A record of a device being used by a patient where the record is the result of a report from the patient or another clinician.

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.

Optional Extension Element - found in all resources.

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

The health professional involved in the indication for use of the medical device implant.

Each occurrence of the zib HealthProfessional is normally represented by two FHIR resources: a PractitionerRole resource (instance of nl-core-HealthProfessional-PractitionerRole) and a Practitioner resource (instance of nl-core-HealthProfessional-Practitioner). The Practitioner resource is referenced from the PractitionerRole instance. For this reason, sending systems should fill the reference to the PractitionerRole instance here, and not the Practitioner resource. Receiving systems can then retrieve the reference to the Practitioner resource from that PractitionerRole instance.

In rare circumstances, there is only a Practitioner instance, in which case it is that instance which will be referenced here. However, since this should be the exception, the nl-core-HealthProfessional-Practitioner profile is not explicitly mentioned as a target profile.

Optional Extension Element - found in all resources.

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

The healthcare provider at which use of the medical device was initiated or where the aid was implanted.

Please note that this zib concept (Location::HealthcareProvider) is also mapped on the Procedure.location element in profile nl-core-Procedure-event. The reason for this is that this zib concept aligns with the Location::HealthcareProvider concept in zib Procedure (NL-CM:14.1.5), but only for the situation that the Procedure is about placing the implant which is described using this instance of zib MedicalDevice. In this situation, the current extension is redundant and it is advised to only use Procedure.location in profile nl-core-Procedure-event to represent the Location concept.

Indicates that the resource is related to either the measurement, achievement or progress towards the referenced goal. For example, a Procedure to exercise pertainsToGoal of losing weight.

This extension is limited to subject-specific activity-related resources (events & intents). I.e. This can't be put on Goal or Patient. This association isn't for the purpose of goal management, but for things such as noting that a particular observation result, prescription or other activity is pertinent to the achievement (or possibly non-achievement) of the referenced goal.

An Extension

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Zib TreatmentObjective (represented by the Goal resource in FHIR) can use the data model of zib FunctionalOrMentalStatus to describe the desired treatment objective, which in turn may refer zib MedicalDevice to indicate the intent to use that device for reaching the treatment objective.

In FHIR, the modeling deviates somewhat from this approach:

• Both zib TreatmentObjective and the desired zib FunctionalOrMentalStatus are represented using the nl-core-TreatmentObjective profile on the Goal resource.
• The reference from TreatmentObjective::FunctionalOrMentalStatus::MedicalDevice is in the opposite direction, to the Goal resource.

This extension may thus be used to represent the link zib TreatmentObjective -> zib FunctionalOrMentalStatus -> zib MedicalDevice. In this situation, it is expected that DeviceUseStatement.status is set to intended.

An extension to link the Encounter during which the Consent, Goal or DeviceUseStatement was created or to which the creation is tightly associated.

An Extension

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

The Encounter during which this resource was created or to which the creation is tightly associated.

This will typically be the encounter the event occurred within, but some activities may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. completing the administrative registration after the encounter).

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).

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.

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.

A code representing the patient or other source's judgment about the state of the device used that this statement is about. Generally this will be active or completed.

This element is implictly mapped to the zib concepts NL-CM:10.1.11 (StartDate) and NL-CM:10.1.14 (EndDate). Unless the status is explicitly recorded, the following guidance applies:

• When StartDate is in the future, .status will usually be set to intended.
• When StartDate is in the past and EndDate has a value and in the future or EndDate has no value, .status will usually be set to active.
• When EndDate has a value and is in the past, .status will usually be set to completed.

A coded concept indicating the current status of the Device Usage.

The patient who used the device.

Allows linking the DeviceUseStatement to the underlying Request, or to other information that supports or is used to derive the DeviceUseStatement.

The most common use cases for deriving a DeviceUseStatement comes from creating it from a request or from an observation or a claim. it should be noted that the amount of information that is available varies from the type resource that you derive the DeviceUseStatement from.

The procedure which has the purpose of placing this product in or on the body.

• Note 1: on a functional level, zib Procedure references zib MedicalDevice, but in FHIR this direction is reversed.
• Note 2: zib Procedure can represent a requested or (to be) performed procedure. This slice represents requested procedures, while slice procedure-event represents performed procedures.

The procedure which has the purpose of placing this product in or on the body.

• Note 1: on a functional level, zib Procedure references zib MedicalDevice, but in FHIR this direction is reversed.
• Note 2: zib Procedure can represent a requested or (to be) performed procedure. This slice represents performed procedures, while slice procedure-request represents requested procedures.

How often the device was used.

How often the device was used.

The start date of the first use or implant of the medical device. A "vague" date, such as only the year, is permitted.

If the low element is missing, the meaning is that the low boundary is not known.

The end date of the last use or explant of the medical device. A "vague" date, such as only the year, is permitted.

The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.

The details of the device used.

Indicates another resource whose existence justifies this DeviceUseStatement.

The medical reason for use of the medical device.

Indicates another resource whose existence justifies this DeviceUseStatement.

Please note that on a functional level, zib Stoma references zib MedicalDevice, but in FHIR this direction is reversed.

Localisation on/in the body.

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Codes describing anatomical locations. May include laterality.

​Knowing where the device is targeted is important for tracking if multiple sites are possible. If more information than just a code is required, use the extension http://hl7.org/fhir/StructureDefinition/bodySite.

Optional Extension Element - found in all resources.

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Laterality adds information about body site to the anatomic location, e.g. left.

Details about the device statement that were not represented at all or sufficiently in one of the attributes provided in a class. These may include for example a comment, an instruction, or a note associated with the statement.

Comment about use or information on the medical device used.

A record of a device being used by a patient where the record is the result of a report from the patient or another clinician.

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.

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.

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).

A human language.

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.

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.

Optional Extension Element - found in all resources.

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.

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.

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

The health professional involved in the indication for use of the medical device implant.

Each occurrence of the zib HealthProfessional is normally represented by two FHIR resources: a PractitionerRole resource (instance of nl-core-HealthProfessional-PractitionerRole) and a Practitioner resource (instance of nl-core-HealthProfessional-Practitioner). The Practitioner resource is referenced from the PractitionerRole instance. For this reason, sending systems should fill the reference to the PractitionerRole instance here, and not the Practitioner resource. Receiving systems can then retrieve the reference to the Practitioner resource from that PractitionerRole instance.

In rare circumstances, there is only a Practitioner instance, in which case it is that instance which will be referenced here. However, since this should be the exception, the nl-core-HealthProfessional-Practitioner profile is not explicitly mentioned as a target profile.

Optional Extension Element - found in all resources.

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.

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.

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

The healthcare provider at which use of the medical device was initiated or where the aid was implanted.

Please note that this zib concept (Location::HealthcareProvider) is also mapped on the Procedure.location element in profile nl-core-Procedure-event. The reason for this is that this zib concept aligns with the Location::HealthcareProvider concept in zib Procedure (NL-CM:14.1.5), but only for the situation that the Procedure is about placing the implant which is described using this instance of zib MedicalDevice. In this situation, the current extension is redundant and it is advised to only use Procedure.location in profile nl-core-Procedure-event to represent the Location concept.

Indicates that the resource is related to either the measurement, achievement or progress towards the referenced goal. For example, a Procedure to exercise pertainsToGoal of losing weight.

This extension is limited to subject-specific activity-related resources (events & intents). I.e. This can't be put on Goal or Patient. This association isn't for the purpose of goal management, but for things such as noting that a particular observation result, prescription or other activity is pertinent to the achievement (or possibly non-achievement) of the referenced goal.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

An Extension

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Zib TreatmentObjective (represented by the Goal resource in FHIR) can use the data model of zib FunctionalOrMentalStatus to describe the desired treatment objective, which in turn may refer zib MedicalDevice to indicate the intent to use that device for reaching the treatment objective.

In FHIR, the modeling deviates somewhat from this approach:

• Both zib TreatmentObjective and the desired zib FunctionalOrMentalStatus are represented using the nl-core-TreatmentObjective profile on the Goal resource.
• The reference from TreatmentObjective::FunctionalOrMentalStatus::MedicalDevice is in the opposite direction, to the Goal resource.

This extension may thus be used to represent the link zib TreatmentObjective -> zib FunctionalOrMentalStatus -> zib MedicalDevice. In this situation, it is expected that DeviceUseStatement.status is set to intended.

An extension to link the Encounter during which the Consent, Goal or DeviceUseStatement was created or to which the creation is tightly associated.

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

An Extension

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

The Encounter during which this resource was created or to which the creation is tightly associated.

This will typically be the encounter the event occurred within, but some activities may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. completing the administrative registration after the encounter).

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).

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.

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.

An external identifier for this statement such as an IRI.

A plan, proposal or order that is fulfilled in whole or in part by this DeviceUseStatement.

Allows tracing of authorization for the DeviceUseStatement and tracking whether proposals/recommendations were acted upon.

A code representing the patient or other source's judgment about the state of the device used that this statement is about. Generally this will be active or completed.

This element is implictly mapped to the zib concepts NL-CM:10.1.11 (StartDate) and NL-CM:10.1.14 (EndDate). Unless the status is explicitly recorded, the following guidance applies:

• When StartDate is in the future, .status will usually be set to intended.
• When StartDate is in the past and EndDate has a value and in the future or EndDate has no value, .status will usually be set to active.
• When EndDate has a value and is in the past, .status will usually be set to completed.

A coded concept indicating the current status of the Device Usage.

The patient who used the device.

Allows linking the DeviceUseStatement to the underlying Request, or to other information that supports or is used to derive the DeviceUseStatement.

The most common use cases for deriving a DeviceUseStatement comes from creating it from a request or from an observation or a claim. it should be noted that the amount of information that is available varies from the type resource that you derive the DeviceUseStatement from.

The procedure which has the purpose of placing this product in or on the body.

• Note 1: on a functional level, zib Procedure references zib MedicalDevice, but in FHIR this direction is reversed.
• Note 2: zib Procedure can represent a requested or (to be) performed procedure. This slice represents requested procedures, while slice procedure-event represents performed procedures.

The procedure which has the purpose of placing this product in or on the body.

• Note 1: on a functional level, zib Procedure references zib MedicalDevice, but in FHIR this direction is reversed.
• Note 2: zib Procedure can represent a requested or (to be) performed procedure. This slice represents performed procedures, while slice procedure-request represents requested procedures.

How often the device was used.

How often the device was used.

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.

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.

The start date of the first use or implant of the medical device. A "vague" date, such as only the year, is permitted.

If the low element is missing, the meaning is that the low boundary is not known.

The end date of the last use or explant of the medical device. A "vague" date, such as only the year, is permitted.

The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.

The time at which the statement was made/recorded.

Who reported the device was being used by the patient.

The details of the device used.

Reason or justification for the use of the device.

Indicates another resource whose existence justifies this DeviceUseStatement.

The medical reason for use of the medical device.

Indicates another resource whose existence justifies this DeviceUseStatement.

Please note that on a functional level, zib Stoma references zib MedicalDevice, but in FHIR this direction is reversed.

Localisation on/in the body.

Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

Codes describing anatomical locations. May include laterality.

​Knowing where the device is targeted is important for tracking if multiple sites are possible. If more information than just a code is required, use the extension http://hl7.org/fhir/StructureDefinition/bodySite.

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.

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.

Optional Extension Element - found in all resources.

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.

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.

Source of the definition for the extension code - a logical name or a URL.

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Laterality adds information about body site to the anatomic location, e.g. left.

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.

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.

Details about the device statement that were not represented at all or sufficiently in one of the attributes provided in a class. These may include for example a comment, an instruction, or a note associated with the statement.

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.

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.

The individual responsible for making the annotation.

Organization is used when there's no need for specific attribution as to who made the comment.

Indicates when this particular annotation was made.

Comment about use or information on the medical device used.