Kanta Potilastietovaranto Ajanvaraus R4

There are no (further) constraints on this element

Element id

Device.meta.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

Mappings

rim: n/a

extension

0..*

There are no (further) constraints on this element

Element id

Device.meta.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

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

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

versionId

0..1

There are no (further) constraints on this element

Element id

Device.meta.versionId

Short description

Version specific identifier

Definition

The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

Comments

The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a

lastUpdated

0..1

instant

There are no (further) constraints on this element

Element id

Device.meta.lastUpdated

Short description

When the resource version last changed

Definition

When the resource last changed - e.g. when the version changed.

Comments

This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.

Data type

instant

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a

source

0..1

There are no (further) constraints on this element

Element id

Device.meta.source

Short description

Identifies where the resource comes from

Definition

A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.

Comments

In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used.

This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.

Data type

canonical(StructureDefinition)

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a

profile

1..1

canonical(StructureDefinition)Fixed Value

Element id

Device.meta.profile

Short description

Profiles this resource claims to conform to

Definition

A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

Comments

It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Fixed value

https://gen.kanta.fi/fhir/StructureDefinition/KantaDevice

Mappings

rim: n/a

security

0..*

CodingBinding

There are no (further) constraints on this element

Element id

Device.meta.security

Short description

Security Labels applied to this resource

Definition

Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

Comments

The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

Data type

Coding

Binding

Security Labels from the Healthcare Privacy and Security Classification System.

All Security Labels (extensible)

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

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 subset one of the sets of component 1-3 or 4-6
rim: CV
orim: fhir:Coding rdfs:subClassOf dt:CDCoding

tag

0..*

Coding

There are no (further) constraints on this element

Element id

Device.meta.tag

Short description

Tags applied to this resource

Definition

Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.

Comments

The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.

Data type

Coding

Binding

Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".

CommonTags (example)

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

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 subset one of the sets of component 1-3 or 4-6
rim: CV
orim: fhir:Coding rdfs:subClassOf dt:CDCoding

implicitRules

Σ ?!

0..1

There are no (further) constraints on this element

Element id

Device.implicitRules

Short description

A set of rules under which this content was created

Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

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.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a

language

0..1

codeBinding

There are no (further) constraints on this element

Element id

Device.language

Short description

Language of the resource content

Definition

The base language in which the resource is written.

Comments

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

Data type

Binding

A human language.

CommonLanguages (preferred)

Binding extensions

maxValueSet	AllLanguages

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a

text

0..1

Narrative

There are no (further) constraints on this element

Element id

Device.text

Short description

Text summary of the resource, for human interpretation

Alternate names

narrative, html, xhtml, display

Definition

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

Comments

Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

Data type

Narrative

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
rim: N/A
rim: Act.text?

contained

0..*

Resource

There are no (further) constraints on this element

Element id

Device.contained

Short description

Contained, inline Resources

Alternate names

inline resources, anonymous resources, contained resources

Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

Data type

Resource

Mappings

rim: Entity. Role, or Act
rim: N/A

extension

0..*

There are no (further) constraints on this element

Element id

Device.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 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.

Comments

Data type

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

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

?! C

0..*

There are no (further) constraints on this element

Element id

Device.modifierExtension

Short description

Extensions that cannot be ignored

Alternate names

extensions, user content

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).

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

Data type

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

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

identifier

1..1

Element id

Device.identifier

Short description

Tietojärjestelmän, ohjelmiston tai lääkinnällisen laitteen yksilöivä tunnus

Definition

Resurssin tallentaneen tietojärjestelmän, ohjelmiston tai lääkinnällisen laitteen yksilöivä tunnus.

Comments

The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used.

Data type

Slicing

Unordered, Open, by system(Value)

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
v2: CX / EI (occasionally, more often EI maps to a resource id or a URL)
rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]
servd: Identifier
w5: FiveWs.identifier
rim: .id
udi: The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty.

UDI

0..*

Element id

Device.identifier:UDI

Short description

Yksilöivä tunnus

Definition

Rakenteessa ilmoitetaan resurssin tallentaneen lääkinnällisen laitteen, ohjelmiston tai tietojärjestelmän yksilöivä tunnus.

Comments

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
v2: CX / EI (occasionally, more often EI maps to a resource id or a URL)
rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]
servd: Identifier
w5: FiveWs.identifier
rim: .id
udi: The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty.

0..0

There are no (further) constraints on this element

Element id

Device.identifier:UDI.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

Mappings

rim: n/a

extension

0..*

There are no (further) constraints on this element

Element id

Device.identifier:UDI.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

Comments

Data type

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

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

use

Σ ?!

0..0

codeBinding

There are no (further) constraints on this element

Element id

Device.identifier:UDI.use

Short description

usual | official | temp | secondary | old (If known)

Definition

The purpose of this identifier.

Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Data type

Binding

Identifies the purpose for this identifier, if known .

IdentifierUse (required)

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
v2: N/A
rim: Role.code or implied by context

type

0..0

CodeableConceptBinding

There are no (further) constraints on this element

Element id

Device.identifier:UDI.type

Short description

Description of identifier

Definition

A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

Requirements

Allows users to make use of identifiers when the identifier system is not known.

Comments

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.

Data type

Identifier Type Codes (extensible)

Binding

A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

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
v2: CX.5
rim: Role.code or implied by context

system

1..1

uriFixed Value

Element id

Device.identifier:UDI.system

Short description

EUDAMED-palvelun yksilöivä tunnus

Definition

Tiedossa ilmoitetaan EUDAMED-palvelun yksilöivä tunnus, jos lääkinnällisen laitteen tai ohjelmiston yksilöivä tunniste on EUDAMED-palvelussa. Muussa tapauksessa ilmoitetaan organisaation tietojärjestelmiensä, ohjelmistojensa tai lääkinnällisten laitteidensa yksilöinnissä käyttämä nimiavaruus.

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.

Comments

Identifier.system is always case sensitive.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Fixed value

urn:oid:1.2.246.537.6.12.999.2003.34

Examples
General

http://www.acme.com/identifiers/patient

Mappings

rim: n/a
v2: CX.4 / EI-2-4
rim: II.root or Role.id.root
servd: ./IdentifierType

value

1..1

Element id

Device.identifier:UDI.value

Short description

Yksilöivä tunnus

Definition

Lääkinnällisen laitteen tai ohjelmiston yksilöivä tunnus ilman käytettävään nimiavaruutta.

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.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Examples
General

Mappings

rim: n/a
v2: CX.1 / EI.1
rim: II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
servd: ./Value

period

Σ C

0..0

Period

There are no (further) constraints on this element

Element id

Device.identifier:UDI.period

Short description

Time period when id is/was valid for use

Definition

Time period during which identifier is/was valid for use.

Comments

A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times").

Period is not used for a duration (a measure of elapsed time). See Duration.

Data type

Period

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
per-1: If present, start SHALL have a lower value than end
start.hasValue().not() or end.hasValue().not() or (start <= end)

Mappings

rim: n/a
v2: DR
rim: IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]
v2: CX.7 + CX.8
rim: Role.effectiveTime or implied by context
servd: ./StartDate and ./EndDate

assigner

Σ C

0..0

There are no (further) constraints on this element

Element id

Device.identifier:UDI.assigner

Short description

Organization that issued id (may be just text)

Definition

Organization that issued/manages the identifier.

Comments

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.

Data type

Reference(DeviceDefinition)

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

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.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource))

Mappings

rim: n/a
rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
v2: CX.4 / (CX.4,CX.9,CX.10)
rim: II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
servd: ./IdentifierIssuingAuthority

definition

0..0

There are no (further) constraints on this element

Element id

Device.definition

Short description

The reference to the definition for the device

Definition

The reference to the definition for the device.

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(DeviceDefinition)

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

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.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource))

Mappings

rim: n/a
rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)

udiCarrier

0..0

There are no (further) constraints on this element

Element id

Device.udiCarrier

Short description

Unique Device Identifier (UDI) Barcode string

Definition

Unique device identifier (UDI) assigned to device label or package. Note that the Device may include multiple udiCarriers as it either may include just the udiCarrier for the jurisdiction it is sold, or for multiple jurisdictions it could have been sold.

Comments

UDI may identify an unique instance of a device, or it may only identify the type of the device. See UDI mappings for a complete mapping of UDI parts to Device.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
w5: FiveWs.identifier
rim: .id and .code

status

Σ ?!

0..0

codeBinding

There are no (further) constraints on this element

Element id

Device.status

Short description

active | inactive | entered-in-error | unknown

Definition

Status of the Device availability.

Comments

This element is labeled as a modifier because the status contains the codes inactive and entered-in-error that mark the device (record)as not currently valid.

Data type

Binding

The availability status of the device.

FHIRDeviceStatus (required)

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
w5: FiveWs.status
rim: .statusCode

statusReason

0..0

CodeableConceptBinding

There are no (further) constraints on this element

Element id

Device.statusReason

Short description

Definition

Reason for the dtatus of the Device availability.

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

FHIRDeviceStatusReason (extensible)

Binding

The availability status reason of the device.

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

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
w5: FiveWs.status

distinctIdentifier

0..0

There are no (further) constraints on this element

Element id

Device.distinctIdentifier

Short description

The distinct identification string

Alternate names

Distinct Identification Code (DIC)

Definition

The distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product.

Comments

For example, this applies to devices in the United States regulated under Code of Federal Regulation 21CFR§1271.290(c).

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
w5: FiveWs.what[x]
rim: .lotNumberText
udi: The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.

manufacturer

0..0

There are no (further) constraints on this element

Element id

Device.manufacturer

Short description

Name of device manufacturer

Definition

A name of the manufacturer.

Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
w5: FiveWs.what[x]
rim: .playedRole[typeCode=MANU].scoper.name
udi: N/A

manufactureDate

0..0

There are no (further) constraints on this element

Element id

Device.manufactureDate

Short description

Date when the device was made

Definition

The date and time when the device was manufactured.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
w5: FiveWs.what[x]
rim: .existenceTime.low
udi: The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.

expirationDate

0..0

There are no (further) constraints on this element

Element id

Device.expirationDate

Short description

Date and time of expiry of this device (if applicable)

Definition

The date and time beyond which this device is no longer valid or should not be used (if applicable).

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
w5: FiveWs.what[x]
rim: .expirationTime
udi: the expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.

lotNumber

0..0

There are no (further) constraints on this element

Element id

Device.lotNumber

Short description

Lot number of manufacture

Definition

Lot number assigned by the manufacturer.

Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
w5: FiveWs.what[x]
rim: .lotNumberText
udi: The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.

serialNumber

0..0

There are no (further) constraints on this element

Element id

Device.serialNumber

Short description

Serial number assigned by the manufacturer

Definition

The serial number assigned by the organization when the device was manufactured.

Comments

Alphanumeric Maximum 20.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
w5: FiveWs.what[x]
rim: .playedRole[typeCode=MANU].id

deviceName

1..1

Element id

Device.deviceName

Short description

Tietojärjestelmän, ohjelmiston tai lääkinnällisen laitteen nimi

Definition

Tiedolla ilmoitetaan resurssin tehneen tietojärjestelmän, ohjelmiston tai lääkinnällisen laitteen nimi.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a

0..0

There are no (further) constraints on this element

Element id

Device.deviceName.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

Mappings

rim: n/a

extension

0..*

There are no (further) constraints on this element

Element id

Device.deviceName.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

Comments

Data type

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

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 ?! C

0..*

There are no (further) constraints on this element

Element id

Device.deviceName.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

Comments

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

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

name

1..1

Element id

Device.deviceName.name

Short description

Tietojärjestelmän, ohjelmiston tai lääkinnällisen laitteen nimi

Alternate names

Definition

Resurssin tehneen tietojärjestelmän, ohjelmiston tai lääkinnällisen laitteen nimi tekstimuodossa.

Tietojärjestelmän nimi on ilmoitettava samassa muodossa kuin se on ilmoitettu Valviran tietojärjestelmärekisteriin sosiaali- ja terveydenhuollon tietojärjestelmistä.

Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a

type

1..1

codeBinding

There are no (further) constraints on this element

Element id

Device.deviceName.type

Short description

Definition

The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName.

Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Data type

Binding

The type of name the device is referred by.

DeviceNameType (required)

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
w5: FiveWs.what[x]
rim: .playedRole[typeCode=MANU].code

modelNumber

0..0

There are no (further) constraints on this element

Element id

Device.modelNumber

Short description

The model number for the device

Definition

The model number for the device.

Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
w5: FiveWs.what[x]
rim: .softwareName (included as part)

partNumber

0..0

There are no (further) constraints on this element

Element id

Device.partNumber

Short description

The part number of the device

Definition

The part number of the device.

Comments

Alphanumeric Maximum 20.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
w5: FiveWs.what[x]
rim: .playedRole[typeCode=MANU].id

type

0..0

There are no (further) constraints on this element

Element id

Device.type

Short description

The kind or type of device

Definition

The kind or type of device.

Comments

Data type

Binding

Codes to identify medical devices.

DeviceType (example)

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

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

specialization

0..0

There are no (further) constraints on this element

Element id

Device.specialization

Short description

The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication

Definition

The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a

version

1..1

Element id

Device.version

Short description

Ohjelmiston, tietojärjestelmän tai lääkinnällisen laitteen versio

Definition

Tiedolla ilmoitetaan resurssin tallentaneen ohjelmiston, tietojärjestelmän tai lääkinnällisen laitteen versio.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a

0..0

There are no (further) constraints on this element

Element id

Device.version.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

Mappings

rim: n/a

extension

0..*

There are no (further) constraints on this element

Element id

Device.version.extension

Short description

Additional content defined by implementations

Alternate names

extensions, user content

Definition

Comments

Data type

Slicing

Unordered, Open, by url(Value)

Extensions are always sliced by (at least) url

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

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 ?! C

0..*

There are no (further) constraints on this element

Element id

Device.version.modifierExtension

Short description

Extensions that cannot be ignored even if unrecognized

Alternate names

extensions, user content, modifiers

Definition

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Requirements

Comments

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

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

type

0..0

There are no (further) constraints on this element

Element id

Device.version.type

Short description

The type of the device version

Alternate names

Definition

The type of the device version.

Comments

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

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

component

0..0

There are no (further) constraints on this element

Element id

Device.version.component

Short description

A single component of the device version

Definition

A single component of the device version.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
v2: CX / EI (occasionally, more often EI maps to a resource id or a URL)
rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]
servd: Identifier
w5: FiveWs.what[x]

value

1..1

Element id

Device.version.value

Short description

Versio

Definition

Resurssin tehneen tietojärjestelmän, ohjelmiston tai lääkinnällisen laitteen versio tekstimuodossa.

Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a

property

0..0

There are no (further) constraints on this element

Element id

Device.property

Short description

The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties

Definition

The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a

patient

0..0

Reference(Patient)

There are no (further) constraints on this element

Element id

Device.patient

Short description

Patient to whom Device is affixed

Definition

Patient information, If the device is affixed to a person.

Requirements

If the device is implanted in a patient, then need to associate the device to the patient.

Comments

Data type

Reference(Patient)

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

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.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource))

Mappings

rim: n/a
rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
w5: FiveWs.subject[x]
rim: .playedRole[typeCode=USED].scoper.playedRole[typeCode=PAT]
w5: FiveWs.subject

owner

0..0

There are no (further) constraints on this element

Element id

Device.owner

Short description

Organization responsible for device

Definition

An organization that is responsible for the provision and ongoing maintenance of the device.

Comments

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

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.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource))

Mappings

rim: n/a
rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
w5: FiveWs.source
rim: .playedRole[typeCode=OWN].scoper

contact

0..0

ContactPoint

There are no (further) constraints on this element

Element id

Device.contact

Short description

Details for human/organization for support

Definition

Contact details for an organization or a particular human that is responsible for the device.

Comments

used for troubleshooting etc.

Data type

ContactPoint

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
cpt-2: A system is required if a value is provided.
value.empty() or system.exists()

Mappings

rim: n/a
v2: XTN
rim: TEL
servd: ContactPoint
w5: FiveWs.source
rim: .scopedRole[typeCode=CON].player

location

0..0

Reference(Location)

There are no (further) constraints on this element

Element id

Device.location

Short description

Where the device is found

Definition

The place where the device can be found.

Requirements

Device.location can be used to track device location.

Comments

Data type

Reference(Location)

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

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.exists() implies (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')) or (reference='#' and %rootResource!=%resource))

Mappings

rim: n/a
rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
w5: FiveWs.where[x]
rim: .playedRole[typeCode=LOCE].scoper

url

0..0

There are no (further) constraints on this element

Element id

Device.url

Short description

Network address to contact device

Definition

A network address on which the device may be contacted directly.

Comments

If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.

Data type

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
w5: FiveWs.where[x]
rim: .telecom

note

0..0

Annotation

There are no (further) constraints on this element

Element id

Device.note

Short description

Device notes and comments

Definition

Descriptive information, usage information or implantation information that is not captured in an existing element.

Comments

For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).

Data type

Annotation

Conditions

The cardinality or value of this element may be affected by these constraints: ele-1

Constraints

ele-1: All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())

Mappings

rim: n/a
v2: N/A
rim: Act
rim: .text

safety

0..0

There are no (further) constraints on this element

Element id

Device.safety

Short description

Safety Characteristics of Device

Definition

Provides additional safety characteristics about a medical device. For example devices containing latex.

Comments

Data type