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

1 Healthcare Information Technology Standards Panel 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

2 Healthcare Information Technology Standards Panel 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

3 Healthcare Information Technology Standards Panel 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

4 Healthcare Information Technology Standards Panel The ability of two or more systems or components to exchange information and to use the information that has been exchanged. Functional Interoperability Semantic Interoperability IEEE dictionary What is Interoperability?

5 Healthcare Information Technology Standards Panel 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

6 Healthcare Information Technology Standards Panel 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

7 Healthcare Information Technology Standards Panel In 2005, HHS awarded contracts to seed a public-private effort to build a nationwide health information network Standards Harmonization

8 Healthcare Information Technology Standards Panel 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 Healthcare Information Technology Standards Panel (HITSP) Nationwide Health Information Network Architecture Projects (NHIN) The Health Information Security and Privacy Collaboration (HISPC) The Certification Commission for Healthcare Information Technology (CCHIT) American Health Information Community 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. 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%) 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%)

9 Healthcare Information Technology Standards Panel Presidents Executive Order For Immediate Release Office of the Press Secretary August 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.

10 Healthcare Information Technology Standards Panel 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

11 Healthcare Information Technology Standards Panel The HITSP team is charged with completing eleven different tasks, with current efforts focused on the harmonization process The Community HHS Secretary Mike Leavitt, Chair 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 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 Delivery Technical Manager Joyce Sensmeier, HIMSS Harmonization Process Delivery Technical Manager Joyce Sensmeier, HIMSS Harmonization Process Definition Technical Manager Michelle Deane, ANSI Harmonization Process Definition Technical Manager Michelle Deane, ANSI HHS ONCHIT1 PO, Dr. John Loonsk HHS ONCHIT1 PO, Dr. John Loonsk HITSP Dr. John Halamka, Chair Member populated Technical Committees Eleven Tasks included in this contract: 1.Comprehensive Work Plan 2.Conduct a Project Start Up Meeting 3.Deliver Recommended Use-Cases 4.Participate in related meetings and activities, including the AHIC Meetings 5.Develop a Gap Analysis 6.Standards Selection, Evaluations and Testing 7.Define a Harmonization Approach 8.Develop Interoperability Specifications 9.Develop and Evaluate a Business Plan for the self-sustaining processes 10.Submit Monthly Reports – ongoing efforts 11.Assist with communications – ongoing efforts

12 Healthcare Information Technology Standards Panel HITSP Standards Harmonization Process 1.Identify a pool of standards for a general breakthrough area 2.Identify gaps and overlaps for a specific context 3.Make recommendations to the HITSP for resolution of gaps and overlaps 4.Develop interoperability specifications for using the selected standard for a specific context 5.Test the instruction for using the standard 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

13 Healthcare Information Technology Standards Panel 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 prevents progress rather than enables it HITSP Definition

14 Healthcare Information Technology Standards Panel HITSP formed Technical Committees to focus on AHIC breakthrough areas - Initial focus is on 4 use cases  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. Current Focus

15 Healthcare Information Technology Standards Panel 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

16 Healthcare Information Technology Standards Panel 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

17 Healthcare Information Technology Standards Panel 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

18 Healthcare Information Technology Standards Panel 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

19 Healthcare Information Technology Standards Panel 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

20 Healthcare Information Technology Standards Panel I Harmonization Request 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 Harmonization Process Steps

21 Healthcare Information Technology Standards Panel  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 Tier 1 Standards Readiness Criteria

22 Healthcare Information Technology Standards Panel 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 Implementation Deferred to future work

23 Healthcare Information Technology Standards Panel Vocabulary Messaging HITSP Interoperability Specifications

24 Healthcare Information Technology Standards Panel 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

25 Healthcare Information Technology Standards Panel HITSP Framework – Basis for Interoperability Specification Template  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.

26 Healthcare Information Technology Standards Panel HITSP Framework - Basis for Interoperability Specification Template  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.

27 Healthcare Information Technology Standards Panel HITSP Framework Use Case Interoperability Specification Transaction Component Base Standard #1 Base Standard # 2 Base Standard # 3 Transaction Package Package ( Composite ) Standard Component ( Composite ) Standard Transaction ( Composite ) Standard P o t e n t i a l f o r R e u s e i n O t h e r C o n t e x t D e f i n e s a n d N a r r o w s C o n t e x t Policy Makers and Industry Base Standard # 4 HITSP Base Standard # 6 Base Standard # 7 Base Standard # 8 Base Standard #9 Base Standard # 5

28 Healthcare Information Technology Standards Panel LevelDefinitionExampleRules Use Case or Harmonization Request  Defines business/functional requirements  Sets Context  EHR Use Case Interoperability Specification  Models business/ functional/ interoperability requirements  Identifies technical/system requirements to meet use-case  Identifies how to use one or more HITSP constructs to meet use-case requirements  HITSP EHR Interoperability Specification  Based on UML diagram to identify technical actors and actions  Sets context  Testable functional requirements  Ids transactions or transaction packages Transaction Package  Defines how two or more transactions are used to support a stand-alone information interchange within a defined context between two or more systems  Record Locator Service  Entity Identification Service  Thin context and interoperability requirements  Testable  Based on analysis of like technical actors, context and content harmonized across transactions  May be fulfilled by one or more transactions or composite standard  Expresses constraints on the transactions or composite standard Transaction  Logical grouping of actions, including necessary content and context, that must all succeed or fail as a group.  Query lab result  Send lab result  Fulfills all actions between two or more systems needed to meet one or more interoperability requirements  Testable  May be fulfilled by components or composite standard  Expresses constraints on components or composite standard Definitions and Rules

29 Healthcare Information Technology Standards Panel Definitions and Rules (cont.) LevelDefinitionExampleRules Component  An atomic construct used to support an information interchange or to meet an infrastructure requirement (e.g., security, logging/audit)  Lab result message  Lab result context  Typically will use one “primary” standard and may have other “secondary” standards  Expresses constraints on base or composite standards Base Standard  A standard capable of fulfilling a discrete function within a single category produced and maintained by a single standards organization.  Messaging standard  Security standard  Code set. Per HITSP definition the term “standard” refers, but is not limited to,: –Specifications –Implementation Guides –Code Sets –Terminologies –Integration Profiles Composite Standard  Grouping of coordinated base standards, often from multiple standards organizations, maintained by a single organization. In HITSP, it can serve as a component, transaction or transaction package functional requirements..  Integration profiles  Implementation guides  Health transaction services Per Definition above

30 Healthcare Information Technology Standards Panel 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

31 Healthcare Information Technology Standards Panel 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 HL 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

32 Healthcare Information Technology Standards Panel 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

33 Healthcare Information Technology Standards Panel EHR- Lab Results Reporting Interoperability Specification

34 Healthcare Information Technology Standards Panel Biosurveillance Interoperability Specification

35 Healthcare Information Technology Standards Panel Consumer Empowerment Interoperability Specification

36 Healthcare Information Technology Standards Panel 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)

37 Healthcare Information Technology Standards Panel 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

38 Healthcare Information Technology Standards Panel 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 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)

39 Healthcare Information Technology Standards Panel 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 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)

40 Healthcare Information Technology Standards Panel HHS Secretary Michael Leavitt.. - “Accepted” all three HITSP Interoperability Specifications – December 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 Impact of 2006 HITSP Interoperability Specifications

41 Healthcare Information Technology Standards Panel 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. For Contracting Purposes Each 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. August 22, 2006 President’s Executive Order GEORGE W. BUSH, THE WHITE HOUSE

42 Healthcare Information Technology Standards Panel 2007 – The second turn of the crank  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

43 Healthcare Information Technology Standards Panel JANFEBMARAPRMAYJUNJULAUGSEPOCTNOVDEC HITSP 2007 Work Plan and Schedule Overview (as of May 2007) 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 S&P and EHR-ER v 1.0 Requirements, Design, Standards Selection Public Input on S&P 05/17 – 06/14

44 Healthcare Information Technology Standards Panel Resources  3 Interoperability Specifications:  IS-01 v2.0EHR-Lab-Result-Reporting  IS-02 v2.0Biosurveillance  IS-03 v2.0Consumer Empowerment  ER-EHR Requirements, Design and Standards Selection (RDSS)  Security and Privacy Requirements, Design and Standards Selection (RDSS)  High Level Executive Summary

45 Healthcare Information Technology Standards Panel Questions? Thank you!

46 Healthcare Information Technology Standards Panel 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