Profile Comparison between http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi vs http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi

Messages

Metadata

Name	Value		Comments
abstract	false
baseDefinition	http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization
copyright
date	2022-12-04T18:49:33+00:00	2023-07-26T13:32:34+00:00	Values Differ
description	RegulatedAuthorization (ePI)
experimental
fhirVersion	5.0.0-ballot	5.0.0	Values Differ
jurisdiction
jurisdiction[0]	http://unstats.un.org/unsd/methods/m49/m49.htm#001
kind	resource
name	RegulatedAuthorizationUvEpi
publisher		HL7 International - Biomedical Research & Regulation Work Group	Added the item 'HL7 International - Biomedical Research & Regulation Work Group'
purpose
status	active
title	RegulatedAuthorization (ePI)
type	RegulatedAuthorization
url	http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi
version	1.0.0-ballot	1.0.0	Values Differ

Structure

Name	L Flags	L Card.	L Type	L Description & Constraints	R Flags	R Card.	L Type	L Description & Constraints	Comments
RegulatedAuthorization		0..*	RegulatedAuthorization	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product		0..*	RegulatedAuthorization	Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
id	Σ	0..1	id	Logical id of this artifact	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created	?!Σ	0..1	uri	A set of rules under which this content was created	Elements differ in comments: 'Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.' vs 'Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.'
language		0..1	code	Language of the resource content Binding: ?? (preferred): IETF language tag Additional Bindings Purpose ?? Max Binding		0..1	code	Language of the resource content Binding: ?? (required): IETF language tag for a human language	Elements differ in binding.description: 'IETF language tag' vs 'IETF language tag for a human language'
text		0..1	Narrative	Text summary of the resource, for human interpretation		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.'
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored	?!Σ	0..*	Extension	Extensions that cannot be ignored	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).' vs 'May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).'
identifier	Σ	1..*	Identifier	Identifier assigned by the health authority to a single medicinal product	Σ	1..*	Identifier	Identifier assigned by the health authority to a single medicinal product
id		0..1	id	Unique id for inter-element referencing		0..1	id	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.'
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: ?? (required)	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: ?? (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: ?? (extensible)	Σ	0..1	CodeableConcept	Description of identifier Binding: ?? (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	1..1	uri	The namespace for the identifier value Binding: ?? (extensible) Example General: http://www.acme.com/identifiers/patient	Σ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient	Elements differ in definition: 'Establishes the namespace for the value - that is, a absolute URL that describes a set values that are unique.' vs 'Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.'
value	Σ	1..1	string	The value that is unique Example General: 123456	ΣC	1..1	string	The value that is unique Example General: 123456	Elements differ in comments: 'If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [Rendered Value extension]. 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.' vs '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]). 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.'
period	Σ	0..1	Period	Time period when id is/was valid for use	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
subject	Σ	1..*	Reference(MedicinalProductDefinition (ePI))	The product type, treatment, facility or activity that is being authorized	Σ	1..*	Reference(MedicinalProductDefinition (ePI))	The product type, treatment, facility or activity that is being authorized
type	Σ	0..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: ?? (extensible)	Σ	0..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation. Binding: ?? (example): Overall type of this authorization.	Elements differ in short: 'Overall type of this authorization, for example drug marketing approval, orphan drug designation' vs 'Overall type of this authorization, for example drug marketing approval, orphan drug designation.'
description	Σ	0..1	markdown	Brief description of the authorization	Σ	0..1	markdown	Brief description of the authorization
region	Σ	0..*	CodeableConcept	The jusrisdiction in which the authorization has been granted Binding: ?? (preferred)	Σ	0..*	CodeableConcept	The territory in which the authorization has been granted Binding: ?? (preferred)	Elements differ in short: 'The jusrisdiction in which the authorization has been granted' vs 'The territory in which the authorization has been granted'
status	Σ	0..1	CodeableConcept	The current status of this authorization Binding: ?? (preferred)	Σ	0..1	CodeableConcept	The current status of this authorization Binding: ?? (preferred): The lifecycle status of an artifact.	Example/preferred bindings differ at RegulatedAuthorization.status using binding from RegulatedAuthorizationUvEpi
statusDate	Σ	0..1	dateTime	The date at which the current status was assigned	Σ	0..1	dateTime	The date at which the current status was assigned.	Elements differ in short: 'The date at which the current status was assigned' vs 'The date at which the current status was assigned.'
validityPeriod	Σ	0..1	Period	The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date	Σ	0..1	Period	The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date
indication	Σ	0..*	CodeableReference(ClinicalUseDefinition Indication (ePI))	Reference to the Clinical Use Definition	Σ	0..*	CodeableReference(ClinicalUseDefinition Indication (ePI))	Reference to the Clinical Use Definition
id		0..1	id	Unique id for inter-element referencing		0..1	id	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.'
concept	Σ	0..1	CodeableConcept	Reference to a concept (by class)	Σ	0..1	CodeableConcept	Reference to a concept (by class)
reference	Σ	1..1	Reference()	Reference to a resource (by instance)	Σ	1..1	Reference()	Reference to a resource (by instance)
intendedUse	Σ	0..1	CodeableConcept	The intended use of the product, e.g. prevention, treatment Binding: ?? (preferred): The overall intended use of a product.	Σ	0..1	CodeableConcept	The intended use of the product, e.g. prevention, treatment Binding: ?? (preferred): The overall intended use of a product.
basis	Σ	0..*	CodeableConcept	The legal/regulatory framework or reasons under which this authorization is granted Binding: ?? (example): A legal or regulatory framework against which an authorization is granted, or other reasons for it.	Σ	0..*	CodeableConcept	The legal/regulatory framework or reasons under which this authorization is granted Binding: ?? (example): A legal or regulatory framework against which an authorization is granted, or other reasons for it.
holder	Σ	1..1	Reference(Organization (ePI))	The organization that has been granted this authorization, by the regulator	Σ	1..1	Reference(Organization (ePI))	The organization that has been granted this authorization, by the regulator
regulator	Σ	0..1	Reference(Organization (ePI))	The regulatory authority or authorizing body granting the authorization	Σ	0..1	Reference(Organization (ePI))	The regulatory authority or authorizing body granting the authorization
attachedDocument	Σ	0..*	Reference(DocumentReference)	Additional information or supporting documentation about the authorization	Σ	0..*	Reference(DocumentReference)	Additional information or supporting documentation about the authorization
case	Σ	0..1	BackboneElement	The regulatory procedure for granting or amending a regulated authorization.	Σ	0..1	BackboneElement	The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)	Elements differ in short: 'The regulatory procedure for granting or amending a regulated authorization.' vs 'The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)'
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.'
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).' vs 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).'
identifier	Σ	0..1	Identifier	Identifier by which this case can be referenced	Σ	0..1	Identifier	Identifier by which this case can be referenced.	Elements differ in short: 'Identifier by which this case can be referenced' vs 'Identifier by which this case can be referenced.'
id		0..1	id	Unique id for inter-element referencing		0..1	id	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.'
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: ?? (required)	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: ?? (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: ?? (extensible)	Σ	0..1	CodeableConcept	Description of identifier Binding: ?? (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	0..1	uri	The namespace for the identifier value Binding: ?? (preferred) Example General: http://www.acme.com/identifiers/patient	Σ	0..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient	Elements differ in definition: 'Establishes the namespace for the value - that is, a absolute URL that describes a set values that are unique.' vs 'Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.'
value	Σ	0..1	string	The value that is unique Example General: 123456	ΣC	0..1	string	The value that is unique Example General: 123456	Elements differ in comments: 'If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [Rendered Value extension]. 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.' vs '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]). 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.'
period	Σ	0..1	Period	Time period when id is/was valid for use	Σ	0..1	Period	Time period when id is/was valid for use
assigner	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
type	Σ	0..1	CodeableConcept	The defining type of case Binding: ?? (preferred)	Σ	0..1	CodeableConcept	The defining type of case. Binding: ?? (example): The type of a case involved in an application.	Elements differ in short: 'The defining type of case' vs 'The defining type of case.' Example/preferred bindings differ at RegulatedAuthorization.case.type using binding from RegulatedAuthorizationUvEpi
status	Σ	0..1	CodeableConcept	The status associated with the case Binding: ?? (preferred)	Σ	0..1	CodeableConcept	The status associated with the case. Binding: ?? (preferred): The lifecycle status of an artifact.	Elements differ in short: 'The status associated with the case' vs 'The status associated with the case.' Example/preferred bindings differ at RegulatedAuthorization.case.status using binding from RegulatedAuthorizationUvEpi
date[x]	Σ	0..1	Period, dateTime	Relevant date for this case	Σ	0..1	Period, dateTime	Relevant date for this case.	Elements differ in short: 'Relevant date for this case' vs 'Relevant date for this case.'
application	Σ	0..*	See case (RegulatedAuthorization)	Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure	Σ	0..*	See case (RegulatedAuthorization)	Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
Documentation for this format