Generated Narrative: StructureDefinition hddt-sensor-type-and-calibration-status Name Flags Card. Type Description & Constraints DeviceMetric 0..* DeviceMetric Configuration or setting capability of a personal health device #xD; unit 0..1 CodeableConcept UCUM code of the unit of the measurement as it is used when presenting data to the patient Binding: UCUMCodes (required): For HDDT only codes from UCUM MUST be used for coding units of measurements #xD; source 1..1 Reference(Device – Personal Health Device) Reference to the Personal Health Device holding the sensor #xD; operationalStatus 0..1 code on | off | standby | entered-in-error #xD; calibration S 0..* BackboneElement Describes the calibrations that have been performed or that are required to be performed #xD; state 1..1 code not-calibrated | calibration-required | calibrated | unspecified #xD; <a href="StructureDefinition-hddt-sensor-type-and-calibration-status-definitions.html#DeviceMetric.calibration.time" title="The time when the last calibration has been performed. This element covers both manual calibration performed #xA;by the patient and automated calibration performed by the device itself. E.g. with a self-calibrating rtCGM `calibration.time`#xA;signals the time when the device started sending calibrated values after the initial calibration phase. #xA;#xA;If the sensor does not require calibration, this element MAY be omitted. ">time S 0..1 instant Time when the last calibration has been performed #xD; Documentation for this format
DeviceMetric – Sensor Type and Calibration Status
The HddtSensorTypeAndCalibrationStatus profile captures the calibration status of a sensor which is part of a Personal Health Device. Personal Health Devices need to be calibrated in order to provide safe measurements. Some devices are already calibrated by the manufacturer while others calibrate themselves after activation and others need to be calibrated by the patient. If a Personal Health Device transmits data from a non calibrated sensor to the resource server at all depends on the concrete product. For a DiGA as a device data consumer to process device data in a safe manner, it must be transparent if the data it received was measured by a calibrated sensor or not. For devices where the sensor that measured a value requires automated or manual calibration, the Observation capturing this value MUST refer to a HddtSensorTypeAndCalibrationStatus resource through its `Observation.device` element. The HddtSensorTypeAndCalibrationStatus implements a FHIR [DeviceMetric](https://hl7.org/fhir/R4/devicemetric.html) resource which holds calibration information in a `calibration.type`, a `calibration.state` and a `calibration.date` element. In addition the HddtSensorTypeAndCalibrationStatus can provide a definition of the `unit` that is preferrably to be used for presenting measured values to the patient. The HddtSensorTypeAndCalibrationStatus of a measurement MUST always refer to a HddTPersonalHealthDevice [Device](https://hl7.org/fhir/R4/device.html) resource that represents the Personal Health Device that contains the sensor. This is a many-to-one relationship which allows for a Personal Health Device to contain multiple sensors for different measured values. E.g. by this a pulse oximeter as a HDDT Personal Health Device can provide _pulse_ and _SPO2_ as two different interoperable values with each of this values being linked with a dedicated HddtSensorTypeAndCalibrationStatus resource. **Obligations and Conventions:** DiGA as device data consumers SHOULD NOT rely on the `DeviceMetric.operationalStatus` of a sensor as this status does only reflect the status of the sensor and does not provide information about the end-to-end status of the flow of device data from the sensor within the Personal Health Device to the resource server in the device backend. Instead DiGA SHOULD process the `Device.status` information that can be obtained through the `DeviceMetric.source` reference. This element considers the end-to-end availability of data and therefore is the only source for information about potentially missing data (e.g. due to temporal problems with the bluetooth or internet connection). **Constraints applied:** - `unit` is restricted to UCUM. - `source` is constrained as a mandatory element in order to enable a DiGA to obtain dynamic and static device attributes through this reference - `calibration` is set to _Must Support_. This element and respective status information MUST be provided if the sensor performs automated or requires manual calibration after the device has been put into operation with the patient (`Device.status`is `active`).
Configuration or setting capability of a personal health device
Describes the sensor type and calibration status of a sensor within a Personal Health Device as a DeviceMetric.
For the initial scope, this DeviceMetric resource is only applicable to describe a single metric 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.
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
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 the device or gateway software, manufacturers, other organizations or owners. For example: handle ID.
For identifiers assigned to a device by the device or gateway software, the `system` element of the identifier should be set to the unique identifier of the device.
Identity of metric, for example Heart Rate or PEEP Setting
Describes the type of the metric. For example: Heart Rate, PEEP Setting, etc.
DeviceMetric.type can be referred to either IEEE 11073-10101 or LOINC.
UCUM code of the unit of the measurement as it is used when presenting data to the patient
The unit in which the Personal Health Device presents its measurement values to the patient.
This element holds the unit of measurement that is preferrably to be used for presenting measured values to the patient. This unit MAY differ from the unit that is used with the `Observation.value[x]` of measured data. _Example_: A rtCGM sensor measures glucose values as mg/dl. All data is stored in the health record in this unit. The resource server provides the data only using mg/dl as the unit. At the mobile app that came with the rtCGM (the rtCGM’s Personal Health Gateway) the patient configured the preferred unit as mmol/l. Therefore all data is calculated (by the device or the app) to mmol/l before displaying it to the patient. In this example the unit of `Observation.value[x]` is mg/dl while `DeviceMetric.unit` is mmol/l. The motivation for this behaviour is to allow the DiGA to obtain information about the patient’s preference and thus to be in sync with the medical aid by displaying measured values in the same unit.
allow a DiGA to detect the unit the patient is used to
For HDDT only codes from UCUM MUST be used for coding units of measurements
Reference to the Personal Health Device holding the sensor
Points to the specific Device resource that holds the sensor for which the documented calibration status applies.
Describes the link to the Device that this DeviceMetric belongs to and that provide information about the location of this DeviceMetric in the containment structure of the parent Device. An example would be a Device that represents a Channel. This reference can be used by a client application to distinguish DeviceMetrics that have the same type, but should be interpreted based on their containment location.
Indicates current operational state of the device. For example: On, Off, Standby, etc.
DiGA as device data consumers SHOULD NOT rely on the `operationalStatus` of a sensor as this status does only reflect the status of the sensor and does not provide information about the end-to-end status of the flow of device data from the sensor within the Personal Health device to the resource server in the device backend. Instead DiGA SHOILD process the `Device.status` information that can be obtained through the `DeviceMetric.source` reference. This element considers the end-to-end availability of data and therefore is the only source for information about potentially missing data (e.g. due to temporal problems with the bluetooth or internet connection).
Describes the operational status of the DeviceMetric.
black | red | green | yellow | blue | magenta | cyan | white
Describes the color representation for the metric. This is often used to aid clinicians to track and identify parameter types by color. In practice, consider a Patient Monitor that has ECG/HR and Pleth for example; the parameters are displayed in different characteristic colors, such as HR-blue, BP-green, and PR and SpO2- magenta.
Describes the typical color of representation.
measurement | setting | calculation | unspecified
Indicates the category of the observation generation process. A DeviceMetric can be for example a setting, measurement, or calculation.
Describes the measurement repetition time
Describes the measurement repetition time. This is not necessarily the same as the update period. The measurement repetition time can range from milliseconds up to hours. An example for a measurement repetition time in the range of milliseconds is the sampling rate of an ECG. An example for a measurement repetition time in the range of hours is a NIBP that is triggered automatically every hour. The update period may be different than the measurement repetition time, if the device does not update the published observed value with the same frequency as it was measured.
Describes the calibrations that have been performed or that are required to be performed
Describes the calibrations that have been performed or that are required to be performed.
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
Describes the type of the calibration method.
Describes the type of a metric calibration.
not-calibrated | calibration-required | calibrated | unspecified
Describes the state of a metric calibration.
Time when the last calibration has been performed
The time when the last calibration has been performed. This element covers both manual calibration performed by the patient and automated calibration performed by the device itself. E.g. with a self-calibrating rtCGM `calibration.time` signals the time when the device started sending calibrated values after the initial calibration phase. If the sensor does not require calibration, this element MAY be omitted.