Device Model

• dev-1: only one Device.name.display SHALL be true when there is more than one Device.name
  name.where(display=true).count() <= 1
• dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
  contained.contained.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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).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-5: If a resource is contained in another resource, it SHALL NOT have a security label
  contained.meta.security.empty()
• dom-6: A resource should have narrative for robust management
  text.`div`.exists()

• rim: Entity, Role, or Act,Device
• w5: administrative.device
• interface: Participant

Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.

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

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

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

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).

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

Contained resources do not have a 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.

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

• rim: Act.text?

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

• rim: N/A

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.

• 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()

• rim: N/A

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

• 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()

• rim: N/A

Certain attributes, like serial number and UDI Carrier (the HRF or AIDC barcode string) are not device instance identifiers as they are not consistently able to uniquely identify the instance of a device, thus are not appropriate to be used to value Device.identifier. The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. The identifier is typically valued if the serialNumber or lotNumber is not valued and represents a different type of identifier. However, it is permissible to still include those identifiers in DeviceDefinition.identifier with the appropriate identifier.type.

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

• w5: FiveWs.identifier
• rim: .id
• interface: Participant.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.

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

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

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.

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

• w5: FiveWs.identifier
• rim: .id and .code

• rim: n/a

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.

• 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()

• rim: n/a

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

• 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()

• rim: N/A

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

• 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.

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

• 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

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

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

• rim: Role.scoper

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.

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

• 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.

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

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

• rim: Role.id.extension
• udi: A unique device identifier (UDI) on a device label in plain text

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

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

• rim: NA

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

• w5: FiveWs.status
• rim: .statusCode
• interface: Participant.active

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

• w5: FiveWs.status

Necessary to support mandatory requirements for traceability from donor/source to recipient and vice versa, while also satisfying donor anonymity requirements. The element is defined consistently across BiologicallyDerivedProduct, NutritionProduct, and Device. The identifier references an event that links to a single biological entity such as a blood donor, or to multiple biological entities (e.g. when the product is an embryo or a pooled platelet product). A single biologicalSourceEvent identifier may appear on multiple products of many types derived from a single donation event or source extraction. As an example, a single donation event may provide 2 kidneys and a liver for organ transplantation, 2 corneas for eye surgery, heart valves and arterial tissue for cardiovascular surgery, multiple skin grafts, tendons, multiple shaped bone grafts and a large number of bone putty/paste products; and each of them may be assigned to the same biological source event identifier.

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

• w5: FiveWs.what[x]

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

• w5: FiveWs.what[x]
• rim: .playedRole[typeCode=MANU].scoper.name
• udi: N/A

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

• 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”.

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

• 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”.

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

• 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.

Alphanumeric Maximum 20. While a serial number is a type of identifier, in the context of devices for which a UDI is required, thus a serial number may be part of the production identifier, it is more informative to have the serial number as a dedicated attribute together with the other UDI production identifier. When the device is not subject to including the UDI (e.g., its presence and exchange is not mandated by local regulatory requirements or specific use case at hand), thus the concept of production identifiers is not relevant as a set, it remains helpful for consistency to still use Device.serialNumber rather than using Device.identifier with an appropriate type. Systems that do not realize an identifier is a serial number may place it in Device.identifier or if the identifier.system is known for the serial number, it may also be populated in the Device.identifier as a globally unique id_.

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

• w5: FiveWs.what[x]
• rim: .playedRole[typeCode=MANU].id

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

• interface: Participant.name

• rim: n/a

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.

• 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()

• rim: n/a

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

• 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()

• rim: N/A

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

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

• w5: FiveWs.what[x]
• rim: .playedRole[typeCode=MANU].code

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

• w5: FiveWs.status
• rim: statusCode

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

• w5: FiveWs.what[x]
• rim: .softwareName (included as part)

Alphanumeric Maximum 20.

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

• w5: FiveWs.what[x]
• rim: .playedRole[typeCode=MANU].id

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

Multiple device types are use when a device is categorized in more than one context – for example, hybrid devices in which the device is both of type gateway and sensor.

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

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

• rim: n/a

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.

• 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()

• rim: n/a

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

• 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()

• rim: N/A

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

Note that the module of the device would not need to be tracked as a separate device, e.g., using different UDI, thus would typically involve one or more software modules. For example, a device may involve two software modules each on a different version.

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

• w5: FiveWs.what[x]

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

• w5: FiveWs.what[x]

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

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

• rim: n/a

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.

• 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()

• rim: n/a

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

• 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()

• rim: N/A

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

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

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

Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific [DeviceMetric] and recorded using [Observation]. Static characteristics of a device could also be documented in an associated [DeviceDefinition] instance. The Device instance's properties, and their values, could be, but need not be, the same as those described in an associated DeviceDefinition.

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

• rim: n/a

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.

• 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()

• rim: n/a

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

• 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()

• rim: N/A

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

The text element in CodeableConcept.text is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g. a custom implant size, or a security classification which depends on configuration). Otherwise the string choice type is used for descriptive properties, or instructions.

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

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

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

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

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

• w5: FiveWs.source
• rim: .playedRole[typeCode=OWN].scoper

used for troubleshooting etc.

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

• w5: FiveWs.source
• rim: .scopedRole[typeCode=CON].player

Device.location can be used to track device location.

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

• w5: FiveWs.where[x]
• rim: .playedRole[typeCode=LOCE].scoper

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

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

• w5: FiveWs.where[x]
• rim: .telecom

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

• rim: n/a

The Device.gateway may be used when the Device being referenced has a gateway and/or to capture one or more gateways associated with the device. If the Gateway is included in the Observation resource, the Observation.gatewayDevice should be used instead.

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

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

• rim: .text

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

• rim: NA

For example a vital signs monitor (parent) where three separate modules can be plugged into such as interchangeable blood pressure, oximeter, temperature modules. These modules are represented as devices with the .parent valued to the vital signs monitor when plugged in.

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