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© 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International.

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1 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. John Quinn HL7 International CTO Vancouver British Columbia Canada May 13, 2012 Tutorial: Introduction to Health Level Seven International (HL7) Organization & Process

2 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. ORGANIZATION May,

3 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. HL7 INTERNATIONAL IS A CONSENSUS DRIVEN STANDARDS ORGANIZATION May,

4 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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 May,

5 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 34 HL7 International Affiliates / Countries Japan Canada Finland United States United Kingdom India China Taiwan Czech Republic And growing Mexico France Argentina Australia Greece Italy Sweden Turkey Uruguay New Zealand The Netherlands Singapore Croatia Austria Columbia South Korea Romania Spain Russia Norway Pakistan 5 Luxembourg Bosnia & Herzegovina Puerto Rico Germany

6 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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. Influencers & Drivers vs. Members

7 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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 May,

8 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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.) May,

9 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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 May,

10 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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 May,

11 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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 May,

12 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. HL7 INTERNATIONAL WHAT IT IS & HOW IT IS ORGANIZED AND THE PROCESSES THAT SUPPORT IT? May,

13 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. HL7 – Health Level Seven International 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 ISO’s Open Systems Interconnect (OSI) model: Application Level” – level 7 May,

14 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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.American National Standards Institute May,

15 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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. May,

16 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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. May,

17 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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. May,

18 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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. May,

19 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. HL7 INTERNATIONAL’S VISION To create the best and most widely used standards in healthcare. May,

20 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. THE MOST HELPFUL SINGLE PIECE OF INFORMATION? May,

21 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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. May,

22 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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). May,

23 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. The OSI Model Physical Data Network Transport Session Presentation Application Physical Data Network Transport Session Presentation Application Application 1Application 2 Physical Connection Logical Connection HL May,

24 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. HL7 Subject Domains ADT Order entry Result reporting Clinical Guidelines Clinical Observations Scheduling Patient care Immunizations Discharge summaries Adverse event reporting Automated waveforms Medical transcriptions Referrals Consultations Clinical trials Nursing care plans Data Warehousing … And Growing … May,

25 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. HL7 Subject Domains SGML, (now XML) Vocabulary Certification Conformance Security transactions Claims attachment Accountability, Quality, Assurance Blood Bank Personnel Management Arden Syntax Component Based Messaging (i.e., Java) Visual/Context Integration Government Projects Master Patient Index SOA Image Management … And Growing … May,

26 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. HL7 International’s 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) Updated: 05/12 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) *includes Board Appointed Committees / Work Groups May,

27 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. HL7 International’s Organization May,

28 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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 May,

29 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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. May,

30 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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 May,

31 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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 May,

32 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Steering Divisions (con’t) Domain Experts Steering Division Focuses 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) May,

33 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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 May,

34 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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) 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) May,

35 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. TC 215 Other Countries / HL7 Affiliates TC 251 May,

36 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. History of HL7 (Through 2009) First Meeting Hospital University of PA Version 2.0 Published Version 2.1 Published Charter member of ANSI HISPP Version st published Version 1.0 Published Implementation Support Guide published Version 2.2 Published Version 2.2 ANSI Version 2.3 Published and ANSI Version Published and ANSI Arden Syntax CCOW PRA (CDA 1.0) First work on SOA (Services) w/HSSP Reorganizes Hires CEO & CTO & starts work on SAIF V2.6 Published V2.7 Published May,

37 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. HL7 INTERNATIONAL PROCESS MEETINGS, BALLOTS & LIFE CYCLE May,

38 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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. May,

39 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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. May,

40 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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 May,

41 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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. May,

42 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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.) May,

43 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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. May,

44 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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. May,

45 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Ballots 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. ALL HL7 Balloted Standards are introduced first as a DSTU and must show some successful implementations before being advanced as a Normative Standard. May,

46 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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. May,

47 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Ballots When 90% (for normative documents) of the responses are registered as affirmatives…and hopefully all negatives withdrawn, a document is ready for publication as an HL7 International Standard. May,

48 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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’ May,

49 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. 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 May,

50 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Request to Sunset Product HL7 Protocol Specifications (.1) Request to enhance or create product Request Approved (.2) Cancel or Withdraw (.3) No Yes Sunset Product (.4) Project Initiation (.5) QVSD Move Forward (.6) No Requirements Analysis (.7) QVSD Yes Logical Design (.8) QVSD Draft Specification (.9) QVSD Ballot Type (.11) Review Normative DSTU (.12) Informative Document Ballot (.19) No Specification and Training (.14) QVSD Industry Use (.15) Go Normative (.20) No Seek Comments (.10) Finalize Specification (.16) QVSD Yes Normative Ballot (.17) Comment Only Ballot Training Materials Implementation Guides Publish Standard (.21) QVSD Yes No COMPLETE END Yes DSTU Ballot (.13) QVSD Pass (.18) No Yes END START HL7 Project Life Cycle for Product Development May,

51 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. HL7 INTERNATIONAL VERSION 2.X May,

52 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. HL7 International Version 2.x First widely used version 2.1 published in 1991 Used in 90%+ provider organizations in the US and widely supported by vendors. Generally requires bi-lateral negotiations between communicating parties. Backwards-fitted (imperfectly to HL7 International Reference Information Model (RIM)) Not well normalized.  Segments & Data Elements moved to a single location (Chapter 2) only in 2.5 in Makes no formal attempt to define process Most implementations are a mix of versions ranging from 2.1 to 2.3 (even though current version is 2.7) May,

53 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. May,

54 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Version 2.7 Chapters* 1. Introduction 2. Control / Data Types / Conformance & Code Tables 3. Patient Administration 4. Orders 5. Queries 6. Financial Management 7. Observations 8. Master Files 9. Medical Records / Information Mgmt 10. Scheduling 11. Patient Referral 2.7 is available on the HL7 “Standards” section of the HL7 web site. CDs are also available. May, Patient Care 13. Clinical Laboratory Automation 14. Application Management 15. Personnel Management 16. Non-US eClaims (new to 2.6) 17. Materials Mgmt. (new to 2.6) Appendices: A. Data Definition Tables B. Lower Layer Protocol C. BNF Definitions D. Glossary E. Index 54

55 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. HL7 INTERNATIONAL VERSION 3 May,

56 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Some HL7 International Version 3 Terms Use-case Models Reference Information Model (RIM) Domain Message Information Model (DMIM) Refined Message Information Model (RMIM) Message Implementation Manual (MIM-UK term for spec) Message Object Diagram Hierarchical Message Description (HMD) Common Message Element Types (CMET) May,

57 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. HL7 International Version 3 First approved for publication and pro- motion to ANSI as an HL7 Standard in September, Current Version: 2010 Published July 2010 HL7 International Version 3 First approved for publication and pro- motion to ANSI as an HL7 Standard in September, Current Version: 2010 Published July 2010 May,

58 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. HL7 International Version 3 May,

59 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. HL7 International Version 3 May,

60 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Appendices Acronyms Glossary May,

61 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Some Acronyms* ADA American Dental Association ACR American College of Radiology AHA American Hospital Association AHICAmerican Health Information Community (an advisory board within DHHS) AHIMA American Healthcare Information Management Association AHRQAgency for Health Research and Quality AMA American Medical Association AMIA American Medical Informatics Association ANA American Nursing Association ANSIAmerican National Standards Institute ASC X12 Accredited Standards Committee X12 – for business transactions ASC X12NAccredited Standards Committee X12N – for insurance and reimbursement data interchange ASC Z80 Accredited Standards Committee Z80 – for Optometry ASN.1Abstract Syntax Notation One ASTM American Society for Testing and Machinery—A US based SDO CAP College of American Pathologists * Courtesy of Ed Hammond, PhD 1999, with some updates from John Quinn, 2007 May,

62 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Some Acronyms* CCHITCertification Commission for Health Information Technology CCOW HL7 Clinical Context Object Workgroup (now Clinical Context Management) CDC Centers for Disease Control and Prevention CEN Comité Européen de Normalisation (EU Standards Body) CENELEC European ` for Electrotechnical Standardization CHIACanadian Health Informatics Association CIHICanadian Institution for Health Information CMAContext Management Architecture CMETHL7 Common Message Element Type—reusable message components such as data types CMSDHHS Centers for Medicare and Medicaid Services (was HCFA) COMComponent Object Model CORBACommon Object Request Broker Architecture CorbaMedOMG group working on health related projects CPRI Computer-based Patient Record Institute CPTCommon Procedural Terminology. A systematic listing and coding of procedures and services performed by physicians. A five-digit code with modifiers, used for Billing Owned & maintained by AMA. CTSHL7 Common Terminology Services * Courtesy of Ed Hammond, PhD 1999, with some updates from John Quinn, 2007 May,

63 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Some Acronyms* DAMHL7 Domain Analysis Model (see HL7 HDF) DCOMDistributed Component Object Model DESData Encryption Standard DHHSDepartment of Health and Human Services DICOM Digital Imaging and Communications in Medicine. Standard for transferring images. Owned by ACR DIMDomain Information Model DINGerman standards organization DISA Data Interchange Standards Organization. The secretariat for ASC X12. DMIMDomain Message Information Model DOD Department of Defense DRGDiagnostic Related Group DSM-IVDiagnostic and Statistical Manual of Mental Disorders; American Psychiatric Assoc. EPAEnvironmental Protection Agency. Has data registry. EU European Union EWGUN/EDIFACT Working Group FDA Food and Drug Administration FDISISO Final Draft International Standard GEHR Good European Health Record * Courtesy of Ed Hammond, PhD 1999, with some updates from John Quinn, 2007 May,

64 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Some Acronyms* HCFA Health Care Financing Administration (now CMS) HCPCSHCFA Procedure Coding System HDFHL7 Healthcare Development Framework HEDIS Health Employers Data and Information Set HHCCHome Health Care Classification. Virginia Saba’s code set for home care. HHS Health and Human Services (sometimes used instead of DHHS) HIBCC Health Industry Business Communications Council HIMA Health Industry Manufacturers Association HIMSSHealthcare Information and Management Systems Society (a trade group) HIPAA Health Insurance Portability and Accountability Act of 1996 HITHealth Information Technology HITSP Healthcare Information Technology Standards Panel (owned and organized under ANSI HL7 Health Level Seven International HMDHL7 Hierarchical Message Definition HMOHealth Maintenance Organization HOST Healthcare Open Systems and Trials HPCCHigh Performance Communications and Computing HTMLHyper-Text Markup Language * Courtesy of Ed Hammond, PhD 1999, with some updates from John Quinn, 2007 May,

65 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Some Acronyms* ICDInternational Classification of Disease ICD9Diagnostic and procedure codes, current version in the US is ICD9-CM ICD9-CM ICD9 with Clinical Modification ICD10Latest version of ICD implemented in most countries IDLInterface Definition Language ICNPInternational Classification for Nursing Practice IEC International Electrotechnical Commission IEEE Institute of Electronic and Electrical Engineers IETFInternet Engineering Task Force IHSIndian Health Service IMIAInternational Medical Informatics Association IOMInstitute of Medicine ISSBInformation Systems Standards Board ISOInternational Standards Organization (part of the UN in Geneva Switzerland) ITSECInformation Technology Security Evaluation Criteria ITU International Telecommunication Union * Courtesy of Ed Hammond, PhD 1999, with some updates from John Quinn, 2007 May,

66 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Some Acronyms* JAHIS Japanese Association for Medical Informatics JCAHOJoint Commission on Accreditation of Healthcare Organizations JIRA Japan Industries Association of Radiation Apparatus LOINCLogical Observations, Identifiers, Names and Codes MDFMessage Development Framework MEDCINNomenclature for healthcare. Produced by Medicomp. MEDINFOWorld Medical Informatics Conference; every 3 years; sponsored by IMIA. MEDIX Medical Data Interchange Standard (IEEE)[P1157] MEDRAMedical Dictionary for Drug Regulatory Affairs MeSHMedical Subject Heading MGMAMedical Group Management Association MIB Medical Informatics Bus (IEEE) MOUMemorandum Of Understanding MPIMaster Patient Index or Master Person Index MPLMaster Patient (Person) Locator MSHUGMicrosoft Healthcare User Group * Courtesy of Ed Hammond, PhD 1999, with some updates from John Quinn, 2007 May,

67 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Some Acronyms* NANDANorth American Nursing Diagnoses Association NCHS National Center for Health Statistics NCCLS National Committee for Clinical Laboratory Standards NCPDP National Council for Prescription Drug Programs NCVHS National Committee for Vital and Health Statistics NDCNational Drug Codes. Produced by the FDA. NEMA National Electrical Manufacturers Association NHSNational Health Service – UK NHS CTNational Health Service Clinical Terms (formerly Read Codes) NICNursing Intervention Classification NILTNursing Intervention Lexicon and Taxonomy NIST National Institute of Standards and Technology NLMNational Library of Medicine NOCNursing Outcomes Classification NPRMNotice of Proposed Rule Making NUBC National Uniform Billing Committee NUCC National Uniform Claims Committee * Courtesy of Ed Hammond, PhD 1999, with some updates from John Quinn, 2007 May,

68 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Some Acronyms* * Courtesy of Ed Hammond, PhD 1999, with some updates from John Quinn, 2007 May, OMAHA System Nursing Codes OMGObject Management Group ORBObject Request Broker PACSPicture Archiving and Communication System PCDSPatient Care Data Set. Judy Ozbolt, Vanderbilt. PHSPublic Health Service PRAPatient Record Architecture PSROProfessional Standards Review Organization READ Classification System: Clinical codes with a bias for primary care. Now part of NHS SNOMED CT. RIMReference Information Model RMIMRefined Message Information Model RSAAlgorithm for encrypting / decrypting data. Developed by Ronald Rivest, Adi Shamir, and Leonard Adleman RSNARadiological Society of North America SCARSociety for Computer Applications in Radiology SDOStandards Development Organization SGMLStandard Generalized Markup Language

69 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Some Acronyms* SCARSociety for Computer Applications in Radiology SDOStandards Development Organization SGMLStructured Graphical Markup Language SNOMED RTSystematized Nomenclature of Medicine Reference Terminology SNOPSystematized Nomenclature of Pathology SQLStructured Query Language TC 215ISO Technical Committee 215 – Healthcare Information TC 215 WG1Working Group 1: Modeling Coordination and Health Records TC 215 WG2Working Group 2: Messaging and Communications TC 215 WG3Working Group 3: Health Concept Representation TC 215 WG4Working Group 4: Security TC 215 WG5Working Group 5: Health Cards * Courtesy of Ed Hammond, PhD 1999, with some updates from John Quinn, 2007 May,

70 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Some Acronyms* TC 251CEN Technical Committee for Medical Informatics TC 251 WG1Healthcare Information Modeling and Medical Records TC 251 WG2Healthcare Terminology, Semantics and Knowledge Bases TC 251 WG3Healthcare Communications and Messages TC 251 WG4Medical Imaging and Multimedia TC 251 WG5Communication with Medical Devices TC 251 WG6Healthcare Security, Privacy, Quality and Safety TC 251 WG8Intermittently Connected Devices (including Cards) TCP/IPTransmission Control Protocol/Internet Protocol TerminfoAn HL7 International General Approach to resolving issues related to the interface between HL7 International Information Model and terminologies or code systems TRISO Technical Report TSISO Technical Specification UCC Uniform Code Council UCDSUniform Clinical Data System UMDNSUniversal Medical Device Nomenclature System UMLUnified Modeling Language UMLS Unified Medical Language System * Courtesy of Ed Hammond, PhD 1999, with some updates from John Quinn, 2007 May,

71 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Some Acronyms* UN/EDIFACTUnited Nations Electronic Data Interchange For Administration, Commerce and Transport UNIX Open Systems Operating system UPCUniversal Product Code. From UCC. URLUniversal Resource Locator (e.g., USHIKUS Health Information Knowledgebase; Data Registry US/TAG United States Technical Advisory Committee VA Veterans Administration WEDI Workgroup on Electronic Data Interchange WHO World Health Organization WS-IWeb Services Interoperability Organization wwwWorld Wide Web W3CWorld Wide Web Consortium. Definers of HTML & XML among other things XMLExtensible Markup Language * Courtesy of Ed Hammond, PhD 1999, with some updates from John Quinn, 2007 May,

72 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. HL7 V 2.7 Glossary May,

73 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. HL7 V3 Glossary May,

74 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. HL7 Healthcare Development Framework (HDF) May,

75 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. ISO TC 215 Joint Initiative for Global Standards Harmonization Health Informatics Document Registry and Glossary Note, this web site requires registration but no fee. If you have interest, you can use this link to obtain a username & password and then access to the above ISO Document Registry and Glossary. May,

76 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. Here are some definitions of organizations that have been mentioned in this presentation. American National Standards Institute (ANSI) : The Institute oversees the creation, promulgation and use of thousands of norms and guidelines that directly impact businesses in nearly every sector: ANSI is also actively engaged in accrediting programs that assess conformance to standards – including globally-recognized cross-sector programs such as the ISO 9000 (quality) and ISO (environmental) management systems. Standards Development Organizations (SDOs)—not healthcare specific : Any organization whose primary activities are developing, coordinating, promulgating, revising, amending, reissuing, interpreting, or otherwise maintaining technical standards that address the interests of a wide base of users outside the standard-developing organization*. Glossary *wikipedia

77 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. ONC  The Office of the National Coordinator for Health Information Technology is an organization in the US Department of Health and Human Services reporting to the DHHS Secretary. ONC is designated in several laws by the US Congress to distribute funds and manage initiatives to meet requirements for the development, deployment and use of health information technology by providers, and public health agencies through inducement of financial incentives and, eventually, financial penalties. International Standards Organization (ISO) Technical Committee (TC) 215 (Health Informatics):  ISO is an organization of the United Nations headquartered in Switzerland. Its governance structure is similar to the UN’s where each country has one vote. The secretariat for ISO TC 215 is held by the American National Standards Institute (ANSI).  ITC 215’s domain of work is standardization in the field of information for health, and Health Information and Communications Technology (ICT) to promote interoperability between independent systems, to enable compatibility and consistency for health information and data, as well as to reduce duplication of effort and redundancies.  The domain of ICT for health includes but is not limited to: − Healthcare delivery; − Disease prevention and wellness promotion; − Public health and surveillance; − Clinical research related to health service. Glossary

78 © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office. EU’s CEN (Comité Européen de Normalisation) TC251  (CEN Technical Committee 251) is a workgroup within the European Union working on standardization in the field of Health Information and Communications Technology (ICT) in the European Union. The goal is to achieve compatibility and interoperability between independent systems and to enable modularity in Electronic Health Records systems.  Workgroups establish requirements for health information structure in order to support clinical and administrative procedures, technical methods to support interoperable systems. In addition they establish requirements regarding safety, security and quality.* *wikipedia Glossary


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