP) Nationwide Health Information Network (NHIN) Architecture Projects The Health Information Security and Privacy Collaboration (HISPC) The Certification Commission for Healthcare Information Technology (CCHIT) American Health Information Community (AHIC)

Standards Harmonization HITSP (Healthcare Information Standards Panel)

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.

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.

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

20 IHE contributes to HITSPs success 18 IHE Profiles adopted by HITSP Interoperability Specifications

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

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:

HIMSS08 Interoperability Showcase 40 out of 51 implementers demonstrated HITSP

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).

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)

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

IT Infrastructure

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

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

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.

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

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

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

Patient Care Coordination

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

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

PCC Profiles Medical Summaries ED Referral Exchanging PHR Content Antepartum Care Summary Emergency Department Encounter Record Preprocedure History and Physical Basic Patient Privacy Consent Lab Report Functional Status Assessments IntegrationContent Query for Existing Data - Among 30 Consensus Standards Recommended by HITSP and accepted by HHS Secretary Leavitt.

Combining IHE Profiles Document Content & Modes of Document Exchange Document Exchange Integration Profiles Document Sharing XDS Sharing XDS Media Interchange XDM Reliable Pt-Pt Interchange XDR Doc Content Profiles (Semantics content) Scanned Doc XDS-SD LaboratoryXD*-Lab PHR Exchange XPHR Discharge & Referrals XDS-MS ImagingXDS-I ConsentBPPCEmergencyEDR Pre- Surgery PPHP Functional Status Assesment FSA

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

2008 HIMSS Interoperability Showcase

Featured this year in the Showcase… 76 connected applications, 32 IHE profiles76 connected applications, 32 IHE profiles Secured Health Information Exchange with broad contentSecured Health Information Exchange with broad content Clinical Scenarios, focusing on clinician and patient access and information sharing across the continuum of careClinical Scenarios, focusing on clinician and patient access and information sharing across the continuum of care Population Health, Quality and ResearchPopulation Health, Quality and Research Privacy and SecurityPrivacy and Security HITSP Interoperability SpecificationsHITSP Interoperability Specifications Vendors Connected 51 Supporters22 Total73 Health information exchange with patient care devicesHealth information exchange with patient care devices Personal health record solutionsPersonal health record solutions Financial and administrative systems for billing and claims attachments (CAQH/CORE)Financial and administrative systems for billing and claims attachments (CAQH/CORE) Expanded distributed demonstration in an HIE format showing connectivity with vendor boothsExpanded distributed demonstration in an HIE format showing connectivity with vendor booths The 2008 Cast: Visit the Virtual Conference April 23 – 24, 2008

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 Vendors 47 Systems 70 Organizations 136 Systems >389 Engineers 2008 Connectathons Proof of concept Annual multi-vendor interoperability tests North America, Europe, Asia

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.

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

Providers and Vendors Working Together to Deliver Interoperable Health Information Systems in the Enterprise and Across Care Settings