Generated Narrative: StructureDefinition hddt-personal-health-device Name Flags Card. Type Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> Device <a style="padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;; padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;" href="http://hl7.org/fhir/R4/conformance-rules.html#constraints" title="This element has or is affected by constraints ( device-definition-reference-check-1 )">C 0..* Device Personal Health Device Constraints: device-definition-reference-check-1 #xD; definition 0..1 Reference(DeviceDefinition) Definition of the Personal health device #xD; status S 0..1 code active | inactive | entered-in-error | unknown #xD; expirationDate S 0..1 dateTime Date and time of expiry of this Personal health device (if applicable) #xD; serialNumber S 0..1 string Serial number of the Personal health device #xD; deviceName S 0..* BackboneElement Name of the Personal health device #xD; type 0..1 CodeableConcept The machine-readable type of the Personal health device Binding: Device Type of personal health devices (required) #xD; <img src="[binary]" alt="doco" style="background-color: inherit"/> Documentation for this format
This profile defines a Personal Health Device within the context of § 374a SGB V. A Personal Health Device acc. to this profile is any medical aid or implant that - is distributed to patients at the expense of the statutory health insurance and - transmits the data about the patient electronically to the device manufacturer or third parties, which make the data available to patients and/or physicians via publicly accessible networks. Personal Health Devices that fulfill the criteria of this regulation MUST be able to pass on data to authorized Digital Health Applications (DiGA acc. § 374a SGB V) using the protocols and interfaces as defined in the HDDT specification. This profile helps a device data consuming DiGA to - increase patient safety by comparing the serial number of a Personal Health Device as presented with this profile with the serial number the patient may have provided to the DiGA - increase data quality by getting information about the current status of the end-to-end communication flow from the Personal Health Device to the device backend and thus being able to detect if there may be more data available for the requested period - optimize its interactions with the device data providing resource server by getting access to the DeviceDefinition resource that holds static attributes about the device and its connected backend (e.g. minimum delay between data measurement and data availability) **Obligations and Conventions:** The Personal Health Device's backend regularely synchronizes with the device hardware through a gateway (_Personal Health Gateway_). The maximum delay that the concrete end-to-end synchronization from the Personal Health Device to the FHIR resource server imposes is provided by the BfArM _HIIS-VZ_ (Device Registry) per MIV through the static attribute `Delay-From-Real-Time`. If a resource server has not synchronized with the connected Personal Health Device for a time span longer than `Delay-From-Real-Time`(e.g. due to temporarely lost Bluetooth or internet connectivity), the `status` of the Device resource that represents the Personal Health Device MUST be set to `unknown`. **Constraints applied:** - `status` is set to _Must Support_ in order to allow a DiGA to detect missing data (e.g. due to connection issues) - `deviceName` and `serialNumber` are set to _Must Support_ to allow a validation of the source of device data by comparing this information with information printed on the Personal Health Device - `definition` is optional. If present it MUST refer to a DeviceDefinition resource in the BfARM HIIS VZ. This ensures that DiGA can only receive static product information which was registered by the vendor of the device. - `expirationDate` is set to _Must Support_ to allow a DiGA to be aware of regular sensor changes (e.g. for patient wearing a rtCGM)
A type of a manufactured device that is used in the provision of healthcare without being substantially changed through that activity. The device MUST be a medical aid or implant.
If the resource is contained in another resource, it SHALL NOT contain nested Resources
not(parent::f:contained and f:contained)
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 in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))
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()
not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))
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
Ensures that any device definition reference points to the HIIS domain.
definition.exists() implies definition.reference.contains('hiis.bfarm.de') or definition.resolve().identifier.where(system ='http://fhir.de/sid/gkv/hmnr').exists()
The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
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.
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.
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
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 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, and nor can they have their own independent transaction scope.
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.
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 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.
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.
Must have either extensions or value[x], not both
exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
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://hl7.org/fhir/R4/extensibility.html#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Unique instance identifiers assigned to a device by manufacturers other organizations or owners.
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 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.
Definition of the Personal health device
Reference to a DeviceDefinition resource of the HIIS that describes the technical and functional details of the Personal health device.
Unique Device Identifier (UDI) Barcode string
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.
UDI may identify an unique instance of a device, or it may only identify the type of the device. See [UDI mappings](http://hl7.org/fhir/R4/device-mappings.html#udi) for a complete mapping of UDI parts to Device.
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 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.
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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
The device identifier (DI) is a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
The device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
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-dI, 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.
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/fda-udi.
Allows a recipient of a UDI to know which database will contain the UDI-associated metadata.
The full UDI carrier of the Automatic Identification and Data Capture (AIDC) technology representation of the barcode string as printed on the packaging of the device - e.g., a barcode or RFID. Because of limitations on character sets in XML and the need to round-trip JSON data through XML, AIDC Formats *SHALL* be base64 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 of the barcode string 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.
A unique device identifier (UDI) on a device label in plain text
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 `status` values _active_ and _inactive_ refer to the ability of the Personal Health Device to record and share measured data. E.g. a real-time Continuous Glucose Monitoring device usually stops recording and sharing glucose values after 14 days of wear, even though the sensor is still alive for a longer time. After these 14 days, the `status` switches from _active_ to _inactive_. If a resource server has not synchronized with the connected Personal Health Device for a time span longer than stated in the static attribute `Delay-From-Real-Time`(e.g. due to temporarely lost Bluetooth or internet connectivity), the `status` of the Device resource that represents the Personal Health Device MUST be set to `unknown`. The device specific value of the static attribute `Delay-From-Real-Time` can be obtained through the device's DeviceDefinition resource.
allow a requesting party to detect missing data (e.g. due to connection issues)
This element is labelled 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
online | paused | standby | offline | not-ready | transduc-discon | hw-discon | off
Reason for the dtatus of the Device availability.
The availability status reason of the device.
The distinct identification string as required by regulation for a human cell, tissue, or cellular and tissue-based product.
For example, this applies to devices in the United States regulated under *Code of Federal Regulation 21CFR§1271.290(c)*.
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.
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”.
Date and time of expiry of this Personal health device (if applicable)
The date and time beyond which this Personal Health Device is no longer valid or should not be used (if applicable).
The expiration date signals the _end of communication_ (which is latest the devices _end of life_). E.g. a real-time Continuous Glucose Monitoring device usually stops recording and sharing glucose values after 14 days of wear, even though the sensor is still alive for a longer time. The `expirationDate` in this case is 14 days after the patient started the sensor.
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”.
Lot number assigned by the manufacturer.
Serial number of the Personal health device
The serial number that uniquely identifies the Personal Health Device instance.
The serial number MAY only be omitted if neither the Personal Health Device nor its manual and packaging hold the printed serial number and if the Personal Health Device does not provide an API for reading a unique number from the device hardware.
The name of the Personal health device as given by the manufacturer and listed in the _HIIS-VZ_ (BfARM Device Registry).
udi-label-name | user-friendly-name | patient-reported-name | manufacturer-name | model-name | other
The type of deviceName. UDILabelName | UserFriendlyName | PatientReportedName | ManufactureDeviceName | ModelName.
The type of name the device is referred by.
The machine-readable type of the Personal health device
The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication
The capabilities supported on a device, the standards to which the device conforms for a particular purpose, and used for the communication.
The standard that is used to operate and communicate
The standard that is used to operate and communicate.
The version of the standard that is used to operate and communicate
The version of the standard that is used to operate and communicate.
The actual design of the device or software version running on the device
The actual design of the device or software version running on the device.
A single component of the device version
A single component of the device version.
The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties
The actual configuration settings of a device as it actually operates, e.g., regulation status, time properties.
Code that specifies the property DeviceDefinitionPropetyCode (Extensible)
Code that specifies the property DeviceDefinitionPropetyCode (Extensible).
Property value as a code, e.g., NTP4 (synced to NTP)
Property value as a code, e.g., NTP4 (synced to NTP).
Patient information, If the device is affixed to a person.
If the device is implanted in a patient, then need to associate the device to the patient.
An organization that is responsible for the provision and ongoing maintenance of the device.
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.
A network address on which the device may be contacted directly.
If the device is running a FHIR server, the network address should be the Base URL from which a conformance statement may be retrieved.
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.