Release 5 Ballot
AdministrationThis page is part of the FHIR Specification (v5.0.0-ballot: FHIR R5 Ballot Preview). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions 
. Page versions: R5 R4B R4
| Orders and Observations Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: Not linked to any defined compartments |
Raw JSON (canonical form + also see JSON Format Specification)
StructureDefinition for devicedefinition
{
"resourceType" : "StructureDefinition",
"id" : "DeviceDefinition",
"meta" : {
"lastUpdated" : "2022-09-07T10:58:29.429+10:00"
},
"text" : {
"status" : "generated",
"div" : "<div>!-- Snipped for Brevity --></div>"
},
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-category",
"valueString" : "Specialized.Definitional Artifacts"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode" : "trial-use"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger" : 1
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category",
"valueCode" : "anonymous"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode" : "oo"
}],
"url" : "http://hl7.org/fhir/StructureDefinition/DeviceDefinition",
"version" : "5.0.0-ballot",
"name" : "DeviceDefinition",
"status" : "draft",
"experimental" : false,
"date" : "2022-09-07T10:58:29+10:00",
"publisher" : "Health Level Seven International (Orders and Observations)",
"contact" : [{
"telecom" : [{
"system" : "url",
"value" : "http://hl7.org/fhir"
}]
},
{
"telecom" : [{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/orders/index.cfm"
}]
}],
"description" : "This is a specialized resource that defines the characteristics and capabilities of a device.",
"fhirVersion" : "5.0.0-ballot",
"mapping" : [{
"identity" : "w5",
"uri" : "http://hl7.org/fhir/fivews",
"name" : "FiveWs Pattern Mapping"
},
{
"identity" : "rim",
"uri" : "http://hl7.org/v3",
"name" : "RIM Mapping"
}],
"kind" : "resource",
"abstract" : false,
"type" : "DeviceDefinition",
"baseDefinition" : "http://hl7.org/fhir/StructureDefinition/DomainResource",
"derivation" : "specialization",
"snapshot" : {
"element" : [{
"id" : "DeviceDefinition",
"path" : "DeviceDefinition",
"short" : "An instance of a medical-related component of a medical device",
"definition" : "The characteristics, operational status and capabilities of a medical-related component of a medical device.",
"comment" : "For the initial scope, this DeviceDefinition resource is only applicable to describe a single node in the containment tree that is produced by the context scanner in any medical device that implements or derives from the ISO/IEEE 11073 standard and that does not represent a metric. Examples for such a node are MDS, VMD, or Channel.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition",
"min" : 0,
"max" : "*"
},
"constraint" : [{
"key" : "dom-2",
"severity" : "error",
"human" : "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
"expression" : "contained.contained.empty()",
"xpath" : "not(parent::f:contained and f:contained)",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-3",
"severity" : "error",
"human" : "If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource",
"expression" : "contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()",
"xpath" : "not(exists(for $contained in f:contained return $contained[not(exists(parent::*/descendant::f:reference/@value=concat('#', $contained/*/f:id/@value)) or exists(descendant::f:reference[@value='#']))]))",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-4",
"severity" : "error",
"human" : "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"expression" : "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()",
"xpath" : "not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-5",
"severity" : "error",
"human" : "If a resource is contained in another resource, it SHALL NOT have a security label",
"expression" : "contained.meta.security.empty()",
"xpath" : "not(exists(f:contained/*/f:meta/f:security))",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation",
"valueMarkdown" : "When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."
}],
"key" : "dom-6",
"severity" : "warning",
"human" : "A resource should have narrative for robust management",
"expression" : "text.`div`.exists()",
"xpath" : "exists(f:text/h:div)",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "Entity. Role, or Act"
},
{
"identity" : "w5",
"map" : "administrative.device"
}]
},
{
"id" : "DeviceDefinition.id",
"path" : "DeviceDefinition.id",
"short" : "Logical id of this artifact",
"definition" : "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"comment" : "Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "id"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "DeviceDefinition.meta",
"path" : "DeviceDefinition.meta",
"short" : "Metadata about the resource",
"definition" : "The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.meta",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Meta"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "DeviceDefinition.implicitRules",
"path" : "DeviceDefinition.implicitRules",
"short" : "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.",
"comment" : "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.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.implicitRules",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "uri"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : true,
"isModifierReason" : "This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation",
"isSummary" : true
},
{
"id" : "DeviceDefinition.language",
"path" : "DeviceDefinition.language",
"short" : "Language of the resource content",
"definition" : "The base language in which the resource is written.",
"comment" : "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).",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.language",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "code"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet",
"valueCanonical" : "http://hl7.org/fhir/ValueSet/all-languages"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "Language"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean" : true
}],
"strength" : "preferred",
"description" : "IETF language tag",
"valueSet" : "http://hl7.org/fhir/ValueSet/languages"
}
},
{
"id" : "DeviceDefinition.text",
"path" : "DeviceDefinition.text",
"short" : "Text summary of the resource, for human interpretation",
"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.",
"comment" : "Contained resources do not have a 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.",
"alias" : ["narrative",
"html",
"xhtml",
"display"],
"min" : 0,
"max" : "1",
"base" : {
"path" : "DomainResource.text",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Narrative"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "Act.text?"
}]
},
{
"id" : "DeviceDefinition.contained",
"path" : "DeviceDefinition.contained",
"short" : "Contained, inline Resources",
"definition" : "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.",
"comment" : "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.",
"alias" : ["inline resources",
"anonymous resources",
"contained resources"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.contained",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Resource"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "DeviceDefinition.extension",
"path" : "DeviceDefinition.extension",
"short" : "Additional content defined by implementations",
"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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "DeviceDefinition.modifierExtension",
"path" : "DeviceDefinition.modifierExtension",
"short" : "Extensions that cannot be ignored",
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"mustSupport" : false,
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "DeviceDefinition.description",
"path" : "DeviceDefinition.description",
"short" : "Additional information to describe the device",
"definition" : "Additional information to describe the device.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.description",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "markdown"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.identifier",
"path" : "DeviceDefinition.identifier",
"short" : "Instance identifier",
"definition" : "Unique instance identifiers assigned to a device by the software, manufacturers, other organizations or owners. For example: handle ID. The identifier is typically valued if the udiDeviceIdentifier, partNumber or modelNumber is not valued and represents a different type of identifier. However, it is permissible to still include those identifiers in DeviceDefinition.identifier with the appropriate identifier.type.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.identifier",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Identifier"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.identifier"
}]
},
{
"id" : "DeviceDefinition.udiDeviceIdentifier",
"path" : "DeviceDefinition.udiDeviceIdentifier",
"short" : "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.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.udiDeviceIdentifier",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.udiDeviceIdentifier.id",
"path" : "DeviceDefinition.udiDeviceIdentifier.id",
"representation" : ["xmlAttr"],
"short" : "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.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.udiDeviceIdentifier.extension",
"path" : "DeviceDefinition.udiDeviceIdentifier.extension",
"short" : "Additional content defined by implementations",
"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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.udiDeviceIdentifier.modifierExtension",
"path" : "DeviceDefinition.udiDeviceIdentifier.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "DeviceDefinition.udiDeviceIdentifier.deviceIdentifier",
"path" : "DeviceDefinition.udiDeviceIdentifier.deviceIdentifier",
"short" : "The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier",
"definition" : "The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.udiDeviceIdentifier.deviceIdentifier",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "string"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.udiDeviceIdentifier.issuer",
"path" : "DeviceDefinition.udiDeviceIdentifier.issuer",
"short" : "The organization that assigns the identifier algorithm",
"definition" : "The organization that assigns the identifier algorithm.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.udiDeviceIdentifier.issuer",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "uri"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.udiDeviceIdentifier.jurisdiction",
"path" : "DeviceDefinition.udiDeviceIdentifier.jurisdiction",
"short" : "The jurisdiction to which the deviceIdentifier applies",
"definition" : "The jurisdiction to which the deviceIdentifier applies.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.udiDeviceIdentifier.jurisdiction",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "uri"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution",
"path" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution",
"short" : "Indicates whether and when the device is available on the market",
"definition" : "Indicates where and when the device is available on the market.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution.id",
"path" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution.id",
"representation" : ["xmlAttr"],
"short" : "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.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution.extension",
"path" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution.extension",
"short" : "Additional content defined by implementations",
"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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution.modifierExtension",
"path" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod",
"path" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod",
"short" : "Begin and end dates for the commercial distribution of the device",
"definition" : "Begin and end dates for the commercial distribution of the device.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "Period"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction",
"path" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction",
"short" : "National state or territory where the device is commercialized",
"definition" : "National state or territory to which the marketDistribution recers, typically where the device is commercialized.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "uri"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.regulatoryIdentifier",
"path" : "DeviceDefinition.regulatoryIdentifier",
"short" : "Regulatory identifier(s) associated with this device",
"definition" : "Identifier associated with the regulatory documentation (certificates, technical documentation, post-market surveillance documentation and reports) of a set of device models sharing the same intended purpose, risk class and essential design and manufacturing characteristics. One example is the Basic UDI-DI in Europe.",
"comment" : "This should not be used for regulatory authorization numbers which are to be captured elsewhere.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.regulatoryIdentifier",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.regulatoryIdentifier.id",
"path" : "DeviceDefinition.regulatoryIdentifier.id",
"representation" : ["xmlAttr"],
"short" : "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.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.regulatoryIdentifier.extension",
"path" : "DeviceDefinition.regulatoryIdentifier.extension",
"short" : "Additional content defined by implementations",
"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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.regulatoryIdentifier.modifierExtension",
"path" : "DeviceDefinition.regulatoryIdentifier.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "DeviceDefinition.regulatoryIdentifier.type",
"path" : "DeviceDefinition.regulatoryIdentifier.type",
"short" : "basic | master | license",
"definition" : "The type of identifier itself.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.regulatoryIdentifier.type",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "code"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "DeviceRegulatoryIdentifierType"
}],
"strength" : "required",
"description" : "Device regulatory identifier type.",
"valueSet" : "http://hl7.org/fhir/ValueSet/devicedefinition-regulatory-identifier-type|5.0.0-ballot"
}
},
{
"id" : "DeviceDefinition.regulatoryIdentifier.deviceIdentifier",
"path" : "DeviceDefinition.regulatoryIdentifier.deviceIdentifier",
"short" : "The identifier itself",
"definition" : "The identifier itself.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.regulatoryIdentifier.deviceIdentifier",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "string"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.regulatoryIdentifier.issuer",
"path" : "DeviceDefinition.regulatoryIdentifier.issuer",
"short" : "The organization that issued this identifier",
"definition" : "The organization that issued this identifier.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.regulatoryIdentifier.issuer",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "uri"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.regulatoryIdentifier.jurisdiction",
"path" : "DeviceDefinition.regulatoryIdentifier.jurisdiction",
"short" : "The jurisdiction to which the deviceIdentifier applies",
"definition" : "The jurisdiction to which the deviceIdentifier applies.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.regulatoryIdentifier.jurisdiction",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "uri"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.partNumber",
"path" : "DeviceDefinition.partNumber",
"short" : "The part number or catalog number of the device",
"definition" : "The part number or catalog number of the device.",
"comment" : "Alphanumeric Maximum 20.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.partNumber",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "string"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.what[x]"
},
{
"identity" : "rim",
"map" : ".playedRole[typeCode=MANU].id"
}]
},
{
"id" : "DeviceDefinition.manufacturer",
"path" : "DeviceDefinition.manufacturer",
"short" : "Name of device manufacturer",
"definition" : "A name of the manufacturer or legal representative e.g. labeler. Whether this is the actual manufacturer or the labeler or responsible depends on implementation and jurisdiction.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.manufacturer",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Organization"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.what[x]"
},
{
"identity" : "rim",
"map" : ".playedRole[typeCode=MANU].scoper.name"
}]
},
{
"id" : "DeviceDefinition.deviceName",
"path" : "DeviceDefinition.deviceName",
"short" : "The name or names of the device as given by the manufacturer",
"definition" : "The name or names of the device as given by the manufacturer.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.deviceName",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.deviceName.id",
"path" : "DeviceDefinition.deviceName.id",
"representation" : ["xmlAttr"],
"short" : "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.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.deviceName.extension",
"path" : "DeviceDefinition.deviceName.extension",
"short" : "Additional content defined by implementations",
"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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.deviceName.modifierExtension",
"path" : "DeviceDefinition.deviceName.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "DeviceDefinition.deviceName.name",
"path" : "DeviceDefinition.deviceName.name",
"short" : "A name that is used to refer to the device",
"definition" : "A human-friendly name that is used to refer to the device - depending on the type, it can be the brand name, the common name or alias, or other.",
"alias" : ["Σ"],
"min" : 1,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.deviceName.name",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "string"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.deviceName.type",
"path" : "DeviceDefinition.deviceName.type",
"short" : "registered-name | user-friendly-name | patient-reported-name",
"definition" : "The type of deviceName.\nRegisteredName | UserFriendlyName | PatientReportedName.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.deviceName.type",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "code"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "DeviceNameType"
}],
"strength" : "required",
"description" : "The type of name the device is referred by.",
"valueSet" : "http://hl7.org/fhir/ValueSet/device-nametype|5.0.0-ballot"
},
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.what[x]"
},
{
"identity" : "rim",
"map" : ".playedRole[typeCode=MANU].code"
}]
},
{
"id" : "DeviceDefinition.modelNumber",
"path" : "DeviceDefinition.modelNumber",
"short" : "The catalog or model number for the device for example as defined by the manufacturer",
"definition" : "The model number for the device for example as defined by the manufacturer or labeler, or other agency.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.modelNumber",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "string"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.what[x]"
},
{
"identity" : "rim",
"map" : ".softwareName (included as part)"
}]
},
{
"id" : "DeviceDefinition.classification",
"path" : "DeviceDefinition.classification",
"short" : "What kind of device or device system this is",
"definition" : "What kind of device or device system this is.",
"comment" : "In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.classification",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.classification.id",
"path" : "DeviceDefinition.classification.id",
"representation" : ["xmlAttr"],
"short" : "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.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.classification.extension",
"path" : "DeviceDefinition.classification.extension",
"short" : "Additional content defined by implementations",
"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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.classification.modifierExtension",
"path" : "DeviceDefinition.classification.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "DeviceDefinition.classification.type",
"path" : "DeviceDefinition.classification.type",
"short" : "A classification or risk class of the device model",
"definition" : "A classification or risk class of the device model.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.classification.type",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "DeviceKind"
}],
"strength" : "example",
"description" : "Type of device e.g. according to official classification.",
"valueSet" : "http://hl7.org/fhir/ValueSet/device-type"
}
},
{
"id" : "DeviceDefinition.classification.justification",
"path" : "DeviceDefinition.classification.justification",
"short" : "Further information qualifying this classification of the device model",
"definition" : "Further information qualifying this classification of the device model.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.classification.justification",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "RelatedArtifact"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.specialization",
"path" : "DeviceDefinition.specialization",
"short" : "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.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.specialization",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "RelatedArtifact"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.hasPart",
"path" : "DeviceDefinition.hasPart",
"short" : "A device, part of the current one",
"definition" : "A device that is part (for example a component) of the present device.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.hasPart",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.hasPart.id",
"path" : "DeviceDefinition.hasPart.id",
"representation" : ["xmlAttr"],
"short" : "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.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.hasPart.extension",
"path" : "DeviceDefinition.hasPart.extension",
"short" : "Additional content defined by implementations",
"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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.hasPart.modifierExtension",
"path" : "DeviceDefinition.hasPart.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "DeviceDefinition.hasPart.reference",
"path" : "DeviceDefinition.hasPart.reference",
"short" : "Reference to the part",
"definition" : "Reference to the device that is part of the current device.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.hasPart.reference",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/DeviceDefinition"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.hasPart.count",
"path" : "DeviceDefinition.hasPart.count",
"short" : "Number of occurrences of the part",
"definition" : "Number of instances of the component device in the current device.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.hasPart.count",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "integer"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.packaging",
"path" : "DeviceDefinition.packaging",
"short" : "Information about the packaging of the device, i.e. how the device is packaged",
"definition" : "Information about the packaging of the device, i.e. how the device is packaged.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.packaging",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.packaging.id",
"path" : "DeviceDefinition.packaging.id",
"representation" : ["xmlAttr"],
"short" : "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.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.packaging.extension",
"path" : "DeviceDefinition.packaging.extension",
"short" : "Additional content defined by implementations",
"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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.packaging.modifierExtension",
"path" : "DeviceDefinition.packaging.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "DeviceDefinition.packaging.identifier",
"path" : "DeviceDefinition.packaging.identifier",
"short" : "Business identifier of the packaged medication",
"definition" : "The business identifier of the packaged medication.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.packaging.identifier",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Identifier"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.packaging.type",
"path" : "DeviceDefinition.packaging.type",
"short" : "A code that defines the specific type of packaging",
"definition" : "A code that defines the specific type of packaging.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.packaging.type",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.packaging.count",
"path" : "DeviceDefinition.packaging.count",
"short" : "The number of items contained in the package (devices or sub-packages)",
"definition" : "The number of items contained in the package (devices or sub-packages).",
"min" : 0,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.packaging.count",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "integer"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.packaging.distributor",
"path" : "DeviceDefinition.packaging.distributor",
"short" : "An organization that distributes the packaged device",
"definition" : "An organization that distributes the packaged device.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.packaging.distributor",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.packaging.distributor.id",
"path" : "DeviceDefinition.packaging.distributor.id",
"representation" : ["xmlAttr"],
"short" : "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.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.packaging.distributor.extension",
"path" : "DeviceDefinition.packaging.distributor.extension",
"short" : "Additional content defined by implementations",
"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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.packaging.distributor.modifierExtension",
"path" : "DeviceDefinition.packaging.distributor.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "DeviceDefinition.packaging.distributor.name",
"path" : "DeviceDefinition.packaging.distributor.name",
"short" : "Distributor's human-readable name",
"definition" : "Distributor's human-readable name.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.packaging.distributor.name",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "string"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.packaging.distributor.organizationReference",
"path" : "DeviceDefinition.packaging.distributor.organizationReference",
"short" : "Distributor as an Organization resource",
"definition" : "Distributor as an Organization resource.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.packaging.distributor.organizationReference",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Organization"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.packaging.udiDeviceIdentifier",
"path" : "DeviceDefinition.packaging.udiDeviceIdentifier",
"short" : "Unique Device Identifier (UDI) Barcode string on the packaging",
"definition" : "Unique Device Identifier (UDI) Barcode string on the packaging.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.packaging.udiDeviceIdentifier",
"min" : 0,
"max" : "*"
},
"contentReference" : "#DeviceDefinition.udiDeviceIdentifier",
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.packaging.packaging",
"path" : "DeviceDefinition.packaging.packaging",
"short" : "Allows packages within packages",
"definition" : "Allows packages within packages.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.packaging.packaging",
"min" : 0,
"max" : "*"
},
"contentReference" : "#DeviceDefinition.packaging",
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.version",
"path" : "DeviceDefinition.version",
"short" : "The version of the device or software",
"definition" : "The version of the device or software.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.version",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.version.id",
"path" : "DeviceDefinition.version.id",
"representation" : ["xmlAttr"],
"short" : "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.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.version.extension",
"path" : "DeviceDefinition.version.extension",
"short" : "Additional content defined by implementations",
"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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.version.modifierExtension",
"path" : "DeviceDefinition.version.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "DeviceDefinition.version.type",
"path" : "DeviceDefinition.version.type",
"short" : "The type of the device version, e.g. manufacturer, approved, internal",
"definition" : "The type of the device version, e.g. manufacturer, approved, internal.",
"alias" : ["Σ"],
"min" : 0,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.version.type",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.version.component",
"path" : "DeviceDefinition.version.component",
"short" : "The hardware or software module of the device to which the version applies",
"definition" : "The hardware or software module of the device to which the version applies.",
"comment" : "Note that the module of the device would not need to be tracked as a separate device, e.g., using different UDI, thus would typically involve one or more software modules. For example, a device may involve two software modules each on a different version.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.version.component",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Identifier"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.what[x]"
}]
},
{
"id" : "DeviceDefinition.version.value",
"path" : "DeviceDefinition.version.value",
"short" : "The version text",
"definition" : "The version text.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.version.value",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "string"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.safety",
"path" : "DeviceDefinition.safety",
"short" : "Safety characteristics of the device",
"definition" : "Safety characteristics of the device.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.safety",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "Safety"
}],
"strength" : "example",
"valueSet" : "http://hl7.org/fhir/ValueSet/device-safety"
}
},
{
"id" : "DeviceDefinition.shelfLifeStorage",
"path" : "DeviceDefinition.shelfLifeStorage",
"short" : "Shelf Life and storage information",
"definition" : "Shelf Life and storage information.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.shelfLifeStorage",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "ProductShelfLife"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.languageCode",
"path" : "DeviceDefinition.languageCode",
"short" : "Language code for the human-readable text strings produced by the device (all supported)",
"definition" : "Language code for the human-readable text strings produced by the device (all supported).",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.languageCode",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.property",
"path" : "DeviceDefinition.property",
"short" : "The potential, valid configuration settings of a device, e.g., regulation status, time properties",
"definition" : "The potential, valid configuration settings of a device, e.g., regulation status, time properties.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.property",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.property.id",
"path" : "DeviceDefinition.property.id",
"representation" : ["xmlAttr"],
"short" : "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.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.property.extension",
"path" : "DeviceDefinition.property.extension",
"short" : "Additional content defined by implementations",
"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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.property.modifierExtension",
"path" : "DeviceDefinition.property.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "DeviceDefinition.property.type",
"path" : "DeviceDefinition.property.type",
"short" : "Code that specifies the property",
"definition" : "Code that specifies the property.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.property.type",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.property.value[x]",
"path" : "DeviceDefinition.property.value[x]",
"short" : "Property value - as a code or quantity",
"definition" : "Property value - the data type depends on the property type.",
"comment" : "The usage of CodeableConcept is for concepts that are normally coded but for which a code is not available - for example a device implant size that is not standardized. The property string is for text characteristics, e.g. long descriptions, warnings, etc.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.property.value[x]",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "Quantity"
},
{
"code" : "CodeableConcept"
},
{
"code" : "string"
},
{
"code" : "boolean"
},
{
"code" : "integer"
},
{
"code" : "Range"
},
{
"code" : "Attachment"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.owner",
"path" : "DeviceDefinition.owner",
"short" : "Organization responsible for device",
"definition" : "An organization that is responsible for the provision and ongoing maintenance of the device.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.owner",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Organization"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.source"
},
{
"identity" : "rim",
"map" : ".playedRole[typeCode=OWN].scoper"
}]
},
{
"id" : "DeviceDefinition.contact",
"path" : "DeviceDefinition.contact",
"short" : "Details for human/organization for support",
"definition" : "Contact details for an organization or a particular human that is responsible for the device.",
"comment" : "used for troubleshooting etc.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.contact",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "ContactPoint"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.source"
},
{
"identity" : "rim",
"map" : ".scopedRole[typeCode=CON].player"
}]
},
{
"id" : "DeviceDefinition.link",
"path" : "DeviceDefinition.link",
"short" : "An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device",
"definition" : "An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.link",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.link.id",
"path" : "DeviceDefinition.link.id",
"representation" : ["xmlAttr"],
"short" : "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.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.link.extension",
"path" : "DeviceDefinition.link.extension",
"short" : "Additional content defined by implementations",
"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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.link.modifierExtension",
"path" : "DeviceDefinition.link.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "DeviceDefinition.link.relation",
"path" : "DeviceDefinition.link.relation",
"short" : "The type indicates the relationship of the related device to the device instance",
"definition" : "The type indicates the relationship of the related device to the device instance.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.link.relation",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "Coding"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "DeviceDefinitionRelationType"
}],
"strength" : "extensible",
"description" : "The type of relation between this and the linked device.",
"valueSet" : "http://hl7.org/fhir/ValueSet/devicedefinition-relationtype"
}
},
{
"id" : "DeviceDefinition.link.relatedDevice",
"path" : "DeviceDefinition.link.relatedDevice",
"short" : "A reference to the linked device",
"definition" : "A reference to the linked device.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.link.relatedDevice",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "CodeableReference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/DeviceDefinition"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.note",
"path" : "DeviceDefinition.note",
"short" : "Device notes and comments",
"definition" : "Descriptive information, usage information or implantation information that is not captured in an existing element.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.note",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Annotation"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : ".text"
}]
},
{
"id" : "DeviceDefinition.parentDevice",
"path" : "DeviceDefinition.parentDevice",
"short" : "The parent device it can be part of",
"definition" : "The parent device it can be part of.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.parentDevice",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/DeviceDefinition"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "DeviceDefinition.material",
"path" : "DeviceDefinition.material",
"short" : "A substance used to create the material(s) of which the device is made",
"definition" : "A substance used to create the material(s) of which the device is made.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.material",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.material.id",
"path" : "DeviceDefinition.material.id",
"representation" : ["xmlAttr"],
"short" : "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.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.material.extension",
"path" : "DeviceDefinition.material.extension",
"short" : "Additional content defined by implementations",
"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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.material.modifierExtension",
"path" : "DeviceDefinition.material.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "DeviceDefinition.material.substance",
"path" : "DeviceDefinition.material.substance",
"short" : "A relevant substance that the device contains, may contain, or is made of",
"definition" : "A substance that the device contains, may contain, or is made of - for example latex - to be used to determine patient compatibility. This is not intended to represent the composition of the device, only the clinically relevant materials.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.material.substance",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.material.alternate",
"path" : "DeviceDefinition.material.alternate",
"short" : "Indicates an alternative material of the device",
"definition" : "Indicates an alternative material of the device.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.material.alternate",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "boolean"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.material.allergenicIndicator",
"path" : "DeviceDefinition.material.allergenicIndicator",
"short" : "Whether the substance is a known or suspected allergen",
"definition" : "Whether the substance is a known or suspected allergen.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.material.allergenicIndicator",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "boolean"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.productionIdentifierInUDI",
"path" : "DeviceDefinition.productionIdentifierInUDI",
"short" : "lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version",
"definition" : "Indicates the production identifier(s) that are expected to appear in the UDI carrier on the device label.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.productionIdentifierInUDI",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "code"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "DeviceProductionIdentifierInUDI"
}],
"strength" : "required",
"description" : "The production identifier(s) that are expected to appear in the UDI carrier.",
"valueSet" : "http://hl7.org/fhir/ValueSet/device-productidentifierinudi|5.0.0-ballot"
}
},
{
"id" : "DeviceDefinition.guideline",
"path" : "DeviceDefinition.guideline",
"short" : "Information aimed at providing directions for the usage of this model of device",
"definition" : "Information aimed at providing directions for the usage of this model of device.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.guideline",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.guideline.id",
"path" : "DeviceDefinition.guideline.id",
"representation" : ["xmlAttr"],
"short" : "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.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.guideline.extension",
"path" : "DeviceDefinition.guideline.extension",
"short" : "Additional content defined by implementations",
"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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.guideline.modifierExtension",
"path" : "DeviceDefinition.guideline.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "DeviceDefinition.guideline.useContext",
"path" : "DeviceDefinition.guideline.useContext",
"short" : "The circumstances that form the setting for using the device",
"definition" : "The circumstances that form the setting for using the device.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.guideline.useContext",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "UsageContext"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.guideline.usageInstruction",
"path" : "DeviceDefinition.guideline.usageInstruction",
"short" : "Detailed written and visual directions for the user on how to use the device",
"definition" : "Detailed written and visual directions for the user on how to use the device.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.guideline.usageInstruction",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "markdown"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.guideline.relatedArtifact",
"path" : "DeviceDefinition.guideline.relatedArtifact",
"short" : "A source of information or reference for this guideline",
"definition" : "A source of information or reference for this guideline.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.guideline.relatedArtifact",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "RelatedArtifact"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.guideline.indication",
"path" : "DeviceDefinition.guideline.indication",
"short" : "A clinical condition for which the device was designed to be used",
"definition" : "A clinical condition for which the device was designed to be used.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.guideline.indication",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "CodeableReference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.guideline.contraindication",
"path" : "DeviceDefinition.guideline.contraindication",
"short" : "A specific situation when a device should not be used because it may cause harm",
"definition" : "A specific situation when a device should not be used because it may cause harm.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.guideline.contraindication",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "CodeableReference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.guideline.warning",
"path" : "DeviceDefinition.guideline.warning",
"short" : "Specific hazard alert information that a user needs to know before using the device",
"definition" : "Specific hazard alert information that a user needs to know before using the device.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.guideline.warning",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "CodeableReference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.guideline.intendedUse",
"path" : "DeviceDefinition.guideline.intendedUse",
"short" : "A description of the general purpose or medical use of the device or its function",
"definition" : "A description of the general purpose or medical use of the device or its function.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.guideline.intendedUse",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "string"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.correctiveAction",
"path" : "DeviceDefinition.correctiveAction",
"short" : "Tracking of latest field safety corrective action",
"definition" : "Tracking of latest field safety corrective action.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.correctiveAction",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.correctiveAction.id",
"path" : "DeviceDefinition.correctiveAction.id",
"representation" : ["xmlAttr"],
"short" : "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.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.correctiveAction.extension",
"path" : "DeviceDefinition.correctiveAction.extension",
"short" : "Additional content defined by implementations",
"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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.correctiveAction.modifierExtension",
"path" : "DeviceDefinition.correctiveAction.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "DeviceDefinition.correctiveAction.recall",
"path" : "DeviceDefinition.correctiveAction.recall",
"short" : "Whether the corrective action was a recall",
"definition" : "Whether the last corrective action known for this device was a recall.",
"comment" : "When a field safety action has been initiated but not yet resulted in a recall, this element will be set to 'false'.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.correctiveAction.recall",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "boolean"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.correctiveAction.scope",
"path" : "DeviceDefinition.correctiveAction.scope",
"short" : "model | lot-numbers | serial-numbers",
"definition" : "The scope of the corrective action - whether the action targeted all units of a given device model, or only a specific set of batches identified by lot numbers, or individually identified devices identified by the serial name.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.correctiveAction.scope",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "code"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "DeviceCorrectiveActionScope"
}],
"strength" : "required",
"description" : "The type or scope of the corrective action.",
"valueSet" : "http://hl7.org/fhir/ValueSet/device-correctiveactionscope|5.0.0-ballot"
}
},
{
"id" : "DeviceDefinition.correctiveAction.period",
"path" : "DeviceDefinition.correctiveAction.period",
"short" : "Start and end dates of the corrective action",
"definition" : "Start and end dates of the corrective action.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.correctiveAction.period",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "Period"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.chargeItem",
"path" : "DeviceDefinition.chargeItem",
"short" : "Billing code or reference associated with the device",
"definition" : "Billing code or reference associated with the device.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.chargeItem",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.chargeItem.id",
"path" : "DeviceDefinition.chargeItem.id",
"representation" : ["xmlAttr"],
"short" : "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.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.chargeItem.extension",
"path" : "DeviceDefinition.chargeItem.extension",
"short" : "Additional content defined by implementations",
"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.",
"comment" : "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.",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "DeviceDefinition.chargeItem.modifierExtension",
"path" : "DeviceDefinition.chargeItem.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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.",
"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](extensibility.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "DeviceDefinition.chargeItem.chargeItemCode",
"path" : "DeviceDefinition.chargeItem.chargeItemCode",
"short" : "The code or reference for the charge item",
"definition" : "The code or reference for the charge item.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.chargeItem.chargeItemCode",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "CodeableReference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/ChargeItemDefinition"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.chargeItem.count",
"path" : "DeviceDefinition.chargeItem.count",
"short" : "Coefficient applicable to the billing code",
"definition" : "Coefficient applicable to the billing code.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.chargeItem.count",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "Quantity"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.chargeItem.effectivePeriod",
"path" : "DeviceDefinition.chargeItem.effectivePeriod",
"short" : "A specific time period in which this charge item applies",
"definition" : "A specific time period in which this charge item applies.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "DeviceDefinition.chargeItem.effectivePeriod",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Period"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.chargeItem.useContext",
"path" : "DeviceDefinition.chargeItem.useContext",
"short" : "The context to which this charge item applies",
"definition" : "The context to which this charge item applies.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "DeviceDefinition.chargeItem.useContext",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "UsageContext"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
}]
},
"differential" : {
"element" : [{
"id" : "DeviceDefinition",
"path" : "DeviceDefinition",
"short" : "An instance of a medical-related component of a medical device",
"definition" : "The characteristics, operational status and capabilities of a medical-related component of a medical device.",
"comment" : "For the initial scope, this DeviceDefinition resource is only applicable to describe a single node in the containment tree that is produced by the context scanner in any medical device that implements or derives from the ISO/IEEE 11073 standard and that does not represent a metric. Examples for such a node are MDS, VMD, or Channel.",
"min" : 0,
"max" : "*",
"mustSupport" : false,
"isModifier" : false,
"mapping" : [{
"identity" : "w5",
"map" : "administrative.device"
}]
},
{
"id" : "DeviceDefinition.description",
"path" : "DeviceDefinition.description",
"short" : "Additional information to describe the device",
"definition" : "Additional information to describe the device.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "markdown"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.identifier",
"path" : "DeviceDefinition.identifier",
"short" : "Instance identifier",
"definition" : "Unique instance identifiers assigned to a device by the software, manufacturers, other organizations or owners. For example: handle ID. The identifier is typically valued if the udiDeviceIdentifier, partNumber or modelNumber is not valued and represents a different type of identifier. However, it is permissible to still include those identifiers in DeviceDefinition.identifier with the appropriate identifier.type.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Identifier"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.identifier"
}]
},
{
"id" : "DeviceDefinition.udiDeviceIdentifier",
"path" : "DeviceDefinition.udiDeviceIdentifier",
"short" : "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.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.udiDeviceIdentifier.deviceIdentifier",
"path" : "DeviceDefinition.udiDeviceIdentifier.deviceIdentifier",
"short" : "The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier",
"definition" : "The identifier that is to be associated with every Device that references this DeviceDefintiion for the issuer and jurisdiction provided in the DeviceDefinition.udiDeviceIdentifier.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "string"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.udiDeviceIdentifier.issuer",
"path" : "DeviceDefinition.udiDeviceIdentifier.issuer",
"short" : "The organization that assigns the identifier algorithm",
"definition" : "The organization that assigns the identifier algorithm.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "uri"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.udiDeviceIdentifier.jurisdiction",
"path" : "DeviceDefinition.udiDeviceIdentifier.jurisdiction",
"short" : "The jurisdiction to which the deviceIdentifier applies",
"definition" : "The jurisdiction to which the deviceIdentifier applies.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "uri"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution",
"path" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution",
"short" : "Indicates whether and when the device is available on the market",
"definition" : "Indicates where and when the device is available on the market.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod",
"path" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution.marketPeriod",
"short" : "Begin and end dates for the commercial distribution of the device",
"definition" : "Begin and end dates for the commercial distribution of the device.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "Period"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction",
"path" : "DeviceDefinition.udiDeviceIdentifier.marketDistribution.subJurisdiction",
"short" : "National state or territory where the device is commercialized",
"definition" : "National state or territory to which the marketDistribution recers, typically where the device is commercialized.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "uri"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.regulatoryIdentifier",
"path" : "DeviceDefinition.regulatoryIdentifier",
"short" : "Regulatory identifier(s) associated with this device",
"definition" : "Identifier associated with the regulatory documentation (certificates, technical documentation, post-market surveillance documentation and reports) of a set of device models sharing the same intended purpose, risk class and essential design and manufacturing characteristics. One example is the Basic UDI-DI in Europe.",
"comment" : "This should not be used for regulatory authorization numbers which are to be captured elsewhere.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.regulatoryIdentifier.type",
"path" : "DeviceDefinition.regulatoryIdentifier.type",
"short" : "basic | master | license",
"definition" : "The type of identifier itself.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "code"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "DeviceRegulatoryIdentifierType"
}],
"strength" : "required",
"description" : "Device regulatory identifier type.",
"valueSet" : "http://hl7.org/fhir/ValueSet/devicedefinition-regulatory-identifier-type|5.0.0-ballot"
}
},
{
"id" : "DeviceDefinition.regulatoryIdentifier.deviceIdentifier",
"path" : "DeviceDefinition.regulatoryIdentifier.deviceIdentifier",
"short" : "The identifier itself",
"definition" : "The identifier itself.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "string"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.regulatoryIdentifier.issuer",
"path" : "DeviceDefinition.regulatoryIdentifier.issuer",
"short" : "The organization that issued this identifier",
"definition" : "The organization that issued this identifier.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "uri"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.regulatoryIdentifier.jurisdiction",
"path" : "DeviceDefinition.regulatoryIdentifier.jurisdiction",
"short" : "The jurisdiction to which the deviceIdentifier applies",
"definition" : "The jurisdiction to which the deviceIdentifier applies.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "uri"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.partNumber",
"path" : "DeviceDefinition.partNumber",
"short" : "The part number or catalog number of the device",
"definition" : "The part number or catalog number of the device.",
"comment" : "Alphanumeric Maximum 20.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "string"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.what[x]"
},
{
"identity" : "rim",
"map" : ".playedRole[typeCode=MANU].id"
}]
},
{
"id" : "DeviceDefinition.manufacturer",
"path" : "DeviceDefinition.manufacturer",
"short" : "Name of device manufacturer",
"definition" : "A name of the manufacturer or legal representative e.g. labeler. Whether this is the actual manufacturer or the labeler or responsible depends on implementation and jurisdiction.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Organization"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.what[x]"
},
{
"identity" : "rim",
"map" : ".playedRole[typeCode=MANU].scoper.name"
}]
},
{
"id" : "DeviceDefinition.deviceName",
"path" : "DeviceDefinition.deviceName",
"short" : "The name or names of the device as given by the manufacturer",
"definition" : "The name or names of the device as given by the manufacturer.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.deviceName.name",
"path" : "DeviceDefinition.deviceName.name",
"short" : "A name that is used to refer to the device",
"definition" : "A human-friendly name that is used to refer to the device - depending on the type, it can be the brand name, the common name or alias, or other.",
"alias" : ["Σ"],
"min" : 1,
"max" : "1",
"type" : [{
"code" : "string"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.deviceName.type",
"path" : "DeviceDefinition.deviceName.type",
"short" : "registered-name | user-friendly-name | patient-reported-name",
"definition" : "The type of deviceName.\nRegisteredName | UserFriendlyName | PatientReportedName.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "code"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "DeviceNameType"
}],
"strength" : "required",
"description" : "The type of name the device is referred by.",
"valueSet" : "http://hl7.org/fhir/ValueSet/device-nametype|5.0.0-ballot"
},
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.what[x]"
},
{
"identity" : "rim",
"map" : ".playedRole[typeCode=MANU].code"
}]
},
{
"id" : "DeviceDefinition.modelNumber",
"path" : "DeviceDefinition.modelNumber",
"short" : "The catalog or model number for the device for example as defined by the manufacturer",
"definition" : "The model number for the device for example as defined by the manufacturer or labeler, or other agency.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "string"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.what[x]"
},
{
"identity" : "rim",
"map" : ".softwareName (included as part)"
}]
},
{
"id" : "DeviceDefinition.classification",
"path" : "DeviceDefinition.classification",
"short" : "What kind of device or device system this is",
"definition" : "What kind of device or device system this is.",
"comment" : "In this element various classifications can be used, such as GMDN, EMDN, SNOMED CT, risk classes, national product codes.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.classification.type",
"path" : "DeviceDefinition.classification.type",
"short" : "A classification or risk class of the device model",
"definition" : "A classification or risk class of the device model.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "DeviceKind"
}],
"strength" : "example",
"description" : "Type of device e.g. according to official classification.",
"valueSet" : "http://hl7.org/fhir/ValueSet/device-type"
}
},
{
"id" : "DeviceDefinition.classification.justification",
"path" : "DeviceDefinition.classification.justification",
"short" : "Further information qualifying this classification of the device model",
"definition" : "Further information qualifying this classification of the device model.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "RelatedArtifact"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.specialization",
"path" : "DeviceDefinition.specialization",
"short" : "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.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "RelatedArtifact"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.hasPart",
"path" : "DeviceDefinition.hasPart",
"short" : "A device, part of the current one",
"definition" : "A device that is part (for example a component) of the present device.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.hasPart.reference",
"path" : "DeviceDefinition.hasPart.reference",
"short" : "Reference to the part",
"definition" : "Reference to the device that is part of the current device.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/DeviceDefinition"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.hasPart.count",
"path" : "DeviceDefinition.hasPart.count",
"short" : "Number of occurrences of the part",
"definition" : "Number of instances of the component device in the current device.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "integer"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.packaging",
"path" : "DeviceDefinition.packaging",
"short" : "Information about the packaging of the device, i.e. how the device is packaged",
"definition" : "Information about the packaging of the device, i.e. how the device is packaged.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.packaging.identifier",
"path" : "DeviceDefinition.packaging.identifier",
"short" : "Business identifier of the packaged medication",
"definition" : "The business identifier of the packaged medication.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Identifier"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.packaging.type",
"path" : "DeviceDefinition.packaging.type",
"short" : "A code that defines the specific type of packaging",
"definition" : "A code that defines the specific type of packaging.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.packaging.count",
"path" : "DeviceDefinition.packaging.count",
"short" : "The number of items contained in the package (devices or sub-packages)",
"definition" : "The number of items contained in the package (devices or sub-packages).",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "integer"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.packaging.distributor",
"path" : "DeviceDefinition.packaging.distributor",
"short" : "An organization that distributes the packaged device",
"definition" : "An organization that distributes the packaged device.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.packaging.distributor.name",
"path" : "DeviceDefinition.packaging.distributor.name",
"short" : "Distributor's human-readable name",
"definition" : "Distributor's human-readable name.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "string"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.packaging.distributor.organizationReference",
"path" : "DeviceDefinition.packaging.distributor.organizationReference",
"short" : "Distributor as an Organization resource",
"definition" : "Distributor as an Organization resource.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Organization"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.packaging.udiDeviceIdentifier",
"path" : "DeviceDefinition.packaging.udiDeviceIdentifier",
"short" : "Unique Device Identifier (UDI) Barcode string on the packaging",
"definition" : "Unique Device Identifier (UDI) Barcode string on the packaging.",
"min" : 0,
"max" : "*",
"contentReference" : "#DeviceDefinition.udiDeviceIdentifier",
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.packaging.packaging",
"path" : "DeviceDefinition.packaging.packaging",
"short" : "Allows packages within packages",
"definition" : "Allows packages within packages.",
"min" : 0,
"max" : "*",
"contentReference" : "#DeviceDefinition.packaging",
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.version",
"path" : "DeviceDefinition.version",
"short" : "The version of the device or software",
"definition" : "The version of the device or software.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.version.type",
"path" : "DeviceDefinition.version.type",
"short" : "The type of the device version, e.g. manufacturer, approved, internal",
"definition" : "The type of the device version, e.g. manufacturer, approved, internal.",
"alias" : ["Σ"],
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.version.component",
"path" : "DeviceDefinition.version.component",
"short" : "The hardware or software module of the device to which the version applies",
"definition" : "The hardware or software module of the device to which the version applies.",
"comment" : "Note that the module of the device would not need to be tracked as a separate device, e.g., using different UDI, thus would typically involve one or more software modules. For example, a device may involve two software modules each on a different version.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Identifier"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.what[x]"
}]
},
{
"id" : "DeviceDefinition.version.value",
"path" : "DeviceDefinition.version.value",
"short" : "The version text",
"definition" : "The version text.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "string"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.safety",
"path" : "DeviceDefinition.safety",
"short" : "Safety characteristics of the device",
"definition" : "Safety characteristics of the device.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "Safety"
}],
"strength" : "example",
"valueSet" : "http://hl7.org/fhir/ValueSet/device-safety"
}
},
{
"id" : "DeviceDefinition.shelfLifeStorage",
"path" : "DeviceDefinition.shelfLifeStorage",
"short" : "Shelf Life and storage information",
"definition" : "Shelf Life and storage information.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "ProductShelfLife"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.languageCode",
"path" : "DeviceDefinition.languageCode",
"short" : "Language code for the human-readable text strings produced by the device (all supported)",
"definition" : "Language code for the human-readable text strings produced by the device (all supported).",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.property",
"path" : "DeviceDefinition.property",
"short" : "The potential, valid configuration settings of a device, e.g., regulation status, time properties",
"definition" : "The potential, valid configuration settings of a device, e.g., regulation status, time properties.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.property.type",
"path" : "DeviceDefinition.property.type",
"short" : "Code that specifies the property",
"definition" : "Code that specifies the property.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.property.value[x]",
"path" : "DeviceDefinition.property.value[x]",
"short" : "Property value - as a code or quantity",
"definition" : "Property value - the data type depends on the property type.",
"comment" : "The usage of CodeableConcept is for concepts that are normally coded but for which a code is not available - for example a device implant size that is not standardized. The property string is for text characteristics, e.g. long descriptions, warnings, etc.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "Quantity"
},
{
"code" : "CodeableConcept"
},
{
"code" : "string"
},
{
"code" : "boolean"
},
{
"code" : "integer"
},
{
"code" : "Range"
},
{
"code" : "Attachment"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.owner",
"path" : "DeviceDefinition.owner",
"short" : "Organization responsible for device",
"definition" : "An organization that is responsible for the provision and ongoing maintenance of the device.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Organization"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.source"
},
{
"identity" : "rim",
"map" : ".playedRole[typeCode=OWN].scoper"
}]
},
{
"id" : "DeviceDefinition.contact",
"path" : "DeviceDefinition.contact",
"short" : "Details for human/organization for support",
"definition" : "Contact details for an organization or a particular human that is responsible for the device.",
"comment" : "used for troubleshooting etc.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "ContactPoint"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.source"
},
{
"identity" : "rim",
"map" : ".scopedRole[typeCode=CON].player"
}]
},
{
"id" : "DeviceDefinition.link",
"path" : "DeviceDefinition.link",
"short" : "An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device",
"definition" : "An associated device, attached to, used with, communicating with or linking a previous or new device model to the focal device.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.link.relation",
"path" : "DeviceDefinition.link.relation",
"short" : "The type indicates the relationship of the related device to the device instance",
"definition" : "The type indicates the relationship of the related device to the device instance.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "Coding"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "DeviceDefinitionRelationType"
}],
"strength" : "extensible",
"description" : "The type of relation between this and the linked device.",
"valueSet" : "http://hl7.org/fhir/ValueSet/devicedefinition-relationtype"
}
},
{
"id" : "DeviceDefinition.link.relatedDevice",
"path" : "DeviceDefinition.link.relatedDevice",
"short" : "A reference to the linked device",
"definition" : "A reference to the linked device.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "CodeableReference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/DeviceDefinition"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.note",
"path" : "DeviceDefinition.note",
"short" : "Device notes and comments",
"definition" : "Descriptive information, usage information or implantation information that is not captured in an existing element.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Annotation"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : ".text"
}]
},
{
"id" : "DeviceDefinition.parentDevice",
"path" : "DeviceDefinition.parentDevice",
"short" : "The parent device it can be part of",
"definition" : "The parent device it can be part of.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/DeviceDefinition"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "DeviceDefinition.material",
"path" : "DeviceDefinition.material",
"short" : "A substance used to create the material(s) of which the device is made",
"definition" : "A substance used to create the material(s) of which the device is made.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.material.substance",
"path" : "DeviceDefinition.material.substance",
"short" : "A relevant substance that the device contains, may contain, or is made of",
"definition" : "A substance that the device contains, may contain, or is made of - for example latex - to be used to determine patient compatibility. This is not intended to represent the composition of the device, only the clinically relevant materials.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.material.alternate",
"path" : "DeviceDefinition.material.alternate",
"short" : "Indicates an alternative material of the device",
"definition" : "Indicates an alternative material of the device.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "boolean"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.material.allergenicIndicator",
"path" : "DeviceDefinition.material.allergenicIndicator",
"short" : "Whether the substance is a known or suspected allergen",
"definition" : "Whether the substance is a known or suspected allergen.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "boolean"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.productionIdentifierInUDI",
"path" : "DeviceDefinition.productionIdentifierInUDI",
"short" : "lot-number | manufactured-date | serial-number | expiration-date | biological-source | software-version",
"definition" : "Indicates the production identifier(s) that are expected to appear in the UDI carrier on the device label.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "code"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "DeviceProductionIdentifierInUDI"
}],
"strength" : "required",
"description" : "The production identifier(s) that are expected to appear in the UDI carrier.",
"valueSet" : "http://hl7.org/fhir/ValueSet/device-productidentifierinudi|5.0.0-ballot"
}
},
{
"id" : "DeviceDefinition.guideline",
"path" : "DeviceDefinition.guideline",
"short" : "Information aimed at providing directions for the usage of this model of device",
"definition" : "Information aimed at providing directions for the usage of this model of device.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.guideline.useContext",
"path" : "DeviceDefinition.guideline.useContext",
"short" : "The circumstances that form the setting for using the device",
"definition" : "The circumstances that form the setting for using the device.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "UsageContext"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.guideline.usageInstruction",
"path" : "DeviceDefinition.guideline.usageInstruction",
"short" : "Detailed written and visual directions for the user on how to use the device",
"definition" : "Detailed written and visual directions for the user on how to use the device.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "markdown"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.guideline.relatedArtifact",
"path" : "DeviceDefinition.guideline.relatedArtifact",
"short" : "A source of information or reference for this guideline",
"definition" : "A source of information or reference for this guideline.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "RelatedArtifact"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.guideline.indication",
"path" : "DeviceDefinition.guideline.indication",
"short" : "A clinical condition for which the device was designed to be used",
"definition" : "A clinical condition for which the device was designed to be used.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "CodeableReference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.guideline.contraindication",
"path" : "DeviceDefinition.guideline.contraindication",
"short" : "A specific situation when a device should not be used because it may cause harm",
"definition" : "A specific situation when a device should not be used because it may cause harm.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "CodeableReference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.guideline.warning",
"path" : "DeviceDefinition.guideline.warning",
"short" : "Specific hazard alert information that a user needs to know before using the device",
"definition" : "Specific hazard alert information that a user needs to know before using the device.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "CodeableReference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.guideline.intendedUse",
"path" : "DeviceDefinition.guideline.intendedUse",
"short" : "A description of the general purpose or medical use of the device or its function",
"definition" : "A description of the general purpose or medical use of the device or its function.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "string"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.correctiveAction",
"path" : "DeviceDefinition.correctiveAction",
"short" : "Tracking of latest field safety corrective action",
"definition" : "Tracking of latest field safety corrective action.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.correctiveAction.recall",
"path" : "DeviceDefinition.correctiveAction.recall",
"short" : "Whether the corrective action was a recall",
"definition" : "Whether the last corrective action known for this device was a recall.",
"comment" : "When a field safety action has been initiated but not yet resulted in a recall, this element will be set to 'false'.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "boolean"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.correctiveAction.scope",
"path" : "DeviceDefinition.correctiveAction.scope",
"short" : "model | lot-numbers | serial-numbers",
"definition" : "The scope of the corrective action - whether the action targeted all units of a given device model, or only a specific set of batches identified by lot numbers, or individually identified devices identified by the serial name.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "code"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "DeviceCorrectiveActionScope"
}],
"strength" : "required",
"description" : "The type or scope of the corrective action.",
"valueSet" : "http://hl7.org/fhir/ValueSet/device-correctiveactionscope|5.0.0-ballot"
}
},
{
"id" : "DeviceDefinition.correctiveAction.period",
"path" : "DeviceDefinition.correctiveAction.period",
"short" : "Start and end dates of the corrective action",
"definition" : "Start and end dates of the corrective action.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "Period"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.chargeItem",
"path" : "DeviceDefinition.chargeItem",
"short" : "Billing code or reference associated with the device",
"definition" : "Billing code or reference associated with the device.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.chargeItem.chargeItemCode",
"path" : "DeviceDefinition.chargeItem.chargeItemCode",
"short" : "The code or reference for the charge item",
"definition" : "The code or reference for the charge item.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "CodeableReference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/ChargeItemDefinition"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.chargeItem.count",
"path" : "DeviceDefinition.chargeItem.count",
"short" : "Coefficient applicable to the billing code",
"definition" : "Coefficient applicable to the billing code.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "Quantity"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.chargeItem.effectivePeriod",
"path" : "DeviceDefinition.chargeItem.effectivePeriod",
"short" : "A specific time period in which this charge item applies",
"definition" : "A specific time period in which this charge item applies.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Period"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "DeviceDefinition.chargeItem.useContext",
"path" : "DeviceDefinition.chargeItem.useContext",
"short" : "The context to which this charge item applies",
"definition" : "The context to which this charge item applies.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "UsageContext"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
}]
}
}
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.
FHIR ®© HL7.org 2011+. FHIR R5 Ballot hl7.fhir.core#5.0.0-ballot generated on Wed, Sep 7, 2022 11:08+1000.
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