swea1 cse 5810 hie, interoperability, and nhin prof. steven a. demurjian, sr. computer science &...

SWEA1 CSE 5810 HIE, Interoperability, and NHIN Prof. Steven A. Demurjian, Sr. Computer Science & Engineering Department The University of Connecticut 371 Fairfield Road, Box U-255 Storrs, CT 06269-2155 [email protected] http://www.engr.uconn.edu/~steve (860) 486 - 4818 Copyright 2014 by S. Demurjian, Storrs, CT.

SWEA2 CSE 5810 Objective of Presentation Health Information Change a Growing Concern Many Efforts are Ongoing/In Progress Standards a Concern to Address Data Exchange Many Efforts in Play NHIN (www.nist.gov/healthcare/testing/nhin.cfm)www.nist.gov/healthcare/testing/nhin.cfm Standards Efforts CONNECT www.connectopensource.org// DIRECT (wiki.directproject.org) IHE http://www.ihe.net/ Well Review Many Efforts by Leveraging Existing Materials and Progress

Towards a Nationwide Health Information Network (NHIN) Where Should We Be in 2014 Building a NHIN NHIN-2004 NHIN-2005-2006 NHIN-2007

On July 21, 2004 the Department of Health and Human Services (DHHS) announced the decade of health information technology for delivering consumercentric and information-rich health care. The vision is to build a National* Health Information Network (NHIN) of regional health information exchanges formed by health care providers who will utilize electronic health record systems. Thompson TG and Brailer DJ. The Decade of Heath Information Technology to Deliver Consumer-centric and Information-rich Health Care. Framework for Strategic Action. US DHHS, July 21, 2004. US National HIT Strategic Plan * Original term National has been changed on Nationwide in January 2006

DHHS Framework for Health Information Technology: Building a NHIN NHIN will be based on: Electronic Health Record Systems (EHRS) that will enable Regional Health Information Exchanges (RHIEs) organized via Regional Health Information Organizations (RHIOs) Thompson TG and Brailer DJ. The Decade of Heath Information Technology to Deliver Consumer-centric and Information-rich Health Care. Framework for Strategic Action. US DHHS, July 21, 2004.

Presidents Strategic Framework for HIT

Provider Record Laboratory Results Specialist Record Records Returned Index of where patients have records Temporary Aggregate Patient History Authorized RHIO Inquiry Requests for Records Another RHIO Patient data to other RHIO Source: Jennie Harvell. The Decade of Health Information Technology Framework for Strategic Actions. MMIS Conference, September 2004 US Nationwide Health Information Network

US Health Information Network - 2014 Source: Dr. Peter Elkin, Mayo Clinic, MN

RHIOs as NHIN Components Source: Dr. Peter Elkin, Mayo Clinic, MN, 2006

Emerging data shows the value that standardized health information exchange will provide to all stakeholders: Healthcare purchasers and payers Hospitals and other healthcare providers Laboratories Practicing clinicians Public health Source: John Glaser, Janet Marchibroda, Jim Schuping. CCBH. Washington, D.C. December 6-7, 2004 URL: www.ehealthinitiative.comwww.ehealthinitiative.com Nationwide Health Information Network (NHIN)

On November 15, 2004 Office of National Coordinator for Health Information Technology (ONC), Department of Health and Human Services (DHHS), released THE REQUEST FOR INFORMATION (RFI) on the Development and Adoption of a National Health Information Network Over 500 responses from various healthcare stakeholders has been submitted. Building a NHIN URL: http://www.dhhs.gov

PHDSC Model: RHIO EHR-PH Info Exchange PHDSC Model for Electronic Health Record-based Data Exchange

In October 2005 DHHS Office of National Coordinator (ONC) awarded several NHIN contracts ($65M) as follows: Standards Harmonization EHR Certification NHIN Architecture Prototypes Health Information Security and Privacy NHIN Development Process URL: http://www.hhs.gov/healthit/ahic.htmlhttp://www.hhs.gov/healthit/ahic.html

DHHS NHIN Contracts Standards Harmonization - Harmonize the health care and technology standards used in health information interchange to address gaps and conflicts in current standards EHR Certification - Set forth certification criteria for the many electronic health care record products and technologies currently available on the market NHIN Prototypes - Develop and evaluate prototypes for the network architecture to assess the feasibility of developing a national health information network prototype Privacy - Address privacy and security policy questions affecting the exchange of health information. Work resulting from each of these projects will be used by HHS to develop and refine the business case for establishing the network.

Nationwide Health Information Network Presented by Lori Blevins

Goals of NIHN: Develop capability for secure data exchange Improve the coordination of care information among healthcare facilities Ensure that appropriate information is available at the time and place that care is provided Ensure that consumers healthcare information is secure and confidential Reduce risks from medical errors and support the delivery of appropriate care Provide consumers with access to their health information Lower healthcare costs by reducing inefficiencies, medical errors, and incomplete patient information (Nationwide Health Information Network 2009)

Function of NIHN The NIHN will serve as a network of networks to connect diverse entities that need to exchange health information. The NIHN will provide for a more effective healthcare marketplace and will promote greater competition, as consumers may realize increased choice in selecting healthcare providers. Accessibility of accurate healthcare information will enhance delivery of care and improve outcomes.

Hardware The hardware utilized by the NIHN will consist of the myriad operating systems that are part of the network. Therefore, the hardware will consist of the hardware components of the participating entities and will include: PCsHard disk DesktopsRandom access memory LaptopsRead-only memory PDAsCache memory CPUsCD-ROM Motherboard

LOOK HOW FAR WEVE COME SINCE 2009! Personal Digital Assistants These small, hand held devices are becoming more commonplace among healthcare workers PDAs will enable healthcare workers to enter data in a more timely fashion, so that patient information is updated in real time The premise of the NIHN is to make health information readily available and accessible to all facets of healthcare delivery. Therefore, PDAs are a logical choice in implementation of the NIHN

Software Sun Microsystems Open Source software Sun GlassFish Open Source Application Platform Java Composite Application Platform Suite Sun Java Identity Management Suite (Sun Microsystems 2009)

Sun Open Source Technology Sun Microsystems open source software is the backbone of the NIHN-CONNECT gateway This software will connect the 26 NIHN member agencies hence the name NIHN-CONNECT The CONNECT software will be available throughout the health information exchange community (Sun Microsystems 2009)

Software Usability Usability refers to the ease with which an interface can be used Sun Microsystems project teams employ a Usability Lab to enhance user-centered design and evaluation Evaluations include: Customer field studiesUsability focus groups Competitive analysisParticipatory design Contextual inquiryExploratory lab studies SurveysHeuristic evaluations (Sun Usability Labs and Services 2009)

CONNECT Information System CONNECT has been developed by federal agencies to link their existing systems CONNECT is an open source gateway information system CONNECT allows existing systems to speak to each other to facilitate the communication of healthcare information (CONNECT Community Portal 2009)

CONNECT Gateway CONNECT is a special purpose open source information system CONNECT will be used by physicians, nurses, clinicians, and administrators anyone within the organization with access to the EHR

CONNECT Gateway The primary function of CONNECT Gateway is to inter-relate separate agencies so that their information systems become connected If the NIHN is the information exchange, CONNECT is the universal on-ramp for federal agencies (CONNECT Community Portal 2009)

CONNECT Gateway CONNECT Gateway CONNECT will utilize ANSI and Healthcare Informatics Standard Planning Panel SNOMED will be employed as the disease/procedure classification CONNECT will encompass many types of configurations

Advantages to NIHN Improve coordination of care Appropriate information is available when and where it is needed Reduce risk of medical errors Reduce inefficiencies and duplication of services Lower health care costs

Disadvantages to NIHN May create a paternalistic environment in healthcare May focus emphasis on the electronic health record and not the patient Accuracy of information may be questionable Possibility of security breach

References CONNECT Community Portal. Retrieved July 10, 2009. www.connectopensource.org. www.connectopensource.org McGonigle, D., Mastrian, K. and Terry, N. (2009). Nursing Informatics. Sudbury, MA. Jones and Bartlett Publishers. Nationwide Health Information Network (NHIN): Background & Scope. Retrieved 5/27/2009. www.HealthIT.hhs.gov.www.HealthIT.hhs.gov Sun Microsystems Helps U.S. Federal Government. Retrieved 06/10/2009. www.sun.com. www.sun.com Sun Usability Labs and Services. Retrieved 06/10/2009. www.sun.com/usability. www.sun.com/usability Terry, Nicholas P. NCVHS Subcommittee on Privacy. Retrieved 07/28/2009. www.ncvhs.hhs.gov.www.ncvhs.hhs.gov

TM Overview of National HIT Standards a presentation to the Seminar Series on Integrated Surveillance Presented by Steven J Steindel, Ph.D. National Center for Public Health Informatics (NCPHI), CDC

TM Government Voluntary standards Consensus standards Industry standards Consortia Standards Etc. Regulatory standards: Levels of Protection Health, Safety Environment LAWS Non-Government MARKET NEEDS When applicable and appropriate, voluntary standards may be referenced in mandatory regulations.

TM Regulations Based on Health & Welfare (Legitimate Objectives) Development Process (openness, public comment, transparency, timely notification) Mandatory Voluntary Standards Based on Market and Business Relevance (Demands or Needs) Development Process (much the same as regulatory; regulators are among the participants in standards development bodies) Voluntary

TM Consideration for Standards Flow - where, when, and how data move Format - mechanics of data transfer Content - which data elements

TM Schematic Public Health Data Flow Example: Laboratory Reporting Pathology Laboratory Text Report Encoding Systematic Report Standards Standard Codes H7 Messages Architecture Reportable Cases Public Health World Clinical Data Users Network Users Public Health System NHIN/RHIO SNOMED, Numbers, Dates, Text 92 Disease specific HL Messages Public Health Surveillance

TM Acronym Soup! AHIC American Health Information Community ONC Office of the National Coordinator for Health Information Technology (IT) HL7 Health Level 7 CCHIT Certification Commission for Health IT HITSP Health IT Standards Panel NHIN Nationwide Health Information Exchange Network

TM ONC Major Initiatives American Health Information Community Standards Harmonization Process Certification of HIT Privacy and Security Solutions Nationwide Health Information Systems Prototypes Health Information Technology and Health-care Anti-fraud Health IT Adoption Initiative Gulf Coast Task Force State RHIO Best Practices In 2004, President Bush called for the widespread use of electronic health records (EHRS) within 10 years. ONC has set the foundation for interoperable EHRs though the following initiatives: For more information: http://www.hhs.gov/healthit/

TM AHIC a Public and Private Sector Collaborative AHIC: American Health Information Community HITSP: Health Information Standards Panel CCHIT: Certification Commission for Health IT NHIN: Nationwide Health Information Community HISPC: Health Information Security and Privacy Collaboration State-Level HIE Initiatives: State-level Health Information Exchange Initiatives AHIC is the public-private collaborative that sets priorities and oversees and/or endorses HIT Standards, certification, the NHIN, and polices on a national level. For More information: http://www.hhs.gov/healthit/community/background/

TM AHIC Workgroups (1/07) Population Health and Clinical Care Subsumes work of the Biosurveillance WG Includes Data Content Steering Group Consumer Empowerment Chronic Care Electronic Health Records Laboratory Reporting Emergency Preparedness Privacy and Security Quality Personalized Healthcare For more information: http://www.hhs.gov/healthit/ahic/index.html

TM Health Information Technology Deployment Coordination

TM Standards Harmonization Process Health Information Standards Panel (HITSP) Business driven standards harmonization process Coordinated with AHIC Use Cases Funded for 3 years by ONC; self-sustaining thereafter Published Implementation Guidance 10/06 Consumer Empowerment Biosurveillance EHR: Laboratory Reporting For more information: http://www.ansi.org/standards_activities/standards_boards_panels/hisb/hitsp.aspx?menuid=3

TM HITSP Technical Committees Cross-Technical Committee Coordination Care Delivery Consumer Empowerment Population Health Security and Privacy Emergency Responder-EHR

TM I Harmonization Request Harmonization Process Steps II Requirements Analysis III Identification of Candidate Standards IV Gaps, Duplications and Overlaps Resolution V Standards Selection VI Construction of Interoperability Specification VII Inspection Test VIII Interoperability Specification Release and Dissemination IX Program Management Begin Support Receive Request HITSP Harmonization Process

TM HITSP Framework

TM JANFEBMARAPRMAYJUNJULAUGSEPOCTNOVDEC HITSP 2007 Timeline 02/05/07 HITSP Board 04/23/07 HITSP Board 07/09/07 HITSP Board 10/09/07 HITSP Board 03/19/07 HITSP Panel 05/11/07 HITSP Panel 09/07/07 HITSP Panel 03/06 03/08 TC Face to Face Chicago IL 5/08 5/10 TC Face to Face Arlington VA 6/18 6/20 TC Face to Face San Diego CA 09/04 09/06 TC Face to Face Arlington VA Public Comment Inspect Test and Public Comment Implementation Support and Testing (with annual updates as required) Comment Resolution and Panel Approval 02/15 05/16 04/13 05/16 IS Construct Development 05/17 07/19 07/20 08/1608/17 10/15 Implementation Support and Testing (includes minor document updates) EHR, CE and BIO v 2.0 Activity 1 Version 2.0 of Existing EHR, CE, BIO ISs Activity 2 Security and Privacy for All Use Cases Activity 3 New Emergency Responder EHR Use Case On-going Support 10/15/07 HITSP Panel 07/16/07 HITSP Panel 02/12/07 HITSP Panel Activity 4 New Use Cases from AHIC Detail Schedule to be Established Upon Review of the Use Cases Work Plan and Schedule Overview S&P and EHR-ER v 1.0 Requirements, Design, Standards Selection Public Input on S&P 05/17 06/14

TM Coordinated Timeline Two Years We are here

TM Certification of EHRs Certification Commission for Health IT (CCHIT) Privately founded and funded 11/04 ONC funding for three years First certified Ambulatory EHRs 7/06 37 systems certified: 1/07 Inpatient EHR Certification 6/07 Network Certification 6/08 For more information: http://www.cchit.org/

TM CCHIT History and Status Sept 2004: AHIMA, HIMSS, and the Alliance partner to launch CCHIT June 2005: Eight organizations add $325k funding support Sept 2005: CCHIT awarded 3-year, $7.5M HHS contract to develop compliance criteria and inspection process Ambulatory EHRs (2006) Inpatient EHRs (2007) Infrastructure and Networks through which EHRs interoperate (2008) July 18, 2006: First batch of certified ambulatory EHRs announced Goals of Product Certification Reduce the risks of investing in HIT Facilitate interoperability of HIT products Enhance availability of adoption incentives Ensure that the privacy of personal health information is protected Goals of Product Certification Reduce the risks of investing in HIT Facilitate interoperability of HIT products Enhance availability of adoption incentives Ensure that the privacy of personal health information is protected

TM Stakeholder priorities Availability in vendor marketplace Practicality of certification Release for public comment CCHIT Development Process Call for participants Random selection for each market segment Conduct pilot Release for public comment Results Final criteria Final test process and scripts Certification handbook and agreement Criteria for next year Functionality Security/ reliability Interoperability Roadmap for Next year + 1 Next year + 2 Release for public comment Methods Self-attestation Juror observation Laboratory testing Test scenarios Step-by-step test scripts Release for public comment Respond to comments Final adjustments Commission review and approve Publish final materials Gather Data Develop Criteria Develop Inspection Process Pilot Test Finalize Launch Certification Program

TM CCHIT Myths and Realities MythReality CCHIT is a government agency CCHIT is an independent, voluntary, private- sector initiative organized as a limited liability corporation. CCHIT will transition from HHS funding to a self-sustaining model. CCHIT is a standards development organization CCHIT develops criteria based on commonly available standards developed by SDOs. Certification could stunt innovation and competition in the HIT marketplace basic criteriaCertification is a pass/fail indication that the product meets basic criteria in every area. It provides a baseline above which HIT vendors may innovate and compete. CCHIT will only be certifying EHRs for the physician practice Work groups are already developing criteria for inpatient EHR certification. In 2007, the effort will expand to the networks and technology components through which EHRs interoperate.

TM HL7 Groups of Importance New Public Health and Emergency Response Patient Safety Established Vocabulary Government Projects Laboratory Attachments Structured Documents (CDA/Templates) For more information: http://www.hl7.org/

TM Key Terminologies LOINC Lab Result Names SNOMED Clinical Terminology Organisms Both distributed free for use http://www.regenstrief.org/medinformatics/loinc/ http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html

TM Get Involved! No restrictions just join: HL7 HITSP Selected Membership CCHIT NCVHS Open Meetings AHIC NCVHS CCHIT Town Halls Registration LOINC SNOMED (IHTSDO)

TM Contact Information Steven J Steindel, Ph.D. Director, Data Standards and Vocabulary Centers for Disease Control and Prevention National Center for Public Health Informatics U.S. Department of Health and Human Services 1600 Clifton Road, MS E-78 Atlanta, GA 30333 (tel) 404-498-2444 [email protected]

54 HIT STANDARDS COMMITTEE DRAFT: S&I Framework Principles and Processes 54

55 S&I Mission Promote a sustainable ecosystem that drives increasing interoperability and standards adoption Create a collaborative, coordinated, incremental standards process that is led by the industry in solving real world problems Leverage government as a platform provide tools, coordination, and harmonization that will support interested parties as they develop solutions to interoperability and standards adoption.

56 ONC Standards and Interoperability Framework Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc) (Stanley) Tools and Services (Use Case Development, Harmonization Tools, Vocabulary Browser, Value Set Repository, Testing Scripts, etc) (Stanley) Use Case Development and Functional Requirements (Accenture) Use Case Development and Functional Requirements (Accenture) Standards Development (TBD) Standards Development (TBD) Certification and Testing (Stanley/Deloitte) Certification and Testing (Stanley/Deloitte) Harmonization of Core Concepts (Deloitte) Harmonization of Core Concepts (Deloitte) Implementation Specifications (Deloitte) Implementation Specifications (Deloitte) Pilot Demonstration Projects (Lockheed Martin) Pilot Demonstration Projects (Lockheed Martin) Reference Implementation (Lockheed Martin) Reference Implementation (Lockheed Martin)

57 Standards and Interoperability Organizational Structure Standards and Interoperability Standards National Health Information Network Certification and Testing FHA Standards Teams NHIN Teams Certification Team FHA Teams Use Cases (Accenture) Use Cases (Accenture) Standards Development (TBD) Standards Development (TBD) Harmonization (Deloitte) Harmonization (Deloitte) Spec Factory (Deloitte) Spec Factory (Deloitte) Architecture Reference Implementations (Lockheed Martin) Reference Implementations (Lockheed Martin) Emergent Pilots (Lockheed Martin) Emergent Pilots (Lockheed Martin) Tools (Stanley) Tools (Stanley) Operations (Stanley) Operations (Stanley) Certification (Stanley/Deloitte) Certification (Stanley/Deloitte) Test Infrastructure (Stanley/Deloitte) Test Infrastructure (Stanley/Deloitte) CONNECT (TBD) CONNECT (TBD)

58 What is an IEPD? An Information Exchange Package Documentation (IEPD) is a collection of artifacts that describe the construction and content of an information exchange Developed to provide the business, functional, and technical details of the information exchange through predefined artifacts Created with a core set of artifacts in a prescribed format and organizational structure to allow for consistency Designed to be shared and reused in the development of new information exchanges through publication in IEPD repositories IEPDs contain design specifications for an information exchange but may not include supplementary information such as implementation decisions.

59 The IEPD Artifacts IEPDs contain both required and recommended artifacts Required : Bold Recommended : Italic Note: Best practices for most organizations include many of the optional artifacts listed here Business Process Use Cases Sequence Diagrams Business Rules Business Requirements Exchange Content Model Mapping Document Subset Schema Exchange Schema XML Wantlist Constraint Schema Extension Schema Main Document IEPD Catalog IEPD Metadata Sample XML Instances XML Stylesheets Scenario Planning Analyze Requirements Map & Model Build & Validate Assemble & Document Publish & Implement No required artifacts. Publish the IEPD to a repository and implement the exchange

60 S&I NIEM Harmonization Strategy ONCs Office of Interoperability and Standards is building a Health Information Exchange Model (NIEM Health) that is harmonized with NIEM Health and Human Services petal to serve as bridge between NIEM and NIEM Health Human Services

61 Capability Elaboration Capability Formulation Construction Release & Publication Use Case Development Spec Development Harmonization Reference Impl Cert &Testing S&I Development Phases S&I Governance Health Community Participants Scenario Planning Analyze Requirements Map & Model Build & Validate Assemble & Document Pub. & Impl. NIEM Lifecycle S&I NIEM Process Harmonized

62 Addressing Challenges for the Health Information Exchange Model ChallengeApproach Existence of disparate health information exchange standards and specifications and implementation approaches Map exchange requirements to existing standards & specifications and address any gaps, duplications, or overlaps Harmonization and management of several well-established, large vocabularies for semantic interoperability Leverage existing vocabulary repositories (e.g. PHIN VADS), coordinate with Unified Medical Language System (UMLS), and collaborate with standards development organizations Usability of existing HIT exchange protocols and specifications Use NIEM processes and adapt supporting tools to create computable, useable implementation specifications NIEM only addresses data content, but transaction behavior and security provisions are necessary for health information exchange Adapt structure and content of S&I IEPD to incorporate transport and security aspects of exchange Compatibility of S&I IEPDs with existing NIEM infrastructure and tools, as well as existing health information exchange protocols Develop and adapt NIEM and health information technology tools and framework to support NHIN goals

63 Requirements for a Model Centric Approach The modeling approach used by the S&I Framework must Provide traceability from Use Case and Requirements through to one or more implementations Provide semantic and syntactic modeling constructs to support defining the information and behavior that are part of exchanges Support the need to harmonize with existing standards defined at different levels of abstraction Be adoptable by different organizations Be able to integrate into NIEM process

64 Model-Centric Solution - MDA Base S&I Framework modeling on the 3 OMG/MDA model abstractions. Computational Independent Model (CIM) Platform Independent Model (PIM) Platform Specific Model (PSM) Define a mechanism to show traceability from Use Cases and Functional Requirements through to technical bindings defined in a PSM. Define a flexible modeling foundation by which different types of specifications can be defined. Provides ability for multiple technology bindings for the same set of logical specifications (multiple PSMs)

65 Specification Models NIEM Processes and Artifacts S&I Activities Harmonization of Core Concepts Implementation Specifications Reference Implementation and Pilots Business Processes, Use Cases Business Rules, Business Requirements Exchange Content Model, Mapping Document Exchange Schema, Subset/Constraint Schema, Main Document, IEPD Catalog, IEPD Metadata, Sample XML Vision Document, Process Model Use Case Model, Interaction Model, Domain Model Behavior Model Domain Model Web Services Schema and WSDL Use Case Development and Functional Requirements Certification and Testing CIM PIM PSM Scenario Planning Analyze Requirements Map and Model Publish and Implement Build and Validate Assemble and Document Model Centric Solution - NIEM

66 Prioritization and Backlog Lists Strategic Priorities Strategic Priorities Operational Priorities Day to Day Priorities within each functional team

67 Whats Next Create a NIEM Health standards harmonization process and governance framework Establish roadmap for existing NHIN standards, MU harmonization, and non-MU health information exchange specifications Establishes a repeatable, iterative process for developing widely reusable, computable implementation specifications Establishing the tooling and repositories needed Establishing the practices and guidelines for modeling Enables semantic traceability so that useable code can be traced back to original requirements and definitions Promotes transparency and collaboration from broad range of health stakeholders Scenario Planning Map & Model Analyze Requirements Build & Validate Assemble & Document Publish & Implement Use Case Development and Functional Requirements Standards Development Certification and Testing Harmonization of Core Concepts (NIEM framework) Implementation Specifications Pilot Demonstration Projects Reference Implementation NIEM IEPD Lifecycle

68 ISSUES TO DISCUSS S&I Framework

69 Coordination Priority Setting Evaluating Artifacts S&I Framework Issues and Challenges (1) Issues and Challenges How and when do we get input from other stakeholders including those outside of meaningful use? VLER Federal partners Other stakeholders How do we foster multiple working groups and create a unified view of priorities? HITSC HITPC Sustainable Operations Shared Infrastructure

70 How do we create simple, easy to implement specifications that will drive adoption? S&I Framework Challenges (2) How do we facilitate access to SDO standards for providers and support sustainable business models? Engaging the SDO community Developing a one stop shop for implementation specifications How do we foster community and industrial participation to support balanced representation and diverse priorities? Identifying champions for S&I lifecycle initiatives Engage communities throughout S&I Framework Identifying demonstrable pilot programs Engaging and incentivizing volunteers from existing community

71 S&I Framework Open Questions cont. What are the appropriate interface points with HITSC through S&I Framework lifecycle? Establish priorities, approve implementation specifications, Identifying appropriate decision makers at S&I control points Identifying appropriate roles and participants in the governance of S&I Framework How do we identify and select tools as shared resources that foster collaboration? Establishing and adhering to agreed upon modeling conventions Tools to support artifact lifecycle management and dissemination How do we extend NIEM to accommodate needs of health care domain?

72 S&I Framework Priorities What should our priorities be for the next six months, twelve months, twenty-four months? From among Meaningful Use Stage 1 Meaningful Use Stage 2 & 3 NHIN Exchange NHIN Direct Health Care Reform VLER New use cases (lab, pharmacy, content specifications) Prioritization needs to accommodate broad stakeholder needs, account for breadth and depth of available expertise, and support a long term growth strategy

FHA Presentation to HIMSS National Capital Area Chapter January 15, 2009 Vish Sankaran Program Director Federal Health Architecture

Phase 1 2004 2008 Foundation for Health Information Exchange Established In April, 2004 Executive Order 13335: Office of the national coordinator created Executive Order 13410: Federal federal agencies required to implement HHS Secretary recognized standards and cost & quality transparency In the last four years, ONC worked with Federal, States and private sector to: Harmonize interoperable standards Create Health IT certification for functionality, security, and interoperability Launch the Nationwide Health Information Network Address Policy variations The Tipping Point for Phase 2 is now at hand 74

President-elect Obamas Commitment to Electronic Health Systems The goal is not to move from paper silos to electronic silos The goal is an electronic health system that supports and requires the movement of interoperable health information supporting: Continuity of Care Population Needs (pandemics and other disasters) Bench to Bedside Research Disability Determination 75 In a January 9, 2009 speech at George Mason University "To improve the quality of our healthcare while lowering its cost, we will make the immediate investments necessary to ensure that, within five years, all of Americas medical records are computerized.

FHA Mission Effective Government Secure Exchange of Interoperable Health Information Working together to provide the tools and solutions to support the development and exchange of interoperable health information within the federal government and with the tribal, state, local and private sector, thereby, enabling better care, increased efficiency, and improved access to care for American citizens. 76

77 Agency Concept of Operations 77 4 Implement Solutions 3 Plan Investments 1 Business Priorities 2 Architect Solutions 5 Measure Progress FHA can provide guidance / support in any phase of your operations. 77

78 2009 Vision Agencies Collaborate to Reform Healthcare through IT VISION Reform HealthCare RESULT Improved Performance GOALS Reduce Costs Improve Quality Increase Access POPULATIONS ElderlyVeteransMilitaryNative AmericansDisabledChildrenUnderserved PROCESS Solutions STAKEHOLDERS State, Local, Private State AgenciesLocal AgenciesProvidersHealth IT VendorsPayers COLLABORATION Federal Programs Others.. ImplementInvestment Business Needs Architect 7878

The Nationwide Health Information Network Health Bank or PHR Support Organization Community #1 Integrated Delivery System Community Health Centers Community #2 State and Local Gov Labs Pharmacies CDC VA FDA DoD SSA The Internet Standards, Specifications and Agreements for Secure Connections Common Dial Tone & Chain of trust 7979

80 CONNECT: Tools for Information Exchange FHAs CONNECT Initiative provides three related tools to enable organizations to connect to the NHIN: The Gateway, which implements the core services defined by the NHIN Enterprise Service Components, which provide robust tools for indexing patient identities, maintaining patient health documents, implementing business rules for authorizing the release of medical information and more The Software Development Kit (SDK), which enables developers to customize the Gateway and add or replace enterprise service components 80

CONNECT 2008 Progress Collaboration you can be proud of! 81 20082009 March 2008 CONNECT development started Sep 2008 3 agencies demonstrated HIE with private sector Dec 2008 6 agencies demonstrated HIE with private sector 2009 Plan to include all health agencies by end of year 81

CONNECT Roadmap: 2008-2011 Participate in NHIN Trial Implementations Develop first release of the Federal NHIN Gateway Demonstrate value of connecting to the NHIN for agencies Move selected agencies into production using NHIN Use of NHIN to solve agency needs and improve performance Distribute Gateway software to facilitate NHIN solution development by marketplace Expand the set of agency programs using the NHIN Begin the process of transitioning to gateway software provided by the marketplace Complete process of transitioning to gateway software provided by the marketplace Support every agency that performs health-related information exchanges using the NHIN 82 2008 2009 2010 2011

83 Private sector and Government Must Care Data flow in our health care systems is a must for the coming years Government Ensure interoperability is in agency business and strategic plans. Systems integrators: Support the federal, state, private providers and public health agencies transformation towards interoperability. Leverage the CONNECT tools as a means to integrate existing health information systems. Product vendors: Create unique HIE solutions for the health marketplace by adding value on the CONNECT solution, or create your own products that provide NHIN services. For this transformation to succeed, all of us must participate

SWEA84 CSE 5810 What is Direct? Allow individuals, providers and organizations to share information with best practices that have trust and privacy considerations Health Information Service Provider (HISP) Manage security/transport for directed exchange Organizational model that performs HISP functions Works to send/receive to organization or individual Legal Business Associate Agreements with HIPAA Includes all data collection, use, retention, and disclosure policies 84

SWEA85 CSE 5810 One Possible Architecture

Other Direct Deployment Models A.e-Mail client (no S/MIME) NHIN-Direct developed security agent off-the-shelf S/MIME proxy B.e-Mail client using Native S/MIME Internet e-Mail Service Provider Healthcare specific e-Mail Service Provider C.Web Portal to common Internet e-Mail service with S/MIME support to Healthcare specific messaging service with S/MIME support D.EHR/PHR with integrated S/MIME functionality deployed inside the Provider deployed as SaaS E.NHIN Direct to/from NHIN Exchange Trusted NHIN Gateway End to End secure

Source Client Destination Client Source Full Service HISP Source Full Service HISP Destination Full Service HISP Destination Full Service HISP Send Locate Destination Certificate POP/IMAP + TLS Receive S/MIME Encrypt w/ Destination Cert S/MIME Encrypt w/ Destination Cert S/MIME Verify w/ Source Cert S/MIME Verify w/ Source Cert S/MIME Decrypt w/ Private Key S/MIME Decrypt w/ Private Key A) e-Mail client with Full Service HISP XDM Xpath Data Model SMTP + S/MIME Locate Destination Address Locate Destination Address SMTP + MIME+ TLS SMTP + MIME+ TLS Document Or XDM Document Or XDM S/MIME Sign w/ Private Key S/MIME Sign w/ Private Key Encrypted Content A.1 A.2 A.3 A.4 A.5 A.6 A.7 A.8 A.9 A.10 A.11 Private Key Store

Destination Client Source Client Destination HISP Send Document Or XDM Receive B) e-Mail client using Native S/MIME Locate Destination Address + Certificate Locate Destination Address + Certificate POP/IMAP + TLS SMTP + S/MIME Document Or XDM S/MIME Encrypt w/ Destination Cert S/MIME Encrypt w/ Destination Cert S/MIME Sign w/ Private Key S/MIME Sign w/ Private Key S/MIME Decrypt w/ Private Key S/MIME Decrypt w/ Private Key Encrypted Content B.1 B.2 B.3 B.4 B.5 B.6 B.7 S/MIME Verify w/ Source Cert S/MIME Verify w/ Source Cert B.8 B.9 Private Key Store

Destination Client Source Client Source web HISP Destination web HISP Send Upload Document(s) HTTP + TLS HTTP + TLS Receive S/MIME Encrypt w/ Destination Cert S/MIME Encrypt w/ Destination Cert S/MIME Verify w/ Source Cert S/MIME Verify w/ Source Cert S/MIME Decrypt w/ Private Key S/MIME Decrypt w/ Private Key C) Web Portal HTTP + TLS HTTP + TLS Document Or XDM Document Or XDM Download Document(s) S/MIME Sign w/ Private Key S/MIME Sign w/ Private Key Find Destination Address + Certificate Find Destination Address + Certificate Build XDM SMTP + S/MIME Encrypted Content C.1 C.2 C.3 C.4 C.5 C.6 C.7 C.8 C.9 C.10 C.11 C.12 Private Key Store

Destination Client Source Client Destination HISP Send Document Or XDM Receive D) EHR/PHR with integrated S/MIME Locate Destination Address + Certificate Locate Destination Address + Certificate POP/IMAP + TLS SMTP + S/MIME Document Or XDM S/MIME Encrypt w/ Destination Cert S/MIME Encrypt w/ Destination Cert S/MIME Sign w/ Private Key S/MIME Sign w/ Private Key S/MIME Decrypt w/ Private Key S/MIME Decrypt w/ Private Key Encrypted Content D.1 Private Key Store D.2 Private Key Store S/MIME Verify w/ Source Cert S/MIME Verify w/ Source Cert D.3 D.4D.5 D.6 D.7 D.8 D.9

Gateway: Direct Project to XDR (Destination HISP) Gateway: Direct Project to XDR (Destination HISP) Receive S/MIME Verify w/ Source Cert S/MIME Verify w/ Source Cert S/MIME Decrypt w/ Private Key S/MIME Decrypt w/ Private Key E) Direct Project sending to XDR with Trusted Service Provider (e.g. NHIN Exchange) Convert XDM metadata and content to XDR format SMTP + S/MIME Direct Project Sender XDR + TLS XDR + TLS Destination Certificate is shared with all XDR destinations in XDR Exchange Endpoint in XDR Exchange E.1.1 E.1.2 E.1.4 E.1.6 E.1.7 Private Key Store Address Book w/ Certs E.1.3 E.1.5

Gateway: Direct Project from XDR (Source HISP) Gateway: Direct Project from XDR (Source HISP) Send S/MIME Encrypt w/ Destination Cert S/MIME Encrypt w/ Destination Cert E) Direct Project receiving from XDR with Trusted Service Provider (e.g. NHIN Exchange) XDR + TLS XDR + TLS S/MIME Sign w/ Private Key S/MIME Sign w/ Private Key Extract Destination Address from XDR metadata Extract Destination Address from XDR metadata Convert XDR Metadata and Documents to XDM Zip file Direct Project Recipient Endpoint in XDR Exchange Locate Destination Certificate SMTP + S/MIME Private Key Store Address Book w/ Certs E.2.6 E.2.4 E.2.1 E.2.2 E.2.3 E.2.5 E.2.7 E.2.9 E.2.8

NHIN Direct to NHIN Exchange (Destination HISP) NHIN Direct to NHIN Exchange (Destination HISP) Receive E) NHIN Direct sending to non-trusted NHIN Exchange (End-to-End Secure) SMTP + S/MIME NHIN Direct Place S/MIME message as XDR content XDR + TLS XDR + TLS Destination Certificate is Individual or Organization NHIN Exchang e

NHIN Direct to NHIN Exchange (Destination HISP) NHIN Direct to NHIN Exchange (Destination HISP) Receive S/MIME Verify w/ Source Cert S/MIME Verify w/ Source Cert S/MIME Decrypt w/ Private Key S/MIME Decrypt w/ Private Key E) NHIN Direct sending to NHIN Exchange Convert XDM metadata and content to XDR format SMTP + S/MIME NHIN Direct Place S/MIME message as XDR content XDR + TLS XDR + TLS Destination Certificate is Group NHIN Exchange Destination Certificate is Individual or Organization NHIN Exchang e

Non Trusted NHIN Exchange Gateway E) NHIN-Direct receiving from non-Trusted NHIN Exchange (End-to-End Secure) NHIN Direct NHIN Exchang e Source Certificate is individual or organizational Source Client S/MIME Encrypt w/ Destination Cert S/MIME Encrypt w/ Destination Cert XDM Zip file S/MIME Sign w/ Private Key S/MIME Sign w/ Private Key Locate Destination Address + Certificate Locate Destination Address + Certificate XDR + TLS XDR + TLS Extract from XDM metadata the To and From addresses Extract S/MIME message from XDR content SMTP + S/MIME

Trusted NHIN Exchange Gateway Non Trusted NHIN Exchange Gateway Send S/MIME Encrypt w/ Destination Cert S/MIME Encrypt w/ Destination Cert E) NHIN-Direct receiving from NHIN Exchange XDR + TLS XDR + TLS S/MIME Sign w/ Private Key S/MIME Sign w/ Private Key Extract Destination Address from XDR metadata Extract Destination Address from XDR metadata Convert XDR Metadata and Documents to XDM Zip file NHIN Direct NHIN Exchang e Locate Destination Certificate Source Certificate is NHIN Exchange Group Certificate Source Certificate is individual or organizational Source Client S/MIME Encrypt w/ Destination Cert S/MIME Encrypt w/ Destination Cert XDM Zip file S/MIME Sign w/ Private Key S/MIME Sign w/ Private Key Locate Destination Address + Certificate Locate Destination Address + Certificate XDR + TLS XDR + TLS Extract from XDM metadata the To and From addresses Extract S/MIME message from XDR content SMTP + S/MIME

June 28-29, 2005 Interoperability Strategy Workshop 97 W W W. I H E. N E T Providers and Vendors Working Together to Deliver Interoperable Health Information Systems in the Enterprise and Across Care Settings

June 28-29, 2005 Interoperability Strategy Workshop 98 Lab Results Document Content Format of the Document Content and associated coded vocabulary For Display Document Format of the Document Content Selected IHE Integration Profiles for RHIOs What is available and is added in 2005 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. Patient Demographics Query Cross-Enterprise Document Sharing Registration, distribution and access across health enterprises of clinical documents forming a patient electronic health record Notification of Document Availability Notification of a remote provider/ health enterprise Imaging Information Sharing Format of the Document Content and associated coded vocabulary Medical Summary Document Content Format of the Document Content and associated coded vocabulary Cross-enterprise User Authentication Authentication & Auditing: Basis for Access Control Document Digital Signature Attesting true-copy and origin Patient Identifier Cross-referencing Map patient identifiers across independent identification domains

June 28-29, 2005 Interoperability Strategy Workshop 99 HIMSS 2005 Interoperability Show Case Vendors Leadership Level CapMed/SanDiskEclipsys GE Healthcare IDXInterSystemsKryptiqQuovadx/CareScienceSiemensWebMD Participant Level AllscriptsCedaraCernerDictaphone Eastman Kodak EclipsysEmageonEpicETIAM INFINITT Tech. MedcomSoftMediNotesMedCommonsMidMark Mortara Instrument, Inc National Institute of Standards & Technology Standards & TechnologyNextGenNovell Open Text Sentillion Supporter Level AccessPtAGFAdbMotionDinmar Oacis EMCHealthvisionHealthrampMcKesson Valco Data Systems

June 28-29, 2005 Interoperability Strategy Workshop 100 IHE North America Vendors (2004-2005) Agfa HealthCare Allscripts Camtronics Medical Systems Cedara Software Corp. Cerner Corporation Dictaphone Corporation Dynamic Imaging, LLC Eastman Kodak Company Eclipsys Emageon Epic Systems Corporation ETIAM FujiFilm Medical Systems, USA, Inc. GE Healthcare Heartlab, Inc Hitachi Medical Corporation Hologic IDX Systems Corp. INFINITT Technology InSite One, Inc. Intelerad Medical Systems InterSystems Corporation Konica-Minolta Medical Imaging, USA, Inc. Kryptiq Marotech McKesson Information Solutions MedCommons Inc. MedCon, Inc. Merge eFilm Mortara Instrument, Inc. Novell, Inc. Philips Medical Systems QRS Diagnostic Quovadx St. Jude Medical A.B. Sectra Imtec A.B. St. Jude Medical A.B. Sectra Imtec A.B. Sentillion Siemens Medical Solutions Stentor Swissray International, Inc. Tiani Medgraph A.G. Tiani Spirit Gmbh Toshiba Medical Systems Company Vital Images WebMD Practice Services

June 28-29, 2005 Interoperability Strategy Workshop 101 community Clinical Encounter Clinical IT System Index of patients records (Document-level) Temporary Aggregate Patient History 4-Patient data presented to Physician Sharing System 3-RecordsReturned Reference to records Clinic Record Specialist Record Hospital Record 2-Reference to Records for Inquiry At HIMSS in 2005 : IHE-XDS

June 28-29, 2005 Interoperability Strategy Workshop 102 community Clinical Encounter Clinical IT System Index of patients records (Document-level) Temporary Aggregate Patient History 3-RecordsReturned Reference to records Laboratory Results Specialist Record Hospital Record 2-Reference to Records for Inquiry At HIMSS in 2005 : IHE-XDS Sharing System Shared prototype cross domain content: Medical Summaries (Pre-CCR) Discharge Summaries (CDA-R1) Lab Results (HL7) Other (PDF)

June 28-29, 2005 Interoperability Strategy Workshop 103 community Clinical Encounter Clinical IT System Index of patients records (Document-level) 1-Patient Authorized Inquiry Temporary Aggregate Patient History 3-RecordsReturned Reference to records Laboratory Results Specialist Record Hospital Record 2-Reference to Records for Inquiry Demo a RHIO with IHE at HIMSS 2006 ? Sharing System Secured Sharing of: Medical Summaries Images & reports ECG Reports PDFs Lab Results ? + Notif of Doc Avail.

June 28-29, 2005 Interoperability Strategy Workshop 104 Document Life Cycle Management A two-way relationship between Original and Addendum Document Addendum Document 1 (Approved) Addendum Replacement Document Replacement Document 1 (Deprecated) Document 2 (transform) Transform Document 1 (Approved) A two-way relationship between Original and Replacement Document. A two-way relationship between Original and Transform (alternative format with same scope or DSG). Time Addendum to a registered document Replacing a registered document by a new document Registering an alternate form or a signature for a registered document Time

June 28-29, 2005 Interoperability Strategy Workshop 105 Local & Regional RHIOs Infrastructure and Interoperability Cross-Enterprise Document Sharing (XDS) minimizes clinical data management by the infrastructure. Transparency = Ease of Evolution XDS works with other IHE Integration Profiles: patient Id mgt, security, etc. Flexibility of RHIO configuration With introduction of new Integration Profiles, IHE ready to build regional health networks linking interoperable EHRs. Major milestone for 2006 RHIO projects Goal is to offer a consistent, standards-based and functional for EHRs and other ancillary systems.

June 28-29, 2005 Interoperability Strategy Workshop 106 Creating a Health Information Network with IHE Care Delivery IT system Care Delivery IT system Care Delivery IT system Tier 1 EHRs and Ancillaries

June 28-29, 2005 Interoperability Strategy Workshop 107 Creating a Health Information Network with IHE Care Delivery IT system Care Delivery IT system XDS Document Registry Document Entries Care Delivery IT system Tier 2 Community HIN What and Where ? XDS Document Repository XDS Document Repository XDS Document Repository

June 28-29, 2005 Interoperability Strategy Workshop 108 Creating a Health Information Network with IHE Care Delivery IT system Care Delivery IT system XDS Document Registry C-HIN Patient Identity Source Document Entries PDQ Consumer Care Delivery IT system Tier 2 Community HIN Patient Demo Supplier Patient Id X-Ref Mgr XDS Document Repository XDS Document Repository XDS Document Repository Patient Id X-Ref Mgr Who, What and Where ?

June 28-29, 2005 Interoperability Strategy Workshop 109 Creating a Health Information Network with IHE Care Delivery IT system Care Delivery IT system XDS Document Registry C-HIN Patient Identity Source Document Entries PDQ Consumer Care Delivery IT system Tier 2 Community HIN Patient Demo Supplier Patient Id X-Ref Mgr XDS Document Repository XDS Document Repository XDS Document Repository Patient Id X-Ref Mgr Time Server Who, What When and Where ?

June 28-29, 2005 Interoperability Strategy Workshop 110 Creating a Health Information Network with IHE Care Delivery IT system Care Deliver y IT system XDS Document Registry C-HIN Patient Identity Source Document Entries PDQ Consumer Care Delivery IT system Tier 2 Community HIN Patient Demo Supplier Patient Id X-Ref Mgr XDS Document Repository XDS Document Repository XDS Document Repository Patient Id X-Ref Mgr Time Server Who, What When and Where ? Trusted !

June 28-29, 2005 Interoperability Strategy Workshop 111 Secured Node Document Consumer Retrieve Document Query Documents Patient Identity Source Patient Identity Feed Document Source Document Registry Document Repository Provide&Register Document Se t Register Document Set Secured Node ATNA creates a secured domain: User Accountability (Audit trail) Node-to-Node Access Control Node-level user authentication User access control provided by node BUT Registry/repository based User-Level Access Control and policy agreements is beyond XDS. User-level Access Control is provided by XUA Security for XDS Security for XDS Leverages IHE Audit Trail & Node Authentication A formal Security and Privacy profile is provided for XDS

June 28-29, 2005 Interoperability Strategy Workshop 112 Cross-Enterprise User Authentication Transaction Diagram Identity Provider 2 Request Assertion (of who this user is) 1 XDS Retrieve 3 Request User ID 4 User Identity 5 Authentication Assertion Record Auditable Event ATNA Audit Repository XDS Repository

June 28-29, 2005 Interoperability Strategy Workshop 113 Is it possible to federate multiple XDS-based HIN ? Care Delivery IT system Care Delivery IT system XDS Document Registry C-HIN Patient Identity Source Document Entries PDQ Consum er Care Delivery IT system Tier 2 Community HIN Patient Demo Supplier Patient Id X-Ref Mgr XDS Document Repository XDS Document Repository XDS Document Repository Patient Id X-Ref Mgr Time Server Who, What When and Where ? Trusted ! Care Delivery IT system Care Delivery IT system XDS Document Registry C-HIN Patient Identity Source Document Entries PDQ Consum er Care Delivery IT system Tier 2 Community HIN Patient Demo Supplier Patient Id X-Ref Mgr XDS Document Repository XDS Document Repository XDS Document Repository Patient Id X-Ref Mgr Time Server Who, What When and Where ? Trusted ! Care Delivery IT system Care Delivery IT system XDS Document Registry C-HIN Patient Identity Source Document Entries PDQ Consum er Care Delivery IT system Tier 2 Community HIN Patient Demo Supplier Patient Id X-Ref Mgr XDS Document Repository XDS Document Repository XDS Document Repository Patient Id X-Ref Mgr Time Server Who, What When and Where ? Trusted ! Care Delivery IT system Care Delivery IT system XDS Document Registry C-HIN Patient Identity Source Document Entries PDQ Consum er Care Delivery IT system Tier 2 Community HIN Patient Demo Supplier Patient Id X-Ref Mgr XDS Document Repository XDS Document Repository XDS Document Repository Patient Id X-Ref Mgr Time Server Who, What When and Where ? Trusted ! Care Delivery IT system Care Delivery IT system XDS Document Registry C-HIN Patient Identity Source Document Entries PDQ Consum er Care Delivery IT system Tier 2 Community HIN Patient Demo Supplier Patient Id X-Ref Mgr XDS Document Repository XDS Document Repository XDS Document Repository Patient Id X-Ref Mgr Time Server Who, What When and Where ? Trusted ! Tier2 Community-HINs e.g. XDS Affinity Domain

June 28-29, 2005 Interoperability Strategy Workshop 114 Federating Tier 2 Health Information Networks On IHE Roadmap for 2006-2007: X-Registry Federation (Addressed by ebXML Registry 3.0) Patient / Registry Locator Service Managed Identification Federated Identification T2 C-HIN B e.g. XDS Affinity Domain T2 C-HIN D e.g. XDS Affinity Domain RG What are the document registries where a patient has information ? Tier 3 HIN e.g. State Level

June 28-29, 2005 Interoperability Strategy Workshop 115 Federating Tier 2 Health Information Networks On IHE Roadmap for 2006-2007: X-Registry Federation Patient / Registry Locator Service T2 C-HIN A e.g. IDN Tier 3 HIN e.g. State Level Managed Identification Federated Identification T2 C-HIN B e.g. XDS Affinity Domain T2 C-HIN C e.g. IDN T2 C-HIN D e.g. XDS Affinity Domain RG +Adapt RG Integrating existing IDNs: Adaptor + Registry

June 28-29, 2005 Interoperability Strategy Workshop 116 Federating Tier 3 Health Information Networks On IHE Roadmap for 2006-2007: X-Registry Communication Patient / Registry Locator Service T1-RHIO A e.g. IDN e.g. State HIN T1-RHIO B e.g. XDS Affinity Domain T1-RHIO C e.g. IDN T1-RHIO D e.g. XDS Affinity Domain RG Patient / Registry Locator Service T1-RHIO A e.g. IDN e.g. State HIN T1-RHIO B e.g. XDS Affinity Domain T1-RHIO C e.g. IDN T1-RHIO D e.g. XDS Affinity Domain RG Patient / Registry Locator Service T1-RHIO A e.g. IDN e.g. State HIN T1-RHIO B e.g. XDS Affinity Domain T1-RHIO C e.g. IDN T1-RHIO D e.g. XDS Affinity Domain RG Patient / Registr y Locato r Servic e T1-RHIO A e.g. IDN e.g. State HIN T1-RHIO B e.g. XDS Affinity Domain T1-RHIO C e.g. IDN T1-RHIO D e.g. XDS Affinity Domain RG Patient / Registr y Locato r Servic e T1-RHIO A e.g. IDN e.g. State HIN T1-RHIO B e.g. XDS Affinity Domain T1-RHIO C e.g. IDN T1-RHIO D e.g. XDS Affinity Domain RG Nation-Wide Health Info network (Tier 4)

June 28-29, 2005 Interoperability Strategy Workshop 117 IHE: RHIOs Interoperability Partner IHE offers a solid technical foundation to establish interoperability for RHIOs. Standards-based, open, multi-vendor, provider-led. Yearly progress, validation testing built in, backed by a proven process. Implementation by many vendors. IHE welcomes RHIOs technical architects active involvement. The IHE Technical Framework accelerates RHIOs pilot development ( e.g. XDS Affinity Domain ). This is being applied: Norway, Italy, then Canada, soon USA, France, ?

June 28-29, 2005 Interoperability Strategy Workshop 118 Clinical Encounter Clinical IT System 1-Expression of a need for additional information Index of patients records (Document-level) Temporary Aggregate Patient History 3-DocumentsReturned Document Repositories 4-Patient data presented to Physician 3-Reference to Docs from Inquiry 2- Inquiry for Docs Clinicians access XDS Services through their clinical IT system (EHRs)

June 28-29, 2005 Interoperability Strategy Workshop 119 Sharing Radiology Reports and Images with XDS in a Regional Health Information Network Radiology Enterprise A Radiology Enterprise B Physician Office Regional Health Information Network PACS B PACS A Radiology-to-radiology Radiology-to- Physicians

June 28-29, 2005 Interoperability Strategy Workshop 120 Sharing Radiology Reports and Images in a Regional Health Information Network Radiology Enterprise A Radiology Enterprise B Physician Office Regional Health Information Network Cross- Enterprise Registry Patient Id= 3547F45 Report 5/21/1998 : CT Head B Study 5/21/1998 : CT Head B Report 2/18/2005 : Chest Xray A Study 2/18/2005 : Chest Xray A PACS B PACS A

June 28-29, 2005 Interoperability Strategy Workshop 121 Physicians and Systems within a Regional Health Network - Routine Imaging Referral Radiology Enterprise A Radiology Enterprise B Physician Office Regional Health Information Network Query for Documents Register Imaging Information for sharing Prior imaging Reports & Studies Cross- Enterprise Registry Register Imaging Information for sharing Patient Id= 3547F45 Report 5/21/1998 : CT Head B Study 5/21/1998 : CT Head B

June 28-29, 2005 Interoperability Strategy Workshop 122 Physicians and Systems within a Regional Health Network - Routine Imaging Referral Radiology Enterprise A Radiology Enterprise B Physician Office Regional Health Information Network Register Imaging Information for sharing Cross- Enterprise Registry Notification of Doc Availability Register Imaging Information for sharing

June 28-29, 2005 Interoperability Strategy Workshop 123 Physicians and Systems within a Regional Health Network for a Routine Imaging Referral Radiology Enterprise A Radiology Enterprise B Physician Office Prior Imaging Report & Study Regional Health Information Network Query for documents Imaging Report & Study Cross- Enterprise Registry Patient Id= 3547F45 Report 5/21/1998 : CT Head B Study 5/21/1998 : CT Head B Report 2/18/2005 : Chest Xray A Study 2/18/2005 : Chest Xray A Notification of Doc Availability

June 28-29, 2005 Interoperability Strategy Workshop 124 Regional Health Information Network Images and reports part of a shared health record Enterprise A Enterprise B Physician Office Retrieve Prior Documents Query for Documents Regional Health Information Network Query for documents Retrieve Documents Register Documents for sharing Retrieve Prior Documents Cross- Enterprise Registry Register Documents for sharing Notification of Doc Availability

June 28-29, 2005 Interoperability Strategy Workshop 125 or Lab Results Document Content Format of the Document Content and associated coded vocabulary For Display Document Content Format of the Document Content Requirements for care delivery IT system in a RHIO (e.g. EHR, Lab, Imaging, etc.) 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. Patient Demographics Query Cross-Enterprise Document Sharing Registration, distribution and access across health enterprises of clinical documents forming a patient electronic health record Notification of Document Availability Notification of a remote provider/ health enterprise Imaging Information Sharing Format of the Document Content and associated coded vocabulary Medical Summary Document Content Format of the Document Content and associated coded vocabulary Document Digital Signature Attesting true-copy and origin Patient Identifier Cross-referencing Map patient identifiers across independent identification domains Cross-enterprise User Authentication Authentication & Auditing: Basis for Access Control

June 28-29, 2005 Interoperability Strategy Workshop 126 IHE: Interoperability for RHIOs By starting with a secured document sharing infrastructure, RHIOs have a a platform on which to build clinical content (more structure & coded terminology, specialized content). Solid SAML 2.0 authentication and document digital signature (need a PKI). Practical HL7 V3 approach with CDA-R2 and other content (e.g. imaging, CCR, legacy, PDF, etc.). Establishing a critical mass of products implementations, both in clinical applications and infrastructure for deployment in 2006. An architecture that caters to various RHIOs architectures: centralized, decentralized and mixed (operational decision).

June 28-29, 2005 Interoperability Strategy Workshop 127 Patient Identification Management PDQ Discovery + Local mapping (coexist with PIX) XDS Document Registry XDS Document Repository Patient Identity Source Patient Identification Domain C Patient Identification Domain XAD Patient Identification Domain D2 Document Entry Dm=XAD Pid=Px Patient Demographics Supplier Patient Identity Feed Dm=XAD, Pid=Px Patient Demo Consumer XDS Document Source XDS Doc Dm=XAD Pid=Px Demo graphics XDS Doc Provide&Register Doc Set Patient Demo Consumer XDS Document Consumer Demo graphics Dm=XAD Pid=Px Query Docs