Package Note to Readers |
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Last Published: 09/29/2005 10:16 PM HL7® Version 3 Standard, © 2005 Health Level Seven®, Inc. All Rights Reserved. HL7 and Health Level Seven are registered trademarks of Health Level Seven, Inc. Reg. U.S. Pat & TM Off |
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Table of Contents
1 Forward
1.1 Copyright Notice
1.3 Contact Us
2.1.1 Foundation Documents
2.1.2 Messaging
Infrastructure
2.1.3 Transport
Specifications
2.1.5 Services
2.1.6 Common Domains
4.1 Mission
4.2 What is HL7?
4.3 Background
5.1.2 Opportunities to Improve
5.2 V3 Principles
5.4.1 Project Scope Definition
5.4.2 HL7 V3 Methodology
6.1 New Implementer
6.1.1 Learn the Basics
6.2 Management
6.2.1 Manager
6.2.2 Project Manager
6.2.3 Marketer
6.2.4 Construct Site Agreement
6.2.5 Sign a Deal
6.3.1 Interface Analyst
6.3.2 Interface Programmer
6.3.3 Develop Interface
6.4.1 Develop the Standard
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1 |
Forward |
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1.1 |
Copyright Notice |
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This 2005 Health Level Seven V3 Publication is copyrighted by Health Level Seven, Inc. (HL7) and is therefore protected by the Copyright Law of the United States and copyright provisions of various international treaties. The effect of such laws and treaties is that you may not, without a license from Health Level Seven, Inc., copy or distribute HL7's publication Product. HL7 Organizational members are authorized to reproduce the publication for internal use in their organization. This authorization use does not include reproduction of any part of this publication for inclusion in products for direct commercial resale. HL7 Individual members may not reproduce any part of this publication. |
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1.2 |
HL7 Special Acknowledgments |
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In addition to acknowledging the Committee Co-chairs and Facilitators, special credit is due a number of contributors: |
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Special thanks go to George Beeler for serving as the V3 project leader and tools developer, Lloyd McKenzie with IBM for developing the Visio tool set for development of CMETs and Austin Kreisler with SAIC for development of the Publication Database. Helen Stevens is acknowledged for her leadership of the Publishing Committee. The following individuals are also acknowledged for their intellectual contributions: Wes Rishel with Gartner Group, Jim Case with University of California, Ken McCaslin with Quest Diagnostics, and Dale Nelson with Zed-Logic Informatics, LLC. The following individuals are acknowledged for their technical support in the production of this publication: Rikki Holland with Double Click, Ltd, Charlie McCay with Ramsey Systems, Ltd, Karen Van Hentenryck and Mike Craig with HL7, Matthew Stephens with Ramsey Systems, Ltd. |
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1.3 |
Contact Us |
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If you have questions regarding this publication you may contact the HL7 office at: |
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Health Level Seven, Inc. 3300 Washtenaw Avenue, Suite 227, Ann Arbor, MI 48104 |
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734-677-7777 (phone) 734-677-6622 (fax) E-mail hq@HL7.org |
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2 |
2005 Version 3 Normative Edition Contents |
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Welcome to the 2005 Normative Edition of the Version 3 (V3) messaging standard. This package is the result of many years of work within the HL7 community and an increasingly focused effort with each new ballot cycle. We believe it is a major step forward for global health information standards. |
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The document you are currently reading is the Package Note to Readers document, which contains the following sections: |
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The HL7 Introduction section provides a brief overview of the HL7 Organization, its mission and philosophy. |
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Review this section to understand what HL7 V3 is, why we developed HL7 V3, and the principles underlying the V3 Standard. |
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The V3 Publication is composed of two types of documents: Foundation and Domain. The Foundation documents are those documents that are broader in scope and tend to apply to all domain documents. THe V3 Guide, the HL7 Vocabulary Domain and Reference Information Model, for example, are Foundation documents. Domain documents are produced for a specific domain such as pharmacy or scheduling and contain the messages relevant to that domain. |
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Below is a graphical representation of the Foundation documents. |
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Version 3 Domains contain specifications for dealing with functional areas of healthcare. For example, Patient Administration, or Medical Redords. |
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Each Domain document has a common structure and contains a common set of artifacts. |
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2.1 |
Documents in the V3 2005 Normative Edition |
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The 2005 Normative Edition contains those Version 3 Standards that are ANSI Approved, those that have passed Membership Level Ballot and are awaiting final ANSI Approval, and Draft Standards for Trial Use (DSTU). |
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2.1.1 |
Foundation Documents |
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Foundation Documents are the basis for all of the other specifications. The RIM is the model on which all V3 Standards are based. Vocabulary defines terms and code sets. The Data Types Abstract Specification specifies the HL7 Version 3 Data Types on an abstract layer, independent of representation. Refinement, Constraints and Localization specifies what the HL7 Technical Committees are permitted to do as part of the Version 3 Refinement process. GELLO is intended to be a standard expression language for decision support. |
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2.1.2 |
Messaging Infrastructure |
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The Master File / Registry domain comprises the classes and attributes needed to support Master Files and Registries. The Message Control Act Infrastructure covers the alternate structures of the message Trigger Event Control Acts in the HL7 Composite Message. The Query Infrastructure domain specifies the formation of information queries and the responses to these queries. Transmission infrastructure describes the information model, messages and interactions related to the assembly of an HL7 v3 composite message. |
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2.1.3 |
Transport Specifications |
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Transport Specifications detail how the messages are sent "over the wire." |
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2.1.4 |
Implementation Technology Specifications (ITS) |
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The ITS:XML Datatypes specification defines standard representations for data values in XML. The ITS:XML Structures document describes how HL7 V3 compliant messages can be expressed using XML.This UML ITS implements the semantics of the Abstract Data Types specification using UML in such a way that HL7 data types are mapped into the core UML and OCL kernel data types where such mappings are appropriate. |
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2.1.5 |
Services |
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The HL7 Common Terminology Services (HL7 CTS) defines an Application Programming Interface (API) that can be used by HL7 Version 3 software when accessing terminological content. |
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2.1.6 |
Common Domains |
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CMETs (Common Message Element Types) are a work product produced by a particular committee for expressing a common, useful and reusable concept. Shared Messages are a work product produced for expressing common, useful and reusable message types. |
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2.1.7 |
Administrative Management Domains |
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Administrative Management Domains contain specifications that support Administrative Functions in healthcare facilities. |
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2.1.8 |
Health and Clinical Management Domains |
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The Health and Clinical Managment Domains contain specifications from a variety of healthcare focus areas. |
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3 |
Reading the HL7 V3 Normative Edition Documents |
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The HL7 V3 Normative Edition is best viewed online due to the size of the document and the availability of extensive supporting materials. We are also making the entire package available on CD-ROM. You may also download the documents from the HL7 website. |
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3.1 |
What do the Colors on the Master Table of Contents Mean |
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If you look at menus that appear in the documents, you will notice that six colors are used. The colors indicate the type of document. The different types are enumerated below: |
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3.2 |
What do the Colored Symbols in the Documents Mean |
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Within the documents, you may find several icons that are designed or colored in such a way as to introduce the status of that particular item. Most commonly, main headings will have an icon for their ballot status. By hovering over the icons, you will find a descriptive term to better understand what this icon means. Here is a list of the ballot status icons used in these documents. |
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Ballot Status Icon Descriptions (link to graphic opens in a new window) |
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Ballot Status Icon Descriptions (continued) (link to graphic opens in a new window) |
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4 |
HL7 Organization Overview |
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4.1 |
Mission |
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HL7's mission is to provide standards for the exchange, management and integration of data that supports clinical patient care and the management, delivery and evaluation of healthcare services. Specifically, to create flexible, cost effective approaches, standards, guidelines, methodologies, and related services for interoperability between healthcare information systems. |
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4.2 |
What is HL7? |
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HL7 is one of several 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 clinical data, pharmacy, medical devices, imaging or insurance (claims processing) transactions. Health Level Seven's domain is clinical and administrative data. |
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HL7 is a not-for-profit volunteer organization. Its members - providers, vendors, payers, consultants, government groups, pharmaceutical and others who have an interest in the development and advancement of clinical and administrative standards for healthcare - develop the standards. Like all ANSI-accredited SDOs, HL7 adheres to a strict and well-defined set of operating procedures that ensure consensus, openness and balance of interest. A frequent misconception about HL7 (and presumably about the other SDOs) is that it develops software. In reality, Health Level Seven develops specifications, the most widely used being a messaging standard that enables disparate healthcare applications to exchange key sets of clinical and administrative data. |
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The HL7 Working Group is composed of volunteers who give their time on a personal basis or under sponsorship of their employers. Membership in the HL7 Working Group has been, and continues to be, open to anyone wishing to contribute to the development and refinement of the HL7 standards. |
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4.3 |
Background |
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The term "Level 7" refers to the highest level of the Open System Interconnection (OSI) model of the International Organization for Standardization (ISO). This is not to say that HL7 conforms to ISO defined elements of the OSI's seventh level. Also, HL7 does not specify a set of ISO approved specifications to occupy layers 1 to 6 under HL7's abstract message specifications. HL7 does, however, correspond to the conceptual definition of an application-to-application interface placed in the seventh layer of the OSI model. |
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In the OSI conceptual model, the functions of both communications software and hardware are separated into seven layers, or levels. The HL7 Messaging Standard is primarily focused on the issues that occur within the seventh, or application, level. These are the definitions of the data to be exchanged, the timing of the exchanges, and the communication of certain application-specific errors between the applications. However, of necessity, protocols that refer to the lower layers of the OSI model are sometimes mentioned to help implementers understand the context of the standard. They are also sometimes specified to assist implementers in establishing working HL7-based systems. |
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It does not try to assume a particular architecture with respect to the placement of data within applications but is designed to support a central patient care system as well as a more distributed environment where data resides in departmental systems. Instead, HL7 serves as a way for inherently disparate applications and data architectures operating in a heterogeneous system environment to communicate with each other. |
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If we consider the multitude of healthcare information systems applications as well as the variety of environments in which healthcare is delivered, it is evident that there are many more interfaces which could benefit from standardization. The interfaces chosen were considered to be of high priority by the members participating in the standards writing process. HL7's intent is to prepare a complete standard for these interfaces, built on a generic framework that is sufficiently robust to support many other interfaces. |
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5 |
HL7 Version 3 Overview |
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5.1 |
Why a Major New Version? |
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HL7 V3, like V2.x, is a standard for exchanging messages among information systems that implement healthcare applications. However, V3 strives to improve the V2 process and its outcomes. The original process for defining HL7 messages was established in 1987. It has served well since. However, as HL7 membership grew and its standards became more widely used, HL7 has become aware of opportunities to revolutionize healthcare interface computing. HL7 interfaces substantially reduce costs and implementation times when compared to the industry's experience with proprietary interfaces. However, these costs and times vary considerably by vendor, and the industry sees a need for improvement. Substantial optionality in HL7 makes it difficult to specify precise contract terms for HL7 interfaces. This can lead to unrealistic expectations that hurt vendors and buyers equally. The development principles behind HL7 V3 lead to a more robust, fully specified standard. |
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5.1.1 |
Difficulties with the Existing Process |
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The HL7 V2.x development process is entirely ad hoc. There is no explicit methodology. Members receive no formal guidance in constructing messages. Trigger events and data fields are described solely in natural language. The structural relationships among data fields are not clear. Segments are reused in many messages and message definitions are reused for many trigger events. In order to accommodate this extensive reuse, most data fields are optional. Chapters are inconsistent in their use of trigger events versus status codes. There is no specification as to when a specific kind of healthcare information system should be expected to honor a trigger event or accept a message. |
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With V2.x, a Technical Committee creates messages by editing word processing documents directly. The metadata is not available in a structured form until the staff and volunteers tediously extract it from the word processing documents after publication. |
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In summary, there is substantial need to improve this old process in order to handle the breadth and complexity of the challenges HL7 faces today. Our industry will benefit because this new process results in a more rigorous specification. |
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5.1.2 |
Opportunities to Improve |
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Fortunately, software practitioners have learned a lot since 1987. There are better methodologies. Computer support is far more available and cost-effective. However, HL7 cannot take advantage of these developments solely by minor tweaks to the old process. |
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HL7 spent four years characterizing its revised goals and creating a methodology to adapt modern analysis techniques from system building to message design. Initially the HL7 Board of Directors chartered an independent task force to establish the broad outline of the approach. In January 1996, the Technical Steering Committee (TSC) agreed to adopt the main features of the approach and take over its management. Planning work continued in the Modeling and Methodology Committee and the Control/Query Committee. At the completion of V2.3, in the spring of 1997, the HL7 Technical Committees all began to use the V3 process. |
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5.2 |
V3 Principles |
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The HL7 V3 standard development methodology is based on a set of principles providing a common philosophy for all HL7 V3 standard developers. |
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5.3 |
What's New with HL7 V3? |
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5.4 |
Managing HL7 V3 Message Development |
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This section outlines the procedures used to develop the HL7 V3 messages. These procedures are based on the V3 Methodology and the HL7 Bylaws. The goal is to assure that the standard is developed expediently, appropriately documented, consistent with the requirements for an approval by a balanced consensus, and that it complies with the requirements for certification by the American National Standards Institute (ANSI). |
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5.4.1 |
Project Scope Definition |
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When a functional Technical Committee undertakes a project to develop new normative material in V3 it creates a brief description of the project for approval by the TSC. The project scope statement contains a concise description of the needs to be met by the transactions. This project scope statement is also be used for coordination of projects with other standards organizations. In fact, project scope statements must be reported to the ANSI so that ANSI can fulfill its standards coordination role.1 |
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Project scope statements are reviewed by the Architectural Review Board (ARB) and must be approved by the HL7 Technical Steering Committee. |
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5.4.2 |
HL7 V3 Methodology |
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The development of V3 messages follows the methodology specified by the HL7 Modeling and Methodology Committee. HL7 may amend the methodology from time to time. The methodology includes a definition of work products delivered by the Technical Committees. Portions of these work products are be designated for three different treatments: |
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The methodology specifies the following requirements. These are annotated to indicate the work products described in the V3 Guide that meet the requirements. The annotations further state whether the work product is normative or informative. |
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The Modeling and Methodology Committee does not have the right to determine the contents of work products created by the Technical Committees. It serves to facilitate their development, and to negotiate changes among the functional Technical Committees to ensure standard-wide consistency. If disputes cannot be resolved by the Technical Committees and/or the Modeling and Methodology Committee, they shall be resolved by the TSC. |
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5.4.3 |
Quality Assurance Process |
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In order to ensure the highest quality of the work products produced during the course of V3 message development, the HL7 Board of Directors has created the ARB. |
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The ARB works with the Technical Committees and Modeling and Methodology Committee to define quality measures for the HL7 work products, measure the work products again them, and that adherence to the defined message development process is documented in a manner consistent with HL7 bylaws and procedures. The ARB does not have the right to amend work products or disallow their distribution. It does have the right to include with any work product a statement describing areas where it has determined that the work product has not met established measures of quality. |
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As a general matter, the ARB is expected to include a statement of its findings in an HL7 general ballot package. However, in order to assist Technical Committees, and to avoid delaying the balloting process, the ARB attempts to make any significant comments as early in the ballot cycle as possible. |
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Disputes with the findings of the ARB are resolved through the TSC and, if necessary, the Board of Directors. |
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6 |
Getting Started |
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The Getting Started section provides guidelines and recommendation for how you should approach the HL7 V3 Publication. Each section below depicts a type of HL7 customer based on his or her relationship to the HL7 standard/organization. Locate the type of user that most closely reflects your experience level. The documentation includes recommended reading that will help you build the HL7 V3 knowledge base you desire. |
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6.1 |
New Implementer |
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A New Implementer is unfamiliar with HL7 terminology, methodology, and organization. A New Implementer may or may not be a member of the HL7 organization. |
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6.1.1 |
Learn the Basics |
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Learning the basics means becoming familiar with the basic terminology and methodology behind HL7. You would expect to learn the basic principles upon which HL7 V3 was constructed. Upon completion of this use case, you would be prepared to learn more detailed information about V3. |
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While learning the basics, refer to: |
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6.2 |
Management |
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6.2.1 |
Manager |
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Managers are responsible for hiring qualified HL7 analysts and programmers. They must supervise interface development and implementation efforts. They do not need to understand all of the details of creating an HL7 message, but they need to understand the concepts enough to review contacts, conformance statements, and assess the skills of their team. |
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6.2.2 |
Project Manager |
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The Project Manager is responsible for ensuring the project is completed within budget, on time, and within scope. Project Managers are not interested in all the details of creating an HL7 V3 message, but he needs to understand the concepts enough to review contacts, conformance statements, and assess the skills of his team. |
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6.2.3 |
Marketer |
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A Marketer is responsible for selling HL7 interfaces. He does not need to know the details, but must understand the major concepts and terminology. |
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6.2.4 |
Construct Site Agreement |
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Constructing a site agreement involves creating a specification for two or more parties to communicate using HL7 messages and documents. |
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When constructing a site agreement, refer to: |
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6.2.5 |
Sign a Deal |
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The deal requires HL7 interfaces, so in order to sign it a basic understanding of trigger events and message types, but not a detailed understanding of message fields, is required. |
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When signing a deal, refer to: |
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6.3 |
Interface Developer |
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6.3.1 |
Interface Analyst |
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Interface Analysts review the interface requirements and write detailed interface specifications. |
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6.3.2 |
Interface Programmer |
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Interface Programmers code and test interface based on the interface specifications. |
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6.3.3 |
Develop Interface |
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Developing an interface requires gathering the interface requirements, analyzing those requirements, developing detailed interface specifications, coding, and testing the interface against the interface specifications and defining the conformance statement. |
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When developing an interface, you must identify the application section you are working within: |
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Once you identify the section you can drill down through to the domain messages. |
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To complete your message development analysis, you will also need to fully understand: |
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For additional reference, be sure to review: |
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6.4 |
HL7 Standard Developer |
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Standard Developers attend HL7 Working Group Meetings and participate in the creation of the HL7 V3 Standard Specification. |
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6.4.1 |
Develop the Standard |
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Developing the HL7 Standards involves an understanding of the HL7 Organization and its development methods. |
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Before committing to HL7 Standards development, review: |
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Identify the section in which you are most interested. |
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Once you identify the section you can drill down to the domain messages. |
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XML Implementation Technology Specification - The XML Implementation Technology Specification defines the representation of HL7 V3 data types and messages in XML, including the method to derive XML DTDs plus additional processing rules from HL7 V3 Hierarchical Message Descriptions (HMDs). |
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Endnotes
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