RegulatedAuthorization

Introduction

Scope and Usage

For an overview of this resource and others in the Medication Definition domain, also see the module page

RegulatedAuthorization is a resource covering the authorization of a type of regulated product, treatment, facility or activity.

Regulated products include animal and human drugs, devices, biologically derived, radiation-emitting, and nutritional products, software, etc. which are subject to local, regional or international legislation for their use.

Regulated treatments include emergency use of a regulated product, sedation/anesthesia or radiation therapy.

Regulated facilities include the storage, manufacturing, distribution, or any other regulated aspect for regulated products

Regulated activities include conducting a Clinical Trial e.g. either parts or the whole of a certain trial. Marketing regulated products to patients in general, manufacturing regulated products. Storage or distribution of controlled substances. Recording whether a laboratory test is approved for use by a regulator, etc.

This is a general authorization and is not related to any particular instance of use or any patient, therefore the following is out of scope for the resource:

Security authorizations - This resource is not directly related to "authorizations" as in permissions for users and actions in a security context.

Consent - which represents the choices and rights of an individual. Although there is a general legal right to give or withhold consent, consent is a record of a specific patients choice. This differs from the high level authorization of class of events or products to be used in general (within some legal framework), for any patient. The concepts are very broadly similar in concept, but are very different use cases in software terms, with little likelihood of confusion or overlap of implementation and properties.

Contract - a contract is a legal agreement between two entities about a specific arrangement. It is optionally entered into by the parties, but then binding. This is different from a generalised legal framework (law) that exists (e.g. legislation about controlled drugs), but is then applied to a series of instances of, say, drug types and organizations. A contract is more similar to the drug legislation itself, rather than the applications of it. However the legal frameworks themselves are mostly static and are not generally represented in clinical systems.

Authorizations of drugs - although the word is the same, the common concept of a physician authorizing a patient to have a certain drug (prescribing) is very different from the legal authorization to use that drug in a territory ("marketing authorization"). The context usually makes it very clear which is which (RegulatedAuthorization vs. MedicationRequest).

StructureDefinition

Elements (Simplified)

• RegulatedAuthorization [0..*]: - Regulatory approval, clearance or licensing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
• RegulatedAuthorization.identifier [0..*]: Identifier Business identifier for the authorization, typically assigned by the authorizing body
• RegulatedAuthorization.subject [0..*]: [Reference(MedicinalProductDefinition](/Reference(MedicinalProductDefinition), BiologicallyDerivedProduct, NutritionProduct, PackagedProductDefinition, ManufacturedItemDefinition, Ingredient, SubstanceDefinition, DeviceDefinition, ResearchStudy, ActivityDefinition, PlanDefinition, ObservationDefinition, Practitioner, Organization, Location)) The product type, treatment, facility or activity that is being authorized
• RegulatedAuthorization.type [0..1]: CodeableConcept example:regulated-authorization-type Overall type of this authorization, for example drug marketing approval, orphan drug designation
• RegulatedAuthorization.description [0..1]: markdown General textual supporting information
• RegulatedAuthorization.region [0..*]: CodeableConcept example:jurisdiction The territory in which the authorization has been granted
• RegulatedAuthorization.status [0..1]: CodeableConcept preferred:publication-status The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
• RegulatedAuthorization.statusDate [0..1]: dateTime The date at which the current status was assigned
• RegulatedAuthorization.validityPeriod [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
• RegulatedAuthorization.indication [0..*]: CodeableReference Condition for which the use of the regulated product applies
• RegulatedAuthorization.intendedUse [0..1]: CodeableConcept preferred:product-intended-use The intended use of the product, e.g. prevention, treatment
• RegulatedAuthorization.basis [0..*]: CodeableConcept example:regulated-authorization-basis The legal/regulatory framework or reasons under which this authorization is granted
• RegulatedAuthorization.holder [0..1]: Reference(Organization) The organization that has been granted this authorization, by the regulator
• RegulatedAuthorization.regulator [0..1]: Reference(Organization) The regulatory authority or authorizing body granting the authorization
• RegulatedAuthorization.attachedDocument [0..*]: Reference(DocumentReference) Additional information or supporting documentation about the authorization
• RegulatedAuthorization.case [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)
• RegulatedAuthorization.case.identifier [0..1]: Identifier Identifier by which this case can be referenced
• RegulatedAuthorization.case.type [0..1]: CodeableConcept example:regulated-authorization-case-type The defining type of case
• RegulatedAuthorization.case.status [0..1]: CodeableConcept preferred:publication-status The status associated with the case
• RegulatedAuthorization.case.date[x] [0..1]: Period, dateTime Relevant date for this case
• RegulatedAuthorization.case.application [0..*]: - Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure

Mappings

• RegulatedAuthorization Mappings — 23 mapping entries

Resource Packs

list-RegulatedAuthorization-packs.xml

<?xml version="1.0" encoding="UTF-8"?>

<List xmlns="http://hl7.org/fhir">
  <id value="RegulatedAuthorization-packs"/>
  <status value="current"/>
  <mode value="working"/>
</List>

Search Parameters

• case — token — The case or procedure number — RegulatedAuthorization.case.identifier
• case-type — token — The defining type of case — RegulatedAuthorization.case.type
• holder — reference — The organization that holds the granted authorization — RegulatedAuthorization.holder
• identifier — token — Business identifier for the authorization, typically assigned by the authorizing body — RegulatedAuthorization.identifier
• region — token — The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted — RegulatedAuthorization.region
• status — token — The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications — RegulatedAuthorization.status
• subject — reference — The type of regulated product, treatment, facility or activity that is being authorized — RegulatedAuthorization.subject
• type — token — Overall type of this authorization, for example drug marketing approval, orphan drug designation — RegulatedAuthorization.type
• validity — date — The time period in which the regulatory approval, clearance or licensing is in effect — RegulatedAuthorization.validityPeriod

Full Search Parameters

Examples

• basic-drug-auth — regulatedauthorization-example-basic-drug-auth — Basic Example of a drug authorization for Equilidem
• example — regulatedauthorization-example — General example
• regulatedauthorization-example — regulatedauthorization-example
• regulatedauthorization-example-basic-drug-auth — regulatedauthorization-example-basic-drug-auth
• regulatedauthorization-examples-header — regulatedauthorization-examples-header

Full Examples

Mapping Exceptions

regulatedauthorization-fivews-mapping-exceptions.xml

Unmapped Elements

• FiveWs.what — Unknown
• FiveWs.recorded — Unknown
• FiveWs.author — Unknown
• FiveWs.actor — Unknown
• FiveWs.cause — Unknown
• FiveWs.version — Unknown
• FiveWs.witness — Unknown
• FiveWs.where — Unknown
• FiveWs.context — Unknown
• FiveWs.init — Unknown
• FiveWs.why — Unknown
• FiveWs.identifier — Unknown
• FiveWs.source — Unknown
• FiveWs.who — Unknown
• FiveWs.grade — Unknown
• FiveWs.status — Unknown
• FiveWs.planned — Unknown
• FiveWs.done — Unknown
• FiveWs.subject — Unknown