This 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.

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content.

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.

An Extension

R5: DeviceAssociation.device (new:Reference(Device))

Element DeviceAssociation.device has a context of Device based on following the parent source element upwards and mapping to Device. Element DeviceAssociation.device has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R5: DeviceAssociation.category (new:CodeableConcept)

Element DeviceAssociation.category has a context of Device based on following the parent source element upwards and mapping to Device. Element DeviceAssociation.category has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R5: DeviceAssociation.status (new:CodeableConcept)

Element DeviceAssociation.status has a context of Device based on following the parent source element upwards and mapping to Device. Element DeviceAssociation.status has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R5: DeviceAssociation.statusReason (new:CodeableConcept)

Element DeviceAssociation.statusReason has a context of Device based on following the parent source element upwards and mapping to Device. Element DeviceAssociation.statusReason has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R5: DeviceAssociation.bodyStructure (new:Reference(BodyStructure))

Element DeviceAssociation.bodyStructure has a context of Device based on following the parent source element upwards and mapping to Device. Element DeviceAssociation.bodyStructure has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R5: DeviceAssociation.period (new:Period)

Element DeviceAssociation.period has a context of Device based on following the parent source element upwards and mapping to Device. Element DeviceAssociation.period has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R5: DeviceAssociation.operation (new:BackboneElement)

Element DeviceAssociation.operation has a context of Device based on following the parent source element upwards and mapping to Device. Element DeviceAssociation.operation has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

May 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.

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.

Status of the Device availability.

This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid.

The availability status of the device.

R5: DeviceAssociation.device (new:Reference(Device))

Element DeviceAssociation.device has a context of Device based on following the parent source element upwards and mapping to Device. Element DeviceAssociation.device has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R5: DeviceAssociation.category (new:CodeableConcept)

Element DeviceAssociation.category has a context of Device based on following the parent source element upwards and mapping to Device. Element DeviceAssociation.category has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R5: DeviceAssociation.status (new:CodeableConcept)

Element DeviceAssociation.status has a context of Device based on following the parent source element upwards and mapping to Device. Element DeviceAssociation.status has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R5: DeviceAssociation.statusReason (new:CodeableConcept)

Element DeviceAssociation.statusReason has a context of Device based on following the parent source element upwards and mapping to Device. Element DeviceAssociation.statusReason has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R5: DeviceAssociation.bodyStructure (new:Reference(BodyStructure))

Element DeviceAssociation.bodyStructure has a context of Device based on following the parent source element upwards and mapping to Device. Element DeviceAssociation.bodyStructure has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R5: DeviceAssociation.period (new:Period)

Element DeviceAssociation.period has a context of Device based on following the parent source element upwards and mapping to Device. Element DeviceAssociation.period has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R5: DeviceAssociation.operation (new:BackboneElement)

Element DeviceAssociation.operation has a context of Device based on following the parent source element upwards and mapping to Device. Element DeviceAssociation.operation has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R5: DeviceAssociation.subject

Element DeviceAssociation.subject is mapped to FHIR STU3 element Device.patient as SourceIsBroaderThanTarget. The standard extension alternate-reference has been mapped as the representation of FHIR R5 element DeviceAssociation.subject with unmapped reference targets: Device, Group, Patient, Practitioner, RelatedPerson.

This 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.

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

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

The 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.

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content.

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.

The base language in which the resource is written.

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

Unless not suitable, these codes SHALL be taken from Common Languages
(extensible to http://hl7.org/fhir/ValueSet/languages|3.0.2)

A human language.

A 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.

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.

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again.

An Extension

R5: DeviceAssociation.device (new:Reference(Device))

Element DeviceAssociation.device has a context of Device based on following the parent source element upwards and mapping to Device. Element DeviceAssociation.device has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R5: DeviceAssociation.category (new:CodeableConcept)

Element DeviceAssociation.category has a context of Device based on following the parent source element upwards and mapping to Device. Element DeviceAssociation.category has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R5: DeviceAssociation.status (new:CodeableConcept)

Element DeviceAssociation.status has a context of Device based on following the parent source element upwards and mapping to Device. Element DeviceAssociation.status has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R5: DeviceAssociation.statusReason (new:CodeableConcept)

Element DeviceAssociation.statusReason has a context of Device based on following the parent source element upwards and mapping to Device. Element DeviceAssociation.statusReason has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R5: DeviceAssociation.bodyStructure (new:Reference(BodyStructure))

Element DeviceAssociation.bodyStructure has a context of Device based on following the parent source element upwards and mapping to Device. Element DeviceAssociation.bodyStructure has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R5: DeviceAssociation.period (new:Period)

Element DeviceAssociation.period has a context of Device based on following the parent source element upwards and mapping to Device. Element DeviceAssociation.period has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

R5: DeviceAssociation.operation (new:BackboneElement)

Element DeviceAssociation.operation has a context of Device based on following the parent source element upwards and mapping to Device. Element DeviceAssociation.operation has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element).

May 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.

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.

Unique instance identifiers assigned to a device by manufacturers other organizations or owners.

The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. 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.

Unique device identifier (UDI) assigned to device label or package.

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.

unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

May 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.

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.

May 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.

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

The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.

Name of device as used in labeling or catalog.

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

The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace. with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/fda-udi.

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

The full UDI carrier as the human readable form (HRF) representation of the barcode string as printed on the packaging of the device.

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

The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - E.g a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats SHALL be base64 encoded.

The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.

Organization 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.

A coded entry to indicate how the data was entered.

The codes SHALL be taken from UDIEntryType
(required to http://hl7.org/fhir/ValueSet/udi-entry-type|3.0.2)

Codes to identify how UDI data was entered

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

Status of the Device availability.

This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid.

The availability status of the device.

Code or identifier to identify a kind of device.

Codes to identify medical devices

Lot number assigned by the manufacturer.

A name of the manufacturer.

The date and time when the device was manufactured.

The date and time beyond which this device is no longer valid or should not be used (if applicable).

The "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.

The version of the device, if the device has multiple releases under the same model, or if the device is software or carries firmware.

Patient information, If the device is affixed to a person.

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

unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

An Extension

R5: DeviceAssociation.subject

Element DeviceAssociation.subject is mapped to FHIR STU3 element Device.patient as SourceIsBroaderThanTarget. The standard extension alternate-reference has been mapped as the representation of FHIR R5 element DeviceAssociation.subject with unmapped reference targets: Device, Group, Patient, Practitioner, RelatedPerson.

A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

An identifier for the other resource. This is used when there is no way to reference the other resource directly, either because the entity is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

Plain text narrative that identifies the resource in addition to the resource reference.

This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

An organization that is responsible for the provision and ongoing maintenance of the device.

Contact details for an organization or a particular human that is responsible for the device.

used for troubleshooting etc.

The place where the device can be found.

Device.location can be used to track device location.

A network address on which the device may be contacted directly.

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

Descriptive information, usage information or implantation information that is not captured in an existing element.

Provides additional safety characteristics about a medical device. For example devices containing latex.

Codes used to identify medical devices safety characterics. These codes are derived in part from the United States Food and Drug Administration recommendations and are provided here as a suggestive example.