1. 0 enabling healthcare interoperability Webinar Series Sponsored by the HITSP Education, Communications and Outreach Committee Webinar 3 June 26, 2008 | 2:00 – 3:30 pm (Eastern) Presenters Co-chairs of HITSP Consumer Perspective Technical Committee  Charles Parisot, Manager, Standards and Testing, GE Healthcare Integrated IT Solutions  Scott Robertson, Standards Architect, Information Technology / Health IT Strategy and Policy, Kaiser Permanente Consumer Access to Clinical Information

2. Slide 1 HITSP – enabling healthcare interoperability Learning Objectives  During this 90-minute webinar, participants will explore the consumer side of health information sharing, gaining a basic knowledge of: — the Personal Health Record (PHR) as the consumer’s collection point for his or her health information; — consumer-controlled access to PHR-based information; — HITSP specifications for PHR health information sharing over a network or on physical media; — the use of Medical Summary Documents and Laboratory Results documents in information exchanges involving PHRs. a webinar series on U.S. healthcare interoperability

3. Slide 2 HITSP – enabling healthcare interoperability  Consumer Access to Clinical and Demographics Information — The PHR as collector and source of consumer’s health information — Security and privacy requirements for PHR information sharing  HITSP Specifications for Consumer Empowerment and Access to Clinical Information via Networks (HITSP IS 03) and portable Media (HITSP IS 05)  Units of Exchange — Health Information Summary Documents — Laboratory Results Documents  Conformance Subsets  Questions and Answers / Open Dialogue Agenda a webinar series on U.S. healthcare interoperability

4. Slide 3 HITSP – enabling healthcare interoperability Introduction: Steve’s Story... part three  Patient is a 26-year-old male coping with the long-term effects of a brain tumor that was removed during his childhood  Access to data from previous care providers has become increasingly difficult — Required by both healthcare and insurance providers  Calendaring and coordination of upcoming appointments and procedures is needed  Patient’s self observations of lifestyle, illness, reactions to medications, etc. are not being tracked effectively

5. Slide 4 HITSP – enabling healthcare interoperability Introduction: Steve’s story (continued)  The FutureHealthcare in an interoperable world — With patient’s consent, personal health records can be seamlessly and securely exchanged between and among diverse systems, including providers and care settings where the patient has previously gone for testing or treatment — Patient will be empowered to access, control, and contribute to his or her own medical data — Care providers will have the most up-to-date records available because healthcare data will be retrieved electronically from its source

6. Slide 5 HITSP – enabling healthcare interoperability  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 public and private-sector experts from across the healthcare community to harmonize and recommend the technical standards that are necessary to assure the interoperability of electronic health records. Overview

7. Slide 6 HITSP – enabling healthcare interoperability  The HITSP Standards Harmonization Framework — Identify a pool of standards for an AHIC (American Health Information Community) Use Case — Identify gaps and overlaps in the standards for this specific Use Case — Make recommendations for resolution of gaps and overlaps — Select standards using HITSP-approved Readiness Criteria — Develop Interoperability Specifications (IS) that use the selected standard(s) for the specific context — Test the IS Deliverables and Mode of Operation

8. Slide 7 HITSP – enabling healthcare interoperability IS 01Electronic Health Record (EHR) Laboratory Results Reporting IS 02Biosurveillance IS 03 Consumer Empowerment and Access to Clinical Information via Networks IS 04Emergency Responder Electronic Health Record (ER-EHR) IS 05 Consumer Empowerment and Access to Clinical Information via Media IS 06Quality IS 07Medication Management Current Interoperability Specifications (IS)

9. Slide 8 HITSP – enabling healthcare interoperability IS 01Electronic Health Record (EHR) Laboratory Results Reporting IS 02Biosurveillance IS 03 Consumer Empowerment and Access to Clinical Information via Networks IS 04Emergency Responder Electronic Health Record (ER-EHR) IS 05 Consumer Empowerment and Access to Clinical Information via Media IS 06Quality IS 07Medication Management Current Interoperability Specifications (IS)

10. Slide 9 HITSP – enabling healthcare interoperability Consumer Empowerment  HITSP IS 03 and HITSP IS 05: Overall Objectives — Harmonize standards pertaining to the collection and (controlled) sharing of clinical information in Personal Health Records (PHRs) — Create consumer-directed secure electronic registration summaries with links to medication history and laboratory results — Enable general EHR-to-EHR information exchange for interoperable patient charts with meds, allergies, problems, registration information, etc.

11. Slide 10 HITSP – enabling healthcare interoperability  Summary: A private and secure Electronic Health Record (EHR) that is managed, shared and controlled by the consumer *  Used to collect, retain and share critical information, including: — Clinical notes and results — Demographics — Family and social history — Insurance information — Medications and allergies — Laboratory and other test results — Procedures — More … What is a Personal Health Record (PHR)? *See the official definition of a PHR at the National Alliance for Health Information Technologyofficial definition

12. Slide 11 HITSP – enabling healthcare interoperability Personal Health Record (PHR) Purpose and Use Consumer patient maintains his/her own well-being  Others — Quality of Healthcare Reporting — Post-market Drug Monitoring — Research — Biosurveillance — Public Health — Disaster Management  Primary Care Provider — coordinating overall healthcare — providing optimal care — reducing duplicate and adverse events  Specialist Providers — complete information leads to more complete assessments and better plan for care — reduced duplicative therapy and fewer adverse events  Pharmacies — medication lists reduce duplicate therapies, reduce interactions — complete problem and allergy lists prevent adverse events  Additional Providers of Care — Imaging centers, long term care providers, and many more providers of care

13. Slide 12 HITSP – enabling healthcare interoperability Learn more about HITSP’s activities in the area of Security, Privacy and Infrastructure Webinar 7: Thursday, August 21, 2008 — 2:00-3:30 pm EDT Personal Health Record (PHR) Secure and Private  Consumer defines access rights to PHR information — The consumer owns and control his or her own health information. — All sensitive communications are secured. — All users are authenticated. — Access is granted based upon the role of the user.  Security and Privacy are common across HITSP specifications

14. Slide 13 HITSP – enabling healthcare interoperability IS 03Consumer Empowerment and Access to Clinical Information via Networks  This Interoperability Specification defines specific standards needed to enable the exchange of data between patients and their caregivers via an electronic network — Version: 2.1* Recognized — Version: 3.0 Accepted * previously referred to as “Consumer Empowerment” IS 03 VIA AN ELECTRONIC NETWORK IS 03 VIA AN ELECTRONIC NETWORK

15. Slide 14 HITSP – enabling healthcare interoperability HITSP IS 03 Consumer Empowerment and Access to Clinical Information via Networks  Consumer establishes an account to host his patient registration summary and clinical information  Consumer provides registration summary and self-entered/externally sourced clinical information during visit with Healthcare Providers  Authorized Healthcare Providers can review patient’s clinical information  Healthcare Provider distributes clinical information, lab and other results (radiology, cardiology, prescriptions, health prevention reminders, referrals to specialists, etc.) to patient  Reconciles identifiers for the same consumer/patient  Queries other organizations for data for that individual IS 03 VIA AN ELECTRONIC NETWORK IS 03 VIA AN ELECTRONIC NETWORK

16. Slide 15 HITSP – enabling healthcare interoperability Sharing clinical information  The sharing of documents is done using HITSP Transaction Package 13 (TP 13), Manage Sharing of Documents  New documents are registered in a Record Locator (index of all documents available for a patient)  Documents are stored in a Document Repository  To get information about a patient 1.Ask the Record Locator if and where any information can be found 2.Go to a Document Repository to actually retrieve the information Document Repository Record Locator

17. Slide 16 HITSP – enabling healthcare interoperability Other Communities IS 03 – Main Business Actors PHR System Document Repository Record Locator Hospital Physician Health Plan Pharmacy etc.

18. Slide 17 HITSP – enabling healthcare interoperability Implementation Architecture Flexibility  Several instances of each Business Actor can be implemented  Business Actors can be grouped: — PHR System may also be a Document Repository — PHR System may also be a Record Locator — EMR/EHR System may also be a Document Repository within or across healthcare organizations — etc.  Several such communities or Health Information Exchanges (HIEs) may be interconnected (e.g. NHIN)

19. Slide 18 HITSP – enabling healthcare interoperability Record Locator Provide and Register Document Set-b HITSP TP 13, Manage Sharing of Documents Based on IHE XDS Profile PHR System Document Repository Other Communities Hospital, Physician, Health Plan, Pharmacy, etc. Document Registry Document Source Document Consumer Document Source Document Consumer Registry Stored Query Registry Stored Query Retrieve Document Set Retrieve Document Set

20. Slide 19 HITSP – enabling healthcare interoperability Verifying Patient Identity  Need — Link patient identifiers from multiple sources — Query for demographics to ensure and verify patient identity  Solution — HITSP TP 22 – Patient ID Cross-Referencing Transaction PackagePatient ID Cross-Referencing Transaction Package  IHE Patient Cross-Referencing Transaction (PIX) — HITSP T 23 – Patient Demographics Query TransactionPatient Demographics Query Transaction  IHE Patient Demographics Query Transaction (PDQ)

21. Slide 20 HITSP – enabling healthcare interoperability Record Locator TP22, Patient Id Cross Referencing and T23, Query Demographics Based on IHE PIX and PDQ Profiles PHR System Document Repository Other Communities Hospital, Physician, Health Plan, Pharmacy, etc. Patient Demo Supplier Patient Id X-Ref Mgr Patient X-ref Consumer Patient Demo Consumer Either PIX or PDQ Query Patient X-ref Consumer Patient Demo Consumer Either PIX or PDQ Query

22. Slide 21 HITSP – enabling healthcare interoperability PHR System Hospital, Physician, Health Plan, Pharmacy, etc. Provide and Register Document Set-b Record Locator IS 03 – Complete Document Repository Other Communities Patient Demo Supplier Patient Id X-Ref Mgr Patient X-ref Consumer Patient Demo Consumer Patient X-ref Consumer Patient Demo Consumer Initiating Gateway Accepting Gateway Document Registry Document Source Document Consumer Document Source Document Consumer Registry Stored Query Retrieve Document Set Retrieve Document Set

23. Slide 22 HITSP – enabling healthcare interoperability IS 03 Complete set of constructs DocumentDocument Description HITSP/TP13HITSP Manage Sharing of Documents Transaction Package HITSP/TP22HITSP Patient ID Cross-Referencing Transaction Package HITSP/T23HITSP Patient Demographics Query Transaction HITSP/C32HITSP Summary Documents Using HL7 Continuity of Care Document (CCD) HITSP/C37HITSP Lab Report Document Using IHE XD* Lab Component HITSP/C35HITSP Lab Report Terminology Component HITSP/T15HITSP Collect and Communicate Security Audit Trail Transaction HITSP/T16HITSP Consistent Time Transaction HITSP/T17HITSP Secured Communication Channel Transaction HITSP/TP20HITSP Access Control Transaction Package HITSP/TP30HITSP Manage Consent Directives Transaction Package HITSP/C19HITSP Entity Identity Assertion Component HITSP/C26HITSP Non-repudiation of Origin Component

24. Slide 23 HITSP – enabling healthcare interoperability IS 05Consumer Empowerment and Access to Clinical Information via Media  This Interoperability Specification defines specific standards needed to assist patients in making decisions regarding care and healthy lifestyles (i.e., registration information, medication history, lab results, current and previous health conditions, allergies, summaries of healthcare encounters and diagnoses). — Version: 1.0 Accepted IS 05 VIA MEDIA

25. Slide 24 HITSP – enabling healthcare interoperability HITSP IS 05 Consumer Empowerment and Access to Clinical Information via Portable Media  Consumer establishes an account to host a patient registration summary AND clinical information  Consumer brings registration and clinical information via media (CD-R or USB key) to visit with Healthcare Providers  Authorized Healthcare Provider reviews patient’s clinical information  Healthcare Provider distributes new/updated clinical information and lab results by Healthcare Provider to patient on portable electronic media  Patient identification reconciliation and most privacy/security requirements accomplished via human-to-human interaction

26. Slide 25 HITSP – enabling healthcare interoperability IS 05 Main Business Actors and Technical Actors PHR System Implementation Flexibility:  Media (CD-R and/or USB Key) to be carried by the patient or exchanged via a secured means. EHR System Portable Media Creator Portable Media Importer Portable Media Creator Portable Media Importer Distribute Document Set on Media Distribute Document Set on Media Uses HITSP T-33 Transfer of Documents on Media Transaction Based on IHE XDM

27. Slide 26 HITSP – enabling healthcare interoperability IS 05 Complete set of constructs ConstructDescription HITSP/T33HITSP Transfer of Documents on Media Transaction HITSP/TP22HITSP Patient ID Cross-Referencing Transaction Package HITSP/T23HITSP Patient Demographics Query Transaction HITSP/C32HITSP Summary Documents Using HL7 Continuity of Care Document (CCD) Component HITSP/C37HITSP Lab Report Document Using IHE XD* Lab Component HITSP/C35HITSP Lab Result Terminology Component HITSP/T15HITSP Collect and Communicate Security Audit Trail Transaction HITSP/T16HITSP Consistent Time Transaction HITSP/C19HITSP Entity Identity Assertion Component HITSP/TP20HITSP Access Control Transaction Package HITSP/TP30HITSP Manage Consent Directives Transaction Package

28. Slide 27 HITSP – enabling healthcare interoperability HITSP IS 05 Consumer Empowerment and Access to Clinical Information via Media HITSP IS 03 Consumer Empowerment and Access to Clinical Information via Networks  Unit of Information Exchange for Personal Health Records Standard structured electronic documents (XML Format) — Uses HL7 Clinical Document Architecture (CDA) and HL7 Continuity of Care Document (CCD) – standard structured electronic document representing clinical information for a patient

29. Slide 28 HITSP – enabling healthcare interoperability Constructs (single purpose or reusable) Type 1: Base or Composite Standards  Re-Use Applying an existing construct to more than one IS  Re-Purpose Updating a construct to meet the needs of a new Use Case  Can extend or constrain when reusing or re-purposing — Specifications contain a common superset — Superset can be extended as new requirements are encountered — Superset can be constrained with use-specific constraints Units of Information Exchange HITSP IS Constructs - Re-Use and Re-Purpose

30. Slide 29 HITSP – enabling healthcare interoperability Units of Information Exchange  HITSP C32 (Component) Summary Document — Summarizes a consumer’s medical status for the purpose of information exchange — May include administrative (e.g., registration, demographics, insurance, etc.) and clinical (problem list, medication list, allergies, test results, etc.) information — Re-Use: Originally developed for Registration and Medical Summary  HITSP C37 (Component) Laboratory Report Document — Specifies content for Laboratory Results data in a document-based functional flow scenario — Re-Use: Originally developed for the Biosurveillance and EHR-Lab Use Cases  Constrained when reused by Consumer Empowerment to require fully computable information  Necessary because Document Consumer (usually the PHR) must be able to import discrete lab data into the patient record.

31. Slide 30 HITSP – enabling healthcare interoperability Example: Continuity of Care Document (CCD)

32. Slide 31 HITSP – enabling healthcare interoperability Example: Lab Report

33. Slide 32 HITSP – enabling healthcare interoperability C37 Laboratory Report Document Structure  Key Concepts — Information is fully computable (not free text)  In HL7 CDA terms, this is referred to as “Level 3” data encoding  Constrains the use of the IHE XD*- Lab Profile which itself is a constrained implementation of HL7 CDA R2  Refers to C35 for terminology and vocabulary support

34. Slide 33 HITSP – enabling healthcare interoperability  LOINC Logical Observation Identifiers Names and Codes Identifies laboratory and other clinical observations — www.loinc.org www.loinc.org  HEDIS Healthcare Effectiveness Data and Information Set Tool to measure care are service performance — www.ncqa.org www.ncqa.org  SNOMED-CT Systematized Nomenclature of Medicine-Clinical Terms Comprehensive clinical terminology — www.ihtsdo.org www.ihtsdo.org  HL7Health Level Seven Develops healthcare informatics standards, mostly for interoperability — www.hl7.org www.hl7.org Examples: Terminology and Vocabulary This will be useful for the next slide

35. Slide 34 HITSP – enabling healthcare interoperability C35 EHR Lab Terminology  Key Concept — Augments minimum terminologies and vocabularies required by the base standard — Specifies vocabulary for Laboratory Results data  LOINC for top 95% of routine tests reported in HEDIS, plus microbiology and cytology  SNOMED-CT for Problem List (VA-KP Subset), Lab Test Findings & Organisms  HL7 V2.5 Code Sets and HL7 V3.0 Code Sets

36. Slide 35 HITSP – enabling healthcare interoperability C32 Summary Document Content Module HITSP Opt Person InformationR Language SpokenR2 SupportR2 Healthcare ProviderO Insurance ProviderO Allergy / Drug SensitivityO ConditionO Medication – Prescription and Non- Prescription O PregnancyO Information SourceR CommentO Advance DirectiveO ImmunizationO Vital SignO ResultO EncounterO ProcedureO  Module Requirements — Requires Person and Information Source Modules — Constraints may include the use of specific code systems, requiring some fields if module is present, other module-specific constraints — Other CCD information modules permitted but interoperability is not guaranteed for those modules  The document, as a whole, contains a designated author that is the consumer and/or their designated agent, such as the parent of a minor child

37. Slide 36 HITSP – enabling healthcare interoperability C32 – Summary Documents Using HL7 Continuity of Care Document (CCD) Component  Key Concepts — HL7 Clinical Document Architecture Release2, HL7 V3 Reference Information Model (RIM), Continuity of Care Medical Summary, Implementation Guide, Object Identifier (OID)  Uses document content description for the required data elements provided in: — HL7 Implementation Guide: CDA Release 2 – Continuity of Care Document (CCD), Release 1.0, April 01, 2007 with additional clarifications and specifications as appropriate «composite stand... CAQH CORE «composite standard» Federal Medication Terminologies «base standard» NCPDP SCRIPT «base stand... X12N 270/271 «base standard» ASTM E2369 «base stand... LOINC «base stand... HL7 CDA R2 «base standard» NDC RxNorm SPL «base stand... ASTM/HL7 CCD «component» Summary Document Using HL7 Continuity of Care (CCD) +docId = C32 constrains references constrains maps to constrains maps to «composite standard» IHE IT Infrastructure constrains

38. Slide 37 HITSP – enabling healthcare interoperability Medications – Prescription and Non-Prescription Module Key Specifications that extend CCD for medications:  Route of Administration: Value drawn from FDA route of administration  Dose: Unit attribute, if present, coded using Unified Code for Units of Measures  Site: Value descending from the SNOMED CT Anatomical Structure (91723000) hierarchy  Product Form: From dosage form - FDA dosage form – source NCI Thesaurus  Product name or brand name: Coded using RxNorm, or NDC. When only the class of the drug is known, it shall be coded using NDF-RT. FDA Unique Ingredient Identifier codes (UNII) codes may be used when there are no suitable codes in the other vocabularies to identify the medication  Indication: Coded using the VA/KP Problem List Subset of SNOMED CT (terms descending from clinical finding (404684003) concept

39. Slide 38 HITSP – enabling healthcare interoperability Allergies and Drug Sensitivities Module Key Specifications that extend CCD for allergies and drug sensitivities:  Adverse Event Type: See below. Support tiered level of specifics  Severity: See below  Product causing the adverse event: Coded to UNII for Food and substance allergies, or RxNorm when to medications, or NDF-RT when to classes of medications  Reaction: coded using the VA/KP Problem List Subset of SNOMED CT (terms descending from clinical finding (404684003) concept

40. Slide 39 HITSP – enabling healthcare interoperability A Successful Collaboration  Interweaving many different standards to address business needs  A successful collaboration between HITSP and several HITSP member organizations developing base standards and implementation guides/profiles

41. Slide 40 HITSP – enabling healthcare interoperability Strengths of IS 03 and IS 05  Effective interoperability — Independent conforming implementations will interoperate  all dimensions of interoperability covered, including sharing/selective access, transport and identity management — Semantic Interoperability with core clinical content  medications, allergies, problems/ conditions, and real-world clipboard information — Designed to equally empower the consumers and their providers (PHR-PHR, PHR-EHR, EHR-EHR) with the same level of robustness (continued)

42. Slide 41 HITSP – enabling healthcare interoperability  Practical interoperability — Standards that already have “implementation feasibility” validated  IHE Connectathon, HIMSS Interoperability Demonstration — Significant number of implementations  prototype and commercial  Flexible interoperability — Designed to allow “receivers of information” to operate at various levels of richness (explicitly defined IS conformance subsets):  display (browser+any CDA style sheet)  Import the “entire document”  Import discrete coded data  Secured and Private interoperability — Encryption, patient consent, user authentication Strengths of IS 03 and IS 05 (continued)

43. Slide 42 HITSP – enabling healthcare interoperability A concrete achievement for Steve  Implementation of HITSP Interoperability Specifications will allow Steve to have his records exchanged seamlessly and securely between and among diverse systems — Create a personal health record to access his registration summary and medication history — Establish permissions and access rights for viewing his data — Authorize healthcare provider to review medication history — Retrieve, store, graph and share laboratory test results — Retrieve and store:  Lists of current and previous health conditions  Lists of current medications, current environment, dietary, medication or medical supply allergies  Test results and medical procedures  A list of diagnosis codes

44. Slide 43 HITSP – enabling healthcare interoperability  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

45. Slide 44 HITSP – enabling healthcare interoperability Webinar 1 Standardizing How We Share Information in Healthcare: An Introduction to HITSP Thursday, June 5, 2008 — 2:00-3:30 pm EDT Webinar 6Quality Thursday, August 7, 2008 — 2:00-3:30 pm EDT Webinar 2HITSP Foundational Components Thursday, June 19, 2008 — 2:00-3:30 pm EDT Webinar 7Security, Privacy and Infrastructure Thursday, August 21, 2008 — 2:00-3:30 pm EDT Webinar 3Consumer Access to Clinical Information Thursday, June 26, 2008 — 2:00-3:30 pm EDT Webinar 8EHR and Emergency Response Thursday, September 4, 2008 — 2:00-3:30 pm EDT Webinar 4Biosurveillance Thursday, July 10, 2008 — 2:00-3:30 pm EDT Webinar 9Medication Management Thursday, September 18, 2008 — 2:00-3:30 pm EDT Webinar 5Electronic Health Record (EHR) and Lab Reporting Thursday, July 24, 2008 — 2:00-3:30 pm EDT www.HITSP.org/webinars How YOU can become involved Learn more about specific HITSP activities during these upcoming webinars:   

46. Slide 45 HITSP – enabling healthcare interoperability 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

47. Slide 46 HITSP – enabling healthcare interoperability Sponsor Strategic Partners www.HITSP.org

48. 47 enabling healthcare interoperability Webinar Series Sponsored by the HITSP Education, Communications and Outreach Committee Consumer Access to Clinical Information Questions and Answers