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Packagede.einwilligungsmanagement
Resource TypeImplementationGuide
Ideinwilligungsmanagement.json
FHIR VersionR4

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Source1

{
  "resourceType": "ImplementationGuide",
  "id": "de.einwilligungsmanagement",
  "version": "2.0.4-rc1",
  "name": "De_einwilligungsmanagement",
  "status": "draft",
  "publisher": "martinbialke",
  "description": "Einwilligungsmanagement Release 2.0.4-rc1\r\n\r\nTechnical Correction, Details siehe Changelog im IG",
  "jurisdiction": [
    {
      "coding": [
        {
          "system": "urn:iso:std:iso:3166",
          "code": "DE"
        }
      ]
    }
  ],
  "packageId": "de.einwilligungsmanagement",
  "fhirVersion": [
    "4.0.1"
  ],
  "definition": {
    "resource": [
      {
        "reference": {
          "reference": "Questionnaire/eb4e03e7-06c6-428c-883e-f9fcdcb7b5c2"
        },
        "name": "Gewinnung, Lagerung und Nutzung von Biomaterial für die medizinische Forschung",
        "description": "Zweites Beispiel-Fragen-Modul aus der MI-Initiative"
      },
      {
        "reference": {
          "reference": "Patient/ac87974e-ce45-4440-bfbd-974c3c76d120"
        },
        "name": "Beispiel 2 pseudonymisierter Studien-Patient",
        "description": "An Example of a Patient"
      },
      {
        "reference": {
          "reference": "Patient/516e77a6-fcc8-453a-b314-4a0490cc6602"
        },
        "name": "Beispiel 1 pseudonymisierter Studien-Patient",
        "description": "An Example of a Patient"
      },
      {
        "reference": {
          "reference": "Patient/9b4a702d-162c-428a-8c5d-8b98af21b693"
        },
        "name": "9b4a702d-162c-428a-8c5d-8b98af21b693",
        "description": "An Example of a Patient"
      },
      {
        "reference": {
          "reference": "Patient/a8e49578-e40f-4a65-bdaa-a579801b37f3"
        },
        "name": "a8e49578-e40f-4a65-bdaa-a579801b37f3",
        "description": "An Example of a Patient"
      },
      {
        "reference": {
          "reference": "Questionnaire/b191dd03-bbb9-45da-ab5f-c811bc27e9a3"
        },
        "name": "Beispiel für einen Fragebogen zur Einwilligung",
        "description": "Beispiel-Fragen-Rahmen mit Auszügen aus dem Consent der MI-Initiative"
      },
      {
        "reference": {
          "reference": "CodeSystem/codesystem-consent-management-consent-mode"
        },
        "name": "ConsentMode",
        "description": "Arten des Standardverfahrens für Einwilligungen, soweit nicht reines Opt-In bzw. Opt-Out."
      },
      {
        "reference": {
          "reference": "CodeSystem/codesystem-consent-management-legal-basis-data-processing"
        },
        "name": "LegalBasisDataProcessing",
        "description": "Rechtsgrundlage der Datenverarbeitung. ANWENDUNGSHINWEIS: die hier als Code hinterlegten URIs sind Ergebnis einer ersten Recherche und sollten zukünftig korrigiert und erweitert werden, idealerweise bundesweit einheitlich durch eine entsprechend autorisierte Institution."
      },
      {
        "reference": {
          "reference": "CodeSystem/codesystem-consent-management-result-type"
        },
        "name": "ResultType",
        "description": "Ergebnistypen des Einwilligungsdokuments"
      },
      {
        "reference": {
          "reference": "CodeSystem/codesystem-consent-management-template-type"
        },
        "name": "TemplateType",
        "description": "Typen des Einwilligungsdokuments"
      },
      {
        "reference": {
          "reference": "StructureDefinition/profile-consent-management-consent"
        },
        "name": "Consent Management: Consent",
        "description": "Consent"
      },
      {
        "reference": {
          "reference": "StructureDefinition/f8a67156-cf41-48ef-8d0e-61d614cd662a"
        },
        "name": "Consent Management Consent Mode",
        "description": "Definiert für eine Domäne, ob als Standardverfahren für Einwilligungen Opt-In (\"deny\") oder Opt-Out (\"permit\") gilt."
      },
      {
        "reference": {
          "reference": "StructureDefinition/extension-consent-management-context-identifier"
        },
        "name": "Consent Management Kontext-Identifikatoren einer Domain",
        "description": "Definiert im Kontext einer Domain, welche Identifikatoren an welcher Ressourcen benötigt werden, um in der Policy Verwendung zu finden.\r\n\r\nExistieren mehrere Extensions im Kontext einer Domain, so werden diese UND-verknüpft.\r\nDie Elemente resourceType, type und system sind ebenfalls UND-verknüpft.\r\n\r\nDer FHIR-Ressourcentyp als Kontext muss immer angegeben werden.\r\nIdentifier-Typen (type) und -Namensräume (system) sind optional. Sind mehrere type- oder system-Elemente angegeben, so sind diese untereinander ODER-verknüpft.\r\nSind diese angegeben, so müssen die dem resourceType entsprechenden Ressourcen einen Identifier mit dem entsprechenden type und/oder system besitzen.\r\nBei logischen Referenzen (Reference by Identifier) gilt dies entsprechend."
      },
      {
        "reference": {
          "reference": "StructureDefinition/profile-consent-management-document-reference"
        },
        "name": "Consent Management DocumentReference",
        "description": "DocumentReference"
      },
      {
        "reference": {
          "reference": "StructureDefinition/profile-consent-management-domain-organization"
        },
        "name": "Consent Management Domain Organization",
        "description": "Gültigkeitsdomäne einer Einwiliigung (Organisation, Versorgungs-Kontext)"
      },
      {
        "reference": {
          "reference": "StructureDefinition/extension-consent-management-domain-reference"
        },
        "name": "Consent Management Domain Reference",
        "description": "Referenz zu einer Domain, in der ein Modul oder Template verwendet wird"
      },
      {
        "reference": {
          "reference": "StructureDefinition/profile-consent-management-domain-research-study"
        },
        "name": "Consent Management Domain Research Study",
        "description": "Gültigkeitsdomäne einer Einwiliigung (Studie, Forschungs-Kontext)"
      },
      {
        "reference": {
          "reference": "StructureDefinition/extension-consent-management-logo"
        },
        "name": "Consent Management Logo",
        "description": "Logo der Domain (Studie, Organisation)"
      },
      {
        "reference": {
          "reference": "StructureDefinition/extension-consent-management-organization-description"
        },
        "name": "Consent Management Organization Description",
        "description": "Beschreibung der Organisation im Sinn einer Zweckbeschreibung der Consent Domain"
      },
      {
        "reference": {
          "reference": "StructureDefinition/profile-consent-management-patient"
        },
        "name": "Consent Management: Patient",
        "description": "Patient"
      },
      {
        "reference": {
          "reference": "StructureDefinition/profile-consent-management-provenance"
        },
        "name": "Consent Management Provenance",
        "description": "Provenance"
      },
      {
        "reference": {
          "reference": "StructureDefinition/profile-consent-management-questionnaire-composed"
        },
        "name": "Consent Management Questionnaire Composed",
        "description": "Aus TemplateFrame und den dort referenzierten TemplateModules generiertes, vollständig renderbares Questionnaire zur Darstellung (Rendering) der Einwilligung."
      },
      {
        "reference": {
          "reference": "StructureDefinition/profile-consent-management-questionnaireresponse"
        },
        "name": "Consent Management QuestionnaireResponse",
        "description": "Der ausgefüllte Fragebogen zur Einwilligung."
      },
      {
        "reference": {
          "reference": "StructureDefinition/extension-consent-management-source-document"
        },
        "name": "Quelldokument des Questionnaires",
        "description": "Dokument, das die Quelle des Questionnaires darstellt"
      },
      {
        "reference": {
          "reference": "StructureDefinition/profile-consent-management-template-frame"
        },
        "name": "Consent Management Template Frame",
        "description": "Gesamtdefinition eines Questionnaires mit Verweis auf einzubindende Unter-Questionnaires sowie Freitext-Erfassung.\r\nWird i.d.R. im Kontext der Domäne definiert/erstellt."
      },
      {
        "reference": {
          "reference": "StructureDefinition/profile-consent-management-template-module"
        },
        "name": "Consent Management Template Module",
        "description": "Wiederverwendbares Modul innerhalb eines Gesamt-Questionnaires.\r\nWird i.d.R. im Kontext des Gesamtsystems erstellt/definiert und in einem oder mehreren Questionnaires verwendet/eingebunden (TemplateFrames)."
      },
      {
        "reference": {
          "reference": "StructureDefinition/extension-consent-management-version-format"
        },
        "name": "Consent Management Version Format",
        "description": "Versionierungsformat der Policies, Modules und Templates eiiner Consent Domain"
      },
      {
        "reference": {
          "reference": "StructureDefinition/extension-consent-management-xacml"
        },
        "name": "Consent Management Xacml",
        "description": "Enthält instantiierte XACML-Policy Rules / RuleSets"
      },
      {
        "reference": {
          "reference": "StructureDefinition/extension-consent-management-xacml-template"
        },
        "name": "Consent Management Xacml Template",
        "description": "Enthält Templates für die XACML-Policy Rules / RuleSets"
      },
      {
        "reference": {
          "reference": "Questionnaire/84c922da-e220-4a64-80dd-46839f6371a6"
        },
        "name": "Verarbeitung und Nutzung von Patientendaten für die medizinische Forschung",
        "description": "Beispiel-Fragen-Modul aus der MI-Initiative"
      },
      {
        "reference": {
          "reference": "SearchParameter/domain"
        },
        "name": "ConsentManagementSpDomain",
        "description": "Eindeutiger Name (Identifikator) der referenzierten Consent Domain"
      },
      {
        "reference": {
          "reference": "Consent/b1d3ed1a-597f-40dc-9270-9c5da9d4c631"
        },
        "name": "Beispiel ausgefüllter aktiver Consent (mit MII-codierten Provision)",
        "description": "The active consent"
      },
      {
        "reference": {
          "reference": "Consent/df4e3ba1-f5d0-4655-986f-7b5fbec95224"
        },
        "name": "Beispiel ausgefüllter aktiver Consent (Provisions mit Consent Action und Consent Content)",
        "description": "The active consent"
      },
      {
        "reference": {
          "reference": "Consent/a1480fd8-5a07-439e-9635-16e81b71447a"
        },
        "name": "Beispiel Consent vom Typ Einwilligungsstand",
        "description": "Consent vom Typ Enwilligungsstand"
      },
      {
        "reference": {
          "reference": "Consent/c6f32bcb-315d-4ce6-88d8-3c3ef5d5f379"
        },
        "name": "Beispiel Consent vom Typ Dokument (vollständiger Widerruf)",
        "description": "The active consent"
      },
      {
        "reference": {
          "reference": "Consent/43f993f6-012e-49fc-a7c0-97497ccbd33e"
        },
        "name": "Beispiel Consent vom Typ Dokument (Opt-Out-Einwilligung)",
        "description": "The active consent"
      },
      {
        "reference": {
          "reference": "Consent/9790aa00-2059-43dd-adfb-b30908c92b48"
        },
        "name": "Beispiel Consent vom Typ Modul",
        "description": "The active consent"
      },
      {
        "reference": {
          "reference": "Consent/d5346fc3-30a2-49ca-b2da-e254d220381d"
        },
        "name": "Beispiel Consent (Widerspruch)",
        "description": "The active consent"
      },
      {
        "reference": {
          "reference": "DocumentReference/237c359c-cb58-432c-a4a3-807bb28edfdb"
        },
        "name": "DocumentReference mit literaler Patientenreferenz",
        "description": "DocumentReferece mit literaler Patientenreferenz"
      },
      {
        "reference": {
          "reference": "DocumentReference/49242792-32c3-4e38-9467-57e7d4dce226"
        },
        "name": "DocumentReference mit logischer Patientenreferenz",
        "description": "DocumentReferece mit logischer Patientenreferenz"
      },
      {
        "reference": {
          "reference": "Provenance/4ac851a6-e0dd-4f9b-a19f-45ac0ae0bea0"
        },
        "name": "Beispiel für Provenance bezogen auf 1 Dokument (Scan) und 1..n Unterschriften",
        "description": "Beispiel einer Provenance"
      },
      {
        "reference": {
          "reference": "Provenance/30973b1c-3b82-4f9e-86f6-aae416b72506"
        },
        "name": "Provenance (Consent, mit mehreren Quell-QuestionnaireResponses)",
        "description": "An instance of Provenance"
      },
      {
        "reference": {
          "reference": "QuestionnaireResponse/02eac854-6a2e-48f9-88d7-edd04faff81c"
        },
        "name": "QuestionnaireResponse (Einwilligung Typ \"Opt-In\")",
        "description": "An instance of QuestionnaireResponse"
      },
      {
        "reference": {
          "reference": "QuestionnaireResponse/a81a2f14-e796-4c9e-9509-b862e6d3c181"
        },
        "name": "QuestionnaireResponse (Ablehnung)",
        "description": "An instance of QuestionnaireResponse"
      },
      {
        "reference": {
          "reference": "QuestionnaireResponse/377f4c53-4fc6-482c-aaf7-f784fc25233f"
        },
        "name": "QuestionnaireResponse (Einwiligung Typ \"Opt-Out\")",
        "description": "An instance of QuestionnaireResponse"
      },
      {
        "reference": {
          "reference": "QuestionnaireResponse/add43c05-d583-4507-b842-81190f5d56dd"
        },
        "name": "QuestionnaireResponse (Widerruf)",
        "description": "An instance of QuestionnaireResponse"
      },
      {
        "reference": {
          "reference": "QuestionnaireResponse/19022494-961c-4794-a17d-bf4d3ff23f27"
        },
        "name": "QuestionnaireResponse (Widerspruch)",
        "description": "An instance of QuestionnaireResponse"
      },
      {
        "reference": {
          "reference": "Organization/example-DomainOrganization"
        },
        "name": "Universitätsklinikum Musterstadt",
        "description": "An instance of Organization"
      },
      {
        "reference": {
          "reference": "ResearchStudy/2e634a72-ea64-4991-92c1-842ae14e31a8"
        },
        "name": "Beispiel Opt-Opt-Domäne",
        "description": "An instance of ResearchStudy"
      },
      {
        "reference": {
          "reference": "ResearchStudy/d7a65ce8-2810-401a-b0db-70782a7b19a6"
        },
        "name": "ResearchStudy",
        "description": "An instance of ResearchStudy"
      },
      {
        "reference": {
          "reference": "Questionnaire/fe4f5dc0-d0cb-4c7e-969e-82db76ad5cd9"
        },
        "name": "Beispiel für einen mittels Questionnaire-Renderern verarbeitbaren Fragebogen zur Einwilligung",
        "description": "Beispiel-Fragen-Rahmen mit Auszügen aus dem Consent der MI-Initiative"
      },
      {
        "reference": {
          "reference": "StructureDefinition/PhysicalDocumentLocation"
        },
        "name": "PhysicalDocumentLocation",
        "description": "Where the physical document is located on which this digital representation is based on. Typically a string value. For more complex use cases a Location resource may be used and referenced."
      },
      {
        "reference": {
          "reference": "StructureDefinition/Policy"
        },
        "name": "Policy",
        "description": "A policy on which the resource content is based on."
      },
      {
        "reference": {
          "reference": "CodeSystem/f45c2b51-0673-40ab-8f22-82be1f263ce3"
        },
        "name": "QuestionnaireComponents",
        "description": "Typen der Questionnaire-Profile zur Unterscheidung als Suchkriterium"
      },
      {
        "reference": {
          "reference": "Questionnaire/d7a65ce8-2810-401a-b0db-70782a7b19a6"
        },
        "name": "Beispiel TemplateModul PatDatErhebenSpeichernNutzen",
        "description": "Beispiel TemplateModul PatDatErhebenSpeichernNutzen"
      },
      {
        "reference": {
          "reference": "ResearchStudy/d7a65ce8-2810-401a-b0db-70782a7b19a6"
        },
        "name": "Beispiel Einwilligungsdomäne vom Typ ResearchStudy",
        "description": "An Example of a ResearchStudy"
      },
      {
        "reference": {
          "reference": "StructureDefinition/SignatureLocation"
        },
        "name": "SignatureLocation",
        "description": "Where the signature took place"
      },
      {
        "reference": {
          "reference": "StructureDefinition/extension-consent-management-sub-questionnaire"
        },
        "name": "Consent Management Sub-Questionnaire",
        "description": "Extension"
      },
      {
        "reference": {
          "reference": "ValueSet/valueset-consent-management-consent-mode"
        },
        "name": "ConsentManagementConsentMode",
        "description": "An instance of ValueSet"
      },
      {
        "reference": {
          "reference": "ValueSet/valueset-consent-management-context-identifier-type"
        },
        "name": "ConsentManagementContextIdentifierType",
        "description": "An instance of ValueSet"
      },
      {
        "reference": {
          "reference": "ValueSet/valueset-consent-management-legal-basis-data-processing"
        },
        "name": "ConsentManagementLegalBasisDataProcessing",
        "description": "An instance of ValueSet"
      },
      {
        "reference": {
          "reference": "CodeSystem/valueset-consent-management-questionnaire-components"
        },
        "name": "QuestionnaireProfileType",
        "description": "Typen der Questionnaire-Profile zur Unterscheidung als Suchkriterium"
      },
      {
        "reference": {
          "reference": "ValueSet/valueset-consent-management-questionnaire-components"
        },
        "name": "ConsentManagementQuestionnaireComponents",
        "description": "An instance of ValueSet"
      },
      {
        "reference": {
          "reference": "ValueSet/valueset-consent-management-result-type"
        },
        "name": "ConsentManagementResultType",
        "description": "An instance of ValueSet"
      },
      {
        "reference": {
          "reference": "ValueSet/valueset-consent-management-template-type"
        },
        "name": "ConsentManagementTemplateType",
        "description": "An instance of ValueSet"
      }
    ],
    "page": {
      "nameUrl": "IGEinwilligungsmanagement.md",
      "title": "IG Einwilligungsmanagement",
      "generation": "markdown",
      "page": [
        {
          "nameUrl": "GlossarundDatenmodell.md",
          "title": "Glossar und Datenmodell",
          "generation": "markdown"
        },
        {
          "nameUrl": "Profiles.md",
          "title": "Profiles",
          "generation": "markdown",
          "page": [
            {
              "nameUrl": "Mitgeltende-Erl-uterungen.md",
              "title": "Mitgeltende Erläuterungen",
              "generation": "markdown"
            },
            {
              "nameUrl": "Consent.md",
              "title": "Consent",
              "generation": "markdown"
            },
            {
              "nameUrl": "DocumentReference.md",
              "title": "DocumentReference",
              "generation": "markdown"
            },
            {
              "nameUrl": "Organization.md",
              "title": "Organization",
              "generation": "markdown"
            },
            {
              "nameUrl": "Patient.md",
              "title": "Patient",
              "generation": "markdown"
            },
            {
              "nameUrl": "Provenance.md",
              "title": "Provenance",
              "generation": "markdown"
            },
            {
              "nameUrl": "QuestionnaireComposed.md",
              "title": "QuestionnaireComposed",
              "generation": "markdown"
            },
            {
              "nameUrl": "QuestionnaireResponse.md",
              "title": "QuestionnaireResponse",
              "generation": "markdown"
            },
            {
              "nameUrl": "ResearchStudy.md",
              "title": "ResearchStudy",
              "generation": "markdown"
            },
            {
              "nameUrl": "TemplateFrame.md",
              "title": "TemplateFrame",
              "generation": "markdown"
            },
            {
              "nameUrl": "TemplateModule.md",
              "title": "TemplateModule",
              "generation": "markdown"
            }
          ]
        },
        {
          "nameUrl": "Extensions.md",
          "title": "Extensions",
          "generation": "markdown",
          "page": [
            {
              "nameUrl": "ContextIdentifier.md",
              "title": "ContextIdentifier",
              "generation": "markdown"
            },
            {
              "nameUrl": "Logo.md",
              "title": "Logo",
              "generation": "markdown"
            },
            {
              "nameUrl": "OrganizationDescription.md",
              "title": "OrganizationDescription",
              "generation": "markdown"
            },
            {
              "nameUrl": "SubQuestionnaire-duplicate-2.md",
              "title": "SubQuestionnaire",
              "generation": "markdown"
            },
            {
              "nameUrl": "VersionFormat.md",
              "title": "VersionFormat",
              "generation": "markdown"
            },
            {
              "nameUrl": "Xacml.md",
              "title": "Xacml",
              "generation": "markdown"
            },
            {
              "nameUrl": "XacmlTemplate.md",
              "title": "XacmlTemplate",
              "generation": "markdown"
            },
            {
              "nameUrl": "SourceDocument.md",
              "title": "SourceDocument",
              "generation": "markdown"
            },
            {
              "nameUrl": "DomainReference.md",
              "title": "DomainReference",
              "generation": "markdown"
            },
            {
              "nameUrl": "ConsentMode.md",
              "title": "ConsentMode",
              "generation": "markdown"
            },
            {
              "nameUrl": "SignatureLocation.md",
              "title": "SignatureLocation",
              "generation": "markdown"
            }
          ]
        },
        {
          "nameUrl": "ValueSets.md",
          "title": "ValueSets",
          "generation": "markdown",
          "page": [
            {
              "nameUrl": "ConsentMode-duplicate-3.md",
              "title": "ConsentMode",
              "generation": "markdown"
            },
            {
              "nameUrl": "ContextIdentifierType.md",
              "title": "ContextIdentifierType",
              "generation": "markdown"
            },
            {
              "nameUrl": "TemplateType.md",
              "title": "TemplateType",
              "generation": "markdown"
            },
            {
              "nameUrl": "ResultType-duplicate-2.md",
              "title": "ResultType",
              "generation": "markdown"
            },
            {
              "nameUrl": "QuestionnaireComponents.md",
              "title": "QuestionnaireComponents",
              "generation": "markdown"
            }
          ]
        },
        {
          "nameUrl": "CodeSystems.md",
          "title": "CodeSystems",
          "generation": "markdown",
          "page": [
            {
              "nameUrl": "ConsentMode-duplicate-2.md",
              "title": "ConsentMode",
              "generation": "markdown"
            },
            {
              "nameUrl": "TemplateType-duplicate-2.md",
              "title": "TemplateType",
              "generation": "markdown"
            },
            {
              "nameUrl": "ResultType.md",
              "title": "ResultType",
              "generation": "markdown"
            },
            {
              "nameUrl": "QuestionnaireComponents-duplicate-2.md",
              "title": "QuestionnaireComponents",
              "generation": "markdown"
            }
          ]
        },
        {
          "nameUrl": "UseCases.md",
          "title": "Use Cases",
          "generation": "markdown"
        }
      ]
    }
  },
  "manifest": {}
}