Tutorial: Introduction to Health Level Seven International (HL7) Organization & Process Orientation Introduction to HL7
John Quinn (HL7 International CTO) Atlanta, GA, USA October 4, 2015
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ORGANIZATION
© 2014 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.
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September, 2014
HL7 International is a Consensus Driven Standards Development Organization (SDO)
© 2014 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.
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September, 2014
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
© 2014 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.
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September, 2014
37 HL7 International Affiliates / Countries Norway Argentina Russia
Romania
Philippines
Pakistan
New Zealand
And grow ing
Australia
United States Austria
Malaysia
Singapore United Kingdom
Brazil Uruguay Canada
Japan
South Korea Turkey Spain
China
Italy Switzerland The Netherlands Sweden
Croatia
Slovenia
India Taiwan Hong Kong
Czech Republic
Denmark
Finland
France
© 2016 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.
Germany
Greece
Updated 01/19/13
What is an Affiliate?
An Affiliate is an independent legal entity that:
Represents its country and country affiliate members at Hl7 International meetings and within its country/ territory on HL7 matters; Participates in HL7 International’s standards development and governance processes; Promotes the relevance and fitness of the HL7 Protocol Specifications, HL7 Educational Material and Other HL7 Material in its country/territory; Distributes, translates and localizes the HL7 Protocol Specifications as appropriate; Promote HL7 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. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
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September, 2014
Examples of Influencers & Drivers
Governments (US ONC, Canada Health Infoway, Australia’s NEHTA, UK’s NHS CfH, …) American National Standards Institute (ANSI—and other complementary national bodies) Vendors HL7 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., X12N, NCPDP, etc.)
© 2014 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.
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September, 2014
The Users
Examples of Our current major stakeholder-users
(imho):
US Office of the National Coordinator for Health Information Technology (ONC) FHIR Community 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. Typical approach to using HL7 is:
A manageable problem when integration is within an organization (intra-organizational) Less manageable when integration is in a large complex organization
Large IDN Reference Lab Network (e.g., US’s Quest & LabCorp)
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. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
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September, 2014
In short
Interoperability beyond a single point to point interface requires:
A profile that includes all of the related Standards Development Organizations (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 (e.g., FHIR) (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. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
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September, 2014
HL7 International Products •
HL7 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 FHIR (Fast Health Interoperability Resources) 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. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
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September, 2014
The Users
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, Singapore, Uruguay, Malaysia, US, etc.) The exact forms of use varies as well:
messaging, electronic documents or services the approach and methodology processes automated and terminologies applied
© 2014 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.
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September, 2014
What the Market Wants
Faster implementations Conformance & Conformability testing Computable Semantic Interoperability Better Quality, Methodology & Tools Confidentiality/Security Harmonization with other standards Support of the latest communication technologies
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September, 2014
A Word about FHIR
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September, 2014
30 second “Intro to FHIR”
As significant as the leap from v2 to v3;
Still leverage v3 infrastructure & knowledge
Pronounced “FIRE”; RESTful enabled and based on resources but also supports document, messaging & services paradigms; All data is contained in a set of 100-150 resource definitions (for all of healthcare); Employs the 80-20 rule: Resources contain the elements 80% of systems will actually use; Everything else is handled by extensions.
© 2014 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.
(c) 2012 HL7
1/19/2016 14
30 Second “Intro to FHIR”
There is strong pressure from the US ONC’s Standards Advisory Panel for FHIR.
Initiative for FHIR is led by Dr. John Halamka
ONC commissioned the creation of the JASON report (suggested reading).
http://www.healthit.gov/facas/sites/faca/files/Joint_ HIT_JTF_JTF%20HITPC%20Final%20Report%20 Presentation%20v3_2014-10-15.pdf
© 2014 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.
(c) 2012 HL7
1/19/2016
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Argonaut
This is not a HL7 project – and it has not consumed any HL7 resources at this time. The Argonaut participants have pooled resources with the intent to focus on FHIR solutions that represent their priorities. Argonaut will provide the resources to move their priorities forward more timely and deliver product or resource to make their priorities successful.
© 2014 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?
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September, 2014
HL7 – Health Level Seven International HL7 International is an ANSI accredited standards organization (ASO) for clinical & operational EDI.
I SO’s Open System s I nterconnect (OSI ) m odel: 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 are also now 34 countries that participate in HL7
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September, 2014
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.
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September, 2014
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.
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September, 2014
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.
© 2014 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.
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September, 2014
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.
© 2014 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.
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September, 2014
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.
© 2014 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.
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September, 2014
HL7 INTERNATIONAL’S VISION To create the best and most widely used standards in healthcare.
© 2014 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.
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September, 2014
THE MOST HELPFUL SINGLE PIECE OF INFORMATION?
http://www.hl7.org
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September, 2014
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. © 2014 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.
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September, 2014
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).
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September, 2014
What is the Origination of the name HL7? 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. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
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The OSI Model HL7
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
Physical Connection
Physical
Application 1 © 2014 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.
Application 2 29
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HL7 Subject Domains
ADT Order entry Result reporting Clinical Guidelines Clinical Observations Scheduling Patient care Immunizations Discharge summaries
Mobile Computing Adverse event reporting Automated waveforms Medical transcriptions Referrals Consultations Clinical trials Nursing care plans Data Warehousing … And Grow ing …
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September, 20134
HL7 Subject Domains
SGML, (now XML) Terminology/Vocabulary/ Ontology 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 Grow ing … © 2014 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.
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September, 2014
HL7 International’s Work Groups HL7 Work Groups:
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 & Tooling Emergency Care
Financial Management Governance and Operations Health Care Devices Healthcare Systems Integration Imaging Integration Implementable Technology Specifications Infrastructure and Messaging International Council International Mentoring Learning Health Systems 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)
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 Vocabulary
(14) Updated: 01/16 Total
(21)
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September, 2014
HL7 Organization
TSC
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September, 2014
TSC Structure
Technical Steering Committee
Foundation & Technologies Steering Division
10 existing workgroups 2 Elected SD Co-Chairs plus Co-Chairs of workgroups in SD
Domain Experts Steering Division
9 existing workgroups 2 Elected SD Co-Chairs plus Co-Chairs of workgroups in SD
Structure & Semantic Design Steering Division
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
8 existing workgroups 2 Elected SD Co-Chairs plus Co-Chairs of workgroups in SD
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September, 2014
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.
© 2014 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.
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September, 2014
Steering Divisions
Foundation & Technologies Provides fundamental tools and building blocks
Application Implementation and Design (AID) Conformance and Guidance for Implementation and Testing (CGIT) Infrastructure & Messaging (InM) Implementable Technology Specifications (ITS) Application Implementation and Design (AID) Modeling & Methodology (MnM) Security Service Oriented Architecture (SOA) Templates Vocabulary
© 2014 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.
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September, 2014
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 Decision Support (CDS) Electronic Health Record (EHR) Financial Management (FM) Imaging Integration Mobile Health Orders & Observations Patient Administration
Structured Documents
© 2014 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.
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September, 2014
Steering Divisions (con’t)
Domain Experts Steering Division Focuses on creation of messages, services, documents using many of the common structures in place
Anatomic Pathology Anesthesiology Attachments Biomedical Research Integration Domain Group (BRIDG) Child Health Clinical Genomics Clinical Interoperability Council Community Based Collaborative Care Emergency Care Health Care Devices Patient Care Public Health Emergency Response (PHER) Pharmacy Regulated Clinical Research Information Management (RCRIM)
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September, 2014
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 and Tools (EST) International Mentoring Learning Health Systems (LHS) Process Improvement Committee (PIC) Project Services -- responsibility for the Project Life Cycle and serves as the primary support for the PMO Publishing
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September, 2014
HL7 Governance Model
Proposed LEGEND
Formalizing process, the work is already being done.
HL7 Board Existing
PLA (Dissolved once BAM is operational)
TSC Final Say
ARB
Steering Divisions Align with domains Suggest new work groups – content conceptual model should be the same (Grouping of peers and topics)
Standards Governance Board (SGB) Align with capabilities Suggest new product family
WG1
Mgmt of ‘small’ Product Families. WG acts as Mgmt. Arden Syntax as example
WG2
Special Interest Grp
WG3
© 2014 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.
Product Family “A” (V2) Management
Product Family “A” Methodology
Product Family “B” Methodology
FGB
Role
Role
Task group 1
New
FHIR Management Group
U.S. Health Messaging Standards Development Efforts HL7 International (Health Level 7)
ACR/NEMA (DICOM) (American College of Radiologists / National Electrical Manufacturers Association) (Digital Image Communications)
X12 (X12N) ASTM (E31) 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. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
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September, 2014
HL7—Country and International Standards
TC 215
Other Countries / HL7 Affiliates
TC 251
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September, 2014
HL7 International Diversifies
HL7 International Started with and is traditionally thought of as “messaging”. For most of its life, however, HL7 International has also produced more than messaging standards.
Electronic Data Exchange in Healthcare Environments (i.e. “messaging”)
Version 2 & Version 3
Arden Syntax
GELLO
Visual / Context Integration (CCOW)
Version 2.x XML (XML encoding of HL7 International messages)
Clinical Document Architecture (CDA)
Clinical Context Document Implementation Guide (CCD)
Electronic Health Record System (EHR-S) Functional Model
Personal Health Record System (PHR-S) Functional Model
Services (i.e., Services as related to a Services Oriented Architecture)
© 2014 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.
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September, 2014
History of HL7 (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 1st 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
V2.6 Published
V2.7
V2.7.1
V3 20xx Normative Editions © 2014 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.
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September, 2014
HL7 INTERNATIONAL PROCESS MEETINGS, BALLOTS & LIFE CYCLE
© 2014 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.
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September, 2014
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.
© 2014 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.
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September, 2014
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.
© 2014 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.
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September, 2014
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
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September, 2014
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.
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September, 2014
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.)
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September, 2014
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.
© 2014 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.
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September, 2014
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.
© 2014 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.
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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 HL7 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. HL7 and Health Level Seven are registered trademarks of Health Level Seven International. Reg. U.S. TM Office.
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September, 2014
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.
© 2014 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.
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September, 2014
Ballots
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 HL7 International Standard.
© 2014 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.
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September, 2014
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’
© 2014 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.
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September, 2014
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
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September, 2014
HL7 Project Life Cycle for Product Development QVSD Training Materials Implementation Guides Publish Standard (.21)
COMPLETE
Request to enhance or create product
HL7 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
Ballot Type (.11)
Yes
(.10) No
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Seek Comments
Draft Specification (.9)
QVSD September, 2014
HL7 INTERNATIONAL VERSION 2.X
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September, 2014
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)
© 2014 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.
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September, 2014
© 2014 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.
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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 eClaims (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 HL7 “Standards” section of the HL7 web site. CDs are also available.
© 2014 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.
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September, 2014
HL7 INTERNATIONAL VERSION 3
© 2014 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.
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September, 2014
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)
© 2014 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.
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September, 2014
HL7 International Version 3 First approved for publication and prom otion to ANSI as an HL7 Standard in Septem ber, 2004. Current Version: 2010 P ublished July 2010 © 2014 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.
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September, 2014
HL7 International Version 3 © 2014 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.
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September, 2014
HL7 International Version 3 © 2014 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.
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September, 2014
Appendices Acronyms Glossary
© 2014 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.
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September, 2014
Some Acronyms*
ADA ACR AHA AHIC AHIMA AHRQ AMA AMIA ANA ANSI ASC X12 ASC X12N interchange ASC Z80 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 X12 – for business transactions Accredited Standards Committee X12N – for insurance and reimbursement data Accredited Standards Committee Z80 – for Optometry Abstract Syntax Notation One American Society for Testing and Machinery—A US based SDO College of American Pathologists
* Courtesy of Ed Hammond, PhD 1999, with some updates from John Quinn, 2007 © 2014 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.
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September, 2014
Some Acronyms*
CCHIT CCOW CDC CEN CENELEC CHIA CIHI CMA CMET types CMS COM CORBA CorbaMed CPRI CPT services CTS
Certification Commission for Health Information Technology HL7 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 HL7 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. HL7 Common Terminology Services
* Courtesy of Ed Hammond, PhD 1999, with some updates from John Quinn, 2007
© 2014 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.
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September, 2014
Some Acronyms*
DAM DCOM DES DHHS DICOM DIM DIN DISA DMIM DOD DRG DSM-IV EPA EU EWG FDA FDIS GEHR
HL7 Domain Analysis Model (see HL7 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 X12. 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, PhD 1999, with some updates from John Quinn, 2007 © 2014 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.
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September, 2014
Some Acronyms*
HCFA HCPCS HDF HEDIS HHCC HHS HIBCC HIMA HIMSS HIPAA HIT HITSP HL7 HMD HMO HOST HPCC HTML
Health Care Financing Administration (now CMS) HCFA Procedure Coding System HL7 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 HL7 Hierarchical Message Definition Health Maintenance Organization Healthcare Open Systems and Trials High Performance Communications and Computing Hyper-Text Markup Language
* Courtesy of Ed Hammond, PhD 1999, with some updates from John Quinn, 2007 © 2014 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.
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September, 2014
Some Acronyms*
ICD ICD9 ICD9-CM ICD10 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 ICD9-CM ICD9 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, PhD 1999, with some updates from John Quinn, 2007 © 2014 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.
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September, 2014
Some Acronyms*
JAHIS JCAHO JIRA LOINC MDF MEDCIN MEDINFO MEDIX MEDRA MeSH 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)[P1157] 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, PhD 1999, with some updates from John Quinn, 2007 © 2014 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.
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September, 2014
Some Acronyms*
NANDA NCHS NCCLS NCPDP NCVHS NDC NEMA NHS 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, PhD 1999, with some updates from John Quinn, 2007 © 2014 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.
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September, 2014
Some Acronyms*
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, PhD 1999, with some updates from John Quinn, 2007
© 2014 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.
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September, 2014
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 © 2014 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.
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September, 2014
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
© 2014 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.
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September, 2014
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 © 2014 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.
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September, 2014
HL7 V 2.7 Glossary
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September, 2014
HL7 V3 Glossary
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September, 2014
HL7 Healthcare Development Framework (HDF)
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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.
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September, 2014
Glossary 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*.
*wikipedia © 2014 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.
September, 2014
Glossary
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.
© 2014 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.
September, 2014
Glossary
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 © 2014 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.
September, 2014