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Healthcare Information Technology Standards Panel (HITSP) Overview HIMSS Advocacy & Public Policy Steering Committee Joyce Sensmeier MS, RN, BC, CPHIMS, FHIMSS HIMSS Vice President Informatics August 25, 2006 The purpose of this presentation is to orient the Committee by providing. . . Information about the formation of HITSP An overview of the HITSP Harmonization Process Schedule and next steps 1 In 2005, HHS awarded contracts to seed a public-private effort to build a national health information network 2 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 The Certification Commission for Health Information Technology (CCHIT) Healthcare Information Technology Standards Panel (HITSP) HITSP includes 206 different member organizations and is administered by a Board of Directors 17 SDOs (8%) 161 Non-SDOs (79%) 18 Govt. bodies (8%) 10 Consumer groups (5%) American Health Information Community The Health Information Security and Privacy Collaboration (HISPC) National Health Information Network (NHIN) Architecture Projects 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. 3 The Community formed workgroups to focus on four breakthrough areas HITSP 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 Record Exchange -- Deploy standardized, widely available, secure solutions for accessing laboratory results and interpretations in a patient-centric manner for clinical care by authorized parties. Chronic Care – Ensure that widespread use of secure messaging, as appropriate, is fostered as a means of communication between clinicians and patients about care delivery 4 The HITSP team was charged with completing eleven different tasks, with current efforts focused on the harmonization process Eleven Tasks are included in this contract: The Community HHS Secretary Mike Leavitt, Chair 1. Comprehensive Work Plan HHS ONCHIT1 PO, Dr. John Loonsk HITSP Dr. John Halamka, Chair Member populated Technical Committees Project Management Team Executive in Charge, F. Schrotter, ANSI Program Manager, L. Jones GSI Deputy PM, J Corley, ATI Project Manager, C Fantaskey, Booz Allen Harmonization Process Definition Technical Manager Michelle Deane, ANSI Harmonization Process Delivery Technical Manager Joyce Sensmeier, HIMSS 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 5 The HITSP process is an open, inclusive, and collaborative process The Community selects breakthrough areas to be worked across ONC contracts The HITSP then charters Technical Committees to address each break through – 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 instructions for using the selected standard for a specific context – Test the interoperability specifications for using the standard A call for participation is announced to all HITSP members 6 HITSP Technical Committees Overview •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. •63 members •Consumer Empowerment •61 members •Electronic Health Record •77 members Floyd P. Eisenberg, MD MPH, SIEMENS Medical Solutions Health Services Peter L. Elkin MD FACP, Mayo Clinic College of Medicine Shaun Grannis, MD, The Regenstrief Institute, Indiana University School of Medicine Allow consumers to establish and manage permissions access rights and informed consent for authorized and secure exchange, viewing, and querying of their linked patient registration summaries and medication histories between designated caregivers and other health professionals. Elaine A. Blechman PhD, Professor, Univ. of ColoradoBoulder Charles Parisot, EHR Vendor Association Allow ordering clinicians to electronically access laboratory results, and allow nonordering authorized clinicians to electronically access historical and other laboratory results for clinical care. Jamie Ferguson, KaiserPermanente John Madden, MD, PhD, SNOMED Intl Steve Wagner, Department of Veterans Affairs 7 Tier 1 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 & Tier 2 Harmonization Readiness Criteria. 8 Tier 2 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 9 Current Work Technical Committees assigned to harmonize standards that support the Community’s breakthroughs – Biosurveillance – Consumer Empowerment – Electronic Health Record exchange Status of work products Use Cases documented Gap and Overlap Analysis completed Standards Selection completed Interoperability Specifications – In Progress – due Sept 29th 10 The purpose of this presentation is to orient the Committee by providing. . . Information about the formation of HITSP An overview of the HITSP Harmonization Process Schedule and next steps 11 The actual harmonization process is a series of steps taken by industry stakeholders within the context of HITSP Harmonization Process Steps Receive Request I Harmonization Request II III IV Requirements Analysis Identification of Candidate Standards Gaps, Duplications and Overlaps Resolution V VI Standards Selection Construction of Interoperability Specification VII Inspection Test VIII Interoperability Specification Release and Dissemination IX Program Management Begin Support 12 HITSP Framework Basis for Interoperability Specification Development 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. 13 HITSP Framework Basis for Interoperability Specification Development 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 successful 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. The first objective for September is meeting Use Case functional/interoperability requirements. HITSP constructs are version controlled and, if reused, will be uniquely identified. 14 Policy Makers and Industry HITSP Framework Defines and Narrows Context Use Case/Modification Request Interoperability Specification Transaction Package 1…n transactions or composite standards Transaction 1… n components or composite standards Package (Composite) Standard Transaction (Composite) Standard Component 1... n base standards or composite standard Component (Composite) Standard s ard s nd tion Sta niza ga Or Base Standard #1 Base Standard #2 Base Standard #3 Base Standard #4 Base Standard #5 Base Standard #6 Base Standard #7 Base Standard #8 Potential for Reuse in Other Context HITSP Base Standard #9 15 HITSP Framework Definitions and Rules Level Definition Use Case or Harmonization Request Interoperability Specification Transaction Package Example Rules Defines business/functional requirements Sets Context ONC Harmonized EHR Use Case 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 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 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 Based on UML diagram to identify technical actors and actions Sets context Testable functional requirements Ids transactions or transaction packages 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 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 16 HITSP Framework Definitions and Rules (cont.) Level Definition Example Rules 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 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,: Base Standard 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 Typically will use one “primary” standard and may have other “secondary” standards Expresses constraints on base or composite standards – Specifications – Implementation Guides – Code Sets – Terminologies – Integration Profiles Per Definition above 17 Current HITSP Document Inventory HITSP Construct Name document number 02 Interoperability Specification BIO 03 Interoperability Specification CE 01 Interoperability Specification EHR. Type TC IS IS IS BIO CE EHR 13 Manage Sharing of Docs 14 Send Lab Result Message to Ordering Clinician and Providers of Care TP TP BIO, CE, EHR BIO, EHR 18 View lab results from a web application TP EHR 24 Pseudonymize 25 Anonymize Tx Tx BIO BIO 22 23 29 19 Tx Tx Tx Tx BIO, CE, EHR BIO, CE, EHR BIO, EHR CE 41 Radiology Results Message C BIO 47 Resource Utilization Message 39 Encounter Message - HL7 ADT C C BIO BIO, CE 45 36 37 32 33 34 35 44 C C C C C C C C BIO, CE, EHR BIO, EHR BIO, EHR CE CE CE EHR EHR Patient ID Cross Referencing (IHE PIX) Patient Demographics Query (IHE PDQ) Notification of lab report availability Patient Registration Information Update Acknowledgements Lab Report Message - HL7 2.5 (as constrained by ELINCS, etc.) Lab Report Document Structure Registration and Med History Document(s) Content Map x12 Registration to Reg/Med Document Map NCPDP 8.1 to Reg/Med Doc EHR Lab Terminology Secure Web Connection 18 The Harmonization Process – Inspection Testing Harmonization Process Steps Receive Request I Harmonization Request II III IV Requirements Analysis Identification of Candidate Standards Gaps, Duplications and Overlaps Resolution V VI Standards Selection Construction of Interoperability Specification VII Inspection Test VIII Interoperability Specification Release and Dissemination IX Program Management We are here Begin Support 19 The Inspection Test is just one in a series of tests that will be performed to validate the utility of the specification The HITSP harmonization process results in an interoperability specification that will be widely disseminated A series of tests is required to validate the quality and usability of the specification Title Inspection Test Due to HHS Sept 29, 06 Stakeholders HITSP, EHRVA, IHE, Gov’t, others Plan for interoperability Sept 29, 06 testing HITSP, NIST, NLM, others Third party testing 2007 HITSP, NIST, CCHIT Orchestration and implementation test 2007 HITSP, IHE, FHA, EHRVA, NHIN The first test in the series of tests is the Inspection Test The objective of the Inspection Test is to ensure that the IS meets the requirements of the Use Case and can be used to implement the requirements 20 The purpose of the inspection test is to ensure the Interoperability Specifications meet the following objectives Conforms to Style and Editorial Ensure the integrity of document pieces – that all the cascading Guidelines documents are present Validate grammar, spelling, and consistency of terminology (Note that this will primarily be the Validate that it follows the style guide for text and graphics responsibility of the HITSP project team and not the testers) Contains Accurate References Validate the references to other documents and data sources are and Data valid and that data in tables is accurate. Meets Use Case Requirements Validate that the IS when implemented will meet the specific requirements as defined in the use case Is Technically Valid Check the specification to determine the existence of the following: • Ambiguities/ lack of specificity • Inconsistencies • Gaps and overlaps • Testability • Completeness • Internal consistency • Ability to implement 21 There are 8 major steps to complete the Interoperability Specification (IS) inspection test process 1. Identify and engage key volunteer test resources 2. Develop the tools and procedures for gathering and responding to test findings 3. Assign testers to IS documents 4. Distribute Interoperability Specifications to the assigned testers 5. Conduct the test and hold test monitoring sessions– including a test kickoff, mid-point test monitoring session, IS specific walkthrough sessions, and final test debrief 6. Consolidate and document test results 7. Writers analyze and disposition test defects, updating IS documents as appropriate 8. Wrap up testing and prepare for posting to HITSP.org for public comment 22 The purpose of this presentation is to orient the Committee by providing. . . Information about the formation of HITSP An overview of the HITSP Harmonization Process The schedule and next steps 23 Meeting Schedule Activity Description of Activity Responsible Dates Meetings TC Face to Face I TC’s meet to draft Interoperability Specifications Four Points Sheraton - Baltimore TCs and Performance Team TC Leadership: July 17 TC: July 18 - 20 TC Face to Face II TC’s meet to finalize Interoperability Specifications Chicago Hilton Garden Inn TCs and Performance Team TC Leadership: August 14 TC: August 15 – 17 Project team only August 18 TC Face to Face III TC’s meet to update Interoperability Specifications post Test and Comment Crystal City Marriott at Reagan National Airport TCs and Performance Team TC: September 6-8 Board Meeting Board meets to review HITSP progress Design Team Lead September 8 Panel Meeting Panel meets to approve Interoperability Specifications Design Team Lead September 20 24 Other Deliverables Activity Description of Activity Responsible Dates TCs & Performance Team July 5 – August 17 COB August 18 – Project team Panel Review I: Comment and/or Interoperability Specification is Inspection Test of IS reviewed and inspection tested by the HITSP Panel and public Design Team Lead Posts, Performance Team manages comments August 18 - 30 Update I: Address Comments from Review / Inspection Test Technical Committees update Interoperability Specifications TCs & Performance Team August 31 – September 12 Panel Review II: Review and comment of IS updates Posted to www.HITSP.org and review and comment thru the 19th – comment review period closes the 20th Design Team Lead Posts, Performance Team manages comments September 13 – 19 Panel Approval: Approval IS HITSP Panel Approves IS Panel September 20 Update II: TCs Finalize Interoperability Specifications TC’s finalize IS for delivery to ONC TCs & Performance Team September 20 – 25 COB Finalize Interoperability Specifications TCs update based on panel comments Project Management September 26 – 28 COB Team Deliver Interoperability Specifications SOW Ref # 9 Project Management Friday, September 29, 2006 Team Draft Interoperability Specifications Technical Committees meet to finalize the draft IS for inspection testing 25 Building a Nationwide Health Information Network Lab Pharmacy Emergency Surgical Copyright © 2002 College of American Pathologists 26 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 [email protected] 27