AMTS ISiK Implementierungsleitfaden
Version 6.0.0-rc - ballot

Resource Profile: ISiKImplantat

Official URL: https://gematik.de/fhir/isik/StructureDefinition/ISiKImplantat Version: 6.0.0-rc
Active as of 2026-04-02 Computable Name: ISiKImplantat

Dieses Profil ermöglicht die strukturierte Abbildung von Implantaten eines Patienten in ISiK-Szenarien. Implantate stellen dauerhaft oder langfristig im Körper befindliche Medizinprodukte dar und sind häufig von hoher klinischer Relevanz, da sie Diagnostik, Therapieentscheidungen sowie zukünftige Behandlungsmaßnahmen unmittelbar beeinflussen können.

Motivation

Die standardisierte Bereitstellung von Implantatinformationen unterstützt insbesondere:

die eindeutige Identifikation implantierter Medizinprodukte,

die Berücksichtigung implantatspezifischer Besonderheiten bei weiteren diagnostischen oder therapeutischen Maßnahmen,

die Nachverfolgbarkeit im Rahmen von Sicherheitsmeldungen und Rückrufaktionen sowie

die Dokumentation wesentlicher Implantatmerkmale (z. B. Hersteller, Modell, Seriennummer).

Darüber hinaus ermöglicht das Profil eine interoperable und maschinenlesbare Darstellung implantatrelevanter Informationen und trägt zur Verbesserung der Patientensicherheit sowie zur Vermeidung von Risiken und Fehlentscheidungen im Behandlungsprozess bei. Als Bestandteil interoperabler Patientendaten stellt es sicher, dass relevante Implantatvorinformationen systemübergreifend verfügbar sind.

Da Implantate auch im Kontext des EHDS berücksichtigt werden, erscheint eine Aufnahme in ISiK sinnvoll, um die Verfügbarkeit von Implantatinformationen in verschiedenen Anwendungsfällen zu gewährleisten, insbesondere in solchen, die über die Dokumentation in einem Entlassbrief hinausgehen.

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Item used in healthcare
... id SΣ 0..1 id serverseitige, interne ID des Datensatzes
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... status ?!SΣ 1..1 code Status des Implantats
Binding: FHIRDeviceStatus (required): The availability status of the device.
... patient S 1..1 Reference(Patient) Patient mit Implantat

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Device.status Base required FHIRDeviceStatus 📍4.0.1 FHIR Std.
Device.type Base example Device Type 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Device If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Device 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 Device 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 Device If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Device 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()

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Item used in healthcare
... id S 0..1 id serverseitige, interne ID des Datensatzes
... meta
.... versionId 0..1 id Eindeutiger Name der serverseitigen Version des Datensatzes
.... lastUpdated 0..1 instant Zeitpunkt der letzten Änderung
... implicitRules 0..0 Verweis auf die Regeln, nach denen die Ressource erstellt wurde
... type S 1..1 CodeableConcept Art des Implantats
... patient S 1..1 Reference(Patient) Patient mit Implantat

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Item used in healthcare
... id SΣ 0..1 id serverseitige, interne ID des Datensatzes
... meta Σ 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 Eindeutiger Name der serverseitigen Version des Datensatzes
.... lastUpdated Σ 0..1 instant Zeitpunkt der letzten Änderung
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile Σ 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".
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
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
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier 0..* Identifier Instance identifier
... definition 0..1 Reference(DeviceDefinition) The reference to the definition for the device
... udiCarrier Σ 0..* BackboneElement Unique Device Identifier (UDI) Barcode string
.... 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
.... deviceIdentifier Σ 0..1 string Mandatory fixed portion of UDI
.... issuer 0..1 uri UDI Issuing Organization
.... jurisdiction 0..1 uri Regional UDI authority
.... carrierAIDC Σ 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF Σ 0..1 string UDI Human Readable Barcode String
.... entryType 0..1 code barcode | rfid | manual +
Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
... status ?!SΣ 1..1 code Status des Implantats
Binding: FHIRDeviceStatus (required): The availability status of the device.
... statusReason 0..* CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.
... distinctIdentifier 0..1 string The distinct identification string
... manufacturer 0..1 string Name of device manufacturer
... manufactureDate 0..1 dateTime Date when the device was made
... expirationDate 0..1 dateTime Date and time of expiry of this device (if applicable)
... lotNumber 0..1 string Lot number of manufacture
... serialNumber 0..1 string Serial number assigned by the manufacturer
... deviceName 0..* BackboneElement The name of the device as given by the manufacturer
.... 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
.... name 1..1 string The name of the device
.... type 1..1 code udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Binding: DeviceNameType (required): The type of name the device is referred by.
... modelNumber 0..1 string The model number for the device
... partNumber 0..1 string The part number of the device
... type S 1..1 CodeableConcept Art des Implantats
Binding: DeviceType (example): Codes to identify medical devices.
... specialization 0..* BackboneElement The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... 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
.... systemType 1..1 CodeableConcept The standard that is used to operate and communicate
.... version 0..1 string The version of the standard that is used to operate and communicate
... version 0..* BackboneElement The actual design of the device or software version running on the device
.... 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 0..1 CodeableConcept The type of the device version
.... component 0..1 Identifier A single component of the device version
.... value 1..1 string The version text
... property 0..* BackboneElement The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... 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 1..1 CodeableConcept Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuantity 0..* Quantity Property value as a quantity
.... valueCode 0..* CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP)
... patient S 1..1 Reference(Patient) Patient mit Implantat
... owner 0..1 Reference(Organization) Organization responsible for device
... contact 0..* ContactPoint Details for human/organization for support
... location 0..1 Reference(Location) Where the device is found
... url 0..1 uri Network address to contact device
... note 0..* Annotation Device notes and comments
... safety Σ 0..* CodeableConcept Safety Characteristics of Device
... parent 0..1 Reference(Device) The parent device

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Device.meta.security Base extensible SecurityLabels 📍4.0.1 FHIR Std.
Device.meta.tag Base example Common Tags 📍4.0.1 FHIR Std.
Device.language Base preferred Common Languages 📍4.0.1 FHIR Std.
Device.udiCarrier.entryType Base required UDIEntryType 📍4.0.1 FHIR Std.
Device.status Base required FHIRDeviceStatus 📍4.0.1 FHIR Std.
Device.statusReason Base extensible FHIRDeviceStatusReason 📍4.0.1 FHIR Std.
Device.deviceName.type Base required DeviceNameType 📍4.0.1 FHIR Std.
Device.type Base example Device Type 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Device If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Device 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 Device 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 Device If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Device 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()
ElementShort descriptionNotes
Device.id serverseitige, interne ID des Datensatzes

bedingtes Pflichtfeld/bedingtes MS: Alle von einem Server bereitgestellten Ressourcen MÜSSEN über eine id verfügen. Von Clients erzeugte Ressourcen, die im Kontext einer CREATE-Interaktion übermittelt werden, MÜSSEN NICHT über eine idverfügen.
Device.patient Patient mit Implantat

Begründung MS: Die Zuordnung zu einem Patient ist für den Datenaustausch im Rahmen von ISiK-Szenarien unerlässlich.
Device.status Status des Implantats

Begründung MS: Der Status gibt an, ob das Implantat aktuell im Körper des Patienten vorhanden ist oder nicht und stellt somit eine überaus wichtige medizinische Information dar, die unmittelbar Einfluss auf Diagnostik, Therapieentscheidungen und zukünftige Behandlungsmaßnahmen haben kann. Daher ist die Angabe des Status zwingend erforderlich.
Device.type Art des Implantats

Begründung MS: Die Angabe der Art des Implantats ermöglicht eine eindeutige Identifikation und Klassifizierung des implantierten Medizinprodukts, was für die Berücksichtigung implantatspezifischer Besonderheiten bei weiteren diagnostischen oder therapeutischen Maßnahmen von entscheidender Bedeutung ist. Daher ist die Angabe der Art des Implantats zwingend erforderlich.

This structure is derived from Device

Summary

Mandatory: 3 elements
Must-Support: 4 elements
Prohibited: 1 element

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Item used in healthcare
... id SΣ 0..1 id serverseitige, interne ID des Datensatzes
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... status ?!SΣ 1..1 code Status des Implantats
Binding: FHIRDeviceStatus (required): The availability status of the device.
... patient S 1..1 Reference(Patient) Patient mit Implantat

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Device.status Base required FHIRDeviceStatus 📍4.0.1 FHIR Std.
Device.type Base example Device Type 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Device If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Device 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 Device 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 Device If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Device A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()

Differential View

This structure is derived from Device

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Item used in healthcare
... id S 0..1 id serverseitige, interne ID des Datensatzes
... meta
.... versionId 0..1 id Eindeutiger Name der serverseitigen Version des Datensatzes
.... lastUpdated 0..1 instant Zeitpunkt der letzten Änderung
... implicitRules 0..0 Verweis auf die Regeln, nach denen die Ressource erstellt wurde
... type S 1..1 CodeableConcept Art des Implantats
... patient S 1..1 Reference(Patient) Patient mit Implantat

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Item used in healthcare
... id SΣ 0..1 id serverseitige, interne ID des Datensatzes
... meta Σ 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 Eindeutiger Name der serverseitigen Version des Datensatzes
.... lastUpdated Σ 0..1 instant Zeitpunkt der letzten Änderung
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile Σ 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".
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
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
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier 0..* Identifier Instance identifier
... definition 0..1 Reference(DeviceDefinition) The reference to the definition for the device
... udiCarrier Σ 0..* BackboneElement Unique Device Identifier (UDI) Barcode string
.... 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
.... deviceIdentifier Σ 0..1 string Mandatory fixed portion of UDI
.... issuer 0..1 uri UDI Issuing Organization
.... jurisdiction 0..1 uri Regional UDI authority
.... carrierAIDC Σ 0..1 base64Binary UDI Machine Readable Barcode String
.... carrierHRF Σ 0..1 string UDI Human Readable Barcode String
.... entryType 0..1 code barcode | rfid | manual +
Binding: UDIEntryType (required): Codes to identify how UDI data was entered.
... status ?!SΣ 1..1 code Status des Implantats
Binding: FHIRDeviceStatus (required): The availability status of the device.
... statusReason 0..* CodeableConcept online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Binding: FHIRDeviceStatusReason (extensible): The availability status reason of the device.
... distinctIdentifier 0..1 string The distinct identification string
... manufacturer 0..1 string Name of device manufacturer
... manufactureDate 0..1 dateTime Date when the device was made
... expirationDate 0..1 dateTime Date and time of expiry of this device (if applicable)
... lotNumber 0..1 string Lot number of manufacture
... serialNumber 0..1 string Serial number assigned by the manufacturer
... deviceName 0..* BackboneElement The name of the device as given by the manufacturer
.... 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
.... name 1..1 string The name of the device
.... type 1..1 code udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
Binding: DeviceNameType (required): The type of name the device is referred by.
... modelNumber 0..1 string The model number for the device
... partNumber 0..1 string The part number of the device
... type S 1..1 CodeableConcept Art des Implantats
Binding: DeviceType (example): Codes to identify medical devices.
... specialization 0..* BackboneElement The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
.... 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
.... systemType 1..1 CodeableConcept The standard that is used to operate and communicate
.... version 0..1 string The version of the standard that is used to operate and communicate
... version 0..* BackboneElement The actual design of the device or software version running on the device
.... 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 0..1 CodeableConcept The type of the device version
.... component 0..1 Identifier A single component of the device version
.... value 1..1 string The version text
... property 0..* BackboneElement The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
.... 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 1..1 CodeableConcept Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
.... valueQuantity 0..* Quantity Property value as a quantity
.... valueCode 0..* CodeableConcept Property value as a code, e.g., NTP4 (synced to NTP)
... patient S 1..1 Reference(Patient) Patient mit Implantat
... owner 0..1 Reference(Organization) Organization responsible for device
... contact 0..* ContactPoint Details for human/organization for support
... location 0..1 Reference(Location) Where the device is found
... url 0..1 uri Network address to contact device
... note 0..* Annotation Device notes and comments
... safety Σ 0..* CodeableConcept Safety Characteristics of Device
... parent 0..1 Reference(Device) The parent device

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Device.meta.security Base extensible SecurityLabels 📍4.0.1 FHIR Std.
Device.meta.tag Base example Common Tags 📍4.0.1 FHIR Std.
Device.language Base preferred Common Languages 📍4.0.1 FHIR Std.
Device.udiCarrier.entryType Base required UDIEntryType 📍4.0.1 FHIR Std.
Device.status Base required FHIRDeviceStatus 📍4.0.1 FHIR Std.
Device.statusReason Base extensible FHIRDeviceStatusReason 📍4.0.1 FHIR Std.
Device.deviceName.type Base required DeviceNameType 📍4.0.1 FHIR Std.
Device.type Base example Device Type 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Device If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Device 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 Device 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 Device If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice Device 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()

This structure is derived from Device

Summary

Mandatory: 3 elements
Must-Support: 4 elements
Prohibited: 1 element

 

Other representations of profile: CSV, Excel, Schematron