HL7 Development Who Does it and How Do They Do It?

1. HL7 DevelopmentWho Does itand How Do They Do It? Shari Dworkin CIHI June 7, 2001 SHIN HL7 Workshop

2. Presentation Overview • Who - The Movers and Shakers • Membership • Working Group • Collaboration • How - The Evolution of the Standard • Balloting • v2.x Development • v3 Development • Publications

3. Who - The Movers and Shakers Membership Working Group Collaboration

4. Who are Members of HL7 (.org) • 450 Organizational Members, 2131 Members of HL7 (US) • 946 Vendors • 641 Providers • 256 Consultants • 119 Non Profits • 13 Payors • 18 Pharmacy • 60 Affiliates • 24 Students • 54 Unknown

5. What Do HL7 Members Do? • Members develop the standard • Participation in Working Group Meetings • Voting on HL7 Ballots • Providing input on listservers and teleconferences • Informing HL7 Canada of issues or recommendations regarding the HL7s standard

6. What is an HL7 Working Group? • The Working Group is the name that shall be given to those activities related to the production and use of the Standard. • The Working Group consists of the set of individual Technical Committees and Special Interest Groups which are focused on particular HL7 protocol specification issues and areas. Taken from HL7 Bylaws

7. Key to HL7 - The Working Group • Draws equally from providers, software vendors, and consultants (interested parties) • Group sets aside their individual interests, rolls up their sleeves and collaborates to get the tough work done • Most discussions stem from • violent agreement, but failure to see the agreement • passionate beliefs • Strong facilitators in the working group that help to resolve issues • Hard Work = • 12 hours x 5 days x 3 general meetings / year + • 12 hours x 3 days x 3 harmonization meetings / year + • Active electronic collaboration in between

8. HL7 TCs and SIGs • Technical Committees (TCs) • Responsible for the development and maintenance of a section of the standard (usually a chapter) • Exceptions (Vocabulary, Education, Marketing, Publishing, and International Affiliates) • Special Interest Groups (SIGs) • Represent a variety of major initiatives in healthcare • Work in conjunction with TCs to advance the efforts of HL7

9. HL7 (.org) Technical Committees • CCOW • Clinical Decision Support • Control / Query • Data Warehousing • Education • Implementation • International Affiliates • Marketing • Medical Records / Info. Management • Modeling and Methodology

10. HL7 (.org) Technical Committees (cont’d) • Orders / Observations • Pt. Admin. / Financial Management • Patient Care • Personnel Management • Publishing • Scheduling and Logistics • Structured Documents • Vocabulary

11. HL7 (.org) Special Interest Groups (SIGs) • Arden Syntax • Attachments • Blood Bank • Clinical Guidelines • Clinical Trials • Community-Based Health Services • Conformance • Government Projects • Image Management • Lab Automation

12. HL7 (.org) Special Interest Groups (SIGs) - cont’d • Medication • Patient/Provider Messaging • Security and Accountability • Templates • XML

13. HL7 (.org) Works with Other Key Stakeholders

14. Collaboration Among Standard Development Organizations • X12 and HL7 - Claims Attachment and Data Modeling • DICOM WG20 and HL7 Imaging SIG - Joint Image Management SIG, IHE Demo • IEEE and HL7 - Merged Activities • HL7 and CEN - Message Development Framework, RIM and XMl syntax • HL7 and ISO TC215 - Message Development Framework

15. So… How does all this lead to a new standard?

16. How - The Evolution of the Standard Balloting v2.x Development v3 Development Publications

17. Balloting • HL7 (.org) is an ANSI approved Standards Development Organization • According to ANSI rules, this means that… • All new versions of the HL7 standard must undergo a balloting process that is open to all members

18. Balloting - The 5Ws • HOW does something go to ballot? • TCs propose new and/or improved content for the standard to HL7 Head Quarters • WHO votes? • HL7 (.org) have 1 vote • HL7 International Affiliates have up to 8 votes • WHEN do ballots take place? • 120 day cycle, Three cycles per year

19. Balloting - The 5Ws (continued) • WHERE can you vote? • Online - Ballots are available on the HL7 (.org) site and the HL7 Canada site • WHY would want to vote? • To influence the standard

20. Balloting Procedures • Two Rounds of Balloting • Technical Committee Ballot • Membership Level Ballot • All negative ballots must be addressed • According to ANSI rules, 90% of ballots must be affirmative

21. HL7 v2.x Development • New and/or improved content came from TCs and SIGs • Members wrote specific chapters of the standard without considerations from other TCs or SIGs • Content was added as needed, and under the discretion of the TC or SIG

22. Limitations of Version 2.x • No explicit information model • Events not tightly coupled to use cases • Need for controlled vocabularies • No explicit support for security functions • Optionality is troublesome • Lack of harmonization between chapter domains • Expansion of the standard led to incoherence

23. Strengths broad functional coverage highly adaptable IS environments differ system capabilities variations vocabulary independent least common denominator technological base Difficulties broad functional coverage highly adaptable “Seen one? Seen one.” vendor capability mismatch vocabulary independent least common denominator technological base Versions 2.x

24. HL7 Version 3 - • HL7 “grew up” on the Version 2 series, culminating in 2.4 • But now, HL7 is into Version 3 • How is it different? • Why is it important?

25. HL7 v3 Development - We do it with Models!

26. Version 3 Goals • Provide a Message Development Framework based on modeling • Improve clarity and precision of specification • Improve adaptability of standards to change • Work with other standards initiatives, such as DICOM • Begin to approach “plug and play”

27. Benefits of V3 to HL7 • Reduces optionality: results in more specific messages • Uncovers hidden assumptions about application boundaries (for everything there is a reason) • Facilitates defining clear, fine-grained, conformance claims • Allows for multiple implementation specifications (XML, CORBA, etc..)

28. HL7 Version 3 Development Approach 1. Define a consensus reference information model (RIM) that defines the data of interest in the healthcare domain. 2. Assemble the terminology and data types necessary to express the attributes of the RIM 3. Apply the model, vocabulary and types to: messages, patient record DTDs, medical logic modules, component specifications, etc. Done Done Happening Now

29. HL7 Version 3 Development Approach 4. For any particular application, draw from the RIM to construct an abstract message structure - the Hierarchical Message Description (HMD) 5. For any particular implementation technology, HL7 will define an implementation technology specification (ITS) for mapping the HMD to that technology. 6. When the message (or equivalent) is sent, the HMD is used to marshal the data, and the ITS is used to format the data for communication. Beginning Now Focus on XML Implementation

30. HL7 Modeling Dispense Medications Manage Care Perform Lab Tests Review Utilization By demanding analysis of the requirements and information content, Version 3 assures consistency in and enhances the value of the resulting products. Encounter Account Provider Patient Order HAL HL7 message HL7 message Finance ADT Pharmacy Abstractions: Version 2.x focused its energies at the communication level and covered the other abstractions only loosely in the specifications. Activities(Use Case Model) Objects (Information Model) Communication (Interaction and Message Models)

31. HL7 Version 3 Models and Specifications Use Case Model Information Model Interaction Model 2-nd Order 1 choice of 0-n Drug 0-1 Nursing Message Specification • Captures healthcare requirements • Defines scope for TSC approval • Specifies data and its semantics • Specifies major state transitions • Specifies vocabulary for domains • Defines information flows • Defines communication roles • Forms basis for conformance claims • Defines message contents • Apply constraints to the information model and vocabulary

32. HL7 V3 Message Development Lifecycle C Code c Codea artb bluec color Analysis Design Application Messaging Message Types for use with XML, ER7, etc (MET) Requirements Analysis Use Case Model (UCM) Domain Analysis Information Model &Vocabulary (RIM) Interaction Design Interaction Model (IM) Message Design HierarchicalMessageDescriptions (HMD) Documents Document Types forHL7 PRA (DTD) Medical logic Variable definition for Arden syntax (AVD) TYPE MPSLOC CONTAINS { id[id].TYPE IID nm[name].TYPE ST ad[addr].TYPE XAD ph[phon].TYPE XTN email_address [emlAdr].TYPE XTN } 2-nd Order 1 choice of 0-n Drug 0-1 Nursing <!ENTITY %DT_MPSLOC“MPSLOC.id, MPSLOC.name?, MPSLOC.addr?, MPSLOC.phon?, MPSLOC.emlAdr?"> data:location_of_action := READ LAST MPSLOC ; ‘ {patient location} Reference Model Repository

33. How do we get to Version 3?

34. v3 Strategy • Board appointed V3 steering committee • Woody Beeler (Chair), Wes Rishel, Abdul-Malik Shakir, Mark Shafarman, W. Ed Hammond • Focus more working group time on Version 3 • One day on Version 2.X • 4 days on Version 3 • Emphasize Version 2.x XML encoding for early adopters • Move quickly on first V3 products: • CDA (Clinical Document Architecture) (Unanimous Approval) • Version 3 data types • V3 data type XML ITS (Implementable Technology Specification)

35. Old and new will coexist. • How will transition happen? • Never touch a running system! • HL7 v2.x versions will be operational for an extended transition period (5 to 10 years) • HL7 v2.x will continue to be maintained for errors and clarification • new features will only go into new versions of v2 and HL7 v3 • New implementations may use HL7 v3 once it has been balloted • V2 and v3 interfaces will coexist for the extended transition period.

36. HL7 v3 Balloting

37. Legend: Reference: Content is harmonized during HL7 meetings or approved by the HL7 Board. It is not subject to ballot acceptance Informative: Content is balloted by general membership; however, it is not considered to be a structural part of the standard, only supporting information. Normative: Content is balloted by general membership and is considered structural component of HL7 standard. Negative ballots MUST be resolved.

38. HL7 3.0 Core Publication Structure Message Ballot Framework Vocabulary Literary Expression Reference Information Model RIM Diagram State Machines Part I Data Types Part II Implementable Technology Specifications XML Data Types Legend: Section Infrastructure Management Reference Sub-sections Informative Normative Section Health & Clinical Management Sub-sections Section Administrative Management Sub-sections • V3 Backbone • Welcome • Introduction • V3 Principles • Quick Start • Getting Started • Glossary

39. V3 Backbone Equivalent to the 2.x Chapter 1 • Introduction • Principles • Managing message development • Quick Start • Getting Started • Glossary • Links to all other documents & content. • V3 Backbone • Welcome • Introduction • Quick Start • Getting Started • Glossary

40. HL7 3.0 Section Publication Structure Legend: Reference Informative Normative CMET R-MIM HMD Message Type Sub-sections Domain Application Roles Message Type R-MIM HMD Interaction Category Storyboard Storyboard Examples Trigger Event Interaction

41. Committee Deliverables Design Repository Visio files R-MIM HMD Message Type R-MIM Domain MDB Domain Application Roles Interaction Category Storyboard Storyboard Examples Trigger Event Interaction

42. Publication Format Publication in two final formats: • PDF • appropriate for printing, submission to ANSII and off-line viewing • Each document available as ‘stand alone’ or will be inter-linked * • HTML • Appropriate for viewing online • Each document can be downloaded separately * * Backbone is required

43. Publication Schedule • June 15th – Deadline for non-Section content • July 9th – Deadline for Section content • July 9th to 13th – Ann Arbour ‘tiger team’ meeting to convert and test content • July 17th to 19th – Indianapolis meeting to review content with TCs • August 8th – Committee Ballot opens • October - Reconciliation of negative Ballots • January - Membership Level Ballot • May - HL7 Version 3 Approved Standard

44. Questions?