Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot International flag

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

Resource Profile: RiskOfBias - Detailed Descriptions

Page standards status: Draft Maturity Level: 1

Definitions for the risk-of-bias resource profile.

Guidance on how to interpret the contents of this table can be found here

0. ArtifactAssessment
2. ArtifactAssessment.extension
SlicingThis element introduces a set of slices on ArtifactAssessment.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 4. ArtifactAssessment.extension:url
    Slice Nameurl
    Control0..1
    TypeExtension(Artifact URL) (Extension Type: uri)
    6. ArtifactAssessment.extension:description
    Slice Namedescription
    Control0..1
    TypeExtension(Artifact Description) (Extension Type: markdown)
    8. ArtifactAssessment.extension:author
    Slice Nameauthor
    Control0..*
    TypeExtension(Artifact Author) (Extension Type: ContactDetail)
    10. ArtifactAssessment.identifier
    Definition

    A formal identifier that is used to identify this RiskOfBias when it is represented in other formats, or referenced in a specification, model, design or an instance.

    ShortAdditional identifier for the RiskOfBias
    Comments

    Typically, this is used for identifiers that can be used in systems outside of FHIR, where it is not sufficient to use the logical URI.

    NoteThis is a business identifier, not a resource identifier (see discussion)
    Requirements

    Allows externally provided and/or usable business identifiers to be easily associated with the RiskOfBias.

    12. ArtifactAssessment.citeAs[x]
    Definition

    Display of or reference to the bibliographic citation of the RiskOfBias.

    ShortHow to cite the RiskOfBias
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    14. ArtifactAssessment.date
    Definition

    The date (and optionally time) when the RiskOfBias was published. The date should change when the substantive content of the RiskOfBias changes.

    16. ArtifactAssessment.copyright
    Definition

    A copyright statement relating to the RiskOfBias and/or its contents. Copyright statements are generally legal restrictions on the use and publishing of the RiskOfBias.

    Requirements

    Consumers must be able to determine any legal restrictions on the use of the RiskOfBias and/or its content.

    18. ArtifactAssessment.approvalDate
    ShortWhen the RiskOfBias was approved by publisher
    20. ArtifactAssessment.lastReviewDate
    ShortWhen the RiskOfBias was last reviewed
    22. ArtifactAssessment.artifact[x]
    Definition

    A reference to a resource, canonical resource, or non-FHIR resource which the RiskOfBias is about.

    ShortThe artifact that is rated
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    SlicingThis element introduces a set of slices on ArtifactAssessment.artifact[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • type @ $this
    • 24. ArtifactAssessment.artifact[x]:artifactReference
      Slice NameartifactReference
      Control0..1
      TypeReference(Evidence, Composition, ResearchStudy, Citation)
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      26. ArtifactAssessment.content
      Definition

      A rating or classification of the artifact.

      ShortA rating
      28. ArtifactAssessment.content.type
      BindingUnless not suitable, these codes SHALL be taken from Risk Of Bias Type Value Set
      (extensible to https://fevir.net/resources/ValueSet/181524)
      30. ArtifactAssessment.content.classifier
      BindingUnless not suitable, these codes SHALL be taken from EvidenceCertaintyRating
      (extensible to http://hl7.org/fhir/ValueSet/certainty-rating)
      32. ArtifactAssessment.content.freeToShare
      Definition

      Acceptable to publicly share the RiskOfBias content, specific to the associated content instance

      ShortAcceptable to publicly share the RiskOfBias content

      Guidance on how to interpret the contents of this table can be found here

      0. ArtifactAssessment
      Definition

      This Resource provides one or more comments, classifiers or ratings about a Resource and supports attribution and rights management metadata for the added content.

      ShortAdds metadata-supported comments, classifiers or ratings related to a Resource
      Control0..*
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
      dom-3: 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
      dom-4: 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())
      dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
      dom-6: A resource should have narrative for robust management (text.`div`.exists())
      2. ArtifactAssessment.implicitRules
      Definition

      A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

      ShortA set of rules under which this content was created
      Comments

      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.

      Control0..1
      Typeuri
      Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      4. ArtifactAssessment.contained
      Definition

      These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

      ShortContained, inline Resources
      Comments

      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.

      Control0..*
      This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
      TypeResource
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Alternate Namesinline resources, anonymous resources, contained resources
      6. ArtifactAssessment.extension
      Definition

      An Extension


      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.

      ShortExtensionAdditional content defined by implementations
      Comments

      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.

      Control0..*
      TypeExtension
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      SlicingThis element introduces a set of slices on ArtifactAssessment.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 8. ArtifactAssessment.extension:url
        Slice Nameurl
        Definition

        An absolute URI that is used to identify this artifact when it is referenced in a specification, model, design or an instance; also called its canonical identifier. This SHOULD be globally unique and SHOULD be a literal address at which an authoritative instance of this artifact is (or will be) published. This URL can be the target of a canonical reference. It SHALL remain the same when the artifact is stored on different servers.

        ShortCanonical identifier for this artifact, represented as a URI (globally unique)
        Comments

        Can be a urn:uuid: or a urn:oid: but real http: addresses are preferred. Multiple instances may share the same URL if they have a distinct version.

        The determination of when to create a new version of a resource (same url, new version) vs. defining a new artifact is up to the author. Considerations for making this decision are found in Technical and Business Versions.

        In some cases, the resource can no longer be found at the stated url, but the url itself cannot change. Implementations can use the meta.source element to indicate where the current master source of the resource can be found.

        Control0..1
        TypeExtension(Artifact URL) (Extension Type: uri)
        Is Modifierfalse
        Must Supportfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        10. ArtifactAssessment.extension:description
        Slice Namedescription
        Definition

        A free text natural language description of the artifact from a consumer's perspective.

        ShortNatural language description of the artifact
        Comments

        This description can be used to capture details such as comments about misuse, instructions for clinical use and interpretation, literature references, examples from the paper world, etc. It is not a rendering of the artifact as conveyed in the 'text' field of the resource itself. This item SHOULD be populated unless the information is available from context (e.g. the language of the artifact is presumed to be the predominant language in the place the artifact was created).

        Control0..1
        TypeExtension(Artifact Description) (Extension Type: markdown)
        Is Modifierfalse
        Must Supportfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        12. ArtifactAssessment.extension:author
        Slice Nameauthor
        Definition

        An individual or organization primarily involved in the creation and maintenance of the artifact.

        ShortWho authored the artifact
        Control0..*
        TypeExtension(Artifact Author) (Extension Type: ContactDetail)
        Is Modifierfalse
        Must Supportfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        14. ArtifactAssessment.modifierExtension
        Definition

        May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and 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).

        ShortExtensions that cannot be ignored
        Comments

        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.

        Control0..*
        TypeExtension
        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
        Must Supportfalse
        Summarytrue
        Requirements

        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        16. ArtifactAssessment.identifier
        Definition

        A formal identifier that is used to identify this RiskOfBias when it is represented in other formats, or referenced in a specification, model, design or an instance.


        A formal identifier that is used to identify this artifact assessment when it is represented in other formats, or referenced in a specification, model, design or an instance.

        ShortAdditional identifier for the RiskOfBiasAdditional identifier for the artifact assessment
        Comments

        Typically, this is used for identifiers that can be used in systems outside of FHIR, where it is not sufficient to use the logical URI.


        Typically, this is used for identifiers that can go in an HL7 V3 II (instance identifier) data type, and can then identify this activity definition outside of FHIR, where it is not possible to use the logical URI.

        NoteThis is a business identifier, not a resource identifier (see discussion)
        Control0..*
        TypeIdentifier
        Is Modifierfalse
        Must Supportfalse
        Summarytrue
        Requirements

        Allows externally provided and/or usable business identifiers to be easily associated with the RiskOfBias.


        Allows externally provided and/or usable business identifiers to be easily associated with the artifact assessment.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        18. ArtifactAssessment.citeAs[x]
        Definition

        Display of or reference to the bibliographic citation of the RiskOfBias.


        Display of or reference to the bibliographic citation of the comment, classifier, or rating.

        ShortHow to cite the RiskOfBiasHow to cite the comment or rating
        Control0..1
        TypeChoice of: Reference(Citation), markdown
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        20. ArtifactAssessment.date
        Definition

        The date (and optionally time) when the RiskOfBias was published. The date should change when the substantive content of the RiskOfBias changes.


        The date (and optionally time) when the artifact assessment was published. The date must change when the disposition changes and it must change if the workflow status code changes. In addition, it should change when the substantive content of the artifact assessment changes.

        ShortDate last changed
        Comments

        The date is often not tracked until the resource is published, but may be present on draft content. Note that this is not the same as the resource last-modified-date, since the resource may be a secondary representation of the artifact assessment. Additional specific dates may be added as extensions or be found by consulting Provenances associated with past versions of the resource.

        Control0..1
        TypedateTime
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        Summarytrue
        Alternate NamesRevision Date
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        22. ArtifactAssessment.copyright
        Definition

        A copyright statement relating to the RiskOfBias and/or its contents. Copyright statements are generally legal restrictions on the use and publishing of the RiskOfBias.


        A copyright statement relating to the artifact assessment and/or its contents. Copyright statements are generally legal restrictions on the use and publishing of the artifact assessment.

        ShortUse and/or publishing restrictions
        Control0..1
        Typemarkdown
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        Summaryfalse
        Requirements

        Consumers must be able to determine any legal restrictions on the use of the RiskOfBias and/or its content.


        Consumers must be able to determine any legal restrictions on the use of the artifact assessment and/or its content.

        Alternate NamesLicense, Restrictions
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        24. ArtifactAssessment.approvalDate
        Definition

        The date on which the resource content was approved by the publisher. Approval happens once when the content is officially approved for usage.

        ShortWhen the RiskOfBias was approved by publisherWhen the artifact assessment was approved by publisher
        Comments

        The 'date' element may be more recent than the approval date because of minor changes or editorial corrections.

        Control0..1
        Typedate
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        Summaryfalse
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        26. ArtifactAssessment.lastReviewDate
        Definition

        The date on which the resource content was last reviewed. Review happens periodically after approval but does not change the original approval date.

        ShortWhen the RiskOfBias was last reviewedWhen the artifact assessment was last reviewed by the publisher
        Comments

        If specified, this date follows the original approval date.

        Control0..1
        Typedate
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        Summarytrue
        Requirements

        Gives a sense of how "current" the content is. Resources that have not been reviewed in a long time may have a risk of being less appropriate/relevant.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        28. ArtifactAssessment.artifact[x]
        Definition

        A reference to a resource, canonical resource, or non-FHIR resource which the RiskOfBias is about.


        A reference to a resource, canonical resource, or non-FHIR resource which the comment or assessment is about.

        ShortThe artifact that is ratedThe artifact assessed, commented upon or rated
        Control1..1
        TypeChoice of: Reference(Resource), canonical, uri
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Must Supportfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        SlicingThis element introduces a set of slices on ArtifactAssessment.artifact[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • type @ $this
        • 30. ArtifactAssessment.artifact[x]:artifactReference
          Slice NameartifactReference
          Definition

          A reference to a resource, canonical resource, or non-FHIR resource which the comment or assessment is about.

          ShortThe artifact assessed, commented upon or rated
          Control01..1
          TypeReference(Evidence, Composition, ResearchStudy, Citation, Resource), canonical, uri
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          32. ArtifactAssessment.content
          Definition

          A rating or classification of the artifact.


          A component comment, classifier, or rating of the artifact.

          ShortA ratingComment, classifier, or rating content
          Control0..*
          TypeBackboneElement
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          34. ArtifactAssessment.content.modifierExtension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and 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).

          ShortExtensions that cannot be ignored even if unrecognized
          Comments

          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.

          Control0..*
          TypeExtension
          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
          Summarytrue
          Requirements

          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

          Alternate Namesextensions, user content, modifiers
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          36. ArtifactAssessment.content.type
          Definition

          Indicates what type of content this component represents.

          ShortWhat type of content
          Control0..1
          BindingUnless not suitable, these codes SHALL be taken from For example codes, see Risk Of Bias Type Value Sethttp://hl7.org/fhir/ValueSet/certainty-type
          (extensible to https://fevir.net/resources/ValueSet/181524)
          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          38. ArtifactAssessment.content.classifier
          Definition

          Represents a rating, classifier, or assessment of the artifact.

          ShortRating, classifier, or assessment
          Control0..*
          BindingUnless not suitable, these codes SHALL be taken from For example codes, see EvidenceCertaintyRatinghttp://hl7.org/fhir/ValueSet/certainty-rating
          (extensible to http://hl7.org/fhir/ValueSet/certainty-rating)
          TypeCodeableConcept
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          40. ArtifactAssessment.content.freeToShare
          Definition

          Acceptable to publicly share the RiskOfBias content, specific to the associated content instance


          Acceptable to publicly share the comment, classifier or rating.

          ShortAcceptable to publicly share the RiskOfBias contentAcceptable to publicly share the resource content
          Control0..1
          Typeboolean
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

          Guidance on how to interpret the contents of this table can be found here

          0. ArtifactAssessment
          Definition

          This Resource provides one or more comments, classifiers or ratings about a Resource and supports attribution and rights management metadata for the added content.

          ShortAdds metadata-supported comments, classifiers or ratings related to a Resource
          Control0..*
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
          dom-3: 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
          dom-4: 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())
          dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
          dom-6: A resource should have narrative for robust management (text.`div`.exists())
          2. ArtifactAssessment.id
          Definition

          The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

          ShortLogical id of this artifact
          Comments

          Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.

          Control0..1
          Typeid
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          4. ArtifactAssessment.meta
          Definition

          The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

          ShortMetadata about the resource
          Control0..1
          TypeMeta
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          6. ArtifactAssessment.implicitRules
          Definition

          A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

          ShortA set of rules under which this content was created
          Comments

          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.

          Control0..1
          Typeuri
          Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          8. ArtifactAssessment.language
          Definition

          The base language in which the resource is written.

          ShortLanguage of the resource content
          Comments

          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).

          Control0..1
          BindingThe codes SHALL be taken from AllLanguages
          (required to http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot2)

          IETF language tag for a human language

          Typecode
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          10. ArtifactAssessment.text
          Definition

          A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

          ShortText summary of the resource, for human interpretation
          Comments

          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.

          Control0..1
          This element is affected by the following invariants: dom-6
          TypeNarrative
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Alternate Namesnarrative, html, xhtml, display
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          12. ArtifactAssessment.contained
          Definition

          These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

          ShortContained, inline Resources
          Comments

          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.

          Control0..*
          This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
          TypeResource
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Alternate Namesinline resources, anonymous resources, contained resources
          14. ArtifactAssessment.extension
          Definition

          An Extension

          ShortExtension
          Control0..*
          TypeExtension
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          SlicingThis element introduces a set of slices on ArtifactAssessment.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 16. ArtifactAssessment.extension:url
            Slice Nameurl
            Definition

            An absolute URI that is used to identify this artifact when it is referenced in a specification, model, design or an instance; also called its canonical identifier. This SHOULD be globally unique and SHOULD be a literal address at which an authoritative instance of this artifact is (or will be) published. This URL can be the target of a canonical reference. It SHALL remain the same when the artifact is stored on different servers.

            ShortCanonical identifier for this artifact, represented as a URI (globally unique)
            Comments

            Can be a urn:uuid: or a urn:oid: but real http: addresses are preferred. Multiple instances may share the same URL if they have a distinct version.

            The determination of when to create a new version of a resource (same url, new version) vs. defining a new artifact is up to the author. Considerations for making this decision are found in Technical and Business Versions.

            In some cases, the resource can no longer be found at the stated url, but the url itself cannot change. Implementations can use the meta.source element to indicate where the current master source of the resource can be found.

            Control0..1
            TypeExtension(Artifact URL) (Extension Type: uri)
            Is Modifierfalse
            Must Supportfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            18. ArtifactAssessment.extension:description
            Slice Namedescription
            Definition

            A free text natural language description of the artifact from a consumer's perspective.

            ShortNatural language description of the artifact
            Comments

            This description can be used to capture details such as comments about misuse, instructions for clinical use and interpretation, literature references, examples from the paper world, etc. It is not a rendering of the artifact as conveyed in the 'text' field of the resource itself. This item SHOULD be populated unless the information is available from context (e.g. the language of the artifact is presumed to be the predominant language in the place the artifact was created).

            Control0..1
            TypeExtension(Artifact Description) (Extension Type: markdown)
            Is Modifierfalse
            Must Supportfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            20. ArtifactAssessment.extension:author
            Slice Nameauthor
            Definition

            An individual or organization primarily involved in the creation and maintenance of the artifact.

            ShortWho authored the artifact
            Control0..*
            TypeExtension(Artifact Author) (Extension Type: ContactDetail)
            Is Modifierfalse
            Must Supportfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            22. ArtifactAssessment.modifierExtension
            Definition

            May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and 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).

            ShortExtensions that cannot be ignored
            Comments

            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.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
            Must Supportfalse
            Summarytrue
            Requirements

            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

            Alternate Namesextensions, user content
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            24. ArtifactAssessment.identifier
            Definition

            A formal identifier that is used to identify this RiskOfBias when it is represented in other formats, or referenced in a specification, model, design or an instance.

            ShortAdditional identifier for the RiskOfBias
            Comments

            Typically, this is used for identifiers that can be used in systems outside of FHIR, where it is not sufficient to use the logical URI.

            NoteThis is a business identifier, not a resource identifier (see discussion)
            Control0..*
            TypeIdentifier
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Requirements

            Allows externally provided and/or usable business identifiers to be easily associated with the RiskOfBias.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            26. ArtifactAssessment.title
            Definition

            A short title for the assessment for use in displaying and selecting.

            ShortA short title for the assessment for use in displaying and selecting
            Control0..1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            28. ArtifactAssessment.citeAs[x]
            Definition

            Display of or reference to the bibliographic citation of the RiskOfBias.

            ShortHow to cite the RiskOfBias
            Control0..1
            TypeChoice of: Reference(Citation), markdown
            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supportfalse
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            30. ArtifactAssessment.date
            Definition

            The date (and optionally time) when the RiskOfBias was published. The date should change when the substantive content of the RiskOfBias changes.

            ShortDate last changed
            Comments

            The date is often not tracked until the resource is published, but may be present on draft content. Note that this is not the same as the resource last-modified-date, since the resource may be a secondary representation of the artifact assessment. Additional specific dates may be added as extensions or be found by consulting Provenances associated with past versions of the resource.

            Control0..1
            TypedateTime
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supportfalse
            Summarytrue
            Alternate NamesRevision Date
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            32. ArtifactAssessment.copyright
            Definition

            A copyright statement relating to the RiskOfBias and/or its contents. Copyright statements are generally legal restrictions on the use and publishing of the RiskOfBias.

            ShortUse and/or publishing restrictions
            Control0..1
            Typemarkdown
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supportfalse
            Summaryfalse
            Requirements

            Consumers must be able to determine any legal restrictions on the use of the RiskOfBias and/or its content.

            Alternate NamesLicense, Restrictions
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            34. ArtifactAssessment.approvalDate
            Definition

            The date on which the resource content was approved by the publisher. Approval happens once when the content is officially approved for usage.

            ShortWhen the RiskOfBias was approved by publisher
            Comments

            The 'date' element may be more recent than the approval date because of minor changes or editorial corrections.

            Control0..1
            Typedate
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supportfalse
            Summaryfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            36. ArtifactAssessment.lastReviewDate
            Definition

            The date on which the resource content was last reviewed. Review happens periodically after approval but does not change the original approval date.

            ShortWhen the RiskOfBias was last reviewed
            Comments

            If specified, this date follows the original approval date.

            Control0..1
            Typedate
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supportfalse
            Summarytrue
            Requirements

            Gives a sense of how "current" the content is. Resources that have not been reviewed in a long time may have a risk of being less appropriate/relevant.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            38. ArtifactAssessment.artifact[x]
            Definition

            A reference to a resource, canonical resource, or non-FHIR resource which the RiskOfBias is about.

            ShortThe artifact that is rated
            Control1..1
            TypeChoice of: Reference(Resource), canonical, uri
            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            SlicingThis element introduces a set of slices on ArtifactAssessment.artifact[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • type @ $this
            • 40. ArtifactAssessment.artifact[x]:artifactReference
              Slice NameartifactReference
              Definition

              A reference to a resource, canonical resource, or non-FHIR resource which the comment or assessment is about.

              ShortThe artifact assessed, commented upon or rated
              Control0..1
              TypeReference(Evidence, Composition, ResearchStudy, Citation)
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              42. ArtifactAssessment.content
              Definition

              A rating or classification of the artifact.

              ShortA rating
              Control0..*
              TypeBackboneElement
              Is Modifierfalse
              Must Supportfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              44. ArtifactAssessment.content.id
              Definition

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

              ShortUnique id for inter-element referencing
              Control0..1
              This element is affected by the following invariants: ele-1
              Typestring
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              46. ArtifactAssessment.content.extension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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.

              ShortAdditional content defined by implementations
              Comments

              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.

              Control0..*
              TypeExtension
              Is Modifierfalse
              Summaryfalse
              Alternate Namesextensions, user content
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              48. ArtifactAssessment.content.modifierExtension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and 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).

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

              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.

              Control0..*
              TypeExtension
              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
              Summarytrue
              Requirements

              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

              Alternate Namesextensions, user content, modifiers
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              50. ArtifactAssessment.content.informationType
              Definition

              The type of information this component of the content represents.

              Shortcomment | classifier | rating | container | response | change-request
              Control0..1
              BindingThe codes SHALL be taken from ArtifactAssessmentInformationType
              (required to http://hl7.org/fhir/ValueSet/artifactassessment-information-type|6.0.0-ballot2)
              Typecode
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supportfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              52. ArtifactAssessment.content.summary
              Definition

              A brief summary of the content of this component.

              ShortBrief summary of the content
              Control0..1
              Typemarkdown
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supportfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              54. ArtifactAssessment.content.type
              Definition

              Indicates what type of content this component represents.

              ShortWhat type of content
              Control0..1
              BindingUnless not suitable, these codes SHALL be taken from Risk Of Bias Type Value Set
              (extensible to https://fevir.net/resources/ValueSet/181524)
              TypeCodeableConcept
              Is Modifierfalse
              Must Supportfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              56. ArtifactAssessment.content.classifier
              Definition

              Represents a rating, classifier, or assessment of the artifact.

              ShortRating, classifier, or assessment
              Control0..*
              BindingUnless not suitable, these codes SHALL be taken from EvidenceCertaintyRating
              (extensible to http://hl7.org/fhir/ValueSet/certainty-rating)
              TypeCodeableConcept
              Is Modifierfalse
              Must Supportfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              58. ArtifactAssessment.content.quantity
              Definition

              A quantitative rating of the artifact.

              ShortQuantitative rating
              Control0..1
              TypeQuantity
              Is Modifierfalse
              Must Supportfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              60. ArtifactAssessment.content.author
              Definition

              Indicates who or what authored the content.

              ShortWho authored the content
              Control0..1
              TypeReference(Patient, Practitioner, PractitionerRole, Organization, Device)
              Is Modifierfalse
              Must Supportfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              62. ArtifactAssessment.content.path
              Definition

              A URI that points to what the comment is about, such as a line of text in the CQL, or a specific element in a resource.

              ShortWhat the comment is directed to
              Comments

              The target element is used to point the comment to aspect of the artifact, such as a text range within a CQL library (e.g. #content?0:0-120:80).

              Control0..*
              Typeuri
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supportfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              64. ArtifactAssessment.content.relatedArtifact
              Definition

              Additional related artifacts that provide supporting documentation, additional evidence, or further information related to the content.

              ShortAdditional information
              Control0..*
              TypeRelatedArtifact
              Is Modifierfalse
              Must Supportfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              66. ArtifactAssessment.content.freeToShare
              Definition

              Acceptable to publicly share the RiskOfBias content, specific to the associated content instance

              ShortAcceptable to publicly share the RiskOfBias content
              Control0..1
              Typeboolean
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supportfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              68. ArtifactAssessment.content.component
              Definition

              If the informationType is container, the components of the content.

              ShortContained content
              Control0..*
              TypeSeettp://hl7.org/fhir/StructureDefinition/ArtifactAssessment#ArtifactAssessment.content
              Is Modifierfalse
              Must Supportfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              70. ArtifactAssessment.workflowStatus
              Definition

              Indicates the workflow status of the comment or change request.

              Shortsubmitted | triaged | waiting-for-input | resolved-no-change | resolved-change-required | deferred | duplicate | applied | published | entered-in-error
              Control0..1
              BindingThe codes SHALL be taken from ArtifactAssessmentWorkflowStatus
              (required to http://hl7.org/fhir/ValueSet/artifactassessment-workflow-status|6.0.0-ballot2)
              Typecode
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              72. ArtifactAssessment.disposition
              Definition

              Indicates the disposition of the responsible party to the comment or change request.

              Shortunresolved | not-persuasive | persuasive | persuasive-with-modification | not-persuasive-with-modification
              Control0..1
              BindingThe codes SHALL be taken from ArtifactAssessmentDisposition
              (required to http://hl7.org/fhir/ValueSet/artifactassessment-disposition|6.0.0-ballot2)
              Typecode
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))