| MII_PR_Bildgebung_Geraet (Device) | C | | Device | There are no (further) constraints on this element Element idDevice Short descriptionItem 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.
Data typeDevice Constraints- dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
contained.contained.empty() - dom-4: 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-3: 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-6: A resource should have narrative for robust management
text.`div`.exists() - dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
contained.meta.security.empty() Mappings- rim: Entity. Role, or Act
- rim: Device
|
| id | S Σ | 0..1 | string | There are no (further) constraints on this element Element idDevice.id Short descriptionLogical id of this artifact DefinitionThe logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
CommentsThe only time that a resource does not have an id is when it is being submitted to the server using a create operation.
Data typestring |
| meta | S Σ | 0..1 | Meta | There are no (further) constraints on this element Element idDevice.meta Short descriptionMetadata 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.
Data typeMeta ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings |
| id | | 0..1 | string | There are no (further) constraints on this element Element idDevice.meta.id Short descriptionUnique 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.
Data typestring Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idDevice.meta.extension Short descriptionAdditional 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.
CommentsThere 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.
Data typeExtension SlicingUnordered, 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- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists() Mappings |
| versionId | Σ | 0..1 | id | There are no (further) constraints on this element Element idDevice.meta.versionId Short descriptionVersion specific identifier DefinitionThe version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.
CommentsThe server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.
Data typeid ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings |
| lastUpdated | Σ | 0..1 | instant | There are no (further) constraints on this element Element idDevice.meta.lastUpdated Short descriptionWhen the resource version last changed DefinitionWhen the resource last changed - e.g. when the version changed.
CommentsThis value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.
Data typeinstant ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings |
| source | S Σ | 0..1 | uri | There are no (further) constraints on this element Element idDevice.meta.source Short descriptionIdentifies where the resource comes from DefinitionA uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.
CommentsIn the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used.
This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.
Data typeuri ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings |
| profile | S Σ | 0..* | canonical(StructureDefinition) | There are no (further) constraints on this element Element idDevice.meta.profile Short descriptionProfiles this resource claims to conform to DefinitionCommentsIt is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.
Data typecanonical(StructureDefinition) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings |
| security | Σ | 0..* | CodingBinding | There are no (further) constraints on this element Element idDevice.meta.security Short descriptionSecurity Labels applied to this resource DefinitionSecurity labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.
CommentsThe security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.
Data typeCoding BindingSecurity Labels from the Healthcare Privacy and Security Classification System.
All Security Labels (extensible) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6
- rim: CV
- orim: fhir:Coding rdfs:subClassOf dt:CDCoding
|
| tag | Σ | 0..* | Coding | There are no (further) constraints on this element Element idDevice.meta.tag Short descriptionTags applied to this resource DefinitionTags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.
CommentsThe tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.
Data typeCoding BindingCodes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
CommonTags (example) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6
- rim: CV
- orim: fhir:Coding rdfs:subClassOf dt:CDCoding
|
| implicitRules | Σ ?! | 0..1 | uri | There are no (further) constraints on this element Element idDevice.implicitRules Short descriptionA 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.
CommentsAsserting 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.
Data typeuri ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings |
| language | | 0..1 | codeBinding | There are no (further) constraints on this element Element idDevice.language Short descriptionLanguage of the resource content DefinitionThe base language in which the resource is written.
CommentsLanguage 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).
Data typecode BindingCommonLanguages (preferred) Binding extensionsConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings |
| text | | 0..1 | Narrative | There are no (further) constraints on this element Element idDevice.text Short descriptionText 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.
CommentsContained 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.
Data typeNarrative ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- rim: N/A
- rim: Act.text?
|
| contained | | 0..* | Resource | There are no (further) constraints on this element Element idDevice.contained Short descriptionContained, 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.
CommentsThis 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.
Data typeResource Mappings- rim: Entity. Role, or Act
- rim: N/A
|
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idDevice.extension Short descriptionAdditional 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.
CommentsThere 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.
Data typeExtension SlicingUnordered, 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- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists() Mappings |
| modifierExtension | ?! C | 0..* | Extension | There are no (further) constraints on this element Element idDevice.modifierExtension Short descriptionExtensions 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).
RequirementsModifier 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.
CommentsThere 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.
Data typeExtension SlicingUnordered, 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- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists() Mappings |
| identifier | | 0..* | Identifier | There are no (further) constraints on this element Element idDevice.identifier Short descriptionInstance identifier DefinitionUnique instance identifiers assigned to a device by manufacturers other organizations or owners.
CommentsThe 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.
Data typeIdentifier ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- v2: CX / EI (occasionally, more often EI maps to a resource id or a URL)
- rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]
- servd: Identifier
- w5: FiveWs.identifier
- rim: .id
- udi: The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty.
|
| definition | C | 0..1 | Reference(DeviceDefinition) | There are no (further) constraints on this element Element idDevice.definition Short descriptionThe reference to the definition for the device DefinitionThe reference to the definition for the device.
CommentsReferences 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.
Data typeReference(DeviceDefinition) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1: SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) Mappings- rim: n/a
- rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
|
| udiCarrier | Σ | 0..* | BackboneElement | There are no (further) constraints on this element Element idDevice.udiCarrier Short descriptionUnique 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.
CommentsUDI 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.
Data typeBackboneElement ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- w5: FiveWs.identifier
- rim: .id and .code
|
| id | | 0..1 | string | There are no (further) constraints on this element Element idDevice.udiCarrier.id Short descriptionUnique 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.
Data typestring Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idDevice.udiCarrier.extension Short descriptionAdditional 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.
CommentsThere 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.
Data typeExtension SlicingUnordered, 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- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists() Mappings |
| modifierExtension | Σ ?! C | 0..* | Extension | There are no (further) constraints on this element Element idDevice.udiCarrier.modifierExtension Short descriptionExtensions 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).
RequirementsModifier 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.
CommentsThere 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.
Data typeExtension ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists() Mappings |
| deviceIdentifier | Σ | 0..1 | string | There are no (further) constraints on this element Element idDevice.udiCarrier.deviceIdentifier Short descriptionMandatory 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.
CommentsNote that FHIR strings SHALL NOT exceed 1MB in size
Data typestring ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- w5: FiveWs.what[x]
- rim: Role.id.extension
- udi: The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
|
| issuer | | 0..1 | uri | There are no (further) constraints on this element Element idDevice.udiCarrier.issuer Short descriptionUDI Issuing Organization Alternate namesBarcode System DefinitionOrganization that is charged with issuing UDIs for devices. For example, the US FDA issuers include :
- GS1:
http://hl7.org/fhir/NamingSystem/gs1-di,
- HIBCC:
http://hl7.org/fhir/NamingSystem/hibcc-dI,
- ICCBBA for blood containers:
http://hl7.org/fhir/NamingSystem/iccbba-blood-di,
- ICCBA for other devices:
http://hl7.org/fhir/NamingSystem/iccbba-other-di.
Commentssee http://en.wikipedia.org/wiki/Uniform_resource_identifier
Data typeuri ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- rim: Role.id.root
- udi: All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency.
GS1 DIs:
http://hl7.org/fhir/NamingSystem/gs1
HIBCC DIs:
http://hl7.org/fhir/NamingSystem/hibcc
ICCBBA DIs for blood containers:
http://hl7.org/fhir/NamingSystem/iccbba-blood
ICCBA DIs for other devices:
http://hl7.org/fhir/NamingSystem/iccbba-other
|
| jurisdiction | | 0..1 | uri | There are no (further) constraints on this element Element idDevice.udiCarrier.jurisdiction Short descriptionRegional 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.
RequirementsAllows a recipient of a UDI to know which database will contain the UDI-associated metadata.
Commentssee http://en.wikipedia.org/wiki/Uniform_resource_identifier
Data typeuri ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings |
| carrierAIDC | Σ | 0..1 | base64Binary | There are no (further) constraints on this element Element idDevice.udiCarrier.carrierAIDC Short descriptionUDI 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.
CommentsThe 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.
Data typebase64Binary ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- rim: Role.id.extension
- udi: A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology.
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| carrierHRF | Σ | 0..1 | string | There are no (further) constraints on this element Element idDevice.udiCarrier.carrierHRF Short descriptionUDI 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.
CommentsIf separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.
Data typestring ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- rim: Role.id.extension
- udi: A unique device identifier (UDI) on a device label in plain text
|
| entryType | | 0..1 | codeBinding | There are no (further) constraints on this element Element idDevice.udiCarrier.entryType Short descriptionbarcode | rfid | manual + DefinitionA coded entry to indicate how the data was entered.
RequirementsSupports a way to distinguish hand entered from machine read data.
CommentsNote that FHIR strings SHALL NOT exceed 1MB in size
Data typecode BindingCodes to identify how UDI data was entered.
UDIEntryType (required) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings |
| status | Σ ?! | 0..1 | codeBinding | There are no (further) constraints on this element Element idDevice.status Short descriptionactive | inactive | entered-in-error | unknown DefinitionStatus of the Device availability.
CommentsThis 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.
Data typecode BindingThe availability status of the device.
FHIRDeviceStatus (required) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- w5: FiveWs.status
- rim: .statusCode
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| statusReason | | 0..* | CodeableConceptBinding | There are no (further) constraints on this element Element idDevice.statusReason Short descriptiononline | paused | standby | offline | not-ready | transduc-discon | hw-discon | off DefinitionReason for the dtatus of the Device availability.
CommentsNot 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.
Data typeCodeableConcept BindingThe availability status reason of the device.
FHIRDeviceStatusReason (extensible) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- v2: CE/CNE/CWE
- rim: CD
- orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
- w5: FiveWs.status
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| distinctIdentifier | | 0..1 | string | There are no (further) constraints on this element Element idDevice.distinctIdentifier Short descriptionThe 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.
CommentsFor example, this applies to devices in the United States regulated under Code of Federal Regulation 21CFR§1271.290(c).
Data typestring ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- w5: FiveWs.what[x]
- rim: .lotNumberText
- udi: The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.
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| manufacturer | S | 0..1 | string | Element idDevice.manufacturer Short descriptionHersteller DefinitionHersteller des Aufnahmegeräts
CommentsNote that FHIR strings SHALL NOT exceed 1MB in size
Data typestring ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- w5: FiveWs.what[x]
- rim: .playedRole[typeCode=MANU].scoper.name
- udi: N/A
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| manufactureDate | | 0..1 | dateTime | There are no (further) constraints on this element Element idDevice.manufactureDate Short descriptionDate when the device was made DefinitionThe date and time when the device was manufactured.
Data typedateTime ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- w5: FiveWs.what[x]
- rim: .existenceTime.low
- udi: The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
|
| expirationDate | | 0..1 | dateTime | There are no (further) constraints on this element Element idDevice.expirationDate Short descriptionDate 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).
Data typedateTime ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- w5: FiveWs.what[x]
- rim: .expirationTime
- udi: the expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
|
| lotNumber | | 0..1 | string | There are no (further) constraints on this element Element idDevice.lotNumber Short descriptionLot number of manufacture DefinitionLot number assigned by the manufacturer.
CommentsNote that FHIR strings SHALL NOT exceed 1MB in size
Data typestring ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- w5: FiveWs.what[x]
- rim: .lotNumberText
- udi: The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.
|
| serialNumber | | 0..1 | string | There are no (further) constraints on this element Element idDevice.serialNumber Short descriptionSerial number assigned by the manufacturer DefinitionThe serial number assigned by the organization when the device was manufactured.
CommentsData typestring ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- w5: FiveWs.what[x]
- rim: .playedRole[typeCode=MANU].id
|
| deviceName | S | 0..* | BackboneElement | Element idDevice.deviceName Short descriptionGerätename DefinitionName und Modell des Aufnahmegeräts
Data typeBackboneElement ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings |
| id | | 0..1 | string | There are no (further) constraints on this element Element idDevice.deviceName.id Short descriptionUnique 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.
Data typestring Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idDevice.deviceName.extension Short descriptionAdditional 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.
CommentsThere 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.
Data typeExtension SlicingUnordered, 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- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists() Mappings |
| modifierExtension | Σ ?! C | 0..* | Extension | There are no (further) constraints on this element Element idDevice.deviceName.modifierExtension Short descriptionExtensions 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).
RequirementsModifier 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.
CommentsThere 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.
Data typeExtension ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists() Mappings |
| name | | 1..1 | string | There are no (further) constraints on this element Element idDevice.deviceName.name Short descriptionThe name of the device Alternate namesΣ DefinitionCommentsNote that FHIR strings SHALL NOT exceed 1MB in size
Data typestring ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings |
| type | | 1..1 | codeBinding | Element idDevice.deviceName.type Short descriptionudi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other DefinitionThe type of deviceName.
UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName.
CommentsNote that FHIR strings SHALL NOT exceed 1MB in size
Data typecode BindingThe type of name the device is referred by.
DeviceNameType (required) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- w5: FiveWs.what[x]
- rim: .playedRole[typeCode=MANU].code
|
| modelNumber | | 0..1 | string | There are no (further) constraints on this element Element idDevice.modelNumber Short descriptionThe model number for the device DefinitionThe model number for the device.
CommentsNote that FHIR strings SHALL NOT exceed 1MB in size
Data typestring ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- w5: FiveWs.what[x]
- rim: .softwareName (included as part)
|
| partNumber | | 0..1 | string | There are no (further) constraints on this element Element idDevice.partNumber Short descriptionThe part number of the device DefinitionThe part number of the device.
CommentsData typestring ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- w5: FiveWs.what[x]
- rim: .playedRole[typeCode=MANU].id
|
| type | | 0..1 | CodeableConcept | There are no (further) constraints on this element Element idDevice.type Short descriptionThe kind or type of device DefinitionThe kind or type of device.
CommentsNot 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.
Data typeCodeableConcept BindingCodes to identify medical devices.
DeviceType (example) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- v2: CE/CNE/CWE
- rim: CD
- orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
|
| specialization | | 0..* | BackboneElement | There are no (further) constraints on this element Element idDevice.specialization Short descriptionThe 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.
Data typeBackboneElement ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings |
| id | | 0..1 | string | There are no (further) constraints on this element Element idDevice.specialization.id Short descriptionUnique 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.
Data typestring Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idDevice.specialization.extension Short descriptionAdditional 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.
CommentsThere 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.
Data typeExtension SlicingUnordered, 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- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists() Mappings |
| modifierExtension | Σ ?! C | 0..* | Extension | There are no (further) constraints on this element Element idDevice.specialization.modifierExtension Short descriptionExtensions 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).
RequirementsModifier 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.
CommentsThere 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.
Data typeExtension ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists() Mappings |
| systemType | | 1..1 | CodeableConcept | There are no (further) constraints on this element Element idDevice.specialization.systemType Short descriptionThe standard that is used to operate and communicate Alternate namesΣ DefinitionThe standard that is used to operate and communicate.
CommentsNot 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.
Data typeCodeableConcept ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- v2: CE/CNE/CWE
- rim: CD
- orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
|
| version | | 0..1 | string | There are no (further) constraints on this element Element idDevice.specialization.version Short descriptionThe version of the standard that is used to operate and communicate DefinitionThe version of the standard that is used to operate and communicate.
CommentsNote that FHIR strings SHALL NOT exceed 1MB in size
Data typestring ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- w5: FiveWs.what[x]
|
| version | | 0..* | BackboneElement | There are no (further) constraints on this element Element idDevice.version Short descriptionThe 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.
Data typeBackboneElement ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings |
| id | | 0..1 | string | There are no (further) constraints on this element Element idDevice.version.id Short descriptionUnique 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.
Data typestring Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idDevice.version.extension Short descriptionAdditional 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.
CommentsThere 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.
Data typeExtension SlicingUnordered, 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- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists() Mappings |
| modifierExtension | Σ ?! C | 0..* | Extension | There are no (further) constraints on this element Element idDevice.version.modifierExtension Short descriptionExtensions 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).
RequirementsModifier 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.
CommentsThere 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.
Data typeExtension ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists() Mappings |
| type | | 0..1 | CodeableConcept | There are no (further) constraints on this element Element idDevice.version.type Short descriptionThe type of the device version Alternate namesΣ DefinitionThe type of the device version.
CommentsNot 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.
Data typeCodeableConcept ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- v2: CE/CNE/CWE
- rim: CD
- orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
|
| component | | 0..1 | Identifier | There are no (further) constraints on this element Element idDevice.version.component Short descriptionA single component of the device version DefinitionA single component of the device version.
Data typeIdentifier ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- v2: CX / EI (occasionally, more often EI maps to a resource id or a URL)
- rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]
- servd: Identifier
- w5: FiveWs.what[x]
|
| value | | 1..1 | string | There are no (further) constraints on this element Element idDevice.version.value Short descriptionThe version text DefinitionCommentsNote that FHIR strings SHALL NOT exceed 1MB in size
Data typestring ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings |
| property | | 0..* | BackboneElement | There are no (further) constraints on this element Element idDevice.property Short descriptionThe 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.
Data typeBackboneElement ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings |
| id | | 0..1 | string | There are no (further) constraints on this element Element idDevice.property.id Short descriptionUnique 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.
Data typestring Mappings |
| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idDevice.property.extension Short descriptionAdditional 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.
CommentsThere 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.
Data typeExtension SlicingUnordered, 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- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists() Mappings |
| modifierExtension | Σ ?! C | 0..* | Extension | There are no (further) constraints on this element Element idDevice.property.modifierExtension Short descriptionExtensions 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).
RequirementsModifier 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.
CommentsThere 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.
Data typeExtension ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ext-1: Must have either extensions or value[x], not both
extension.exists() != value.exists() Mappings |
| type | | 1..1 | CodeableConcept | There are no (further) constraints on this element Element idDevice.property.type Short descriptionCode that specifies the property DeviceDefinitionPropetyCode (Extensible) DefinitionCode that specifies the property DeviceDefinitionPropetyCode (Extensible).
CommentsNot 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.
Data typeCodeableConcept ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- v2: CE/CNE/CWE
- rim: CD
- orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
|
| valueQuantity | C | 0..* | Quantity | There are no (further) constraints on this element Element idDevice.property.valueQuantity Short descriptionProperty value as a quantity DefinitionProperty value as a quantity.
CommentsThe 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.
Data typeQuantity ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - qty-3: If a code for the unit is present, the system SHALL also be present
code.empty() or system.exists() Mappings- rim: n/a
- v2: SN (see also Range) or CQ
- rim: PQ, IVL<PQ>, MO, CO, depending on the values
|
| valueCode | | 0..* | CodeableConcept | There are no (further) constraints on this element Element idDevice.property.valueCode Short descriptionProperty value as a code, e.g., NTP4 (synced to NTP) DefinitionProperty value as a code, e.g., NTP4 (synced to NTP).
CommentsNot 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.
Data typeCodeableConcept ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- v2: CE/CNE/CWE
- rim: CD
- orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
|
| patient | C | 0..1 | Reference(Patient) | There are no (further) constraints on this element Element idDevice.patient Short descriptionPatient to whom Device is affixed DefinitionPatient information, If the device is affixed to a person.
RequirementsIf the device is implanted in a patient, then need to associate the device to the patient.
CommentsReferences 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.
Data typeReference(Patient) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1: SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) Mappings- rim: n/a
- rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- w5: FiveWs.subject[x]
- rim: .playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT]
- w5: FiveWs.subject
|
| owner | C | 0..1 | Reference(Organization) | There are no (further) constraints on this element Element idDevice.owner Short descriptionOrganization responsible for device DefinitionAn organization that is responsible for the provision and ongoing maintenance of the device.
CommentsReferences 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.
Data typeReference(Organization) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1: SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) Mappings- rim: n/a
- rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- w5: FiveWs.source
- rim: .playedRole[typeCode=OWN].scoper
|
| contact | C | 0..* | ContactPoint | There are no (further) constraints on this element Element idDevice.contact Short descriptionDetails for human/organization for support DefinitionContact details for an organization or a particular human that is responsible for the device.
Commentsused for troubleshooting etc.
Data typeContactPoint ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - cpt-2: A system is required if a value is provided.
value.empty() or system.exists() Mappings- rim: n/a
- v2: XTN
- rim: TEL
- servd: ContactPoint
- w5: FiveWs.source
- rim: .scopedRole[typeCode=CON].player
|
| location | C | 0..1 | Reference(Location) | There are no (further) constraints on this element Element idDevice.location Short descriptionWhere the device is found DefinitionThe place where the device can be found.
RequirementsDevice.location can be used to track device location.
CommentsReferences 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.
Data typeReference(Location) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1: SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) Mappings- rim: n/a
- rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
- w5: FiveWs.where[x]
- rim: .playedRole[typeCode=LOCE].scoper
|
| url | | 0..1 | uri | There are no (further) constraints on this element Element idDevice.url Short descriptionNetwork address to contact device DefinitionA network address on which the device may be contacted directly.
CommentsIf the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.
Data typeuri ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- w5: FiveWs.where[x]
- rim: .telecom
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| note | | 0..* | Annotation | There are no (further) constraints on this element Element idDevice.note Short descriptionDevice notes and comments DefinitionDescriptive information, usage information or implantation information that is not captured in an existing element.
CommentsFor 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).
Data typeAnnotation ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- v2: N/A
- rim: Act
- rim: .text
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| safety | Σ | 0..* | CodeableConcept | There are no (further) constraints on this element Element idDevice.safety Short descriptionSafety Characteristics of Device DefinitionProvides additional safety characteristics about a medical device. For example devices containing latex.
CommentsNot 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.
Data typeCodeableConcept ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) Mappings- rim: n/a
- v2: CE/CNE/CWE
- rim: CD
- orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
- rim: NA
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| parent | C | 0..1 | Reference(Device) | There are no (further) constraints on this element Element idDevice.parent Short descriptionThe parent device DefinitionCommentsReferences 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.
Data typeReference(Device) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints- ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count()) - ref-1: SHALL have a contained resource if a local reference is provided
reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) Mappings- rim: n/a
- rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
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