1. 0 enabling healthcare interoperability 2009 Webinar Series Sponsored by the HITSP Education, Communications and Outreach Committee Personalized Healthcare Date: February 12, 2009 | 2:00 – 3:30 pm (Eastern) Presenters: Allen Hobbs, Ph.D., Stephen Hufnagel, Ph.D., Keith Boone and Michael Glickman Using genetics and family history to enhance targeted diagnosis and treatment

2. Slide 1 HITSP – enabling healthcare interoperability2009 Webinar Series Learning Objectives  Explore the concept of personalized healthcare — genetics and family history information can provide more targeted diagnosis and therapy  Examine the initiation of personalized healthcare — “Genomics and Personalized Medicine Act of 2006” introduced to the Senate by Barack Obama — Personalized Healthcare Use Case by the American Health Information Community  Discover how the requirements of the Personalized Healthcare Use Case map to HITSP constructs  Learn how family and genetic history are communicated between healthcare IT systems, and how this information can support genetic risk assessment

3. Slide 2 HITSP – enabling healthcare interoperability2009 Webinar Series Agenda  What is HITSP  What is Personalized Healthcare?  Personalized Healthcare Scenarios: (1) Clinical Assessment (2) Genetic Testing, Reporting and Clinical Management  Data Requirements and Constructs: Genetic Data, Personal and Family History, Risk Analysis and Decision Support  Next Steps  Conclusion  Questions and Answers

4. Slide 3 HITSP – enabling healthcare interoperability2009 Webinar Series What is HITSP?

5. Slide 4 HITSP – enabling healthcare interoperability2009 Webinar Series  HITSP is a volunteer-driven, consensus-based organization that is funded through a contract from the Department of Health and Human Services  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 that are actually writing healthcare IT standards. Overview

6. Slide 5 HITSP – enabling healthcare interoperability2009 Webinar Series Roles and Responsibilities  Harmonizes and recommends the technical standards that are necessary to assure the interoperability of electronic health records — Creates HITSP-recommended Interoperability Specifications (IS) that specify how and what standards should be used for a particular Use Case/Value Case — Supports deployment and implementation of these IS — Works with Standards Development Organizations (SDOs) to identify gaps and maintain, revise or develop new standards as required to support the IS

7. Slide 6 HITSP – enabling healthcare interoperability2009 Webinar Series  Each HITSP Interoperability Specification defines a set of “constructs” that: — specify how to integrate and constrain selected standards to meet the business needs of a Use/Value Case; and — define a Roadmap to use emerging standards and to harmonize overlapping standards when resolved.  In essence, a HITSP IS represents a suite of documents that integrate and constrain existing standards to satisfy a Use Case  Personalized Healthcare Interoperability Specification (IS08) Deliverables and Mode of Operation

8. Slide 7 HITSP – enabling healthcare interoperability2009 Webinar Series What is Personalized Healthcare?  Personalized healthcare enables providers to customize treatment and management plans for individuals based on their unique genetic makeup  Personalized healthcare focuses on the exchange of genomic/genetic test information, family medical history and the use of analytical tools in the EHR to support clinical decision-making

9. Slide 8 HITSP – enabling healthcare interoperability2009 Webinar Series  I’m worried that without a complete personal and family medical history on file, my doctors will miss seeing a trend in my progress ̶ My grandfather struggles with diabetes and my grandmother died from her thyroid condition  My doctor said that genetic/genomic test information may uncover disease predisposition, and can help determine which medication would be more effective  I support the availability of genetic information, but I’m concerned that my personal data is shared in a safe, secure way Steve’s story... current situation Patient is a 27-year-old man who had a brain tumor removed as a child

10. Slide 9 HITSP – enabling healthcare interoperability2009 Webinar Series  Steve’s health information can be seamlessly and securely exchanged between and among diverse systems  The seamless and secure exchange of information will allow Steve to: − create a personal health record to access his personal health information and grant access to his various providers − exchange clinically useful genetic/genomic test information − exchange personal and family health history − access results, conditions, allergies, and diagnosis codes in layperson terms  Steve’s provider can access analytical tools and electronic health records (EHRs) to support clinical decision-making Steve’s story... future

11. Slide 10 HITSP – enabling healthcare interoperability2009 Webinar Series Background and Introduction to the Personalized Health Care (PHC) Use Case A Clear, Highly Visible and Compelling Use Case  Michael O. Leavitt, Secretary of the Department of Health and Human Services stated at the American Health Information Community (AHIC) meeting on September 12, 2006: …genomics will play an increasingly larger role in medicine, and now is the time to figure out how best to incorporate genetic information into e-health records, before multiple nonstandard approaches take hold.”

12. Slide 11 HITSP – enabling healthcare interoperability2009 Webinar Series Background and Introduction to the Personalized Health Care (PHC) Use Case 109 th Congress  Genomics and Personalized Medicine Act of 2006 Introduced by Senator Obama to improve access to and appropriate utilization of valid reliable and accurate molecular genetic tests 110 th Congress  Genetic Information Nondiscrimination Act of 2008 Prohibits discrimination on the basis of genetic information with respect to health insurance and employment

13. Slide 12 HITSP – enabling healthcare interoperability2009 Webinar Series Today – Prior to Personalized Healthcare Visit your Doctor with Illness Symptom-based Diagnosis (In-vitro Diagnostics, Anatomical Imaging) Generic Treatment, Cost-centric Broad Based Populations Recover or Revisit

14. Slide 13 HITSP – enabling healthcare interoperability2009 Webinar Series Tomorrow – The Vision of Personalized Healthcare Diagnostic systems and genetic information are integrated Treatment(s) become targeted Optimal treatment of disease is individualized Standards of care become patient centric 1 2 3 4

15. Slide 14 HITSP – enabling healthcare interoperability2009 Webinar Series Tomorrow – A Framework for Personalized Healthcare Aggregating biomedical knowledge and adoption of interoperable HIT as a supportive foundation Standards of care become patient centric in EHR/PHR Identifying regulatory structure (e.g. FDA) supporting adoption of targeted drugs and diagnostics Demonstrate evidence-based medicine to assure approaches work for patients and providers Intervention Development + Review Integration into Clinical Practice Expansion of the Science Base Health Information Technology Personalized Health Care Adapted from DHHS: “PHC, Opportunities, Pathways, Resources” 2007

16. Slide 15 HITSP – enabling healthcare interoperability2009 Webinar Series HITSP IS 08: Personalized Healthcare  The Personalized Healthcare Interoperability Specification focuses on the exchange of clinically useful genetic/genomic test information, personal and family health history, and the use of analytical tools in electronic health records (EHRs) to support clinical decision-making. Enabling clinical decisions and therapies to be more targeted to the individual, their genetics, and personal/family history

17. Slide 16 HITSP – enabling healthcare interoperability2009 Webinar Series Scenario One: Clinical Assessment  The Clinician’s Perspective (physicians and other clinicians that conduct clinical assessment, clinical management and evaluation activities) — gathering of a patient’s personal and family history information — diagnostic planning — genetic/genomic test ordering — result interpretation  The Consumer Perspective (patients, caregivers, patient advocates, family members, etc) — reports family health information — requests genetic/genomic tests and results

18. Slide 17 HITSP – enabling healthcare interoperability2009 Webinar Series My Family Health Portrait a tool from the U.S. Surgeon General

19. Slide 18 HITSP – enabling healthcare interoperability2009 Webinar Series Scenario Two: Testing, Reporting and Clinical Management  The Testing Laboratory Perspective — performs the tests, analyzes the test data using genetic/genomic databases and repositories, and interprets the data — considers other personal and family health information by performing a risk assessment — develops a patient report including fully structured results (and interpretation) — transmits the report back to the authorized providers  The Clinician Perspective — determines appropriate preventive action, treatment protocol, messaging, and clinical interpretation of test results using decision support tools

20. Slide 19 HITSP – enabling healthcare interoperability2009 Webinar Series Requirements Mapping to HITSP Constructs Information Exchange Requirements IERDescription IER 01Provide authorization and consent IER 12Identify laboratory IER 14Send/receive health plan eligibility IER 15Send/receive health plan authorization IER 19Send/receive genetic/genomic test results IER 20Send/receive genomic information IER 21Receive updated clinical information IER 23Request/provide additional information IER 25Send/receive decision support data IER 41Receive risk analysis report IER 44Send/receive genetic test order IER 58Send/receive patient health history IER 62Send/receive encounter or full episode of care record

21. Slide 20 HITSP – enabling healthcare interoperability2009 Webinar Series Data Requirement Number (DR) Description DR 1Demographic Data, including (but not limited to): DR 3Clinical History, including (but not limited to): DR 4Personal genetic/genomic data, including (but not limited to): DR 5Family genetic/genomic information, including (but not limited to): DR 6Health Plan Eligibility Information, including (but not limited to): DR 7Genomic Laboratory registry DR 8Unstructured Data Requirements Mapping to HITSP Constructs Data Requirements

22. Slide 21 HITSP – enabling healthcare interoperability2009 Webinar Series See HITSP website for more detail  For detailed list of the following, download this PowerPoint from http://www.hitsp.org/archived_webinars_09.aspx http://www.hitsp.org/archived_webinars_09.aspx — Requirements Mapping to HITSP Constructs — IERs and DRS Mapped to HITSP Constructs — Use Case Requirements and Associated Standards Gaps

23. Slide 22 HITSP – enabling healthcare interoperability2009 Webinar Series Data Sets for Personalized Medicine  Demographic Data — Name, Identifiers, Age, Gender, Race, Ethnicity  Personal Medical History — Disorders, Age of Onset, Environmental Exposures, Treatments, Social History  Personal Genetic Data — Genetic Test Results, Genetic Status, Risk Analysis  Family Medical History — Pedigree, Disorders, Age of Onset/Death/Cause of Death  Family Genetic Data — Genetic Test Results, Genetic Status, Risk Analysis

24. Slide 23 HITSP – enabling healthcare interoperability2009 Webinar Series Genetic Data  Reason for the Test — Genetic Condition Status/Risk/Carrier — Medication Effectiveness/Metabolization/Toxicity  Type of Specimen — Germline – Containing genes you were born with — Somatic – Containing genes mutated after birth — Prenatal – Containing genes of a fetus  Genetic Region of Interest — Gene Name – Human Genome Name Committee (HGNC) — Genetic Variant – Human Genome Variation Society (HGVS)  Interpretations

25. Slide 24 HITSP – enabling healthcare interoperability2009 Webinar Series HITSP Constructs  C28 – Emergency Care Summary Document  C32 – Summary Documents Using CCD *  C48 – Encounter Document  C84 – Consult and History and Physical Note  C83 – CDA Content Modules *  C80 – Clinical Document and Message Vocabulary *  TP13 – Manage Sharing of Documents  T31 – Document Reliable Interchange  T33 – Transfer of Documents on Media  C90 – Clinical Genomic Decision Support *  T81 – Retrieval of Medical Knowledge * * Key constructs for IS 08

26. Slide 25 HITSP – enabling healthcare interoperability2009 Webinar Series  T17 – Secured Communication Channel  TP13 – Manage Sharing of Documents  TP20 – Access Control  TP30 – Manage Consent Directive  C19 – Entity Identity Assertion  C26 – Non-repudiation of Origin  T15 – Security Audit Trail  T16 – Consistent Time For more information about how HITSP addresses security and privacy, refer to the August 2008 Security and Privacy Webinar at http://www.hitsp.org/ archived_webinars.aspx http://www.hitsp.org/ archived_webinars.aspx HITSP Security and Privacy Constructs Safeguard Exchange of Personalized Healthcare Info

27. Slide 26 HITSP – enabling healthcare interoperability2009 Webinar Series Information Flows Patient Centric Knowledge Banks Clinical Knowledge Banks Genetic Risk Analysis Family and Genetic History Personal, Family and Genetic History Family Member PHR Patient PHR Provider EHR Personal, Family and Genetic History and Lab Results Lab Information System Lab Results EHR = Electronic Health Record PHR = Personal Health Record

28. Slide 27 HITSP – enabling healthcare interoperability2009 Webinar Series Where they are used Patient Centric Knowledge Banks Clinical Knowledge Banks Genetic Risk Analysis Family and Genetic History C32 C83/C80 TP13/T31/T33 Personal, Family and Genetic History C28/C32/C48/C84 C83/C80 TP13/T31/T33 Family Member PHR Patient PHR Provider EHR Personal, Family and Genetic History and Lab Results Lab Information System Lab Results T14/C35/C36 TP13/T31/T33/C35/C37 EHR = Electronic Health Record PHR = Personal Health Record Medical Knowledge T81 C28/C32/C48/C84 C83/C80 TP13/T31/T33 And T14/C35/C36 C35/C37

29. Slide 28 HITSP – enabling healthcare interoperability2009 Webinar Series Next Steps: Where we are with IS 08

30. Slide 29 HITSP – enabling healthcare interoperability2009 Webinar Series Future Enhancements  HITSP harmonization of: — Genomic lab orders and results — Genetic risk assessments

31. Slide 30 HITSP – enabling healthcare interoperability2009 Webinar Series Sample References  Understanding Genetics — http://motorcycleguy.blogspot.com/ 2008/07/understanding- genetics.html http://motorcycleguy.blogspot.com/ 2008/07/understanding- genetics.html  Reporting Genetic Test Results — http://motorcycleguy.blogspot.com/ 2008/07/reporting-genetic-test- results.html http://motorcycleguy.blogspot.com/ 2008/07/reporting-genetic-test- results.html  HL7 Clinical Document Architecture — http://www.hl7.org/Library/standard s_non1.htm#CDA (Nonmembers) http://www.hl7.org/Library/standard s_non1.htm#CDA — http://www.hl7.org/Library/standard s_mem1.cfm#CDA (Members only) http://www.hl7.org/Library/standard s_mem1.cfm#CDA  IHE Patient Care Coordination Technical Framework — http://wiki.ihe.net/index.php?title=Fa mily_History_Organizer http://wiki.ihe.net/index.php?title=Fa mily_History_Organizer  Human Genome Variation Society — http://www.hgvs.org/ http://www.hgvs.org/  Human Gene Nomenclature Committee — http://www.genenames.org/ http://www.genenames.org/

32. Slide 31 HITSP – enabling healthcare interoperability2009 Webinar Series IS08 – Personalized Medicine Benefits of Implementation...  IS08 enables an integrated approach to personalized medicine that:  supports and offers interoperability for information exchange among consumers, providers, and researchers;  enables an evidence-based approach to personalized medicine; and  minimizes the negative effects of less targeted treatment.

33. Slide 32 HITSP – enabling healthcare interoperability2009 Webinar Series Steve’s story... accomplished  Steve’s health information can be seamlessly and securely exchanged between and among diverse systems  The seamless and secure exchange of information will allow Steve to: − create a personal health record to access his personal health information and grant access to his various providers − exchange clinically useful genetic/genomic test information − exchange personal and family health history − access results, conditions, allergies, and diagnosis codes in layperson terms  Steve’s provider can access analytical tools and electronic health records (EHRs) to support clinical decision-making

34. Slide 33 HITSP – enabling healthcare interoperability 2009 Webinar Series Webinar 1 Advances in Sharing Information in Healthcare IT Thursday, January 15 th, 2009 — 2:00-3:30 pm EDT Webinar 7Health Information Exchange (HIEs) in the Real World Thursday, July 9 th, 2009 — 2:00-3:30 pm EDT Webinar 2Personalized Healthcare Interoperability Specification (IS 08) Thursday, February 12 th, 2009 — 2:00-3:30 pm EDT Webinar 8Patient - Provider Secure Messaging Interoperability Specification (IS 12) Thursday, August 13 th, 2009 — 2:00-3:30 pm EDT Webinar 3Consultations and Transfers of Care Interoperability Specification (IS 09) Thursday, March 12 th, 2009 — 2:00-3:30 pm EST Webinar 9Remote Monitoring Interoperability Specification (IS 77) Thursday, September 10 th, 2009 — 2:00-3:30 pm EDT Webinar 4 NHIN Real World Sites Thursday, April 16 th, 2009 — 2:00-3:30 pm EDT Webinar 10Medication Management Real World Sites Thursday, October 8 th, 2009 — 2:00-3:30 pm EDT Webinar 5Immunization & Response Management Interoperability Specification (IS 10) Thursday, May 14 th, 2009 — 1:30-3:00 pm EDT Webinar 11Security, Privacy, and Infrastructure Thursday, November 12 th, 2009 — 2:00-3:30 pm EDT Webinar 6Public Health Case Reporting Interoperability Specification (IS 11) Thursday, June 18 th, 2009 — 1:30-3:00 pm EDT Webinar 12Real World Sites – TBA Thursday, December 10 th, 2009 — 2:00-3:30 pm EDT  The 2009 Webinar Series www.HITSP.org/webinars 

35. Slide 34 HITSP – enabling healthcare interoperability2009 Webinar Series  Use or specify HITSP Interoperability Specifications in your HIT efforts and in your Requests for Proposals (RFPs)  Ask for CCHIT certification  Leverage Health Information Exchanges to promote HITSP specifications to make connections easier in the future  Ask... Is there a HITSP standard we could be using?  Get involved in HITSP... Help shape the standards How YOU can become involved

36. Slide 35 HITSP – enabling healthcare interoperability2009 Webinar Series Jessica Kant, HIMSSTheresa Wisdom, HIMSS jkant@himss.orgjkant@himss.org twisdom@himss.orgtwisdom@himss.org Re: HITSP Technical Committees Michelle Deane, ANSI mmaasdeane@ansi.org Re: HITSP, its Board and Coordinating Committees Join HITSP in developing a safe and secure health information network for the United States. Visit www.hitsp.org or contact...www.hitsp.org

37. Slide 36 HITSP – enabling healthcare interoperability2009 Webinar Series Sponsor Strategic Partners www.HITSP.org

38. Slide 37 HITSP – enabling healthcare interoperability2009 Webinar Series Personalized Healthcare Questions and Answers

39. Slide 38 HITSP – enabling healthcare interoperability2009 Webinar Series Appendix  Requirements Mapping to HITSP Constructs  IERs and DRS Mapped to HITSP Constructs  Use Case Requirements and Associated Standards Gaps

40. Slide 39 HITSP – enabling healthcare interoperability2009 Webinar Series Requirements Mapping to HITSP Constructs Information Exchange Requirements IERDescription IER 01Provide authorization and consent IER 12Identify laboratory IER 14Send/receive health plan eligibility IER 15Send/receive health plan authorization IER 19Send/receive genetic/genomic test results IER 20Send/receive genomic information IER 21Receive updated clinical information IER 23Request/provide additional information IER 25Send/receive decision support data IER 41Receive risk analysis report IER 44Send/receive genetic test order IER 58Send/receive patient health history IER 62Send/receive encounter or full episode of care record

41. Slide 40 HITSP – enabling healthcare interoperability2009 Webinar Series Data Requirement Number (DR) Description DR 1Demographic Data, including (but not limited to): DR 3Clinical History, including (but not limited to): DR 4Personal genetic/genomic data, including (but not limited to): DR 5Family genetic/genomic information, including (but not limited to): DR 6Health Plan Eligibility Information, including (but not limited to): DR 7Genomic Laboratory registry DR 8Unstructured Data Requirements Mapping to HITSP Constructs Data Requirements

42. Slide 41 HITSP – enabling healthcare interoperability2009 Webinar Series Scenario 1: Clinical Assessment Component Data Flow Diagram

43. Slide 42 HITSP – enabling healthcare interoperability2009 Webinar Series Scenario 2: Testing, Reporting and Clinical Management Component Data Flow Diagram

44. Slide 43 HITSP – enabling healthcare interoperability2009 Webinar Series Requirements Mapping to HITSP Constructs Constructs Used HITSP/C19 - Entity Identity Assertion HITSP/C32 - Summary Documents Using HL7 Continuity of Care Document (CCD) HITSP/C36 - Lab Result Message HITSP/C37 - Lab Report Document HITSP/C48 - Encounter Document Using IHE Medical Summary (XDS-MS) HITSP/C62 - Unstructured Document HITSP/C80 - Clinical Document and Message Terminology HITSP/C84 - Consult and History & Physical Note HITSP/C90 - Clinical Genomic Decision Support HITSP/T14 - Send Laboratory Result Message HITSP/T15 - Collect and Communicate Security Audit Trail HITSP/T16 - Consistent Time HITSP/T17 - Secured Communication Channel

45. Slide 44 HITSP – enabling healthcare interoperability2009 Webinar Series HITSP/T23 - Patient Demographics Query HITSP/T29 - Notification of Document Availability HITSP/T31 - Document Reliable Interchange HITSP/T17 - Secured Communication Channel HITSP/T23 - Patient Demographics Query HITSP/T29 - Notification of Document Availability HITSP/T31 - Document Reliable Interchange HITSP/T33 - Transfer of Documents on Media HITSP/T40 - Patient Health Plan Eligibility Verification Transaction HITSP/T64 - Identify Communication Recipients HITSP/T66 - Retrieve Value Set HITSP/T68 - Patient Health Plan Authorization Request and Response HITSP/T81 - Retrieval of Medical Knowledge Requirements Mapping to HITSP Constructs Constructs Used

46. Slide 45 HITSP – enabling healthcare interoperability2009 Webinar Series HITSP/T85 - Administrative Transport to Health Plan HITSP/TP13 - Manage Sharing of Documents HITSP/TP20 - Access Control HITSP/TP22 - Patient ID Cross-Referencing HITSP/TP30 - Manage Consent Directives HITSP/TP89 - Sharing Imaging Results Requirements Mapping to HITSP Constructs Constructs Used

47. Slide 46 HITSP – enabling healthcare interoperability2009 Webinar Series IERs and DRS mapped to HITSP Constructs IER1 Provide authorization and consent DR1 Demographic DataHITSP/C19 - Entity Identity Assertion HITSP/T15 - Collect and Communicate Security Audit Trail HITSP/T16 - Consistent Time HITSP/T17 - Secured Communication Channel HITSP/T64 - Identify Communication Recipients (service) HITSP/TP13 - Manage Sharing of Documents HITSP/TP20 - Access Control HITSP/TP30 - Manage Consent Directives Info Exchange Requirement Data RequirementHITSP Construct

48. Slide 47 HITSP – enabling healthcare interoperability2009 Webinar Series IERs and DRS mapped to HITSP Constructs Underlying Infrastructure Constructs are NOT shown (e.g., T15, T16, T17, C19, TP20, TP30) IER14 Send/ receive health plan eligibility DR6 Health Plan Eligibility Information HITSP/T40 - Patient Health Plan Eligibility Verification Transaction HITSP/T68 - Patient Health Plan Authorization Request and Response HITSP/T85 – Administrative Transport to Health Plan HITSP/T64 - Identify Communication Recipients IER15 Send/ receive health plan author- ization DR6 Health Plan Eligibility Information HITSP/T85 – Administrative Transport to Health Plan HITSP/T40 - Patient Health Plan Eligibility Verification Transaction HITSP/T68 - Patient Health Plan Authorization Request and Response HITSP/T64 - Identify Communication Recipients

49. Slide 48 HITSP – enabling healthcare interoperability2009 Webinar Series IERs and DRS mapped to HITSP Constructs Underlying Infrastructure Constructs are NOT shown (e.g., T15, T16, T17, C19, TP20, TP30) IER19 Send/receive genetic/ genomic test results DR1 Demographic Data DR4 Personal genetic/ genomic data HITSP/C80 - Clinical Document and Message Terminology HITSP/C37 - Lab Report Document HITSP/C36 - Lab Result Message HITSP/C62 - Unstructured Document HITSP/T23 - Patient Demographics Query HITSP/T29 - Notification of Document Availability HITSP/T31 - Document Reliable Interchange HITSP/T33 - Transfer of Documents on Media HITSP/T64 - Identify Communication Recipients HITSP/T66 – Retrieve Value Set HITSP/TP13 - Manage Sharing of Documents HITSP/TP22 - Patient ID Cross-Referencing

50. Slide 49 HITSP – enabling healthcare interoperability2009 Webinar Series IERs and DRS mapped to HITSP Constructs Underlying Infrastructure Constructs are NOT shown (e.g., T15, T16, T17, C19, TP20, TP30) IER20 Send/ receive genomic info DR1 Demographic Data DR3 Clinical History DR4 Personal genetic/ genomic data HITSP/C32 - Summary Documents Using HL7 CCD HITSP/C80 - Clinical Document and Message Terminology HITSP/C36 - Lab Result Message HITSP/C37 - Lab Report Document HITSP/C48 - Encounter & Discharge Document Using IHE Medical Summary HITSP/C84 - Consult and History & Physical Note HITSP/T23 - Patient Demographics Query HITSP/T29 - Notification of Document Availability HITSP/T31 - Document Reliable Interchange HITSP/T33 - Transfer of Documents on Media HITSP/T64 - Identify Communication Recipients HITSP/T66 - Retrieve Value Set HITSP/TP13 - Manage Sharing of Documents HITSP/TP22 - Patient ID Cross-Referencing

51. Slide 50 HITSP – enabling healthcare interoperability2009 Webinar Series IERs and DRS mapped to HITSP Constructs Underlying Infrastructure Constructs are NOT shown (e.g., T15, T16, T17, C19, TP20, TP30) IER21 Receive updated clinical information DR3 Clinical History HITSP/C19 - Entity Identity Assertion HITSP/C62 - Unstructured Document HITSP/C84 – Consult and History & Physical Note HITSP/T23 - Patient Demographics Query HITSP/T29 - Notification of Document Availability HITSP/T31 - Document Reliable Interchange HITSP/T64 – Identify Communication Recipients HITSP/TP13 - Manage Sharing of Documents HITSP/TP22 - Patient ID Cross-Referencing

52. Slide 51 HITSP – enabling healthcare interoperability2009 Webinar Series IERs and DRS mapped to HITSP Constructs IER23 Request or provide additional information DR1 Demographic Data DR3 Clinical History DR4 Personal genetic/ genomic data DR5 Family genetic/ genomic information DR8 Unstructured Data Gap HITSP/C36 - Lab Result Message is necessary but not sufficient HITSP/C80 - Clinical Document and Message Terminology HITSP/C36 - Lab Result Message HITSP/C62 - Unstructured Document HITSP/T23 - Patient Demographics Query HITSP/T31 - Document Reliable Interchange HITSP/TP13 - Manage Sharing of Documents HITSP/TP22 - Patient ID Cross-Referencing HITSP/T29 - Notification of Document Availability HITSP/T66 - Retrieve Value Set Underlying Infrastructure Constructs are NOT shown (e.g., T15, T16, T17, C19, TP20, TP30)

53. Slide 52 HITSP – enabling healthcare interoperability2009 Webinar Series IERs and DRS mapped to HITSP Constructs Underlying Infrastructure Constructs are NOT shown (e.g., T15, T16, T17, C19, TP20, TP30) IER41 Receive Risk Analysis Report DR4 Personal genetic/ genomic data Gap (use HITSP/C62 - Unstructured Document until construct is developed) HITSP/C80 - Clinical Document and Message Terminology HITSP/C37 - Lab Report Document HITSP/C62 - Unstructured Document HITSP/C19 - Entity Identity Assertion HITSP/T64 - Identify Communication Recipients HITSP/T66 – Retrieve Value Set

54. Slide 53 HITSP – enabling healthcare interoperability2009 Webinar Series IERs and DRS mapped to HITSP Constructs Underlying Infrastructure Constructs are NOT shown (e.g., T15, T16, T17, C19, TP20, TP30) IER44 Send/ receive genetic test orders DR1 Demographic Data DR3 Clinical History DR4 Personal genetic/ genomic data Gap HITSP/C62 – Unstructured Document HITSP/T23 - Patient Demographics Query HITSP/T29 - Notification of Document Availability HITSP/T31 - Document Reliable Interchange HITSP/T64 - Identify Communication Recipients HITSP/TP13 - Manage Sharing of Documents HITSP/TP22 - Patient ID Cross-Referencing IER12 Identify Laboratory DR7 Genomic Laboratory Registry HITSP/T64 - Identify Communication Recipients

55. Slide 54 HITSP – enabling healthcare interoperability2009 Webinar Series IERs and DRS mapped to HITSP Constructs IER58 Send /receive patient health history DR1 Demographic Data DR3 Clinical History DR4 Personal genetic/ genomic data DR5 Family genetic/ genomic information HITSP/C32 - Summary Documents Using HL7 Continuity of Care Document (CCD) HITSP/C80 - Clinical Document and Message Terminology HITSP/C36 - Lab Result Message HITSP/C48 - Encounter Document Using IHE Medical Summary (XDS-MS) HITSP/C62 - Unstructured Document HITSP/C84 - Consult and History & Physical Note HITSP/T23 - Patient Demographics Query HITSP/T29 - Notification of Document Availability HITSP/T31 - Document Reliable Interchange HITSP/T33 - Transfer of Documents on Media HITSP/T64 - Identify Communication Recipients HITSP/TP13 - Manage Sharing of Documents HITSP/TP22 - Patient ID Cross-Referencing Underlying Infrastructure Constructs are NOT shown (e.g., T15, T16, T17, C19, TP20, TP30)

56. Slide 55 HITSP – enabling healthcare interoperability2009 Webinar Series IERs and DRS mapped to HITSP Constructs Underlying Infrastructure Constructs are NOT shown (e.g., T15, T16, T17, C19, TP20, TP30) IER62 Send/receive encounter or full episode of care record DR1 Demographic Data DR3 Clinical History DR4 Personal genetic/genomic data HITSP/C48 - Encounter Document Using IHE Medical Summary (XDS-MS) HITSP/C84 – Consult and History & Physical Note HITSP/T23 - Patient Demographics Query HITSP/T29 - Notification of Document Availability HITSP/T31 - Document Reliable Interchange HITSP/T64 - Identify Communication Recipients HITSP/TP13 - Manage Sharing of Documents HITSP/TP22 - Patient ID Cross-Referencing

57. Slide 56 HITSP – enabling healthcare interoperability2009 Webinar Series Use Case Requirements and Associated Standards Gaps IERSummaryGapsRecommended Resolution IER41Ability to receive report including analysis of risk from a Genetic Clinical Decision Support System No way to receive a Risk Analysis report into an EHR/ PHR Care Management and Health Records Domain TC will investigate current standards The resulting Risk Analysis report should use standard Interoperable Clinician/Nursing Terminology with the following local/Interoperable language agreed to by HITSP: This Interoperability Specification will use the CHI recommended SNOMED CT as a reference terminology to communicate interoperable information among and between systems, with the HITSP Interoperability Specification Pre-condition that the sending and using systems must use formal coded nursing terminologies such as the Clinical Care Classification (CCC) System and the Omaha System that are integrated in SNOMED CT

58. Slide 57 HITSP – enabling healthcare interoperability2009 Webinar Series Use Case Requirements and Associated Standards Gaps IERSummaryGapsRecommended Resolution IER44Ability to: Send/receive genetic test orders No way to send a lab order to a genetic/genomic testing laboratory Evaluating the creation of construct for lab orders is on the Care Management and Health Records Domain TC 2009 roadmap IER44 IER23 Ability to: Send/receive genetic test orders, and Request or provide additional information No way to receive genetic results. The HL7 standard is still under development The intent is to constrain HITSP/C36 – Lab Result Message and HITSP/C37 – Lab Report Document usage here to the HL7 standard once it is ready

59. Slide 58 HITSP – enabling healthcare interoperability2009 Webinar Series Use Case Requirements and Associated Standards Gaps IERSummaryGapsRecommended Resolution IER25Send/receive Decision Support data The component for clinical decision support does not exist in HITSP Track HL7 work in this area DR4 DR5 IER20 IER19 Personal genetic/genomic data Family genetic/genomic information Send/receive genomic information Send/receive genetic/genomic test results HITSP/C36 – Lab Result Message is necessary but not sufficient to communicate genomic lab results. More detailed implementation guidance is necessary to satisfy the requirements. Pending approval of 2009 HL7 2.5.1 ballot