Notice
- Important: This guidance is under active development by NHS England and content may be added or updated on a regular basis.
- This Implementation Guide is currently in Draft and SHOULD NOT be used for development or active implementation without express direction from the NHS England Genomics Unit.
StructureDefinition Device
The Device resource is currently only used by the Community Cloud project for capturing hardware and software used when generating a Genomic Data File. Details of its usage and mapping from the Community Cloud minimum dataset are provided on Community Cloud Integration
It is expected the Device resource will be referenced from the GenomicStudyAnalysis Procedure resource, via extension:device.
The Device to be used within genomics is currently based on the HL7 international version of the resource. The base Device resource is provided below.
| Profile url | FHIR Module | Normative Status |
|---|---|---|
| http://hl7.org/fhir/StructureDefinition/Device | HL7 International | trial-use |
| Device | C | DomainResource | Element idDeviceShort description Item used in healthcare DefinitionA type of a manufactured item that is used in the provision of healthcare without being substantially changed through that activity. The device may be a medical or non-medical device.
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| id | Σ | 0..1 | string | There are no (further) constraints on this element Element idDevice.idShort description Logical id of this artifact DefinitionThe logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. The only time that a resource does not have an id is when it is being submitted to the server using a create operation. | ||
| meta | Σ | 0..1 | Meta | There are no (further) constraints on this element Element idDevice.metaShort description Metadata about the resource DefinitionThe metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| implicitRules | Σ ?! | 0..1 | uri | There are no (further) constraints on this element Element idDevice.implicitRulesShort description A set of rules under which this content was created DefinitionA reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| language | 0..1 | codeBinding | There are no (further) constraints on this element Element idDevice.languageShort description Language of the resource content DefinitionThe base language in which the resource is written. Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). A human language.
The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| text | 0..1 | Narrative | There are no (further) constraints on this element Element idDevice.textShort description Text summary of the resource, for human interpretation Alternate namesnarrative, html, xhtml, display DefinitionA human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| contained | 0..* | Resource | There are no (further) constraints on this element Element idDevice.containedShort description Contained, inline Resources Alternate namesinline resources, anonymous resources, contained resources DefinitionThese resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.
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| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idDevice.extensionShort description Additional content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| modifierExtension | ?! C | 0..* | Extension | There are no (further) constraints on this element Element idDevice.modifierExtensionShort description Extensions that cannot be ignored Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| identifier | 0..* | Identifier | Element idDevice.identifierShort description Instance identifier DefinitionUnique instance identifiers assigned to a device by manufacturers other organizations or owners. The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| definition | C | 0..1 | Reference(DeviceDefinition) | Element idDevice.definitionShort description The reference to the definition for the device DefinitionThe reference to the definition for the device. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| udiCarrier | Σ | 0..* | BackboneElement | Element idDevice.udiCarrierShort description Unique Device Identifier (UDI) Barcode string DefinitionUnique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold. UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| id | 0..1 | string | There are no (further) constraints on this element Element idDevice.udiCarrier.idShort description Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idDevice.udiCarrier.extensionShort description Additional content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| modifierExtension | Σ ?! C | 0..* | Extension | There are no (further) constraints on this element Element idDevice.udiCarrier.modifierExtensionShort description Extensions that cannot be ignored even if unrecognized Alternate namesextensions, user content, modifiers DefinitionMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| deviceIdentifier | Σ | 0..1 | string | Element idDevice.udiCarrier.deviceIdentifierShort description Mandatory fixed portion of UDI Alternate namesDI DefinitionThe device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. Note that FHIR strings SHALL NOT exceed 1MB in size The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| issuer | 0..1 | uri | Element idDevice.udiCarrier.issuerShort description UDI Issuing Organization Alternate namesBarcode System DefinitionOrganization that is charged with issuing UDIs for devices. For example, the US FDA issuers include :
see http://en.wikipedia.org/wiki/Uniform_resource_identifier The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| jurisdiction | 0..1 | uri | Element idDevice.udiCarrier.jurisdictionShort description Regional UDI authority DefinitionThe identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi. Allows a recipient of a UDI to know which database will contain the UDI-associated metadata. see http://en.wikipedia.org/wiki/Uniform_resource_identifier The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| carrierAIDC | Σ | 0..1 | base64Binary | Element idDevice.udiCarrier.carrierAIDCShort description UDI Machine Readable Barcode String Alternate namesAutomatic Identification and Data Capture DefinitionThe full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be base64 encoded. The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| carrierHRF | Σ | 0..1 | string | Element idDevice.udiCarrier.carrierHRFShort description UDI Human Readable Barcode String Alternate namesHuman Readable Form DefinitionThe full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| entryType | 0..1 | codeBinding | Element idDevice.udiCarrier.entryTypeShort description barcode | rfid | manual + DefinitionA coded entry to indicate how the data was entered. Supports a way to distinguish hand entered from machine read data. Note that FHIR strings SHALL NOT exceed 1MB in size Codes to identify how UDI data was entered. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| status | Σ ?! | 0..1 | codeBinding | Element idDevice.statusShort description active | inactive | entered-in-error | unknown DefinitionStatus of the Device availability. This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid. The availability status of the device. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| statusReason | 0..* | CodeableConceptBinding | Element idDevice.statusReasonShort description online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off DefinitionReason for the dtatus of the Device availability. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. The availability status reason of the device. FHIRDeviceStatusReason (extensible) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| distinctIdentifier | 0..1 | string | Element idDevice.distinctIdentifierShort description The distinct identification string Alternate namesDistinct Identification Code (DIC) DefinitionThe distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product. For example, this applies to devices in the United States regulated under Code of Federal Regulation 21CFR§1271.290(c). The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| manufacturer | 0..1 | string | Element idDevice.manufacturerShort description Name of device manufacturer DefinitionA name of the manufacturer. Note that FHIR strings SHALL NOT exceed 1MB in size The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| manufactureDate | 0..1 | dateTime | Element idDevice.manufactureDateShort description Date when the device was made DefinitionThe date and time when the device was manufactured. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| expirationDate | 0..1 | dateTime | Element idDevice.expirationDateShort description Date and time of expiry of this device (if applicable) DefinitionThe date and time beyond which this device is no longer valid or should not be used (if applicable). The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| lotNumber | 0..1 | string | Element idDevice.lotNumberShort description Lot number of manufacture DefinitionLot number assigned by the manufacturer. Note that FHIR strings SHALL NOT exceed 1MB in size The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| serialNumber | 0..1 | string | Element idDevice.serialNumberShort description Serial number assigned by the manufacturer DefinitionThe serial number assigned by the organization when the device was manufactured. Alphanumeric Maximum 20. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| deviceName | 0..* | BackboneElement | Element idDevice.deviceNameShort description The name of the device as given by the manufacturer DefinitionThis represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| id | 0..1 | string | There are no (further) constraints on this element Element idDevice.deviceName.idShort description Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idDevice.deviceName.extensionShort description Additional content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| modifierExtension | Σ ?! C | 0..* | Extension | There are no (further) constraints on this element Element idDevice.deviceName.modifierExtensionShort description Extensions that cannot be ignored even if unrecognized Alternate namesextensions, user content, modifiers DefinitionMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| name | 1..1 | string | Element idDevice.deviceName.nameShort description The name of the device Alternate namesΣ DefinitionThe name of the device. Note that FHIR strings SHALL NOT exceed 1MB in size The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| type | 1..1 | codeBinding | Element idDevice.deviceName.typeShort description udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other DefinitionThe type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName. Note that FHIR strings SHALL NOT exceed 1MB in size The type of name the device is referred by. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| modelNumber | 0..1 | string | Element idDevice.modelNumberShort description The model number for the device DefinitionThe model number for the device. Note that FHIR strings SHALL NOT exceed 1MB in size The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| partNumber | 0..1 | string | Element idDevice.partNumberShort description The part number of the device DefinitionThe part number of the device. Alphanumeric Maximum 20. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| type | 0..1 | CodeableConcept | Element idDevice.typeShort description The kind or type of device DefinitionThe kind or type of device. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Codes to identify medical devices. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| specialization | 0..* | BackboneElement | Element idDevice.specializationShort description The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication DefinitionThe capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| id | 0..1 | string | There are no (further) constraints on this element Element idDevice.specialization.idShort description Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idDevice.specialization.extensionShort description Additional content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| modifierExtension | Σ ?! C | 0..* | Extension | There are no (further) constraints on this element Element idDevice.specialization.modifierExtensionShort description Extensions that cannot be ignored even if unrecognized Alternate namesextensions, user content, modifiers DefinitionMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| systemType | 1..1 | CodeableConcept | Element idDevice.specialization.systemTypeShort description The standard that is used to operate and communicate Alternate namesΣ DefinitionThe standard that is used to operate and communicate. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| version | 0..1 | string | Element idDevice.specialization.versionShort description The version of the standard that is used to operate and communicate DefinitionThe version of the standard that is used to operate and communicate. Note that FHIR strings SHALL NOT exceed 1MB in size The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| version | 0..* | BackboneElement | Element idDevice.versionShort description The actual design of the device or software version running on the device DefinitionThe actual design of the device or software version running on the device. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| id | 0..1 | string | There are no (further) constraints on this element Element idDevice.version.idShort description Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idDevice.version.extensionShort description Additional content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| modifierExtension | Σ ?! C | 0..* | Extension | There are no (further) constraints on this element Element idDevice.version.modifierExtensionShort description Extensions that cannot be ignored even if unrecognized Alternate namesextensions, user content, modifiers DefinitionMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| type | 0..1 | CodeableConcept | Element idDevice.version.typeShort description The type of the device version Alternate namesΣ DefinitionThe type of the device version. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| component | 0..1 | Identifier | Element idDevice.version.componentShort description A single component of the device version DefinitionA single component of the device version. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| value | 1..1 | string | Element idDevice.version.valueShort description The version text DefinitionThe version text. Note that FHIR strings SHALL NOT exceed 1MB in size The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| property | 0..* | BackboneElement | Element idDevice.propertyShort description The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties DefinitionThe actual configuration settings of a device as it actually operates, e.g., regulation status, time properties. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| id | 0..1 | string | There are no (further) constraints on this element Element idDevice.property.idShort description Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idDevice.property.extensionShort description Additional content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| modifierExtension | Σ ?! C | 0..* | Extension | There are no (further) constraints on this element Element idDevice.property.modifierExtensionShort description Extensions that cannot be ignored even if unrecognized Alternate namesextensions, user content, modifiers DefinitionMay be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| type | 1..1 | CodeableConcept | Element idDevice.property.typeShort description Code that specifies the property DeviceDefinitionPropetyCode (Extensible) DefinitionCode that specifies the property DeviceDefinitionPropetyCode (Extensible). Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| valueQuantity | C | 0..* | Quantity | Element idDevice.property.valueQuantityShort description Property value as a quantity DefinitionProperty value as a quantity. The context of use may frequently define what kind of quantity this is and therefore what kind of units can be used. The context of use may also restrict the values for the comparator. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| valueCode | 0..* | CodeableConcept | Element idDevice.property.valueCodeShort description Property value as a code, e.g., NTP4 (synced to NTP) DefinitionProperty value as a code, e.g., NTP4 (synced to NTP). Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| patient | C | 0..1 | Reference(Patient) | Element idDevice.patientShort description Patient to whom Device is affixed DefinitionPatient information, If the device is affixed to a person. If the device is implanted in a patient, then need to associate the device to the patient. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| owner | C | 0..1 | Reference(Organization) | Element idDevice.ownerShort description Organization responsible for device DefinitionAn organization that is responsible for the provision and ongoing maintenance of the device. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| contact | C | 0..* | ContactPoint | Element idDevice.contactShort description Details for human/organization for support DefinitionContact details for an organization or a particular human that is responsible for the device. used for troubleshooting etc. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| location | C | 0..1 | Reference(Location) | Element idDevice.locationShort description Where the device is found DefinitionThe place where the device can be found. Device.location can be used to track device location. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| url | 0..1 | uri | Element idDevice.urlShort description Network address to contact device DefinitionA network address on which the device may be contacted directly. If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| note | 0..* | Annotation | Element idDevice.noteShort description Device notes and comments DefinitionDescriptive information, usage information or implantation information that is not captured in an existing element. For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible). The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| safety | Σ | 0..* | CodeableConcept | Element idDevice.safetyShort description Safety Characteristics of Device DefinitionProvides additional safety characteristics about a medical device. For example devices containing latex. Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| parent | C | 0..1 | Reference(Device) | Element idDevice.parentShort description The parent device DefinitionThe parent device. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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Additional Guidance
manufacturer
SHOULD be present if the Device represents a physical (hardware) device."manufacturer": "Illumina",
deviceName
SHALL be present. Human readable name for the Device."deviceName": [ { "name": "Novaseq 6000", "type": "user-friendly-name" } ],
version
SHOULD be present if known."version": [ { "value": "202308.03" } ]
property
MAY be included where additional attributes of the device needs to be captured. Within the Genomics Community Cloud project it is expected this would likely be free text but may be codified as knowledge of the device landscape and required properties matures."property": [ { "type": { "text": "Sequencing assay name" }, "valueCode": [ { "text": "CEN" } ] } ]