© 2012 health level seven ® international. all rights reserved. hl7 and health level seven are...

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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. 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

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Page 1: © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International

© 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 QuinnHL7 International CTO

Vancouver British Columbia CanadaMay 13, 2012

Tutorial:Introduction to Health Level Seven International (HL7)

Organization & Process

Page 2: © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International

© 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, 20122

Page 3: © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International

© 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, 20123

Page 4: © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International

© 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, 20124

Page 5: © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International

© 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

NorwayPakistan

5

Luxembourg

Bosnia & Herzegovina

Puerto Rico

Germany

Page 6: © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International

© 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

Page 7: © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International

© 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, 20127

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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. 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, 20128

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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. 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, 20129

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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. 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, 201210

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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. 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, 201211

Page 12: © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International

© 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, 201212

Page 13: © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International

© 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 SevenInternational

HL7 International is an ANSI accredited standards organization (ASO) for clinical & operational EDI.

Members include: user (hospital, physicians practices, physician group practices, academic faculty practice plans, health maintenance organizations (HMO), preferred provider organizations (PPO), independent practice affiliations (IPA), utilization review (UR) companies, fiscal intermediaries, third-party administrators (TPA), peer review organizations (PRO), insurers and payers, manufacturers (pharmaceuticals, medical devices, etc.), professional associations and societies, industry consortia, regulators, and government agencies.

There are also now 34 countries that participate in HL7

ISO’s Open Systems Interconnect (OSI) model:Application Level” – level 7

ISO’s Open Systems Interconnect (OSI) model:Application Level” – level 7

May, 201213

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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. 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.

May, 201214

Page 15: © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International

© 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, 201215

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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. 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, 201216

Page 17: © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International

© 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, 201217

Page 18: © 2012 Health Level Seven ® International. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven International

© 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, 201218

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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. Reg. U.S. TM Office.

HL7 INTERNATIONAL’S VISION

To create the best and most widely used standards in healthcare.

To create the best and most widely used standards in healthcare.

May, 201219

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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. Reg. U.S. TM Office.

THE MOST HELPFUL SINGLE PIECE OF INFORMATION?

http://www.hl7.orghttp://www.hl7.org

May, 201220

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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. 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.

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, 201221

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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. 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).

"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, 201222

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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. Reg. U.S. TM Office.

The OSI Model

Physical

Data

Network

Transport

Session

Presentation

Application

Physical

Data

Network

Transport

Session

Presentation

Application

Application 1 Application 2

Physical Connection

Logical Connection

Logical Connection

Logical Connection

Logical ConnectionLogical Connection

Logical Connection

Logical Connection

HL7

7

6

5

4

3

2

1

May, 201223

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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. 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, 201224

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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. 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, 201225

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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. 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, 201226

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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. Reg. U.S. TM Office.

HL7 International Board of Directors

Chuck Jaffe MDHL7 International

CEO

Advisory Council

International Council

John QuinnCTO / Vice Chair Mark McDougal

COO (AMG)

TSC ChairAustin Kreisler

Architecture Board Charlie Mead

Foundation & TechnologiesWoody Beeler

Structure & Semantic Design

Calvin Beebe

Domain ExpertsEd Tripp

Technical & Support Services

Freida Hall

Work Groups

Operations(AMG)

Steering Divisions

2Representatives

TSC2

Representatives

May 2012

HL

7 In

tern

atio

nal

’s O

rgan

izat

ion

May, 201227

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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. 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, 201228

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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. 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, 201229

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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. 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, 201230

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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. 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, 201231

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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. Reg. U.S. TM Office.

Steering Divisions (con’t)

Domain Experts Steering DivisionFocuses on creation of messages, services, documents using many of the common structures in place

Anatomic Pathology Anesthesiology Attachments Cardiology Clinical Genomics Clinical Guidelines Community Based Health Services Emergency Care Government Projects Health Care Devices Laboratory Patient Care Patient Safety Pediatrics Data Standards Public Health Emergency Response (PHER) Pharmacy Regulated Clinical Research Information Management (RCRIM)

May, 201232

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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. 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, 201233

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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. 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, 201234

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TC 215

Other Countries / HL7 Affiliates

TC 251

May, 201235

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History of HL7(Through 2009)

1987 88 89 90 91 92 93 94 95 96 97 98 99 2000 01 02 03 04

First MeetingHospital

University of PA

Version 2.0Published

Version 2.1Published

Charter member ofANSI HISPP

Version 3.01st published

Version 1.0Published

ImplementationSupport Guide

published

Version 2.2Published

Version 2.2ANSI

Version 2.3Publishedand ANSI

Version 2.3.1Publishedand ANSI

ArdenSyntax

2.0 2.4

CCOW

PRA(CDA 1.0)

2.5

2005 06 07 08 09 10 11

First work on SOA (Services) w/HSSP

ReorganizesHires CEO & CTO & starts work on SAIF

V2.6 Published

V2.7 Published

May, 201236

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HL7 INTERNATIONAL PROCESS

MEETINGS, BALLOTS & LIFE CYCLE

May, 201237

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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, 201238

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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, 201239

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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, 201240

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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, 201241

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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, 201242

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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, 201243

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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, 201244

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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.

ALL HL7 Balloted Standards are introduced first as a DSTU and must show some successful implementations

before being advanced as a Normative Standard.

May, 201245

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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, 201246

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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, 201247

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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, 201248

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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, 201249

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Request toSunsetProduct

HL7 ProtocolSpecifications

(.1)

Request toenhanceor createproduct

RequestApproved

(.2)

RequestApproved

(.2)

Cancel orWithdraw (.3)

No

No

Yes

Yes

SunsetProduct

(.4)

ProjectInitiation

(.5)

QVSD

MoveForward

(.6)

No

RequirementsAnalysis

(.7)

QVSD

Yes

LogicalDesign

(.8)

QVSD

DraftSpecification

(.9)

QVSD

BallotType(.11)

Review

Normative

DSTU(.12)

InformativeDocumentBallot (.19)

No

Specificationand Training

(.14)

QVSD

Industry Use(.15)

GoNormative

(.20)

No

SeekComments

(.10)

FinalizeSpecification

(.16)

QVSD

Yes

NormativeBallot(.17)

CommentOnlyBallot

Training MaterialsImplementation Guides

Publish Standard(.21)

QVSD

Yes

No

COMPLETE

END

Yes

DSTUBallot(.13)

QVSD

QVSD

Pass(.18)

NoYes

END

START

HL7 Project Life Cycle for Product Development

May, 201250

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HL7 INTERNATIONAL VERSION 2.X

May, 201251

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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 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)

May, 201252

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May, 201253

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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, 2012

12. 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

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HL7 INTERNATIONAL VERSION 3

May, 201255

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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, 201256

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HL7 International Version 3First approved for publication and pro-motion to ANSI as an HL7 Standard in September, 2004.

Current Version: 2010 Published July 2010

HL7 International Version 3First approved for publication and pro-motion to ANSI as an HL7 Standard in September, 2004.

Current Version: 2010 Published July 2010 May, 2012

57

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HL7 International Version 3

May, 201258

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HL7 International Version 3May, 2012

59

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AppendicesAcronyms

Glossary

May, 201260

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Some Acronyms*

ADA American Dental Association ACR American College of Radiology AHA American Hospital Association AHIC American Health Information Community (an advisory board within DHHS) AHIMA American Healthcare Information Management Association AHRQ Agency for Health Research and Quality AMA American Medical Association AMIA American Medical Informatics Association ANA American Nursing Association ANSI American National Standards Institute ASC X12 Accredited Standards Committee X12 – for business transactions ASC X12N Accredited Standards Committee X12N – for insurance and reimbursement data

interchange ASC Z80 Accredited Standards Committee Z80 – for Optometry ASN.1 Abstract 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, 201261

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Some Acronyms*

CCHIT Certification 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 CHIA Canadian Health Informatics Association CIHI Canadian Institution for Health Information CMA Context Management Architecture CMET HL7 Common Message Element Type—reusable message components such as

data types CMS DHHS Centers for Medicare and Medicaid Services (was HCFA) COM Component Object Model CORBA Common Object Request Broker Architecture CorbaMed OMG group working on health related projects CPRI Computer-based Patient Record Institute CPT Common 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.

CTS HL7 Common Terminology Services* Courtesy of Ed Hammond, PhD 1999, with some updates from John Quinn, 2007

May, 201262

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Some Acronyms* DAM HL7 Domain Analysis Model (see HL7 HDF) DCOM Distributed Component Object Model DES Data Encryption Standard DHHS Department of Health and Human Services DICOM Digital Imaging and Communications in Medicine. Standard for transferring images.

Owned by ACR DIM Domain Information Model DIN German standards organization DISA Data Interchange Standards Organization. The secretariat for ASC X12. DMIM Domain Message Information Model DOD Department of Defense DRG Diagnostic Related Group DSM-IV Diagnostic and Statistical Manual of Mental Disorders; American Psychiatric Assoc. EPA Environmental Protection Agency. Has data registry. EU European Union EWG UN/EDIFACT Working Group FDA Food and Drug Administration FDIS ISO Final Draft International Standard GEHR Good European Health Record

* Courtesy of Ed Hammond, PhD 1999, with some updates from John Quinn, 2007

May, 201263

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Some Acronyms* HCFA Health Care Financing Administration (now CMS) HCPCS HCFA Procedure Coding System HDF HL7 Healthcare Development Framework HEDIS Health Employers Data and Information Set HHCC Home 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 HIMSS Healthcare Information and Management Systems Society (a trade group) HIPAA Health Insurance Portability and Accountability Act of 1996 HIT Health Information Technology HITSP Healthcare Information Technology Standards Panel (owned and organized under ANSI HL7 Health Level Seven International HMD HL7 Hierarchical Message Definition HMO Health Maintenance Organization HOST Healthcare Open Systems and Trials HPCC High Performance Communications and Computing HTML Hyper-Text Markup Language

* Courtesy of Ed Hammond, PhD 1999, with some updates from John Quinn, 2007

May, 201264

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Some Acronyms* ICD International Classification of Disease ICD9 Diagnostic and procedure codes, current version in the US is ICD9-CM ICD9-CM ICD9 with Clinical Modification ICD10 Latest version of ICD implemented in most countries IDL Interface Definition Language ICNP International Classification for Nursing Practice IEC International Electrotechnical Commission IEEE Institute of Electronic and Electrical Engineers IETF Internet Engineering Task Force IHS Indian Health Service IMIA International Medical Informatics Association IOM Institute of Medicine ISSB Information Systems Standards Board ISO International Standards Organization (part of the UN in Geneva Switzerland) ITSEC Information Technology Security Evaluation Criteria ITU International Telecommunication Union

* Courtesy of Ed Hammond, PhD 1999, with some updates from John Quinn, 2007

May, 201265

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Some Acronyms* JAHIS Japanese Association for Medical Informatics JCAHO Joint Commission on Accreditation of Healthcare Organizations JIRA Japan Industries Association of Radiation Apparatus LOINC Logical Observations, Identifiers, Names and Codes MDF Message Development Framework MEDCIN Nomenclature for healthcare. Produced by Medicomp. MEDINFO World Medical Informatics Conference; every 3 years; sponsored by IMIA. MEDIX Medical Data Interchange Standard (IEEE)[P1157] MEDRA Medical Dictionary for Drug Regulatory Affairs MeSH Medical Subject Heading MGMA Medical Group Management Association MIB Medical Informatics Bus (IEEE) MOU Memorandum Of Understanding MPI Master Patient Index or Master Person Index MPL Master Patient (Person) Locator MSHUG Microsoft Healthcare User Group

* Courtesy of Ed Hammond, PhD 1999, with some updates from John Quinn, 2007

May, 201266

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Some Acronyms* NANDA North 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 NDC National Drug Codes. Produced by the FDA. NEMA National Electrical Manufacturers Association NHS National Health Service – UK NHS CT National Health Service Clinical Terms (formerly Read Codes) NIC Nursing Intervention Classification NILT Nursing Intervention Lexicon and Taxonomy NIST National Institute of Standards and Technology NLM National Library of Medicine NOC Nursing Outcomes Classification NPRM Notice 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, 201267

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Some Acronyms*

* Courtesy of Ed Hammond, PhD 1999, with some updates from John Quinn, 2007

May, 201268

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

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Some Acronyms* 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 WG1 Working Group 1: Modeling Coordination and Health Records TC 215 WG2 Working Group 2: Messaging and Communications TC 215 WG3 Working Group 3: Health Concept Representation TC 215 WG4 Working Group 4: Security TC 215 WG5 Working Group 5: Health Cards

* Courtesy of Ed Hammond, PhD 1999, with some updates from John Quinn, 2007

May, 201269

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Some Acronyms* TC 251 CEN Technical Committee for Medical Informatics TC 251 WG1 Healthcare Information Modeling and Medical Records TC 251 WG2 Healthcare Terminology, Semantics and Knowledge Bases TC 251 WG3 Healthcare Communications and Messages TC 251 WG4 Medical Imaging and Multimedia TC 251 WG5 Communication with Medical Devices TC 251 WG6 Healthcare Security, Privacy, Quality and Safety TC 251 WG8 Intermittently Connected Devices (including Cards) TCP/IP Transmission Control Protocol/Internet Protocol Terminfo An HL7 International General Approach to resolving issues related to the interface

between HL7 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, PhD 1999, with some updates from John Quinn, 2007

May, 201270

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Some Acronyms*

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.hl7.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 W3C World Wide Web Consortium. Definers of HTML & XML among other things XML Extensible Markup Language

* Courtesy of Ed Hammond, PhD 1999, with some updates from John Quinn, 2007

May, 201271

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HL7 V 2.7 Glossary

May, 201272

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HL7 V3 Glossary

May, 201273

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HL7 Healthcare Development Framework (HDF)

May, 201274

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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.

May, 201275

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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 14000 (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

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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

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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