Generated Narrative: StructureDefinition PhgDevice Last updated: 2017-10-16 05:10:49-0400 Name Flags Card. Type Description & Constraints Device 0..* Device Item used in healthcare #xD; Slices for identifier 1..* Identifier Information that uniquely describes the personal health device Slice: Unordered, Open by value:type #xD; identifier:All Slices Content/Rules for all slices #xD; type 0..1 CodeableConcept The type of identifier Binding: MDC Device Identifier Types (<a href="http://hl7.org/fhir/6.0.0-ballot5/terminologies.html#extensible" title="To be conformant, the concept in this element SHALL be from the specified value set if any of the codes within the value set can apply to the concept being communicated. If the value set does not cover the concept (based on human review), alternate codings (or, data type allowing, text) may be included instead." class="binding">extensible): MDC Device Identifier Types #xD; identifier:systemIdIdentifier 0..1 Identifier System Id identifier #xD; type 1..1 CodeableConcept Required IEEE 11073-10206 System Id code system coding Required Pattern: At least the following #xD; coding 1..* Coding Code defined by a terminology system Fixed Value: (Complex) #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/ContinuaDeviceIdentifiers #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: SYSID #xD; system 1..1 uri EUI-64 system identifier Required Pattern: urn:oid:1.2.840.10004.1.1.1.0.0.1.0.0.1.2680 #xD; value 1..1 string System id value from System-Id attribute #xD; identifier:btmacAddressIdentifier 0..1 Identifier Bluetooth MAC Transport address identifier #xD; type 1..1 CodeableConcept Required Bluetooth MAC address code system coding Required Pattern: At least the following #xD; coding 1..* Coding Code defined by a terminology system Fixed Value: (Complex) #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/ContinuaDeviceIdentifiers #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: BTMAC #xD; system 1..1 uri The namespace for the identifier value Required Pattern: http://hl7.org/fhir/sid/eui-48/bluetooth #xD; value 1..1 string The value that is unique #xD; identifier:macAddressIdentifier 0..1 Identifier MAC Transport address identifier #xD; type 1..1 CodeableConcept Required Ethernet MAC address code system coding Required Pattern: At least the following #xD; coding 1..* Coding Code defined by a terminology system Fixed Value: (Complex) #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/ContinuaDeviceIdentifiers #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: ETHMAC #xD; system 1..1 uri The namespace for the identifier value Required Pattern: http://hl7.org/fhir/sid/eui-48/ethernet #xD; value 1..1 string The value that is unique #xD; type 1..* CodeableConcept Indicates the device is a PHG. #xD; Slices for coding 1..* Coding Code defined by a terminology system Slice: Unordered, Open by value:system #xD; coding:MDCType 1..1 Coding Required MDC code system entry #xD; system 1..1 uri Identifies IEEE 11073-10101 coding system Required Pattern: urn:iso:std:iso:11073:10101 #xD; code 1..1 code Indicates PHG Required Pattern: 531981 #xD; Slices for deviceVersion 1..* BackboneElement A PHG may report firmware, hardware, software, internal protocol, nomenclature and ACOM versions. Slice: Unordered, Open by value:type.coding #xD; deviceVersion:MDCType 1..* BackboneElement Required MDC device version type entry #xD; type #xD; coding 0..* Coding Code defined by a terminology system Binding: MDC Device Version Type codes (required) #xD; component 0..0 The hardware or software module of the device to which the version applies #xD; value 1..1 string The version #xD; Slices for conformsTo 1..* BackboneElement This element contains an entry for each supported specialization or a generic representation. Slice: Unordered, Open by value:specification.coding #xD; conformsTo:MDCType 1..* BackboneElement The specialization(s) supported by the PHG. #xD; specification 1..1 CodeableConcept The specialization standard supported by the PHG. #xD; coding 1..* Coding Code defined by a terminology system Binding: MDC Device Specialization codes (required) #xD; Slices for property 0..* BackboneElement Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc. Slice: Unordered, Open by value:type #xD; property:timeSyncProperty 0..1 BackboneElement Time synchronization method #xD; type 1..1 CodeableConcept Code that specifies the property being represented Required Pattern: At least the following #xD; coding 1..* Coding Code defined by a terminology system Fixed Value: (Complex) #xD; system 1..1 uri Identity of the terminology system Fixed Value: urn:iso:std:iso:11073:10101 #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: 68220 #xD; Slices for value[x] 1..1 Quantity, CodeableConcept, string, boolean, integer, Range, Attachment Value of the property Slice: Unordered, Open by type:$this #xD; Slices for value[x] Content/Rules for all slices #xD; value[x]:valueCodeableConcept 0..1 CodeableConcept Value of the property #xD; coding 1..* Coding Code defined by a terminology system Binding: MDC Time Synchronization Methods (<a href="http://hl7.org/fhir/6.0.0-ballot5/terminologies.html#extensible" title="To be conformant, the concept in this element SHALL be from the specified value set if any of the codes within the value set can apply to the concept being communicated. If the value set does not cover the concept (based on human review), alternate codings (or, data type allowing, text) may be included instead." class="binding">extensible) #xD; property:continuaCertPHDProperty 0..* BackboneElement Continua certified PHD interfaces (from IEEE 11073-20601) #xD; type 1..1 CodeableConcept Code that specifies the property being represented Required Pattern: At least the following #xD; coding 1..* Coding Code defined by a terminology system Fixed Value: (Complex) #xD; system 1..1 uri Identity of the terminology system Fixed Value: urn:iso:std:iso:11073:10101 #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: 532353 #xD; Slices for value[x] 1..1 Quantity, CodeableConcept, string, boolean, integer, Range, Attachment Value of the property Slice: Unordered, Open by type:$this #xD; Slices for value[x] Content/Rules for all slices #xD; value[x]:valueCodeableConcept 0..1 CodeableConcept Value of the property Binding: Continua PHD-PHG Device Interfaces ValueSet (<a href="http://hl7.org/fhir/6.0.0-ballot5/terminologies.html#extensible" title="To be conformant, the concept in this element SHALL be from the specified value set if any of the codes within the value set can apply to the concept being communicated. If the value set does not cover the concept (based on human review), alternate codings (or, data type allowing, text) may be included instead." class="binding">extensible) #xD; property:continuaCertPHGProperty 0..* BackboneElement Continua certified PHG interfaces #xD; type 1..1 CodeableConcept Code that specifies the property being represented Required Pattern: At least the following #xD; coding 1..* Coding Code defined by a terminology system Fixed Value: (Complex) #xD; system 1..1 uri Identity of the terminology system Fixed Value: urn:iso:std:iso:11073:10101 #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: 532355 #xD; Slices for value[x] 1..1 Quantity, CodeableConcept, string, boolean, integer, Range, Attachment Value of the property Slice: Unordered, Open by type:$this #xD; Slices for value[x] Content/Rules for all slices #xD; value[x]:valueCodeableConcept 0..1 CodeableConcept Value of the property Binding: Continua PHG-HFS Interfaces ValueSet (<a href="http://hl7.org/fhir/6.0.0-ballot5/terminologies.html#extensible" title="To be conformant, the concept in this element SHALL be from the specified value set if any of the codes within the value set can apply to the concept being communicated. If the value set does not cover the concept (based on human review), alternate codings (or, data type allowing, text) may be included instead." class="binding">extensible) #xD; property:clockBitProperty 0..* BackboneElement Boolean Properties reported by the Clock #xD; type 1..1 CodeableConcept Tells what the clock capability item is Binding: ANS1ToHL7 codes defined for Boolean Clock attributes (required) #xD; Slices for value[x] 1..1 Quantity, CodeableConcept, string, boolean, integer, Range, Attachment Value of the property Slice: Unordered, Open by type:$this #xD; Slices for value[x] Content/Rules for all slices #xD; value[x]:valueBoolean 0..1 boolean Value of the property #xD; property:isRegulatedProperty 0..1 BackboneElement Regulatory status of the PHG #xD; type 1..1 CodeableConcept Negated regulatory status of the PHG Required Pattern: At least the following #xD; coding 1..* Coding Code defined by a terminology system Fixed Value: (Complex) #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/ASN1ToHL7 #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: 532354.0 #xD; Slices for value[x] 1..1 boolean Value of the property Slice: Unordered, Open by type:$this #xD; Slices for value[x] Content/Rules for all slices #xD; value[x]:valueBoolean 1..1 boolean Value of the property #xD; property:clockResolutionProperty 0..1 BackboneElement Clock Resolution as reported #xD; type 1..1 CodeableConcept Tells what the clock resolution type is Binding: MDC Clock Resolution Types (required) #xD; Slices for value[x] 1..1 Quantity Value of the property Slice: Unordered, Open by type:$this #xD; Slices for value[x] Content/Rules for all slices #xD; value[x]:valueQuantity 1..1 Quantity Value of the property #xD; system 1..1 uri System that defines coded unit form Required Pattern: http://unitsofmeasure.org #xD; code 0..1 code Coded form of the unit Required Pattern: us #xD; property:timeSyncAccuracyProperty 0..1 BackboneElement Time Synchronization Accuracy #xD; type 1..1 CodeableConcept Tells what the time synchronization accuracy is Required Pattern: At least the following #xD; coding 1..* Coding Code defined by a terminology system Fixed Value: (Complex) #xD; system 1..1 uri Identity of the terminology system Fixed Value: urn:iso:std:iso:11073:10101 #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: 68221 #xD; Slices for value[x] 1..1 Quantity Value of the property Slice: Unordered, Open by type:$this #xD; Slices for value[x] Content/Rules for all slices #xD; value[x]:valueQuantity 1..1 Quantity Value of the property #xD; system 1..1 uri System that defines coded unit form Required Pattern: http://unitsofmeasure.org #xD; code 0..1 code Coded form of the unit Required Pattern: us #xD; parent 0..0 No reference to a parent device in PHG. PHGs are not part of a device hierarchy. #xD; Documentation for this format
Profile for the Device Resource for a PHG
This resource describes the primary features of the Personal Health Gateway (PHG). A PHG does not have any IEEE 11073-10206 Objects or attributes though it is required to have a system identifier. However, for the purposes of reporting the information about the PHG entity, it is treated as if it can provide system information, clock and power source information. For compliance with this IG, the quantities that are required to be reported are the system identifier, the time synchronization method, the manufacturer and model number (of the software, not necessarily the hardware on which the application resides), and the PCHA certified interfaces.
ISO/IEEE 11073-10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication
ISO/IEEE 11073-10206: Personal health device communication--Abstract content information model
ISO/IEEE 11073-10201: Domain Information Model
The characteristics, operational status and capabilities of the PHG.
only one Device.name.display SHALL be true when there is more than one Device.name
If the resource is contained in another resource, it SHALL NOT contain nested Resources
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
contained.where((('#'+id.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()
If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
If a resource is contained in another resource, it SHALL NOT have a security label
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.
A resource should have narrative for robust management
The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
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 resource id depends on the given use case.
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.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
A set of rules under which this content was created
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. For DomainResources, if more than one implicitRules policy applies, additional policies may be conveyed using the [additionalImplicitRules](https://build.fhir.org/ig/HL7/fhir-extensions/StructureDefinition-additionalImplicitRules.html) extension.
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 its narrative along with other profiles, value sets, etc.
This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
The base language in which the resource is written.
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).
Text summary of the resource, for human interpretation
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.
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.
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.
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. Contained resources may be a resource type defined in the FHIR specification, or an [additional resource](http://build.fhir.org/resource.html#additional).
Extensions are always sliced by (at least) url
Additional content defined by implementations
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 managable, 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.
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.
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 managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
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](http://build.fhir.org/extensibility.html#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Information that uniquely describes the personal health device
An assigned unique identification of the device that is semantically meaningful outside of the FHIR resource context. An example would be the IEEE EUI-64 System-Id or transport address.
Certain attributes, like serial number and UDI Carrier (the HRF or AIDC barcode string) are not device instance identifiers as they are not consistently able to uniquely identify the instance of a device, thus are not appropriate to be used to value Device.identifier. The barcode string from a barcode present on a device label or package may identify the instance, include names given to the device in local usage, or may identify the type of device. If the identifier identifies the type of device, Device.type element should be used. The identifier is typically valued if the serialNumber or lotNumber 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.
11073-10206 System id, transport address, etc.
system = urn:oid value = DIS System ID characteristic value (8 octets hexadecimal string)
The serial number which is a component of the production identifier (PI), a conditional, variable portion of a UDI. The identifier.type code should be set to “SNO”(Serial Number) and the system left empty.
system = .../ProductionSpecification/ComponentId/Root value = .../ProductionSpecification/ComponentId/Extension
system = IEEE EUI-64 or similar value = SystemInfo.system-identifier
system = IEEE EUI-64 or a local system value = VMS::System-Id, MDS::Soft-ID
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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 managable, 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.
usual | official | temp | secondary | old (If known)
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Identifies the purpose for this identifier, if known .
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.
Allows users to make use of identifiers when the identifier system is not known.
Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.
Identifier.system is always case sensitive. The FHIR specification, terminology.hl7.org and HL7 affiliates (for identifiers specific to their jurisdiction) define identifier systems that SHALL be used for certain types of identifiers. Specific rules can be found [here](http://build.fhir.org/identifier-registry.html).
There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [Rendered Value](https://build.fhir.org/ig/HL7/fhir-extensions/StructureDefinition-rendered-value.html)). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processor to be confident that non-case-sensitive processing is safe.
II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
Time period when id is/was valid for use
Time period during which identifier is/was valid for use.
Role.effectiveTime or implied by context
Organization that issued id (may be just text)
Organization that issued/manages the identifier.
The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.
II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
Required IEEE 11073-10206 System Id code system coding
System id value from System-Id attribute
The System id from the System-Id attribute as an 8-byte HEX string where each byte is separated by dashes, for example FE-ED-AB-EE-DE-AD-77-C3.
The formatting is specified in the IEEE RA Guidelines for use of EUIs.
Bluetooth MAC Transport address identifier
This entry contains the Bluetooth MAC transport address.
Required Bluetooth MAC address code system coding
The Bluetooth MAC as an EUI-48 such as 00-E5-DE-AD-77-C3.
Transport addresses are supposed to be unique for a given device.
This entry contains the MAC transport address.
Required Ethernet MAC address code system coding
The MAC as an EUI-48 such as 00-E5-DE-AD-77-C8.
The reference to the definition for the device
The reference to the definition for the device.
Unique Device Identifier (UDI) placed on a device label or package. Note that the Device may include multiple UDIs if it is sold in multiple jurisdictions.
UDI may identify an unique instance of a device, or it may only identify the type of the device. See [UDI mappings](http://build.fhir.org/device-mappings.html#udi) for a complete mapping of UDI parts to Device.
All FHIR elements must have a @value or children or both
DIS UDI for Medical Devices characteristic value fields - See Bluetooth GATT Specification Supplement (https://www.bluetooth.com/specifications/gss/) for details)
Extensions that cannot be ignored even if unrecognized
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 managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
The device identifier (UDI-DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device. The UDI-DI portion is placed on a device label or package. Note that the DeviceDefinition may include multiple UDI-DIs if it is sold in multiple jurisdictions.
Device Identifier field from DIS UDI for Medical Devices characteristic
The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
The namespace for the device identifier value
Establishes the namespace for the issuing agency's system (e.g, GS1's GTIN, ICCBBA's ISBT-128) used to create the device identifier.
Organization that is charged with issuing UDIs for devices. For example, the US FDA issuers include: 1) GS1: http://hl7.org/fhir/NamingSystem/gs1-di, 2) HIBCC: http://hl7.org/fhir/NamingSystem/hibcc-diI, 3) ICCBBA for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood-di, 4) ICCBA for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other-di # Informationsstelle für Arzneispezialitäten (IFA GmbH) (EU only): http://hl7.org/fhir/NamingSystem/ifa-gmbh-di.
Issuer field from DIS UDI for Medical Devices characteristic
All UDIs are to be issued under a system operated by an Jurisdiction-accredited issuing agency. GS1 DIs: http://hl7.org/fhir/NamingSystem/gs1 HIBCC DIs: http://hl7.org/fhir/NamingSystem/hibcc ICCBBA DIs for blood containers: http://hl7.org/fhir/NamingSystem/iccbba-blood ICCBA DIs for other devices: http://hl7.org/fhir/NamingSystem/iccbba-other
The identity of the authoritative source for UDI generation within a jurisdiction. All UDIs are globally unique within a single namespace with the appropriate repository uri as the system. For example, UDIs of devices managed in the U.S. by the FDA, the value is http://hl7.org/fhir/NamingSystem/us-fda-udi or in the European Union by the European Commission http://hl7.org/fhir/NamingSystem/eu-ec-udi.
Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.
Authority field from DIS UDI for Medical Devices characteristic
The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation as printed on the packaging of the device - e.g., a barcode , 2D Matrix, or RFID. Some AIDC representations contain non-printable characters and cannot be represented in a string format. For this reason, AIDC format SHALL be base64Binary encoded.
The AIDC form of UDIs should be scanned or otherwise used for the identification of the device whenever possible to minimize errors in records resulting from manual transcriptions. If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.
Automatic Identification and Data Capture
A unique device identifier (UDI) on a device label a form that uses automatic identification and data capture (AIDC) technology.
The full UDI carrier as the human readable form (HRF) representation as printed on the packaging of the device.
If separate barcodes for DI and PI are present, concatenate the string with DI first and in order of human readable expression on label.
Label field from DIS UDI for Medical Devices characteristic
A unique device identifier (UDI) on a device label in plain text
barcode | rfid | manual | card | self-reported | electronic-transmission | unknown
A coded entry to indicate how the data was entered.
Supports a way to distinguish hand entered from machine read data.
Codes to identify how UDI data was entered.
active | inactive | entered-in-error | unknown
The Device record status. This is not the status of the device like availability.
This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
The availability status reason of the device.
A production identifier of the donor, donation, or pooling event associated with the biological material incorporated into the device
A production identifier of the donor, donation, or pooling event associated with the biological material incorporated into the device.
Necessary to support mandatory requirements for traceability from donor/source to recipient and vice versa, while also satisfying donor anonymity requirements. The element is defined consistently across BiologicallyDerivedProduct, NutritionProduct, and Device. The identifier references an event that links to a single biological entity such as a blood donor, or to multiple biological entities (e.g. when the product is an embryo or a pooled platelet product). A single biologicalSourceEvent identifier may appear on multiple products of many types derived from a single donation event or source extraction. As an example, a single donation event may provide 2 kidneys and a liver for organ transplantation, 2 corneas for eye surgery, heart valves and arterial tissue for cardiovascular surgery, multiple skin grafts, tendons, multiple shaped bone grafts and a large number of bone putty/paste products; and each of them may be assigned to the same biological source event identifier.
A distinct identification code required by §1271.290(c), the product contains or consists of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient as defined under 21 CFR 1271.3. This may also be known as the donation identification number (DIN) or a value to trace the product's origin.
A name of the manufacturer or entity legally responsible for the device.
DIS Manufacturer Name String characteristic value
VMS::System-Model::manufacturer, VMD::Vmd-Model::manufacturer
A production identifier that indicates the date when the device was made
The date and time when the device was manufactured.
The date a specific device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
A production identifier that indicates the date and time of expiry of this device (if applicable)
The date and time beyond which this device is no longer valid or should not be used (if applicable).
the expiration date of a specific device - which is a component of the production identifier (PI), a conditional, variable portion of a UDI. For FHIR, The datetime syntax must converted to YYYY-MM-DD[THH:MM:SS]. If hour is present, the minutes and seconds should both be set to “00”.
A production identifier that indicates the Lot number of manufacture
Lot number assigned by the manufacturer.
The lot or batch number within which a device was manufactured - which is a component of the production identifier (PI), a conditional, variable portion of a UDI.
A production identifier that indicates the Serial number assigned by the manufacturer
The serial number assigned by the organization when the device was manufactured.
Alphanumeric Maximum 20. While a serial number is a type of identifier, in the context of devices for which a UDI is required, thus a serial number may be part of the production identifier, it is more informative to have the serial number as a dedicated attribute together with the other UDI production identifier. When the device is not subject to including the UDI (e.g., its presence and exchange is not mandated by local regulatory requirements or specific use case at hand), thus the concept of production identifiers is not relevant as a set, it remains helpful for consistency to still use Device.serialNumber rather than using Device.identifier with an appropriate type. Systems that do not realize an identifier is a serial number may place it in Device.identifier or if the identifier.system is known for the serial number, it may also be populated in the Device.identifier as a globally unique id_.
DIS Serial Number String characteristic value
The name or names of the device as known to the manufacturer and/or patient
This represents the manufacturer's name of the device as provided by the device, from a UDI label, or by a person describing the Device. This typically would be used when a person provides the name(s) or when the device represents one of the names available from DeviceDefinition.
The actual name that identifies the device.
registered-name | user-friendly-name | patient-reported-name
Indicates the kind of name. RegisteredName | UserFriendlyName | PatientReportedName.
The implementation or jurisdiction must clarify which name is to be used as the registered-name. As a result a device definition may have multiple names that are the same, but then used for different purposes per the name type and jurisdictional guidance.
The type of name the device is referred by.
Indicates the default or preferred name to be displayed.
The manufacturer's model number for the device
The manufacturer's model number for the device.
DIS Model Number String characteristic value
modelNumber = MdsDescriptor/MetaData/ModelNumber name = MdsDescriptor/MetaData/ModelName
VMS::System-Model::model-number, VMD::Vmd-Model::model-number
The part number or catalog number of the device
The part number or catalog number of the device.
Indicates a high-level grouping of the device
Devices may be associated with one or more categories.
The kind or type of device. A device instance may have more than one type - in which case those are the types that apply to the specific instance of the device.
Multiple device types are use when a device is categorized in more than one context – for example, hybrid devices in which the device is both of type gateway and sensor. Device.type relates DeviceDefinition.classification.type using the same binding enabling referencing.
text = Appearance Value name or Primary Service name coding = Appearance Value or Primary Service UUID
MdsDescriptor/Type, MdsDescriptor/Vmd/Type, MdsDescriptor/Vmd/Channel/Type
MDC_MOC_VMS_MDS_SIMP (fixed value for PHD)
type = VMO::Type, VMS::System-Type type.text = VMO::Label-String
A reference to a code defined by a terminology system.
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Allows for alternative encodings within a code system, and translations to other code systems.
fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
Identifies IEEE 11073-10101 coding system
This value identifies the IEEE 11073-10101 coding system
The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.
Need to be unambiguous about the source of the definition of the symbol.
fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.
Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.
fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
MDC code indicating that this unit is a personal health gateway (PHG).
Need to refer to a particular code in the system.
fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
A representation of the meaning of the code in the system, following the rules of the system.
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
C*E.2 - but note this is not well followed
fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
If this coding was chosen directly by the user
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.
This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.
fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
Plain text representation of the concept
A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
Very often the text is the same as a displayName of one of the codings.
The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
C*E.9. But note many systems use C*E.2 for this
fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
A PHG may report firmware, hardware, software, internal protocol, nomenclature and ACOM versions.
The actual design of the device or software version running on the device.
There are several versions that may be reported by a PHG. PHGs compliant to this IG report at least one of these versions. A separate version entry is needed for each of the versions reported by the PHG.
The type of the device version, e.g. manufacturer, approved, internal
The type of the device version, e.g. manufacturer, approved, internal.
The type of version indicated for the device.
MDC code for a version (MDC_ID_PROD_SPEC_FW, MDC_ID_PROD_SPEC_HW, MDC_ID_PROD_SPEC_SW)
VMS::Production-Specification[spec-type=xx-revision]::spec-type (with xx replaced by hw, sw or fw)
The hardware or software module of the device to which the version applies
The hardware or software module of the device to which the version applies.
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.
VMS::Production-Specification[spec-type=xx-revision]::component-id (with xx replaced by hw, sw or fw)
The date the version was installed on the device
The date the version was installed on the device.
DIS Firmware Revision characteristic value or DIS Hardware Revision characteristic value or DIS Software Revision characteristic value
SystemInfo.firmware-, hardware-, software-revision
VMS::Production-Specification[spec-type=xx-revision]::prod-spec (with xx replaced by hw, sw or fw)
The combination of type and component SHOULD be unique across all repetitions of version.
This element contains an entry for each supported specialization or a generic representation.
Identifies the standards, specifications, or formal guidances for the capabilities supported by the device. The device may be certified as conformant to these specifications e.g., communication, performance, process, measurement, or specialization standards.
Describes the common type of the standard, specification, or formal guidance. communication | performance | measurement
Describes the type of the standard, specification, or formal guidance.
The kind of standards used by the device.
Identifies the standard, specification, or formal guidance that the device adheres to
Code that identifies the specific standard, specification, protocol, formal guidance, regulation, legislation, or certification scheme to which the device adheres.
Specific form or variant of the standard
Identifies the specific form or variant of the standard, specification, or formal guidance. This may be a 'version number', release, document edition, publication year, or other label.
The specialization(s) supported by the PHG.
The specialization(s) supported by the PHG. This element contains an entry for each supported specialization.
The specialization standard supported by the PHG.
Inherent, essentially fixed, characteristics of the device. e.g., time properties, size, material, etc.
Static or essentially fixed characteristics or features of the device (e.g., time or timing attributes, resolution, accuracy, intended use or instructions for use, and physical attributes) that are not otherwise captured in more specific attributes.
Dynamic or current properties, such as settings, of an individual device are described using a Device instance-specific [DeviceMetric] and recorded using [Observation]. Static characteristics of a device could also be documented in an associated [DeviceDefinition] instance. The Device instance's properties, and their values, could be, but need not be, the same as those described in an associated DeviceDefinition.
MdsDescriptor/Clock/TimeProtocol, MdsDescriptor/Clock/Type
Code that specifies the property being represented
Code that specifies the property, such as resolution, color, size, being represented.
The value of the property specified by the associated property.type code.
The text element in CodeableConcept.text is used for properties which would usually be coded (such as the size of an implant, or a security classification) but for which there is not currently an appropriate concept in the vocabulary (e.g. a custom implant size, or a security classification which depends on configuration). Otherwise the string choice type is used for descriptive properties, or instructions.
This element represents the time synchronization method used by the PHG. It is an MDC coded value.
This element reflects the time synchronization method used to set the PHG's clock.
Continua certified PHD interfaces (from IEEE 11073-20601)
This element represents a Continua certified PHD interface that is supported by the PHG. It is an MDC coded value.
This element represents a Continua certified PHG to HFS interface that is supported by the PHG. It is an MDC coded value.
Boolean Properties reported by the Clock
For each Boolean clock capability reported a `property` element is used.
One of the capabilities of the clock as reported.
The value of the clock capability item as reported by the PHG.
This element represents the regulatory status of the PHG.
This element represents the negated regulatory status of the PHG.
If true, the device is not regulated. If false, the device is regulated.
The resolution of the clock as reported.
The value. All the time fields are scaled to microseconds
Numerical value (with implicit precision)
The value of the measured amount. The value includes an implicit precision in the presentation of the value.
The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).
Precision is handled implicitly in almost all cases of measurement.
PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value
< | <= | >= | > | ~ | ad - how to understand the value
How the value should be understood and represented - whether the actual value is greater than, less than, or approximately equal to the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.
Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.
If there is no comparator, then there is no modification of the value
This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
How the Quantity should be understood and represented.
There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.
The identification of the system that provides the coded form of the unit.
Need to know the system that defines the coded form of the unit.
CO.codeSystem, PQ.translation.codeSystem
The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.
Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.
PQ.code, MO.currency, PQ.translation.code
The time synchronization accuracy in microseconds.
Tells what the time synchronization accuracy is
The time synchronization accuracy of the clock.
Material added to a container device (typically used in specimen collection or initial processing). The material may be added by the device manufacturer or by a different party subsequent to manufacturing.
A Procedure can be used to document details of the addition of a substance to the device.
The type of the substance added to the container. This is represented as a concept from a code system or described in a Substance or SubstanceDefinition resource.
Quantity of additive substance within container
The quantity of the additive substance in the container; may be volume, dimensions, or other appropriate measurements, depending on the container and additive substance type.
Details for human/organization for support
Contact details for an organization or a particular human that is responsible for the device.
The place where the device can be found.
Device.location can be used to track device location.
Descriptive information, usage information or implantation information that is not captured in an existing element.
Provides additional safety characteristics about a medical device. For example devices containing latex.
No reference to a parent device in PHG. PHGs are not part of a device hierarchy.
The higher level or encompassing device that this device is a logical part of.
For example a vital signs monitor (parent) where three separate modules can be plugged into such as interchangeable blood pressure, oximeter, temperature modules. These modules are represented as devices with the .parent valued to the vital signs monitor when plugged in.