MII IG Kerndatensatz-Modul Seltene Erkrankungen
2027.0.0-ballot -
Germany
MII IG Kerndatensatz-Modul Seltene Erkrankungen
2027.0.0-ballot -
Germany
MII IG Kerndatensatz-Modul Seltene Erkrankungen - Downloaded Version 2027.0.0-ballot See the Directory of published versions
| Active as of 2026-09-14 |
XML representation of the mii-pr-seltene-registerteilnahme resource profile.
<StructureDefinition xmlns="http://hl7.org/fhir">
<id value="mii-pr-seltene-registerteilnahme"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/crmi/StructureDefinition/crmi-shareablestructuredefinition"/>
<profile
value="http://hl7.org/fhir/uv/crmi/StructureDefinition/crmi-publishablestructuredefinition"/>
</meta>
<language value="en"/>
<text>
<status value="extensions"/>
<div xml:lang="en" lang="en"><hr/><p><b>English</b></p><hr/><p class="res-header-id"><b>Generated Narrative: StructureDefinition mii-pr-seltene-registerteilnahme</b></p><a name="mii-pr-seltene-registerteilnahme"> </a><a name="hcmii-pr-seltene-registerteilnahme"> </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"/><p style="margin-bottom: 0px">Profiles: <a href="http://hl7.org/fhir/uv/crmi/STU2/StructureDefinition-crmi-shareablestructuredefinition.html">CRMI Shareable StructureDefinition</a>, <a href="http://hl7.org/fhir/uv/crmi/STU2/StructureDefinition-crmi-publishablestructuredefinition.html">CRMI Publishable StructureDefinition</a></p></div><table border="0" cellpadding="0" cellspacing="0" style="border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><tr style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top"><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="The logical name of the element">Name</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Information about the use of the element">Flags</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Minimum and Maximum # of times the element can appear in the instance">Card.</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px; width: 100px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Reference to the type of the element">Type</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Additional information about the element">Description & Constraints</a><span style="float: right"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/></a></span></th></tr><tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_resource.png" alt="." style="background-color: white; background-color: inherit" title="Resource" class="hierarchy"/> <a href="StructureDefinition-mii-pr-seltene-registerteilnahme-definitions.html#ResearchSubject">ResearchSubject</a><a name="ResearchSubject"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/researchsubject.html">ResearchSubject</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Physical entity which is the primary unit of interest in the study</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a href="StructureDefinition-mii-pr-seltene-registerteilnahme-definitions.html#ResearchSubject.extension">Slices for extension</a><a name="ResearchSubject.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R4/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span><br/><span style="font-weight:bold">Slice: </span>Unordered, Open by value:url</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck124.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-mii-pr-seltene-registerteilnahme-definitions.html#ResearchSubject.extension:register" title="Extension URL = https://www.medizininformatik-initiative.de/fhir/ext/modul-seltene/StructureDefinition/mii-ex-seltene-register">extension:register</a><a name="ResearchSubject.extension:register"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/references.html">Reference</a>(<a href="http://hl7.org/fhir/R4/library.html">Library</a>)</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Katalogeintrag des Registers als Library (optional)<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-mii-ex-seltene-register.html">https://www.medizininformatik-initiative.de/fhir/ext/modul-seltene/StructureDefinition/mii-ex-seltene-register</a></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-mii-pr-seltene-registerteilnahme-definitions.html#ResearchSubject.identifier">identifier</a><a name="ResearchSubject.identifier"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span>..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#Identifier">Identifier</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Pseudonym der Person im Register</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-mii-pr-seltene-registerteilnahme-definitions.html#ResearchSubject.status">status</a><a name="ResearchSubject.status"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Status der Teilnahme</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-mii-pr-seltene-registerteilnahme-definitions.html#ResearchSubject.period">period</a><a name="ResearchSubject.period"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#Period">Period</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Zeitraum der Registerteilnahme</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-mii-pr-seltene-registerteilnahme-definitions.html#ResearchSubject.period.start">start</a><a name="ResearchSubject.period.start"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#dateTime">dateTime</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Starting time with inclusive boundary</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-mii-pr-seltene-registerteilnahme-definitions.html#ResearchSubject.study">study</a><a name="ResearchSubject.study"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/references.html">Reference</a>(<a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R4/researchstudy.html">ResearchStudy</a>)</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Das Register, als ResearchStudy geführt</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-mii-pr-seltene-registerteilnahme-definitions.html#ResearchSubject.individual">individual</a><a name="ResearchSubject.individual"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/references.html">Reference</a>(<a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R4/patient.html">Patient</a>)</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Who is part of study</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck00.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-mii-pr-seltene-registerteilnahme-definitions.html#ResearchSubject.consent">consent</a><a name="ResearchSubject.consent"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: #D50000" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/references.html">Reference</a>(<a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R4/consent.html">Consent</a>)</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Nur zu setzen, wenn die Einwilligung am dokumentierenden Standort tatsaechlich als Ressource vorliegt</td></tr>
<tr><td colspan="5" class="hierarchy"><br/><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/cqf-knowledgeCapability">
<valueCode value="shareable"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/cqf-knowledgeCapability">
<valueCode value="publishable"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/artifact-usage">
<valueMarkdown
value="Use this profile as the technical FHIR representation of the corresponding Medical Informatics Initiative logical model. The profile constrains a base FHIR resource for the MII module context by specifying how elements are used, which elements are required or not used, which extensions and terminology bindings apply, and how the resource maps to the module-specific content model. Implementers should produce and consume resource instances that conform to this profile when exchanging data for the corresponding MII module."/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/artifact-versionPolicy">
<valueCodeableConcept>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/artifact-version-policy-codes"/>
<code value="package"/>
<display value="Package"/>
</coding>
</valueCodeableConcept>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/resource-approvalDate">
<valueDate value="2026-09-02"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/artifact-topic">
<valueCodeableConcept>
<coding>
<system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C4873"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/artifact-author">
<valueContactDetail>
<telecom>
<system value="email"/>
<value value="thomas.debertshaeuser@charite.de"/>
</telecom>
</valueContactDetail>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/artifact-editor">
<valueContactDetail>
<name value="Taskforce Core Data Set"/>
</valueContactDetail>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/artifact-reviewer">
<valueContactDetail>
<name value="Interoperability Working Group"/>
<telecom>
<system value="url"/>
<value
value="https://www.medizininformatik-initiative.de/en/collaboration/interoperability-working-group"/>
</telecom>
</valueContactDetail>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/artifact-reviewer">
<valueContactDetail>
<name value="National Steering Committee"/>
<telecom>
<system value="url"/>
<value
value="https://www.medizininformatik-initiative.de/en/collaboration/national-steering-committee"/>
</telecom>
</valueContactDetail>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/artifact-endorser">
<valueContactDetail>
<name value="Interoperability Working Group"/>
<telecom>
<system value="url"/>
<value
value="https://www.medizininformatik-initiative.de/en/collaboration/interoperability-working-group"/>
</telecom>
</valueContactDetail>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/artifact-endorser">
<valueContactDetail>
<name value="National Steering Committee"/>
<telecom>
<system value="url"/>
<value
value="https://www.medizininformatik-initiative.de/en/collaboration/national-steering-committee"/>
</telecom>
</valueContactDetail>
</extension>
<url
value="https://www.medizininformatik-initiative.de/fhir/ext/modul-seltene/StructureDefinition/mii-pr-seltene-registerteilnahme"/>
<version value="2027.0.0-ballot"/>
<name value="MII_PR_Seltene_Registerteilnahme"/>
<title value="MII PR SE Registerteilnahme"/>
<status value="active"/>
<experimental value="false"/>
<date value="2026-09-14T22:11:28+00:00"/>
<publisher value="Medizininformatik Initiative"/>
<contact>
<name value="Medizininformatik Initiative"/>
<telecom>
<system value="url"/>
<value value="https://www.medizininformatik-initiative.de/"/>
</telecom>
</contact>
<description
value="Teilnahme einer Person an einem Register für seltene Erkrankungen, insbesondere an einem Register eines European Reference Network (ERN). Gedacht für die Dokumentation aus zweiter Hand im Versorgungskontext: festgehalten wird, dass die Person teilnimmt. Nah am Probanden-Profil des MII KDS Moduls Studie, aber bewusst nicht davon abgeleitet, weil dessen Pflichtangabe consent den Sekundärfall ausschließt."/>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="DE"/>
<display value="Germany"/>
</coding>
</jurisdiction>
<fhirVersion value="4.0.1"/>
<mapping>
<identity value="SE-LogicalModel"/>
<uri
value="https://www.medizininformatik-initiative.de/fhir/ext/modul-seltene/StructureDefinition/LogicalModel/Seltene"/>
<name value="Mapping FHIR zu Seltene Erkrankungen Logical Model"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<uri value="https://bridgmodel.nci.nih.gov"/>
<name value="BRIDG 5.1 Mapping"/>
</mapping>
<mapping>
<identity value="v2"/>
<uri value="http://hl7.org/v2"/>
<name value="HL7 v2 Mapping"/>
</mapping>
<mapping>
<identity value="w5"/>
<uri value="http://hl7.org/fhir/fivews"/>
<name value="FiveWs Pattern Mapping"/>
</mapping>
<kind value="resource"/>
<abstract value="false"/>
<type value="ResearchSubject"/>
<baseDefinition
value="http://hl7.org/fhir/StructureDefinition/ResearchSubject"/>
<derivation value="constraint"/>
<snapshot>
<extension
url="http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version">
<valueString value="4.0.1"/>
</extension>
<element id="ResearchSubject">
<path value="ResearchSubject"/>
<short
value="Physical entity which is the primary unit of interest in the study"/>
<definition
value="A physical entity which is the primary unit of operational and/or administrative interest in a study."/>
<comment value="Need to make sure we encompass public health studies."/>
<alias value="Study Subject"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchSubject"/>
<min value="0"/>
<max value="*"/>
</base>
<constraint>
<key value="dom-2"/>
<severity value="error"/>
<human
value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/>
<expression value="contained.contained.empty()"/>
<xpath value="not(parent::f:contained and f:contained)"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="dom-3"/>
<severity value="error"/>
<human
value="If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource"/>
<expression
value="contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()"/>
<xpath
value="not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="dom-4"/>
<severity value="error"/>
<human
value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated"/>
<expression
value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/>
<xpath
value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="dom-5"/>
<severity value="error"/>
<human
value="If a resource is contained in another resource, it SHALL NOT have a security label"/>
<expression value="contained.meta.security.empty()"/>
<xpath value="not(exists(f:contained/*/f:meta/f:security))"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation">
<valueMarkdown
value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."/>
</extension>
<key value="dom-6"/>
<severity value="warning"/>
<human
value="A resource should have narrative for robust management"/>
<expression value="text.`div`.exists()"/>
<xpath value="exists(f:text/h:div)"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="Entity. Role, or Act"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudySubject"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="OBX"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Observation[classCode=CLNTRL, moodCode=EVN]"/>
</mapping>
</element>
<element id="ResearchSubject.id">
<path value="ResearchSubject.id"/>
<short value="Logical id of this artifact"/>
<definition
value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes."/>
<comment
value="The only time that a resource does not have an id is when it is being submitted to the server using a create operation."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="id"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="ResearchSubject.meta">
<path value="ResearchSubject.meta"/>
<short value="Metadata about the resource"/>
<definition
value="The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.meta"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Meta"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="ResearchSubject.implicitRules">
<path value="ResearchSubject.implicitRules"/>
<short value="A set of rules under which this content was created"/>
<definition
value="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc."/>
<comment
value="Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.implicitRules"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="uri"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation"/>
<isSummary value="true"/>
</element>
<element id="ResearchSubject.language">
<path value="ResearchSubject.language"/>
<short value="Language of the resource content"/>
<definition
value="The base language in which the resource is written."/>
<comment
value="Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.language"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet">
<valueCanonical value="http://hl7.org/fhir/ValueSet/all-languages"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="Language"/>
</extension>
<strength value="preferred"/>
<description value="A human language."/>
<valueSet value="http://hl7.org/fhir/ValueSet/languages|4.0.1"/>
</binding>
</element>
<element id="ResearchSubject.text">
<path value="ResearchSubject.text"/>
<short value="Text summary of the resource, for human interpretation"/>
<definition
value="A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety."/>
<comment
value="Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later."/>
<alias value="narrative"/>
<alias value="html"/>
<alias value="xhtml"/>
<alias value="display"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="DomainResource.text"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Narrative"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="Act.text?"/>
</mapping>
</element>
<element id="ResearchSubject.contained">
<path value="ResearchSubject.contained"/>
<short value="Contained, inline Resources"/>
<definition
value="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope."/>
<comment
value="This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels."/>
<alias value="inline resources"/>
<alias value="anonymous resources"/>
<alias value="contained resources"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.contained"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Resource"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="ResearchSubject.extension">
<path value="ResearchSubject.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<ordered value="false"/>
<rules value="open"/>
</slicing>
<short value="Extension"/>
<definition value="An Extension"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
<element id="ResearchSubject.extension:register">
<path value="ResearchSubject.extension"/>
<sliceName value="register"/>
<short value="Katalogeintrag des Registers als Library (optional)"/>
<definition
value="Optionaler Verweis auf den Library-Katalogeintrag des Registers nach dem Profil mii-pr-studie-register des MII KDS Moduls Studie. Der verbindliche Registerbezug läuft über ResearchSubject.study, das in R4 zwingend auf eine ResearchStudy zeigt."/>
<comment
value="Optionaler Verweis auf den Library-Katalogeintrag nach mii-pr-studie-register. Der verbindliche Registerbezug läuft über study, weil R4 das so erzwingt."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="https://www.medizininformatik-initiative.de/fhir/ext/modul-seltene/StructureDefinition/mii-ex-seltene-register"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="false"/>
</element>
<element id="ResearchSubject.modifierExtension">
<path value="ResearchSubject.modifierExtension"/>
<short value="Extensions that cannot be ignored"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="ResearchSubject.identifier">
<path value="ResearchSubject.identifier"/>
<short value="Pseudonym der Person im Register"/>
<definition
value="Identifiers assigned to this research subject for a study."/>
<comment
value="Das registereigene Pseudonym, nicht die Patienten-ID des Standorts. Bewusst optional: beim Dokumentieren aus zweiter Hand ist oft bekannt, DASS jemand teilnimmt, ohne dass das Pseudonym des Registers am Standort vorliegt. Wenn es vorliegt, ist es die wertvollste Angabe dieses Profils, weil erst sie die Verknuepfung erlaubt."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchSubject.identifier"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Identifier"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="w5"/>
<map value="FiveWs.identifier"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudySubject > Subject.identifier"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".identifier"/>
</mapping>
</element>
<element id="ResearchSubject.status">
<path value="ResearchSubject.status"/>
<short value="Status der Teilnahme"/>
<definition value="The current state of the subject."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ResearchSubject.status"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="true"/>
<isModifierReason
value="This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ResearchSubjectStatus"/>
</extension>
<strength value="required"/>
<description
value="Indicates the progression of a study subject through a study."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/research-subject-status|4.0.1"/>
</binding>
<mapping>
<identity value="SE-LogicalModel"/>
<map value="registerteilnahme.teilnahmestatus"/>
<comment value="Teilnahmestatus"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.status"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudySubject.statusCode"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".status"/>
</mapping>
</element>
<element id="ResearchSubject.period">
<path value="ResearchSubject.period"/>
<short value="Zeitraum der Registerteilnahme"/>
<definition
value="The dates the subject began and ended their participation in the study."/>
<comment
value="Optional, aus demselben Grund wie identifier: das Einschlussdatum ist am dokumentierenden Standort nicht immer bekannt."/>
<alias value="timing"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchSubject.period"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Period"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="SE-LogicalModel"/>
<map value="registerteilnahme.teilnahmezeitraum"/>
<comment value="Teilnahmezeitraum"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.planned"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="PerformedStudySubjectMilestone.studyReferenceDateRange"/>
</mapping>
</element>
<element id="ResearchSubject.period.id">
<path value="ResearchSubject.period.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="ResearchSubject.period.extension">
<path value="ResearchSubject.period.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="ResearchSubject.period.start">
<path value="ResearchSubject.period.start"/>
<short value="Starting time with inclusive boundary"/>
<definition
value="The start of the period. The boundary is inclusive."/>
<comment
value="If the low element is missing, the meaning is that the low boundary is not known."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Period.start"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="dateTime"/>
</type>
<condition value="per-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="DR.1"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="./low"/>
</mapping>
</element>
<element id="ResearchSubject.period.end">
<path value="ResearchSubject.period.end"/>
<short value="End time with inclusive boundary, if not ongoing"/>
<definition
value="The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time."/>
<comment
value="The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Period.end"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="dateTime"/>
</type>
<meaningWhenMissing
value="If the end of the period is missing, it means that the period is ongoing"/>
<condition value="per-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="DR.2"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="./high"/>
</mapping>
</element>
<element id="ResearchSubject.study">
<path value="ResearchSubject.study"/>
<short value="Das Register, als ResearchStudy geführt"/>
<definition
value="Reference to the study the subject is participating in."/>
<comment
value="In R4 ist study 1..1 Pflicht und auf ResearchStudy festgelegt. Ein Register muss daher als ResearchStudy vorliegen; der Library-Katalogeintrag des Moduls Studie kann hier nicht stehen. Siehe Kopfkommentar."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ResearchSubject.study"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/ResearchStudy|4.0.1"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="SE-LogicalModel"/>
<map value="registerteilnahme.registerName"/>
<comment value="Register"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudySubjectProtocolVersionRelationship"/>
</mapping>
</element>
<element id="ResearchSubject.individual">
<path value="ResearchSubject.individual"/>
<short value="Who is part of study"/>
<definition
value="The record of the person or animal who is involved in the study."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ResearchSubject.individual"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Patient|4.0.1"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudySubject"/>
</mapping>
</element>
<element id="ResearchSubject.assignedArm">
<path value="ResearchSubject.assignedArm"/>
<short value="What path should be followed"/>
<definition
value="The name of the arm in the study the subject is expected to follow as part of this study."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchSubject.assignedArm"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="BRIDG5.1"/>
<map
value="Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject"/>
</mapping>
</element>
<element id="ResearchSubject.actualArm">
<path value="ResearchSubject.actualArm"/>
<short value="What path was followed"/>
<definition
value="The name of the arm in the study the subject actually followed as part of this study."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchSubject.actualArm"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="BRIDG5.1"/>
<map
value="Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject"/>
</mapping>
</element>
<element id="ResearchSubject.consent">
<path value="ResearchSubject.consent"/>
<short
value="Nur zu setzen, wenn die Einwilligung am dokumentierenden Standort tatsaechlich als Ressource vorliegt"/>
<definition
value="A record of the patient's informed agreement to participate in the study."/>
<comment
value="Eine Registeraufnahme beruht selbstverständlich auf einer Einwilligung — aber die liegt beim Registerbetreiber. Ein Standort, der die Teilnahme nur nachhält, kann sie nicht referenzieren. Die Angabe leer zu lassen bedeutet daher NICHT, dass keine Einwilligung existiert, sondern nur, dass sie hier nicht als FHIR-Ressource greifbar ist. Genau deshalb leitet dieses Profil nicht vom Probanden-Profil des Moduls Studie ab, das consent mit 1..1 fordert."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchSubject.consent"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Consent|4.0.1"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="BRIDG5.1"/>
<map
value="ResearchStudy.consent is related to PerformedStudySubjectMilestone.informedConsentIndicator in that the informedConsentIndicator can be derived from the data in the Consent resource."/>
</mapping>
</element>
</snapshot>
<differential>
<element id="ResearchSubject">
<path value="ResearchSubject"/>
</element>
<element id="ResearchSubject.extension">
<path value="ResearchSubject.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<ordered value="false"/>
<rules value="open"/>
</slicing>
</element>
<element id="ResearchSubject.extension:register">
<path value="ResearchSubject.extension"/>
<sliceName value="register"/>
<short value="Katalogeintrag des Registers als Library (optional)"/>
<comment
value="Optionaler Verweis auf den Library-Katalogeintrag nach mii-pr-studie-register. Der verbindliche Registerbezug läuft über study, weil R4 das so erzwingt."/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Extension"/>
<profile
value="https://www.medizininformatik-initiative.de/fhir/ext/modul-seltene/StructureDefinition/mii-ex-seltene-register"/>
</type>
<mustSupport value="true"/>
</element>
<element id="ResearchSubject.identifier">
<path value="ResearchSubject.identifier"/>
<short value="Pseudonym der Person im Register"/>
<comment
value="Das registereigene Pseudonym, nicht die Patienten-ID des Standorts. Bewusst optional: beim Dokumentieren aus zweiter Hand ist oft bekannt, DASS jemand teilnimmt, ohne dass das Pseudonym des Registers am Standort vorliegt. Wenn es vorliegt, ist es die wertvollste Angabe dieses Profils, weil erst sie die Verknuepfung erlaubt."/>
<max value="1"/>
<mustSupport value="true"/>
</element>
<element id="ResearchSubject.status">
<path value="ResearchSubject.status"/>
<short value="Status der Teilnahme"/>
<mustSupport value="true"/>
<mapping>
<identity value="SE-LogicalModel"/>
<map value="registerteilnahme.teilnahmestatus"/>
<comment value="Teilnahmestatus"/>
</mapping>
</element>
<element id="ResearchSubject.period">
<path value="ResearchSubject.period"/>
<short value="Zeitraum der Registerteilnahme"/>
<comment
value="Optional, aus demselben Grund wie identifier: das Einschlussdatum ist am dokumentierenden Standort nicht immer bekannt."/>
<mustSupport value="true"/>
<mapping>
<identity value="SE-LogicalModel"/>
<map value="registerteilnahme.teilnahmezeitraum"/>
<comment value="Teilnahmezeitraum"/>
</mapping>
</element>
<element id="ResearchSubject.period.start">
<path value="ResearchSubject.period.start"/>
<mustSupport value="true"/>
</element>
<element id="ResearchSubject.study">
<path value="ResearchSubject.study"/>
<short value="Das Register, als ResearchStudy geführt"/>
<comment
value="In R4 ist study 1..1 Pflicht und auf ResearchStudy festgelegt. Ein Register muss daher als ResearchStudy vorliegen; der Library-Katalogeintrag des Moduls Studie kann hier nicht stehen. Siehe Kopfkommentar."/>
<mustSupport value="true"/>
<mapping>
<identity value="SE-LogicalModel"/>
<map value="registerteilnahme.registerName"/>
<comment value="Register"/>
</mapping>
</element>
<element id="ResearchSubject.individual">
<path value="ResearchSubject.individual"/>
<mustSupport value="true"/>
</element>
<element id="ResearchSubject.consent">
<path value="ResearchSubject.consent"/>
<short
value="Nur zu setzen, wenn die Einwilligung am dokumentierenden Standort tatsaechlich als Ressource vorliegt"/>
<comment
value="Eine Registeraufnahme beruht selbstverständlich auf einer Einwilligung — aber die liegt beim Registerbetreiber. Ein Standort, der die Teilnahme nur nachhält, kann sie nicht referenzieren. Die Angabe leer zu lassen bedeutet daher NICHT, dass keine Einwilligung existiert, sondern nur, dass sie hier nicht als FHIR-Ressource greifbar ist. Genau deshalb leitet dieses Profil nicht vom Probanden-Profil des Moduls Studie ab, das consent mit 1..1 fordert."/>
<mustSupport value="true"/>
</element>
</differential>
</StructureDefinition>