1. HITSP Technical Committee Orientation Joyce Sensmeier MS, RN-BC, CPHIMS, FHIMSS Vice President, Informatics, HIMSS

2. 1 Evaluation of Standards Harmonization Process for HIT Agenda Welcome/Introductions Overview of National Health IT Agenda Relationship between HITSP, HISPC and CCHIT HITSP Mission and Process HITSP Technical Committee Focus/Use Cases Technical Committee Structure/Leadership Technical Committee Terms of Reference Harmonization Process Steps Timeline Overview/Schedule of Meetings Definition of a Standard Standards Readiness Criteria – Tier1, Tier 2 HITSP Framework/Constructs Resources/Tools: ANSI Member Library: http://members.ansi.org/default.aspx http://members.ansi.org/default.aspx ANSI Public Library: www.hitsp.org www.hitsp.org Standing Meetings and Numbers

3. 2 Evaluation of Standards Harmonization Process for HIT In 2005, HHS awarded contracts to seed a public-private effort to build a nationwide health information network

4. 3 Evaluation of Standards Harmonization Process for HIT 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 379 different member organizations and is administered by a Board of Directors 24 SDOs (6%) 308 Non-SDOs (81%) 32 Govt. bodies (9%) 15 Consumer groups (4%) HITSP includes 379 different member organizations and is administered by a Board of Directors 24 SDOs (6%) 308 Non-SDOs (81%) 32 Govt. bodies (9%) 15 Consumer groups (4%)

5. 4 Evaluation of Standards Harmonization Process for HIT 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 More info at: www.hitsp.org

6. 5 Evaluation of Standards Harmonization Process for HIT 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, F. Schrotter, ANSI Program Manager, L. Jones GSI Deputy PM, J Corley, ATI Project Manager, Julie Pooley, Booz Allen Project Management Team Executive in Charge, F. Schrotter, ANSI Program Manager, L. Jones GSI Deputy PM, J 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 are 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

7. 6 Evaluation of Standards Harmonization Process for HIT 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 www.hitsp.org

8. 7 Evaluation of Standards Harmonization Process for HIT HITSP formed Technical Committees to focus on AHIC breakthrough areas Overview/Structure and Current Use Cases  Care Delivery Technical Committee: Care Delivery Technical Committee –EHR - Lab Reporting -- Deploy standardized, widely available, secure solutions for accessing laboratory results and interpretations in a patient-centric manner for clinical care by authorized parties.EHR - Lab Reporting –Emergency Responder – EHR -- Covers the use of the ER-EHR from the perspective of on-site care providers and emergency care clinicians. Definitive care clinicians involved in the care and treatment of emergency incident victims, medical examiner/fatality managers investigating cause of death, and public health practitioners using information contained in the ER-EHR, are included because of their interactions with the other portions of this use case.Emergency Responder – EHR –Medication Management – Focuses on patient medication and allergies information exchange, and the sharing of that information between consumers, clinicians (in multiple sites and settings of care), pharmacists, and organizations that provide health insurance and pharmacy benefits.Medication Management

9. 8 Evaluation of Standards Harmonization Process for HIT  Consumer Empowerment Technical Committee: Consumer Empowerment Technical Committee –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.Consumer Empowerment –Consumer Access to Clinical Information – Includes three scenarios which describe highlights of the processes, roles and information exchanges which could enable a consumer’s access to clinical information via a personal health record (PHR). The three scenarios are: Consumers receive and access clinical information; Consumers create provider lists and establish provider access permissions; and Consumers transfer PHR information.Consumer Access to Clinical Information HITSP formed Technical Committees to focus on AHIC breakthrough areas Overview/Structure and Current Use Cases

10. 9 Evaluation of Standards Harmonization Process for HIT  Population Health Technical Committee: Population Health Technical Committee –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.Biosurveillance –Quality – This use case depicts two scenarios related to quality measurement, feedback and reporting with respect to a patient’s encounter with the healthcare delivery system: quality measurement of hospital-based care and of care provided by clinicians.Quality HITSP formed Technical Committees to focus on AHIC breakthrough areas Overview/Structure and Current Use Cases

11. 10 Evaluation of Standards Harmonization Process for HIT Technical Committees Structure/Leadership  Care Delivery – 185 members –Co-chairs –Allen Hobbs, PhD, Kaiser Permanente, Allen.Hobbs@kp.org Allen.Hobbs@kp.org –Steve Hufnagel, DoD/Medical Health System (MHS), SHufnagel@tiag.net SHufnagel@tiag.net –Steve Wagner, Department of Veterans Affairs, Steve.Wagner@va.gov Steve.Wagner@va.gov  Consumer Empowerment – 180 members –Co-chairs –Mureen Allen, MD, FACP, ActiveHealth Management mallen@activehealth.net mallen@activehealth.net –Charles Parisot, EHR Vendor Association, charles.parisot@med.ge.com charles.parisot@med.ge.com –Scott Robertson, PharmD, Kaiser Permanente, scott.m.robertson@kp.org scott.m.robertson@kp.org

12. 11 Evaluation of Standards Harmonization Process for HIT Technical Committees Structure/Leadership  Population Health – 144 members –Co-chairs –Floyd Eisenberg, MD, MPH, Siemens Medical Solutions, Floyd.Eisenberg@siemens.com Floyd.Eisenberg@siemens.com –Peter Elkin, MD, Mayo Clinic College of Medicine, Elkin.Peter@mayo.edu Elkin.Peter@mayo.edu –Steve Steindel, PhD, Centers for Disease Control & Prevention, sns6@cdc.gov sns6@cdc.gov  Security and Privacy – 127 members –Co-chairs –Glen Marshall, Siemens Medical Solutions, glen.f.marshall@siemens.com glen.f.marshall@siemens.com –John Moehrke, GE Healthcare, John.Moehrke@med.ge.com John.Moehrke@med.ge.com –Walter Suarez, MD, Institute for HIPAA/HIT Education and Research, walter.suarez@sga.us.com walter.suarez@sga.us.com  Total Technical Committee Membership – 399 individuals

13. 12 Evaluation of Standards Harmonization Process for HIT HITSP Coordinating Committees and Leadership  Foundations Committee –Steve Wagner –Bob Dolin  HITSP Process Review Committee –Lynne Gilbertson –Erik Pupo  HITSP-CCHIT Joint Work Group –Jamie Ferguson, Kaiser Permanente CCHIT Orientation Material  Harmonization Readiness Committee –Lynne Gilbertson  Business Plan Committee –Steve Lieber  International Landscape Committee –Bill Braithwaite  Governance Committee – Michael Aisenberg

14. 13 Evaluation of Standards Harmonization Process for HIT HITSP project team and staff supports each Technical Committee  HITSP Technical Committee - Care Delivery –Don Van Syckle, DVS Consulting, don@dvsconsult.com don@dvsconsult.com  HITSP Technical Committee - Consumer Empowerment –John Donnelly, IntePro Solutions, Inc., jtdonnelly@intepro.biz jtdonnelly@intepro.biz –Mike Nusbaum, M.H. Nusbaum & Associates Ltd., michael@mhnusbaum.com michael@mhnusbaum.com  HITSP Technical Committee - Population Health –Lori Reed-Fourquet, e-HealthSign LLC, Lori.fourquet@sbcglobal.net Lori.fourquet@sbcglobal.net  HITSP Cross - Technical Committee Coordination –Bob Yencha, Alschuler Associates, bob@alschulerassociates.com bob@alschulerassociates.com  HITSP Security and Privacy Technical Committee –Johnathan Coleman CISM, CISSP, Security Risk Solutions, Inc., jc@securityrisksolutions.com jc@securityrisksolutions.com –Sarah Quaynor, ANSI, sarah.quaynor@GSIHEALTH.COM sarah.quaynor@GSIHEALTH.COM  HITSP Emergency Responder - EHR Work Group (Care Delivery TC) –Michael Glickman, Computer Network Architects, Inc., mglickman@CNAInc.com mglickman@CNAInc.com –Carl F. Husa, Jr., MA, Patriot Technology, jabberwockycarl@gmail.com jabberwockycarl@gmail.com  HITSP Medication Management Work Group (Consumer Empowerment TC) –Suzi Hines, Principal, Sage Consulting, LLC, sfhines@bellsouth.net sfhines@bellsouth.net

15. 14 Evaluation of Standards Harmonization Process for HIT HITSP 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.

16. 15 Evaluation of Standards Harmonization Process for HIT HITSP Technical Committees Terms of Reference (cont.)  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.

17. 16 Evaluation of Standards Harmonization Process for HIT Security and Privacy Technical Committee Terms of Reference  Harmonize HITSP standards for EHR-Lab reporting, Population Health and Consumer Empowerment with relevant Security and Privacy standards, including the HIPAA Security and Privacy Rules, and basic consents, where appropriate.  Assemble HITSP Security and Privacy Technical Committee (S&PTC) with adequate representation from each TC.  Convene regular meetings of the S&PTC to review current Interoperability Specifications and identify areas of Security and Privacy that were deferred.  Begin work on identifying security standards, approaches, and identifying unresolved issues (e.g. policy issues). Leverage activities of other Security and Privacy related workgroups.  In developing Security and Privacy related content, it will be important to maintain traceability on how existing and emerging HITSP constructs may be affected.

18. 17 Evaluation of Standards Harmonization Process for HIT 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 The actual harmonization process is a series of steps taken by industry stakeholders within the context of HITSP

19. 18 Evaluation of Standards Harmonization Process for HIT Update constructs with S&P NOVDECJAN FEB MAR APR HITSP 2008 Work Plan – TC IS Development 6/16/08 HITSP Board S&P v 1.0 ER-EHR v 1.1, CA Media and Quality v 1.0 and CA Network v 3.0 Construct Dev Comment Comment Resolution Medications Management v 1.0 12/13/07 HITSP Panel 1/23 – 1/25 TC F2F Chicago 3/24 – 3/26 TC F2F DC Area 3/27/08 HITSP Panel 2/11/08 HITSP Board 2/20/08 HITSP Panel WE ARE HERE EHR and BIO v 3.0 RDSS Comment Comment Res 2008 Use Cases v 1.0 MAYJUNEJULYAUGSEPTOCTNOVDECAPR 5/12 – 5/14 TC F2F TBD 6/11 – 6/13 TC F2F DC Area 9/8 – 9/10 TC F2F TBD 10/28 – 10/30 TC F2F Chicago 10/6/08 HITSP Panel 9/29/08 HITSP Board 12/2/08 HITSP Board 12/8/08 HITSP Panel 6/23/08 HITSP Panel IS Development Comment Potential Phase 3 timeline based on receipt of final use cases in mid-March 2008 and based on “standard” 9 to 10 month delivery cycle. Subject to change based on TC analysis of use cases Phase I Use Cases Phase 2 Use Cases Phase 3 Use Cases ? Plan

20. 19 Evaluation of Standards Harmonization Process for HIT HITSP Definition of a Standard  A standard specifies a well-defined approach that supports a business process and: (1) has been agreed upon by a group of experts; (2) has been publicly vetted; (3) provides rules, guidelines, or characteristics; (4) helps to ensure that materials, products, processes, and services are fit for their intended purpose; (5) is available in an accessible format; and (6) is subject to an ongoing review and revision process.

21. 20 Evaluation of Standards Harmonization Process for HIT  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. 21 Evaluation of Standards Harmonization Process for HIT 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. 22 Evaluation of Standards Harmonization Process for HIT 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.  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.

24. 23 Evaluation of Standards Harmonization Process for HIT HITSP Framework

25. 24 Evaluation of Standards Harmonization Process for HIT LevelDefinitionExampleRules Use Case or Harmonization Request  Defines business/functional requirements  Sets Context  ONC EHR- Lab 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 – Lab Interoperability Specification (IS01)  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

26. 25 Evaluation of Standards Harmonization Process for HIT 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

27. 26 Evaluation of Standards Harmonization Process for HIT Familiarization with existing HITSP Constructs  Document Naming Convention: [Document Type]_HITSP_[Document Number]_[Version]_[year]_[Short_Title]_[Date] Example: IS_HITSP_02_v1.2_2006_Biosurveillance_10202006.pdf Document Type: IS (Interoperability Specification) Document Number: 02 Version:1.2 Year:2006 Short Title:Biosurveillance Date:October 20 th, 2006  Document Types: IS: Interoperability Specification ISTP: Transaction Package IST:Transaction ISC:Component  Collectively known as “Constructs”

28. 27 Evaluation of Standards Harmonization Process for HIT Familiarization with existing HITSP Constructs  There are three approved Interoperability Specifications: –IS-01 v1.2EHR-Lab-Result-Reporting –IS-02 v1.2Biosurveillance –IS-03 v1.2Consumer Empowerment  There is also a high-level Executive Summary of the three main ISsExecutive Summary  Each IS has a number of HITSP Constructs which it calls upon to describe the implementation of lower level, specific interactions  The beginning of each IS contains a diagrammatic overview of the lower level constructs it calls upon and their relationship to the IS

29. 28 Evaluation of Standards Harmonization Process for HIT Technical Committee Resources  The ANSI Public Document Library is used for publicly posting completed works and related materials. It can be found on the “Document Library” links from the main HITSP site: www.hitsp.orgwww.hitsp.org  HITSP Interoperability Specifications (ISs) and Executive Summary can also found at www.hitsp.org which links to them directly. www.hitsp.org  The Use Cases are located in the Public Document Library in the following link: –AHIC Harmonized Use CasesAHIC Harmonized Use Cases –The Members Document Library is used for works in progress and can be found at: – http://members.ansi.org/sites/http://members.ansi.org/sites/ –Login using: ANSI_Membership\{your ANSI assigned user ID} –Password: {your ANSI assigned password}  Technical Committees have standing meeting times with dedicated conference bridge lines supported by various web-based collaboration tools including: –GoToMeeting: Up to 26 participants; “Meet Now” capability –GoToWebinar: Up to 1001 participants; Survey, Poll and Q &A Capabilities

30. 29 Evaluation of Standards Harmonization Process for HIT Technical Committee Resources  Standing Conference Calls all scheduled for the TCs and Work Groups as follows:  For all standing meetings: Dial in: 1-866-469-3239  Consumer Empowerment: Every Monday 12:00pm to 1:00 pm EST –Participant code: 67737291  Care Delivery, ER-EHR: Every Monday from 3:00 -5:00pm EST. –Participant code: 57455041  Care Delivery, Medication Management: Every Thursday from 2:00 -4:00pm EST. –Participant code: 88796841  Population Health: Every Monday from 1:00 -3:00 pm EST. –Participant code: 64035221  Security and Privacy: Every Thursday from 1:00-2:00pm EST –Participant code: 67278751  Security and Privacy, Identity Credentials Management Work Group: Every Wednesday from 2:00- 3:00pm EST –Participant code: 67278751

31. 30 Evaluation of Standards Harmonization Process for HIT Troubleshooting  For Technical Committee related questions please contact your TC facilitators or: Joyce Sensmeier MS, RN-BC, CPHIMS, FHIMSS Vice President, Informatics HIMSS 230 East Ohio, Suite 500 Chicago, IL 60611-3269 Phone: 312-915-9281 email: jsensmeier@himss.orgjsensmeier@himss.org Theresa Wisdom, MBA, RHIA Manager, Standards Harmonization HIMSS 230 East Ohio, Suite 500 Chicago, IL 60611-3269 Phone: 312-915-9513 email: twisdom@himss.orgtwisdom@himss.org Jessica Kant Coordinator, Standards Harmonization Healthcare Information & Management Systems Society 230 E. Ohio St., Suite 500 Chicago, IL 60611 Phone: 312-915-9283 Fax: 312-915-9511 email: jkant@himss.orgjkant@himss.org  For ANSI Document Library related questions please contact: Alison Ziegler Program Administrator, Standards Panels American National Standards Institute 25 West 43rd Street New York, NY 10036 Phone: 212-642.4947 email: aziegler@ansi.orgaziegler@ansi.org

32. 31 Evaluation of Standards Harmonization Process for HIT Questions? Thank you for volunteering to participate in HITSP. We cannot succeed without you!