Summary
Request & Response
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Conformance
Terminology
Documents
Definitional Artifacts
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Public Health & Research
Complex
Primitive
ActivityDefinition
CanonicalResource
CapabilityStatement
ChargeItemDefinition
Claim
CodeSystem
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DocumentReference
Encounter
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Library
List
Measure
MedicinalProductDefinition
MessageHeader
NamingSystem
Observation
Patient
PlanDefinition
Resource
SpecimenDefinition
StructureDefinition
StructureMap
Subscription
ValueSet
default
This is a specialized resource that defines the characteristics and capabilities of a device.
DeviceDefinition
Path
DeviceDefinition
Id
DeviceDefinition
Cardinality
0 - *
Definition
The characteristics, operational status and capabilities of a medical-related component of a medical device.
Comment
For the initial scope, this DeviceDefinition resource is only applicable to describe a single node in the containment tree that is produced by the context scanner in any medical device that implements or derives from the ISO/IEEE 11073 standard and that does not represent a metric. Examples for such a node are MDS, VMD, or Channel.
Constraint
dom-2 [error]
If the resource is contained in another resource, it SHALL NOT contain nested Resources
dom-3 [error]
If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
dom-4 [error]
If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
dom-5 [error]
If a resource is contained in another resource, it SHALL NOT have a security label
dom-6 [warning]
A resource should have narrative for robust management
Path
DeviceDefinition.description
Id
DeviceDefinition.description
Type
Cardinality
0 - 1
Definition
Additional information to describe the device.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.identifier
Id
DeviceDefinition.identifier
Type
Cardinality
0 - *
Definition
Unique instance identifiers assigned to a device by the software, manufacturers, other organizations or owners. For example: handle ID. The identifier is typically valued if the udiDeviceIdentifier, partNumber or modelNumber is not valued and represents a different type of identifier. However, it is permissible to still include those identifiers in DeviceDefinition.identifier with the appropriate identifier.type.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Requirements
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Binding
Strength
required
Description
Identifies the purpose for this identifier, if known .
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.identifier.Identifier.type
Id
Identifier.type
Type
Cardinality
0 - 1
Definition
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Comment
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.
Requirements
Allows users to make use of identifiers when the identifier system is not known.
Binding
Strength
extensible
Description
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.identifier.Identifier.type.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.identifier.Identifier.type.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 be an absolute reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.identifier.Identifier.type.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.identifier.Identifier.type.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.identifier.Identifier.type.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.identifier.Identifier.type.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.identifier.Identifier.system
Id
Identifier.system
Type
Cardinality
0 - 1
Definition
Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.
Comment
Identifier.system is always case sensitive.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.identifier.Identifier.value
Id
Identifier.value
Type
Cardinality
0 - 1
Definition
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Comment
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 [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ident-1
Path
DeviceDefinition.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.identifier.Identifier.period.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
DeviceDefinition.identifier.Identifier.period.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. 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.
Comment
The end value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
DeviceDefinition.identifier.Identifier.assigner
Id
Identifier.assigner
Type
Cardinality
0 - 1
Definition
Organization that issued/manages the identifier.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.identifier.Identifier.assigner.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
ref-1
Path
DeviceDefinition.identifier.Identifier.assigner.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
Definition
The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.
The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).
Comment
This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.identifier.Identifier.assigner.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents 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.
Comment
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.
Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).
This element only allows for a single identifier. In the case where additional identifers are required, use the [http://hl7.org/fhir/StructureDefinition/additionalIdentifier](http://hl7.org/fhir/extensions/StructureDefinition-additionalIdentifier.html) extension.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.identifier.Identifier.assigner.Reference.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Requirements
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Binding
Strength
required
Description
Identifies the purpose for this identifier, if known .
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.identifier.Identifier.assigner.Reference.identifier.Identifier.type
Id
Identifier.type
Type
Cardinality
0 - 1
Definition
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Comment
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.
Requirements
Allows users to make use of identifiers when the identifier system is not known.
Binding
Strength
extensible
Description
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.identifier.Identifier.assigner.Reference.identifier.Identifier.system
Id
Identifier.system
Type
Cardinality
0 - 1
Definition
Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.
Comment
Identifier.system is always case sensitive.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.identifier.Identifier.assigner.Reference.identifier.Identifier.value
Id
Identifier.value
Type
Cardinality
0 - 1
Definition
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Comment
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 [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ident-1
Path
DeviceDefinition.identifier.Identifier.assigner.Reference.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.identifier.Identifier.assigner.Reference.identifier.Identifier.assigner
Id
Identifier.assigner
Type
Cardinality
0 - 1
Definition
Organization that issued/manages the identifier.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.identifier.Identifier.assigner.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.udiDeviceIdentifier
Id
DeviceDefinition.udiDeviceIdentifier
Type
Cardinality
0 - *
Definition
Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
deviceIdentifier
The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier
Path
DeviceDefinition.udiDeviceIdentifier.deviceIdentifier
Id
DeviceDefinition.udiDeviceIdentifier.deviceIdentifier
Type
Cardinality
1 - 1
Definition
The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.udiDeviceIdentifier.issuer
Id
DeviceDefinition.udiDeviceIdentifier.issuer
Type
Cardinality
1 - 1
Definition
The organization that assigns the identifier algorithm.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.udiDeviceIdentifier.jurisdiction
Id
DeviceDefinition.udiDeviceIdentifier.jurisdiction
Type
Cardinality
1 - 1
Definition
The jurisdiction to which the deviceIdentifier applies.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.udiDeviceIdentifier.marketDistribution
Id
DeviceDefinition.udiDeviceIdentifier.marketDistribution
Type
Cardinality
0 - *
Definition
Indicates where and when the device is available on the market.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod
Id
DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod
Type
Cardinality
1 - 1
Definition
Begin and end dates for the commercial distribution of the device.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. 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.
Comment
The end value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction
Id
DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction
Type
Cardinality
1 - 1
Definition
National state or territory to which the marketDistribution recers, typically where the device is commercialized.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.regulatoryIdentifier
Id
DeviceDefinition.regulatoryIdentifier
Type
Cardinality
0 - *
Definition
Identifier associated with the regulatory documentation (certificates, technical documentation, post-market surveillance documentation and reports) of a set of device models sharing the same intended purpose, risk class and essential design and manufacturing characteristics. One example is the Basic UDI-DI in Europe.
Comment
This should not be used for regulatory authorization numbers which are to be captured elsewhere.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.regulatoryIdentifier.type
Id
DeviceDefinition.regulatoryIdentifier.type
Type
Cardinality
1 - 1
Definition
The type of identifier itself.
Comment
Binding
Strength
required
Description
Device regulatory identifier type.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.regulatoryIdentifier.deviceIdentifier
Id
DeviceDefinition.regulatoryIdentifier.deviceIdentifier
Type
Cardinality
1 - 1
Definition
The identifier itself.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.regulatoryIdentifier.issuer
Id
DeviceDefinition.regulatoryIdentifier.issuer
Type
Cardinality
1 - 1
Definition
The organization that issued this identifier.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.regulatoryIdentifier.jurisdiction
Id
DeviceDefinition.regulatoryIdentifier.jurisdiction
Type
Cardinality
1 - 1
Definition
The jurisdiction to which the deviceIdentifier applies.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.partNumber
Id
DeviceDefinition.partNumber
Type
Cardinality
0 - 1
Definition
The part number or catalog number of the device.
Comment
Alphanumeric Maximum 20.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.manufacturer
Id
DeviceDefinition.manufacturer
Type
Cardinality
0 - 1
Definition
A name of the manufacturer or legal representative e.g. labeler. Whether this is the actual manufacturer or the labeler or responsible depends on implementation and jurisdiction.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.manufacturer.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
ref-1
Path
DeviceDefinition.manufacturer.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
Definition
The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.
The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).
Comment
This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.manufacturer.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents 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.
Comment
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.
Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).
This element only allows for a single identifier. In the case where additional identifers are required, use the [http://hl7.org/fhir/StructureDefinition/additionalIdentifier](http://hl7.org/fhir/extensions/StructureDefinition-additionalIdentifier.html) extension.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.manufacturer.Reference.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Requirements
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Binding
Strength
required
Description
Identifies the purpose for this identifier, if known .
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.manufacturer.Reference.identifier.Identifier.type
Id
Identifier.type
Type
Cardinality
0 - 1
Definition
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Comment
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.
Requirements
Allows users to make use of identifiers when the identifier system is not known.
Binding
Strength
extensible
Description
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.manufacturer.Reference.identifier.Identifier.type.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.manufacturer.Reference.identifier.Identifier.system
Id
Identifier.system
Type
Cardinality
0 - 1
Definition
Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.
Comment
Identifier.system is always case sensitive.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.manufacturer.Reference.identifier.Identifier.value
Id
Identifier.value
Type
Cardinality
0 - 1
Definition
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Comment
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 [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ident-1
Path
DeviceDefinition.manufacturer.Reference.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.manufacturer.Reference.identifier.Identifier.period.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
DeviceDefinition.manufacturer.Reference.identifier.Identifier.period.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. 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.
Comment
The end value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
DeviceDefinition.manufacturer.Reference.identifier.Identifier.assigner
Id
Identifier.assigner
Type
Cardinality
0 - 1
Definition
Organization that issued/manages the identifier.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.manufacturer.Reference.identifier.Identifier.assigner.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
ref-1
Path
DeviceDefinition.manufacturer.Reference.identifier.Identifier.assigner.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
Definition
The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.
The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).
Comment
This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.manufacturer.Reference.identifier.Identifier.assigner.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents 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.
Comment
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.
Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).
This element only allows for a single identifier. In the case where additional identifers are required, use the [http://hl7.org/fhir/StructureDefinition/additionalIdentifier](http://hl7.org/fhir/extensions/StructureDefinition-additionalIdentifier.html) extension.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.manufacturer.Reference.identifier.Identifier.assigner.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.manufacturer.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.deviceName
Id
DeviceDefinition.deviceName
Type
Cardinality
0 - *
Definition
The name or names of the device as given by the manufacturer.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.deviceName.name
Id
DeviceDefinition.deviceName.name
Type
Cardinality
1 - 1
Definition
A human-friendly name that is used to refer to the device - depending on the type, it can be the brand name, the common name or alias, or other.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.deviceName.type
Id
DeviceDefinition.deviceName.type
Type
Cardinality
1 - 1
Definition
The type of deviceName.
RegisteredName | UserFriendlyName | PatientReportedName.
Comment
Binding
Strength
required
Description
The type of name the device is referred by.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
modelNumber
The catalog or model number for the device for example as defined by the manufacturer
Path
DeviceDefinition.modelNumber
Id
DeviceDefinition.modelNumber
Type
Cardinality
0 - 1
Definition
The model number for the device for example as defined by the manufacturer or labeler, or other agency.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification
Id
DeviceDefinition.classification
Type
Cardinality
0 - *
Definition
What kind of device or device system this is.
Comment
In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification.type
Id
DeviceDefinition.classification.type
Type
Cardinality
1 - 1
Definition
A classification or risk class of the device model.
Comment
Binding
Strength
example
Description
Type of device e.g. according to official classification.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification.type.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification.type.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 be an absolute reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification.type.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification.type.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.classification.type.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.classification.type.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
justification
Further information qualifying this classification of the device model
Path
DeviceDefinition.classification.justification
Id
DeviceDefinition.classification.justification
Type
Cardinality
0 - *
Definition
Further information qualifying this classification of the device model.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
type
documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as
Path
DeviceDefinition.classification.justification.RelatedArtifact.type
Id
RelatedArtifact.type
Type
Cardinality
1 - 1
Definition
The type of relationship to the related artifact.
Comment
The presence of both sides of a relationship type (e.g. successor and predecessor) is required to support use cases where one side of a relationship is not represented in FHIR. However, this feature SHALL NOT be used to create bi-directional resource links in FHIR instances. Specifically, following the methodology of "new points to old" and "many points to one", when using related artifact elements to describe and reference FHIR resources, the type element SHALL be drawn from the fhir-related-artifact-type ValueSet.
Binding
Strength
required
Description
The type of relationship to the related artifact.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification.justification.RelatedArtifact.classifier
Id
RelatedArtifact.classifier
Type
Cardinality
0 - *
Definition
Provides additional classifiers of the related artifact.
Comment
Binding
Strength
example
Description
Additional classifiers for the related artifact.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification.justification.RelatedArtifact.classifier.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification.justification.RelatedArtifact.label
Id
RelatedArtifact.label
Type
Cardinality
0 - 1
Definition
A short label that can be used to reference the citation from elsewhere in the containing artifact, such as a footnote index.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification.justification.RelatedArtifact.display
Id
RelatedArtifact.display
Type
Cardinality
0 - 1
Definition
A brief description of the document or knowledge resource being referenced, suitable for display to a consumer.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification.justification.RelatedArtifact.citation
Id
RelatedArtifact.citation
Type
Cardinality
0 - 1
Definition
A bibliographic citation for the related artifact. This text SHOULD be formatted according to an accepted citation format.
Comment
Additional structured information about citations should be captured as extensions.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification.justification.RelatedArtifact.document
Id
RelatedArtifact.document
Type
Cardinality
0 - 1
Definition
The document being referenced, represented as an attachment. This is exclusive with the resource element.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification.justification.RelatedArtifact.document.Attachment.contentType
Id
Attachment.contentType
Type
Cardinality
0 - 1
Definition
Identifies the type of the data in the attachment and allows a method to be chosen to interpret or render the data. Includes mime type parameters such as charset where appropriate.
Comment
Requirements
Processors of the data need to be able to know how to interpret the data.
Binding
Strength
required
Description
BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049)
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
att-1
Path
DeviceDefinition.classification.justification.RelatedArtifact.document.Attachment.data
Id
Attachment.data
Type
Cardinality
0 - 1
Definition
The actual data of the attachment - a sequence of bytes, base64 encoded.
Comment
The base64-encoded data SHALL be expressed in the same character set as the base resource XML or JSON.
Requirements
The data needs to able to be transmitted inline.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
att-1
Path
DeviceDefinition.classification.justification.RelatedArtifact.document.Attachment.url
Id
Attachment.url
Type
Cardinality
0 - 1
Definition
A location where the data can be accessed.
Comment
If both data and url are provided, the url SHALL point to the same content as the data contains. Urls may be relative references or may reference transient locations such as a wrapping envelope using cid: though this has ramifications for using signatures. Relative URLs are interpreted relative to the service url, like a resource reference, rather than relative to the resource itself. If a URL is provided, it SHALL resolve to actual data.
Requirements
The data needs to be transmitted by reference.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification.justification.RelatedArtifact.document.Attachment.size
Id
Attachment.size
Type
Cardinality
0 - 1
Definition
The number of bytes of data that make up this attachment (before base64 encoding, if that is done).
Comment
The number of bytes is redundant if the data is provided as a base64binary, but is useful if the data is provided as a url reference.
Requirements
Representing the size allows applications to determine whether they should fetch the content automatically in advance, or refuse to fetch it at all.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification.justification.RelatedArtifact.document.Attachment.hash
Id
Attachment.hash
Type
Cardinality
0 - 1
Definition
The calculated hash of the data using SHA-1. Represented using base64.
Comment
The hash is calculated on the data prior to base64 encoding, if the data is based64 encoded. The hash is not intended to support digital signatures. Where protection against malicious threats a digital signature should be considered, see [Provenance.signature](provenance-definitions.html#Provenance.signature) for mechanism to protect a resource with a digital signature.
Requirements
Included so that applications can verify that the contents of a location have not changed due to technical failures (e.g., storage rot, transport glitch, incorrect version).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification.justification.RelatedArtifact.document.Attachment.title
Id
Attachment.title
Type
Cardinality
0 - 1
Definition
A label or set of text to display in place of the data.
Comment
May sometimes be derived from the source filename.
Requirements
Applications need a label to display to a human user in place of the actual data if the data cannot be rendered or perceived by the viewer.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification.justification.RelatedArtifact.document.Attachment.creation
Id
Attachment.creation
Type
Cardinality
0 - 1
Definition
The date that the attachment was first created.
Comment
Requirements
This is often tracked as an integrity issue for use of the attachment.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification.justification.RelatedArtifact.document.Attachment.height
Id
Attachment.height
Type
Cardinality
0 - 1
Definition
Height of the image in pixels (photo/video).
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification.justification.RelatedArtifact.document.Attachment.width
Id
Attachment.width
Type
Cardinality
0 - 1
Definition
Width of the image in pixels (photo/video).
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification.justification.RelatedArtifact.document.Attachment.frames
Id
Attachment.frames
Type
Cardinality
0 - 1
Definition
The number of frames in a photo. This is used with a multi-page fax, or an imaging acquisition context that takes multiple slices in a single image, or an animated gif. If there is more than one frame, this SHALL have a value in order to alert interface software that a multi-frame capable rendering widget is required.
Comment
if the number of frames is not supplied, the value may be unknown. Applications should not assume that there is only one frame unless it is explicitly stated.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification.justification.RelatedArtifact.document.Attachment.duration
Id
Attachment.duration
Type
Cardinality
0 - 1
Definition
The duration of the recording in seconds - for audio and video.
Comment
The duration might differ from occurrencePeriod if recording was paused.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification.justification.RelatedArtifact.document.Attachment.pages
Id
Attachment.pages
Type
Cardinality
0 - 1
Definition
The number of pages when printed.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification.justification.RelatedArtifact.resource
Id
RelatedArtifact.resource
Type
Cardinality
0 - 1
Definition
The related artifact, such as a library, value set, profile, or other knowledge resource.
Comment
If the type is predecessor, this is a reference to the succeeding knowledge resource. If the type is successor, this is a reference to the prior knowledge resource.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification.justification.RelatedArtifact.resourceReference
Id
RelatedArtifact.resourceReference
Type
Cardinality
0 - 1
Definition
The related artifact, if the artifact is not a canonical resource, or a resource reference to a canonical resource.
Comment
If both resource and resourceReference are present, they SHOULD be consistent and reference the same resource. Although relatedArtifact is intended to support references to definitional resources, there are cases where non-definitional resources can be definitional (such as Location where the kind is mode). Related artifacts SHOULD be used to reference definitional resources, and profiles SHOULD be used to make that explicit for particular use cases.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification.justification.RelatedArtifact.resourceReference.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
ref-1
Path
DeviceDefinition.classification.justification.RelatedArtifact.resourceReference.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
Definition
The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.
The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).
Comment
This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification.justification.RelatedArtifact.resourceReference.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents 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.
Comment
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.
Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).
This element only allows for a single identifier. In the case where additional identifers are required, use the [http://hl7.org/fhir/StructureDefinition/additionalIdentifier](http://hl7.org/fhir/extensions/StructureDefinition-additionalIdentifier.html) extension.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.classification.justification.RelatedArtifact.resourceReference.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.classification.justification.RelatedArtifact.publicationStatus
Id
RelatedArtifact.publicationStatus
Type
Cardinality
0 - 1
Definition
The publication status of the artifact being referred to.
Comment
Binding
Strength
required
Description
Publication status of an artifact being referred to.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.classification.justification.RelatedArtifact.publicationDate
Id
RelatedArtifact.publicationDate
Type
Cardinality
0 - 1
Definition
The date of publication of the artifact being referred to.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
conformsTo
Identifies the standards, specifications, or formal guidances for the capabilities supported by the device
Path
DeviceDefinition.conformsTo
Id
DeviceDefinition.conformsTo
Type
Cardinality
0 - *
Definition
Identifies the standards, specifications, or formal guidances for the capabilities supported by the device. The device may be certified as conformant to these specifications e.g., communication, performance, process, measurement, or specialization standards.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
category
Describes the common type of the standard, specification, or formal guidance
Path
DeviceDefinition.conformsTo.category
Id
DeviceDefinition.conformsTo.category
Type
Cardinality
0 - 1
Definition
Describes the type of the standard, specification, or formal guidance.
Comment
Binding
Strength
example
Description
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.category.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.category.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 be an absolute reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.category.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.category.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.conformsTo.category.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.conformsTo.category.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
specification
Identifies the standard, specification, or formal guidance that the device adheres to the Device Specification type
Path
DeviceDefinition.conformsTo.specification
Id
DeviceDefinition.conformsTo.specification
Type
Cardinality
1 - 1
Definition
Code that identifies the specific standard, specification, protocol, formal guidance, regulation, legislation, or certification scheme to which the device adheres.
Comment
Binding
Strength
example
Description
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.specification.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.specification.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 be an absolute reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.specification.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.specification.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.conformsTo.specification.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.conformsTo.specification.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.version
Id
DeviceDefinition.conformsTo.version
Type
Cardinality
0 - *
Definition
Identifies the specific form or variant of the standard, specification, or formal guidance. This may be a 'version number', release, document edition, publication year, or other label.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
source
Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance
Path
DeviceDefinition.conformsTo.source
Id
DeviceDefinition.conformsTo.source
Type
Cardinality
0 - *
Definition
Standard, regulation, certification, or guidance website, document, or other publication, or similar, supporting the conformance.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
type
documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.type
Id
RelatedArtifact.type
Type
Cardinality
1 - 1
Definition
The type of relationship to the related artifact.
Comment
The presence of both sides of a relationship type (e.g. successor and predecessor) is required to support use cases where one side of a relationship is not represented in FHIR. However, this feature SHALL NOT be used to create bi-directional resource links in FHIR instances. Specifically, following the methodology of "new points to old" and "many points to one", when using related artifact elements to describe and reference FHIR resources, the type element SHALL be drawn from the fhir-related-artifact-type ValueSet.
Binding
Strength
required
Description
The type of relationship to the related artifact.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.classifier
Id
RelatedArtifact.classifier
Type
Cardinality
0 - *
Definition
Provides additional classifiers of the related artifact.
Comment
Binding
Strength
example
Description
Additional classifiers for the related artifact.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.classifier.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.label
Id
RelatedArtifact.label
Type
Cardinality
0 - 1
Definition
A short label that can be used to reference the citation from elsewhere in the containing artifact, such as a footnote index.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.display
Id
RelatedArtifact.display
Type
Cardinality
0 - 1
Definition
A brief description of the document or knowledge resource being referenced, suitable for display to a consumer.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.citation
Id
RelatedArtifact.citation
Type
Cardinality
0 - 1
Definition
A bibliographic citation for the related artifact. This text SHOULD be formatted according to an accepted citation format.
Comment
Additional structured information about citations should be captured as extensions.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.document
Id
RelatedArtifact.document
Type
Cardinality
0 - 1
Definition
The document being referenced, represented as an attachment. This is exclusive with the resource element.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.document.Attachment.contentType
Id
Attachment.contentType
Type
Cardinality
0 - 1
Definition
Identifies the type of the data in the attachment and allows a method to be chosen to interpret or render the data. Includes mime type parameters such as charset where appropriate.
Comment
Requirements
Processors of the data need to be able to know how to interpret the data.
Binding
Strength
required
Description
BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049)
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
att-1
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.document.Attachment.data
Id
Attachment.data
Type
Cardinality
0 - 1
Definition
The actual data of the attachment - a sequence of bytes, base64 encoded.
Comment
The base64-encoded data SHALL be expressed in the same character set as the base resource XML or JSON.
Requirements
The data needs to able to be transmitted inline.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
att-1
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.document.Attachment.url
Id
Attachment.url
Type
Cardinality
0 - 1
Definition
A location where the data can be accessed.
Comment
If both data and url are provided, the url SHALL point to the same content as the data contains. Urls may be relative references or may reference transient locations such as a wrapping envelope using cid: though this has ramifications for using signatures. Relative URLs are interpreted relative to the service url, like a resource reference, rather than relative to the resource itself. If a URL is provided, it SHALL resolve to actual data.
Requirements
The data needs to be transmitted by reference.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.document.Attachment.size
Id
Attachment.size
Type
Cardinality
0 - 1
Definition
The number of bytes of data that make up this attachment (before base64 encoding, if that is done).
Comment
The number of bytes is redundant if the data is provided as a base64binary, but is useful if the data is provided as a url reference.
Requirements
Representing the size allows applications to determine whether they should fetch the content automatically in advance, or refuse to fetch it at all.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.document.Attachment.hash
Id
Attachment.hash
Type
Cardinality
0 - 1
Definition
The calculated hash of the data using SHA-1. Represented using base64.
Comment
The hash is calculated on the data prior to base64 encoding, if the data is based64 encoded. The hash is not intended to support digital signatures. Where protection against malicious threats a digital signature should be considered, see [Provenance.signature](provenance-definitions.html#Provenance.signature) for mechanism to protect a resource with a digital signature.
Requirements
Included so that applications can verify that the contents of a location have not changed due to technical failures (e.g., storage rot, transport glitch, incorrect version).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.document.Attachment.title
Id
Attachment.title
Type
Cardinality
0 - 1
Definition
A label or set of text to display in place of the data.
Comment
May sometimes be derived from the source filename.
Requirements
Applications need a label to display to a human user in place of the actual data if the data cannot be rendered or perceived by the viewer.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.document.Attachment.creation
Id
Attachment.creation
Type
Cardinality
0 - 1
Definition
The date that the attachment was first created.
Comment
Requirements
This is often tracked as an integrity issue for use of the attachment.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.document.Attachment.height
Id
Attachment.height
Type
Cardinality
0 - 1
Definition
Height of the image in pixels (photo/video).
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.document.Attachment.width
Id
Attachment.width
Type
Cardinality
0 - 1
Definition
Width of the image in pixels (photo/video).
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.document.Attachment.frames
Id
Attachment.frames
Type
Cardinality
0 - 1
Definition
The number of frames in a photo. This is used with a multi-page fax, or an imaging acquisition context that takes multiple slices in a single image, or an animated gif. If there is more than one frame, this SHALL have a value in order to alert interface software that a multi-frame capable rendering widget is required.
Comment
if the number of frames is not supplied, the value may be unknown. Applications should not assume that there is only one frame unless it is explicitly stated.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.document.Attachment.duration
Id
Attachment.duration
Type
Cardinality
0 - 1
Definition
The duration of the recording in seconds - for audio and video.
Comment
The duration might differ from occurrencePeriod if recording was paused.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.document.Attachment.pages
Id
Attachment.pages
Type
Cardinality
0 - 1
Definition
The number of pages when printed.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.resource
Id
RelatedArtifact.resource
Type
Cardinality
0 - 1
Definition
The related artifact, such as a library, value set, profile, or other knowledge resource.
Comment
If the type is predecessor, this is a reference to the succeeding knowledge resource. If the type is successor, this is a reference to the prior knowledge resource.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.resourceReference
Id
RelatedArtifact.resourceReference
Type
Cardinality
0 - 1
Definition
The related artifact, if the artifact is not a canonical resource, or a resource reference to a canonical resource.
Comment
If both resource and resourceReference are present, they SHOULD be consistent and reference the same resource. Although relatedArtifact is intended to support references to definitional resources, there are cases where non-definitional resources can be definitional (such as Location where the kind is mode). Related artifacts SHOULD be used to reference definitional resources, and profiles SHOULD be used to make that explicit for particular use cases.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.resourceReference.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
ref-1
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.resourceReference.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
Definition
The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.
The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).
Comment
This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.resourceReference.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents 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.
Comment
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.
Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).
This element only allows for a single identifier. In the case where additional identifers are required, use the [http://hl7.org/fhir/StructureDefinition/additionalIdentifier](http://hl7.org/fhir/extensions/StructureDefinition-additionalIdentifier.html) extension.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.resourceReference.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.publicationStatus
Id
RelatedArtifact.publicationStatus
Type
Cardinality
0 - 1
Definition
The publication status of the artifact being referred to.
Comment
Binding
Strength
required
Description
Publication status of an artifact being referred to.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.conformsTo.source.RelatedArtifact.publicationDate
Id
RelatedArtifact.publicationDate
Type
Cardinality
0 - 1
Definition
The date of publication of the artifact being referred to.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.hasPart
Id
DeviceDefinition.hasPart
Type
Cardinality
0 - *
Definition
A device that is part (for example a component) of the present device.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.hasPart.reference
Id
DeviceDefinition.hasPart.reference
Type
Cardinality
1 - 1
Definition
Reference to the device that is part of the current device.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.hasPart.reference.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
ref-1
Path
DeviceDefinition.hasPart.reference.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
Definition
The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.
The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).
Comment
This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.hasPart.reference.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents 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.
Comment
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.
Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).
This element only allows for a single identifier. In the case where additional identifers are required, use the [http://hl7.org/fhir/StructureDefinition/additionalIdentifier](http://hl7.org/fhir/extensions/StructureDefinition-additionalIdentifier.html) extension.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.hasPart.reference.Reference.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Requirements
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Binding
Strength
required
Description
Identifies the purpose for this identifier, if known .
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.hasPart.reference.Reference.identifier.Identifier.type
Id
Identifier.type
Type
Cardinality
0 - 1
Definition
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Comment
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.
Requirements
Allows users to make use of identifiers when the identifier system is not known.
Binding
Strength
extensible
Description
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.hasPart.reference.Reference.identifier.Identifier.system
Id
Identifier.system
Type
Cardinality
0 - 1
Definition
Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.
Comment
Identifier.system is always case sensitive.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.hasPart.reference.Reference.identifier.Identifier.value
Id
Identifier.value
Type
Cardinality
0 - 1
Definition
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Comment
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 [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ident-1
Path
DeviceDefinition.hasPart.reference.Reference.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.hasPart.reference.Reference.identifier.Identifier.assigner
Id
Identifier.assigner
Type
Cardinality
0 - 1
Definition
Organization that issued/manages the identifier.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.hasPart.reference.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.hasPart.count
Id
DeviceDefinition.hasPart.count
Type
Cardinality
0 - 1
Definition
Number of instances of the component device in the current device.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
packaging
Information about the packaging of the device, i.e. how the device is packaged
Path
DeviceDefinition.packaging
Id
DeviceDefinition.packaging
Type
Cardinality
0 - *
Definition
Information about the packaging of the device, i.e. how the device is packaged.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.packaging.identifier
Id
DeviceDefinition.packaging.identifier
Type
Cardinality
0 - 1
Definition
The business identifier of the packaged medication.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.packaging.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Requirements
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Binding
Strength
required
Description
Identifies the purpose for this identifier, if known .
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.packaging.identifier.Identifier.type
Id
Identifier.type
Type
Cardinality
0 - 1
Definition
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Comment
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.
Requirements
Allows users to make use of identifiers when the identifier system is not known.
Binding
Strength
extensible
Description
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.packaging.identifier.Identifier.type.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.packaging.identifier.Identifier.system
Id
Identifier.system
Type
Cardinality
0 - 1
Definition
Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.
Comment
Identifier.system is always case sensitive.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.packaging.identifier.Identifier.value
Id
Identifier.value
Type
Cardinality
0 - 1
Definition
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Comment
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 [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ident-1
Path
DeviceDefinition.packaging.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.packaging.identifier.Identifier.period.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
DeviceDefinition.packaging.identifier.Identifier.period.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. 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.
Comment
The end value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
DeviceDefinition.packaging.identifier.Identifier.assigner
Id
Identifier.assigner
Type
Cardinality
0 - 1
Definition
Organization that issued/manages the identifier.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.packaging.identifier.Identifier.assigner.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
ref-1
Path
DeviceDefinition.packaging.identifier.Identifier.assigner.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
Definition
The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.
The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).
Comment
This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.packaging.identifier.Identifier.assigner.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents 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.
Comment
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.
Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).
This element only allows for a single identifier. In the case where additional identifers are required, use the [http://hl7.org/fhir/StructureDefinition/additionalIdentifier](http://hl7.org/fhir/extensions/StructureDefinition-additionalIdentifier.html) extension.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.packaging.identifier.Identifier.assigner.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.packaging.type
Id
DeviceDefinition.packaging.type
Type
Cardinality
0 - 1
Definition
A code that defines the specific type of packaging.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.packaging.type.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.packaging.type.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 be an absolute reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.packaging.type.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.packaging.type.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.packaging.type.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.packaging.type.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.packaging.count
Id
DeviceDefinition.packaging.count
Type
Cardinality
0 - 1
Definition
The number of items contained in the package (devices or sub-packages).
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.packaging.distributor
Id
DeviceDefinition.packaging.distributor
Type
Cardinality
0 - *
Definition
An organization that distributes the packaged device.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.packaging.distributor.name
Id
DeviceDefinition.packaging.distributor.name
Type
Cardinality
0 - 1
Definition
Distributor's human-readable name.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.packaging.distributor.organizationReference
Id
DeviceDefinition.packaging.distributor.organizationReference
Type
Cardinality
0 - *
Definition
Distributor as an Organization resource.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.packaging.distributor.organizationReference.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
ref-1
Path
DeviceDefinition.packaging.distributor.organizationReference.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
Definition
The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.
The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).
Comment
This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.packaging.distributor.organizationReference.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents 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.
Comment
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.
Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).
This element only allows for a single identifier. In the case where additional identifers are required, use the [http://hl7.org/fhir/StructureDefinition/additionalIdentifier](http://hl7.org/fhir/extensions/StructureDefinition-additionalIdentifier.html) extension.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.packaging.distributor.organizationReference.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
udiDeviceIdentifier
Unique Device Identifier (UDI) Barcode string on the packaging
Path
DeviceDefinition.packaging.udiDeviceIdentifier
Id
DeviceDefinition.packaging.udiDeviceIdentifier
Type
Cardinality
0 - *
Definition
Unique Device Identifier (UDI) Barcode string on the packaging.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.packaging.packaging
Id
DeviceDefinition.packaging.packaging
Type
Cardinality
0 - *
Definition
Allows packages within packages.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.version
Id
DeviceDefinition.version
Type
Cardinality
0 - *
Definition
The version of the device or software.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.version.type
Id
DeviceDefinition.version.type
Type
Cardinality
0 - 1
Definition
The type of the device version, e.g. manufacturer, approved, internal.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.version.type.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.version.type.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 be an absolute reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.version.type.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.version.type.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.version.type.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.version.type.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.version.component
Id
DeviceDefinition.version.component
Type
Cardinality
0 - 1
Definition
The hardware or software module of the device to which the version applies.
Comment
Note that the module of the device would not need to be tracked as a separate device, e.g., using different UDI, thus would typically involve one or more software modules. For example, a device may involve two software modules each on a different version.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.version.component.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Requirements
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Binding
Strength
required
Description
Identifies the purpose for this identifier, if known .
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.version.component.Identifier.type
Id
Identifier.type
Type
Cardinality
0 - 1
Definition
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Comment
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.
Requirements
Allows users to make use of identifiers when the identifier system is not known.
Binding
Strength
extensible
Description
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.version.component.Identifier.type.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.version.component.Identifier.system
Id
Identifier.system
Type
Cardinality
0 - 1
Definition
Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.
Comment
Identifier.system is always case sensitive.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.version.component.Identifier.value
Id
Identifier.value
Type
Cardinality
0 - 1
Definition
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Comment
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 [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ident-1
Path
DeviceDefinition.version.component.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.version.component.Identifier.period.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
DeviceDefinition.version.component.Identifier.period.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. 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.
Comment
The end value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
DeviceDefinition.version.component.Identifier.assigner
Id
Identifier.assigner
Type
Cardinality
0 - 1
Definition
Organization that issued/manages the identifier.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.version.component.Identifier.assigner.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
ref-1
Path
DeviceDefinition.version.component.Identifier.assigner.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
Definition
The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.
The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).
Comment
This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.version.component.Identifier.assigner.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents 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.
Comment
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.
Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).
This element only allows for a single identifier. In the case where additional identifers are required, use the [http://hl7.org/fhir/StructureDefinition/additionalIdentifier](http://hl7.org/fhir/extensions/StructureDefinition-additionalIdentifier.html) extension.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.version.component.Identifier.assigner.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.version.value
Id
DeviceDefinition.version.value
Type
Cardinality
1 - 1
Definition
The version text.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.safety
Id
DeviceDefinition.safety
Type
Cardinality
0 - *
Definition
Safety characteristics of the device.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.safety.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.safety.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 be an absolute reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.safety.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.safety.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.safety.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.safety.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.shelfLifeStorage
Id
DeviceDefinition.shelfLifeStorage
Type
Cardinality
0 - *
Definition
Shelf Life and storage information.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
type
This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified
Path
DeviceDefinition.shelfLifeStorage.ProductShelfLife.type
Id
ProductShelfLife.type
Type
Cardinality
0 - 1
Definition
This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.shelfLifeStorage.ProductShelfLife.type.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.shelfLifeStorage.ProductShelfLife.type.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 be an absolute reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.shelfLifeStorage.ProductShelfLife.type.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.shelfLifeStorage.ProductShelfLife.type.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.shelfLifeStorage.ProductShelfLife.type.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.shelfLifeStorage.ProductShelfLife.type.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
period[x]
The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used
Path
DeviceDefinition.shelfLifeStorage.ProductShelfLife.period[x]
Id
ProductShelfLife.period[x]
Type
Cardinality
0 - 1
Definition
The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.shelfLifeStorage.ProductShelfLife.period[x].Duration.value
Id
Duration.value
Type
Cardinality
0 - 1
Definition
The value of the measured amount. The value includes an implicit precision in the presentation of the value.
Comment
The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
Requirements
Precision is handled implicitly in almost all cases of measurement.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.shelfLifeStorage.ProductShelfLife.period[x].Duration.comparator
Id
Duration.comparator
Type
Cardinality
0 - 1
Definition
How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
Comment
Requirements
Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
Binding
Strength
required
Description
How the Quantity should be understood and represented.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.shelfLifeStorage.ProductShelfLife.period[x].Duration.unit
Id
Duration.unit
Type
Cardinality
0 - 1
Definition
A human-readable form of the unit.
Comment
Requirements
There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.shelfLifeStorage.ProductShelfLife.period[x].Duration.system
Id
Duration.system
Type
Cardinality
0 - 1
Definition
The identification of the system that provides the coded form of the unit.
Comment
Requirements
Need to know the system that defines the coded form of the unit.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
qty-3
Path
DeviceDefinition.shelfLifeStorage.ProductShelfLife.period[x].Duration.code
Id
Duration.code
Type
Cardinality
0 - 1
Definition
A computer processable form of the unit in some unit representation system.
Comment
The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
Requirements
Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
qty-3
specialPrecautionsForStorage
Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified
Path
DeviceDefinition.shelfLifeStorage.ProductShelfLife.specialPrecautionsForStorage
Id
ProductShelfLife.specialPrecautionsForStorage
Type
Cardinality
0 - *
Definition
Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.shelfLifeStorage.ProductShelfLife.specialPrecautionsForStorage.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.shelfLifeStorage.ProductShelfLife.specialPrecautionsForStorage.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 be an absolute reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.shelfLifeStorage.ProductShelfLife.specialPrecautionsForStorage.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.shelfLifeStorage.ProductShelfLife.specialPrecautionsForStorage.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.shelfLifeStorage.ProductShelfLife.specialPrecautionsForStorage.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.shelfLifeStorage.ProductShelfLife.specialPrecautionsForStorage.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
languageCode
Language code for the human-readable text strings produced by the device (all supported)
Path
DeviceDefinition.languageCode
Id
DeviceDefinition.languageCode
Type
Cardinality
0 - *
Definition
Language code for the human-readable text strings produced by the device (all supported).
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.languageCode.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.languageCode.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 be an absolute reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.languageCode.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.languageCode.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.languageCode.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.languageCode.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
property
Inherent, essentially fixed, characteristics of this kind of device, e.g., time properties, size, etc
Path
DeviceDefinition.property
Id
DeviceDefinition.property
Type
Cardinality
0 - *
Definition
Static or essentially fixed characteristics or features of this kind of device that are otherwise not captured in more specific attributes, e.g., time or timing attributes, resolution, accuracy, and physical attributes.
Comment
Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific DeviceMetric and recorded using Observation. Static characteristics of an individual device could also be documented in a [Device] instance. The Device instance's properties, and their values, could be, but need not be, the same as in the associated DeviceDefinition.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.property.type
Id
DeviceDefinition.property.type
Type
Cardinality
1 - 1
Definition
Code that specifies the property such as a resolution or color being represented.
Comment
Binding
Strength
example
Description
Device property type.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.property.type.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.property.type.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 be an absolute reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.property.type.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.property.type.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.property.type.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.property.type.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.property.value[x]
Id
DeviceDefinition.property.value[x]
Type
Cardinality
1 - 1
Definition
The value of the property specified by the associated property.type code.
Comment
This use of string or CodeableConcept is supported to address different purposes The text element of the valueCodeableConcept choice type is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g., a custom implant size, or a security classification which depends on configuration. Otherwise the valueString choice type is used for textual descriptive device properties that cannot be expressed in other elements.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.property.value[x].Quantity.value
Id
Quantity.value
Type
Cardinality
0 - 1
Definition
The value of the measured amount. The value includes an implicit precision in the presentation of the value.
Comment
The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
Requirements
Precision is handled implicitly in almost all cases of measurement.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.property.value[x].Quantity.comparator
Id
Quantity.comparator
Type
Cardinality
0 - 1
Definition
How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
Comment
Requirements
Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
Binding
Strength
required
Description
How the Quantity should be understood and represented.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.property.value[x].Quantity.unit
Id
Quantity.unit
Type
Cardinality
0 - 1
Definition
A human-readable form of the unit.
Comment
Requirements
There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.property.value[x].Quantity.system
Id
Quantity.system
Type
Cardinality
0 - 1
Definition
The identification of the system that provides the coded form of the unit.
Comment
Requirements
Need to know the system that defines the coded form of the unit.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
qty-3
Path
DeviceDefinition.property.value[x].Quantity.code
Id
Quantity.code
Type
Cardinality
0 - 1
Definition
A computer processable form of the unit in some unit representation system.
Comment
The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
Requirements
Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
qty-3
Path
DeviceDefinition.owner
Id
DeviceDefinition.owner
Type
Cardinality
0 - 1
Definition
An organization that is responsible for the provision and ongoing maintenance of the device.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.owner.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
ref-1
Path
DeviceDefinition.owner.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
Definition
The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.
The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).
Comment
This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.owner.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents 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.
Comment
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.
Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).
This element only allows for a single identifier. In the case where additional identifers are required, use the [http://hl7.org/fhir/StructureDefinition/additionalIdentifier](http://hl7.org/fhir/extensions/StructureDefinition-additionalIdentifier.html) extension.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.owner.Reference.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Requirements
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Binding
Strength
required
Description
Identifies the purpose for this identifier, if known .
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.owner.Reference.identifier.Identifier.type
Id
Identifier.type
Type
Cardinality
0 - 1
Definition
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Comment
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.
Requirements
Allows users to make use of identifiers when the identifier system is not known.
Binding
Strength
extensible
Description
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.owner.Reference.identifier.Identifier.type.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.owner.Reference.identifier.Identifier.system
Id
Identifier.system
Type
Cardinality
0 - 1
Definition
Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.
Comment
Identifier.system is always case sensitive.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.owner.Reference.identifier.Identifier.value
Id
Identifier.value
Type
Cardinality
0 - 1
Definition
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Comment
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 [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ident-1
Path
DeviceDefinition.owner.Reference.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.owner.Reference.identifier.Identifier.period.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
DeviceDefinition.owner.Reference.identifier.Identifier.period.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. 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.
Comment
The end value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
DeviceDefinition.owner.Reference.identifier.Identifier.assigner
Id
Identifier.assigner
Type
Cardinality
0 - 1
Definition
Organization that issued/manages the identifier.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.owner.Reference.identifier.Identifier.assigner.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
ref-1
Path
DeviceDefinition.owner.Reference.identifier.Identifier.assigner.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
Definition
The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.
The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).
Comment
This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.owner.Reference.identifier.Identifier.assigner.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents 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.
Comment
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.
Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).
This element only allows for a single identifier. In the case where additional identifers are required, use the [http://hl7.org/fhir/StructureDefinition/additionalIdentifier](http://hl7.org/fhir/extensions/StructureDefinition-additionalIdentifier.html) extension.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.owner.Reference.identifier.Identifier.assigner.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.owner.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.contact
Id
DeviceDefinition.contact
Type
Cardinality
0 - *
Definition
Contact details for an organization or a particular human that is responsible for the device.
Comment
used for troubleshooting etc.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.contact.ContactPoint.system
Id
ContactPoint.system
Type
Cardinality
0 - 1
Definition
Telecommunications form for contact point - what communications system is required to make use of the contact.
Comment
Binding
Strength
required
Description
Telecommunications form for contact point.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cpt-2
Path
DeviceDefinition.contact.ContactPoint.value
Id
ContactPoint.value
Type
Cardinality
0 - 1
Definition
The actual contact point details, in a form that is meaningful to the designated communication system (i.e. phone number or email address).
Comment
Additional text data such as phone extension numbers, or notes about use of the contact are sometimes included in the value.
Requirements
Need to support legacy numbers that are not in a tightly controlled format.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cpt-2
Path
DeviceDefinition.contact.ContactPoint.use
Id
ContactPoint.use
Type
Cardinality
0 - 1
Definition
Identifies the purpose for the contact point.
Comment
Applications can assume that a contact is current unless it explicitly says that it is temporary or old.
Requirements
Need to track the way a person uses this contact, so a user can choose which is appropriate for their purpose.
Binding
Strength
required
Description
Use of contact point.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.contact.ContactPoint.rank
Id
ContactPoint.rank
Type
Cardinality
0 - 1
Definition
Specifies a preferred order in which to use a set of contacts. ContactPoints with lower rank values are more preferred than those with higher rank values.
Comment
Note that rank does not necessarily follow the order in which the contacts are represented in the instance.
Ranks need not be unique. E.g. it's possible to have multiple contacts with rank=1. If the ranks have different systems or uses, this would be interpreted to mean "X is my most preferred phone number, Y is my most preferred email address" or "X is my preferred home email and Y is my preferred work email". If the system and use for equally-ranked contacts are the same, then the level of preference is equivalent for both repetitions.
Ranks need not be sequential and not all repetitions must have a rank. For example, it's possible to have 4 contacts with ranks of 2, 5 and two with no rank specified. That would be interpreted to mean the first is preferred over the second and no preference stated for the remaining contacts.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.contact.ContactPoint.period
Id
ContactPoint.period
Type
Cardinality
0 - 1
Definition
Time period when the contact point was/is in use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.contact.ContactPoint.period.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
DeviceDefinition.contact.ContactPoint.period.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. 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.
Comment
The end value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
link
An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device
Path
DeviceDefinition.link
Id
DeviceDefinition.link
Type
Cardinality
0 - *
Definition
An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.link.relation
Id
DeviceDefinition.link.relation
Type
Cardinality
1 - 1
Definition
The type indicates the relationship of the related device to the device instance.
Comment
Binding
Strength
extensible
Description
The type of relation between this and the linked device.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.link.relation.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 be an absolute reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.link.relation.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.link.relation.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.link.relation.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.link.relation.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.link.relatedDevice
Id
DeviceDefinition.link.relatedDevice
Type
Cardinality
1 - 1
Definition
A reference to the linked device.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.link.relatedDevice.CodeableReference.concept
Id
CodeableReference.concept
Type
Cardinality
0 - 1
Definition
A reference to a concept - e.g. the information is identified by its general class to the degree of precision found in the terminology.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.link.relatedDevice.CodeableReference.concept.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.link.relatedDevice.CodeableReference.reference
Id
CodeableReference.reference
Type
Cardinality
0 - 1
Definition
A reference to a resource the provides exact details about the information being referenced.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.link.relatedDevice.CodeableReference.reference.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
ref-1
Path
DeviceDefinition.link.relatedDevice.CodeableReference.reference.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
Definition
The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.
The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).
Comment
This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.link.relatedDevice.CodeableReference.reference.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents 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.
Comment
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.
Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).
This element only allows for a single identifier. In the case where additional identifers are required, use the [http://hl7.org/fhir/StructureDefinition/additionalIdentifier](http://hl7.org/fhir/extensions/StructureDefinition-additionalIdentifier.html) extension.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.link.relatedDevice.CodeableReference.reference.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.note
Id
DeviceDefinition.note
Type
Cardinality
0 - *
Definition
Descriptive information, usage information or implantation information that is not captured in an existing element.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.note.Annotation.author[x]
Id
Annotation.author[x]
Type
Cardinality
0 - 1
Definition
The individual responsible for making the annotation.
Comment
Organization is used when there's no need for specific attribution as to who made the comment.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.note.Annotation.author[x].Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
ref-1
Path
DeviceDefinition.note.Annotation.author[x].Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
Definition
The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.
The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).
Comment
This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.note.Annotation.author[x].Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents 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.
Comment
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.
Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).
This element only allows for a single identifier. In the case where additional identifers are required, use the [http://hl7.org/fhir/StructureDefinition/additionalIdentifier](http://hl7.org/fhir/extensions/StructureDefinition-additionalIdentifier.html) extension.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.note.Annotation.author[x].Reference.identifier.Identifier.use
Id
Identifier.use
Type
Cardinality
0 - 1
Definition
The purpose of this identifier.
Comment
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Requirements
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
Binding
Strength
required
Description
Identifies the purpose for this identifier, if known .
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.note.Annotation.author[x].Reference.identifier.Identifier.type
Id
Identifier.type
Type
Cardinality
0 - 1
Definition
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Comment
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.
Requirements
Allows users to make use of identifiers when the identifier system is not known.
Binding
Strength
extensible
Description
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.note.Annotation.author[x].Reference.identifier.Identifier.system
Id
Identifier.system
Type
Cardinality
0 - 1
Definition
Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.
Comment
Identifier.system is always case sensitive.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.note.Annotation.author[x].Reference.identifier.Identifier.value
Id
Identifier.value
Type
Cardinality
0 - 1
Definition
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Comment
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 [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ident-1
Path
DeviceDefinition.note.Annotation.author[x].Reference.identifier.Identifier.period
Id
Identifier.period
Type
Cardinality
0 - 1
Definition
Time period during which identifier is/was valid for use.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.note.Annotation.author[x].Reference.identifier.Identifier.assigner
Id
Identifier.assigner
Type
Cardinality
0 - 1
Definition
Organization that issued/manages the identifier.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.note.Annotation.author[x].Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.note.Annotation.time
Id
Annotation.time
Type
Cardinality
0 - 1
Definition
Indicates when this particular annotation was made.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.material
Id
DeviceDefinition.material
Type
Cardinality
0 - *
Definition
A substance used to create the material(s) of which the device is made.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.material.substance
Id
DeviceDefinition.material.substance
Type
Cardinality
1 - 1
Definition
A substance that the device contains, may contain, or is made of - for example latex - to be used to determine patient compatibility. This is not intended to represent the composition of the device, only the clinically relevant materials.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.material.substance.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.material.substance.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 be an absolute reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.material.substance.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.material.substance.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.material.substance.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.material.substance.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.material.alternate
Id
DeviceDefinition.material.alternate
Type
Cardinality
0 - 1
Definition
Indicates an alternative material of the device.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.material.allergenicIndicator
Id
DeviceDefinition.material.allergenicIndicator
Type
Cardinality
0 - 1
Definition
Whether the substance is a known or suspected allergen.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
productionIdentifierInUDI
lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version
Path
DeviceDefinition.productionIdentifierInUDI
Id
DeviceDefinition.productionIdentifierInUDI
Type
Cardinality
0 - *
Definition
Indicates the production identifier(s) that are expected to appear in the UDI carrier on the device label.
Comment
Binding
Strength
required
Description
The production identifier(s) that are expected to appear in the UDI carrier.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
guideline
Information aimed at providing directions for the usage of this model of device
Path
DeviceDefinition.guideline
Id
DeviceDefinition.guideline
Type
Cardinality
0 - 1
Definition
Information aimed at providing directions for the usage of this model of device.
Comment
For more structured data, a ClinicalUseDefinition that points to the DeviceDefinition can be used.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.useContext
Id
DeviceDefinition.guideline.useContext
Type
Cardinality
0 - *
Definition
The circumstances that form the setting for using the device.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.useContext.UsageContext.code
Id
UsageContext.code
Type
Cardinality
1 - 1
Definition
A code that identifies the type of context being specified by this usage context.
Comment
Binding
Strength
extensible
Description
A code that specifies a type of context being specified by a usage context.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.useContext.UsageContext.code.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 be an absolute reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.useContext.UsageContext.code.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.useContext.UsageContext.code.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.guideline.useContext.UsageContext.code.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.guideline.useContext.UsageContext.code.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.useContext.UsageContext.value[x]
Id
UsageContext.value[x]
Type
Cardinality
1 - 1
Definition
A value that defines the context specified in this context of use. The interpretation of the value is defined by the code.
Comment
Binding
Strength
example
Description
A code that defines the specific value for the context being specified.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.useContext.UsageContext.value[x].CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
usageInstruction
Detailed written and visual directions for the user on how to use the device
Path
DeviceDefinition.guideline.usageInstruction
Id
DeviceDefinition.guideline.usageInstruction
Type
Cardinality
0 - 1
Definition
Detailed written and visual directions for the user on how to use the device.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.relatedArtifact
Id
DeviceDefinition.guideline.relatedArtifact
Type
Cardinality
0 - *
Definition
A source of information or reference for this guideline.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
type
documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.type
Id
RelatedArtifact.type
Type
Cardinality
1 - 1
Definition
The type of relationship to the related artifact.
Comment
The presence of both sides of a relationship type (e.g. successor and predecessor) is required to support use cases where one side of a relationship is not represented in FHIR. However, this feature SHALL NOT be used to create bi-directional resource links in FHIR instances. Specifically, following the methodology of "new points to old" and "many points to one", when using related artifact elements to describe and reference FHIR resources, the type element SHALL be drawn from the fhir-related-artifact-type ValueSet.
Binding
Strength
required
Description
The type of relationship to the related artifact.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.classifier
Id
RelatedArtifact.classifier
Type
Cardinality
0 - *
Definition
Provides additional classifiers of the related artifact.
Comment
Binding
Strength
example
Description
Additional classifiers for the related artifact.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.classifier.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.label
Id
RelatedArtifact.label
Type
Cardinality
0 - 1
Definition
A short label that can be used to reference the citation from elsewhere in the containing artifact, such as a footnote index.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.display
Id
RelatedArtifact.display
Type
Cardinality
0 - 1
Definition
A brief description of the document or knowledge resource being referenced, suitable for display to a consumer.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.citation
Id
RelatedArtifact.citation
Type
Cardinality
0 - 1
Definition
A bibliographic citation for the related artifact. This text SHOULD be formatted according to an accepted citation format.
Comment
Additional structured information about citations should be captured as extensions.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.document
Id
RelatedArtifact.document
Type
Cardinality
0 - 1
Definition
The document being referenced, represented as an attachment. This is exclusive with the resource element.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.document.Attachment.contentType
Id
Attachment.contentType
Type
Cardinality
0 - 1
Definition
Identifies the type of the data in the attachment and allows a method to be chosen to interpret or render the data. Includes mime type parameters such as charset where appropriate.
Comment
Requirements
Processors of the data need to be able to know how to interpret the data.
Binding
Strength
required
Description
BCP 13 (RFCs 2045, 2046, 2047, 4288, 4289 and 2049)
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
att-1
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.document.Attachment.data
Id
Attachment.data
Type
Cardinality
0 - 1
Definition
The actual data of the attachment - a sequence of bytes, base64 encoded.
Comment
The base64-encoded data SHALL be expressed in the same character set as the base resource XML or JSON.
Requirements
The data needs to able to be transmitted inline.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
att-1
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.document.Attachment.url
Id
Attachment.url
Type
Cardinality
0 - 1
Definition
A location where the data can be accessed.
Comment
If both data and url are provided, the url SHALL point to the same content as the data contains. Urls may be relative references or may reference transient locations such as a wrapping envelope using cid: though this has ramifications for using signatures. Relative URLs are interpreted relative to the service url, like a resource reference, rather than relative to the resource itself. If a URL is provided, it SHALL resolve to actual data.
Requirements
The data needs to be transmitted by reference.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.document.Attachment.size
Id
Attachment.size
Type
Cardinality
0 - 1
Definition
The number of bytes of data that make up this attachment (before base64 encoding, if that is done).
Comment
The number of bytes is redundant if the data is provided as a base64binary, but is useful if the data is provided as a url reference.
Requirements
Representing the size allows applications to determine whether they should fetch the content automatically in advance, or refuse to fetch it at all.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.document.Attachment.hash
Id
Attachment.hash
Type
Cardinality
0 - 1
Definition
The calculated hash of the data using SHA-1. Represented using base64.
Comment
The hash is calculated on the data prior to base64 encoding, if the data is based64 encoded. The hash is not intended to support digital signatures. Where protection against malicious threats a digital signature should be considered, see [Provenance.signature](provenance-definitions.html#Provenance.signature) for mechanism to protect a resource with a digital signature.
Requirements
Included so that applications can verify that the contents of a location have not changed due to technical failures (e.g., storage rot, transport glitch, incorrect version).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.document.Attachment.title
Id
Attachment.title
Type
Cardinality
0 - 1
Definition
A label or set of text to display in place of the data.
Comment
May sometimes be derived from the source filename.
Requirements
Applications need a label to display to a human user in place of the actual data if the data cannot be rendered or perceived by the viewer.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.document.Attachment.creation
Id
Attachment.creation
Type
Cardinality
0 - 1
Definition
The date that the attachment was first created.
Comment
Requirements
This is often tracked as an integrity issue for use of the attachment.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.document.Attachment.height
Id
Attachment.height
Type
Cardinality
0 - 1
Definition
Height of the image in pixels (photo/video).
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.document.Attachment.width
Id
Attachment.width
Type
Cardinality
0 - 1
Definition
Width of the image in pixels (photo/video).
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.document.Attachment.frames
Id
Attachment.frames
Type
Cardinality
0 - 1
Definition
The number of frames in a photo. This is used with a multi-page fax, or an imaging acquisition context that takes multiple slices in a single image, or an animated gif. If there is more than one frame, this SHALL have a value in order to alert interface software that a multi-frame capable rendering widget is required.
Comment
if the number of frames is not supplied, the value may be unknown. Applications should not assume that there is only one frame unless it is explicitly stated.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.document.Attachment.duration
Id
Attachment.duration
Type
Cardinality
0 - 1
Definition
The duration of the recording in seconds - for audio and video.
Comment
The duration might differ from occurrencePeriod if recording was paused.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.document.Attachment.pages
Id
Attachment.pages
Type
Cardinality
0 - 1
Definition
The number of pages when printed.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.resource
Id
RelatedArtifact.resource
Type
Cardinality
0 - 1
Definition
The related artifact, such as a library, value set, profile, or other knowledge resource.
Comment
If the type is predecessor, this is a reference to the succeeding knowledge resource. If the type is successor, this is a reference to the prior knowledge resource.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.resourceReference
Id
RelatedArtifact.resourceReference
Type
Cardinality
0 - 1
Definition
The related artifact, if the artifact is not a canonical resource, or a resource reference to a canonical resource.
Comment
If both resource and resourceReference are present, they SHOULD be consistent and reference the same resource. Although relatedArtifact is intended to support references to definitional resources, there are cases where non-definitional resources can be definitional (such as Location where the kind is mode). Related artifacts SHOULD be used to reference definitional resources, and profiles SHOULD be used to make that explicit for particular use cases.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.resourceReference.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
ref-1
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.resourceReference.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
Definition
The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.
The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).
Comment
This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.resourceReference.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents 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.
Comment
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.
Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).
This element only allows for a single identifier. In the case where additional identifers are required, use the [http://hl7.org/fhir/StructureDefinition/additionalIdentifier](http://hl7.org/fhir/extensions/StructureDefinition-additionalIdentifier.html) extension.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.resourceReference.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.publicationStatus
Id
RelatedArtifact.publicationStatus
Type
Cardinality
0 - 1
Definition
The publication status of the artifact being referred to.
Comment
Binding
Strength
required
Description
Publication status of an artifact being referred to.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.relatedArtifact.RelatedArtifact.publicationDate
Id
RelatedArtifact.publicationDate
Type
Cardinality
0 - 1
Definition
The date of publication of the artifact being referred to.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.indication
Id
DeviceDefinition.guideline.indication
Type
Cardinality
0 - *
Definition
A clinical condition for which the device was designed to be used.
Comment
A ClinicalUseDefinition that points to the DeviceDefinition can be used if more structured data is needed.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.indication.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.indication.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 be an absolute reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.indication.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.indication.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.guideline.indication.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.guideline.indication.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
contraindication
A specific situation when a device should not be used because it may cause harm
Path
DeviceDefinition.guideline.contraindication
Id
DeviceDefinition.guideline.contraindication
Type
Cardinality
0 - *
Definition
A specific situation when a device should not be used because it may cause harm.
Comment
A ClinicalUseDefinition that points to the DeviceDefinition can be used if more structured data is needed.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.contraindication.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.contraindication.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 be an absolute reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.contraindication.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.contraindication.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.guideline.contraindication.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.guideline.contraindication.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
warning
Specific hazard alert information that a user needs to know before using the device
Path
DeviceDefinition.guideline.warning
Id
DeviceDefinition.guideline.warning
Type
Cardinality
0 - *
Definition
Specific hazard alert information that a user needs to know before using the device.
Comment
A ClinicalUseDefinition that points to the DeviceDefinition can be used if more structured data is needed.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.warning.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.warning.CodeableConcept.coding.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 be an absolute reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.warning.CodeableConcept.coding.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.guideline.warning.CodeableConcept.coding.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.guideline.warning.CodeableConcept.coding.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.guideline.warning.CodeableConcept.coding.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
intendedUse
A description of the general purpose or medical use of the device or its function
Path
DeviceDefinition.guideline.intendedUse
Id
DeviceDefinition.guideline.intendedUse
Type
Cardinality
0 - 1
Definition
A description of the general purpose or medical use of the device or its function.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.correctiveAction
Id
DeviceDefinition.correctiveAction
Type
Cardinality
0 - 1
Definition
Tracking of latest field safety corrective action.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.correctiveAction.recall
Id
DeviceDefinition.correctiveAction.recall
Type
Cardinality
1 - 1
Definition
Whether the last corrective action known for this device was a recall.
Comment
When a field safety action has been initiated but not yet resulted in a recall, this element will be set to 'false'.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.correctiveAction.scope
Id
DeviceDefinition.correctiveAction.scope
Type
Cardinality
0 - 1
Definition
The scope of the corrective action - whether the action targeted all units of a given device model, or only a specific set of batches identified by lot numbers, or individually identified devices identified by the serial name.
Comment
Binding
Strength
required
Description
The type or scope of the corrective action.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.correctiveAction.period
Id
DeviceDefinition.correctiveAction.period
Type
Cardinality
1 - 1
Definition
Start and end dates of the corrective action.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.correctiveAction.period.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
DeviceDefinition.correctiveAction.period.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. 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.
Comment
The end value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
DeviceDefinition.chargeItem
Id
DeviceDefinition.chargeItem
Type
Cardinality
0 - *
Definition
Billing code or reference associated with the device.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.chargeItem.chargeItemCode
Id
DeviceDefinition.chargeItem.chargeItemCode
Type
Cardinality
1 - 1
Definition
The code or reference for the charge item.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.chargeItem.chargeItemCode.CodeableReference.concept
Id
CodeableReference.concept
Type
Cardinality
0 - 1
Definition
A reference to a concept - e.g. the information is identified by its general class to the degree of precision found in the terminology.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.chargeItem.chargeItemCode.CodeableReference.concept.CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.chargeItem.chargeItemCode.CodeableReference.reference
Id
CodeableReference.reference
Type
Cardinality
0 - 1
Definition
A reference to a resource the provides exact details about the information being referenced.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.chargeItem.chargeItemCode.CodeableReference.reference.Reference.reference
Id
Reference.reference
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
ref-1
Path
DeviceDefinition.chargeItem.chargeItemCode.CodeableReference.reference.Reference.type
Id
Reference.type
Type
Cardinality
0 - 1
Definition
The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.
The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).
Comment
This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.
Binding
Strength
extensible
Description
Aa resource (or, for logical models, the URI of the logical model).
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.chargeItem.chargeItemCode.CodeableReference.reference.Reference.identifier
Id
Reference.identifier
Type
Cardinality
0 - 1
Definition
An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents 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.
Comment
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.
Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).
This element only allows for a single identifier. In the case where additional identifers are required, use the [http://hl7.org/fhir/StructureDefinition/additionalIdentifier](http://hl7.org/fhir/extensions/StructureDefinition-additionalIdentifier.html) extension.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.chargeItem.chargeItemCode.CodeableReference.reference.Reference.display
Id
Reference.display
Type
Cardinality
0 - 1
Definition
Plain text narrative that identifies the resource in addition to the resource reference.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
ref-2
Path
DeviceDefinition.chargeItem.count
Id
DeviceDefinition.chargeItem.count
Type
Cardinality
1 - 1
Definition
Coefficient applicable to the billing code.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.chargeItem.count.Quantity.value
Id
Quantity.value
Type
Cardinality
0 - 1
Definition
The value of the measured amount. The value includes an implicit precision in the presentation of the value.
Comment
The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
Requirements
Precision is handled implicitly in almost all cases of measurement.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.chargeItem.count.Quantity.comparator
Id
Quantity.comparator
Type
Cardinality
0 - 1
Definition
How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
Comment
Requirements
Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
Binding
Strength
required
Description
How the Quantity should be understood and represented.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.chargeItem.count.Quantity.unit
Id
Quantity.unit
Type
Cardinality
0 - 1
Definition
A human-readable form of the unit.
Comment
Requirements
There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.chargeItem.count.Quantity.system
Id
Quantity.system
Type
Cardinality
0 - 1
Definition
The identification of the system that provides the coded form of the unit.
Comment
Requirements
Need to know the system that defines the coded form of the unit.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
qty-3
Path
DeviceDefinition.chargeItem.count.Quantity.code
Id
Quantity.code
Type
Cardinality
0 - 1
Definition
A computer processable form of the unit in some unit representation system.
Comment
The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
Requirements
Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
qty-3
Path
DeviceDefinition.chargeItem.effectivePeriod
Id
DeviceDefinition.chargeItem.effectivePeriod
Type
Cardinality
0 - 1
Definition
A specific time period in which this charge item applies.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.chargeItem.effectivePeriod.Period.start
Id
Period.start
Type
Cardinality
0 - 1
Definition
The start of the period. The boundary is inclusive.
Comment
If the low element is missing, the meaning is that the low boundary is not known.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
DeviceDefinition.chargeItem.effectivePeriod.Period.end
Id
Period.end
Type
Cardinality
0 - 1
Definition
The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. 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.
Comment
The end value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
per-1
Path
DeviceDefinition.chargeItem.useContext
Id
DeviceDefinition.chargeItem.useContext
Type
Cardinality
0 - *
Definition
The context to which this charge item applies.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.chargeItem.useContext.UsageContext.code
Id
UsageContext.code
Type
Cardinality
1 - 1
Definition
A code that identifies the type of context being specified by this usage context.
Comment
Binding
Strength
extensible
Description
A code that specifies a type of context being specified by a usage context.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.chargeItem.useContext.UsageContext.code.Coding.system
Id
Coding.system
Type
Cardinality
0 - 1
Definition
The identification of the code system that defines the meaning of the symbol in the code.
Comment
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 be an absolute reference to some definition that establishes the system clearly and unambiguously.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.chargeItem.useContext.UsageContext.code.Coding.version
Id
Coding.version
Type
Cardinality
0 - 1
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.
Comment
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.chargeItem.useContext.UsageContext.code.Coding.code
Id
Coding.code
Type
Cardinality
0 - 1
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).
Comment
Requirements
Need to refer to a particular code in the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.chargeItem.useContext.UsageContext.code.Coding.display
Id
Coding.display
Type
Cardinality
0 - 1
Definition
A representation of the meaning of the code in the system, following the rules of the system.
Comment
Requirements
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Condition
cod-1
Path
DeviceDefinition.chargeItem.useContext.UsageContext.code.Coding.userSelected
Id
Coding.userSelected
Type
Cardinality
0 - 1
Definition
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Comment
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.
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.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.chargeItem.useContext.UsageContext.value[x]
Id
UsageContext.value[x]
Type
Cardinality
1 - 1
Definition
A value that defines the context specified in this context of use. The interpretation of the value is defined by the code.
Comment
Binding
Strength
example
Description
A code that defines the specific value for the context being specified.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
DeviceDefinition.chargeItem.useContext.UsageContext.value[x].CodeableConcept.coding
Id
CodeableConcept.coding
Type
Cardinality
0 - *
Definition
A reference to a code defined by a terminology system.
Comment
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.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Constraint
ele-1 [error]
All FHIR elements must have a @value or children