Overview

idΣ0..1id
metaΣ0..1Meta
implicitRulesΣ ?!0..1uri
language0..1codeBinding
textI0..1Narrative
contained0..*Resource
extensionI0..*Extension
modifierExtension?! I0..*Extension
identifier0..0Identifier
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
deviceIdentifierΣ0..1string
nameΣ0..1string
jurisdiction0..1uri
carrierHRFΣ0..1string
carrierAIDCΣ0..1base64Binary
issuer0..1uri
entryType0..1codeBinding
statusΣ ?!1..1codeBindingFixed Value
id0..1string
extensionI0..*Extension
id0..1string
extensionI0..*Extension
systemΣ0..1uri
versionΣ0..1string
codeΣ1..1code
displayΣ0..1string
userSelectedΣ0..1boolean
textΣ0..1string
lotNumber0..0string
manufacturer1..1string
manufactureDate0..0dateTime
expirationDate0..0dateTime
model1..1string
version1..1string
patientI0..0Reference(Patient)
ownerI0..0Reference(Organization)
contactI0..0ContactPoint
locationI0..0Reference(Location)
url0..0uri
note0..*Annotation
safetyΣ0..0CodeableConcept

Details

Device
DefinitionThis resource identifies an instance or a 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. Medical devices include durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment, and research for healthcare and public health. Non-medical devices may include items such as a machine, cellphone, computer, application, etc.
Cardinality0...*
Invariants
  • dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
    contained.contained.empty()
  • dom-1: If the resource is contained in another resource, it SHALL NOT contain any narrative
    contained.text.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
    contained.where(('#'+id in %resource.descendants().reference).not()).empty()
Mappings
  • rim: Entity. Role, or Act
  • rim: Device
  • w5: administrative.device
Device.id
DefinitionThe logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Cardinality0...1
Typeid
SummaryTrue
Comments

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
Device.meta
DefinitionThe metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content may not always be associated with version changes to the resource.
Cardinality0...1
TypeMeta
SummaryTrue
Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
  • rim: N/A
Device.implicitRules
DefinitionA reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content.
Cardinality0...1
Typeuri
ModifierTrue
SummaryTrue
Comments

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.

This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
Device.language
DefinitionThe base language in which the resource is written.
Cardinality0...1
Typecode
Binding
A human language.
Common Languages (extensible)
Comments

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).

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
Device.text
DefinitionA human-readable narrative that contains a summary of the resource, and may 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.
Cardinality0...1
TypeNarrative
Aliasnarrative, html, xhtml, display
Comments

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 in formation is added later.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
  • rim: N/A
  • rim: Act.text?
Device.contained
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.
Cardinality0...*
TypeResource
Aliasinline resources, anonymous resources, contained resources
Comments

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.

Mappings
  • rim: Entity. Role, or Act
  • rim: N/A
Device.extension
DefinitionMay be used to represent additional information that is not part of the basic definition of the resource. In order 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.
Cardinality0...*
TypeExtension
Aliasextensions, user content
Comments

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.

SlicingUnordered, Open, by url(Value)
Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
Device.modifierExtension
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. Usually modifier elements provide negation or qualification. In order 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.
Cardinality0...*
TypeExtension
ModifierTrue
Aliasextensions, user content
Comments

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.

SlicingUnordered, Open, by url(Value)
Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
Device.identifier
DefinitionUnique instance identifiers assigned to a device by manufacturers other organizations or owners.
Cardinality0...0
TypeIdentifier
AliasSerial Number
Comments

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. For UDI, this element corresponds to the variable portion of the UDI that identifies the serial number of a specific device. See UDI mappings for a complete mapping of UDI parts to Device.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (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 - see see identifier pattern at http://wiki.hl7.org/index.php?title=Common_Design_Patterns#Identifier_Pattern for relevant discussion. 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
  • 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.
  • rim: .id
  • w5: id
Device.udi
Definition[Unique device identifier (UDI)](device.html#5.11.3.2.2) assigned to device label or package.
Cardinality0...1
TypeBackboneElement
SummaryTrue
Comments

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.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
  • rim: .id and .code
  • w5: id
Device.udi.id
Definitionunique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Cardinality0...1
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
Device.udi.extension
DefinitionMay be used to represent additional information that is not part of the basic definition of the element. In order 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.
Cardinality0...*
TypeExtension
Aliasextensions, user content
Comments

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.

SlicingUnordered, Open, by url(Value)
Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
Device.udi.modifierExtension
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 that contains it. Usually modifier elements provide negation or qualification. In order 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.
Cardinality0...*
TypeExtension
ModifierTrue
SummaryTrue
Aliasextensions, user content, modifiers
Comments

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.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
Device.udi.deviceIdentifier
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.
Cardinality0...1
Typestring
SummaryTrue
AliasDI
Comments

Note that FHIR strings may not exceed 1MB in size

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
  • 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.
  • rim: Role.id.extension
  • w5: what
Device.udi.name
DefinitionName of device as used in labeling or catalog.
Cardinality0...1
Typestring
SummaryTrue
AliasBrand Name
Comments

Use the Device.type for a generic type or kind of device name. Note the GUDID lists the name as the 'Brand Name'.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
  • udi: Propietary/Trade Name of the medical Device as used in the labeling or catalog
  • rim: .displayName
  • w5: what
Device.udi.jurisdiction
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.
Cardinality0...1
Typeuri
Requirements

Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.

Comments

see http://en.wikipedia.org/wiki/Uniform_resource_identifier

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
  • rim: Role.scoper
Device.udi.carrierHRF
DefinitionThe full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.
Cardinality0...1
Typestring
SummaryTrue
AliasHuman Readable Form
Comments

If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
  • udi: A unique device identifier (UDI) on a device label in plain text
  • rim: Role.id.extension
Device.udi.carrierAIDC
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.
Cardinality0...1
Typebase64Binary
SummaryTrue
AliasAutomatic Identification and Data Capture
Comments

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.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
  • udi: A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology.
  • rim: Role.id.extension
Device.udi.issuer
DefinitionOrganization that is charged with issuing UDIs for devices. For example, the US FDA issuers include : 1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-dI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di.
Cardinality0...1
Typeuri
AliasBarcode System
Comments

see http://en.wikipedia.org/wiki/Uniform_resource_identifier

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
  • 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
  • rim: Role.id.root
Device.udi.entryType
DefinitionA coded entry to indicate how the data was entered.
Cardinality0...1
Typecode
Binding
Codes to identify how UDI data was entered
UDIEntryType (required)
Requirements

Supports a way to distinguish hand entered from machine read data.

Comments

Note that FHIR strings may not exceed 1MB in size

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
  • rim: NA
Device.status
DefinitionStatus of the Device availability.
Cardinality1...1
Typecode
Binding
The availability status of the device.
FHIRDeviceStatus (required)
ModifierTrue
SummaryTrue
Comments

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.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Fixed Value

active

Mappings
  • rim: n/a
  • rim: .statusCode
  • w5: status
  • ACSPIX2FHIR: active
  • GREENDOT: active
  • CDF2FHIR: active
Device.type
DefinitionCode or identifier to identify a kind of device.
Cardinality1...1
TypeCodeableConcept
Binding
Codes to identify medical devices
device-kind (required)
Comments

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.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: CE/CNE/CWE
  • rim: CD
  • orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
  • udi: Type description using GMDN or other code system
  • rim: .code
  • w5: what
  • GLUCI-CHEK: Software
Device.type.id
Definitionunique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Cardinality0...1
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
Device.type.extension
DefinitionMay be used to represent additional information that is not part of the basic definition of the element. In order 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.
Cardinality0...*
TypeExtension
Aliasextensions, user content
Comments

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.

SlicingUnordered, Open, by url(Value)
Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
Device.type.coding
DefinitionA reference to a code defined by a terminology system.
Cardinality1...1
TypeCoding
SummaryTrue
Requirements

Allows for translations and alternate encodings within a code system. Also supports communication of the same instance to systems requiring different encodings.

Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (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
  • v2: C*E.1-8, C*E.10-22
  • rim: union(., ./translation)
  • orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
Device.type.coding.id
Definitionunique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Cardinality0...1
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
Device.type.coding.extension
DefinitionMay be used to represent additional information that is not part of the basic definition of the element. In order 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.
Cardinality0...*
TypeExtension
Aliasextensions, user content
Comments

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.

SlicingUnordered, Open, by url(Value)
Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
  • ext-1: Must have either extensions or value[x], not both
    extension.exists() != value.exists()
Mappings
  • rim: n/a
  • rim: N/A
Device.type.coding.system
DefinitionThe identification of the code system that defines the meaning of the symbol in the code.
Cardinality0...1
Typeuri
SummaryTrue
Requirements

Need to be unambiguous about the source of the definition of the symbol.

Comments

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should de-reference to some definition that establish the system clearly and unambiguously.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: C*E.3
  • rim: ./codeSystem
  • orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
  • ACSPIX2FHIR: http://roche.com/fhir/rdc/cdf
  • GREENDOT: http://roche.com/fhir/rdc/cdf
  • CDF2FHIR: http://roche.com/fhir/rdc/cdf
Device.type.coding.version
DefinitionThe version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured. and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.
Cardinality0...1
Typestring
SummaryTrue
Comments

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: C*E.7
  • rim: ./codeSystemVersion
  • orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
Device.type.coding.code
DefinitionA symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).
Cardinality1...1
Typecode
SummaryTrue
Requirements

Need to refer to a particular code in the system.

Comments

Note that FHIR strings may not exceed 1MB in size

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: C*E.1
  • rim: ./code
  • orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
  • ACSPIX2FHIR: cdf.dev.im
  • GREENDOT: cdf.dev.im
  • CDF2FHIR: cdf.dev.im
Device.type.coding.display
DefinitionA representation of the meaning of the code in the system, following the rules of the system.
Cardinality0...1
Typestring
SummaryTrue
Requirements

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

Comments

Note that FHIR strings may not exceed 1MB in size

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: C*E.2 - but note this is not well followed
  • rim: CV.displayName
  • orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
  • ACSPIX2FHIR: Manual interface
  • GREENDOT: Manual interface
  • CDF2FHIR: Manual interface
Device.type.coding.userSelected
DefinitionIndicates that this coding was chosen by a user directly - i.e. off a pick list of available items (codes or displays).
Cardinality0...1
Typeboolean
SummaryTrue
Requirements

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Comments

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: Sometimes implied by being first
  • rim: CD.codingRationale
  • orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
Device.type.text
DefinitionA human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
Cardinality0...1
Typestring
SummaryTrue
Requirements

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Comments

Very often the text is the same as a displayName of one of the codings.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: C*E.9. But note many systems use C*E.2 for this
  • rim: ./originalText[mediaType/code="text/plain"]/data
  • orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
Device.lotNumber
DefinitionLot number assigned by the manufacturer.
Cardinality0...0
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
  • 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.
  • rim: .lotNumberText
  • w5: what
Device.manufacturer
DefinitionActual options: "Roche" and "mySugr"
Cardinality1...1
Typestring
Comments

Actual options: "Roche" and "mySugr"

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
  • udi: N/A
  • rim: .playedRole[typeCode=MANU].scoper.name
  • w5: what
  • ACSPIX2FHIR: Roche
  • GREENDOT: Roche
  • CDF2FHIR: Roche
Device.manufactureDate
DefinitionThe date and time when the device was manufactured.
Cardinality0...0
TypedateTime
Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
  • 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”.
  • rim: .existenceTime.low
  • w5: what
Device.expirationDate
DefinitionThe date and time beyond which this device is no longer valid or should not be used (if applicable).
Cardinality0...0
TypedateTime
Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
  • 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”.
  • rim: .expirationTime
  • w5: what
Device.model
DefinitionThe "model" is an identifier assigned by the manufacturer to identify the product by its type. This number is shared by the all devices sold as the same type.
Cardinality1...1
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
  • rim: .playedRole[typeCode=MANU].code
  • w5: what
  • ACSPIX2FHIR: source
  • GREENDOT: GreenDot
  • GLUCI-CHEK: ACSPIX.SN
  • CDF2FHIR: source
Device.version
DefinitionThe version of the device, if the device has multiple releases under the same model, or if the device is software or carries firmware.
Cardinality1...1
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
  • rim: .softwareName (included as part)
  • w5: what
  • ACSPIX2FHIR: version
  • GREENDOT: software version
  • GLUCI-CHEK: ACSPIX.Ver
  • CDF2FHIR: version
Device.patient
DefinitionPatient information, If the device is affixed to a person.
Cardinality0...0
TypeReference(Patient)
Requirements

If the device is implanted in a patient, then need to associate the device to the patient.

Comments

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.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (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 %resource.contained.id.trace('ids'))
Mappings
  • rim: n/a
  • rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
  • rim: .playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT]
  • w5: who.focus
Device.owner
DefinitionAn organization that is responsible for the provision and ongoing maintenance of the device.
Cardinality0...0
TypeReference(Organization)
Comments

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.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (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 %resource.contained.id.trace('ids'))
Mappings
  • rim: n/a
  • rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
  • rim: .playedRole[typeCode=OWN].scoper
  • w5: who.source
Device.contact
DefinitionContact details for an organization or a particular human that is responsible for the device.
Cardinality0...0
TypeContactPoint
Comments

used for troubleshooting etc.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (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
  • rim: .scopedRole[typeCode=CON].player
  • w5: who.source
Device.location
DefinitionThe place where the device can be found.
Cardinality0...0
TypeReference(Location)
Requirements

Device.location can be used to track device location.

Comments

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.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (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 %resource.contained.id.trace('ids'))
Mappings
  • rim: n/a
  • rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
  • rim: .playedRole[typeCode=LOCE].scoper
  • w5: where
Device.url
DefinitionA network address on which the device may be contacted directly.
Cardinality0...0
Typeuri
Comments

If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
  • rim: .telecom
  • w5: where
Device.note
DefinitionDescriptive information, usage information or implantation information that is not captured in an existing element.
Cardinality0...*
TypeAnnotation
Comments

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).

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: N/A
  • rim: Act
  • rim: .text
Device.safety
DefinitionProvides additional safety characteristics about a medical device. For example devices containing latex.
Cardinality0...0
TypeCodeableConcept
Binding
Codes used to identify medical devices safety characterics. These codes are derived in part from the [United States Food and Drug Administration recommendations](http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm107708.pdf) and are provided here as a suggestive example.
DeviceSafety (example)
SummaryTrue
Comments

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.

Invariants
  • ele-1: All FHIR elements must have a @value or children
    hasValue() | (children().count() > id.count())
Mappings
  • rim: n/a
  • v2: CE/CNE/CWE
  • rim: CD
  • orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
  • rim: NA

Table

Device..
Device.identifier..0
Device.status1..
Device.type1..
Device.type.coding1..1
Device.type.coding.system..
Device.type.coding.code1..
Device.type.coding.display..
Device.lotNumber..0
Device.manufacturer1..
Device.manufactureDate..0
Device.expirationDate..0
Device.model1..
Device.version1..
Device.patient..0
Device.owner..0
Device.contact..0
Device.location..0
Device.url..0
Device.safety..0

XML

idΣ0..1id
metaΣ0..1Meta
implicitRulesΣ ?!0..1uri
language0..1codeBinding
textI0..1Narrative
contained0..*Resource
extensionI0..*Extension
modifierExtension?! I0..*Extension
identifier0..0Identifier
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
deviceIdentifierΣ0..1string
nameΣ0..1string
jurisdiction0..1uri
carrierHRFΣ0..1string
carrierAIDCΣ0..1base64Binary
issuer0..1uri
entryType0..1codeBinding
statusΣ ?!1..1codeBindingFixed Value
id0..1string
extensionI0..*Extension
id0..1string
extensionI0..*Extension
systemΣ0..1uri
versionΣ0..1string
codeΣ1..1code
displayΣ0..1string
userSelectedΣ0..1boolean
textΣ0..1string
lotNumber0..0string
manufacturer1..1string
manufactureDate0..0dateTime
expirationDate0..0dateTime
model1..1string
version1..1string
patientI0..0Reference(Patient)
ownerI0..0Reference(Organization)
contactI0..0ContactPoint
locationI0..0Reference(Location)
url0..0uri
note0..*Annotation
safetyΣ0..0CodeableConcept

JSON

{
    "resourceType": "StructureDefinition",
    "id": "8c41a3a4-590b-47f3-a30d-4bb2533ac7ea",
    "meta": {
        "versionId": "17",
        "lastUpdated": "2019-06-24T12:18:45.2236762+00:00"
    },
    "url": "http://roche.com/fhir/rdc/StructureDefinition/phg-device",
    "version": "1",
    "name": "phg-device",
    "status": "active",
    "date": "2019-06-24T12:18:44.899747+00:00",
    "description": "A Device represents a gateway or PHG",
    "fhirVersion": "3.0.1",
    "mapping":  [
        {
            "identity": "ACSPIX2FHIR",
            "name": "ACSPIX"
        },
        {
            "identity": "GREENDOT",
            "name": "Greendot"
        },
        {
            "identity": "GLUCI-CHEK",
            "name": "FHIR2ACSPIX"
        },
        {
            "identity": "CDF2FHIR",
            "name": "CDF2FHIR"
        }
    ],
    "kind": "resource",
    "abstract": false,
    "type": "Device",
    "baseDefinition": "http://hl7.org/fhir/StructureDefinition/Device",
    "derivation": "constraint",
    "differential": {
        "element":  [
            {
                "id": "Device.identifier",
                "path": "Device.identifier",
                "max": "0"
            },
            {
                "id": "Device.status",
                "path": "Device.status",
                "min": 1,
                "fixedCode": "active",
                "mapping":  [
                    {
                        "identity": "ACSPIX2FHIR",
                        "map": "active",
                        "comment": "Fixed value"
                    },
                    {
                        "identity": "GREENDOT",
                        "map": "active",
                        "comment": "Fixed value"
                    },
                    {
                        "identity": "CDF2FHIR",
                        "map": "active",
                        "comment": "."
                    }
                ]
            },
            {
                "id": "Device.type",
                "path": "Device.type",
                "min": 1,
                "binding": {
                    "strength": "required",
                    "valueSetReference": {
                        "reference": "http://roche.com/fhir/rdc/ValueSet/device-kind"
                    }
                },
                "mapping":  [
                    {
                        "identity": "GLUCI-CHEK",
                        "map": "Software",
                        "comment": "Hardcoded value for Gluci-Check"
                    }
                ]
            },
            {
                "id": "Device.type.coding",
                "path": "Device.type.coding",
                "min": 1,
                "max": "1"
            },
            {
                "id": "Device.type.coding.system",
                "path": "Device.type.coding.system",
                "mapping":  [
                    {
                        "identity": "ACSPIX2FHIR",
                        "map": "http://roche.com/fhir/rdc/cdf",
                        "comment": "Fixed value"
                    },
                    {
                        "identity": "GREENDOT",
                        "map": "http://roche.com/fhir/rdc/cdf",
                        "comment": "Fixed value"
                    },
                    {
                        "identity": "CDF2FHIR",
                        "map": "http://roche.com/fhir/rdc/cdf"
                    }
                ]
            },
            {
                "id": "Device.type.coding.code",
                "path": "Device.type.coding.code",
                "min": 1,
                "mapping":  [
                    {
                        "identity": "ACSPIX2FHIR",
                        "map": "cdf.dev.im",
                        "comment": "Fixed value"
                    },
                    {
                        "identity": "GREENDOT",
                        "map": "cdf.dev.im",
                        "comment": "Fixed value"
                    },
                    {
                        "identity": "CDF2FHIR",
                        "map": "cdf.dev.im"
                    }
                ]
            },
            {
                "id": "Device.type.coding.display",
                "extension":  [
                    {
                        "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable",
                        "valueBoolean": true
                    }
                ],
                "path": "Device.type.coding.display",
                "mapping":  [
                    {
                        "identity": "ACSPIX2FHIR",
                        "map": "Manual interface",
                        "comment": "Fixed value"
                    },
                    {
                        "identity": "GREENDOT",
                        "map": "Manual interface",
                        "comment": "Fixed value"
                    },
                    {
                        "identity": "CDF2FHIR",
                        "map": "Manual interface"
                    }
                ]
            },
            {
                "id": "Device.lotNumber",
                "path": "Device.lotNumber",
                "max": "0"
            },
            {
                "id": "Device.manufacturer",
                "path": "Device.manufacturer",
                "short": "Actual options: \"Roche\" and \"mySugr\"",
                "definition": "Actual options: \"Roche\" and \"mySugr\"",
                "comment": "Actual options: \"Roche\" and \"mySugr\"",
                "min": 1,
                "mapping":  [
                    {
                        "identity": "ACSPIX2FHIR",
                        "map": "Roche",
                        "comment": "Fixed value"
                    },
                    {
                        "identity": "GREENDOT",
                        "map": "Roche",
                        "comment": "APP.MANUFACTURER = 'Roche'"
                    },
                    {
                        "identity": "CDF2FHIR",
                        "map": "Roche"
                    }
                ]
            },
            {
                "id": "Device.manufactureDate",
                "path": "Device.manufactureDate",
                "max": "0"
            },
            {
                "id": "Device.expirationDate",
                "path": "Device.expirationDate",
                "max": "0"
            },
            {
                "id": "Device.model",
                "path": "Device.model",
                "min": 1,
                "mapping":  [
                    {
                        "identity": "ACSPIX2FHIR",
                        "map": "source",
                        "comment": "Its mapped from metadata.source from aws"
                    },
                    {
                        "identity": "GREENDOT",
                        "map": "GreenDot",
                        "comment": "Fixed value"
                    },
                    {
                        "identity": "GLUCI-CHEK",
                        "map": "ACSPIX.SN",
                        "comment": "Mapped to ACSPIX tag SN attribute"
                    },
                    {
                        "identity": "CDF2FHIR",
                        "map": "source"
                    }
                ]
            },
            {
                "id": "Device.version",
                "path": "Device.version",
                "min": 1,
                "mapping":  [
                    {
                        "identity": "ACSPIX2FHIR",
                        "map": "version",
                        "comment": "Its mapped from metadata.version from aws"
                    },
                    {
                        "identity": "GREENDOT",
                        "map": "software version",
                        "comment": "packageManager.getPackageInfo(packageName, 0).versionName"
                    },
                    {
                        "identity": "GLUCI-CHEK",
                        "map": "ACSPIX.Ver",
                        "comment": "Mapped to ACSPIX Tag Ver attribute"
                    },
                    {
                        "identity": "CDF2FHIR",
                        "map": "version"
                    }
                ]
            },
            {
                "id": "Device.patient",
                "path": "Device.patient",
                "max": "0"
            },
            {
                "id": "Device.owner",
                "path": "Device.owner",
                "max": "0"
            },
            {
                "id": "Device.contact",
                "path": "Device.contact",
                "max": "0"
            },
            {
                "id": "Device.location",
                "path": "Device.location",
                "max": "0"
            },
            {
                "id": "Device.url",
                "path": "Device.url",
                "max": "0"
            },
            {
                "id": "Device.safety",
                "path": "Device.safety",
                "max": "0"
            }
        ]
    }
}

Examples