International Patient Summary Implementation Guide Implementation Guide Release 0.1.0

This page is part of the International Patient Summary Implementation Guide (v0.1.0: STU 1 Ballot 1) based on FHIR R3. The current version which supercedes this version is 1.1.0. For a full list of available versions, see the Directory of published versions

Definitions for the StructureDefinition-device-uv-ips Profile.

Device
Definition

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.

Control0..*
Comments

This profile applies the rules defined by HL7 International for representing the UDI in the FHIR standard, by the document "Medical Devices and Unique Device Identification (UDI) Pattern, Release 1"

InvariantsDefined on this element
dom-1: If the resource is contained in another resource, it SHALL NOT contain any narrative (: contained.text.empty())
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 (: contained.where(('#'+id in %resource.descendants().reference).not()).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())
Device.id
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typeid
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.meta
Definition

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.

Control0..1 This element is affected by the following invariants: ele-1
TypeMeta
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.implicitRules
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typeuri
Is Modifiertrue
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.language
Definition

The base language in which the resource is written.

Control0..1 This element is affected by the following invariants: ele-1
BindingA human language.
The codes SHALL be taken from Common Languages; other codes may be used where these codes are not suitable
Typecode
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).

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.text
Definition

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.

Control0..1 This element is affected by the following invariants: ele-1, dom-1
TypeNarrative
Alternate Namesnarrative, 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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.contained
Definition

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.

Control0..*
TypeResource
Alternate Namesinline 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.

Device.extension
Definition

May 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.

Control0..* This element is affected by the following invariants: ele-1
TypeExtension
Alternate Namesextensions, 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.

InvariantsDefined on this element
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())
Device.modifierExtension
Definition

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.

Control0..* This element is affected by the following invariants: ele-1
TypeExtension
Is Modifiertrue
Alternate Namesextensions, 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.

InvariantsDefined on this element
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())
Device.identifier
Definition

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

NoteThis is a business identifer, not a resource identifier (see discussion)
Control0..1 This element is affected by the following invariants: ele-1
TypeIdentifier
Alternate NamesSerial 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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.identifier.id
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.identifier.extension
Definition

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.

Control0..* This element is affected by the following invariants: ele-1
TypeExtension
Alternate Namesextensions, 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.

InvariantsDefined on this element
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())
Device.identifier.use
Definition

The purpose of this identifier.

Control0..0 This element is affected by the following invariants: ele-1
BindingIdentifies the purpose for this identifier, if known .
The codes SHALL be taken from IdentifierUse
Typecode
Is Modifiertrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Comments

This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.identifier.type
Definition

The type of identifier represents "serial number" (SNO)

Control0..1 This element is affected by the following invariants: ele-1
BindingA coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
The codes SHALL be taken from Identifier Type Codes; other codes may be used where these codes are not suitable
TypeCodeableConcept
Requirements

Allows users to make use of identifiers when the identifier system is not known.

Comments

This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage.

Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.identifier.type.id
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.identifier.type.extension
Definition

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.

Control0..* This element is affected by the following invariants: ele-1
TypeExtension
Alternate Namesextensions, 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.

InvariantsDefined on this element
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())
Device.identifier.type.coding
Definition

A reference to a code defined by a terminology system.

Control0..* This element is affected by the following invariants: ele-1
TypeCoding
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.identifier.type.coding.id
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.identifier.type.coding.extension
Definition

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.

Control0..* This element is affected by the following invariants: ele-1
TypeExtension
Alternate Namesextensions, 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.

InvariantsDefined on this element
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())
Device.identifier.type.coding.system
Definition

The identification of the code system that defines the meaning of the symbol in the code.

Control0..0 This element is affected by the following invariants: ele-1
Typeuri
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.identifier.type.coding.version
Definition

The 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.

NoteThis is a business versionId, not a resource version id (see discussion)
Control0..0 This element is affected by the following invariants: ele-1
Typestring
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.identifier.type.coding.code
Definition

A 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).

Control0..1 This element is affected by the following invariants: ele-1
Typecode
Requirements

Need to refer to a particular code in the system.

Comments

Note that FHIR strings may not exceed 1MB in size

Fixed ValueSNO
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.identifier.type.coding.display
Definition

A representation of the meaning of the code in the system, following the rules of the system.

Control0..1 This element is affected by the following invariants: ele-1
Typestring
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

Fixed Valueserial number
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.identifier.type.coding.userSelected
Definition

Indicates that this coding was chosen by a user directly - i.e. off a pick list of available items (codes or displays).

Control0..0 This element is affected by the following invariants: ele-1
Typeboolean
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.identifier.type.text
Definition

A 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.

Control0..0 This element is affected by the following invariants: ele-1
Typestring
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.identifier.system
Definition

Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

Control0..0 This element is affected by the following invariants: ele-1
Typeuri
Requirements

There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

Comments

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

Example
General:http://www.acme.com/identifiers/patient
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.identifier.value
Definition

The serial number of the medical device

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Comments

If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension.

Example
General:123456
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.identifier.period
Definition

Time period during which identifier is/was valid for use.

Control0..0 This element is affected by the following invariants: ele-1
TypePeriod
Comments

This is not a duration - that's a measure of time (a separate type), but a duration that occurs at a fixed value of time. A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times"). If duration is required, specify the type as Interval|Duration.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
per-1: If present, start SHALL have a lower value than end (: start.empty() or end.empty() or (start <= end))
Device.identifier.period.id
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.identifier.period.extension
Definition

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.

Control0..* This element is affected by the following invariants: ele-1
TypeExtension
Alternate Namesextensions, 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.

InvariantsDefined on this element
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())
Device.identifier.period.start
Definition

The start of the period. The boundary is inclusive.

Control0..1 This element is affected by the following invariants: ele-1, per-1
TypedateTime
Comments

If the low element is missing, the meaning is that the low boundary is not known.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.identifier.period.end
Definition

The end of the period. If the end of the period is missing, it means that the period is ongoing. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.

Control0..1 This element is affected by the following invariants: ele-1, per-1
TypedateTime
Comments

The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has a end value of 2012-02-03.

Meaning if MissingIf the end of the period is missing, it means that the period is ongoing
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.identifier.assigner
Definition

Organization that issued/manages the identifier.

Control0..0 This element is affected by the following invariants: ele-1
TypeReference(Organization)
Comments

The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

InvariantsDefined on this element
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')))
Device.identifier.assigner.id
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.identifier.assigner.extension
Definition

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.

Control0..* This element is affected by the following invariants: ele-1
TypeExtension
Alternate Namesextensions, 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.

InvariantsDefined on this element
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())
Device.identifier.assigner.reference
Definition

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.

Control0..1 This element is affected by the following invariants: ele-1, ref-1
Typestring
Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.identifier.assigner.identifier
Definition

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.

NoteThis is a business identifer, not a resource identifier (see discussion)
Control0..1 This element is affected by the following invariants: ele-1
TypeIdentifier
Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.identifier.assigner.display
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.udi
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
TypeBackboneElement
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.udi.id
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.udi.extension
Definition

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.

Control0..* This element is affected by the following invariants: ele-1
TypeExtension
Alternate Namesextensions, 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.

InvariantsDefined on this element
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())
Device.udi.modifierExtension
Definition

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.

Control0..* This element is affected by the following invariants: ele-1
TypeExtension
Is Modifiertrue
Alternate Namesextensions, 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.

InvariantsDefined on this element
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())
Device.udi.deviceIdentifier
Definition

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.

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Alternate NamesDI
Comments

Note that FHIR strings may not exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.udi.name
Definition

Name of device as used in labeling or catalog.

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Alternate NamesBrand 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'.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.udi.jurisdiction
Definition

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.

Control0..1 This element is affected by the following invariants: ele-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/Uniformresourceidentifier

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.udi.carrierHRF
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Alternate NamesHuman 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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.udi.carrierAIDC
Definition

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.

Control0..1 This element is affected by the following invariants: ele-1
Typebase64Binary
Alternate NamesAutomatic 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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.udi.issuer
Definition

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.

Control0..1 This element is affected by the following invariants: ele-1
Typeuri
Alternate NamesBarcode System
Comments

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

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.udi.entryType
Definition

A coded entry to indicate how the data was entered.

Control0..1 This element is affected by the following invariants: ele-1
BindingCodes to identify how UDI data was entered
The codes SHALL be taken from UDIEntryType
Typecode
Requirements

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

Comments

Note that FHIR strings may not exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.status
Definition

Status of the Device availability.

Control0..1 This element is affected by the following invariants: ele-1
BindingThe availability status of the device.
The codes SHALL be taken from FHIRDeviceStatus
Typecode
Is Modifiertrue
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.type
Definition

Code or identifier to identify a kind of device.

Control0..1 This element is affected by the following invariants: ele-1
BindingCodes to identify medical devices
For example codes, see IPSMedicalDevices
TypeCodeableConcept
Comments

The FHIR-defined value set is different from the value set "IPS Medical Devices" defined by the IPS CDA IG: http://art-decor.org/art-decor/decor-valuesets--hl7ips-?id=2.16.840.1.113883.11.22.23&effectiveDate=2017-07-19T00:00:00&language=en-US

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.type.id
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.type.extension
Definition

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.

Control0..* This element is affected by the following invariants: ele-1
TypeExtension
Alternate Namesextensions, 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.

InvariantsDefined on this element
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())
Device.type.coding
Definition

A reference to a code defined by a terminology system.

Control0..* This element is affected by the following invariants: ele-1
TypeCoding(coding-uv-ips)
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.type.text
Definition

A 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.

Control0..1 This element is affected by the following invariants: ele-1
Typestring
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.type(absentOrUnknownDevice)
Definition

Code or identifier to identify a kind of device.

Control0..1 This element is affected by the following invariants: ele-1
BindingCodes to identify medical devices
The codes SHALL be taken from IPSMedicalDevices
TypeCodeableConcept
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.type.id
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.type.extension
Definition

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.

Control0..* This element is affected by the following invariants: ele-1
TypeExtension
Alternate Namesextensions, 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.

InvariantsDefined on this element
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())
Device.type.coding
Definition

A reference to a code defined by a terminology system.

Control0..* This element is affected by the following invariants: ele-1
TypeCoding
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.type.text
Definition

A 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.

Control0..1 This element is affected by the following invariants: ele-1
Typestring
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.type(device)
Definition

Code or identifier to identify a kind of device.

Control0..1 This element is affected by the following invariants: ele-1
BindingCodes to identify medical devices
The codes SHOULD be taken from IPSMedicalDevices
TypeCodeableConcept
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.type.id
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.type.extension
Definition

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.

Control0..* This element is affected by the following invariants: ele-1
TypeExtension
Alternate Namesextensions, 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.

InvariantsDefined on this element
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())
Device.type.coding
Definition

A reference to a code defined by a terminology system.

Control0..* This element is affected by the following invariants: ele-1
TypeCoding
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.type.text
Definition

A 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.

Control0..1 This element is affected by the following invariants: ele-1
Typestring
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.lotNumber
Definition

Lot number assigned by the manufacturer.

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.manufacturer
Definition

A name of the manufacturer.

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.manufactureDate
Definition

The date and time when the device was manufactured. If hour is present, minutes and seconds should be both set to "00"

Control0..1 This element is affected by the following invariants: ele-1
TypedateTime
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.expirationDate
Definition

The date and time beyond which this device is no longer valid or should not be used (if applicable). If hour is present, minutes and seconds should be both set to "00".

Control0..1 This element is affected by the following invariants: ele-1
TypedateTime
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.model
Definition

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.

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.version
Definition

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

NoteThis is a business versionId, not a resource version id (see discussion)
Control0..1 This element is affected by the following invariants: ele-1
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.patient
Definition

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

Control1..1 This element is affected by the following invariants: ele-1
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.

InvariantsDefined on this element
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')))
Device.patient.id
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.patient.extension
Definition

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.

Control0..* This element is affected by the following invariants: ele-1
TypeExtension
Alternate Namesextensions, 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.

InvariantsDefined on this element
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())
Device.patient.reference
Definition

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.

Control0..1 This element is affected by the following invariants: ele-1, ref-1
Typestring
Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.patient.identifier
Definition

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.

NoteThis is a business identifer, not a resource identifier (see discussion)
Control0..1 This element is affected by the following invariants: ele-1
TypeIdentifier
Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.patient.display
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.owner
Definition

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

Control0..0 This element is affected by the following invariants: ele-1
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.

InvariantsDefined on this element
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')))
Device.owner.id
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.owner.extension
Definition

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.

Control0..* This element is affected by the following invariants: ele-1
TypeExtension
Alternate Namesextensions, 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.

InvariantsDefined on this element
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())
Device.owner.reference
Definition

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.

Control0..1 This element is affected by the following invariants: ele-1, ref-1
Typestring
Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.owner.identifier
Definition

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.

NoteThis is a business identifer, not a resource identifier (see discussion)
Control0..1 This element is affected by the following invariants: ele-1
TypeIdentifier
Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.owner.display
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.contact
Definition

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

Control0..0 This element is affected by the following invariants: ele-1
TypeContactPoint
Comments

used for troubleshooting etc.

InvariantsDefined on this element
cpt-2: A system is required if a value is provided. (: value.empty() or system.exists())
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.contact.id
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.contact.extension
Definition

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.

Control0..* This element is affected by the following invariants: ele-1
TypeExtension
Alternate Namesextensions, 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.

InvariantsDefined on this element
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())
Device.contact.system
Definition

Telecommunications form for contact point - what communications system is required to make use of the contact.

Control0..1 This element is affected by the following invariants: ele-1, cpt-2
BindingTelecommunications form for contact point
The codes SHALL be taken from ContactPointSystem
Typecode
Comments

Note that FHIR strings may not exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.contact.value
Definition

The actual contact point details, in a form that is meaningful to the designated communication system (i.e. phone number or email address).

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Requirements

Need to support legacy numbers that are not in a tightly controlled format.

Comments

Additional text data such as phone extension numbers, or notes about use of the contact are sometimes included in the value.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.contact.use
Definition

Identifies the purpose for the contact point.

Control0..1 This element is affected by the following invariants: ele-1
BindingUse of contact point
The codes SHALL be taken from ContactPointUse
Typecode
Is Modifiertrue
Requirements

Need to track the way a person uses this contact, so a user can choose which is appropriate for their purpose.

Comments

This is labeled as "Is Modifier" because applications should not mistake a temporary or old contact etc.for a current/permanent one. Applications can assume that a contact is current unless it explicitly says that it is temporary or old.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.contact.rank
Definition

Specifies a preferred order in which to use a set of contacts. Contacts are ranked with lower values coming before higher values.

Control0..1 This element is affected by the following invariants: ele-1
TypepositiveInt
Comments

Note that rank does not necessarily follow the order in which the contacts are represented in the instance.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.contact.period
Definition

Time period when the contact point was/is in use.

Control0..1 This element is affected by the following invariants: ele-1
TypePeriod
Comments

This is not a duration - that's a measure of time (a separate type), but a duration that occurs at a fixed value of time. A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times"). If duration is required, specify the type as Interval|Duration.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
per-1: If present, start SHALL have a lower value than end (: start.empty() or end.empty() or (start <= end))
Device.contact.period.id
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.contact.period.extension
Definition

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.

Control0..* This element is affected by the following invariants: ele-1
TypeExtension
Alternate Namesextensions, 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.

InvariantsDefined on this element
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())
Device.contact.period.start
Definition

The start of the period. The boundary is inclusive.

Control0..1 This element is affected by the following invariants: ele-1, per-1
TypedateTime
Comments

If the low element is missing, the meaning is that the low boundary is not known.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.contact.period.end
Definition

The end of the period. If the end of the period is missing, it means that the period is ongoing. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.

Control0..1 This element is affected by the following invariants: ele-1, per-1
TypedateTime
Comments

The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has a end value of 2012-02-03.

Meaning if MissingIf the end of the period is missing, it means that the period is ongoing
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.location
Definition

The place where the device can be found.

Control0..0 This element is affected by the following invariants: ele-1
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.

InvariantsDefined on this element
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')))
Device.location.id
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.location.extension
Definition

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.

Control0..* This element is affected by the following invariants: ele-1
TypeExtension
Alternate Namesextensions, 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.

InvariantsDefined on this element
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())
Device.location.reference
Definition

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.

Control0..1 This element is affected by the following invariants: ele-1, ref-1
Typestring
Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.location.identifier
Definition

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.

NoteThis is a business identifer, not a resource identifier (see discussion)
Control0..1 This element is affected by the following invariants: ele-1
TypeIdentifier
Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.location.display
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.url
Definition

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

Control0..0 This element is affected by the following invariants: ele-1
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.note
Definition

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

Control0..0 This element is affected by the following invariants: ele-1
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).

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.note.id
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.note.extension
Definition

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.

Control0..* This element is affected by the following invariants: ele-1
TypeExtension
Alternate Namesextensions, 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.

InvariantsDefined on this element
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())
Device.note.author[x]
Definition

The individual responsible for making the annotation.

Control0..1 This element is affected by the following invariants: ele-1
TypeChoice of: Reference(Practitioner | Patient | RelatedPerson), string
[x] NoteSee Choice of Data Types for further information about how to use [x]
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.

InvariantsDefined on this element
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')))
Device.note.time
Definition

Indicates when this particular annotation was made.

Control0..1 This element is affected by the following invariants: ele-1
TypedateTime
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.note.text
Definition

The text of the annotation.

Control1..1 This element is affected by the following invariants: ele-1
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.safety
Definition

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

Control0..0 This element is affected by the following invariants: ele-1
BindingCodes 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.
For example codes, see DeviceSafety
TypeCodeableConcept
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.safety.id
Definition

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

Control0..1 This element is affected by the following invariants: ele-1
Typestring
Comments

Note that FHIR strings may not exceed 1MB in size

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.safety.extension
Definition

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.

Control0..* This element is affected by the following invariants: ele-1
TypeExtension
Alternate Namesextensions, 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.

InvariantsDefined on this element
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())
Device.safety.coding
Definition

A reference to a code defined by a terminology system.

Control0..* This element is affected by the following invariants: ele-1
TypeCoding
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
Device.safety.text
Definition

A 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.

Control0..1 This element is affected by the following invariants: ele-1
Typestring
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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))