January 2009

1. HL7 Clinical Interoperability Council (CIC) Clinician Orientation January 2009

2. Introductions • Tell us a bit about yourself • Your name and organization • Why you are here today/this week • What you hope to gain from today’s session

3. Welcome!

4. Objectives for Today • Convey mission and purpose of the HL7 Clinical Interoperability Council (CIC) • Discuss how standards can support the clinical community • Discuss how CIC conducts work • Describe what standards look like • Understand how to get involved • Understand general information about HL7 and how workgroup meetings function

5. Introduction to HL7 Crystal Kallem

6. Health Level Seven, Inc. (HL7) • An international standards development organization (SDO) established more than 20 years ago • Creates standards for the exchange, management and integration of electronic healthcare information • Develops specifications that enable disparate healthcare applications to exchange key sets of clinical and administrative data

7. HL7 Vision/Mission Vision To create the best and most widely used standards in healthcare. Mission HL7 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.

8. Why Standards? • Standards enable interoperability of healthcare information • Three aspects of interoperability • Technical: Moving data from system A to system B • Semantic: Ensuring that system A and system B understand the data in the same way • Process: Enabling business processes at organizations housing system A and system B to work together

9. HL7 Workgroups • Multiple workgroups function within HL7 today addressing various aspects of standards development • The Clinical Interoperability Council (CIC) is an official workgroup of HL7

10. HL7 Workgroup Meetings • HL7 face-to-face workgroup meetings occur in January, May and September each year • Workgroup meetings offer • A chance to meet face-to-face to work on standards and conduct administrative work • An opportunity to exchange knowledge and ideas that lead to advancement in healthcare information technology utilization

11. Introduction to the Clinical Interoperability Council (CIC) Crystal Kallem

12. A Bit of History • Early standards addressed what was needed as part of hospital information systems and departmental system • Most current standards are transparent to the clinical community • The needs for standards change as we progress with information technology • The future must be different

13. The Problem Data Collected or Generated During Patient Care Data Used

14. Uses of Data Have Significant Overlap Research Population Health Reporting Quality Measurement & Patient Safety Reimbursement Management Clinical Data

15. Data Uses Healthcare Data Systems • Patient care • Quality Improvement • Research • Reimbursement • Post Marketing Safety • Decision Support • Administration & Mgt. • Population Health Reporting • … Clinician Patient Goal: Exchange and Use of Data Single Source Multiple Uses

16. Data Element: chest x-ray result Funding & Development Partners Surveillance Research Patient Care Regulatory

17. Data Element: chest x-ray result Funding & Development Partners Surveillance Research Data Mapping = = = = Patient Care Regulatory

18. Data Element: chest x-ray result Funding & Development Partners Surveillance Research Global Data Standards: An agreed upon set of common data elements, how they are defined, and how they “look” electronically Patient Care Regulatory

19. Where are the Gaps? • No clinical content standards • Siloed approaches for: • Terminology • Guidelines • Performance measures • EHR development & implementation • Research • … • Clinician involvement

20. History of the CIC • Initiated by HL7 in May 2006 • Initial focus: Survey the landscape of clinically oriented standards efforts • Many presentations providing a wealth of information, all available on the CIC web page • CIC objectives are now a strategic priority for HL7

21. CIC Mission This Council provides the standards development framework, organizational processes and forums to collaborate with the clinical community to define content, flow and other domain requirements necessary to the development of robust health data standards. The Council will provide mechanism for clinical domains to develop common approaches to standards-related activities and form consensus on issues of interest among multiple groups. This Council will be unique to Health Level Seven in that the focus is on the clinical content, not the technology of the standards.

22. CIC Mission This Council provides the standards development framework, organizational processes and forums to collaborate with the clinical community to define content, flow and other domain requirements necessary to the development of robust health data standards. The Council will provide mechanism for clinical domains to develop common approaches to standards-related activities and form consensus on issues of interest among multiple groups. This Council will be unique to Health Level Seven in that the focus is on the clinical content, not the technology of the standards.

23. CIC’s Role • Actively engage clinicians in standardizing their domains • Provide a community for those standardizing their domain • Provide a forum and process for harmonization of data elements and clinical information model • Maintain awareness of, employ, and teach the best methodology for clinical content representation • Provide a process for clinical content representation and access to experience • Provide infrastructure, process and imprimatur associated with an international SDO • Access port through which clinical content can be made available to HL7 technical community, i.e., for development of messages, documents, profile, services, etc. Near-term products with a long-term outlook

24. Questions/comments?

25. Methodology for Developing Standards and DAMs Anita Walden

26. Terms You May Hear

27. Version 2.x • APPROVED AS AN ANSI STANDARD JUNE 26, 2003. • The HL7 version 2 standard has the aim to support hospital workflows. • HL7 version 2 defines a series of electronic messages to support administrative, logistical, financial as well as clinical processes • Most widely implemented standard for healthcare information in the world.

28. Version 3.0 Uses an object-oriented development methodology and a Reference Information Model (RIM) to create messages. The RIM is an essential part of the HL7 Version 3 development methodology, as it provides an explicit representation of the semantic and lexical connections that exist between the information carried in the fields of HL7 messages.

29. Class : 1. A kind or category of things or concepts. 2. A definition of objects, in terms of properties (attributes, methods, and relationships) that all objects of the class have in common. • Model : A representation of a problem or subject area that uses abstraction to express the relevant concepts. A model is often a collection of schema and other documentation.

30. Data Element • In metadata, the term data element is an atomic unit of data that has: • An identification such as a data element name • A clear data element definition • One or more representation terms • Optional enumerated values Code (metadata) • A list of synonyms to data elements in other metadata registries Synonym ring

31. Data Element Example

32. Reference Information Model (RIM) • The Reference Information Model (RIM) is the cornerstone of the HL7 Version 3 development process. • An object model created as part of the Version 3 methodology, the RIM is a large pictorial representation of the clinical data (domains) and identifies the life cycle of events that a message or groups of related messages will carry. • It is a shared model between all the domains and as such is the model from which all domains create their messages.

33. Other Terms You May Hear • Balloting – Voting process. Before a standard is ANSI-approved, it must be balloted by the HL7 membership. • Public Comment – Releasing developed standards to the community for review and comment • CDISC – Clinical Data Interchange Standards Consortium – An organization that develops and supports standards for clinical research use • EHR – Electronic Health Record • Message* – Atomic unit of data transferred between electronic systems. It is comprised of a group of segments in a defined sequence. • Project Scope Statement – Form completed by project team to outline the project. This form is used by HL7 to review approve official HL7 projects that may be balloted as an official HL7 standard • SNOMED CT (Systematized Nomenclature of Medicine -- Clinical Terms)- Terminology for diseases, findings, procedures, microorganisms, pharmaceuticals. reducing the variability in the way data is captured, encoded and used for clinical care of patients and research.

34. Domain Analysis Model • The DAM is a set of requirements which are submitted to design and implementation procedures and processes (e.g., HL7 specification development). It is a structured way to describe and document the information requirements of a particular area of interest (or domain). • A description of the domain or environment

35. DAM Methodology and Process

36. Domain Analysis Model Content • Document Business Process - Clinicians • Storyboard- Patient Scenarios – Clinician • Glossary/data elements – Clinician/Data Manager • Activity diagram – Clinician/Data Manager • Use case model – Clinician/Modeler • Message content (data requirements)-Modeler • Class model (aka Domain Analysis Model)-Modelers • State diagram -Modeler • Business rules – Clinicians/Data Managers/Modelers

37. Storyboard/Scenario Example Darlene Dobson goes to the local office of her state Department of Motor Vehicles to renew her drivers license and fills out a Drivers License Renewal form. The license clerk requests her current drivers license and using the drivers license number, S057864389, inquires on the status of her current drivers license, sees that it is active but scheduled to expire in three weeks, verifies that Darlene’s date of birth and current address are the same as the data currently in the system, enters Darlene’s responses from the form indicating that she has not been convicted of a moving motor vehicle violation in the previous three years and that she does not have any health issues that affect her driving ability. After that information is entered the system sends an inquiry to the state court system for moving motor vehicle violations in the previous three years and after receiving a response that there have been none, requests payment information. Darlene indicates she would like to pay with a MasterCard debit card and gives the card to the license clerk. The clerk enters the MasterCard number and expiration date. The registry system sends an electronic request to MasterCard to have the $35 drivers license renewal fee debited from Darlene’s account and credited to the Department’s bank account. After receiving an acceptance response from the MasterCard system, the registry system prints Darlene’s new drivers license good for three years and a payment receipt. Given that the entire visit only took 10 minutes, Darlene leaves the office with a smile on her face.

38. Use Case Requirements Analysis: Building a Domain Analysis Model HL7 Training;May 1, 2007,Norman Daoust, HDF Contributor for Ioana Singureanu,

39. CV Activity Model

40. CV Class Model Example

41. Methodology for Developing DAMs • Gather existing information • Data Elements/Definitions • Forms/Data Dictionaries • Engage and meet w/ Stakeholders to discuss project and gather additional existing information • Initial Face to Face meeting with Domain Stakeholders • Create small working group to define data elements and definitions • Weekly-Bi/Weekly Teleconferences or webinars, • 2- Face 2 Face mtgs a year to accomplish largest amount of work • Subset work- break up data elements into smaller chunks of work • Some domains are too large to accomplish all at once • Focus on domain data elements only-General Data Elements are developed by others groups • Public Comment – the entire community should have opportunity to review defined data elements • Have webinars to review work with broader community • Publicize activities • Develop a standards and DAM maintenance plan

42. Methodology for Developing DAMs (cont.) • Identify tools used to develop UML /ActivityModels • Use common class models examples • CV • TB • Platform independent

43. Roles • Stakekholders –provide clinical content and information • Project Manager – facilitate process • Data Manager or Informaticists – gather requirements, create artifacts • Modeler – design models

44. Key to Success • Identify a Project Manager • Keeps the process moving • Ensures all key stakeholders are involved • Identifies scope • Communicates needs, status • Facilitates meetings • Ensures products are produced w/in timeframe • Keeps project within budget and scope

45. Meetings Recommendations • Initial kick of meeting of all stakeholders • Inform them of project • Gather information • Identify stakeholder working groups participants • Weekly or bi-weekly Web/Teleconferences • Created and Define Data Elements • Participants – stakeholders, project manager, informaticists/data manager • Modeler will attend once data elements have been developed • 1-2 Face to Face mtgs a year to accomplish large chuncks of work • Present work at conferences and working group mtgs • Attend HL7 CIC mtgs • Attend HL7 CIC Data Element Facilitation mtgs • Biweekly mtg to assist groups with the process, monitor status and keep consistency between DAMs

46. Tooling Recommendations • Communication tools • Conference phone # • Web Conferencing system • Modeling tools • Examples: Visio/Enterprise Architecture/Rational Software Model • Spreadsheet - data gathering • Excel • Website for accessing data standard

47. Helpful Hints for a Sound Process • Providing stakeholders with information to respond to will speed up the process. • Giving them blank slate will take more time for decision making • Scope • Data Elements/Definitions • Identify where data elements and DAMs will be stored for public access • Engage those groups early on • Be aware other standards development activities and their direction • Hold meetings on a consistent schedule • Inconsistency reduces participation • Use Ontologies • Keep DAMs General not specific to a tool or process

48. Work Done to Date Meredith Nahm

49. Accomplishing the Goal Requires Standardizing the Clinical Domain* • Information Model • Domain Analysis Model • (what concepts & how grouped) • HL7 RIM based models • Content for EHR screens Content • Data Elements • Link concept to terminologies • Link concept to definition • Inference Model • Clinical Guidelines • Decision Support • Performance Measures • Concept Model • Ontology • Formal Logic Definitions Language Knowledge *Adapted from model in Rector, et al 2004 MEDINFO/IMIA. Full reference in slide notes.

50. Example Inference Model* Information Model Decision Support: Confirmed cases of TB should be flagged for local health authority notification (from CDC) Inference Model Concept Model *In reality, these rules would be written in a syntax that resembles computer code