MII IG Kerndatensatz-Modul Seltene Erkrankungen
2027.0.0-ballot -
Germany
MII IG Kerndatensatz-Modul Seltene Erkrankungen
2027.0.0-ballot -
Germany
This page is part of the MII Implementation Guide Seltene Erkrankungen (v2027.0.0-ballot: 2027 Ballot 1) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version. For a full list of available versions, see the Directory of published versions
| Official URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-seltene/StructureDefinition/mii-pr-seltene-registerteilnahme | Version: 2027.0.0-ballot | |||
| Active as of 2026-09-14 | Computable Name: MII_PR_Seltene_Registerteilnahme | |||
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.
Usages:
You can also check for usages in the FHIR IG Statistics
Description of Profiles, Differentials, Snapshots, and their representations.
| Name | Flags | Card. | Type | Description & Constraints Filter:   |
|---|---|---|---|---|
  ResearchSubject |
0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |
  implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
  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 |
 modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored |
 identifier |
SΣ | 0..1 | Identifier | Pseudonym der Person im Register |
| status |
?!SΣ | 1..1 | code | Status der Teilnahme Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study. |
| period |
SΣ | 0..1 | Period | Zeitraum der Registerteilnahme |
 start |
SΣC | 0..1 | dateTime | Starting time with inclusive boundary |
 study |
SΣ | 1..1 | Reference(ResearchStudy) | Das Register, als ResearchStudy geführt |
| individual |
SΣ | 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 | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchSubject.status | Base | required | ResearchSubjectStatus | 📍4.0.1 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | ResearchSubject | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | ResearchSubject | 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 |
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()
|
| dom-4 | error | ResearchSubject | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated |
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
|
| dom-5 | error | ResearchSubject | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | ResearchSubject | A resource should have narrative for robust management |
text.`div`.exists()
|
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| 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 | ||||
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||
|---|---|---|---|---|---|---|---|---|
| ResearchSubject |
0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |||||
| contained |
0..* | Resource | Contained, inline Resources | |||||
| 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 | ||||
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
SΣ | 0..1 | Identifier | Pseudonym der Person im Register | ||||
| status |
?!SΣ | 1..1 | code | Status der Teilnahme Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study. | ||||
| period |
SΣ | 0..1 | Period | Zeitraum der Registerteilnahme | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| start |
SΣC | 0..1 | dateTime | Starting time with inclusive boundary | ||||
| end |
ΣC | 0..1 | dateTime | End time with inclusive boundary, if not ongoing | ||||
| study |
SΣ | 1..1 | Reference(ResearchStudy) | Das Register, als ResearchStudy geführt | ||||
| individual |
SΣ | 1..1 | Reference(Patient) | Who is part of study | ||||
| assignedArm |
0..1 | string | What path should be followed | |||||
| actualArm |
0..1 | string | What path was followed | |||||
| consent |
S | 0..1 | Reference(Consent) | Nur zu setzen, wenn die Einwilligung am dokumentierenden Standort tatsaechlich als Ressource vorliegt | ||||
| Documentation for this format | ||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchSubject.language | Base | preferred | Common Languages | 📍4.0.1 | FHIR Std. |
| ResearchSubject.status | Base | required | ResearchSubjectStatus | 📍4.0.1 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | ResearchSubject | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | ResearchSubject | 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 |
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()
|
| dom-4 | error | ResearchSubject | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated |
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
|
| dom-5 | error | ResearchSubject | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | ResearchSubject | A resource should have narrative for robust management |
text.`div`.exists()
|
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| ResearchSubject |
0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| 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 |
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored |
| identifier |
SΣ | 0..1 | Identifier | Pseudonym der Person im Register |
| status |
?!SΣ | 1..1 | code | Status der Teilnahme Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study. |
| period |
SΣ | 0..1 | Period | Zeitraum der Registerteilnahme |
| start |
SΣC | 0..1 | dateTime | Starting time with inclusive boundary |
| study |
SΣ | 1..1 | Reference(ResearchStudy) | Das Register, als ResearchStudy geführt |
| individual |
SΣ | 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 | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchSubject.status | Base | required | ResearchSubjectStatus | 📍4.0.1 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | ResearchSubject | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | ResearchSubject | 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 |
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()
|
| dom-4 | error | ResearchSubject | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated |
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
|
| dom-5 | error | ResearchSubject | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | ResearchSubject | A resource should have narrative for robust management |
text.`div`.exists()
|
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
Differential View
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| 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 | ||||
Snapshot ViewView
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||
|---|---|---|---|---|---|---|---|---|
| ResearchSubject |
0..* | ResearchSubject | Physical entity which is the primary unit of interest in the study | |||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |||||
| contained |
0..* | Resource | Contained, inline Resources | |||||
| 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 | ||||
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
SΣ | 0..1 | Identifier | Pseudonym der Person im Register | ||||
| status |
?!SΣ | 1..1 | code | Status der Teilnahme Binding: ResearchSubjectStatus (required): Indicates the progression of a study subject through a study. | ||||
| period |
SΣ | 0..1 | Period | Zeitraum der Registerteilnahme | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| start |
SΣC | 0..1 | dateTime | Starting time with inclusive boundary | ||||
| end |
ΣC | 0..1 | dateTime | End time with inclusive boundary, if not ongoing | ||||
| study |
SΣ | 1..1 | Reference(ResearchStudy) | Das Register, als ResearchStudy geführt | ||||
| individual |
SΣ | 1..1 | Reference(Patient) | Who is part of study | ||||
| assignedArm |
0..1 | string | What path should be followed | |||||
| actualArm |
0..1 | string | What path was followed | |||||
| consent |
S | 0..1 | Reference(Consent) | Nur zu setzen, wenn die Einwilligung am dokumentierenden Standort tatsaechlich als Ressource vorliegt | ||||
| Documentation for this format | ||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchSubject.language | Base | preferred | Common Languages | 📍4.0.1 | FHIR Std. |
| ResearchSubject.status | Base | required | ResearchSubjectStatus | 📍4.0.1 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | ResearchSubject | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | ResearchSubject | 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 |
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()
|
| dom-4 | error | ResearchSubject | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated |
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
|
| dom-5 | error | ResearchSubject | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | ResearchSubject | A resource should have narrative for robust management |
text.`div`.exists()
|
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
Other representations of profile: CSV, Excel, Schematron