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584 lines
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<title>Health Data Standards and Terminologies: A Tutorial</title>
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data-bs-toggle="dropdown" data-bs-auto-close="false"
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aria-haspopup="true"
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aria-expanded="false">
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1: Functions and Types of Health Information Standards
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</a>
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<ul class="dropdown-menu" aria-labelledby="navbarDropdown-1">
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<li><a class="dropdown-item" href="01-100.html" aria-current="true">Intro</a></li>
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<li><a class="dropdown-item" href="01-200.html">The Electronic Health Record (EHR)</a></li>
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<li><a class="dropdown-item" href="01-300.html">Interoperability</a></li>
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<li><a class="dropdown-item" href="01-400.html">Health Data Standards</a></li>
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<li><a class="dropdown-item" href="01-500.html">Module 1 Knowledge Check</a></li>
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href="#" role="button" data-bs-toggle="dropdown" data-bs-auto-close="false" id="navbarDropdown-2" aria-haspopup="true" aria-expanded="true">
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2: Terminology Standards and Tools
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</a>
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<ul class="dropdown-menu show" aria-labelledby="navbarDropdown-2">
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<li><a class="dropdown-item" href="02-100.html">Intro</a></li>
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<li><a class="dropdown-item" href="02-200.html">What are Terminology Standards?</a></li>
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<li><a class="dropdown-item" href="02-300.html">Characteristics of a Standardized Terminology</a></li>
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<li><a class="dropdown-item" href="02-400.html">ASTP/ONC and USCDI</a></li>
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<li><a class="dropdown-item dropdown-toggle" href="#" role="button" data-bs-toggle="dropdown" data-bs-auto-close="false" id="navbarDropdown-Term" aria-haspopup="true" aria-expanded="false">Overview of Terminologies</a>
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<ul class="dropdown-menu" aria-labelledby="navbarDropdown-Term">
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<li><a class="dropdown-item" href="02-500.html">Terminology Examples</a></li>
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<li><a class="dropdown-item" href="02-510.html">SNOMED CT</a></li>
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<li><a class="dropdown-item" href="02-520.html">RxNorm</a></li>
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<li><a class="dropdown-item" href="02-530.html">LOINC</a></li>
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<li><a class="dropdown-item" href="02-540.html">ICD</a></li>
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<li><a class="dropdown-item" href="02-550.html">CPT</a></li>
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<li><a class="dropdown-item" href="02-560.html">MeSH</a></li>
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<li><a class="dropdown-item" href="02-570.html">UCUM</a></li>
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</ul>
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</li>
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<li><a class="dropdown-item dropdown-toggle" href="#" role="button" data-bs-toggle="dropdown" data-bs-auto-close="false" id="navbarDropdown-Tool" aria-haspopup="true" aria-expanded="true">Terminology Tools and Resources</a>
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<ul class="dropdown-menu show" aria-labelledby="navbarDropdown-Tool">
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<li><a class="dropdown-item" href="02-600.html">NLM Examples</a></li>
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<li><a class="dropdown-item" href="02-610.html">UMLS</a></li>
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<li><a class="dropdown-item" href="02-620.html">RxNav</a></li>
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<li><a class="dropdown-item" href="02-630.html">DailyMed</a></li>
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<li><a class="dropdown-item" href="02-640.html">VSAC</a></li>
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<li><a class="dropdown-item active" href="02-650.html">AccessGUDID</a></li>
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<li><a class="dropdown-item" href="02-660.html">MedlinePlus Connect</a></li>
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<li><a class="dropdown-item" href="02-670.html">NIH Common Data Element Repository (CDE-R)</a></li>
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</ul>
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</li>
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<li><a class="dropdown-item" href="02-700.html">Module 2 Knowledge Check</a></li>
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</ul>
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<li class="nav-item dropdown">
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href="#" role="button" data-bs-toggle="dropdown" data-bs-auto-close="false" id="navbarDropdown-3" aria-haspopup="true" aria-expanded="false">
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3: Exchange Standards
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</a>
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<li><a class="dropdown-item" href="03-100.html">Intro</a></li>
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<li><a class="dropdown-item" href="03-300.html">Version 2 (V2)</a></li>
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<li><a class="dropdown-item" href="03-400.html">Version 3 (V3)</a></li>
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<li><a class="dropdown-item" href="03-500.html">Clinical Document Architecture (CDA)</a></li>
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<li><a class="dropdown-item" href="03-600.html">Fast Healthcare Interoperability Resources (FHIR)</a></li>
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<li><a class="dropdown-item" href="03-700.html">Module 3 Knowledge Check</a></li>
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</ul>
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</li>
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<a class="nav-link dropdown-toggle"
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href="#" role="button" data-bs-toggle="dropdown" data-bs-auto-close="false" id="navbarDropdown-4" aria-haspopup="true" aria-expanded="false">
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4: Working Together - Revisiting Organizational Interoperability
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</a>
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<ul class="dropdown-menu" aria-labelledby="navbarDropdown-3">
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<li><a class="dropdown-item" href="04-100.html">Intro</a></li>
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<li><a class="dropdown-item" href="04-200.html">Implementation Guides</a></li>
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<li><a class="dropdown-item" href="04-300.html">Health Information Exchange (HIE)</a></li>
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<li><a class="dropdown-item" href="04-400.html">Government Programs</a></li>
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<a class="nav-link" href="nav.html">How to Navigate This Course</a>
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<div class="row">
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<header class="bg-secondary p-3 truncate shadow" style="border-bottom: 1px solid #eee;">
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<strong>Health Data Standards and Terminologies</strong>
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<small class="text-muted">A Tutorial</small>
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<a href="https://learn.nlm.nih.gov/" id="anch_30" target="_blank">Learning Resources</a>
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<li class="nav-item">
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<a class="nav-link" href="index.html">Course Home</a>
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</li>
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<li class="nav-item">
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<a class="nav-link" data-bs-toggle="collapse" href="#collapse-item-1">1: Functions and Types of Health Information Standards</a>
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<div id="collapse-item-1" class="collapse">
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<ul class="nav flex-column ps-3">
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<li class="nav-item">
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<a class="nav-link" href="01-100.html">Intro</a>
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</li>
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<li class="nav-item">
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<a class="nav-link" href="01-200.html">The Electronic Health Record (EHR)</a>
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</li>
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<li class="nav-item">
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<a class="nav-link" href="01-300.html">Interoperability</a>
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</li>
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<li class="nav-item">
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<a class="nav-link" href="01-400.html">Health Data Standards</a>
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</li>
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<li class="nav-item">
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<a class="nav-link" href="01-500.html">Module 1 Knowledge Check</a>
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</li>
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</ul>
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</div>
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</li>
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<li class="nav-item">
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<a class="nav-link" data-bs-toggle="collapse" href="#collapse-item-2">2: Terminology Standards and Tools</a>
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<div id="collapse-item-2" class="collapse show">
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<ul class="nav flex-column ps-3">
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<li class="nav-item">
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<a class="nav-link" href="02-100.html">Intro</a>
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</li>
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<li class="nav-item">
|
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<a class="nav-link" href="02-200.html">What are Terminology Standards?</a>
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</li>
|
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<li class="nav-item">
|
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<a class="nav-link" href="02-300.html">Characteristics of a Standardized Terminology</a>
|
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</li>
|
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<li class="nav-item">
|
||
<a class="nav-link" href="02-400.html">ASTP/ONC and USCDI</a>
|
||
</li>
|
||
<li class="nav-item">
|
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<a class="nav-link" href="#collapse-item-Term" data-bs-toggle="collapse">Overview of Terminologies</a>
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<div id="collapse-item-Term" class="collapse">
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<ul class="nav flex-column ps-3">
|
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<li class="nav-item">
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<a class="nav-link" href="02-500.html">Terminology Examples</a>
|
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</li>
|
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<li class="nav-item">
|
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<a class="nav-link" href="02-510.html">SNOMED CT</a>
|
||
</li>
|
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<li class="nav-item">
|
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<a class="nav-link" href="02-520.html">RxNorm</a>
|
||
</li>
|
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<li class="nav-item">
|
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<a class="nav-link" href="02-530.html">LOINC</a>
|
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</li>
|
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<li class="nav-item">
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<a class="nav-link" href="02-540.html">ICD</a>
|
||
</li>
|
||
<li class="nav-item">
|
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<a class="nav-link" href="02-550.html">CPT</a>
|
||
</li>
|
||
<li class="nav-item">
|
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<a class="nav-link" href="02-560.html">MeSH</a>
|
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</li>
|
||
<li class="nav-item">
|
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<a class="nav-link" href="02-570.html">UCUM</a>
|
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</li>
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</ul>
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</div>
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</li>
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<li class="nav-item">
|
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<a class="nav-link" href="#collapse-item-Tool" data-bs-toggle="collapse">Terminology Tools and Resources</a>
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<div id="collapse-item-Tool" class="collapse show">
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<ul class="nav flex-column ps-3">
|
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<li class="nav-item">
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<a class="nav-link" href="02-600.html">NLM Examples</a>
|
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</li>
|
||
<li class="nav-item">
|
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<a class="nav-link" href="02-610.html">UMLS</a>
|
||
</li>
|
||
<li class="nav-item">
|
||
<a class="nav-link" href="02-620.html">RxNav</a>
|
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</li>
|
||
<li class="nav-item">
|
||
<a class="nav-link" href="02-630.html">DailyMed</a>
|
||
</li>
|
||
<li class="nav-item">
|
||
<a class="nav-link" href="02-640.html">VSAC</a>
|
||
</li>
|
||
<li class="nav-item">
|
||
<a class="nav-link active" href="02-650.html">AccessGUDID</a>
|
||
</li>
|
||
<li class="nav-item">
|
||
<a class="nav-link" href="02-660.html">MedlinePlus Connect</a>
|
||
</li>
|
||
<li class="nav-item">
|
||
<a class="nav-link" href="02-670.html">NIH Common Data Element Repository (CDE-R)</a>
|
||
</li>
|
||
|
||
</ul>
|
||
</div>
|
||
|
||
|
||
</li>
|
||
<li class="nav-item">
|
||
<a class="nav-link" href="02-700.html">Module 2 Knowledge Check</a>
|
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</li>
|
||
</ul>
|
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</div>
|
||
</li>
|
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|
||
|
||
<li class="nav-item">
|
||
<a class="nav-link" data-bs-toggle="collapse" href="#collapse-item-3">3: Exchange Standards</a>
|
||
<div id="collapse-item-3" class="collapse">
|
||
<ul class="nav flex-column ps-3">
|
||
<li class="nav-item">
|
||
<a class="nav-link" href="03-100.html">Intro</a>
|
||
</li>
|
||
<li class="nav-item">
|
||
<a class="nav-link" href="03-200.html">HL7 International</a>
|
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</li>
|
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<li class="nav-item">
|
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<a class="nav-link" href="03-300.html">Version 2 (V2)</a>
|
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</li>
|
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<li class="nav-item">
|
||
<a class="nav-link" href="03-400.html">Version 3 (V3)</a>
|
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</li>
|
||
<li class="nav-item">
|
||
<a class="nav-link" href="03-500.html">Clinical Document Architecture (CDA)</a>
|
||
</li>
|
||
<li class="nav-item">
|
||
<a class="nav-link" href="03-600.html">Fast Healthcare Interoperability Resources (FHIR)</a>
|
||
</li>
|
||
<li class="nav-item">
|
||
<a class="nav-link" href="03-700.html">Module 3 Knowledge Check</a>
|
||
</li>
|
||
</ul>
|
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</div>
|
||
</li>
|
||
|
||
<li class="nav-item">
|
||
<a class="nav-link" data-bs-toggle="collapse" href="#collapse-item-4">4: Working Together - Revisiting Organizational Interoperability</a>
|
||
<div id="collapse-item-4" class="collapse">
|
||
<ul class="nav flex-column ps-3">
|
||
<li class="nav-item">
|
||
<a class="nav-link" href="04-100.html">Intro</a>
|
||
</li>
|
||
<li class="nav-item">
|
||
<a class="nav-link" href="04-200.html">Implementation Guides</a>
|
||
</li>
|
||
<li class="nav-item">
|
||
<a class="nav-link" href="04-300.html">Health Information Exchange (HIE)</a>
|
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</li>
|
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<li class="nav-item">
|
||
<a class="nav-link" href="04-400.html">Government Programs</a>
|
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</li>
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</ul>
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</div>
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</li>
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<li class="nav-item">
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<a class="nav-link" href="05-000.html">Closing</a>
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<li style="height: auto; line-height: 0;"><hr></li>
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<li class="nav-item">
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<a class="nav-link" href="06-000.html">Additional Resources</a>
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<li class="nav-item">
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<a class="nav-link" data-bs-toggle="modal" data-bs-target="#navModal">How to Navigate This Course</a>
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There are a variety of ways you can navigate this course. You can:</p>
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<li>Click the Prev and Next buttons at the bottom of each page to move through the material.</li>
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<li>Use the main navigation with dropdown subsections featured on all pages.</li>
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<li>Use a combination of the above methods to explore the course contents.</li>
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<!-- Header -->
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<h2>2: Terminology Standards and Tools
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</h2>
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<hr>
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<h3>AccessGUDID</h3>
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<br>
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<div class="row">
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<div class="col-lg-12">
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<img class="img-fluid float-end" style="height: 115px" src="img/accessgudid.png" alt="Access GUDID logo">
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<p>The Global Unique Device Identification Database (GUDID – pronounced “Good ID”) contains key device identification information submitted to the FDA about medical devices that have <strong>Unique Device Identifiers (UDI)</strong>. NLM and the FDA created the <a href="https://accessgudid.nlm.nih.gov/" title="AccessGUDID" target="_blank">AccessGUDID</a> portal to make device information in the GUDID available for everyone including patients, caregivers, healthcare providers, hospitals, and industry.</p>
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<p>UDIs are created based on international standards for unique identification. Private organizations, called "Issuing Agencies," are accredited by the FDA to operate a system for the issuance of UDIs based on these standards.</p>
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<div class="alert alert-info" role="alert">
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<p><strong>A UDI is composed of two parts (UDI = DI + PI):</strong></p>
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<ol>
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<li><strong>Device Identifier (DI)</strong> - unique numeric or alphanumeric code specific to a device version or model.</li>
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<li><strong>Production Identifier(s) (PI)</strong> - numeric or alphanumeric codes that identify production for a device and can include the lot or batch number, serial number, expiration date, date device manufactured.</li>
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||
</ol>
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</div>
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<p>A UDI appears in plain text and machine-readable format. Below is an example of a UDI from GS1, one of the FDA-accredited issuing agencies. In GS1’s systems, the numbers in the parentheses indicate the different parts of the UDI.</p>
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<a href="img/barcode.png" target="_blank"><img class="img-fluid" src="img/barcode.png" alt="Example of barcode (01)12345678901234(17)140102(11)100102(10)A1234(21)1234"></a>
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</div>
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</div>
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<br>
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<div class="row">
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<div class="col-lg-12">
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<p><strong>Device Identifier (DI)</strong>: 12345678901234</p>
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<p><strong>Production Identifiers (PI)</strong>:</p>
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<ul>
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<li>Expiration Date: 140102</li>
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<li>Manufacturing Date: 100102</li>
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<li>Lot Number: A1234</li>
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<li>Serial Number: 1234</li>
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</ul>
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<div>
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<hr>
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<p class="small"><em>References</em></p>
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<p class="small">"AccessGUDID - ABOUT AccessGUDID." <em>U.S. National Library of Medicine</em>, National Institutes of Health, <a href="https://accessgudid.nlm.nih.gov/about-gudid" title="https://accessgudid.nlm.nih.gov/about-gudid" target="_blank">https://accessgudid.nlm.nih.gov/about-gudid</a>.</p>
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