December 13, 2007

1. HITSP Project Report to the Healthcare Information Technology Standards Panel HITSP Technical Committee Co-Chairs December 13, 2007

2. The purpose of this presentation is to provide a report from the HITSP Technical Committees regarding. . . Technical Committees Structure/Use Cases Co-chair Election Process Reports from the Technical Committee Co-chairs

3. Technical Committees Structure/Leadership • Care Delivery – 181 members • James Ferguson, Kaiser Permanente • Steve Hufnagel, DoD/Medical Health System (MHS) • Steve Wagner, Department of Veterans Affairs • Consumer Empowerment – 178 members • Elaine Blechman, PhD, University of Colorado, Boulder • Charles Parisot, EHR Vendor Association • Scott Robertson, Kaiser Permanente

4. Technical Committees Structure/Leadership • Population Health – 137 members • Floyd Eisenberg, MD, MPH, Siemens Medical Solutions • Peter Elkin, MD, Mayo Clinic College of Medicine • Shaun Grannis, MD, MS Indiana University School of Medicine & The Regenstrief Institute • Security and Privacy – 121 members • Glen Marshall, Siemens Medical Solutions • John Moehrke, GE Healthcare • Walter Suarez, MD, MPH, Institute for HIPAA/HIT Education and Research & Public Health Data Standards Consortium • Total Technical Committee Membership – 391 individuals

5. Technical Committees Structure/Use Cases • Care Delivery • 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. • 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. • 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.

6. Technical Committees Structure and Use Cases • Consumer Empowerment • 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 Access to Clinical Data – 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.

7. Technical Committees Structure and Use Cases • Population Health • 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. • Quality – 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 1) hospital-based care and 2) care provided by clinicians.

8. Technical Committees Structure and Use Cases • Security and Privacy • Identification of Core Set of Constructs -- A core set of Privacy and Security constructs identified from all use cases; constructs reviewed and validated/modified upon receipt of new use cases • Incorporation of Constructs into Other Technical Committee Documents – Privacy and security constructs are incorporated into the documents created by the other TCs to address interoperability in their respective use cases

9. The purpose of this presentation is to provide a report from the HITSP Technical Committees regarding. . . Technical Committees Overview/Structure & Use Cases Co-chair Election Schedule and Process Reports from the Technical Committee Co-chairs

10. Technical Committee Co-chair Open Positions Terms of Office - 2 years – maximum of 2 terms 5 open positions as of January 2008: Care Delivery Jamie Ferguson Steve Wagner Population Health Shaun Grannis MD Consumer Empowerment Elaine Blechman PhD Charles Parisot

11. TC Co-chair Elections Schedule and Process A call for nominations for open Co-chair positions was announced on November 30th to the Technical Committee membership with a request for nomination of self or others Response due by December 14th Nominees will be reviewed/approved by the HITSP Chair prior to election and announced on December 17th Members of each TC must submit their vote by December 31st A Co-chair election requires 66% of Technical Committee members casting a vote, and formal appointment by the HITSP Chair Appointed Co-chairs will be announced on January 2nd

12. The purpose of this presentation is to provide a report from the HITSP Technical Committees regarding. . . Technical Committees Overview/Structure & Use Cases Co-chair Election Schedule and Process Reports from the Technical Committee Co-chairs

13. Completion of IS-06 Update to C47 – Resource Utilization OASIS HAVE V1.0 is included in the C47 Resource Utilization Construct as Intended for Use. This standard is anticipated to be approved before the end of the first quarter of 2008. OASIS HAVE V1.0 will not be approved by the time the C47 Resource Utilization Construct is released, but the standard is sufficiently defined to enable detailed evaluation of how well it will meet technical and business requirements. The HL7 specifications and constraints provided by this construct are aligned with this standard. Report from Population Health Technical Committee

14. Report from Population Health Technical Committee <transaction> Notification of Document Availability <transaction> Collect and Communicate Security Audit Trail <transaction package> Manage Consent Directives <component> Nonrepudiation of Origin <transaction package> Access Control <component> Anonymize <component> Entity Identity Assertion <transaction> Secured Communication Channel <transaction> Consistent Time DOCID: = C 26 DOCID: = C 26 DOCID: = T 16 DOCID = T 29 DOCID = T 15 DOCID = TP 30 DOCID: = TP 20 DOCID: = C 25 DOCID: = C 19 Quality Interoperability Specification • Document Name: IS-06 <transaction package> Manage Sharing of Documents <transaction package> Query for Existing Data <transaction> Patient Demographics Query <transaction> Pseudonymize <transaction package> Patient ID Cross-Referencing <component> Patient-Level Quality Data Message <component> Patient-Level Quality Data Document <transaction package> Retrieve Form for Data Capture DOCID: = TP 13 DOCID: = TP 22 DOCID: = TP 21 DOCID: = T 24 DOCID: = C 38 DOCID: = T 23 DOCID: = C 34 DOCID: = TP 50

15. Report from Population Health Technical Committee Next Steps Toward Completion of Quality Use Case Tentative Schedule Release II ------- 2008 Release III ------ 2009 <component> Validation and Data Quality Checking Component (Release III) <component> Quality Measurement Document Component (Release III) <component> Case Review Message (Release II) <component> Measurement Criteria Document (Release II) <component> Quality Measurement Message Component (Release III) <component> Derived Information (Release II) <component> Case Review Document (Release II) <component> Measurement Criteria Message (Release II)

16. 2008 Scope of Work Effort - Population Health Technical Committee Complete Referrals to Foundations and Other Organizations Foundations Committee: Allergy and Adverse Event Terminology Foundations Committee: Use of metadata registries for navigating multiple user interface terminologies Foundations Committee: Diagnosis and Problem attribute standardization (Active / Inactive, Chronic / Acute, Suspected / Presumptive / Confirmed / Final, Priority of Diagnosis <currently only 'principal' or 'secondary', etc.) Foundation Committee / HL7: Leverage Expression of Knowledge Structure - simple logic representation standard Foundation Committee / HL7: Leverage Expression of Knowledge Logic - harmonization of clinical decision support logic representations Report from Population Health Technical Committee

17. 2008 Scope of Work Effort - Population Health Technical Committee Complete Referrals to Foundations and Other Organizations HL7 - Methodology for representation of aggregate / population-based quality measure results (vs Individual patient results) NQF - Standardize Quality Measure Developer terminologies and representations for Exclusions, Inclusions and Pre-Conditions IHE / Collaborative for Performance Measure Integration with EHRs - 'Import' structure for measure specifications Project Team: Specific AHIC Expert Panel requirement for collaborative work with HITSP for each use case requiring data re-purposing (Immunizations and Public Health Reporting next) Report from Population Health Technical Committee

18. 2008 Scope of Work Effort - Population Health Technical Committee Maintenance work from Quality IS and Biosurveillance IS Publish Biosurveillance with Privacy and Security Components -- Jan 2008 Draft Use Case Review Immunizations and Public Health Reporting ------------------------- Jan 2008 New Use Case Effort --------------------------------------------- Begin March 2008 Quality Use Case Next Steps Release II constructs------------------------- for Completion September 2008 Biosurveillance Review additional efforts for Biosurveillance Use Case from 2006 Report from Population Health Technical Committee

19. Consumer Empowerment Technical Committee • IS03 (to be V3.0) Consumer Empowerment and Access to Clinical Information via Networks. Extends IS03 V2.0 (May 2007): • add laboratory reports C37 (Lab Report Document using IHE XD*-Lab) • new lab tests extracts and immunization section in C32 (Summary using HL7 CDD) • use of TP13 (Manage sharing of documents with Option XDS.b) • Adds security and privacy constructs approved in October 2008 • IS05 (to be V1.0) Consumer Empowerment and Access to Clinical Information via Media • Supports USB and CD-R media interchange  widespread, highly interoperable file systems • Same document Content as IS03  network and media content continuity • Includes appropriate security and privacy constructs approved in October 2008 • Both Use Cases (2006-CE and 2007-CACI) supported by both IS03 “v3.0” and IS05 “v1.0”, but distinguished by mode of exchange

20. Consumer Empowerment Technical Committee • C32 Summary Documents using CCD (to be V3.0) • Add new section on structured entry for lab tests extracts • Adds immunization section (consistent with medication section) • Applicable Cross-TC, no longer only in PHR centric use cases. • Renamed and expanded to support IS04 and IS06 requirements • Anticipates IS07 requirements • Content module optionality (to be constrained by referencing IS) to support re-use (Implications for IS03 v2.0 to be discussed later)

21. Consumer Empowerment Technical Committee • TP13 Manage Sharing of Documents (to be V2.1) • Added optional use of IHE XDS.b for support of new web services standards (SOAP 1.2, MTOM/XOP). • Added optional use of IHE XCA (Cross Community Access) for peer to peer HIE access. • T33 Transfer of Document Sets on Media • IHE XDM Cross-Enterprise Document Media Interchange • Document Sets and Document Content agnostic. • Constrained media to USB and CD-R for wide interoperability at the physical and file system level. • No changes to TP22 V2.0 (patient Id X-ref) and T23 V2.0 (patient demographics query)

22. Consumer Empowerment Technical Committee • Inclusion in IS03 and IS05 of HITSP approved security and privacy constructs • HITSP T16 - Consistent Time • HITSP T17 – Secured Communication Channel • HITSP T15 - Collect and Communicate Security Audit Trail • HITSP C19 - Entity Identity Assertion • HITSP C26 – Non repudiation of Origin • HITSP TP30 - Manage Consent Directives • HITSP TP20 - Access Control

23. Consumer Empowerment Technical CommitteeApproval of new ISs and associated constructs: • IS03 (to be V3.0) Consumer Empowerment and Access to Clinical Information via Networks. • IS05 (to be V1.0) Consumer Empowerment and Access to Clinical Information via Media • C32 (to be V3.0) Summary Document using HL7 CCD • TP13 Manage Sharing of Documents (to be V2.1) • T33 Transfer of Document Sets on Media (to be V1.0)

24. Consumer Empowerment Technical Committee • Next Steps • Maintenance review and update of published IS and constructs • Review, assess and schedule resolution of gaps noted in published constructs • Industry work • Committee work • Develop education and informative materials • New Use Cases

25. Consumer EmpowermentProposed Editorial Change to IS03 v2.0 IS03 v2.0 and C32 v2.0 HITSP Panel approved in May 2007 C32 Registration/med History Content optionality based on IS03 CE requirements Limits re-use of C32 Introduction of C32 V3.0 (extension of V2.0) may be a source of confusion. New C32 v3.0 Includes additional Content Modules from base standard (CCD) Remove (most) Content Modules requirements and expects the IS to specify optionality (used by IS03v3.0, IS04 and IS06). Maximizes re-use of C32 across new ISs and future ISs. Proposal: Edit IS03 v2.0 to reference new C32 v3.0 No technical changes to IS03 v2.0 and the Registration/Medication History Move Content Module optionality table from C32 v2.0 in “edited IS03 v2.0” (see explanation next slide).

26. Consumer EmpowermentProposal Editorial Change to IS03 v2.0 Edited IS03 v2.0 Person – Required Medications – Required Allergies – Required Adv Directives – Optional Current IS03 v2.0 References C32 v2.0 ISnn Person – Required Medications – Optional Allergies – Optional Adv Directives – Required C32 v2.0 Person – Required Medications – Optional Allergies – Optional Adv Directives – Optional C32 v3.0 Person – Required Medications – Optional Allergies – Optional Adv Directives – Optional Simplifies HITSP documentation and allows new IS to reuse C32 v3.0

27. Report from Care Delivery Technical Committee - EHR Lab Results IS-01 and C-36 were released for panel approval Dec. 6 In HITSP standards guidance, nothing changed! So why are we approving new documents? HL7 successfully balloted a lab message implementation guide that reflects HITSP interoperability specifications.(“HL7 U.S. REALM - INTEROPERABILITY SPECIFICATION: LAB RESULT MESSAGE TO EHR ORU^R01 HL7 Version 2.5.1 July, 2007”) Revised C-36 and IS-01 refer to this HL7 document Sole specific guidance remaining in the revised C-36: Use SNOMED-CT for specimen collection body site (HL7 provides no guidance on optional elements, i.e. not always reported)

28. Interoperability Specification (IS04)Ver. 1.0, Dec 07 HITSP Nursing Terminology Work Group Plan within 45 days for Nursing Terminology NEMSIS chaired work group Plan within 45 days for : Finding a method of assigning and adopting unique identifiers for both incidents and patients so data from heterogeneous systems can be linked Common approaches of delivering third party incident information such as telematics data to the Emergency Communications System (ECS) and emergency responders Reaching agreement between healthcare and other emergency responders on a common terminology (“Managed List”) for incident types Harmonizing the data taxonomies of hospital, EMS, and other emergency responders to the extent necessary to implement the ER-EHR Four additional gap area projects are: Decision Support Tool interoperability Core Services Situation Awareness Messaging Emergency Contact Registry (ECON) Report from Care Delivery Technical Committee - Emergency Responder EHR

29. Cross TC: HITSP Reuse Tool • The HITSP Reuse Tool supports:   -  the efficient development of Interoperability Specifications (IS) for new AHIC use cases.   -  the effective use of  HITSP constructs in CCHIT certification specifications. • - the risk-based integration of security and privacy within HITSP constructs. • The HITSP Reuse Tool manages HITSP business-technical actors’ role-specific:   -  associations within AHIC use case scenarios.   -  harmonization of definitions across IS and use cases.   -  mappings to HITSP construct(s)   -  traceability roadmaps to appropriate HITSP construct document section   -  traceability roadmaps to referenced IHE profile, data standards and transport standards • The HITSP Reuse Tool should be updated/versioned/distributed with each HITSP IS. • KEY CONCEPTS: 1) Effective use, reuse or repurposing of HITSP IS constructs (e.g., Components, Transaction Packages and/or Transactions) MUST maintain appropriate business-technical actors’ role-specific context 2) Integration of HITSP security and privacy is based on risk mitigation of each specific business-technical actor's role specific context. • BENEFIT: Clear, complete, concise, correct, consistent and easy-to-use HITSP constructs.

30. Unofficial HITSP Collaboration Wiki www.HITSP.wikispaces.com • DISCLAIMER: This is NOT an official HITSP web site. It is the work of HITSP stakeholders and interested private citizens. Participation is voluntary. • OBJECTIVE: The objective of this collaboration wiki is to efficiently organize, rapidly share and discuss publically available Healthcare Information Technology Standards Panel (HITSP) Electronic Healthcare Record (EHR) interoperability Specification, especially as they would interact with Certification Commission for Healthcare Information Technology (CCHIT) certification in a United States Nationwide Health Information Network (NHIN). • HITSP BOOK: "Roadmap to EHR Systems' Interoperability: The HITSP Implementation Guide" is being prepared for HIMSS publication in June '2008 by HITSP stakeholders; it is NOT an official HITSP publication. • HITSP stakeholders are invited to be contributing authors.

31. HITSP ER-EHR Gap Closure Process ER-EHR IS Identifies Several Gaps (IS04)- No SDO Approved Standards, Candidate Standard Overlaps or Gap (No Standard) HITSP ER-EHR TC Tasked NEMSIS with Developing Process for Closing the Gaps Process Driven – Repeatable Operates within the Established HITSP Process Open, Transparent, Consensus Based Minimize Redundancy among Efforts Specific Deliverables that Support Stakeholders Public (Local, State and Federal Agencies), Private-(Vendors, Services, Health Care Facilities and Organizations) Multiple Gaps/Efforts – Core Leadership 9/16/2014 30

32. Proposed ApproachEmergency Medical Awareness and Response –EMAR Core Leadership Support and Facilitation Provided by HITSP Create and Maintain Process Standards and Validate Adherence Modeling Guidelines, Templates Create/Approve Projects Announce and Call for Participation in Domain Specific Workgroup Review Scope of Work –Project Specific Workgroups Manage Consolidation of all Workgroup Products–Create a Single Comprehensive EMAR Analysis Model 9/16/2014 31

33. Formal SDO Submission EMAR Analysis Model Mature Synthesis Project Specifications Identify Project Specification/Standards Project Analysis Model (PAM) Initial Scope Initiate and Frame Proposed ProcessHITSP Identified Gap Closure • Messages • Documents • Templates • Services 6. Complete EMAR Specific -PAM All Classes, Attributes, Code and Value Sets. Actors, Activity and Work Flows 5. 4. Narrative and UML for Each Specification. Inventory of Value and Code Sets Identification of Known Specifications and SMEs Workgroup. SDO Pre-coordination 3.. Initial UML Model (Based on ER-EHR UML) Static and Dynamic Components 2. 1. Steps Project Scope and Initiation Document 9/16/2014 32 Deliverables

34. Domain Specific Work GroupExample Timeline JAN 08 Oct 08 4 Wks 6 -8 Wks 4 Wks 12-16 Wks 6 -8 Wks SDO Step 1. Step 2. Step 3. Step 4. Step 5. SDO Coordination ------------------------------------------------------------------------------------------------------- 9/16/2014 33

35. Initial EMAR Work Groups EMAR Core Leadership Unique Identifiers Incident Info Common Terms Taxonomies Decision Support Core Services Situation Aware ECON ISO4: Minimum Workgroup members; NHTSA, HL7, DHS-DM, IHE, NTDB, NASEMSO, APCO, COMCARE, HIMSS, NENA and others. 9/16/2014 34

36. HITSP ER-EHR Gap Closure Process - Next Steps Complete Plan for Submission to ER-EHR TC and HITSP (January 30, 2008) Create Template for Project Scope Create Core Leadership Team Create and Announce Work Groups 9/16/2014 35

37. Report from Care Delivery Technical Committee - Medication Management Following documents went out for public comment and inspection testing on Friday. IS07 – Medication Management T40 – Patient Generic Health Plan Eligibility Verification T42 – Medication Dispensing Status TP43 – Medication Orders TP46 - Medication Formulary and Benefits Information Gaps and overlaps were found in the areas of data representation, terminologies/code sets and information exchange formats. These are being referred to the Foundations Committee for harmonization. Will continue defining outstanding T40 issues and begin dispositioning comments when received.