Achieving Breakthroughs Towards Health Information Exchange

1. Achieving Breakthroughs Towards Health Information Exchange 17th Annual Summer Institute in Nursing Informatics July 20, 2007 Joyce Sensmeier MS, RN-BC, CPHIMS, FHIMSS

2. Objectives • Examine the role of standards in providing a foundation for interoperability • Describe the current landscape for health information exchange • Explore the potential impact of the HITSP Interoperability Specifications on consumers and healthcare systems

3. Globally Recognized Standards: Critical to Improvements in Healthcare Delivery • Standards • Establish a common terminology • Facilitate interoperability and integration • Create structured information models for data structure and interchange • Enhance security and privacy

4. Standards: Necessary… not Sufficient • Standards are: • Foundational - to 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

5. What is Interoperability? The ability of two or more systems or componentsto exchange informationand touse the informationthat has been exchanged. Semantic Interoperability IEEE dictionary Functional Interoperability

6. Current Landscape: Disparate vendor systems, applications, and connectivity suites • Historically, “unique” market needs within the healthcare community were addressed with customized systems, applications and standards • More than a dozen standards-setting organizations – from ANSI-accredited bodies to industry consortia and other forums – have developed a plethora of standards to meet the needs of specific sectors within the healthcare IT market • However, the disparate messaging systems, data elements and vocabulary now prevent the cross-system exchange of health information. Content, structure and transmission methods are all in HITSP scope

7. Impact on Healthcare IT • Technology trends can no longer develop in a void • Systems must connect with each other • Organizational • Local • National • Global • Public/Private partnerships needed

8. Standards Harmonization In 2005, HHS awarded contracts to seed a public-private effort to build a nationwide health information network

9. The Certification Commission for Healthcare Information Technology (CCHIT) Healthcare Information Technology Standards Panel (HITSP) American Health Information Community The Health Information Security and Privacy Collaboration (HISPC) Nationwide Health Information Network Architecture Projects(NHIN) A public-private “Community” was then established to serve as the focal point for America’s health information concerns and drive opportunities for increasing interoperability HITSP includes 351 different member organizations and is administered by a Board of Directors 24 SDOs (7%) 248 Non-SDOs (71%) 30 Govt. bodies (9%) 13 Consumer groups (3%) 36 Project Team and Undeclared (10%) The Community is a federally-chartered commission and will provide input and recommendations to HHS on how to make health records digital and interoperable, and assure that the privacy and security of those records are protected, in a smooth, market-led way.

10. Presidents Executive Order For Immediate ReleaseOffice of the Press SecretaryAugust 22, 2006 Executive Order: Promoting Quality and Efficient Health Care in Federal Government Administered or Sponsored Health Care Programs Sec. 3. Directives for Agencies. Agencies shall perform the following functions: Health Information Technology - For Federal Agencies. As each agency implements, acquires, or upgrades health information technology systems used for the direct exchange of health information between agencies and with non-Federal entities, it shall utilize, where available, health information technology systems and products that meet recognized interoperability standards.

11. What is the Healthcare Information Technology Standards Panel? • The Healthcare Information Technology Standards Panel (HITSP) is a volunteer, consensus-driven organization • The Panel brings together experts from across the healthcare community – from consumers to doctors, nurses, and hospitals; from those who develop healthcare IT products to those who use them; and from the government agencies who monitor the U.S. healthcare system to those organizations who are actually writing the standards

12. The HITSP team is charged with completing eleven different tasks, with current efforts focused on the harmonization process Eleven Tasks included in this contract: • Comprehensive Work Plan • Conduct a Project Start Up Meeting • Deliver Recommended Use-Cases • Participate in related meetings and activities, including the AHIC Meetings • Develop a Gap Analysis • Standards Selection, Evaluations and Testing • Define a Harmonization Approach • Develop Interoperability Specifications • Develop and Evaluate a Business Plan for the self-sustaining processes • Submit Monthly Reports – ongoing efforts • Assist with communications – ongoing efforts The Community HHS Secretary Mike Leavitt, Chair HHS ONCHIT1 PO, Dr. John Loonsk HITSP Dr. John Halamka, Chair Member populated Technical Committees Project Management Team Executive in Charge, Fran Schrotter, ANSI Program Manager, Leroy Jones GSI Deputy PM, Jack Corley, ATI Project Manager, Julie Pooley, Booz Allen Harmonization Process Definition Technical Manager Michelle Deane, ANSI Harmonization Process Delivery Technical Manager Joyce Sensmeier, HIMSS

13. Identify a pool of standards for a general breakthrough area Identify gaps and overlaps for a specific context Make recommendations to the HITSP for resolution of gaps and overlaps Develop interoperability specifications for using the selected standard for a specific context Test the instruction for using the standard HITSP Standards Harmonization Process Mission: To harmonize relevant standards in the health care industry to enable and advance interoperability The standards harmonization process is an open, inclusive, collaborative, use case driven process www.hitsp.org

14. What is a Standard? • A standard specifies a well defined approach that supports a business process and . . . • has been agreed upon by a group of experts • has been publicly vetted • provides rules, guidelines, or characteristics • helps to ensure that materials, products, processes and services are fit for their intended purpose • is available in an accessible format • is subject to ongoing review and revision process • Harmonization is required when a proliferation of standards preventsprogress rather than enables it HITSP Definition

15. HITSP formed Technical Committees to focus on AHIC breakthrough areas - Initial focus is on 4 use cases Current Focus • Biosurveillance -- Transmit essential ambulatory care and emergency department visit, utilization, and lab result data from electronically enabled health care delivery and public health systems in standardized and anonymized format to authorized public health agencies with less than one day lag time. • Consumer Empowerment -- Deploy to targeted populations a pre-populated, consumer-directed and secure electronic registration summary. Deploy a widely available pre-populated medication history linked to the registration summary. • Electronic Health Records -- Deploy standardized, widely available, secure solutions for accessing laboratory results and interpretations in a patient-centric manner for clinical care by authorized parties. • Emergency Response EHR – Describes the role that an emergency responder electronic health record, comprising at minimum demographics, medication, allergy and problem list information, can be used to support emergency and routine health care activities.

16. HITSP Technical Committees and Leadership • HITSP Technical Committee - Care Delivery • James Ferguson, Kaiser Permanente • Steve Hufnagel, Department of Defense/Medical Health System • Steve Wagner, Department of Veterans Affairs • HITSP Technical Committee - Consumer Empowerment • Elaine Blechman, PhD, University of Colorado, Boulder • Charles Parisot, EHR Vendor Association • Scott Robertson, Kaiser Permanente • HITSP Technical Committee- Population Health • Floyd Eisenberg, MD, MPH, Siemens Medical Solutions • Peter Elkin, MD, Mayo Clinic College of Medicine • Shaun Grannis, MD, Department of Family Medicine, Indiana University School of Medicine • HITSP Technical Committee – Security and Privacy • Glen Marshall, Siemens Medical Solutions • John Moehrke, GE Healthcare • Walter Suarez, MD, Institute for HIPAA/HIT Education and Research

17. Coordinating Committees • Harmonization Readiness • Lynn Gilbertson, convener • Develop appropriateness criteria • Business Sustainability • Steve Lieber, convener • Develop a business model that will sustain the HITSP for as long as standards harmonization and coordination is necessary • International Standards Landscape • Bill Braithwaithe, convener • Lessons learned from the UK, Canada, Sweden • Foundations • Steve Wagner & Bob Dolin, conveners • Recommend a long-term direction for achieving standards harmonization, collaboration and coordination

18. Technical Committees Terms of Reference • Perform high level Requirements Analysis and Design of HITSP Interoperability Specifications, transaction packages, transactions, components, constructs including requirements analysis, and minimum data set • Identify and analyze gaps and duplications within the standards industry as they are related to each specific Use Case • Provide a description of the gaps, including missing or incomplete standards • Provide a description of the duplications, overlaps, or competition among standards for the relevant Use Case • Review and scope statements of work for each new Use Case

19. Technical Committees Terms of Reference • Provide a listing of all standards that satisfy the requirements imposed by the relevant use cases as well as readiness criteria that shall be used to evaluate the standard • Select and evaluate recommended standards to meet the relevant Use Case • Develop, review and evaluate ‘interoperability specifications’ for the selected standards • Submit recommendations to HITSP for review, approval and resolution • Ensure timely response and disposition of comments • Ensure on-going process for addressing corrections/change requests and resolutions

20. Security and Privacy Terms of Reference • Harmonize HITSP standards for EHR-Lab reporting, Population Health and Consumer Empowerment Use Cases with relevant Security and Privacy standards, including the HIPAA Security and Privacy Rules, and basic consents, where appropriate. • Review current Interoperability Specifications and identify areas of Security and Privacy that were deferred. • Identify security standards, approaches, and unresolved issues (e.g. policy issues) • Maintain traceability on how existing and emerging HITSP constructs may be affected when developing Security and Privacy content

21. Harmonization Process Steps ReceiveRequest VII InspectionTest VIIIInteroperabilitySpecificationReleaseandDissemination II RequirementsAnalysis V Standards Selection VI ConstructionofInteroperabilitySpecification III Identificationof CandidateStandards IV Gaps,Duplicationsand Overlaps Resolution I Harmonization Request IXProgram Management BeginSupport

22. Tier 1 Standards Readiness Criteria • The standards required to support each major Use Case event were organized within an agreed upon standards taxonomy • The standards selected for inclusion in the pool were examined using ‘HITSP approved’ Tier 1 and Tier 2 Harmonization Readiness Criteria

23. Tier 2 Standards Readiness Criteria • Suitability • The standard is named at a proper level of specificity and meets technical and business criteria of use case • Compatibility • The standard shares common context, information exchange structures, content or data elements, security and processes with other HITSP harmonized standards or adopted frameworks as appropriate • Preferred Standards Characteristics • Approved standards, widely used, readily available, technology neutral, supporting uniformity, demonstrating flexibility and international usage are preferred • Standards Development Organization and Process • Meet selected criteria including balance, transparency, developer due process, stewardship and others. • Total Costs and Ease of ImplementationDeferred to future work

24. HITSP Interoperability Specifications Vocabulary Messaging www.hhs.gov/fedhealtharch/standards.html

25. Standards Harmonization Objectives • In order to achieve the primary goal of full healthcare interoperability, harmonization must be achieved in five major areas: • Context/Information Model – establishing a common reference information model to support clinical, public health, financial, and administrative healthcare functions • Terminology/Content Definition – establishing common reference terminology models and data content specifications that are integrated with the information model • Privacy and Security – establishing a common security framework • Methodology – establishing a common methodology/process that all standards organizations and code set maintainers will follow to achieve standards harmonization • Information Interchange – establishing a common information interchange format and standards-based application roles and interactions in a comprehensive dynamic model • Achievement creates a Common Standards Harmonization Framework

26. HITSP receives Use Cases and Harmonization Requests from external sources, such as AHIC and ONC. The Use Case or Request defines scenarios, business actors, and business and functional/interoperability requirements. HITSP decomposes the Use Case requirements into scenario(s) and then into transactions providing context: technical actors, actions and content. It may create or reuse a transaction or a grouping of transactions (transaction package) based on commonality at this level. Transactions are logical groupings of actions that are decomposed into components, which are groupings of base standards that work together, such as message and terminology. HITSP Framework – Basis for Interoperability Specification Template

27. Each HITSP construct, i.e., transaction package, transaction or component, may constrain the construct or standard below it. Constraints follow a strict hierarchy and are only imposed by the next higher construct. Transaction packages, transactions and components all are potential candidates for reuse if a new set of requirements and context are successfully fulfilled by the existing construct. While reuse is a HITSP goal, it is established in the context of a Use Case and its functional/interoperability requirements. HITSP constructs are version controlled and, if reused, will be uniquely identified. HITSP Framework - Basis for Interoperability Specification Template

28. Policy Makers and Industry Use Case D e f i n e s a n d N a r r o w s C o n InteroperabilitySpecification t e x t HITSP Transaction Package t x e Transaction t n o C Package r e Composite ( ) h t O Standard n Transaction i e Composite ( ) Component s u e Standard R Component r o f Composite ( ) l a i Standard t n e t o P Base Base Base Base Base Base Base Base Base Standard Standard Standard Standard Standard Standard Standard Standard Standard # 1 # 2 # 3 # 4 # 5 # 6 # 7 # 8 # 9 HITSPFramework

29. Definitions and Rules

30. Definitions and Rules (cont.)

31. Harmonization Initiatives: Laying the Foundation for the NHIN • HITSP members and experts have committed themselves to setting and implementing standards that will ensure the integrity and interoperability of health data • In some cases, redundant or duplicative standards will be eliminated • In other cases, new standards may be established to span information gaps • In all cases, the resulting standards serve the consumer and other healthcare stakeholders by addressing issues such as data accessibility, privacy and security

32. What did HITSP do in 2006? • Established the HITSP Organization and its Committees • Created the standards harmonization process including all coordinating committee sub-processes • Harmonized 3 Use Cases and resolved three controversies along the way • To resolve CCR v. CDA, the CCD was successfully balloted • To resolve the need for Interim standards we accelerated CCD • To resolve HL7 2.4 v. 2.5, ELINCS will be maintained by HL7 and an HL7 2.51 version of ELINCS will be completed by Summer 2007 • To align HITSP interoperability specifications with CCHIT functional criteria, the CCHIT/HITSP Joint Working group is establishing a joint timeline for the next 3 years

33. Interoperability Specification Process • The specifications are intended to be used by architects and system designers as a way to guide future implementation efforts based on health IT • The specifications represent an ongoing effort to create a framework/template that represents a solution set for solving the known problems related to a Use Case

34. EHR- Lab Results Reporting Interoperability Specification

35. Biosurveillance Interoperability Specification

36. Consumer Empowerment Interoperability Specification

37. HITSP Recommended Standards – Electronic Health Record • Clinical Laboratory Improvement Amendments (CLIA) • Health Insurance Portability and Accountability Act (HIPAA) • Health Level Seven (HL7) CDA R2 – HL7 Clinical Document Architecture Release 2 • Health Level Seven (HL7) v. 2.5, 3.0 • Hypertext Transfer Protocol Secure (HTTPS) • IHE-XDS Lab – IHE Laboratory Report Document Sharing • IHE-PIX – IHE Patient Identification Cross-Referencing • IHE-PDQ – IHE Patient Demographics Query • International Organization for Standardization (ISO) ebXML • Logical Observation Identifiers Names and Codes (LOINC) • Systematized Nomenclature of Medicine – Clinical Terms (SNOMED – CT) • Unified Code for Units of Measure (UCUM)

38. HITSP Recommended Standards - Biosurveillance • Clinical Care Classification (CCC) formerly Home Healthcare Classification System • Clinical Laboratory Improvement Amendments (CLIA) • Current Procedural Terminology (CPT-4) • Federal Information Processing Standards (FIPS) • Healthcare Common Procedure Coding System (HCPCS) • Health Insurance Portability and Accountability Act (HIPAA) • Health Level Seven (HL7) v. 2.5 • Health Level Seven (HL7) Version 3.0 Clinical Document Architecture (CDA) • ICD-9CM – International Classification of Diseases v. 9 Clinical Modifications & ICD-10 CM – Diagnoses and Procedures • IHE-XDS – Integrating the Healthcare Enterprise (IHE) Cross-Enterprise Document Sharing • IHE-XDS Lab – IHE Laboratory Report Document Sharing

39. HITSP Recommended Standards - Biosurveillance • IHE-RFD – IHE Retrieve Form for Data Capture • IHE-PIX – IHE Patient Identification Cross-Referencing • IHE-RAD – XDS-I – IHE Cross-Enterprise Sharing of Images • IHE-NAV – IHE Notification of Document Availability • IHE-XDS-MS – IHE Medical Summary Document Sharing • ISO/TC215 -DTS 25237 - Health Informatics Pseudonymization • LOINC – Logical Observation Identifiers Names and Codes • National Uniform Billing Committee (NUBC) UB-92 Patient Discharge Status • NCCLS – National Committee for Clinical Laboratory Standards • OASIS – Emergency Data Exchange Language (EDXL) • RxNorm – National Library of Medicine (UMLS) • Systematized Nomenclature of Medicine – Clinical Terms (SNOMED – CT) • Unified Code for Units of Measure (UCUM)

40. HITSP Recommended Standards – Consumer Empowerment • American Standards Committee (ASC) X12 Insurance/financial • CDC Race and Ethnicity Code Sets • Federal Medication Terminologies • Healthcare Provider Taxonomy • IHE-XDS – IHE Cross-Enterprise Document Sharing • IHE-PIX – IHE Patient Identification Cross-Referencing • IHE-PDQ – IHE Patient Demographics Query • Health Level Seven (HL7) CDA R2 – HL7 Clinical Document Architecture Release 2 • HL7 CCD – HL7 Clinical Document Architecture Release 2 and ASTM E 2369-05 Standard Specification for Continuity of Care Record (CCR) • HL7 v. 2.5, 3.0 • HL7 EHR Systems Functional Model Draft Standard for Trial Use (DSTU) • Logical Observation Identifiers Names and Codes (LOINC) • National Council for Prescription Drug Programs (NCPDP)

41. Impact of 2006 HITSP Interoperability Specifications HHS Secretary Michael Leavitt.. - “Accepted” all three HITSP Interoperability Specifications – December 2006 - Will “recognize” them in December 2007 assuming “minor changes of a technical nature” - “Recognition” triggers Executive Order expectations - Several states including Texas have introduced laws to require implementation of HITSP Interoperability Standards

42. For Federal Agencies – As each agency implements, acquires, or upgrades health information technology systems used for the direct exchange of health information between agencies and with non-Federal entities, it shall utilize, where available, health information technology systems and products that meet recognized interoperability standards. August 22, 2006 President’s Executive Order For Contracting PurposesEach agency shall require in contracts or agreements with health care providers, health plans, or health insurance issuers that as each provider, plan, or issuer implements, acquires, or upgrades health information technology systems, it shall utilize, where available, health information technology systems and products that meet recognized interoperability standards. GEORGE W. BUSH, THE WHITE HOUSE

43. Privacy and Security standards Emergency First Responder Emergency summary record exchange Provider authentication, authorization and credentialing Consumer Access to Clinical Information Lab results as needed by patient List of conditions and allergies Health problems Diagnosis codes Medication Management Medication reconciliation Pharmacy/Allergy Monitoring of medications Quality Inpatient Quality Measures (core set) Ambulatory measures (core set) Clinician access (self-assessment) Public reporting 2007 – The second turn of the crank

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

45. www.hitsp.org www.hhs.gov/healthit/ Resources • 3 Interoperability Specifications: • IS-01 v2.0 EHR-Lab-Result-Reporting • IS-02 v2.0 Biosurveillance • IS-03 v2.0 Consumer Empowerment • ER-EHR Requirements, Design and Standards Selection (RDSS) • Security and Privacy Requirements, Design and Standards Selection (RDSS) • High Level Executive Summary

46. Thank you! Questions?

47. Contact Information Joyce Sensmeier MS, RN-BC, CPHIMS, FHIMSS Vice President, Informatics Healthcare Information and Management Systems Society (HIMSS) 230 East Ohio, Suite 500 Chicago, IL 60611 312-915-9281 jsensmeier@himss.org