Tutorial: Introduction to Health Level Seven International (HL7) Organization & Process

1. Tutorial:Introduction to Health Level Seven International (HL7) Organization & Process John Quinn HL7 International CTO Vancouver British Columbia Canada May 13, 2012

2. Organization

3. HL7 International Is a Consensus Driven Standards Organization

4. Consensus Driven Standards • Are: • Volunteer-driven • Not a full-time commitment by most • Marked by uneven levels of participation • Participant developers have unequal levels of understanding • Balloted with required resolution of negative ballots • Therefore they are also prone to compromise which often leads to ambiguity

5. 34 HL7 International Affiliates / Countries Argentina Mexico New Zealand Romania Puerto Rico Pakistan Norway Australia And growing Russia Luxembourg Uruguay Singapore Austria Japan United States South Korea Spain Bosnia & Herzegovina Italy United Kingdom Sweden Turkey The Netherlands India Taiwan Canada 5 Columbia Greece Croatia France China Czech Republic Finland Germany

6. Influencers & Drivers vs. Members • While Similar, Influencers and Drivers shape and move the organizations shape and move the organization from mostly the outside of the organizations • Members influence and change the organization from through the HL7’s procedures. • Both are important but both act on the organization in different ways.

7. Examples of Influencers & Drivers • Governments (US ONC, Canada Health Infoway, Australia’s NEHTA, UK CfH, …) • Vendors • International Affiliates • Clinical users • Consultants • American National Standards Institute (ANSI) • International Standards Organization (ISO) • Other Standards Developing Organizations

8. The Users • Our current four major stakeholder-users(imho): • ONC/US Federal Health Architecture • CDA Community • Canada Health Infoway • NHS Connecting for Health (CfH) • HL7 V3 (or V2) is not being applied to any two stakeholders in the same way. No two of the stakeholders have the same problem-set or the same approach and use of HL7. • A manageable problem when integration is within an organization (intra-organizational) • Less manageable when integration is in a large copmplex organization • Large IDN • Reference Lab Network (e.g., Quest, LabCorp) • Unacceptable when organization is large geographic areas that have little formal healthcare organizational governance (e.g., countries, states, counties, etc.)

9. HL7 International Products • HL7 International has a number of major products. Example groups include: • Version 2.x • Version 3 Reference Information Based Products • Version 3 Messaging • Version 3 Clinical Document Architecture (CDA) • CDA Implementation Specifications or IGs (e.g., CCD) • Version 3 Services (near-term future) • Gello • Attachments • Structured Product Labeling • EHR-S & PHR-S Set of Standards • CCOW • Arden Syntax

10. The Use of HL7 Products • V3 products (e.g., messaging, CDA, SPL, etc.) are now much more widely used around the world than even a few years ago. • Users include governments and government funded entities (e.g., NHS, CHI, Turkey, Argentina, Uruguay, Columbia, US, etc.) • The exact forms of use varies as well: • messaging, electronic documents or services • the approach and methodology • processes automated and terminologies applied

11. What the Market Always Wants • Better and Faster: • Implementations • Conformance & Conformability testing • Computable Semantic Interoperability • Quality, Methodology & Tools • Support of Confidentiality/Security • Harmonization with other standards • Support of the latest communication technologies

12. HL7 InternationalWhat It Is & How It Is Organized and the Processes that support it?

13. HL7 – Health Level SevenInternational HL7 International is an ANSI accredited standards organization (ASO) for clinical & operational EDI. Members include: user (hospital, physicians practices, physician group practices, academic faculty practice plans, health maintenance organizations (HMO), preferred provider organizations (PPO), independent practice affiliations (IPA), utilization review (UR) companies, fiscal intermediaries, third-party administrators (TPA), peer review organizations (PRO), insurers and payers, manufacturers (pharmaceuticals, medical devices, etc.), professional associations and societies, industry consortia, regulators, and government agencies. There are also now 34 countries that participate in HL7 ISO’s Open Systems Interconnect (OSI) model: Application Level” – level 7

14. What is HL7 International? • HL7 International is one of several American National Standards Institute (ANSI) accredited Standards Developing Organizations (SDOs) operating in the healthcare arena. Most SDOs produce standards (sometimes called specifications or protocols) for a particular healthcare domain such as pharmacy, medical devices, imaging or insurance (claims processing) transactions.

15. What is HL7 International? • HL7 International’s domain is clinical and administrative data. • Many of our Standards are also ISO TC-215 Standards. • ISO TC-215 both adopts specific HL7 International Standards and also works with HL7 International to jointly develop standards.

16. Where & Who is HL7 International? • Headquartered in Ann Arbor, MI, HL7 International is like many other SDOs in that it is a not-for-profit volunteer organization. HL7 International also has an office in Brussels, Belgium. • Its members (providers, vendors, payers, consultants, government groups and others who have an interest in the development and advancement of clinical and administrative standards for healthcare) develop HL7’s standards.

17. What is HL7 International? • Like all ANSI-accredited SDOs, HL7 International adheres to a strict and well-defined set of operating procedures that ensures consensus, openness and balance of interest. • A frequent misconception about HL7 International (and presumably about the other SDOs) is that it develops software. While some small amount of software is developed (e.g., tools), what we actually develop are standards specifications. Our most widely used standards specifications enable disparate healthcare IT applications to exchange keys sets of clinical and administrative data.

18. What is HL7 International? • Members of Health Level Seven International are known collectively as the “Working Group”, which is organized into individual work groups. • The work groups are directly responsible for the content of the our products. • Work groups can also serve as a source for exploring new areas that need to be covered by HL7 International’s published standards.

19. To create the best and most widely used standards in healthcare. HL7 International’s Vision

20. http://www.hl7.org The Most Helpful Single Piece of Information?

21. HL7 International’s Mission HL7 International provides standards for interoperability that improve care delivery, optimize workflow, reduce ambiguity and enhance knowledge transfer among all of our stakeholders, including healthcare providers, government agencies, the vendor community, fellow SDOs and patients. In all of our processes we exhibit timeliness, scientific rigor and technical expertise without compromising transparency, accountability, practicality, or our willingness to put the needs of our stakeholders first.

22. What is the Origination of the name HL7? "Level Seven" refers to the highest level of the International Standards Organization (ISO) communications model for Open Systems Interconnection (OSI)(i.e., the Application Layer).

23. Application Application Presentation Presentation Session Session Transport Transport Network Network Data Data Physical Physical The OSI Model HL7 Logical Connection 7 Logical Connection 6 Logical Connection Logical Connection 5 Logical Connection 4 Logical Connection 3 Logical Connection 2 Physical Connection 1 Application 1 Application 2

24. HL7 Subject Domains • ADT • Order entry • Result reporting • Clinical Guidelines • Clinical Observations • Scheduling • Patient care • Immunizations • Discharge summaries … And Growing … Adverse event reporting Automated waveforms Medical transcriptions Referrals Consultations Clinical trials Nursing care plans Data Warehousing

25. HL7 Subject Domains • SGML, (now XML) • Vocabulary • Certification • Conformance • Security transactions • Claims attachment • Accountability, Quality, Assurance • Blood Bank … And Growing … Personnel Management Arden Syntax Component Based Messaging (i.e., Java) Visual/Context Integration Government Projects Master Patient Index SOA Image Management

26. HL7 International’s Work Groups* • Patient Safety • Pharmacy • Policy Advisory • Process Improvement • Project Services • Public Health and Emergency Response • Publishing • Recognition and Awards • Regulated Clinical Research Information Management (RCRIM) • RIM Based Application Architecture • Security • Services Oriented Architecture • Strategic Initiative Committee • Structured Documents • Templates • Tooling • Vocabulary • (17) Updated: 05/12 *includes Board Appointed Committees / Work Groups HL7 Work Groups: Affiliate Due Diligence Anatomic Pathology Architecture Board Arden Syntax Attachments Child Health Clinical Context Object Workgroup (CCOW) Clinical Decision Support Clinical Genomics Clinical Interoperability Council Clinical Statement Community Based Collaborative Care Conformance and Guidance for Implementation and Testing Education Electronic Health Record Electronic Services Emergency Care Financial Management (18) Generation of Anesthesia Standards Governance and Operations Government Projects Health Care Devices Imaging Integration Implementable Technology Specifications Implementation / Conformance Infrastructure and Messaging International Council International Mentoring Marketing Mobile Health Modeling and Methodology Nomination Committee Orders and Observations Organizational Relations Outreach Committee for Clinical Research Patient Administration Patient Care (21)

27. HL7 International’s Organization

28. TSC Structure • Technical Steering Committee - • 6 elected voting representatives, 4 appointed voting members • TSC-elects their Chair; CTO is ex-officio co-chair • Foundation & Technologies Steering Division • 9 existing workgroups • 2 Elected SD Co-Chairs plus Co-Chairs of workgroups in SD • Structure & Semantic Design Steering Division • 11 existing workgroups • 2 Elected SD Co-Chairs plus Co-Chairs of workgroups in SD • Domain Experts Steering Division • 16 existing workgroups • 2 Elected SD Co-Chairs plus Co-Chairs of workgroups in SD • Technical & Support Services Steering Division • 6 existing workgroups • 2 Elected SD Co-Chairs plus Co-Chairs of workgroups in SD

29. TSC – Mission HL7 International’s Technical Steering Committee’s Mission • This group supports the HL7 International mission to create and promote its standards by: • Overseeing and coordinating the technical efforts contributed by the HL7 International participants, who make up the HL7 International Working Group, and assuring that the efforts of the Working Group are focused on the overall HL7 mission. • The Technical Steering Committee and the HL7 International Working Group operate in such a way so as to: • Respect the contributions and ideas of the talented individuals who make up the Working Group; • Maintain an effective focus on the goals of HL7 International; • Assure that the all major decisions are based on consensus of the stakeholders; • Maximize sharing and "re-use" of work products between elements of the Working Group; • Use project management to assure that project goals are articulated and met; • Reduce competition and conflict between the elements of the Working Group; and • Assure that HL7 International Standards are developed on a solid architectural foundation that assures consistency and interoperability.

30. Steering Divisions • Foundation & Technologies Provides fundamental tools and building blocks • Conformance • Infrastructure & Messaging • Implementable Technology Specifications (ITS) • Java • Modeling & Methodology • Security • Service Oriented Architecture (SOA) • Templates • Vocabulary

31. Steering Divisions (con’t) • Structure & Semantic Design Steering Division Focuses on creation of basic patterns and common messages that could exist on their own, but are mostly used by others: • Arden Syntax • Clinical Context Object Workgroup (CCOW) • Clinical Decision Support • Electronic Health Record (EHR) • Financial Management • Imaging Integration • Orders & Observations • Patient Administration • Personnel Management • Scheduling & Logistics • Structured Documents

32. Steering Divisions (con’t) • Domain Experts Steering DivisionFocuses on creation of messages, services, documents using many of the common structures in place • Anatomic Pathology • Anesthesiology • Attachments • Cardiology • Clinical Genomics • Clinical Guidelines • Community Based Health Services • Emergency Care • Government Projects • Health Care Devices • Laboratory • Patient Care • Patient Safety • Pediatrics Data Standards • Public Health Emergency Response (PHER) • Pharmacy • Regulated Clinical Research Information Management (RCRIM)

33. Steering Divisions (con’t) Technical & Support Services Steering Division • The primary feature of these work groups is to support the Technical Steering Committee and work groups of the Working Group. • Education • Electronic Services • Implementation • Marketing Committee • Process Improvement Committee (PIC) • Project Services -- a new group that will take responsibility for the Project Life Cycle and will serve as the primary support for the PMO • Publishing • Tooling

34. U.S. Realm Health Messaging Standards Development Efforts HL7 International(Health Level 7) ACR/NEMA (DICOM)(American College of Radiologists /National Electrical Manufacturers Association)(Digital Image Communications) ADA(American Dental Association) ASTM (E31)ASTM International (was American Society of Testing Materials) CORE CAQH(Operating Rules for information exchange of healthcare administrative data) –i.e., real-time exchange of billing and administrative data IEEE(Institute of Electrical and Electronic Engineers) NCPDP(National Council of Prescription Drug Producers) OASIS(International First Responder (e.g., ambulance) X12N(Insurance workgroup of X12 including payment and administrative billing and reimbursement transactions) US TAG to ISO TC 215 (ISO Medical Informatics Standards. The US TAG is held by ANSI) ANSI(American National Standards Institute)

35. TC 215 Other Countries / HL7 Affiliates TC 251

36. History of HL7(Through 2009) Version 1.0Published ImplementationSupport Guidepublished Version 2.2Published Version 2.2ANSI Version 2.3.1Publishedand ANSI PRA(CDA 1.0) 1987 88 89 90 91 92 93 94 95 96 97 98 99 2000 01 02 03 04 ArdenSyntax2.0 Version 2.0Published Charter member ofANSI HISPP 2.4 2.5 First MeetingHospitalUniversity of PA Version 3.01st published Version 2.3Publishedand ANSI Version 2.1Published CCOW 2005 06 07 08 09 10 11 ReorganizesHires CEO & CTO & starts work on SAIF V2.6 Published V2.7 Published First work on SOA (Services) w/HSSP

37. HL7 International ProcessMeetings, Ballots & Life Cycle

38. HL7 International Meetings • Working Group Meetings occur three times a year. • September meeting is designated a “plenary” meeting. • Monday AM is a special program dedicated to business and reporting state of the organization. • Most (if not all) HL7 International work groups have face-to-face meetings during a working group meeting.

39. HL7 International Meetings • Workgroups set agendas for the “next” meeting at the end of the last meeting. • Agenda usually progresses work with time allocated to: • Version 2 • Version 3 • Joint meetings with related work groups • Current ballots normally take priority.

40. HL7 International Meetings • Work Groups have defined decision making processes that specify how they run meetings, debate and vote on issues discussed in a meetings. • HL7 International Process Improvement Committee (PIC) has default template procedures

41. HL7 International Meetings • Work Groups can customize their decision making processes. However: • PIC guidelines constrain the framework. • HL7 International’s By-Laws and Policy and Procedures take precedence • Default conduct is Robert’s Rules of Order.

42. Ballots • The end product of a ballot process is a document. The document could stand on its own. However, most balloted documents are a part of a published Standards Document (e.g., HL7 2.6, HL7 3.0, etc.)

43. Ballots • Documents can be: • Informative • An Informative Document is the product of a Work Group that is not currently deemed normative, but nonetheless is intended for general publication. It explains or supports the structure of the HL7 Protocol Specifications, or provides detailed information regarding the interpretation or implementation of an HL7 Protocol Specification. The TSC shall approve the issuance of an informative document ballot. • Draft Document for Comment Only • A Work Group, with the concurrence of the TSC, may submit proposed content or requirements documents, such as a Domain Analysis Model (DAM), to comment-only review. The intent is to gather input from members outside of the Work Group on the viability and clarity of the proposed content or requirements document. The review of proposed content or requirements documents does not seek a vote, per se, but will capture all comments.

44. Ballots • Draft Standards for Trial Use (DSTU) • Content is balloted by the general membership as the draft of a future standard which will, following a pre-specified period of evaluation and comment (usually 2 years), be expeditiously incorporated into normative standard. DSTU’s require at least two verified implementations that demonstrate the standard’s use. • Normative Standard • Content is balloted by the general membership and is considered a structural component of the HL7 Standard. Negative ballots must be resolved. Normative Standards are typically registered with ANSI.

45. Ballots ALL HL7 Balloted Standards are introduced first as a DSTU and must show some successful implementations before being advanced as a Normative Standard. • Ballots normally progress through two or more cycles of ballots. • Ballot pool is limited to declared interested members • Negative votes must be accompanied with a specific reason justifying the negative vote. • Affirmative w/edit change; Abstention with comment.

46. Ballots • Work Groups must resolve negative votes: • Accept the voters comment and recommended solution. • Negotiate with the voter and get them to agree to withdraw their negative. • Declare the vote non-persuasive. • Voters may appeal to the TSC and Board. They can also re-vote their same negative vote on the next round of balloting. • Substantive changes to a ballot (either to fix a negative or add new material) merit another round of balloting.

47. Ballots • When 90% (for normativedocuments) of the responses are registered as affirmatives…and hopefully all negatives withdrawn, a document is ready for publication as an HL7 International Standard.

48. HL7 Products and Projects • Project Lifecycle relies on the concept of HL7 International Products. • Examples: • Product Brand • Messaging, Arden Syntax, CCOW, CDA, XML,…. • Version • V2, V3, R1, R2, R3, … • Multiple projects may be required to create viable ‘product’

49. HL7 Project Criteria • Be consistent with HL7 strategic direction • Include appropriate project documentation - project charter, scope, resources, timelines, assumptions, constraints, planned deliverables, etc. per PMO methodology • Be aligned with market demand • Be sponsored by stakeholders intending to implement the product produced by the project • Define a reasonable balloting strategy to meet market demand and implementation timelines • Define how the project will engage with other impacted work groups • Follow project approval protocols to ensure appropriate project socialization and sign-off has taken place

50. QVSD RequestApproved(.2) HL7 Project Life Cycle for Product Development HL7 ProtocolSpecifications(.1) Request toenhanceor createproduct Training MaterialsImplementation GuidesPublish Standard(.21) ProjectInitiation(.5) Yes COMPLETE No QVSD Yes Pass(.18) START No Request toSunsetProduct MoveForward(.6) QVSD Cancel orWithdraw (.3) No FinalizeSpecification(.16) NormativeBallot(.17) END Yes RequestApproved(.2) No Industry Use(.15) RequirementsAnalysis(.7) Yes GoNormative(.20) QVSD No QVSD Specificationand Training(.14) SunsetProduct (.4) Yes LogicalDesign(.8) QVSD DSTUBallot(.13) END QVSD Normative Yes QVSD DSTU(.12) BallotType(.11) SeekComments(.10) Review Yes InformativeDocumentBallot (.19) CommentOnlyBallot DraftSpecification(.9) No QVSD No