Prototype ISO IDMP Compliant Datafeed to eHealth (Deliverable D4.12), published by UNICOM. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/unicom-project-eu/d4.12/ and changes regularly. See the Directory of published versions

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Resource Profile: MedicinalProductD412 - Mappings

Draft as of 2024-08-20

Mappings for the MedicinalProductD412 resource profile.

Mappings for FiveWs Pattern Mapping (http://hl7.org/fhir/fivews)

MedicinalProductD412
MedicinalProductDefinition	administrative.medication
identifier	FiveWs.class
identifier (mpid)	FiveWs.class
identifier (pmsid)	FiveWs.class

Mappings for IDMP Mapping (https://www.iso.org/obp/ui/#iso:std:iso:11615)

MedicinalProductD412
MedicinalProductDefinition	Medicinal Product and Investigational Medicinal Product
identifier	Medicinal Product.MPID, Investigational Medicinal Product.IMPID
identifier (mpid)	Medicinal Product.MPID, Investigational Medicinal Product.IMPID
identifier (pmsid)	Medicinal Product.MPID, Investigational Medicinal Product.IMPID
type	(indicates if this is Medicinal Product or an Investigational Medicinal Product)
domain	n/a
version	Medicinal Product.Header.Version Number
status	n/a
statusDate	n/a
description	n/a
combinedPharmaceuticalDoseForm	Medicinal Product.Combined Pharmaceutical Dose Form
route	Pharmaceutical Product.Route of Administration
indication	(roll up of all text in Therapeutic Indication.Indication Text, for common case where information is not granular)
legalStatusOfSupply	Marketing Authorisation.Legal Status of Supply (moved here for practicality)
additionalMonitoringIndicator	Medicinal Product.Additional Monitoring Indicator
specialMeasures	Medicinal Product.Special Measures
pediatricUseIndicator	Medicinal Product.Pediatric Use Indicator
classification	Product Classification.Value
classification (atc)	Product Classification.Value
marketingStatus	Marketing Status
packagedMedicinalProduct	Packaged Medicinal Product
comprisedOf	Manufactured Item
ingredient	Medicinal Product.Ingredient (see also FHIR Ingredient resource)
impurity	n/a
attachedDocument	Attached Document
masterFile	Master File
contact	n/a
type	n/a
contact	n/a
clinicalTrial	Investigational Medicinal Product.Clinical Trial Status
code	n/a
name	Medicinal Product Name
productName	Medicinal Product Name.Full Name
type	n/a
part	(any and all of the name parts e.g. Medicinal Product Name.Formulation Part)
part	(text of any of the name parts e.g. Medicinal Product Name.Formulation Part)
type	(which of the name parts this is e.g. Formulation Part)
usage	Country / Language
country	Country / Language.Country
jurisdiction	Country / Language.Jurisdiction
language	Country / Language.Language
crossReference	Product Cross-Reference
product	Product Cross-Reference
type	Product Cross-Reference
operation	Manufacturing / Business Operation
type	Manufacturing / Business Operation.Operation Type
effectiveDate	Manufacturing / Business Operation.Effective Date
organization	Manufacturer / Establishment (Organisation)
confidentialityIndicator	Manufacturing / Business Operation.Confidentiality Indicator
characteristic	Package Item (Container).Physical Characteristics
type	Physical Characteristics, all attributes
value[x]	Physical Characteristics, attribute's value

Mappings for RIM Mapping (http://hl7.org/v3)

MedicinalProductD412
MedicinalProductDefinition	Entity, Role, or Act,ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT']
text	Act.text?
contained	N/A
extension	N/A
modifierExtension	N/A
identifier	ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].code
identifier (mpid)	ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].code
id	n/a
extension	n/a
use	Role.code or implied by context
type	Role.code or implied by context
system	II.root or Role.id.root
value	II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
period	Role.effectiveTime or implied by context
assigner	II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
identifier (pmsid)	ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].code
id	n/a
extension	n/a
use	Role.code or implied by context
type	Role.code or implied by context
system	II.root or Role.id.root
value	II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
period	Role.effectiveTime or implied by context
assigner	II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
type	ManufacturedProduct[classCode='MANU'].manufacturedProduct.asSpecializedKind.generalizedMaterialKind.code
domain	ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{domain}'].value
version	n/a
status	n/a
statusDate	n/a
description	ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].desc
combinedPharmaceuticalDoseForm	ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].formCode
route	ManufacturedProduct[classCode='MANU'].productOf.reconstitution.consumable.administerableMaterial.consumedIn.substanceAdministration1.routeCode
indication	ManufacturedProduct[classCode='MANU'].consumedIn.substanceAdministration1.reason.indicationObservationCriterion[@code='{Observation_MedicalProblem}'].value.originalText.@value
legalStatusOfSupply	ManufacturedProduct[classCode='MANU'].subjectOf.approval[@code='{Approval_MarketingAuthorization}'].pertinentInformation.policy.code
additionalMonitoringIndicator	ManufacturedProduct[classCode='MANU'].subjectOf.policy.code
specialMeasures	ManufacturedProduct[classCode='MANU'].subjectOf.policy.code[@nullFlavor='OTH'].displayName
pediatricUseIndicator	ManufacturedProduct[classCode='MANU'].subjectOf.policy.code
classification	ManufacturedProduct[classCode='MANU'].manufacturedProduct/asSpecializedKind/generalizedMaterialKind/code
classification (atc)	ManufacturedProduct[classCode='MANU'].manufacturedProduct/asSpecializedKind/generalizedMaterialKind/code
id	n/a
extension	n/a
coding	union(., ./translation)
coding (ema)	union(., ./translation)
id	n/a
extension	n/a
system	./codeSystem
version	./codeSystemVersion
code	./code
display	CV.displayName
userSelected	CD.codingRationale
coding (who)	union(., ./translation)
id	n/a
extension	n/a
system	./codeSystem
version	./codeSystemVersion
code	./code
display	CV.displayName
userSelected	CD.codingRationale
text	./originalText[mediaType/code="text/plain"]/data
marketingStatus	ManufacturedProduct[classCode='MANU'].subjectOf.approval[@code='{Approval_MarketingAuthorization}'].statusCode
packagedMedicinalProduct	ManufacturedProduct[classCode='MANU'].manufacturedProduct.asContent.containerPackagedProduct.asContent.containerPackagedProduct.code
comprisedOf	ManufacturedProduct[classCode='MANU'].manufacturedProduct.formCode
ingredient	ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].ingredient.ingredientSubstance.code
impurity	(to do)
attachedDocument	ManufacturedProduct[classCode='MANU'].subjectOf.document
masterFile	ManufacturedProduct[classCode='MANU'].subjectOf.document
contact	ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty
id	n/a
extension	n/a
modifierExtension	N/A
type	ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty.code
contact	ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty
clinicalTrial	ManufacturedProduct[classCode='MANU'].subjectOf.monitoringProgram
code	ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].code
name	ManufacturedProduct[classCode='MANU'].manufacturedProduct.name
id	n/a
extension	n/a
modifierExtension	N/A
productName	ManufacturedProduct[classCode='MANU'].manufacturedProduct.name
type	ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
part	ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
id	n/a
extension	n/a
modifierExtension	N/A
part	ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
type	ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
usage	ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity
id	n/a
extension	n/a
modifierExtension	N/A
country	ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.assigningTerritory.code
id	n/a
extension	n/a
coding	union(., ./translation)
coding (ema)	union(., ./translation)
id	n/a
extension	n/a
system	./codeSystem
version	./codeSystemVersion
code	./code
display	CV.displayName
userSelected	CD.codingRationale
coding (iso)	union(., ./translation)
id	n/a
extension	n/a
system	./codeSystem
version	./codeSystemVersion
code	./code
display	CV.displayName
userSelected	CD.codingRationale
text	./originalText[mediaType/code="text/plain"]/data
jurisdiction	ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.assigningTerritory.code
language	ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.name.@xml:lang
id	n/a
extension	n/a
coding	union(., ./translation)
coding (ema)	union(., ./translation)
id	n/a
extension	n/a
system	./codeSystem
version	./codeSystemVersion
code	./code
display	CV.displayName
userSelected	CD.codingRationale
coding (bcp)	union(., ./translation)
id	n/a
extension	n/a
system	./codeSystem
version	./codeSystemVersion
code	./code
display	CV.displayName
userSelected	CD.codingRationale
text	./originalText[mediaType/code="text/plain"]/data
crossReference	ManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity
id	n/a
extension	n/a
modifierExtension	N/A
product	ManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity.definingMaterialKind.code
type	ManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity.code
operation	ManufacturedProduct[classCode='MANU'].subjectOf.action
id	n/a
extension	n/a
modifierExtension	N/A
type	ManufacturedProduct[classCode='MANU'].subjectOf.action.code
effectiveDate	ManufacturedProduct[classCode='MANU'].subjectOf.action.effectiveTime
organization	ManufacturedProduct[classCode='MANU'].subjectOf.action.participation.organzation
confidentialityIndicator	ManufacturedProduct[classCode='MANU'].subjectOf.action.confidentialityCode
characteristic	ManufacturedProduct[classCode='MANU'].subjectOf.characteristic
id	n/a
extension	n/a
modifierExtension	N/A
type	ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{type}']
value[x]	ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{type}'].value