Summary
Diagnostics
Care Provision
Request & Response
Medications
Workflow
Entities
Management
Individuals
General
Billing
Support
Payment
Security
Other
Conformance
Documents
Terminology
Definitional Artifacts
Evidence-Based Medicine
Quality Reporting & Testing
Medication Definition
Public Health & Research
Complex
Primitive
ActivityDefinition
CapabilityStatement
ChargeItemDefinition
Claim
CodeSystem
Composition
ConceptMap
CoverageEligibilityRequest
Encounter
Group
Library
List
Measure
MedicinalProduct
MessageHeader
NamingSystem
Observation
Patient
PlanDefinition
Resource
StructureDefinition
StructureMap
ValueSet
default
The manufactured item as contained in the packaged medicinal product.
MedicinalProductManufactured
Path
MedicinalProductManufactured
Id
MedicinalProductManufactured
Cardinality
0 - *
Definition
The manufactured item as contained in the packaged medicinal product.
Comment
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
manufacturedDoseForm
Dose form as manufactured and before any transformation into the pharmaceutical product
Path
MedicinalProductManufactured.manufacturedDoseForm
Id
MedicinalProductManufactured.manufacturedDoseForm
Type
Cardinality
1 - 1
Definition
Dose form as manufactured and before any transformation into the pharmaceutical product.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProductManufactured.manufacturedDoseForm.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
MedicinalProductManufactured.manufacturedDoseForm.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 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
MedicinalProductManufactured.manufacturedDoseForm.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
MedicinalProductManufactured.manufacturedDoseForm.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
Path
MedicinalProductManufactured.manufacturedDoseForm.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
Path
MedicinalProductManufactured.manufacturedDoseForm.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
unitOfPresentation
The “real world” units in which the quantity of the manufactured item is described
Path
MedicinalProductManufactured.unitOfPresentation
Id
MedicinalProductManufactured.unitOfPresentation
Type
Cardinality
0 - 1
Definition
The “real world” units in which the quantity of the manufactured item is described.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProductManufactured.unitOfPresentation.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
MedicinalProductManufactured.unitOfPresentation.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 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
MedicinalProductManufactured.unitOfPresentation.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
MedicinalProductManufactured.unitOfPresentation.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
Path
MedicinalProductManufactured.unitOfPresentation.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
Path
MedicinalProductManufactured.unitOfPresentation.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
MedicinalProductManufactured.quantity
Id
MedicinalProductManufactured.quantity
Type
Cardinality
1 - 1
Definition
The quantity or "count number" of the manufactured item.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProductManufactured.quantity.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
MedicinalProductManufactured.quantity.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
MedicinalProductManufactured.quantity.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
MedicinalProductManufactured.quantity.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
MedicinalProductManufactured.quantity.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
manufacturer
Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues)
Path
MedicinalProductManufactured.manufacturer
Id
MedicinalProductManufactured.manufacturer
Type
Cardinality
0 - *
Definition
Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues).
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProductManufactured.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-1
Path
MedicinalProductManufactured.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 RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.
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
MedicinalProductManufactured.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).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProductManufactured.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
MedicinalProductManufactured.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
MedicinalProductManufactured.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
MedicinalProductManufactured.manufacturer.Reference.identifier.Identifier.system
Id
Identifier.system
Type
Cardinality
0 - 1
Definition
Establishes the namespace for the value - that is, a 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
MedicinalProductManufactured.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 [Rendered Value extension](extension-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
Path
MedicinalProductManufactured.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
MedicinalProductManufactured.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
MedicinalProductManufactured.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 high 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
MedicinalProductManufactured.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
MedicinalProductManufactured.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-1
Path
MedicinalProductManufactured.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 RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.
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
MedicinalProductManufactured.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).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProductManufactured.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
Path
MedicinalProductManufactured.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
Path
MedicinalProductManufactured.ingredient
Id
MedicinalProductManufactured.ingredient
Type
Cardinality
0 - *
Definition
Ingredient.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProductManufactured.ingredient.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-1
Path
MedicinalProductManufactured.ingredient.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 RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.
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
MedicinalProductManufactured.ingredient.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).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProductManufactured.ingredient.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
MedicinalProductManufactured.ingredient.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
MedicinalProductManufactured.ingredient.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
MedicinalProductManufactured.ingredient.Reference.identifier.Identifier.system
Id
Identifier.system
Type
Cardinality
0 - 1
Definition
Establishes the namespace for the value - that is, a 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
MedicinalProductManufactured.ingredient.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 [Rendered Value extension](extension-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
Path
MedicinalProductManufactured.ingredient.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
MedicinalProductManufactured.ingredient.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
MedicinalProductManufactured.ingredient.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 high 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
MedicinalProductManufactured.ingredient.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
MedicinalProductManufactured.ingredient.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-1
Path
MedicinalProductManufactured.ingredient.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 RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.
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
MedicinalProductManufactured.ingredient.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).
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProductManufactured.ingredient.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
Path
MedicinalProductManufactured.ingredient.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
Path
MedicinalProductManufactured.physicalCharacteristics
Id
MedicinalProductManufactured.physicalCharacteristics
Type
Cardinality
0 - 1
Definition
Dimensions, color etc.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
height
Where applicable, the height can be specified using a numerical value and its unit of 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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.height
Id
ProdCharacteristic.height
Type
Cardinality
0 - 1
Definition
Where applicable, the height can be specified using a numerical value and its unit of 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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.height.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.height.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.height.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.height.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.height.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
width
Where applicable, the width can be specified using a numerical value and its unit of 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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.width
Id
ProdCharacteristic.width
Type
Cardinality
0 - 1
Definition
Where applicable, the width can be specified using a numerical value and its unit of 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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.width.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.width.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.width.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.width.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.width.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
depth
Where applicable, the depth can be specified using a numerical value and its unit of 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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.depth
Id
ProdCharacteristic.depth
Type
Cardinality
0 - 1
Definition
Where applicable, the depth can be specified using a numerical value and its unit of 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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.depth.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.depth.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.depth.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.depth.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.depth.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
weight
Where applicable, the weight can be specified using a numerical value and its unit of 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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.weight
Id
ProdCharacteristic.weight
Type
Cardinality
0 - 1
Definition
Where applicable, the weight can be specified using a numerical value and its unit of 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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.weight.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.weight.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.weight.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.weight.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.weight.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
nominalVolume
Where applicable, the nominal volume can be specified using a numerical value and its unit of 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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.nominalVolume
Id
ProdCharacteristic.nominalVolume
Type
Cardinality
0 - 1
Definition
Where applicable, the nominal volume can be specified using a numerical value and its unit of 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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.nominalVolume.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.nominalVolume.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.nominalVolume.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.nominalVolume.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.nominalVolume.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
externalDiameter
Where applicable, the external diameter can be specified using a numerical value and its unit of 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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.externalDiameter
Id
ProdCharacteristic.externalDiameter
Type
Cardinality
0 - 1
Definition
Where applicable, the external diameter can be specified using a numerical value and its unit of 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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.externalDiameter.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.externalDiameter.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.externalDiameter.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.externalDiameter.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.externalDiameter.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
shape
Where applicable, the shape can be specified An appropriate controlled vocabulary shall be used The term and the term identifier shall be used
Path
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.shape
Id
ProdCharacteristic.shape
Type
Cardinality
0 - 1
Definition
Where applicable, the shape can be specified An appropriate controlled vocabulary shall be used The term and the term identifier shall be used.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
color
Where applicable, the color can be specified An appropriate controlled vocabulary shall be used The term and the term identifier shall be used
Path
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.color
Id
ProdCharacteristic.color
Type
Cardinality
0 - *
Definition
Where applicable, the color can be specified An appropriate controlled vocabulary shall be used The term and the term identifier shall be used.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.imprint
Id
ProdCharacteristic.imprint
Type
Cardinality
0 - *
Definition
Where applicable, the imprint can be specified as text.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
image
Where applicable, the image can be provided The format of the image attachment shall be specified by regional implementations
Path
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.image
Id
ProdCharacteristic.image
Type
Cardinality
0 - *
Definition
Where applicable, the image can be provided The format of the image attachment shall be specified by regional implementations.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.image.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
The mime type of an attachment. Any valid mime type is allowed.
ValueSet
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.image.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
Path
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.image.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.image.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.image.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.image.Attachment.title
Id
Attachment.title
Type
Cardinality
0 - 1
Definition
A label or set of text to display in place of the data.
Comment
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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.image.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
scoring
Where applicable, the scoring can be specified An appropriate controlled vocabulary shall be used The term and the term identifier shall be used
Path
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.scoring
Id
ProdCharacteristic.scoring
Type
Cardinality
0 - 1
Definition
Where applicable, the scoring can be specified An appropriate controlled vocabulary shall be used The term and the term identifier shall be used.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.scoring.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.scoring.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 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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.scoring.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
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.scoring.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
Path
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.scoring.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
Path
MedicinalProductManufactured.physicalCharacteristics.ProdCharacteristic.scoring.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
MedicinalProductManufactured.otherCharacteristics
Id
MedicinalProductManufactured.otherCharacteristics
Type
Cardinality
0 - *
Definition
Other codeable characteristics.
Comment
Constraint
ele-1 [error]
All FHIR elements must have a @value or children
Path
MedicinalProductManufactured.otherCharacteristics.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
MedicinalProductManufactured.otherCharacteristics.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 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
MedicinalProductManufactured.otherCharacteristics.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
MedicinalProductManufactured.otherCharacteristics.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
Path
MedicinalProductManufactured.otherCharacteristics.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
Path
MedicinalProductManufactured.otherCharacteristics.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