Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions
| Page standards status: Informative |
{
"resourceType" : "CodeSystem",
"id" : "419455",
"meta" : {
"versionId" : "8",
"lastUpdated" : "2026-01-22T16:57:47.498Z"
},
"language" : "en",
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: CodeSystem 419455</b></p><a name=\"419455\"> </a><a name=\"hc419455\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 8; Last updated: 2026-01-22 16:57:47+0000</p></div><p>This code system <code>https://fevir.net/resources/CodeSystem/419455</code> defines the following codes:</p><table class=\"codes\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td style=\"white-space:nowrap\">fda-regulated-drug<a name=\"419455-fda-regulated-drug\"> </a></td><td>FDA regulated drug</td><td>A medication regulated by the U.S. Food and Drug Administration.</td></tr><tr><td style=\"white-space:nowrap\">fda-regulated-device<a name=\"419455-fda-regulated-device\"> </a></td><td>FDA regulated device</td><td>A medical device regulated by the U.S. Food and Drug Administration.</td></tr><tr><td style=\"white-space:nowrap\">irb-exempt<a name=\"419455-irb-exempt\"> </a></td><td>IRB-exempt</td><td>Human subjects research that is excempt from oversight and monitoring by an institutional review board (IRB).</td></tr><tr><td style=\"white-space:nowrap\">mpg-paragraph-23b<a name=\"419455-mpg-paragraph-23b\"> </a></td><td>MPG Paragraph 23b</td><td>Research regulated by a specific German legal requirement (Medizinproduktegesetz MPG Paragraph 23b).</td></tr><tr><td style=\"white-space:nowrap\">includes-females<a name=\"419455-includes-females\"> </a></td><td>Includes female subjects</td><td>Includes female subjects</td></tr><tr><td style=\"white-space:nowrap\">does-not-include-females<a name=\"419455-does-not-include-females\"> </a></td><td>Does not include female subjects</td><td>Does not include female subjects</td></tr><tr><td style=\"white-space:nowrap\">includes-males<a name=\"419455-includes-males\"> </a></td><td>Includes male subjects</td><td>Includes male subjects</td></tr><tr><td style=\"white-space:nowrap\">does-not-include-males<a name=\"419455-does-not-include-males\"> </a></td><td>Does not include male subjects</td><td>Does not include male subjects</td></tr><tr><td style=\"white-space:nowrap\">includes-vulnerable-population<a name=\"419455-includes-vulnerable-population\"> </a></td><td>Includes vulnerable populations</td><td>Includes vulnerable populations</td></tr><tr><td style=\"white-space:nowrap\">does-not-include-vulnerable-population<a name=\"419455-does-not-include-vulnerable-population\"> </a></td><td>Does not include vulnerable populations</td><td>Does not include vulnerable populations</td></tr><tr><td style=\"white-space:nowrap\">includes-healthy-volunteers<a name=\"419455-includes-healthy-volunteers\"> </a></td><td>Includes healthy volunteers</td><td>Includes healthy volunteers</td></tr><tr><td style=\"white-space:nowrap\">does-not-include-healthy-volunteers<a name=\"419455-does-not-include-healthy-volunteers\"> </a></td><td>Does not include healthy volunteers</td><td>Does not include healthy volunteers</td></tr><tr><td style=\"white-space:nowrap\">includes-ages-in-utero<a name=\"419455-includes-ages-in-utero\"> </a></td><td>Includes ages in utero</td><td>Includes subjects who are not yet born</td></tr><tr><td style=\"white-space:nowrap\">includes-ages-0-17<a name=\"419455-includes-ages-0-17\"> </a></td><td>Includes ages 0-17 years</td><td>Includes subjects between birth and 17 years of age (not yet 18 years old)</td></tr><tr><td style=\"white-space:nowrap\">includes-ages-18-64<a name=\"419455-includes-ages-18-64\"> </a></td><td>Includes ages 18-64 years</td><td>Includes subjects between 18 and 64 years of age (not yet 65 years old)</td></tr><tr><td style=\"white-space:nowrap\">includes-ages-65-and-older<a name=\"419455-includes-ages-65-and-older\"> </a></td><td>Includes ages 65 and older</td><td>Includes subjects aged 65 years and older</td></tr><tr><td style=\"white-space:nowrap\">includes-preterm-newborns<a name=\"419455-includes-preterm-newborns\"> </a></td><td>Includes preterm newborns</td><td>Includes subjects who are preterm newborns (up to gestational age < 37 weeks)</td></tr><tr><td style=\"white-space:nowrap\">includes-neonates<a name=\"419455-includes-neonates\"> </a></td><td>Includes neonates</td><td>Includes subjects between 0 and 27 days of age</td></tr><tr><td style=\"white-space:nowrap\">includes-ages-28-day-23-month<a name=\"419455-includes-ages-28-day-23-month\"> </a></td><td>Includes ages 28 days to 23 months</td><td>Includes subjects between 28 days and 23 months of age</td></tr><tr><td style=\"white-space:nowrap\">includes-ages-2-5<a name=\"419455-includes-ages-2-5\"> </a></td><td>Includes ages 2-5 years</td><td>Includes subjects between 2 and 5 years of age (not yet 6 years old)</td></tr><tr><td style=\"white-space:nowrap\">includes-ages-6-11<a name=\"419455-includes-ages-6-11\"> </a></td><td>Includes ages 6-11 years</td><td>Includes subjects between 6 and 11 years of age (not yet 12 years old)</td></tr><tr><td style=\"white-space:nowrap\">includes-ages-12-17<a name=\"419455-includes-ages-12-17\"> </a></td><td>Includes ages 12-17 years</td><td>Includes subjects between 12 and 17 years of age (not yet 18 years old)</td></tr><tr><td style=\"white-space:nowrap\">includes-ages-65-84<a name=\"419455-includes-ages-65-84\"> </a></td><td>Includes ages 65-84 years</td><td>Includes subjects between 65 and 84 years of age (not yet 85 years old)</td></tr><tr><td style=\"white-space:nowrap\">includes-ages-85-and-older<a name=\"419455-includes-ages-85-and-older\"> </a></td><td>Includes ages 85 and older</td><td>Includes subjects aged 85 years and older</td></tr><tr><td style=\"white-space:nowrap\">includes-patients<a name=\"419455-includes-patients\"> </a></td><td>Includes patients</td><td>Includes patients</td></tr><tr><td style=\"white-space:nowrap\">does-not-include-patients<a name=\"419455-does-not-include-patients\"> </a></td><td>Does not include patients</td><td>Does not include patients</td></tr></table></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/cite-as",
"valueMarkdown" : "ResearchStudy Classifier Code System [Database Entry: FHIR CodeSystem Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 419455. Revised 2026-01-22. Available at: https://fevir.net/resources/CodeSystem/419455. Computable resource at: https://fevir.net/resources/CodeSystem/419455#json."
}
],
"url" : "https://fevir.net/resources/CodeSystem/419455",
"identifier" : [
{
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
"code" : "ACSN",
"display" : "Accession ID"
}
],
"text" : "FEvIR Object Identifier"
},
"system" : "https://fevir.net/FOI",
"value" : "419455",
"assigner" : {
"display" : "Computable Publishing LLC"
}
},
{
"system" : "urn:ietf:rfc:3986",
"value" : "urn:oid:2.16.840.1.113883.4.642.40.44.16.8"
}
],
"version" : "1.0.0-ballot3",
"name" : "ResearchStudyClassifierCodeSystem",
"title" : "ResearchStudy Classifier Code System",
"status" : "active",
"date" : "2026-02-10T14:00:26+00:00",
"publisher" : "HL7 International / Clinical Decision Support",
"contact" : [
{
"name" : "HL7 International / Clinical Decision Support",
"telecom" : [
{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/dss"
}
]
}
],
"description" : "This CodeSystem is used for common values for the ResearchStudy.classifier element and will likely move to terminology.hl7.org when it is mature.",
"jurisdiction" : [
{
"coding" : [
{
"system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code" : "001",
"display" : "World"
}
]
}
],
"copyright" : "https://creativecommons.org/licenses/by-nc-sa/4.0/",
"author" : [
{
"name" : "Brian S. Alper, MD, MSPH"
}
],
"content" : "complete",
"concept" : [
{
"code" : "fda-regulated-drug",
"display" : "FDA regulated drug",
"definition" : "A medication regulated by the U.S. Food and Drug Administration."
},
{
"code" : "fda-regulated-device",
"display" : "FDA regulated device",
"definition" : "A medical device regulated by the U.S. Food and Drug Administration."
},
{
"code" : "irb-exempt",
"display" : "IRB-exempt",
"definition" : "Human subjects research that is excempt from oversight and monitoring by an institutional review board (IRB)."
},
{
"code" : "mpg-paragraph-23b",
"display" : "MPG Paragraph 23b",
"definition" : "Research regulated by a specific German legal requirement (Medizinproduktegesetz MPG Paragraph 23b)."
},
{
"code" : "includes-females",
"display" : "Includes female subjects",
"definition" : "Includes female subjects"
},
{
"code" : "does-not-include-females",
"display" : "Does not include female subjects",
"definition" : "Does not include female subjects"
},
{
"code" : "includes-males",
"display" : "Includes male subjects",
"definition" : "Includes male subjects"
},
{
"code" : "does-not-include-males",
"display" : "Does not include male subjects",
"definition" : "Does not include male subjects"
},
{
"code" : "includes-vulnerable-population",
"display" : "Includes vulnerable populations",
"definition" : "Includes vulnerable populations"
},
{
"code" : "does-not-include-vulnerable-population",
"display" : "Does not include vulnerable populations",
"definition" : "Does not include vulnerable populations"
},
{
"code" : "includes-healthy-volunteers",
"display" : "Includes healthy volunteers",
"definition" : "Includes healthy volunteers"
},
{
"code" : "does-not-include-healthy-volunteers",
"display" : "Does not include healthy volunteers",
"definition" : "Does not include healthy volunteers"
},
{
"code" : "includes-ages-in-utero",
"display" : "Includes ages in utero",
"definition" : "Includes subjects who are not yet born"
},
{
"code" : "includes-ages-0-17",
"display" : "Includes ages 0-17 years",
"definition" : "Includes subjects between birth and 17 years of age (not yet 18 years old)"
},
{
"code" : "includes-ages-18-64",
"display" : "Includes ages 18-64 years",
"definition" : "Includes subjects between 18 and 64 years of age (not yet 65 years old)"
},
{
"code" : "includes-ages-65-and-older",
"display" : "Includes ages 65 and older",
"definition" : "Includes subjects aged 65 years and older"
},
{
"code" : "includes-preterm-newborns",
"display" : "Includes preterm newborns",
"definition" : "Includes subjects who are preterm newborns (up to gestational age < 37 weeks)"
},
{
"code" : "includes-neonates",
"display" : "Includes neonates",
"definition" : "Includes subjects between 0 and 27 days of age"
},
{
"code" : "includes-ages-28-day-23-month",
"display" : "Includes ages 28 days to 23 months",
"definition" : "Includes subjects between 28 days and 23 months of age"
},
{
"code" : "includes-ages-2-5",
"display" : "Includes ages 2-5 years",
"definition" : "Includes subjects between 2 and 5 years of age (not yet 6 years old)"
},
{
"code" : "includes-ages-6-11",
"display" : "Includes ages 6-11 years",
"definition" : "Includes subjects between 6 and 11 years of age (not yet 12 years old)"
},
{
"code" : "includes-ages-12-17",
"display" : "Includes ages 12-17 years",
"definition" : "Includes subjects between 12 and 17 years of age (not yet 18 years old)"
},
{
"code" : "includes-ages-65-84",
"display" : "Includes ages 65-84 years",
"definition" : "Includes subjects between 65 and 84 years of age (not yet 85 years old)"
},
{
"code" : "includes-ages-85-and-older",
"display" : "Includes ages 85 and older",
"definition" : "Includes subjects aged 85 years and older"
},
{
"code" : "includes-patients",
"display" : "Includes patients",
"definition" : "Includes patients"
},
{
"code" : "does-not-include-patients",
"display" : "Does not include patients",
"definition" : "Does not include patients"
}
]
}
IG © 2024+ HL7 International / Clinical Decision Support.
Package hl7.fhir.uv.ebm#1.0.0-ballot3 based on FHIR 6.0.0-ballot3.
Generated
2026-02-10
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