FHIR IG analytics| Package | de.medizininformatikinitiative.kerndatensatz.seltene |
| Resource Type | StructureDefinition |
| Id | StructureDefinition-mii-pr-seltene-registerteilnahme.json |
| FHIR Version | R4 |
| Source | https://medizininformatik-initiative.github.io/kerndatensatzmodul-seltene-erkrankungen/2027.0.0-ballot/StructureDefinition-mii-pr-seltene-registerteilnahme.html |
| URL | https://www.medizininformatik-initiative.de/fhir/ext/modul-seltene/StructureDefinition/mii-pr-seltene-registerteilnahme |
| Version | 2027.0.0-ballot |
| Status | active |
| Date | 2026-09-14T21:59:44+00:00 |
| Name | MII_PR_Seltene_Registerteilnahme |
| Title | MII PR SE Registerteilnahme |
| Realm | de |
| Description | 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. |
| Type | ResearchSubject |
| Kind | resource |
No resources found
| StructureDefinition | ||
| de.medizininformatikinitiative.kerndatensatz.seltene#2027.0.0-ballot | mii-ex-seltene-register | MII EX SE Register |
Note: links and images are rebased to the (stated) source
English
Generated Narrative: StructureDefinition mii-pr-seltene-registerteilnahme
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  ResearchSubject | 0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |
  Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
   extension:register | S | 0..1 | Reference(Library) | Katalogeintrag des Registers als Library (optional) URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-seltene/StructureDefinition/mii-ex-seltene-register |
 identifier | S | 0..1 | Identifier | Pseudonym der Person im Register |
| status | S | 1..1 | code | Status der Teilnahme |
| period | S | 0..1 | Period | Zeitraum der Registerteilnahme |
 start | S | 0..1 | dateTime | Starting time with inclusive boundary |
| study | S | 1..1 | Reference(ResearchStudy) | Das Register, als ResearchStudy geführt |
| individual | S | 1..1 | Reference(Patient) | Who is part of study |
| consent | S | 0..1 | Reference(Consent) | Nur zu setzen, wenn die Einwilligung am dokumentierenden Standort tatsaechlich als Ressource vorliegt |
| Documentation for this format | ||||
German
Generated Narrative: StructureDefinition mii-pr-seltene-registerteilnahme
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| ResearchSubject | 0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |
 Slices for extension | Content/Rules for all slices | |||
| extension:register | S | 0..1 | Reference(Library) | Katalogeintrag des Registers als Library (optional) URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-seltene/StructureDefinition/mii-ex-seltene-register |
| identifier | S | 0..1 | Identifier | Pseudonym der Person im Register |
| status | S | 1..1 | code | Status der Teilnahme |
| period | S | 0..1 | Period | Zeitraum der Registerteilnahme |
| start | S | 0..1 | dateTime | Starting time with inclusive boundary |
| study | S | 1..1 | Reference(ResearchStudy) | Das Register, als ResearchStudy geführt |
| individual | S | 1..1 | Reference(Patient) | Who is part of study |
| consent | S | 0..1 | Reference(Consent) | Nur zu setzen, wenn die Einwilligung am dokumentierenden Standort tatsaechlich als Ressource vorliegt |
| Documentation for this format | ||||
FHIR
FHIRsmith{
"resourceType": "StructureDefinition",
"id": "mii-pr-seltene-registerteilnahme",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/crmi/StructureDefinition/crmi-shareablestructuredefinition",
"http://hl7.org/fhir/uv/crmi/StructureDefinition/crmi-publishablestructuredefinition"
]
},
"text": {
"status": "extensions",
"div": "<!-- snip (see above) -->"
},
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/cqf-knowledgeCapability",
"valueCode": "shareable"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/cqf-knowledgeCapability",
"valueCode": "publishable"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/artifact-usage",
"valueMarkdown": "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."
},
{
"url": "http://hl7.org/fhir/StructureDefinition/artifact-versionPolicy",
"valueCodeableConcept": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/artifact-version-policy-codes",
"code": "package",
"display": "Package"
}
]
}
},
{
"url": "http://hl7.org/fhir/StructureDefinition/resource-approvalDate",
"valueDate": "2026-09-02"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/artifact-topic",
"valueCodeableConcept": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C4873"
}
]
}
},
{
"url": "http://hl7.org/fhir/StructureDefinition/artifact-author",
"valueContactDetail": {
"telecom": [
{
"system": "email",
"value": "thomas.debertshaeuser@charite.de"
}
]
}
},
{
"url": "http://hl7.org/fhir/StructureDefinition/artifact-editor",
"valueContactDetail": {
"name": "Taskforce Core Data Set"
}
},
{
"url": "http://hl7.org/fhir/StructureDefinition/artifact-reviewer",
"valueContactDetail": {
"name": "Interoperability Working Group",
"telecom": [
{
"system": "url",
"value": "https://www.medizininformatik-initiative.de/en/collaboration/interoperability-working-group"
}
]
}
},
{
"url": "http://hl7.org/fhir/StructureDefinition/artifact-reviewer",
"valueContactDetail": {
"name": "National Steering Committee",
"telecom": [
{
"system": "url",
"value": "https://www.medizininformatik-initiative.de/en/collaboration/national-steering-committee"
}
]
}
},
{
"url": "http://hl7.org/fhir/StructureDefinition/artifact-endorser",
"valueContactDetail": {
"name": "Interoperability Working Group",
"telecom": [
{
"system": "url",
"value": "https://www.medizininformatik-initiative.de/en/collaboration/interoperability-working-group"
}
]
}
},
{
"url": "http://hl7.org/fhir/StructureDefinition/artifact-endorser",
"valueContactDetail": {
"name": "National Steering Committee",
"telecom": [
{
"system": "url",
"value": "https://www.medizininformatik-initiative.de/en/collaboration/national-steering-committee"
}
]
}
}
],
"url": "https://www.medizininformatik-initiative.de/fhir/ext/modul-seltene/StructureDefinition/mii-pr-seltene-registerteilnahme",
"version": "2027.0.0-ballot",
"name": "MII_PR_Seltene_Registerteilnahme",
"title": "MII PR SE Registerteilnahme",
"status": "active",
"experimental": false,
"date": "2026-09-14T21:59:44+00:00",
"publisher": "Medizininformatik Initiative",
"_publisher": {
"extension": [
{
"extension": [
{
"url": "lang",
"valueCode": "de"
},
{
"url": "content",
"valueString": "Medizininformatik Initiative"
}
],
"url": "http://hl7.org/fhir/StructureDefinition/translation"
}
]
},
"contact": [
{
"name": "Medizininformatik Initiative",
"telecom": [
{
"system": "url",
"value": "https://www.medizininformatik-initiative.de/"
}
]
}
],
"description": "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": "urn:iso:std:iso:3166",
"code": "DE",
"display": "Germany"
}
]
}
],
"fhirVersion": "4.0.1",
"mapping": [
{
"identity": "SE-LogicalModel",
"uri": "https://www.medizininformatik-initiative.de/fhir/ext/modul-seltene/StructureDefinition/LogicalModel/Seltene",
"name": "Mapping FHIR zu Seltene Erkrankungen Logical Model"
},
{
"identity": "BRIDG5.1",
"uri": "https://bridgmodel.nci.nih.gov",
"name": "BRIDG 5.1 Mapping"
},
{
"identity": "v2",
"uri": "http://hl7.org/v2",
"name": "HL7 v2 Mapping"
},
{
"identity": "w5",
"uri": "http://hl7.org/fhir/fivews",
"name": "FiveWs Pattern Mapping"
}
],
"kind": "resource",
"abstract": false,
"type": "ResearchSubject",
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/ResearchSubject",
"derivation": "constraint",
"snapshot": {
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version",
"valueString": "4.0.1"
}
],
"element": [
{
"id": "ResearchSubject",
"path": "ResearchSubject",
"short": "Physical entity which is the primary unit of interest in the study",
"definition": "A physical entity which is the primary unit of operational and/or administrative interest in a study.",
"comment": "Need to make sure we encompass public health studies.",
"alias": [
"Study Subject"
],
"min": 0,
"max": "*",
"base": {
"path": "ResearchSubject",
"min": 0,
"max": "*"
},
"constraint": [
{
"key": "dom-2",
"severity": "error",
"human": "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
"expression": "contained.contained.empty()",
"xpath": "not(parent::f:contained and f:contained)",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key": "dom-3",
"severity": "error",
"human": "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": "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": "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": "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key": "dom-4",
"severity": "error",
"human": "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"expression": "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()",
"xpath": "not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key": "dom-5",
"severity": "error",
"human": "If a resource is contained in another resource, it SHALL NOT have a security label",
"expression": "contained.meta.security.empty()",
"xpath": "not(exists(f:contained/*/f:meta/f:security))",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice",
"valueBoolean": true
},
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation",
"valueMarkdown": "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."
}
],
"key": "dom-6",
"severity": "warning",
"human": "A resource should have narrative for robust management",
"expression": "text.`div`.exists()",
"xpath": "exists(f:text/h:div)",
"source": "http://hl7.org/fhir/StructureDefinition/DomainResource"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "Entity. Role, or Act"
},
{
"identity": "BRIDG5.1",
"map": "StudySubject"
},
{
"identity": "v2",
"map": "OBX"
},
{
"identity": "rim",
"map": "Observation[classCode=CLNTRL, moodCode=EVN]"
}
]
},
{
"id": "ResearchSubject.id",
"path": "ResearchSubject.id",
"short": "Logical id of this artifact",
"definition": "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"comment": "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": 0,
"max": "1",
"base": {
"path": "Resource.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "id"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "ResearchSubject.meta",
"path": "ResearchSubject.meta",
"short": "Metadata about the resource",
"definition": "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": 0,
"max": "1",
"base": {
"path": "Resource.meta",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Meta"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true
},
{
"id": "ResearchSubject.implicitRules",
"path": "ResearchSubject.implicitRules",
"short": "A set of rules under which this content was created",
"definition": "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": "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": 0,
"max": "1",
"base": {
"path": "Resource.implicitRules",
"min": 0,
"max": "1"
},
"type": [
{
"code": "uri"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": true,
"isModifierReason": "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": true
},
{
"id": "ResearchSubject.language",
"path": "ResearchSubject.language",
"short": "Language of the resource content",
"definition": "The base language in which the resource is written.",
"comment": "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": 0,
"max": "1",
"base": {
"path": "Resource.language",
"min": 0,
"max": "1"
},
"type": [
{
"code": "code"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet",
"valueCanonical": "http://hl7.org/fhir/ValueSet/all-languages"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "Language"
}
],
"strength": "preferred",
"description": "A human language.",
"valueSet": "http://hl7.org/fhir/ValueSet/languages|4.0.1"
}
},
{
"id": "ResearchSubject.text",
"path": "ResearchSubject.text",
"short": "Text summary of the resource, for human interpretation",
"definition": "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": "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": [
"narrative",
"html",
"xhtml",
"display"
],
"min": 0,
"max": "1",
"base": {
"path": "DomainResource.text",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Narrative"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "Act.text?"
}
]
},
{
"id": "ResearchSubject.contained",
"path": "ResearchSubject.contained",
"short": "Contained, inline Resources",
"definition": "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": "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": [
"inline resources",
"anonymous resources",
"contained resources"
],
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.contained",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Resource"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ResearchSubject.extension",
"path": "ResearchSubject.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"ordered": false,
"rules": "open"
},
"short": "Extension",
"definition": "An Extension",
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchSubject.extension:register",
"path": "ResearchSubject.extension",
"sliceName": "register",
"short": "Katalogeintrag des Registers als Library (optional)",
"definition": "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": "Optionaler Verweis auf den Library-Katalogeintrag nach mii-pr-studie-register. Der verbindliche Registerbezug läuft über study, weil R4 das so erzwingt.",
"min": 0,
"max": "1",
"base": {
"path": "DomainResource.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension",
"profile": [
"https://www.medizininformatik-initiative.de/fhir/ext/modul-seltene/StructureDefinition/mii-ex-seltene-register"
]
}
],
"condition": [
"ele-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false
},
{
"id": "ResearchSubject.modifierExtension",
"path": "ResearchSubject.modifierExtension",
"short": "Extensions that cannot be ignored",
"definition": "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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment": "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": "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": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "DomainResource.modifierExtension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier": true,
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "N/A"
}
]
},
{
"id": "ResearchSubject.identifier",
"path": "ResearchSubject.identifier",
"short": "Pseudonym der Person im Register",
"definition": "Identifiers assigned to this research subject for a study.",
"comment": "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": 0,
"max": "1",
"base": {
"path": "ResearchSubject.identifier",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Identifier"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "w5",
"map": "FiveWs.identifier"
},
{
"identity": "BRIDG5.1",
"map": "StudySubject > Subject.identifier"
},
{
"identity": "rim",
"map": ".identifier"
}
]
},
{
"id": "ResearchSubject.status",
"path": "ResearchSubject.status",
"short": "Status der Teilnahme",
"definition": "The current state of the subject.",
"min": 1,
"max": "1",
"base": {
"path": "ResearchSubject.status",
"min": 1,
"max": "1"
},
"type": [
{
"code": "code"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": true,
"isModifierReason": "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": true,
"binding": {
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString": "ResearchSubjectStatus"
}
],
"strength": "required",
"description": "Indicates the progression of a study subject through a study.",
"valueSet": "http://hl7.org/fhir/ValueSet/research-subject-status|4.0.1"
},
"mapping": [
{
"identity": "SE-LogicalModel",
"map": "registerteilnahme.teilnahmestatus",
"comment": "Teilnahmestatus"
},
{
"identity": "w5",
"map": "FiveWs.status"
},
{
"identity": "BRIDG5.1",
"map": "StudySubject.statusCode"
},
{
"identity": "rim",
"map": ".status"
}
]
},
{
"id": "ResearchSubject.period",
"path": "ResearchSubject.period",
"short": "Zeitraum der Registerteilnahme",
"definition": "The dates the subject began and ended their participation in the study.",
"comment": "Optional, aus demselben Grund wie identifier: das Einschlussdatum ist am dokumentierenden Standort nicht immer bekannt.",
"alias": [
"timing"
],
"min": 0,
"max": "1",
"base": {
"path": "ResearchSubject.period",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Period"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "SE-LogicalModel",
"map": "registerteilnahme.teilnahmezeitraum",
"comment": "Teilnahmezeitraum"
},
{
"identity": "w5",
"map": "FiveWs.planned"
},
{
"identity": "BRIDG5.1",
"map": "PerformedStudySubjectMilestone.studyReferenceDateRange"
}
]
},
{
"id": "ResearchSubject.period.id",
"path": "ResearchSubject.period.id",
"representation": [
"xmlAttr"
],
"short": "Unique id for inter-element referencing",
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min": 0,
"max": "1",
"base": {
"path": "Element.id",
"min": 0,
"max": "1"
},
"type": [
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl": "string"
}
],
"code": "http://hl7.org/fhirpath/System.String"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ResearchSubject.period.extension",
"path": "ResearchSubject.period.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"description": "Extensions are always sliced by (at least) url",
"rules": "open"
},
"short": "Additional content defined by implementations",
"definition": "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": "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": [
"extensions",
"user content"
],
"min": 0,
"max": "*",
"base": {
"path": "Element.extension",
"min": 0,
"max": "*"
},
"type": [
{
"code": "Extension"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key": "ext-1",
"severity": "error",
"human": "Must have either extensions or value[x], not both",
"expression": "extension.exists() != value.exists()",
"xpath": "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source": "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "rim",
"map": "n/a"
}
]
},
{
"id": "ResearchSubject.period.start",
"path": "ResearchSubject.period.start",
"short": "Starting time with inclusive boundary",
"definition": "The start of the period. The boundary is inclusive.",
"comment": "If the low element is missing, the meaning is that the low boundary is not known.",
"min": 0,
"max": "1",
"base": {
"path": "Period.start",
"min": 0,
"max": "1"
},
"type": [
{
"code": "dateTime"
}
],
"condition": [
"per-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "v2",
"map": "DR.1"
},
{
"identity": "rim",
"map": "./low"
}
]
},
{
"id": "ResearchSubject.period.end",
"path": "ResearchSubject.period.end",
"short": "End time with inclusive boundary, if not ongoing",
"definition": "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": "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": 0,
"max": "1",
"base": {
"path": "Period.end",
"min": 0,
"max": "1"
},
"type": [
{
"code": "dateTime"
}
],
"meaningWhenMissing": "If the end of the period is missing, it means that the period is ongoing",
"condition": [
"per-1"
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "v2",
"map": "DR.2"
},
{
"identity": "rim",
"map": "./high"
}
]
},
{
"id": "ResearchSubject.study",
"path": "ResearchSubject.study",
"short": "Das Register, als ResearchStudy geführt",
"definition": "Reference to the study the subject is participating in.",
"comment": "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": 1,
"max": "1",
"base": {
"path": "ResearchSubject.study",
"min": 1,
"max": "1"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/ResearchStudy|4.0.1"
]
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "SE-LogicalModel",
"map": "registerteilnahme.registerName",
"comment": "Register"
},
{
"identity": "BRIDG5.1",
"map": "StudySubjectProtocolVersionRelationship"
}
]
},
{
"id": "ResearchSubject.individual",
"path": "ResearchSubject.individual",
"short": "Who is part of study",
"definition": "The record of the person or animal who is involved in the study.",
"min": 1,
"max": "1",
"base": {
"path": "ResearchSubject.individual",
"min": 1,
"max": "1"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/Patient|4.0.1"
]
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": true,
"mapping": [
{
"identity": "BRIDG5.1",
"map": "StudySubject"
}
]
},
{
"id": "ResearchSubject.assignedArm",
"path": "ResearchSubject.assignedArm",
"short": "What path should be followed",
"definition": "The name of the arm in the study the subject is expected to follow as part of this study.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchSubject.assignedArm",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "BRIDG5.1",
"map": "Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject"
}
]
},
{
"id": "ResearchSubject.actualArm",
"path": "ResearchSubject.actualArm",
"short": "What path was followed",
"definition": "The name of the arm in the study the subject actually followed as part of this study.",
"min": 0,
"max": "1",
"base": {
"path": "ResearchSubject.actualArm",
"min": 0,
"max": "1"
},
"type": [
{
"code": "string"
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "BRIDG5.1",
"map": "Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject"
}
]
},
{
"id": "ResearchSubject.consent",
"path": "ResearchSubject.consent",
"short": "Nur zu setzen, wenn die Einwilligung am dokumentierenden Standort tatsaechlich als Ressource vorliegt",
"definition": "A record of the patient's informed agreement to participate in the study.",
"comment": "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": 0,
"max": "1",
"base": {
"path": "ResearchSubject.consent",
"min": 0,
"max": "1"
},
"type": [
{
"code": "Reference",
"targetProfile": [
"http://hl7.org/fhir/StructureDefinition/Consent|4.0.1"
]
}
],
"constraint": [
{
"key": "ele-1",
"severity": "error",
"human": "All FHIR elements must have a @value or children",
"expression": "hasValue() or (children().count() > id.count())",
"xpath": "@value|f:*|h:div",
"source": "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport": true,
"isModifier": false,
"isSummary": false,
"mapping": [
{
"identity": "BRIDG5.1",
"map": "ResearchStudy.consent is related to PerformedStudySubjectMilestone.informedConsentIndicator in that the informedConsentIndicator can be derived from the data in the Consent resource."
}
]
}
]
},
"differential": {
"element": [
{
"id": "ResearchSubject",
"path": "ResearchSubject"
},
{
"id": "ResearchSubject.extension",
"path": "ResearchSubject.extension",
"slicing": {
"discriminator": [
{
"type": "value",
"path": "url"
}
],
"ordered": false,
"rules": "open"
}
},
{
"id": "ResearchSubject.extension:register",
"path": "ResearchSubject.extension",
"sliceName": "register",
"short": "Katalogeintrag des Registers als Library (optional)",
"comment": "Optionaler Verweis auf den Library-Katalogeintrag nach mii-pr-studie-register. Der verbindliche Registerbezug läuft über study, weil R4 das so erzwingt.",
"min": 0,
"max": "1",
"type": [
{
"code": "Extension",
"profile": [
"https://www.medizininformatik-initiative.de/fhir/ext/modul-seltene/StructureDefinition/mii-ex-seltene-register"
]
}
],
"mustSupport": true
},
{
"id": "ResearchSubject.identifier",
"path": "ResearchSubject.identifier",
"short": "Pseudonym der Person im Register",
"comment": "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": "1",
"mustSupport": true
},
{
"id": "ResearchSubject.status",
"path": "ResearchSubject.status",
"short": "Status der Teilnahme",
"mustSupport": true,
"mapping": [
{
"identity": "SE-LogicalModel",
"map": "registerteilnahme.teilnahmestatus",
"comment": "Teilnahmestatus"
}
]
},
{
"id": "ResearchSubject.period",
"path": "ResearchSubject.period",
"short": "Zeitraum der Registerteilnahme",
"comment": "Optional, aus demselben Grund wie identifier: das Einschlussdatum ist am dokumentierenden Standort nicht immer bekannt.",
"mustSupport": true,
"mapping": [
{
"identity": "SE-LogicalModel",
"map": "registerteilnahme.teilnahmezeitraum",
"comment": "Teilnahmezeitraum"
}
]
},
{
"id": "ResearchSubject.period.start",
"path": "ResearchSubject.period.start",
"mustSupport": true
},
{
"id": "ResearchSubject.study",
"path": "ResearchSubject.study",
"short": "Das Register, als ResearchStudy geführt",
"comment": "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": true,
"mapping": [
{
"identity": "SE-LogicalModel",
"map": "registerteilnahme.registerName",
"comment": "Register"
}
]
},
{
"id": "ResearchSubject.individual",
"path": "ResearchSubject.individual",
"mustSupport": true
},
{
"id": "ResearchSubject.consent",
"path": "ResearchSubject.consent",
"short": "Nur zu setzen, wenn die Einwilligung am dokumentierenden Standort tatsaechlich als Ressource vorliegt",
"comment": "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": true
}
]
}
}