MII IG Kerndatensatz-Modul Molekulares Tumorboard
2027.0.0-ballot.1 - Germany

This page is part of the MII Implementation Guide Molecular Tumor Board (v2027.0.0-ballot.1: Release) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Resource Profile: Genomic Study Device

Official URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/genomic-study-device Version: 2027.0.0-ballot.1
Active as of 2026-09-15 Computable Name: MII_PR_MTB_Genomic_Study_Device

Profil für die Abbildung von Geräten, Labormaterialien und Pipelines, die in der Genomic Study Analysis verwendet werden.

Content

This profile describes the devices, laboratory materials, and software pipelines referenced in the Genomic Study Analysis profile.

Content

Mapping dataset to FHIR

Search parameters

The following search parameters are relevant for this module, including in combination:

  1. The search parameter "_id" MUST be supported:

    Examples:

    GET [base]/Device?_id=12345

    Usage notes: Further information on searching for "_id" can be found in the FHIR base specification - section "Parameters for all resources".

  2. The search parameter "_profile" MUST be supported:

    Examples:

    GET [base]/Device?_profile=https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-genomic-study-device

    Usage notes: Further information on searching for "_profile" can be found in the FHIR base specification - section "Parameters for all resources".

  3. The search parameter "device-name" MUST be supported:

    Examples:

    GET [base]/Device?deviceName=NextSeq+2000

    Usage notes: Further information on searching for "code" can be found in the FHIR base specification - section "Token Search"..

  4. The search parameter "manufacturer" MUST be supported:

    Examples:

    GET [base]/Device?manufacturer=Illumina

    Usage notes: Further information on searching for "subject" can be found in the FHIR base specification - section "reference".

  5. The search parameter "type" MUST be supported:

    Examples:

    GET [base]/Device?type=sequencer

    Usage notes: Further information on searching for "encounter" can be found in the FHIR base specification - section "reference".

Examples

Preparation Library

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots, and their representations.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Item used in healthcare
... meta SΣ 0..1 Meta Metadata about the resource
.... 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
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... manufacturer S 0..1 string Device manufacturer
... deviceName S 0..* BackboneElement Device name
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name S 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.
Required Pattern: user-friendly-name
... type S 0..1 CodeableConcept Genomic Study Device Type
Binding: DeviceType (example): Codes to identify medical devices.

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Device.status Base required FHIRDeviceStatus 📍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()

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Item used in healthcare
... meta S 0..1 Meta Metadata about the resource
.... profile S 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... manufacturer S 0..1 string Device manufacturer
... deviceName S 0..* BackboneElement Device name
.... name S 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
Required Pattern: user-friendly-name

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Item used in healthcare
... id Σ 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 Σ 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 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 ?!Σ 0..1 code active | inactive | entered-in-error | unknown
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 S 0..1 string 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 S 0..* BackboneElement Device name
.... 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 S 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.
Required Pattern: user-friendly-name
... modelNumber 0..1 string The model number for the device
... partNumber 0..1 string The part number of the device
... type S 0..1 CodeableConcept Genomic Study Device Type
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 0..1 Reference(Patient) Patient to whom Device is affixed
... 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()

Summary

Must-Support: 6 elements

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Item used in healthcare
... meta SΣ 0..1 Meta Metadata about the resource
.... 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
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... manufacturer S 0..1 string Device manufacturer
... deviceName S 0..* BackboneElement Device name
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... name S 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.
Required Pattern: user-friendly-name
... type S 0..1 CodeableConcept Genomic Study Device Type
Binding: DeviceType (example): Codes to identify medical devices.

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
Device.status Base required FHIRDeviceStatus 📍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()

Differential View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Item used in healthcare
... meta S 0..1 Meta Metadata about the resource
.... profile S 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... manufacturer S 0..1 string Device manufacturer
... deviceName S 0..* BackboneElement Device name
.... name S 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
Required Pattern: user-friendly-name

doco Documentation for this format

Snapshot ViewView

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Device 0..* Device Item used in healthcare
... id Σ 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 Σ 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 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 ?!Σ 0..1 code active | inactive | entered-in-error | unknown
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 S 0..1 string 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 S 0..* BackboneElement Device name
.... 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 S 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.
Required Pattern: user-friendly-name
... modelNumber 0..1 string The model number for the device
... partNumber 0..1 string The part number of the device
... type S 0..1 CodeableConcept Genomic Study Device Type
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 0..1 Reference(Patient) Patient to whom Device is affixed
... 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()

Summary

Must-Support: 6 elements

 

Other representations of profile: CSV, Excel, Schematron