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HdBe-MedischHulpmiddel

CBB	Concept	Status
HdBe-MedicalDevice	Medische hulpmiddelen kunnen worden omschreven als de inwendig geïmplanteerde en uitwendige apparatuur en/of hulpmiddelen die de patiënt gebruikt of heeft gebruikt om de gevolgen van functionele beperkingen van orgaansystemen te verminderen of om de behandeling van een ziekte mogelijk te maken. Purpose Het vastleggen van gegevens over medische hulpmiddelen heeft een aantal redenen. Kennis van aanwezigheid biedt mogelijkheid om implantaten te kunnen traceren en rekening te houden met het hulpmiddel of apparaat bij diagnostische of therapeutische procedures, verzorging en transport. Voorbeelden hier van zijn: De consequenties voor transport, toiletgebruik, etc. indien gebruik wordt gemaakt van een rolstoel; De aanwezigheid van een pacemaker is van medisch belang, maar heeft ook consequenties voor planning van radiologisch onderzoek. Evidence Base Het vastleggen van gegevens van medisch complexe apparatuur, zoals pacemakers, is in EPD systemen in Nederland nog niet gebruikelijk, maar soms wel een gemis: uit een specialistenbrief valt bv. vaak niet op te maken welke type pacemaker van welke fabrikant bij de patiënt aanwezig is. VWS zal met wetgeving komen voor een landelijk basisregister voor implantaten. Elke zorginstelling zal de UDI (Unique Device Identification, met een relatie naar GTIN) en UPI (Unique Patient Identification) moeten aanleveren aan het basisregister. Dit voorkomt de situatie dat een groot deel van de patiënten met een hulpmiddel of implantaat waar problemen mee zijn gesignaleerd, niet te traceren zijn. References Kamerbrief over het voorstel voor een register van implantaten. [Online] Beschikbaar op: http://www.rijksoverheid.nl/documenten-en-publicaties/kamerstukken/2012/11/20/kamerbrief-over-het-voorstel-voor-een-register-van-implantaten.html [Geraadpleegd: 15 september 2014].	active

CBB

Concept

Status

HdBe-MedicalDevice

Medische hulpmiddelen kunnen worden omschreven als de inwendig geïmplanteerde en uitwendige apparatuur en/of hulpmiddelen die de patiënt gebruikt of heeft gebruikt om de gevolgen van functionele beperkingen van orgaansystemen te verminderen of om de behandeling van een ziekte mogelijk te maken.

Purpose

Het vastleggen van gegevens over medische hulpmiddelen heeft een aantal redenen. Kennis van aanwezigheid biedt mogelijkheid om implantaten te kunnen traceren en rekening te houden met het hulpmiddel of apparaat bij diagnostische of therapeutische procedures, verzorging en transport.

Voorbeelden hier van zijn:

De consequenties voor transport, toiletgebruik, etc. indien gebruik wordt gemaakt van een rolstoel;
De aanwezigheid van een pacemaker is van medisch belang, maar heeft ook consequenties voor planning van radiologisch onderzoek.

Evidence Base

Het vastleggen van gegevens van medisch complexe apparatuur, zoals pacemakers, is in EPD systemen in Nederland nog niet gebruikelijk, maar soms wel een gemis: uit een specialistenbrief valt bv. vaak niet op te maken welke type pacemaker van welke fabrikant bij de patiënt aanwezig is. VWS zal met wetgeving komen voor een landelijk basisregister voor implantaten. Elke zorginstelling zal de UDI (Unique Device Identification, met een relatie naar GTIN) en UPI (Unique Patient Identification) moeten aanleveren aan het basisregister. Dit voorkomt de situatie dat een groot deel van de patiënten met een hulpmiddel of implantaat waar problemen mee zijn gesignaleerd, niet te traceren zijn.

References

Kamerbrief over het voorstel voor een register van implantaten. [Online] Beschikbaar op: http://www.rijksoverheid.nl/documenten-en-publicaties/kamerstukken/2012/11/20/kamerbrief-over-het-voorstel-voor-een-register-van-implantaten.html [Geraadpleegd: 15 september 2014].

active

MedicalDevice			MedicalDevice	Element id MedicalDevice Short description MedischHulpmiddel Definition Rootconcept van de bouwsteen MedischHulpmiddel. Dit rootconcept bevat alle gegevenselementen van de bouwsteen MedischHulpmiddel. Data type MedicalDevice Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id MedicalDevice.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id MedicalDevice.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
Product		1..1	BackboneElement	Element id MedicalDevice.Product Short description Product Definition Het medische hulpmiddel dat wordt gebruikt (inwendig of uitwendig). Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id MedicalDevice.Product.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id MedicalDevice.Product.extension Short description Additional content defined by implementations Alternate names extensions, user content 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. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id MedicalDevice.Product.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers 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). Requirements Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions. Comments There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
ProductId		0..1	string	Element id MedicalDevice.Product.ProductId Short description ProductID Definition Unieke identificatie van het product, bijvoorbeeld het serienummer. Veel gebruikte coderingen zijn HIBC en GTIN. Indien de wet verplicht stelt dat deze geregistreerd wordt op basis van een UDI (Unique Device Identifier), dient de unieke identificatie opgebouwd te zijn uit een UDI-DI (Device Identifier) en een UDI-PI (Production Identifier(s)). Voor meer informatie, zie: http://www.gs1.org/healthcare/udi . De UDI-DI dient m.b.t. GS1 GTIN (01) coderingen worden vastgelegd, waarmee o.a. een firma aan het producttype wordt gekoppeld. De UDI-PI dient te bestaan uit de volgende application identifier (AI); vervaldatum (17) en serienummer (21) en/of batch- of lotnummer (10). Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
ProductType		0..1	CodeableConceptBinding	Element id MedicalDevice.Product.ProductType Short description ProductType Definition De code van het type product. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding ProductType codes ProductType (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
ProductDescription		0..1	string	Element id MedicalDevice.ProductDescription Short description ProductOmschrijving Definition Tekstuele beschrijving van het product. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
AnatomicalLocation	I	0..1	Reference(HdBe-AnatomicalLocation)	Element id MedicalDevice.AnatomicalLocation Short description AnatomischeLocatie Definition Anatomische locatie van het gebruikte hulpmiddel bij de patiënt. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(HdBe-AnatomicalLocation) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
Indication	I	0..*	Reference(HdBe-Problem)	Element id MedicalDevice.Indication Short description Indicatie Definition De medische reden voor het gebruik van het medisch hulpmiddel. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(HdBe-Problem) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
StartDate		0..1	dateTime	Element id MedicalDevice.StartDate Short description BeginDatum Definition De startdatum van eerste toepassing of implantatie het medische hulpmiddel. Een vage datum, bijv. alleen een jaartal, is toegestaan. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
EndDate		0..1	dateTime	Element id MedicalDevice.EndDate Short description EindDatum Definition De einddatum van de laatste toepassing of explantatie van het medische hulpmiddel. Een vage datum, bijv. alleen een jaartal, is toegestaan. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
Comment		0..1	string	Element id MedicalDevice.Comment Short description Toelichting Definition Opmerking bij de toepassing of informatie over het gebruikte hulpmiddel. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
Location	I	0..1	Reference(HdBe-HealthcareOrganization)	Element id MedicalDevice.Location Short description Locatie Definition De zorgaanbieder waar het gebruik van het hulpmiddel geïnitieerd werd of waar het hulpmiddel geïmplanteerd werd. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(HdBe-HealthcareOrganization) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
HealthProfessional	I	0..1	Reference(HdBe-HealthProfessional)	Element id MedicalDevice.HealthProfessional Short description Zorgverlener Definition De zorgverlener betrokken bij de indicatiestelling voor het gebruik of de implantatie van het hulpmiddel. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(HdBe-HealthProfessional) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)

MedicalDevice		0..*
MedicalDevice.Product	BackboneElement	1..1
MedicalDevice.Product.ProductId	string	0..1
MedicalDevice.Product.ProductType	CodeableConcept	0..1
MedicalDevice.ProductDescription	string	0..1
MedicalDevice.AnatomicalLocation	Reference(HdBe-AnatomicalLocation)	0..1
MedicalDevice.Indication	Reference(HdBe-Problem)	0..*
MedicalDevice.StartDate	dateTime	0..1
MedicalDevice.EndDate	dateTime	0..1
MedicalDevice.Comment	string	0..1
MedicalDevice.Location	Reference(HdBe-HealthcareOrganization)	0..1
MedicalDevice.HealthProfessional	Reference(HdBe-HealthProfessional)	0..1

MedicalDevice
Definition	Root concept of the MedicalDevice information model. This root concept contains all data elements of the MedicalDevice information model.
Cardinality	0...*
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	rim: n/a
MedicalDevice.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Cardinality	0...1
Type	string
Mappings	rim: n/a
MedicalDevice.extension
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.
Cardinality	0...*
Type	Extension
Alias	extensions, user content
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Slicing	Unordered, Open, by url(Value)
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()`
Mappings	rim: n/a rim: N/A
MedicalDevice.Product
Definition	The medical device (internally or externally).
Cardinality	1...1
Type	BackboneElement
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	rim: n/a
MedicalDevice.Product.id
Definition	Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Cardinality	0...1
Type	string
Mappings	rim: n/a
MedicalDevice.Product.extension
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.
Cardinality	0...*
Type	Extension
Alias	extensions, user content
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Slicing	Unordered, Open, by url(Value)
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()`
Mappings	rim: n/a rim: N/A
MedicalDevice.Product.modifierExtension
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).
Cardinality	0...*
Type	Extension
Modifier	True
Summary	True
Alias	extensions, user content, modifiers
Requirements	Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Comments	There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()`
Mappings	rim: n/a rim: N/A
MedicalDevice.Product.ProductId
Definition	Unique identification code of the product. Preferably the UDI (Unique Device Identifier) is used, consisting of a UDI-DI (Device Identifier) and a UDI-PI (Production Identifier(s)). Additionally, other codes can be registered if needed. Such as: - a serial number - a NIHDI notification code (medical devices on the Belgian market: https://www.vas.ehealth.fgov.be/registers/sadm/web/search/public) - an identification code as indicated on the Nominative lists published by NIHDI: https://webappsa.riziv-inami.fgov.be/IRREQPublic/nl/Home/SearchNominative). Devices on these Nominative lists meet certain criteria for reimbursement.
Cardinality	0...1
Type	string
Comments	Note that FHIR strings SHALL NOT exceed 1MB in size
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	rim: n/a
MedicalDevice.Product.ProductType
Definition	The code of the type of product.
Cardinality	0...1
Type	CodeableConcept
Binding	ProductType codes ProductType (required)
Comments	Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
MedicalDevice.ProductDescription
Definition	Textual description of the product.
Cardinality	0...1
Type	string
Comments	Note that FHIR strings SHALL NOT exceed 1MB in size
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	rim: n/a
MedicalDevice.AnatomicalLocation
Definition	Patient’s anatomical location of the medical device used.
Cardinality	0...1
Type	Reference(HdBe-AnatomicalLocation)
Comments	References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))`
Mappings	rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
MedicalDevice.Indication
Definition	The medical reason for use of the medical device.
Cardinality	0...*
Type	Reference(HdBe-Problem)
Comments	References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))`
Mappings	rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
MedicalDevice.StartDate
Definition	The start date of the first use or implant of the medical device. A ‘vague’ date, such as only the year, is permitted.
Cardinality	0...1
Type	dateTime
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	rim: n/a
MedicalDevice.EndDate
Definition	The end date of the last use or explant of the medical device. A ‘vague’ date, such as only the year, is permitted.
Cardinality	0...1
Type	dateTime
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	rim: n/a
MedicalDevice.Comment
Definition	Comment about use or information on the medical device used.
Cardinality	0...1
Type	string
Comments	Note that FHIR strings SHALL NOT exceed 1MB in size
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())`
Mappings	rim: n/a
MedicalDevice.Location
Definition	The healthcare organization where the use of the medical device was initiated or where the aid was implanted.
Cardinality	0...1
Type	Reference(HdBe-HealthcareOrganization)
Comments	References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))`
Mappings	rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
MedicalDevice.HealthProfessional
Definition	The health professional involved in the indication for use of the medical device implant.
Cardinality	0...1
Type	Reference(HdBe-HealthProfessional)
Comments	References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
Invariants	ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))`
Mappings	rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)

Example instances

MedicalDevice
Product	--
Product.ProductId	(01)00810323008108(17)231005(21)6789UV0 (identification by GTIN)
Product.ProductType	360283003 - Auditory appliance (code by SNOMED CT)
ProductDescription	TuneAmp auditory appliance
AnatomicalLocation
Indication	--
Indication.Problem	Reference to Problem (Listeriosis)
StartDate	2022-05-01
EndDate
Comment	Might need replacement in the near future.
Location	--
Location.HealthcareOrganization	Reference to HealthcareOrganization (GRAND HOPITAL DE CHARLEROI - SAINT-JOSEPH)
HealthProfessional	Reference to HealthProfessional (Dr. E. Penninx, Dermatology)

zib MedicalDevice-v3.3.1 difference

Concept	Category	Description
description	textual	Removed 'Evidence Base' section because of Dutch focus.
`Product.ProductId`	type	Replaced the CodeableConcept datatype with a string datatype as pre-adopt from a higher zib version ( MedicationDevice in prerelease 2022-1).
`Product.ProductId`	cardinality	Relaxed the cardinality from 0..1 to 0..* as multiple product identifications codes could be possible.
`Product.ProductId`	textual	Replaced definition of product identification codes to the Belgian context.
`Product.ProductType`	terminology	Loosened the binding strength from required to extensible (zib issue #1536).
`EndDate`	naming	Translated the concept to English as it was provided in Dutch (zib issue #1534).
`HealthProfessional`	textual	Replaced the term healthcare provider with health professional.
`Location`	textual	Replaced 'at which' with 'where'.

Terminology Bindings

Path	Name	Strength	URL
Product.ProductType	ProductType	required	https://fhir.healthdata.be/ValueSet/ProductType