SPL Mapping FHIR Implementation Guide
0.1.0 - Build CI
SPL Mapping FHIR Implementation Guide
0.1.0 - Build CI
SPL Mapping FHIR Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions
| Page standards status: Trial-use | Maturity Level: 1 |
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><ul><li>Include these codes as defined in <a href=\"http://loinc.org\"><code>http://loinc.org</code></a><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td><a href=\"https://loinc.org/51945-4/\">51945-4</a></td><td>Principal display panel of package</td></tr><tr><td><a href=\"https://loinc.org/100382-1/\">100382-1</a></td><td>REMS addressed risk</td></tr><tr><td><a href=\"https://loinc.org/103572-4/\">103572-4</a></td><td>Cosmetic product listing</td></tr><tr><td><a href=\"https://loinc.org/103573-2/\">103573-2</a></td><td>Cosmetic facility registration</td></tr><tr><td><a href=\"https://loinc.org/34066-1/\">34066-1</a></td><td>Boxed warning section</td></tr><tr><td><a href=\"https://loinc.org/34067-9/\">34067-9</a></td><td>Indications and usage section</td></tr><tr><td><a href=\"https://loinc.org/34068-7/\">34068-7</a></td><td>Dosage and administration section</td></tr><tr><td><a href=\"https://loinc.org/34069-5/\">34069-5</a></td><td>How supplied section</td></tr><tr><td><a href=\"https://loinc.org/34070-3/\">34070-3</a></td><td>Contraindications section</td></tr><tr><td><a href=\"https://loinc.org/34071-1/\">34071-1</a></td><td>Warnings section</td></tr><tr><td><a href=\"https://loinc.org/34072-9/\">34072-9</a></td><td>General precautions section</td></tr><tr><td><a href=\"https://loinc.org/34073-7/\">34073-7</a></td><td>Drug interactions section</td></tr><tr><td><a href=\"https://loinc.org/34074-5/\">34074-5</a></td><td>Drug/laboratory test interactions section</td></tr><tr><td><a href=\"https://loinc.org/34075-2/\">34075-2</a></td><td>Laboratory tests section</td></tr><tr><td><a href=\"https://loinc.org/34076-0/\">34076-0</a></td><td>Information for patients section</td></tr><tr><td><a href=\"https://loinc.org/34077-8/\">34077-8</a></td><td>Teratogenic effects section</td></tr><tr><td><a href=\"https://loinc.org/34078-6/\">34078-6</a></td><td>Nonteratogenic effects section</td></tr><tr><td><a href=\"https://loinc.org/34079-4/\">34079-4</a></td><td>Labor and delivery section</td></tr><tr><td><a href=\"https://loinc.org/34080-2/\">34080-2</a></td><td>Nursing mothers section</td></tr><tr><td><a href=\"https://loinc.org/34081-0/\">34081-0</a></td><td>Pediatric use section</td></tr><tr><td><a href=\"https://loinc.org/34082-8/\">34082-8</a></td><td>Geriatric use section</td></tr><tr><td><a href=\"https://loinc.org/34083-6/\">34083-6</a></td><td>Carcinogenesis and mutagenesis and impairment of fertility section</td></tr><tr><td><a href=\"https://loinc.org/34084-4/\">34084-4</a></td><td>Adverse reactions section</td></tr><tr><td><a href=\"https://loinc.org/34085-1/\">34085-1</a></td><td>Controlled substance section</td></tr><tr><td><a href=\"https://loinc.org/34086-9/\">34086-9</a></td><td>Abuse section</td></tr><tr><td><a href=\"https://loinc.org/34087-7/\">34087-7</a></td><td>Dependence section</td></tr><tr><td><a href=\"https://loinc.org/34088-5/\">34088-5</a></td><td>Overdosage section</td></tr><tr><td><a href=\"https://loinc.org/34089-3/\">34089-3</a></td><td>Description section</td></tr><tr><td><a href=\"https://loinc.org/34090-1/\">34090-1</a></td><td>Clinical pharmacology section</td></tr><tr><td><a href=\"https://loinc.org/34091-9/\">34091-9</a></td><td>Animal pharmacology/toxicology section</td></tr><tr><td><a href=\"https://loinc.org/34092-7/\">34092-7</a></td><td>Clinical studies section</td></tr><tr><td><a href=\"https://loinc.org/34093-5/\">34093-5</a></td><td>References section</td></tr><tr><td><a href=\"https://loinc.org/38056-8/\">38056-8</a></td><td>Structured product laballing supplemental patient material</td></tr><tr><td><a href=\"https://loinc.org/42227-9/\">42227-9</a></td><td>Drug abuse and dependence section</td></tr><tr><td><a href=\"https://loinc.org/42228-7/\">42228-7</a></td><td>Pregnancy section</td></tr><tr><td><a href=\"https://loinc.org/42229-5/\">42229-5</a></td><td>Structured patient labelling unclassified section</td></tr><tr><td><a href=\"https://loinc.org/42230-3/\">42230-3</a></td><td>Structured product laballing patient package insert section</td></tr><tr><td><a href=\"https://loinc.org/42231-1/\">42231-1</a></td><td>Structured product labelling medguide section</td></tr><tr><td><a href=\"https://loinc.org/42232-9/\">42232-9</a></td><td>Precautions section</td></tr><tr><td><a href=\"https://loinc.org/43678-2/\">43678-2</a></td><td>Dosage forms and strengths section</td></tr><tr><td><a href=\"https://loinc.org/43679-0/\">43679-0</a></td><td>Mechanism of action section</td></tr><tr><td><a href=\"https://loinc.org/43680-8/\">43680-8</a></td><td>Nonclinical toxicology section</td></tr><tr><td><a href=\"https://loinc.org/43681-6/\">43681-6</a></td><td>Pharmacodynamics section</td></tr><tr><td><a href=\"https://loinc.org/43682-4/\">43682-4</a></td><td>Pharmacokinetics section</td></tr><tr><td><a href=\"https://loinc.org/43683-2/\">43683-2</a></td><td>Recent major changes section</td></tr><tr><td><a href=\"https://loinc.org/43684-0/\">43684-0</a></td><td>Use in specific populations section</td></tr><tr><td><a href=\"https://loinc.org/43685-7/\">43685-7</a></td><td>Warnings and precautions section</td></tr><tr><td><a href=\"https://loinc.org/44425-7/\">44425-7</a></td><td>Storage and handling section</td></tr><tr><td><a href=\"https://loinc.org/48779-3/\">48779-3</a></td><td>Structured product labelling indexing data elements section</td></tr><tr><td><a href=\"https://loinc.org/48780-1/\">48780-1</a></td><td>Structured product labelling listing data elements section</td></tr><tr><td><a href=\"https://loinc.org/49489-8/\">49489-8</a></td><td>Microbiology section</td></tr><tr><td><a href=\"https://loinc.org/54433-8/\">54433-8</a></td><td>User safety warnings section</td></tr><tr><td><a href=\"https://loinc.org/59845-8/\">59845-8</a></td><td>Instructions for use section</td></tr><tr><td><a href=\"https://loinc.org/60555-0/\">60555-0</a></td><td>Accessories</td></tr><tr><td><a href=\"https://loinc.org/60556-8/\">60556-8</a></td><td>Assembly or installation instructions</td></tr><tr><td><a href=\"https://loinc.org/60557-6/\">60557-6</a></td><td>Calibration instructions</td></tr><tr><td><a href=\"https://loinc.org/60558-4/\">60558-4</a></td><td>Cleaning, disinfecting, and sterilization instructions</td></tr><tr><td><a href=\"https://loinc.org/60559-2/\">60559-2</a></td><td>Components</td></tr><tr><td><a href=\"https://loinc.org/60560-0/\">60560-0</a></td><td>Intended use of the device</td></tr><tr><td><a href=\"https://loinc.org/60561-8/\">60561-8</a></td><td>Other safety information</td></tr><tr><td><a href=\"https://loinc.org/60562-6/\">60562-6</a></td><td>Route, method and frequency of administration</td></tr><tr><td><a href=\"https://loinc.org/60563-4/\">60563-4</a></td><td>Summary of safety and effectiveness</td></tr><tr><td><a href=\"https://loinc.org/60685-5/\">60685-5</a></td><td>Indexing - pharmacologic class</td></tr><tr><td><a href=\"https://loinc.org/64123-3/\">64123-3</a></td><td>Indexing - adverse reaction</td></tr><tr><td><a href=\"https://loinc.org/64124-1/\">64124-1</a></td><td>Indexing - substance</td></tr><tr><td><a href=\"https://loinc.org/66105-8/\">66105-8</a></td><td>Lot distribution data</td></tr><tr><td><a href=\"https://loinc.org/66106-6/\">66106-6</a></td><td>Pharmacogenomics section</td></tr><tr><td><a href=\"https://loinc.org/69758-1/\">69758-1</a></td><td>Diagram of device</td></tr><tr><td><a href=\"https://loinc.org/69759-9/\">69759-9</a></td><td>Risks</td></tr><tr><td><a href=\"https://loinc.org/69760-7/\">69760-7</a></td><td>Compatible accessories</td></tr><tr><td><a href=\"https://loinc.org/69761-5/\">69761-5</a></td><td>Alarms</td></tr><tr><td><a href=\"https://loinc.org/69762-3/\">69762-3</a></td><td>Troubleshooting</td></tr><tr><td><a href=\"https://loinc.org/69763-1/\">69763-1</a></td><td>Disposal and waste handling</td></tr><tr><td><a href=\"https://loinc.org/71446-9/\">71446-9</a></td><td>Indexing - billing unit</td></tr><tr><td><a href=\"https://loinc.org/71681-1/\">71681-1</a></td><td>PMI - Common side effects section</td></tr><tr><td><a href=\"https://loinc.org/71682-9/\">71682-9</a></td><td>PMI - Get emergency medical help section</td></tr><tr><td><a href=\"https://loinc.org/71683-7/\">71683-7</a></td><td>PMI - Stop taking and call your doctor section</td></tr><tr><td><a href=\"https://loinc.org/71684-5/\">71684-5</a></td><td>PMI - Directions for use section</td></tr><tr><td><a href=\"https://loinc.org/71685-2/\">71685-2</a></td><td>PMI - Tell your doctor before taking section</td></tr><tr><td><a href=\"https://loinc.org/71686-0/\">71686-0</a></td><td>PMI - Do not take section</td></tr><tr><td><a href=\"https://loinc.org/71687-8/\">71687-8</a></td><td>PMI - Important information section</td></tr><tr><td><a href=\"https://loinc.org/71688-6/\">71688-6</a></td><td>PMI - Uses section</td></tr><tr><td><a href=\"https://loinc.org/71744-7/\">71744-7</a></td><td>Health care provider letter</td></tr><tr><td><a href=\"https://loinc.org/73815-3/\">73815-3</a></td><td>Indexing - product concept</td></tr><tr><td><a href=\"https://loinc.org/77288-9/\">77288-9</a></td><td>Indexing - warning letter alert</td></tr><tr><td><a href=\"https://loinc.org/77289-7/\">77289-7</a></td><td>Identification of suspect product and notification</td></tr><tr><td><a href=\"https://loinc.org/77290-5/\">77290-5</a></td><td>Lactation</td></tr><tr><td><a href=\"https://loinc.org/77291-3/\">77291-3</a></td><td>Females and males reproductive potential</td></tr><tr><td><a href=\"https://loinc.org/77292-1/\">77292-1</a></td><td>eFacility</td></tr><tr><td><a href=\"https://loinc.org/82336-9/\">82336-9</a></td><td>REMS header</td></tr><tr><td><a href=\"https://loinc.org/82344-3/\">82344-3</a></td><td>REMS communication plan</td></tr><tr><td><a href=\"https://loinc.org/82345-0/\">82345-0</a></td><td>REMS elements to assure safe use</td></tr><tr><td><a href=\"https://loinc.org/82346-8/\">82346-8</a></td><td>REMS material</td></tr><tr><td><a href=\"https://loinc.org/82347-6/\">82347-6</a></td><td>REMS summary</td></tr><tr><td><a href=\"https://loinc.org/82348-4/\">82348-4</a></td><td>REMS elements</td></tr><tr><td><a href=\"https://loinc.org/82349-2/\">82349-2</a></td><td>REMS goals</td></tr><tr><td><a href=\"https://loinc.org/82350-0/\">82350-0</a></td><td>REMS implementation system</td></tr><tr><td><a href=\"https://loinc.org/82351-8/\">82351-8</a></td><td>Risk evaluation and mitigation strategies</td></tr><tr><td><a href=\"https://loinc.org/82352-6/\">82352-6</a></td><td>REMS timetable for submission assessments</td></tr><tr><td><a href=\"https://loinc.org/82353-4/\">82353-4</a></td><td>Indexing - risk evaluation and mitigation strategies</td></tr><tr><td><a href=\"https://loinc.org/82598-4/\">82598-4</a></td><td>REMS medication guide</td></tr><tr><td><a href=\"https://loinc.org/85273-1/\">85273-1</a></td><td>REMS conversion to shared system</td></tr><tr><td><a href=\"https://loinc.org/85274-9/\">85274-9</a></td><td>REMS release</td></tr><tr><td><a href=\"https://loinc.org/86445-4/\">86445-4</a></td><td>Blanket no changes certification of product listing</td></tr><tr><td><a href=\"https://loinc.org/87523-7/\">87523-7</a></td><td>REMS administrative information</td></tr><tr><td><a href=\"https://loinc.org/87524-5/\">87524-5</a></td><td>REMS requirements</td></tr><tr><td><a href=\"https://loinc.org/87525-2/\">87525-2</a></td><td>REMS participant requirements</td></tr><tr><td><a href=\"https://loinc.org/87526-0/\">87526-0</a></td><td>REMS applicant requirements</td></tr><tr><td><a href=\"https://loinc.org/88436-1/\">88436-1</a></td><td>Patient counseling information</td></tr><tr><td><a href=\"https://loinc.org/88437-9/\">88437-9</a></td><td>How supplied and storage and handling section</td></tr><tr><td><a href=\"https://loinc.org/88828-9/\">88828-9</a></td><td>Renal Impairment subsection</td></tr><tr><td><a href=\"https://loinc.org/88829-7/\">88829-7</a></td><td>Hepatic Impairment subsection</td></tr><tr><td><a href=\"https://loinc.org/88830-5/\">88830-5</a></td><td>Immunogenicity</td></tr><tr><td><a href=\"https://loinc.org/90374-0/\">90374-0</a></td><td>Clinical trials experience section</td></tr><tr><td><a href=\"https://loinc.org/90375-7/\">90375-7</a></td><td>Postmarketing experience section</td></tr></table></li></ul></div>"
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"description" : "Section Codes for SPL Product Submission documents",
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"copyright" : "This material contains content from LOINC (http://loinc.org). LOINC is copyright © 1995-2020, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license. LOINC® is a registered United States trademark of Regenstrief Institute, Inc.",
"compose" : {
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{
"code" : "51945-4",
"display" : "Principal display panel of package"
},
{
"code" : "100382-1",
"display" : "REMS addressed risk"
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{
"code" : "103572-4",
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{
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"display" : "Structured product laballing supplemental patient material"
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{
"code" : "71683-7",
"display" : "PMI - Stop taking and call your doctor section"
},
{
"code" : "71684-5",
"display" : "PMI - Directions for use section"
},
{
"code" : "71685-2",
"display" : "PMI - Tell your doctor before taking section"
},
{
"code" : "71686-0",
"display" : "PMI - Do not take section"
},
{
"code" : "71687-8",
"display" : "PMI - Important information section"
},
{
"code" : "71688-6",
"display" : "PMI - Uses section"
},
{
"code" : "71744-7",
"display" : "Health care provider letter"
},
{
"code" : "73815-3",
"display" : "Indexing - product concept"
},
{
"code" : "77288-9",
"display" : "Indexing - warning letter alert"
},
{
"code" : "77289-7",
"display" : "Identification of suspect product and notification"
},
{
"code" : "77290-5",
"display" : "Lactation"
},
{
"code" : "77291-3",
"display" : "Females and males reproductive potential"
},
{
"code" : "77292-1",
"display" : "eFacility"
},
{
"code" : "82336-9",
"display" : "REMS header"
},
{
"code" : "82344-3",
"display" : "REMS communication plan"
},
{
"code" : "82345-0",
"display" : "REMS elements to assure safe use"
},
{
"code" : "82346-8",
"display" : "REMS material"
},
{
"code" : "82347-6",
"display" : "REMS summary"
},
{
"code" : "82348-4",
"display" : "REMS elements"
},
{
"code" : "82349-2",
"display" : "REMS goals"
},
{
"code" : "82350-0",
"display" : "REMS implementation system"
},
{
"code" : "82351-8",
"display" : "Risk evaluation and mitigation strategies"
},
{
"code" : "82352-6",
"display" : "REMS timetable for submission assessments"
},
{
"code" : "82353-4",
"display" : "Indexing - risk evaluation and mitigation strategies"
},
{
"code" : "82598-4",
"display" : "REMS medication guide"
},
{
"code" : "85273-1",
"display" : "REMS conversion to shared system"
},
{
"code" : "85274-9",
"display" : "REMS release"
},
{
"code" : "86445-4",
"display" : "Blanket no changes certification of product listing"
},
{
"code" : "87523-7",
"display" : "REMS administrative information"
},
{
"code" : "87524-5",
"display" : "REMS requirements"
},
{
"code" : "87525-2",
"display" : "REMS participant requirements"
},
{
"code" : "87526-0",
"display" : "REMS applicant requirements"
},
{
"code" : "88436-1",
"display" : "Patient counseling information"
},
{
"code" : "88437-9",
"display" : "How supplied and storage and handling section"
},
{
"code" : "88828-9",
"display" : "Renal Impairment subsection"
},
{
"code" : "88829-7",
"display" : "Hepatic Impairment subsection"
},
{
"code" : "88830-5",
"display" : "Immunogenicity"
},
{
"code" : "90374-0",
"display" : "Clinical trials experience section"
},
{
"code" : "90375-7",
"display" : "Postmarketing experience section"
}
]
}
]
}
}
IG © 2020+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.spl#0.1.0 based on FHIR 4.3.0. Generated 2024-05-21
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