Dieses Profil beschreibt eine operationalisierte, automatisch erzeugte und prozessierbare Einwilligung in der Medizininformatik-Initiative.

Beim Einschluss einer Person in eine Studie (auch in einen MII-Use Case) wird eine Einwilligung für diese Person auf Basis der MII Broad Consent Mustertexte erhoben und entsprechende Einwilligungsdokument am jeweiligen Standort strukturiert dokumentiert gemäß den Vorgaben der MII Task Force Consent Umsetzung.

Auf Grundlage dieser Einwilligungsdokumente wird die FHIR Consent Ressource automatisiert erzeugt. Der Projektkontext bleibt erhalten.

Die Erstellung der Ressource muss vor der Teilnahme an Standort-übergreifenden Feasability-Anfragen und Datenherausgaben erfolgen. Weitere Pflichten und Anpassungen sind für jeden Use Case zu prüfen.

Die Datenschutz-Aspekte dieses Profils beschreibt die Seite Sicherheit und Datenschutz; die Suchparameter beschreibt die Seite Suchparameter.

Interoperabilität

Um die Austauschbarkeit der operationalisierten Einwilligungsinhalte auch über FHIR hinaus sicherzustellen, wurde mit der MII AG Consent ein einheitliches PolicyValueSet zur semantischen Abbildung der im MII Broad Consent enthaltenen Aussagen im Dezember 2021 abgestimmt und im ART-DECOR (Policy-OIDs) dokumentiert.

Die Verwendung dieses Codesystems ist bezogen auf das KDS-Modul Consent verpflichtend.

Grundsätzliche Verwendung des Profils FHIR Consent

Nachfolgend werden nur die Unterschiede zum Basis-Profil erläutert.

Die obenstehende Tabelle beschreibt den Stand des Release 2026.0.0. Mit der Inkorporation des develop-Standes (744f7ba, 2026-08-21) gelten drei Änderungen: (1) das Profil leitet jetzt vom HL7-D-Profil ConsentManagement/Consent ab; (2) die Category-Slices heißen consentCategory (LOINC 57016-8), mii (Version-Modules-CodeSystem), resultType (required) und templateType (extensible); (3) die Beispiele verwenden für die MII-Kategorie das CodeSystem mii-cs-consent-version-modules. Die Zeilen zu Consent.category ("mindestens zwei Categories") sind entsprechend überholt.

Eindeutige Identifikation des MII-Broad Consent

Um FHIR-Consent Ressourcen nach Einwilligungen zu filtern, die auf dem MII Broad Consent basieren, wird ein verpflichtendes Uri für die Consent.policy.uri verwendet. Die TFCU hat im ART-DECOR Repräsentationen für die unterschiedlichen Versionen des MII Broad Consent angelegt. Diese können über eine eindeutige OID (vgl. nachstehende Tabelle) referenziert werden.

Verschachtelte Provision-Elemente

Die FHIR Consent Ressource folgt der DSGVO-Vorgabe zum Opt-In: es ist nur erlaubt, was explizit zu einem bestimmten Zeitpunkt (Zeitpunkt der Einwilligung) eingewilligt wurde. Dies wird über verschachtelte Provision-Elemente realisiert.

In Opt-In-Szenarien verbietet das übergeordnete Provision-Element (->Level1-Provision) alles (Provision.Type=DENY), außer es ist in Form von untergeordneten Provision-Elementen (->Level2-Provision) explizit erlaubt. Daher sind als untergeordnete Provisions Provision-Elemente mit Provision.Type=PERMIT verbindlich zu verwenden. Für Zusatzinformationen sind Level-2-Provision mit Provision.Type=DENY möglich.

Die grundsätzliche Gültigkeitsdauer der Einwilligung wird ebenfalls über das übergeordnetete Provision-Element mittels provision.period realisiert (für den MII Broad Consent: 30 Jahre).

Sollten einzelne Bestandteile der Einwilligung jedoch bereits frühzeitig ablaufen, können diese Ausnahmen als Teil der untergeordneter Provisions mit Bezug zum relevanten Einwilligungsbestandteil mittels provision.provision.period definiert werden (z.B. Provision mit Code 2.16.840.1.113883.3.1937.777.24.5.3.6 für Policy MDAT\_erheben läuft bereits nach 5 Jahren ab).

Übergeordnete Provision (Consent.Provision)

Untergeordnete Provision-Elemente (Consent.Provision.Provision)

Je Consent-Policy sollte exakt ein untergeordnetes Provision-Element genutzt werden.

Ende der Einwilligung und Consent-Ressourcen im Kontext von Widerruf, Ablehnung oder Widerspruch

Die Einwilligung des Patienten endet nach Vorgaben der MII AG Consent grundsätzlich nach 30 Jahren. Einen Sonderfall stellen die Einwilligungen von Minderjährigen (von der Einwilligung betroffene Person) dar. Im Fall von Einwilligungen für Minderjährige, die ggf. durch entsprechende Sorgeberechtigte stellvertretend ausgefüllt wurden, endet die Einwilligung mit Erreichung der Volljährigkeit der betroffenen Person. Dies ist entsprechend technisch umzusetzen. Referenzimplementierungen existieren.

Die Widerrufsvorlage (kompatibel mit MII BC 1.7.2) ist ebenfalls für den Widerruf von Einwilligungen Minderjähriger gedacht, da diese in der Regel ebenfalls durch die Sorgeberechtigten ausgefüllt werden.

Bezogen auf Consent-Ressourcen, die im Zusammenhang mit Widerrufen (vollständig, oder teilweise), Ablehnungen oder Widersprüchen erstellt wurden, gelten im Allgemeinen die Empfehlungen der HL7-D AG Einwilligungsmanagement (vgl. Abschnitt 'Angepasste Empfehlungen zur Verwendung von Consent und Consent-Provisions nach Dokumentenart und Szenario'):

Level-2 Provisions sollten insofern nach Möglichkeit stets angegeben werden. Hat ein Dokument konzeptuell kein definiertes Ende (beispielsweise Widerruf, Ablehnung, Widerspruch) kann auf die Angabe von period.end bei Provisions entsprechend verzichtet werden.

• Schlüsselelemente-Tabelle
• Differential-Tabelle
• Snapshot-Tabelle
• Statistiken/Referenzen
• Alle

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Consent	C	0..*	ConsentManagementConsent	A healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time Constraints: ppc-1, ppc-2, ppc-3, ppc-4, ppc-5
id	SΣ	0..1	id	Logical id of this artifact
meta	SΣ	0..1	Meta	Metadata about the resource
source	SΣ	0..1	uri	Identifies where the resource comes from
profile	SΣ	0..*	canonical(StructureDefinition)	Profiles this resource claims to conform to
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
Slices for extension				Content/Rules for all slices
extension:domainReference	S	0..*	(Complex)	Optional Extensions Element URL: http://fhir.de/ConsentManagement/StructureDefinition/DomainReference
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
Slices for extension				Content/Rules for all slices
extension:domain	S	1..1	Extension	Extension
url		1..1	uri	"domain"
value[x]		1..1	Reference(Consent Management Domain Organization | Consent Management Domain Research Study)	Value of extension
extension:status	N	0..1	Extension	Extension
url		1..1	uri	"status"
value[x]	N	1..1	Coding	Value of extension Binding: PublicationStatus (required)
system	ΣN	1..1	uri	Identity of the terminology system
code	ΣN	1..1	code	Symbol in syntax defined by the system
url		1..1	uri	"http://fhir.de/ConsentManagement/StructureDefinition/DomainReference"
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
status	?!SΣN	1..1	code	draft | proposed | active | rejected | inactive | entered-in-error Binding: ConsentState (required): Indicates the state of the consent.
scope	?!Σ	1..1	CodeableConcept	Which of the four areas this resource covers (extensible) Binding: ConsentScopeCodes (extensible): The four anticipated uses for the Consent Resource.
coding	Σ	1..1	Coding	Code defined by a terminology system
system	Σ	1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/consentscope
code	Σ	1..1	code	Symbol in syntax defined by the system Fixed Value: research
Slices for category	SΣ	2..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Slice: Unordered, Open by pattern:$this Binding: ConsentCategoryCodes (extensible): A classification of the type of consents found in a consent statement.
category:consentCategory	SΣ	1..1	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentCategoryCodes (extensible): A classification of the type of consents found in a consent statement. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
text		0..1	string	Plain text representation of the concept
coding	SΣ	1..1	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
version		0..1	string	Version of the system - if relevant
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
system	SΣ	1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
code	SΣ	1..1	code	Symbol in syntax defined by the system Fixed Value: 57016-8
category:mii	SΣ	1..1	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentCategoryCodes (extensible): A classification of the type of consents found in a consent statement. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
text		0..1	string	Plain text representation of the concept
coding	SΣ	1..1	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
version		0..1	string	Version of the system - if relevant
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
system	SΣ	1..1	uri	Identity of the terminology system Fixed Value: https://www.medizininformatik-initiative.de/fhir/modul-consent/CodeSystem/mii-cs-consent-version-modules
code	SΣ	1..1	code	Symbol in syntax defined by the system Fixed Value: 2.16.840.1.113883.3.1937.777.24.2.184
category:resultType	SΣ	0..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentManagementResultType (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
text		0..1	string	Plain text representation of the concept
coding	SΣ	1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
version		0..1	string	Version of the system - if relevant
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
system	SΣ	1..1	uri	Identity of the terminology system Fixed Value: http://fhir.de/ConsentManagement/CodeSystem/ResultType
code	SΣ	1..1	code	Symbol in syntax defined by the system
category:templateType	SΣ	0..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentManagementTemplateType (extensible) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
text		0..1	string	Plain text representation of the concept
coding	SΣ	1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
version		0..1	string	Version of the system - if relevant
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
system	SΣ	1..1	uri	Identity of the terminology system Fixed Value: http://fhir.de/ConsentManagement/CodeSystem/TemplateType
code	SΣ	1..1	code	Symbol in syntax defined by the system
patient	SΣ	1..1	Reference(Consent Management: Patient)	Who the consent applies to
reference	SΣCN	0..1	string	Literal reference, Relative, internal or absolute URL
identifier	SΣ	0..1	Identifier	Logical reference, when literal reference is not known
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	SΣ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	SΣ	1..1	string	The value that is unique Example General: 123456
dateTime	SΣN	1..1	dateTime	Erstellungszeitpunkt der Einwilligung
organization	SΣ	0..*	Reference(Organization)	Organisation, in der die Einwilligung erfasst wurde.
source[x]	SΣ	0..1	Reference(Consent Management QuestionnaireResponse)	Source from which this consent is taken
reference	SΣCN	1..1	string	Literal reference, Relative, internal or absolute URL
policy	S	1..*	BackboneElement	Policies covered by this consent
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
uri	SCN	1..1	uri	Specific policy covered by this consent Binding: ConsentManagementLegalBasisDataProcessing (extensible)
policyRule	SΣC	0..1	CodeableConcept	Regulation that this consents to Binding: ConsentPolicyRuleCodes (extensible): Regulatory policy examples.
Slices for extension				Content/Rules for all slices
extension:xacml	S	0..1	base64Binary	Optional Extensions Element URL: http://fhir.de/ConsentManagement/StructureDefinition/Xacml
provision	SΣ	0..1	BackboneElement	Constraints to the base Consent.policyRule
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	code	deny | permit Binding: ConsentProvisionType (required): How a rule statement is applied, such as adding additional consent or removing consent.
period	SΣ	1..1	Period	Timeframe for this rule
start	SΣC	1..1	dateTime	Starting time with inclusive boundary
end	SΣC	0..1	dateTime	End time with inclusive boundary, if not ongoing
provision	S	0..*	BackboneElement	Nested Exception Rules
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	code	deny | permit Binding: ConsentProvisionType (required): How a rule statement is applied, such as adding additional consent or removing consent.
period	SΣ	1..1	Period	Timeframe for this rule
start	SΣC	1..1	dateTime	Starting time with inclusive boundary
end	SΣC	0..1	dateTime	End time with inclusive boundary, if not ongoing
code	SΣ	1..*	CodeableConcept	e.g. LOINC or SNOMED CT code, etc. in the content Binding: MII Consent: Policy ValueSet (required)
coding	SΣ	1..*	Coding	Code defined by a terminology system
system	SΣ	1..1	uri	Identity of the terminology system
code	SΣ	1..1	code	Symbol in syntax defined by the system
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Consent.extension:domainReference.​extension:status.value[x]	Base	required	PublicationStatus	📦4.0.1	FHIR Std.
Consent.status	Base	required	ConsentState	📍4.0.1	FHIR Std.
Consent.scope	Base	extensible	Consent Scope Codes	📍4.0.1	FHIR Std.
Consent.category	Base	extensible	Consent Category Codes	📍4.0.1	FHIR Std.
Consent.category:consentCategory	Base	extensible	Consent Category Codes	📍4.0.1	FHIR Std.
Consent.category:mii	Base	extensible	Consent Category Codes	📍4.0.1	FHIR Std.
Consent.category:resultType	Base	required	ConsentManagementResultType	📦2.0.4	de.einwilligungsmanagement v2.0
Consent.category:templateType	Base	extensible	ConsentManagementTemplateType	📦2.0.4	de.einwilligungsmanagement v2.0
Consent.patient.identifier.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
Consent.policy.uri	Base	extensible	ConsentManagementLegalBasisDataProcessing	📦2.0.4	de.einwilligungsmanagement v2.0
Consent.policyRule	Base	extensible	Consent PolicyRule Codes	📍4.0.1	FHIR Std.
Consent.provision.type	Base	required	ConsentProvisionType	📍4.0.1	FHIR Std.
Consent.provision.provision.​type	Base	required	ConsentProvisionType	📍4.0.1	FHIR Std.
Consent.provision.provision.​code	Base	required	MII Consent: Policy ValueSet	📦2027.0.0-ballot	This IG

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	Consent	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	Consent	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	Consent	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	Consent	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	Consent	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()
ppc-1	error	Consent	Either a Policy or PolicyRule	policy.exists() or policyRule.exists()
ppc-2	error	Consent	IF Scope=privacy, there must be a patient	patient.exists() or scope.coding.where(system='something' and code='patient-privacy').exists().not()
ppc-3	error	Consent	IF Scope=research, there must be a patient	patient.exists() or scope.coding.where(system='something' and code='research').exists().not()
ppc-4	error	Consent	IF Scope=adr, there must be a patient	patient.exists() or scope.coding.where(system='something' and code='adr').exists().not()
ppc-5	error	Consent	IF Scope=treatment, there must be a patient	patient.exists() or scope.coding.where(system='something' and code='treatment').exists().not()

Diese Struktur ist abgeleitet von ConsentManagementConsent

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Consent		0..*	ConsentManagementConsent	A healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time
id	S	0..1	id	Logical id of this artifact
meta	S	0..1	Meta	Metadata about the resource
source	S	0..1	uri	Identifies where the resource comes from
profile	S	0..*	canonical(StructureDefinition)	Profiles this resource claims to conform to
status	N	1..1	code	draft | proposed | active | rejected | inactive | entered-in-error
scope
coding		1..1	Coding	Code defined by a terminology system
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/consentscope
code		1..1	code	Symbol in syntax defined by the system Fixed Value: research
Slices for category		2..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Slice: Unordered, Open by pattern:$this
category:consentCategory	S	1..1	CodeableConcept	Classification of the consent statement - for indexing/retrieval Required Pattern: At least the following
coding	S	1..1	Coding	Code defined by a terminology system Fixed Value: (Complex)
system	S	1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
code	S	1..1	code	Symbol in syntax defined by the system Fixed Value: 57016-8
category:mii	S	1..1	CodeableConcept	Classification of the consent statement - for indexing/retrieval Required Pattern: At least the following
coding	S	1..1	Coding	Code defined by a terminology system Fixed Value: (Complex)
system	S	1..1	uri	Identity of the terminology system Fixed Value: https://www.medizininformatik-initiative.de/fhir/modul-consent/CodeSystem/mii-cs-consent-version-modules
code	S	1..1	code	Symbol in syntax defined by the system Fixed Value: 2.16.840.1.113883.3.1937.777.24.2.184
category:resultType	S	0..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentManagementResultType (required) Required Pattern: At least the following
coding	S	1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
system	S	1..1	uri	Identity of the terminology system Fixed Value: http://fhir.de/ConsentManagement/CodeSystem/ResultType
code	S	1..1	code	Symbol in syntax defined by the system
category:templateType	S	0..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentManagementTemplateType (extensible) Required Pattern: At least the following
coding	S	1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
system	S	1..1	uri	Identity of the terminology system Fixed Value: http://fhir.de/ConsentManagement/CodeSystem/TemplateType
code	S	1..1	code	Symbol in syntax defined by the system
patient
reference	SN	0..1	string	Literal reference, Relative, internal or absolute URL
identifier	S	0..1	Identifier	Logical reference, when literal reference is not known
system	S	1..1	uri	The namespace for the identifier value
value	S	1..1	string	The value that is unique
dateTime	N	1..1	dateTime	Erstellungszeitpunkt der Einwilligung
source[x]
reference	N	1..1	string	Literal reference, Relative, internal or absolute URL
policy		1..*	BackboneElement	Policies covered by this consent
uri	N	1..1	uri	Specific policy covered by this consent
provision
type	S	1..1	code	deny | permit
period		1..1	Period	Timeframe for this rule
start	S	1..1	dateTime	Starting time with inclusive boundary
end	S	0..1	dateTime	End time with inclusive boundary, if not ongoing
action		0..0		Actions controlled by this rule
code		0..0		e.g. LOINC or SNOMED CT code, etc. in the content
provision	S	0..*	BackboneElement	Nested Exception Rules
type	S	1..1	code	deny | permit
period	S	1..1	Period	Timeframe for this rule
start	S	1..1	dateTime	Starting time with inclusive boundary
end	S	0..1	dateTime	End time with inclusive boundary, if not ongoing
action		0..0		Actions controlled by this rule
code	S	1..*	CodeableConcept	e.g. LOINC or SNOMED CT code, etc. in the content Binding: MII Consent: Policy ValueSet (required)
coding	S	1..*	Coding	Code defined by a terminology system
system	S	1..1	uri	Identity of the terminology system
code	S	1..1	code	Symbol in syntax defined by the system
provision		0..0		Nested Exception Rules
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Consent.category:resultType	Base	required	ConsentManagementResultType	📦2.0.4	de.einwilligungsmanagement v2.0
Consent.category:templateType	Base	extensible	ConsentManagementTemplateType	📦2.0.4	de.einwilligungsmanagement v2.0
Consent.provision.provision.​code	Base	required	MII Consent: Policy ValueSet	📦2027.0.0-ballot	This IG

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Consent	C	0..*	ConsentManagementConsent	A healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time Constraints: ppc-1, ppc-2, ppc-3, ppc-4, ppc-5
id	SΣ	0..1	id	Logical id of this artifact
meta	SΣ	0..1	Meta	Metadata about the resource
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
versionId	Σ	0..1	id	Version specific identifier
lastUpdated	Σ	0..1	instant	When the resource version last changed
source	SΣ	0..1	uri	Identifies where the resource comes from
profile	SΣ	0..*	canonical(StructureDefinition)	Profiles this resource claims to conform to
security	Σ	0..*	Coding	Security Labels applied to this resource Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
tag	Σ	0..*	Coding	Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
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. Additional Bindings Purpose AllLanguages Max Binding
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:domainReference	S	0..*	(Complex)	Optional Extensions Element URL: http://fhir.de/ConsentManagement/StructureDefinition/DomainReference
id		0..1	string	Unique id for inter-element referencing
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
Slices for extension				Content/Rules for all slices
extension:domain	S	1..1	Extension	Extension
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
url		1..1	uri	"domain"
value[x]		1..1	Reference(Consent Management Domain Organization | Consent Management Domain Research Study)	Value of extension
extension:status	N	0..1	Extension	Extension
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
url		1..1	uri	"status"
value[x]	N	1..1	Coding	Value of extension Binding: PublicationStatus (required)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	ΣN	1..1	uri	Identity of the terminology system
version	Σ	0..1	string	Version of the system - if relevant
code	ΣN	1..1	code	Symbol in syntax defined by the system
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
url		1..1	uri	"http://fhir.de/ConsentManagement/StructureDefinition/DomainReference"
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Identifier for this record (external references) Example General: {"system":"http://acme.org/identifier/local/eCMS","value":"Local eCMS identifier"}
status	?!SΣN	1..1	code	draft | proposed | active | rejected | inactive | entered-in-error Binding: ConsentState (required): Indicates the state of the consent.
scope	?!Σ	1..1	CodeableConcept	Which of the four areas this resource covers (extensible) Binding: ConsentScopeCodes (extensible): The four anticipated uses for the Consent Resource.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	1..1	Coding	Code defined by a terminology system
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/consentscope
version	Σ	0..1	string	Version of the system - if relevant
code	Σ	1..1	code	Symbol in syntax defined by the system Fixed Value: research
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
Slices for category	SΣ	2..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Slice: Unordered, Open by pattern:$this Binding: ConsentCategoryCodes (extensible): A classification of the type of consents found in a consent statement.
category:consentCategory	SΣ	1..1	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentCategoryCodes (extensible): A classification of the type of consents found in a consent statement. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..1	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	SΣ	1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
version	Σ	0..1	string	Version of the system - if relevant
code	SΣ	1..1	code	Symbol in syntax defined by the system Fixed Value: 57016-8
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
category:mii	SΣ	1..1	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentCategoryCodes (extensible): A classification of the type of consents found in a consent statement. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..1	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	SΣ	1..1	uri	Identity of the terminology system Fixed Value: https://www.medizininformatik-initiative.de/fhir/modul-consent/CodeSystem/mii-cs-consent-version-modules
version	Σ	0..1	string	Version of the system - if relevant
code	SΣ	1..1	code	Symbol in syntax defined by the system Fixed Value: 2.16.840.1.113883.3.1937.777.24.2.184
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
category:resultType	SΣ	0..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentManagementResultType (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	SΣ	1..1	uri	Identity of the terminology system Fixed Value: http://fhir.de/ConsentManagement/CodeSystem/ResultType
version	Σ	0..1	string	Version of the system - if relevant
code	SΣ	1..1	code	Symbol in syntax defined by the system
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
category:templateType	SΣ	0..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentManagementTemplateType (extensible) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	SΣ	1..1	uri	Identity of the terminology system Fixed Value: http://fhir.de/ConsentManagement/CodeSystem/TemplateType
version	Σ	0..1	string	Version of the system - if relevant
code	SΣ	1..1	code	Symbol in syntax defined by the system
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
patient	SΣ	1..1	Reference(Consent Management: Patient)	Who the consent applies to
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	SΣCN	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	SΣ	0..1	Identifier	Logical reference, when literal reference is not known
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	SΣ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	SΣ	1..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
display	Σ	0..1	string	Text alternative for the resource
dateTime	SΣN	1..1	dateTime	Erstellungszeitpunkt der Einwilligung
performer	Σ	0..*	Reference(Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)	Who is agreeing to the policy and rules
organization	SΣ	0..*	Reference(Organization)	Organisation, in der die Einwilligung erfasst wurde.
source[x]	SΣ	0..1	Reference(Consent Management QuestionnaireResponse)	Source from which this consent is taken
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	SΣCN	1..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
policy	S	1..*	BackboneElement	Policies covered by this consent
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
authority	C	0..1	uri	Enforcement source for policy
uri	SCN	1..1	uri	Specific policy covered by this consent Binding: ConsentManagementLegalBasisDataProcessing (extensible)
policyRule	SΣC	0..1	CodeableConcept	Regulation that this consents to Binding: ConsentPolicyRuleCodes (extensible): Regulatory policy examples.
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:xacml	S	0..1	base64Binary	Optional Extensions Element URL: http://fhir.de/ConsentManagement/StructureDefinition/Xacml
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	0..1	string	Plain text representation of the concept
verification	Σ	0..*	BackboneElement	Consent Verified by patient or family
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
verified	Σ	1..1	boolean	Has been verified
verifiedWith		0..1	Reference(Patient | RelatedPerson)	Person who verified
verificationDate		0..1	dateTime	When consent verified
provision	SΣ	0..1	BackboneElement	Constraints to the base Consent.policyRule
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	code	deny | permit Binding: ConsentProvisionType (required): How a rule statement is applied, such as adding additional consent or removing consent.
period	SΣ	1..1	Period	Timeframe for this rule
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	1..1	dateTime	Starting time with inclusive boundary
end	SΣC	0..1	dateTime	End time with inclusive boundary, if not ongoing
actor		0..*	BackboneElement	Who|what controlled by this rule (or group, by role)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
role		1..1	CodeableConcept	How the actor is involved Binding: SecurityRoleType (extensible): How an actor is involved in the consent considerations.
reference		1..1	Reference(Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)	Resource for the actor (or group, by role)
securityLabel	Σ	0..*	Coding	Security Labels that define affected resources Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
purpose	Σ	0..*	Coding	Context of activities covered by this rule Binding: PurposeOfUse (extensible): What purposes of use are controlled by this exception. If more than one label is specified, operations must have all the specified labels.
class	Σ	0..*	Coding	e.g. Resource Type, Profile, CDA, etc. Binding: ConsentContentClass (extensible): The class (type) of information a consent rule covers.
dataPeriod	Σ	0..1	Period	Timeframe for data controlled by this rule
data	Σ	0..*	BackboneElement	Data controlled by this rule
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
meaning	Σ	1..1	code	instance | related | dependents | authoredby Binding: ConsentDataMeaning (required): How a resource reference is interpreted when testing consent restrictions.
reference	Σ	1..1	Reference(Resource)	The actual data reference
provision	S	0..*	BackboneElement	Nested Exception Rules
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	code	deny | permit Binding: ConsentProvisionType (required): How a rule statement is applied, such as adding additional consent or removing consent.
period	SΣ	1..1	Period	Timeframe for this rule
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	1..1	dateTime	Starting time with inclusive boundary
end	SΣC	0..1	dateTime	End time with inclusive boundary, if not ongoing
actor		0..*	BackboneElement	Who|what controlled by this rule (or group, by role)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
role		1..1	CodeableConcept	How the actor is involved Binding: SecurityRoleType (extensible): How an actor is involved in the consent considerations.
reference		1..1	Reference(Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)	Resource for the actor (or group, by role)
securityLabel	Σ	0..*	Coding	Security Labels that define affected resources Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
purpose	Σ	0..*	Coding	Context of activities covered by this rule Binding: PurposeOfUse (extensible): What purposes of use are controlled by this exception. If more than one label is specified, operations must have all the specified labels.
class	Σ	0..*	Coding	e.g. Resource Type, Profile, CDA, etc. Binding: ConsentContentClass (extensible): The class (type) of information a consent rule covers.
code	SΣ	1..*	CodeableConcept	e.g. LOINC or SNOMED CT code, etc. in the content Binding: MII Consent: Policy ValueSet (required)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..*	Coding	Code defined by a terminology system
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	SΣ	1..1	uri	Identity of the terminology system
version	Σ	0..1	string	Version of the system - if relevant
code	SΣ	1..1	code	Symbol in syntax defined by the system
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
dataPeriod	Σ	0..1	Period	Timeframe for data controlled by this rule
data	Σ	0..*	BackboneElement	Data controlled by this rule
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
meaning	Σ	1..1	code	instance | related | dependents | authoredby Binding: ConsentDataMeaning (required): How a resource reference is interpreted when testing consent restrictions.
reference	Σ	1..1	Reference(Resource)	The actual data reference
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Consent.meta.security	Base	extensible	SecurityLabels	📍4.0.1	FHIR Std.
Consent.meta.tag	Base	example	Common Tags	📍4.0.1	FHIR Std.
Consent.language	Base	preferred	Common Languages	📍4.0.1	FHIR Std.
Consent.extension:domainReference.​extension:status.value[x]	Base	required	PublicationStatus	📦4.0.1	FHIR Std.
Consent.status	Base	required	ConsentState	📍4.0.1	FHIR Std.
Consent.scope	Base	extensible	Consent Scope Codes	📍4.0.1	FHIR Std.
Consent.category	Base	extensible	Consent Category Codes	📍4.0.1	FHIR Std.
Consent.category:consentCategory	Base	extensible	Consent Category Codes	📍4.0.1	FHIR Std.
Consent.category:mii	Base	extensible	Consent Category Codes	📍4.0.1	FHIR Std.
Consent.category:resultType	Base	required	ConsentManagementResultType	📦2.0.4	de.einwilligungsmanagement v2.0
Consent.category:templateType	Base	extensible	ConsentManagementTemplateType	📦2.0.4	de.einwilligungsmanagement v2.0
Consent.patient.type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
Consent.patient.identifier.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
Consent.patient.identifier.​type	Base	extensible	IdentifierType	📍4.0.1	FHIR Std.
Consent.source[x].type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
Consent.policy.uri	Base	extensible	ConsentManagementLegalBasisDataProcessing	📦2.0.4	de.einwilligungsmanagement v2.0
Consent.policyRule	Base	extensible	Consent PolicyRule Codes	📍4.0.1	FHIR Std.
Consent.provision.type	Base	required	ConsentProvisionType	📍4.0.1	FHIR Std.
Consent.provision.actor.​role	Base	extensible	SecurityRoleType	📍4.0.1	FHIR Std.
Consent.provision.securityLabel	Base	extensible	SecurityLabels	📍4.0.1	FHIR Std.
Consent.provision.purpose	Base	extensible	PurposeOfUse	📦3.1.0	THO v7.3
Consent.provision.class	Base	extensible	Consent Content Class	📍4.0.1	FHIR Std.
Consent.provision.data.​meaning	Base	required	ConsentDataMeaning	📍4.0.1	FHIR Std.
Consent.provision.provision.​type	Base	required	ConsentProvisionType	📍4.0.1	FHIR Std.
Consent.provision.provision.​actor.role	Base	extensible	SecurityRoleType	📍4.0.1	FHIR Std.
Consent.provision.provision.​securityLabel	Base	extensible	SecurityLabels	📍4.0.1	FHIR Std.
Consent.provision.provision.​purpose	Base	extensible	PurposeOfUse	📦3.1.0	THO v7.3
Consent.provision.provision.​class	Base	extensible	Consent Content Class	📍4.0.1	FHIR Std.
Consent.provision.provision.​code	Base	required	MII Consent: Policy ValueSet	📦2027.0.0-ballot	This IG
Consent.provision.provision.​data.meaning	Base	required	ConsentDataMeaning	📍4.0.1	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	Consent	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	Consent	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	Consent	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	Consent	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	Consent	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()
ppc-1	error	Consent	Either a Policy or PolicyRule	policy.exists() or policyRule.exists()
ppc-2	error	Consent	IF Scope=privacy, there must be a patient	patient.exists() or scope.coding.where(system='something' and code='patient-privacy').exists().not()
ppc-3	error	Consent	IF Scope=research, there must be a patient	patient.exists() or scope.coding.where(system='something' and code='research').exists().not()
ppc-4	error	Consent	IF Scope=adr, there must be a patient	patient.exists() or scope.coding.where(system='something' and code='adr').exists().not()
ppc-5	error	Consent	IF Scope=treatment, there must be a patient	patient.exists() or scope.coding.where(system='something' and code='treatment').exists().not()

Schlüsselelemente-Ansicht

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Consent	C	0..*	ConsentManagementConsent	A healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time Constraints: ppc-1, ppc-2, ppc-3, ppc-4, ppc-5
id	SΣ	0..1	id	Logical id of this artifact
meta	SΣ	0..1	Meta	Metadata about the resource
source	SΣ	0..1	uri	Identifies where the resource comes from
profile	SΣ	0..*	canonical(StructureDefinition)	Profiles this resource claims to conform to
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
Slices for extension				Content/Rules for all slices
extension:domainReference	S	0..*	(Complex)	Optional Extensions Element URL: http://fhir.de/ConsentManagement/StructureDefinition/DomainReference
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
Slices for extension				Content/Rules for all slices
extension:domain	S	1..1	Extension	Extension
url		1..1	uri	"domain"
value[x]		1..1	Reference(Consent Management Domain Organization | Consent Management Domain Research Study)	Value of extension
extension:status	N	0..1	Extension	Extension
url		1..1	uri	"status"
value[x]	N	1..1	Coding	Value of extension Binding: PublicationStatus (required)
system	ΣN	1..1	uri	Identity of the terminology system
code	ΣN	1..1	code	Symbol in syntax defined by the system
url		1..1	uri	"http://fhir.de/ConsentManagement/StructureDefinition/DomainReference"
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
status	?!SΣN	1..1	code	draft | proposed | active | rejected | inactive | entered-in-error Binding: ConsentState (required): Indicates the state of the consent.
scope	?!Σ	1..1	CodeableConcept	Which of the four areas this resource covers (extensible) Binding: ConsentScopeCodes (extensible): The four anticipated uses for the Consent Resource.
coding	Σ	1..1	Coding	Code defined by a terminology system
system	Σ	1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/consentscope
code	Σ	1..1	code	Symbol in syntax defined by the system Fixed Value: research
Slices for category	SΣ	2..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Slice: Unordered, Open by pattern:$this Binding: ConsentCategoryCodes (extensible): A classification of the type of consents found in a consent statement.
category:consentCategory	SΣ	1..1	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentCategoryCodes (extensible): A classification of the type of consents found in a consent statement. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
text		0..1	string	Plain text representation of the concept
coding	SΣ	1..1	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
version		0..1	string	Version of the system - if relevant
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
system	SΣ	1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
code	SΣ	1..1	code	Symbol in syntax defined by the system Fixed Value: 57016-8
category:mii	SΣ	1..1	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentCategoryCodes (extensible): A classification of the type of consents found in a consent statement. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
text		0..1	string	Plain text representation of the concept
coding	SΣ	1..1	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
version		0..1	string	Version of the system - if relevant
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
system	SΣ	1..1	uri	Identity of the terminology system Fixed Value: https://www.medizininformatik-initiative.de/fhir/modul-consent/CodeSystem/mii-cs-consent-version-modules
code	SΣ	1..1	code	Symbol in syntax defined by the system Fixed Value: 2.16.840.1.113883.3.1937.777.24.2.184
category:resultType	SΣ	0..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentManagementResultType (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
text		0..1	string	Plain text representation of the concept
coding	SΣ	1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
version		0..1	string	Version of the system - if relevant
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
system	SΣ	1..1	uri	Identity of the terminology system Fixed Value: http://fhir.de/ConsentManagement/CodeSystem/ResultType
code	SΣ	1..1	code	Symbol in syntax defined by the system
category:templateType	SΣ	0..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentManagementTemplateType (extensible) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
text		0..1	string	Plain text representation of the concept
coding	SΣ	1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
version		0..1	string	Version of the system - if relevant
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
system	SΣ	1..1	uri	Identity of the terminology system Fixed Value: http://fhir.de/ConsentManagement/CodeSystem/TemplateType
code	SΣ	1..1	code	Symbol in syntax defined by the system
patient	SΣ	1..1	Reference(Consent Management: Patient)	Who the consent applies to
reference	SΣCN	0..1	string	Literal reference, Relative, internal or absolute URL
identifier	SΣ	0..1	Identifier	Logical reference, when literal reference is not known
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
system	SΣ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	SΣ	1..1	string	The value that is unique Example General: 123456
dateTime	SΣN	1..1	dateTime	Erstellungszeitpunkt der Einwilligung
organization	SΣ	0..*	Reference(Organization)	Organisation, in der die Einwilligung erfasst wurde.
source[x]	SΣ	0..1	Reference(Consent Management QuestionnaireResponse)	Source from which this consent is taken
reference	SΣCN	1..1	string	Literal reference, Relative, internal or absolute URL
policy	S	1..*	BackboneElement	Policies covered by this consent
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
uri	SCN	1..1	uri	Specific policy covered by this consent Binding: ConsentManagementLegalBasisDataProcessing (extensible)
policyRule	SΣC	0..1	CodeableConcept	Regulation that this consents to Binding: ConsentPolicyRuleCodes (extensible): Regulatory policy examples.
Slices for extension				Content/Rules for all slices
extension:xacml	S	0..1	base64Binary	Optional Extensions Element URL: http://fhir.de/ConsentManagement/StructureDefinition/Xacml
provision	SΣ	0..1	BackboneElement	Constraints to the base Consent.policyRule
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	code	deny | permit Binding: ConsentProvisionType (required): How a rule statement is applied, such as adding additional consent or removing consent.
period	SΣ	1..1	Period	Timeframe for this rule
start	SΣC	1..1	dateTime	Starting time with inclusive boundary
end	SΣC	0..1	dateTime	End time with inclusive boundary, if not ongoing
provision	S	0..*	BackboneElement	Nested Exception Rules
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	code	deny | permit Binding: ConsentProvisionType (required): How a rule statement is applied, such as adding additional consent or removing consent.
period	SΣ	1..1	Period	Timeframe for this rule
start	SΣC	1..1	dateTime	Starting time with inclusive boundary
end	SΣC	0..1	dateTime	End time with inclusive boundary, if not ongoing
code	SΣ	1..*	CodeableConcept	e.g. LOINC or SNOMED CT code, etc. in the content Binding: MII Consent: Policy ValueSet (required)
coding	SΣ	1..*	Coding	Code defined by a terminology system
system	SΣ	1..1	uri	Identity of the terminology system
code	SΣ	1..1	code	Symbol in syntax defined by the system
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Consent.extension:domainReference.​extension:status.value[x]	Base	required	PublicationStatus	📦4.0.1	FHIR Std.
Consent.status	Base	required	ConsentState	📍4.0.1	FHIR Std.
Consent.scope	Base	extensible	Consent Scope Codes	📍4.0.1	FHIR Std.
Consent.category	Base	extensible	Consent Category Codes	📍4.0.1	FHIR Std.
Consent.category:consentCategory	Base	extensible	Consent Category Codes	📍4.0.1	FHIR Std.
Consent.category:mii	Base	extensible	Consent Category Codes	📍4.0.1	FHIR Std.
Consent.category:resultType	Base	required	ConsentManagementResultType	📦2.0.4	de.einwilligungsmanagement v2.0
Consent.category:templateType	Base	extensible	ConsentManagementTemplateType	📦2.0.4	de.einwilligungsmanagement v2.0
Consent.patient.identifier.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
Consent.policy.uri	Base	extensible	ConsentManagementLegalBasisDataProcessing	📦2.0.4	de.einwilligungsmanagement v2.0
Consent.policyRule	Base	extensible	Consent PolicyRule Codes	📍4.0.1	FHIR Std.
Consent.provision.type	Base	required	ConsentProvisionType	📍4.0.1	FHIR Std.
Consent.provision.provision.​type	Base	required	ConsentProvisionType	📍4.0.1	FHIR Std.
Consent.provision.provision.​code	Base	required	MII Consent: Policy ValueSet	📦2027.0.0-ballot	This IG

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	Consent	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	Consent	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	Consent	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	Consent	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	Consent	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()
ppc-1	error	Consent	Either a Policy or PolicyRule	policy.exists() or policyRule.exists()
ppc-2	error	Consent	IF Scope=privacy, there must be a patient	patient.exists() or scope.coding.where(system='something' and code='patient-privacy').exists().not()
ppc-3	error	Consent	IF Scope=research, there must be a patient	patient.exists() or scope.coding.where(system='something' and code='research').exists().not()
ppc-4	error	Consent	IF Scope=adr, there must be a patient	patient.exists() or scope.coding.where(system='something' and code='adr').exists().not()
ppc-5	error	Consent	IF Scope=treatment, there must be a patient	patient.exists() or scope.coding.where(system='something' and code='treatment').exists().not()

Differential-Ansicht

Diese Struktur ist abgeleitet von ConsentManagementConsent

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Consent		0..*	ConsentManagementConsent	A healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time
id	S	0..1	id	Logical id of this artifact
meta	S	0..1	Meta	Metadata about the resource
source	S	0..1	uri	Identifies where the resource comes from
profile	S	0..*	canonical(StructureDefinition)	Profiles this resource claims to conform to
status	N	1..1	code	draft | proposed | active | rejected | inactive | entered-in-error
scope
coding		1..1	Coding	Code defined by a terminology system
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/consentscope
code		1..1	code	Symbol in syntax defined by the system Fixed Value: research
Slices for category		2..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Slice: Unordered, Open by pattern:$this
category:consentCategory	S	1..1	CodeableConcept	Classification of the consent statement - for indexing/retrieval Required Pattern: At least the following
coding	S	1..1	Coding	Code defined by a terminology system Fixed Value: (Complex)
system	S	1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
code	S	1..1	code	Symbol in syntax defined by the system Fixed Value: 57016-8
category:mii	S	1..1	CodeableConcept	Classification of the consent statement - for indexing/retrieval Required Pattern: At least the following
coding	S	1..1	Coding	Code defined by a terminology system Fixed Value: (Complex)
system	S	1..1	uri	Identity of the terminology system Fixed Value: https://www.medizininformatik-initiative.de/fhir/modul-consent/CodeSystem/mii-cs-consent-version-modules
code	S	1..1	code	Symbol in syntax defined by the system Fixed Value: 2.16.840.1.113883.3.1937.777.24.2.184
category:resultType	S	0..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentManagementResultType (required) Required Pattern: At least the following
coding	S	1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
system	S	1..1	uri	Identity of the terminology system Fixed Value: http://fhir.de/ConsentManagement/CodeSystem/ResultType
code	S	1..1	code	Symbol in syntax defined by the system
category:templateType	S	0..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentManagementTemplateType (extensible) Required Pattern: At least the following
coding	S	1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
system	S	1..1	uri	Identity of the terminology system Fixed Value: http://fhir.de/ConsentManagement/CodeSystem/TemplateType
code	S	1..1	code	Symbol in syntax defined by the system
patient
reference	SN	0..1	string	Literal reference, Relative, internal or absolute URL
identifier	S	0..1	Identifier	Logical reference, when literal reference is not known
system	S	1..1	uri	The namespace for the identifier value
value	S	1..1	string	The value that is unique
dateTime	N	1..1	dateTime	Erstellungszeitpunkt der Einwilligung
source[x]
reference	N	1..1	string	Literal reference, Relative, internal or absolute URL
policy		1..*	BackboneElement	Policies covered by this consent
uri	N	1..1	uri	Specific policy covered by this consent
provision
type	S	1..1	code	deny | permit
period		1..1	Period	Timeframe for this rule
start	S	1..1	dateTime	Starting time with inclusive boundary
end	S	0..1	dateTime	End time with inclusive boundary, if not ongoing
action		0..0		Actions controlled by this rule
code		0..0		e.g. LOINC or SNOMED CT code, etc. in the content
provision	S	0..*	BackboneElement	Nested Exception Rules
type	S	1..1	code	deny | permit
period	S	1..1	Period	Timeframe for this rule
start	S	1..1	dateTime	Starting time with inclusive boundary
end	S	0..1	dateTime	End time with inclusive boundary, if not ongoing
action		0..0		Actions controlled by this rule
code	S	1..*	CodeableConcept	e.g. LOINC or SNOMED CT code, etc. in the content Binding: MII Consent: Policy ValueSet (required)
coding	S	1..*	Coding	Code defined by a terminology system
system	S	1..1	uri	Identity of the terminology system
code	S	1..1	code	Symbol in syntax defined by the system
provision		0..0		Nested Exception Rules
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Consent.category:resultType	Base	required	ConsentManagementResultType	📦2.0.4	de.einwilligungsmanagement v2.0
Consent.category:templateType	Base	extensible	ConsentManagementTemplateType	📦2.0.4	de.einwilligungsmanagement v2.0
Consent.provision.provision.​code	Base	required	MII Consent: Policy ValueSet	📦2027.0.0-ballot	This IG

Snapshot-AnsichtView

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Consent	C	0..*	ConsentManagementConsent	A healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time Constraints: ppc-1, ppc-2, ppc-3, ppc-4, ppc-5
id	SΣ	0..1	id	Logical id of this artifact
meta	SΣ	0..1	Meta	Metadata about the resource
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
versionId	Σ	0..1	id	Version specific identifier
lastUpdated	Σ	0..1	instant	When the resource version last changed
source	SΣ	0..1	uri	Identifies where the resource comes from
profile	SΣ	0..*	canonical(StructureDefinition)	Profiles this resource claims to conform to
security	Σ	0..*	Coding	Security Labels applied to this resource Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
tag	Σ	0..*	Coding	Tags applied to this resource Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
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. Additional Bindings Purpose AllLanguages Max Binding
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:domainReference	S	0..*	(Complex)	Optional Extensions Element URL: http://fhir.de/ConsentManagement/StructureDefinition/DomainReference
id		0..1	string	Unique id for inter-element referencing
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
Slices for extension				Content/Rules for all slices
extension:domain	S	1..1	Extension	Extension
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
url		1..1	uri	"domain"
value[x]		1..1	Reference(Consent Management Domain Organization | Consent Management Domain Research Study)	Value of extension
extension:status	N	0..1	Extension	Extension
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
url		1..1	uri	"status"
value[x]	N	1..1	Coding	Value of extension Binding: PublicationStatus (required)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	ΣN	1..1	uri	Identity of the terminology system
version	Σ	0..1	string	Version of the system - if relevant
code	ΣN	1..1	code	Symbol in syntax defined by the system
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
url		1..1	uri	"http://fhir.de/ConsentManagement/StructureDefinition/DomainReference"
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Identifier for this record (external references) Example General: {"system":"http://acme.org/identifier/local/eCMS","value":"Local eCMS identifier"}
status	?!SΣN	1..1	code	draft | proposed | active | rejected | inactive | entered-in-error Binding: ConsentState (required): Indicates the state of the consent.
scope	?!Σ	1..1	CodeableConcept	Which of the four areas this resource covers (extensible) Binding: ConsentScopeCodes (extensible): The four anticipated uses for the Consent Resource.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	1..1	Coding	Code defined by a terminology system
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	Σ	1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/consentscope
version	Σ	0..1	string	Version of the system - if relevant
code	Σ	1..1	code	Symbol in syntax defined by the system Fixed Value: research
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
Slices for category	SΣ	2..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Slice: Unordered, Open by pattern:$this Binding: ConsentCategoryCodes (extensible): A classification of the type of consents found in a consent statement.
category:consentCategory	SΣ	1..1	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentCategoryCodes (extensible): A classification of the type of consents found in a consent statement. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..1	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	SΣ	1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
version	Σ	0..1	string	Version of the system - if relevant
code	SΣ	1..1	code	Symbol in syntax defined by the system Fixed Value: 57016-8
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
category:mii	SΣ	1..1	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentCategoryCodes (extensible): A classification of the type of consents found in a consent statement. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..1	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	SΣ	1..1	uri	Identity of the terminology system Fixed Value: https://www.medizininformatik-initiative.de/fhir/modul-consent/CodeSystem/mii-cs-consent-version-modules
version	Σ	0..1	string	Version of the system - if relevant
code	SΣ	1..1	code	Symbol in syntax defined by the system Fixed Value: 2.16.840.1.113883.3.1937.777.24.2.184
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
category:resultType	SΣ	0..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentManagementResultType (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	SΣ	1..1	uri	Identity of the terminology system Fixed Value: http://fhir.de/ConsentManagement/CodeSystem/ResultType
version	Σ	0..1	string	Version of the system - if relevant
code	SΣ	1..1	code	Symbol in syntax defined by the system
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
category:templateType	SΣ	0..*	CodeableConcept	Classification of the consent statement - for indexing/retrieval Binding: ConsentManagementTemplateType (extensible) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	SΣ	1..1	uri	Identity of the terminology system Fixed Value: http://fhir.de/ConsentManagement/CodeSystem/TemplateType
version	Σ	0..1	string	Version of the system - if relevant
code	SΣ	1..1	code	Symbol in syntax defined by the system
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
patient	SΣ	1..1	Reference(Consent Management: Patient)	Who the consent applies to
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	SΣCN	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	SΣ	0..1	Identifier	Logical reference, when literal reference is not known
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	SΣ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	SΣ	1..1	string	The value that is unique Example General: 123456
period	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
display	Σ	0..1	string	Text alternative for the resource
dateTime	SΣN	1..1	dateTime	Erstellungszeitpunkt der Einwilligung
performer	Σ	0..*	Reference(Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)	Who is agreeing to the policy and rules
organization	SΣ	0..*	Reference(Organization)	Organisation, in der die Einwilligung erfasst wurde.
source[x]	SΣ	0..1	Reference(Consent Management QuestionnaireResponse)	Source from which this consent is taken
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	SΣCN	1..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
policy	S	1..*	BackboneElement	Policies covered by this consent
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
authority	C	0..1	uri	Enforcement source for policy
uri	SCN	1..1	uri	Specific policy covered by this consent Binding: ConsentManagementLegalBasisDataProcessing (extensible)
policyRule	SΣC	0..1	CodeableConcept	Regulation that this consents to Binding: ConsentPolicyRuleCodes (extensible): Regulatory policy examples.
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:xacml	S	0..1	base64Binary	Optional Extensions Element URL: http://fhir.de/ConsentManagement/StructureDefinition/Xacml
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	0..1	string	Plain text representation of the concept
verification	Σ	0..*	BackboneElement	Consent Verified by patient or family
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
verified	Σ	1..1	boolean	Has been verified
verifiedWith		0..1	Reference(Patient | RelatedPerson)	Person who verified
verificationDate		0..1	dateTime	When consent verified
provision	SΣ	0..1	BackboneElement	Constraints to the base Consent.policyRule
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	code	deny | permit Binding: ConsentProvisionType (required): How a rule statement is applied, such as adding additional consent or removing consent.
period	SΣ	1..1	Period	Timeframe for this rule
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	1..1	dateTime	Starting time with inclusive boundary
end	SΣC	0..1	dateTime	End time with inclusive boundary, if not ongoing
actor		0..*	BackboneElement	Who|what controlled by this rule (or group, by role)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
role		1..1	CodeableConcept	How the actor is involved Binding: SecurityRoleType (extensible): How an actor is involved in the consent considerations.
reference		1..1	Reference(Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)	Resource for the actor (or group, by role)
securityLabel	Σ	0..*	Coding	Security Labels that define affected resources Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
purpose	Σ	0..*	Coding	Context of activities covered by this rule Binding: PurposeOfUse (extensible): What purposes of use are controlled by this exception. If more than one label is specified, operations must have all the specified labels.
class	Σ	0..*	Coding	e.g. Resource Type, Profile, CDA, etc. Binding: ConsentContentClass (extensible): The class (type) of information a consent rule covers.
dataPeriod	Σ	0..1	Period	Timeframe for data controlled by this rule
data	Σ	0..*	BackboneElement	Data controlled by this rule
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
meaning	Σ	1..1	code	instance | related | dependents | authoredby Binding: ConsentDataMeaning (required): How a resource reference is interpreted when testing consent restrictions.
reference	Σ	1..1	Reference(Resource)	The actual data reference
provision	S	0..*	BackboneElement	Nested Exception Rules
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
type	SΣ	1..1	code	deny | permit Binding: ConsentProvisionType (required): How a rule statement is applied, such as adding additional consent or removing consent.
period	SΣ	1..1	Period	Timeframe for this rule
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	1..1	dateTime	Starting time with inclusive boundary
end	SΣC	0..1	dateTime	End time with inclusive boundary, if not ongoing
actor		0..*	BackboneElement	Who|what controlled by this rule (or group, by role)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
role		1..1	CodeableConcept	How the actor is involved Binding: SecurityRoleType (extensible): How an actor is involved in the consent considerations.
reference		1..1	Reference(Device | Group | CareTeam | Organization | Patient | Practitioner | RelatedPerson | PractitionerRole)	Resource for the actor (or group, by role)
securityLabel	Σ	0..*	Coding	Security Labels that define affected resources Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
purpose	Σ	0..*	Coding	Context of activities covered by this rule Binding: PurposeOfUse (extensible): What purposes of use are controlled by this exception. If more than one label is specified, operations must have all the specified labels.
class	Σ	0..*	Coding	e.g. Resource Type, Profile, CDA, etc. Binding: ConsentContentClass (extensible): The class (type) of information a consent rule covers.
code	SΣ	1..*	CodeableConcept	e.g. LOINC or SNOMED CT code, etc. in the content Binding: MII Consent: Policy ValueSet (required)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	SΣ	1..*	Coding	Code defined by a terminology system
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
system	SΣ	1..1	uri	Identity of the terminology system
version	Σ	0..1	string	Version of the system - if relevant
code	SΣ	1..1	code	Symbol in syntax defined by the system
display	Σ	0..1	string	Representation defined by the system
userSelected	Σ	0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
dataPeriod	Σ	0..1	Period	Timeframe for data controlled by this rule
data	Σ	0..*	BackboneElement	Data controlled by this rule
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
meaning	Σ	1..1	code	instance | related | dependents | authoredby Binding: ConsentDataMeaning (required): How a resource reference is interpreted when testing consent restrictions.
reference	Σ	1..1	Reference(Resource)	The actual data reference
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Consent.meta.security	Base	extensible	SecurityLabels	📍4.0.1	FHIR Std.
Consent.meta.tag	Base	example	Common Tags	📍4.0.1	FHIR Std.
Consent.language	Base	preferred	Common Languages	📍4.0.1	FHIR Std.
Consent.extension:domainReference.​extension:status.value[x]	Base	required	PublicationStatus	📦4.0.1	FHIR Std.
Consent.status	Base	required	ConsentState	📍4.0.1	FHIR Std.
Consent.scope	Base	extensible	Consent Scope Codes	📍4.0.1	FHIR Std.
Consent.category	Base	extensible	Consent Category Codes	📍4.0.1	FHIR Std.
Consent.category:consentCategory	Base	extensible	Consent Category Codes	📍4.0.1	FHIR Std.
Consent.category:mii	Base	extensible	Consent Category Codes	📍4.0.1	FHIR Std.
Consent.category:resultType	Base	required	ConsentManagementResultType	📦2.0.4	de.einwilligungsmanagement v2.0
Consent.category:templateType	Base	extensible	ConsentManagementTemplateType	📦2.0.4	de.einwilligungsmanagement v2.0
Consent.patient.type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
Consent.patient.identifier.​use	Base	required	IdentifierUse	📍4.0.1	FHIR Std.
Consent.patient.identifier.​type	Base	extensible	IdentifierType	📍4.0.1	FHIR Std.
Consent.source[x].type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
Consent.policy.uri	Base	extensible	ConsentManagementLegalBasisDataProcessing	📦2.0.4	de.einwilligungsmanagement v2.0
Consent.policyRule	Base	extensible	Consent PolicyRule Codes	📍4.0.1	FHIR Std.
Consent.provision.type	Base	required	ConsentProvisionType	📍4.0.1	FHIR Std.
Consent.provision.actor.​role	Base	extensible	SecurityRoleType	📍4.0.1	FHIR Std.
Consent.provision.securityLabel	Base	extensible	SecurityLabels	📍4.0.1	FHIR Std.
Consent.provision.purpose	Base	extensible	PurposeOfUse	📦3.1.0	THO v7.3
Consent.provision.class	Base	extensible	Consent Content Class	📍4.0.1	FHIR Std.
Consent.provision.data.​meaning	Base	required	ConsentDataMeaning	📍4.0.1	FHIR Std.
Consent.provision.provision.​type	Base	required	ConsentProvisionType	📍4.0.1	FHIR Std.
Consent.provision.provision.​actor.role	Base	extensible	SecurityRoleType	📍4.0.1	FHIR Std.
Consent.provision.provision.​securityLabel	Base	extensible	SecurityLabels	📍4.0.1	FHIR Std.
Consent.provision.provision.​purpose	Base	extensible	PurposeOfUse	📦3.1.0	THO v7.3
Consent.provision.provision.​class	Base	extensible	Consent Content Class	📍4.0.1	FHIR Std.
Consent.provision.provision.​code	Base	required	MII Consent: Policy ValueSet	📦2027.0.0-ballot	This IG
Consent.provision.provision.​data.meaning	Base	required	ConsentDataMeaning	📍4.0.1	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	Consent	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	Consent	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	Consent	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	Consent	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	Consent	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()
ppc-1	error	Consent	Either a Policy or PolicyRule	policy.exists() or policyRule.exists()
ppc-2	error	Consent	IF Scope=privacy, there must be a patient	patient.exists() or scope.coding.where(system='something' and code='patient-privacy').exists().not()
ppc-3	error	Consent	IF Scope=research, there must be a patient	patient.exists() or scope.coding.where(system='something' and code='research').exists().not()
ppc-4	error	Consent	IF Scope=adr, there must be a patient	patient.exists() or scope.coding.where(system='something' and code='adr').exists().not()
ppc-5	error	Consent	IF Scope=treatment, there must be a patient	patient.exists() or scope.coding.where(system='something' and code='treatment').exists().not()

Diese Struktur ist abgeleitet von ConsentManagementConsent

Summary

Mandatory: 12 elements(18 nested mandatory elements)
Must-Support: 36 elements
Fixed: 2 elements
Prohibited: 4 elements

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of Consent.category