Tutorial Introduction to Health Level Seven International HL

Tutorial: Introduction to Health Level Seven International (HL 7) Organization & Process John Quinn (HL 7 International CTO) Chicago, Illinois, US September 14, 2014 © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office.

ORGANIZATION © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 2 September, 2014

HL 7 International is a Consensus Driven Standards Development Organization (SDO) © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 3 September, 2014

Consensus Driven Standards n Are: Ø Ø Ø 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 © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 4 September, 2014

36 HL 7 International Affiliates / Countries Argentina Romania Puerto Rico Russia Australia Philippines And growing Pakistan Norway New Zealand Uruguay Malaysia Austria Bosnia and Herzegovina Singapore United States Japan South Korea Italy Spain Brazil Sweden United Kingdom India Canada Switzerland Taiwan Turkey The Netherlands 5 Hong Kong Greece China Croatia Czech Republic © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. Finland France Germany Updated 09/14/14

Examples of Influencers & Drivers n n n n Governments (US ONC, Canada Health Infoway, Australia’s NEHTA, UK’s NHS Cf. H, …) American National Standards Institute (ANSI) Vendors International Affiliates Clinical users & Consultants Healthcare Ontology/Terminology SDOs (e. g. , IHTSDO (SNOMED), Regenstrief (LOINC), WHO (ICD), etc. ) Other International Standards Organization (ISO, DICOM, GS/1, CEN TC 251, etc. ) Other US Healthcare related SDOs (e. g. , X 12 N, NCPDP, etc. ) © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 7 September, 2014

What is an Affiliate? n An Affiliate is an independent legal entity that: Ø Ø Ø Represents its members at Hl 7 International and within its country/ territory on HL 7 matters; Participates in HL 7 International’s standards development and governance processes; Promotes the relevance and fitness of the HL 7 Protocol Specifications, HL 7 Educational Material and Other HL 7 Material in its country/territory; Distributes, translates and localizes the HL 7 Protocol Specifications as appropriate; Administers and proctors HL 7 Certification tests within its Territory when suitable and authorized to do so as provided below; and Promote HL 7 standards, educates, informs and supports current and potential users within the Territory to promote consistent and widespread usage of the standards. © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 8 September, 2014

The Users n Our current four major stakeholder-users Ø Ø n (imho): ONC/US Federal Health Architecture CDA Community Canada Health Infoway NHS Connecting for Health (Cf. H) HL 7 V 3 (or V 2) 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 HL 7. Typical approach to using HL 7 is: Ø Ø A manageable problem when integration is within an organization (intra-organizational) Less manageable when integration is in a large complex organization n n Ø Large IDN Reference Lab Network (e. g. , Quest, Lab. Corp) Unacceptable when organization is large geographic areas that have little formal healthcare organizational governance (e. g. , countries, states, counties, etc. ) © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 9 September, 2014

In short n Interoperability beyond a single point to point interface requires: Ø Ø Ø A profile that includes all of the related SDOs’ elements (e. g. , terminologies), and other directed references within the primary SDO product (e. g. , state names & abbreviations). A resolution of all pre-coordinated decisions to remove all optionality; Full specification from Layers 1 -7 (not just Level 7) The publication of an implementation guide that is used by all communicating parties. A published governance and update process that supports needed fixes and related updates. © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 10 September, 2014

HL 7 International Products • HL 7 International has a number of major product lines: – – 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 A project to create Product-Line Management and coordinate common elements and better define “backward-break” issues is now being formulated in the Technical Steering Committee. © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 11 September, 2014

The Users n n n V 3 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, Malaysia, US, etc. ) The exact forms of use varies as well: Ø Ø Ø messaging, electronic documents or services the approach and methodology processes automated and terminologies applied © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 12 September, 2014

What the Market Wants n n n n Faster implementations Conformance & Conformability testing Computable Semantic Interoperability Better Quality, Methodology & Tools Confidentiality/Security Harmonization with other standards Support of the latest communication technologies © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 13 September, 2014

HL 7 INTERNATIONAL WHAT IT IS & HOW IT IS ORGANIZED? © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 14 September, 2014

HL 7 – Health Level Seven International HL 7 International is an ANSI accredited standards organization (ASO) for clinical & operational EDI. ISO’s Open Systems Interconnect (OSI) model: Application Level” – level 7 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, thirdparty 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 also now 34 countries that participate in HL 7 © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 15 September, 2014

What is HL 7 International? n HL 7 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. © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 16 September, 2014

What is HL 7 International? HL 7 International’s domain is clinical and administrative data. n Many of our Standards are also ISO TC-215 Standards. n ISO TC-215 both adopts specific HL 7 International Standards and also works with HL 7 International to jointly develop standards. n © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 17 September, 2014

Where & Who is HL 7 International? n Headquartered in Ann Arbor, MI, HL 7 International is like many other SDOs in that it is a not-for-profit volunteer organization. HL 7 International also has an office in Brussels, Belgium. n 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 HL 7’s standards. © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 18 September, 2014

What is HL 7 International? n Like all ANSI-accredited SDOs, HL 7 International adheres to a strict and well-defined set of operating procedures that ensures consensus, openness and balance of interest. n A frequent misconception about HL 7 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. © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 19 September, 2014

What is HL 7 International? n n n 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 HL 7 International’s published standards. © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 20 September, 2014

HL 7 INTERNATIONAL’S VISION To create the best and most widely used standards in healthcare. © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 21 September, 2014

THE MOST HELPFUL SINGLE PIECE OF INFORMATION? http: //www. hl 7. org © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 22 September, 2014

HL 7 International’s Mission HL 7 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. © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 23 September, 2014

What is the Origination of the name HL 7? "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). © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 24 September, 2014

What is the Origination of the name HL 7? The application level addresses definition of the data to be exchanged, the timing of the interchange, and the communication of certain errors to the application. The seventh level supports such functions as security checks, participant identification, availability checks, exchange mechanism negotiations and, most importantly, data exchange structuring. © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 25 September, 2014

The OSI Model HL 7 7 Application Logical Connection Application 6 Presentation Logical Connection Presentation 5 Session Logical Connection Session 4 Transport Logical Connection Transport 3 Network Logical Connection Network 2 Data Logical Connection Data 1 Physical Connection Physical Application 1 © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. Application 2 26 September, 2014

HL 7 Subject Domains n n n n n ADT Order entry Result reporting Clinical Guidelines Clinical Observations Scheduling Patient care Immunizations Discharge summaries n n n n n Mobile Computing Adverse event reporting Automated waveforms Medical transcriptions Referrals Consultations Clinical trials Nursing care plans Data Warehousing … And Growing … © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 27 September, 20134

HL 7 Subject Domains n n n n SGML, (now XML) Terminology/Vocabulary/ Ontology Certification Conformance Security transactions Claims attachment Accountability, Quality, Assurance Blood Bank n n n n Personnel Management Arden Syntax Component Based Messaging (i. e. , Java) Visual/Context Integration Government Projects Master Patient Index SOA Image Management … And Growing … © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 28 September, 2014

HL 7 International’s Work Groups HL 7 Work Groups: n n n n n Affiliate Due Diligence Anatomic Pathology Anesthesia Application Implementation and Design Architecture Board Arden Syntax Attachments Child Health Clinical Decision Support Clinical Genomics Clinical Interoperability Council Clinical Quality Information Clinical Statement Community Based Collaborative Care Conformance & Guidance for Implementation/Testing Education Electronic Health Record s Electronic Services Emergency Care n n n n n Financial Management Governance and Operations Health Care Devices Imaging Integration Implementable Technology Specifications Infrastructure and Messaging International Council International Mentoring Marketing Mobile Health Modeling and Methodology Nomination Orders and Observations Organizational Relations Outreach Committee for Clinical Research Patient Administration Patient Care Patient Safety Pharmacy (19) n n n n Policy Advisory Process Improvement Project Services Public Health and Emergency Response Publishing Recognition and Awards Regulated Clinical Research Information Management (RCRIM) Security Services Oriented Architecture Strategic Initiative Committee Structured Documents Technical Steering Committee Templates Tooling Vocabulary (15) (19) Updated: 01/14 53 Total © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 29 September, 2014

HL 7 Organization Two Representatives HL 7 Board of Directors Advisory Council Executive Committee (Bo. D Officers) International Council & HL 7 Affiliates CEO Chuck Jaffe MD Ph. D COO CTO Mark Mc. Dougall Wayne Kubick Technical Steering Committee (TSC) Chair: Ken Mc. Caslin Operations AMG International Representatives Giorgio Cangioli & Jean Duteau Steering Division: Foundation & Technology Russ Hamm & Paul Knapp Steering Division: Structure & Semantic Design Steering Division: Domain Experts Melva Peters & John Roberts Calvin Beebe & Gora Datta Steering Division: Technical & Support Sandra Stuart & Andy Stechishin Other Members ARB Co-Chairs: Anthony Julian & Lorraine Constable Ad-Hoc: Austin Kreisler & Freida Hall Work Groups © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 30 September, 2014

TSC Structure n Technical Steering Committee Ø Ø n Foundation & Technologies Steering Division Ø Ø n Ø 10 existing workgroups 2 Elected SD Co-Chairs plus Co-Chairs of workgroups in SD Domain Experts Steering Division Ø Ø n 9 existing workgroups 2 Elected SD Co-Chairs plus Co-Chairs of workgroups in SD Structure & Semantic Design Steering Division Ø n 6 elected voting representatives, 4 appointed voting members TSC-elects their Chair; CTO is ex-officio co-chair 17 existing workgroups 2 Elected SD Co-Chairs plus Co-Chairs of workgroups in SD Technical & Support Services Steering Division Ø Ø 8 existing workgroups 2 Elected SD Co-Chairs plus Co-Chairs of workgroups in SD © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 31 September, 2014

TSC – Mission HL 7 International’s Technical Steering Committee’s Mission n This group supports the HL 7 International mission to create and promote its standards by: Ø n Overseeing and coordinating the technical efforts contributed by the HL 7 International participants, who make up the HL 7 International Working Group, and assuring that the efforts of the Working Group are focused on the overall HL 7 mission. The Technical Steering Committee and the HL 7 International Working Group operate in such a way so as to: Ø Ø Ø Ø Respect the contributions and ideas of the talented individuals who make up the Working Group; Maintain an effective focus on the goals of HL 7 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 HL 7 International Standards are developed on a solid architectural foundation that assures consistency and interoperability. © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 32 September, 2014

Steering Divisions n Foundation & Technologies Provides fundamental tools and building blocks Ø Ø Ø Ø Ø Conformance Infrastructure & Messaging Implementable Technology Specifications (ITS) Java Modeling & Methodology Security Service Oriented Architecture (SOA) Templates Vocabulary © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 33 September, 2014

Steering Divisions (con’t) n 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: Ø Ø Ø Ø Ø Arden Syntax Clinical Decision Support Electronic Health Record (EHR) Financial Management Imaging Integration Orders & Observations Patient Administration Personnel Management Scheduling & Logistics Structured Documents © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 34 September, 2014

Steering Divisions (con’t) n Domain Experts Steering Division Focuses on creation of messages, services, documents using many of the common structures in place Ø Ø Ø Ø Ø 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) © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 35 September, 2014

Steering Divisions (con’t) Technical & Support Services Steering Division n The primary feature of these work groups is to support the Technical Steering Committee and work groups of the Working Group. Ø Ø Ø Ø 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 © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 36 September, 2014

U. S. Health Messaging Standards Development Efforts HL 7 International (Health Level 7) ACR/NEMA (DICOM) (American College of Radiologists / National Electrical Manufacturers Association) (Digital Image Communications) X 12 (X 12 N) ASTM (E 31) ASTM International (was American Society of Testing Materials) IEEE (Institute of Electrical and Electronic Engineers) NCPDP (National Council of Prescription Drug Producers) ADA (American Dental Association) © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 37 September, 2014

HL 7—Country and International Standards TC 215 Other Countries / HL 7 Affiliates TC 251 38 September, 2014

HL 7 International Diversifies n HL 7 International Started with and is traditionally thought of as “messaging”. For most of its life, however, HL 7 International has also produced more than messaging standards. Ø Electronic Data Exchange in Healthcare Environments (i. e. “messaging”) n Version 2 & Version 3 Ø Arden Syntax Ø GELLO Ø Visual / Context Integration (CCOW) Ø Version 2. x XML (XML encoding of HL 7 International messages) Ø Clinical Document Architecture (CDA) n Clinical Context Document Implementation Guide (CCD) Ø Electronic Health Record System (EHR-S) Functional Model Ø Personal Health Record System (PHR-S) Functional Model Ø Services (i. e. , Services as related to a Services Oriented Architecture) © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 39 September, 2014

History of HL 7 (Through 2012) Version 1. 0 Published 1987 88 89 Implementation Support Guide published 90 Version 2. 0 Published First Meeting Hospital University of PA 91 Version 2. 2 Published 92 93 94 Version 2. 2 ANSI 95 96 Version 2. 3. 1 Published and ANSI 97 98 99 2000 Arden Syntax 2. 0 Charter member of ANSI HISPP 01 02 03 2. 4 04 2. 5 Version 3. 0 1 st published Version 2. 3 Published and ANSI Version 2. 1 Published PRA (CDA 1. 0) CCOW 2005 First work on SOA (Services) w/HSSP 06 07 08 09 10 11 12 13 14 Reorganizes Hires CEO & CTO & starts work on SAIF V 2. 6 Published V 2. 7. 1 V 3 20 xx Normative Editions © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 40 September, 2014

HL 7 INTERNATIONAL PROCESS MEETINGS, BALLOTS & LIFE CYCLE © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 41 September, 2014

HL 7 International Meetings n n Working Group Meetings occur three times a year. September meeting is designated a “plenary” meeting. n n Monday AM is a special program dedicated to business and reporting state of the organization. Most (if not all) HL 7 International work groups have face-to-face meetings during a working group meeting. © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 42 September, 2014

HL 7 International Meetings n n Workgroups set agendas for the “next” meeting at the end of the last meeting. Agenda usually progresses work with time allocated to: Ø Ø Ø n Version 2 Version 3 Joint meetings with related work groups Current ballots normally take priority. © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 43 September, 2014

HL 7 International Meetings Work Groups have defined decision making processes that specify how they run meetings, debate and vote on issues discussed in a meetings. n HL 7 International Process Improvement Committee (PIC) has default template procedures n © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 44 September, 2014

HL 7 International Meetings n Work Groups can customize their decision making processes. However: Ø Ø Ø PIC guidelines constrain the framework. HL 7 International’s By-Laws and Policy and Procedures take precedence Default conduct is Robert’s Rules of Order. © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 45 September, 2014

Ballots n 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. , HL 7 2. 6, HL 7 3. 0, etc. ) © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 46 September, 2014

Ballots n Documents can be: Ø Informative n Ø 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 HL 7 Protocol Specifications, or provides detailed information regarding the interpretation or implementation of an HL 7 Protocol Specification. The TSC shall approve the issuance of an informative document ballot. Draft Document for Comment Only n 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. © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 47 September, 2014

Ballots Ø Draft Standards for Trial Use (DSTU) n Ø 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 n Content is balloted by the general membership and is considered a structural component of the HL 7 Standard. Negative ballots must be resolved. Normative Standards are typically registered with ANSI. © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 48 September, 2014

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 HL 7 Balloted Standards are introduced first as a DSTU and must show some successful implementations before being advanced as a Normative Standard. © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 49 September, 2014

Ballots n Work Groups must resolve negative votes: Ø Accept the voters comment and recommended solution. Ø Negotiate with the voter and get them to agree to withdraw their negative. Ø Declare the vote non-persuasive. Ø Voters may appeal to the TSC and Board. They can also re-vote their same negative vote on the next round of balloting. Ø Substantive changes to a ballot (either to fix a negative or add new material) merit another round of balloting. © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 50 September, 2014

Ballots n When 75% (for normative documents) of the responses are registered as affirmatives…and hopefully all negatives withdrawn, a document is ready for publication as an HL 7 International Standard. © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 51 September, 2014

HL 7 Products and Projects n n Project Lifecycle relies on the concept of HL 7 International Products. Examples: Ø Ø Ø Product Brand n Messaging, Arden Syntax, CCOW, CDA, XML, …. Version n V 2, V 3, R 1, R 2, R 3, … Multiple projects may be required to create viable ‘product’ © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 52 September, 2014

HL 7 Project Criteria n n n n Be consistent with HL 7 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 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 © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 53 September, 2014

HL 7 Project Life Cycle for Product Development QVSD Training Materials Implementation Guides Publish Standard (. 21) COMPLETE Request to enhance or create product HL 7 Protocol Specifications (. 1) Request Approved (. 2) QVSD No Yes No Project Initiation (. 5) Yes Pass (. 18) START Request to Sunset Product QVSD Normative Ballot (. 17) Finalize Specification (. 16) Cancel or Withdraw (. 3) END No Move Forward (. 6) Yes Request Approved Industry Use (. 15) No Requirements Analysis (. 7) (. 2) No Yes QVSD Go Normative (. 20) QVSD Specification and Training (. 14) Sunset Product (. 4) Yes QVSD DSTU Ballot (. 13) Logical Design (. 8) END QVSD Normative QVSD Informative Document Ballot (. 19) Yes Review No DSTU (. 12) Comment Only Ballot Type (. 11) Yes (. 10) No © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 54 Seek Comments Draft Specification (. 9) QVSD September, 2014

HL 7 INTERNATIONAL VERSION 2. X © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 55 September, 2014

HL 7 International Version 2. x n n n 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 HL 7 International Reference Information Model (RIM)) Not well normalized. Ø n n Segments & Data Elements moved to a single location (Chapter 2) only in 2. 5 in 2003. 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) © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 56 September, 2014

© 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 57 September, 2014

Version 2. 7 Chapters* 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. Introduction Control / Data Types / Conformance & Code Tables Patient Administration Orders Queries Financial Management Observations Master Files Medical Records / Information Mgmt Scheduling Patient Referral 12. 13. 14. 15. 16. 17. Patient Care Clinical Laboratory Automation Application Management Personnel Management Non-US e. Claims (new to 2. 6) Materials Mgmt. (new to 2. 6) Appendices: A. Data Definition Tables B. Lower Layer Protocol C. BNF Definitions D. Glossary E. Index 2. 7 is available on the HL 7 “Standards” section of the HL 7 web site. CDs are also available. © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 58 September, 2014

HL 7 INTERNATIONAL VERSION 3 © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 59 September, 2014

Some HL 7 International Version 3 Terms n n n n 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) © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 60 September, 2014

HL 7 International Version 3 First approved for publication and promotion to ANSI as an HL 7 Standard in September, 2004. Current Version: 2010 Published July 2010 © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 61 September, 2014

HL 7 International Version 3 © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 62 September, 2014

HL 7 International Version 3 © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 63 September, 2014

Appendices Acronyms Glossary © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 64 September, 2014

Some Acronyms* n n n n ADA ACR AHA AHIC AHIMA AHRQ AMA AMIA ANSI ASC X 12 N interchange ASC Z 80 ASN. 1 ASTM CAP American Dental Association American College of Radiology American Hospital Association American Health Information Community (an advisory board within DHHS) American Healthcare Information Management Association Agency for Health Research and Quality American Medical Association American Medical Informatics Association American Nursing Association American National Standards Institute Accredited Standards Committee X 12 – for business transactions Accredited Standards Committee X 12 N – for insurance and reimbursement data Accredited Standards Committee Z 80 – for Optometry Abstract Syntax Notation One American Society for Testing and Machinery—A US based SDO College of American Pathologists * Courtesy of Ed Hammond, Ph. D 1999, with some updates from John Quinn, 2007 © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 65 September, 2014

Some Acronyms* n n n n CCHIT CCOW CDC CENELEC CHIA CIHI CMA CMET types CMS COM CORBA Corba. Med CPRI CPT services CTS Certification Commission for Health Information Technology HL 7 Clinical Context Object Workgroup (now Clinical Context Management) Centers for Disease Control and Prevention Comité Européen de Normalisation (EU Standards Body) European ` for Electrotechnical Standardization Canadian Health Informatics Association Canadian Institution for Health Information Context Management Architecture HL 7 Common Message Element Type—reusable message components such as data DHHS Centers for Medicare and Medicaid Services (was HCFA) Component Object Model Common Object Request Broker Architecture OMG group working on health related projects Computer-based Patient Record Institute Common Procedural Terminology. A systematic listing and coding of procedures and performed by physicians. A five-digit code with modifiers, used for Billing Owned & maintained by AMA. HL 7 Common Terminology Services * Courtesy of Ed Hammond, Ph. D 1999, with some updates from John Quinn, 2007 © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 66 September, 2014

Some Acronyms* n n n n n DAM DCOM DES DHHS DICOM DIN DISA DMIM DOD DRG DSM-IV EPA EU EWG FDA FDIS GEHR HL 7 Domain Analysis Model (see HL 7 HDF) Distributed Component Object Model Data Encryption Standard Department of Health and Human Services Digital Imaging and Communications in Medicine. Standard for transferring images. Owned by ACR Domain Information Model German standards organization Data Interchange Standards Organization. The secretariat for ASC X 12. Domain Message Information Model Department of Defense Diagnostic Related Group Diagnostic and Statistical Manual of Mental Disorders; American Psychiatric Assoc. Environmental Protection Agency. Has data registry. European Union UN/EDIFACT Working Group Food and Drug Administration ISO Final Draft International Standard Good European Health Record * Courtesy of Ed Hammond, Ph. D 1999, with some updates from John Quinn, 2007 © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 67 September, 2014

Some Acronyms* n n n n n HCFA HCPCS HDF HEDIS HHCC HHS HIBCC HIMA HIMSS HIPAA HITSP HL 7 HMD HMO HOST HPCC HTML Health Care Financing Administration (now CMS) HCFA Procedure Coding System HL 7 Healthcare Development Framework Health Employers Data and Information Set Home Health Care Classification. Virginia Saba’s code set for home care. Health and Human Services (sometimes used instead of DHHS) Health Industry Business Communications Council Health Industry Manufacturers Association Healthcare Information and Management Systems Society (a trade group) Health Insurance Portability and Accountability Act of 1996 Health Information Technology Healthcare Information Technology Standards Panel (owned and organized under ANSI Health Level Seven International HL 7 Hierarchical Message Definition Health Maintenance Organization Healthcare Open Systems and Trials High Performance Communications and Computing Hyper-Text Markup Language * Courtesy of Ed Hammond, Ph. D 1999, with some updates from John Quinn, 2007 © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 68 September, 2014

Some Acronyms* n n n n ICD 9 -CM ICD 10 IDL ICNP IEC IEEE IETF IHS IMIA IOM ISSB ISO ITSEC ITU International Classification of Disease Diagnostic and procedure codes, current version in the US is ICD 9 -CM ICD 9 with Clinical Modification Latest version of ICD implemented in most countries Interface Definition Language International Classification for Nursing Practice International Electrotechnical Commission Institute of Electronic and Electrical Engineers Internet Engineering Task Force Indian Health Service International Medical Informatics Association Institute of Medicine Information Systems Standards Board International Standards Organization (part of the UN in Geneva Switzerland) Information Technology Security Evaluation Criteria International Telecommunication Union * Courtesy of Ed Hammond, Ph. D 1999, with some updates from John Quinn, 2007 © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 69 September, 2014

Some Acronyms* n n n n JAHIS JCAHO JIRA LOINC MDF MEDCIN MEDINFO MEDIX MEDRA Me. SH MGMA MIB MOU MPI MPL MSHUG Japanese Association for Medical Informatics Joint Commission on Accreditation of Healthcare Organizations Japan Industries Association of Radiation Apparatus Logical Observations, Identifiers, Names and Codes Message Development Framework Nomenclature for healthcare. Produced by Medicomp. World Medical Informatics Conference; every 3 years; sponsored by IMIA. Medical Data Interchange Standard (IEEE)[P 1157] Medical Dictionary for Drug Regulatory Affairs Medical Subject Heading Medical Group Management Association Medical Informatics Bus (IEEE) Memorandum Of Understanding Master Patient Index or Master Person Index Master Patient (Person) Locator Microsoft Healthcare User Group * Courtesy of Ed Hammond, Ph. D 1999, with some updates from John Quinn, 2007 © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 70 September, 2014

Some Acronyms* n n n n n NANDA NCHS NCCLS NCPDP NCVHS NDC NEMA NHS CT NIC NILT NIST NLM NOC NPRM NUBC NUCC North American Nursing Diagnoses Association National Center for Health Statistics National Committee for Clinical Laboratory Standards National Council for Prescription Drug Programs National Committee for Vital and Health Statistics National Drug Codes. Produced by the FDA. National Electrical Manufacturers Association National Health Service – UK National Health Service Clinical Terms (formerly Read Codes) Nursing Intervention Classification Nursing Intervention Lexicon and Taxonomy National Institute of Standards and Technology National Library of Medicine Nursing Outcomes Classification Notice of Proposed Rule Making National Uniform Billing Committee National Uniform Claims Committee * Courtesy of Ed Hammond, Ph. D 1999, with some updates from John Quinn, 2007 © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 71 September, 2014

Some Acronyms* n n n n OMAHA System Nursing Codes OMG Object Management Group ORB Object Request Broker PACS Picture Archiving and Communication System PCDS Patient Care Data Set. Judy Ozbolt, Vanderbilt. PHS Public Health Service PRA Patient Record Architecture PSRO Professional Standards Review Organization READ Classification System: Clinical codes with a bias for primary care. Now part of NHS SNOMED CT. RIM Reference Information Model RMIM Refined Message Information Model RSA Algorithm for encrypting / decrypting data. Developed by Ronald Rivest, Adi Shamir, and Leonard Adleman RSNA Radiological Society of North America SCAR Society for Computer Applications in Radiology SDO Standards Development Organization SGML Standard Generalized Markup Language * Courtesy of Ed Hammond, Ph. D 1999, with some updates from John Quinn, 2007 © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 72 September, 2014

Some Acronyms* n n n SCAR Society for Computer Applications in Radiology SDO Standards Development Organization SGML Structured Graphical Markup Language SNOMED RT Systematized Nomenclature of Medicine Reference Terminology SNOP Systematized Nomenclature of Pathology SQL Structured Query Language TC 215 ISO Technical Committee 215 – Healthcare Information TC 215 WG 1 Working Group 1: Modeling Coordination and Health Records TC 215 WG 2 Working Group 2: Messaging and Communications TC 215 WG 3 Working Group 3: Health Concept Representation TC 215 WG 4 Working Group 4: Security TC 215 WG 5 Working Group 5: Health Cards * Courtesy of Ed Hammond, Ph. D 1999, with some updates from John Quinn, 2007 © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 73 September, 2014

Some Acronyms* n n n n n TC 251 CEN Technical Committee for Medical Informatics TC 251 WG 1 Healthcare Information Modeling and Medical Records TC 251 WG 2 Healthcare Terminology, Semantics and Knowledge Bases TC 251 WG 3 Healthcare Communications and Messages TC 251 WG 4 Medical Imaging and Multimedia TC 251 WG 5 Communication with Medical Devices TC 251 WG 6 Healthcare Security, Privacy, Quality and Safety TC 251 WG 8 Intermittently Connected Devices (including Cards) TCP/IP Transmission Control Protocol/Internet Protocol Terminfo An HL 7 International General Approach to resolving issues related to the interface between HL 7 International Information Model and terminologies or code systems TR ISO Technical Report TS ISO Technical Specification UCC Uniform Code Council UCDS Uniform Clinical Data System UMDNS Universal Medical Device Nomenclature System UML Unified Modeling Language UMLS Unified Medical Language System * Courtesy of Ed Hammond, Ph. D 1999, with some updates from John Quinn, 2007 © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 74 September, 2014

Some Acronyms* n n n n UN/EDIFACT United Nations Electronic Data Interchange For Administration, Commerce and Transport UNIX Open Systems Operating system UPC Universal Product Code. From UCC. URL Universal Resource Locator (e. g. , http: //www. hl 7. org) USHIK US 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-I Web Services Interoperability Organization www World Wide Web W 3 C World Wide Web Consortium. Definers of HTML & XML among other things XML Extensible Markup Language * Courtesy of Ed Hammond, Ph. D 1999, with some updates from John Quinn, 2007 © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 75 September, 2014

HL 7 V 2. 7 Glossary © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 76 September, 2014

HL 7 V 3 Glossary © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 77 September, 2014

HL 7 Healthcare Development Framework (HDF) © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 78 September, 2014

ISO TC 215 Joint Initiative for Global Standards Harmonization Health Informatics Document Registry and Glossary http: //www. skmtglossary. org/ 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. © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. 79 September, 2014

Glossary Here are some definitions of organizations that have been mentioned in this presentation. n American National Standards Institute (ANSI) : n n 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 14000 (environmental) management systems. Standards Development Organizations (SDOs)—not healthcare specific : n 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*. *wikipedia © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. September, 2014

Glossary n ONC Ø n 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): Ø Ø Ø 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. © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. September, 2014

Glossary n EU’s CEN (Comité Européen de Normalisation) TC 251 Ø Ø (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 © 2014 Health Level Seven ® International. All Rights Reserved. HL 7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U. S. TM Office. September, 2014