NCPI FHIR Implementation Guide
0.2.0 - ci-build

NCPI FHIR Implementation Guide - Local Development build (v0.2.0). See the Directory of published versions

Resource Profile: ResearchStudyConsent - Detailed Descriptions

Draft as of 2023-06-28

Definitions for the research-study-consent resource profile.

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

1. Consent
InvariantsDefined on this element
completed-consent-code: If category is DS then there must be a ResearchConsentDiseaseAbbreviation (: provision.purpose.where(code = 'DS').empty() or provision.extension.where(url='https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation').exists())
2. Consent.category
Pattern Value<valueCodeableConcept xmlns="http://hl7.org/fhir">
  <coding>
    <system value="http://terminology.hl7.org/CodeSystem/consentcategorycodes"/>
    <code value="research"/>
    <display value="Research Information Access"/>
  </coding>
</valueCodeableConcept>
3. Consent.provision
Control0..?
4. Consent.provision.extension
SlicingThis element introduces a set of slices on Consent.provision.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
5. Consent.provision.extension:diseaseUseLimitation
SliceNamediseaseUseLimitation
Control0..1
TypeExtension(ResearchDiseaseUseLimitation) (Extension Type: CodeableConcept)
6. Consent.provision.purpose
BindingThe codes SHALL be taken from NIH Consent Code ValueSet; other codes may be used where these codes are not suitableThe codes SHALL be taken from PurposeOfUse; other codes may be used where these codes are not suitable

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

1. Consent
Definition

A record of a healthcare consumer’s choices, which permits or denies identified recipient(s) or recipient role(s) to perform one or more actions within a given policy context, for specific purposes and periods of time.

Control0..*
Summaryfalse
Comments

Broadly, there are 3 key areas of consent for patients: Consent around sharing information (aka Privacy Consent Directive - Authorization to Collect, Use, or Disclose information), consent for specific treatment, or kinds of treatment, and general advance care directives.

InvariantsDefined on this element
completed-consent-code: If category is DS then there must be a ResearchConsentDiseaseAbbreviation (: provision.purpose.where(code = 'DS').empty() or provision.extension.where(url='https://nih-ncpi.github.io/ncpi-fhir-ig/StructureDefinition/research-disease-use-limitation').exists())
dom-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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
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())
ppc-1: Either a Policy or PolicyRule (: policy.exists() or policyRule.exists())
ppc-2: IF Scope=privacy, there must be a patient (: patient.exists() or scope.coding.where(system='something' and code='patient-privacy').exists().not())
ppc-3: IF Scope=research, there must be a patient (: patient.exists() or scope.coding.where(system='something' and code='research').exists().not())
ppc-4: IF Scope=adr, there must be a patient (: patient.exists() or scope.coding.where(system='something' and code='adr').exists().not())
ppc-5: IF Scope=treatment, there must be a patient (: patient.exists() or scope.coding.where(system='something' and code='treatment').exists().not())
2. Consent.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.

Control0..1
Typeuri
Is Modifiertrue
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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 it's narrative along with other profiles, value sets, etc.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
3. Consent.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 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).

Control0..*
TypeExtension
Is Modifiertrue
Summaryfalse
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
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.

InvariantsDefined on this element
ele-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())
4. Consent.status
Definition

Indicates the current state of this consent.

Control1..1
BindingThe codes SHALL be taken from ConsentState

Indicates the state of the consent.

Typecode
Is Modifiertrue
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

The Consent Directive that is pointed to might be in various lifecycle states, e.g., a revoked Consent Directive.

Comments

This element is labeled as a modifier because the status contains the codes rejected and entered-in-error that mark the Consent as not currently valid.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
5. Consent.scope
Definition

A selector of the type of consent being presented: ADR, Privacy, Treatment, Research. This list is now extensible.

Control1..1
BindingThe codes SHALL be taken from ConsentScopeCodes; other codes may be used where these codes are not suitable

The four anticipated uses for the Consent Resource.

TypeCodeableConcept
Is Modifiertrue
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
6. Consent.category
Definition

A classification of the type of consents found in the statement. This element supports indexing and retrieval of consent statements.

Control1..*
BindingThe codes SHALL be taken from ConsentCategoryCodes; other codes may be used where these codes are not suitable

A classification of the type of consents found in a consent statement.

TypeCodeableConcept
Summarytrue
Pattern Value<valueCodeableConcept xmlns="http://hl7.org/fhir">
  <coding>
    <system value="http://terminology.hl7.org/CodeSystem/consentcategorycodes"/>
    <code value="research"/>
    <display value="Research Information Access"/>
  </coding>
</valueCodeableConcept>
InvariantsDefined on this element
ele-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.

1. Consent
Definition

A record of a healthcare consumer’s choices, which permits or denies identified recipient(s) or recipient role(s) to perform one or more actions within a given policy context, for specific purposes and periods of time.

Control0..*
Summaryfalse
Comments

Broadly, there are 3 key areas of consent for patients: Consent around sharing information (aka Privacy Consent Directive - Authorization to Collect, Use, or Disclose information), consent for specific treatment, or kinds of treatment, and general advance care directives.

2. Consent.id
Definition

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

Control0..1
Typeid
Summarytrue
Comments

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

3. Consent.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.

Control0..1
TypeMeta
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
4. Consent.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.

Control0..1
Typeuri
Is Modifiertrue
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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 it's narrative along with other profiles, value sets, etc.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
5. Consent.language
Definition

The base language in which the resource is written.

Control0..1
BindingThe codes SHOULD be taken from CommonLanguages A human language
Additional BindingsPurpose
AllLanguagesMax Binding
Typecode
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
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).

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
6. Consent.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.

Control0..1
TypeNarrative
Summaryfalse
Alternate Namesnarrative, html, xhtml, display
Comments

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.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
7. Consent.contained
Definition

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.

Control0..*
TypeResource
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained 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.

8. Consent.extension
Definition

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.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
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.

InvariantsDefined on this element
ele-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())
9. Consent.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 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).

Control0..*
TypeExtension
Is Modifiertrue
Summaryfalse
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
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.

InvariantsDefined on this element
ele-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. Consent.identifier
Definition

Unique identifier for this copy of the Consent Statement.

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
TypeIdentifier
Summarytrue
Comments

This identifier identifies this copy of the consent. Where this identifier is also used elsewhere as the identifier for a consent record (e.g. a CDA consent document) then the consent details are expected to be the same.

Example
General:<valueIdentifier xmlns="http://hl7.org/fhir">
  <system value="urn:ietf:rfc:3986"/>
  <value value="Local eCMS identifier"/>
</valueIdentifier>
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
11. Consent.status
Definition

Indicates the current state of this consent.

Control1..1
BindingThe codes SHALL be taken from ConsentState Indicates the state of the consent
Typecode
Is Modifiertrue
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

The Consent Directive that is pointed to might be in various lifecycle states, e.g., a revoked Consent Directive.

Comments

This element is labeled as a modifier because the status contains the codes rejected and entered-in-error that mark the Consent as not currently valid.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
12. Consent.scope
Definition

A selector of the type of consent being presented: ADR, Privacy, Treatment, Research. This list is now extensible.

Control1..1
BindingThe codes SHALL be taken from ConsentScopeCodes; other codes may be used where these codes are not suitable The four anticipated uses for the Consent Resource
TypeCodeableConcept
Is Modifiertrue
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
13. Consent.category
Definition

A classification of the type of consents found in the statement. This element supports indexing and retrieval of consent statements.

Control1..*
BindingThe codes SHALL be taken from ConsentCategoryCodes; other codes may be used where these codes are not suitable A classification of the type of consents found in a consent statement
TypeCodeableConcept
Summarytrue
Pattern Value<valueCodeableConcept xmlns="http://hl7.org/fhir">
  <coding>
    <system value="http://terminology.hl7.org/CodeSystem/consentcategorycodes"/>
    <code value="research"/>
    <display value="Research Information Access"/>
  </coding>
</valueCodeableConcept>
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
14. Consent.patient
Definition

The patient/healthcare consumer to whom this consent applies.

Control0..1
TypeReference(Patient)
Summarytrue
Comments

Commonly, the patient the consent pertains to is the author, but for young and old people, it may be some other person.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
15. Consent.dateTime
Definition

When this Consent was issued / created / indexed.

Control0..1
TypedateTime
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Comments

This is not the time of the original consent, but the time that this statement was made or derived.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
16. Consent.performer
Definition

Either the Grantor, which is the entity responsible for granting the rights listed in a Consent Directive or the Grantee, which is the entity responsible for complying with the Consent Directive, including any obligations or limitations on authorizations and enforcement of prohibitions.

Control0..*
TypeReference(Organization|Patient|Practitioner|RelatedPerson|PractitionerRole)
Summarytrue
Alternate Namesconsentor
Comments

Commonly, the patient the consent pertains to is the consentor, but particularly for young and old people, it may be some other person - e.g. a legal guardian.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
17. Consent.organization
Definition

The organization that manages the consent, and the framework within which it is executed.

Control0..*
TypeReference(Organization)
Summarytrue
Alternate Namescustodian
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
18. Consent.source[x]
Definition

The source on which this consent statement is based. The source might be a scanned original paper form, or a reference to a consent that links back to such a source, a reference to a document repository (e.g. XDS) that stores the original consent document.

Control0..1
TypeChoice of: Attachment, Reference(Consent|DocumentReference|Contract|QuestionnaireResponse)
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
Comments

The source can be contained inline (Attachment), referenced directly (Consent), referenced in a consent repository (DocumentReference), or simply by an identifier (Identifier), e.g. a CDA document id.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
19. Consent.policy
Definition

The references to the policies that are included in this consent scope. Policies may be organizational, but are often defined jurisdictionally, or in law.

Control0..*
TypeBackboneElement
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
20. Consent.policy.id
Definition

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

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
21. Consent.policy.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 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.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
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.

InvariantsDefined on this element
ele-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. Consent.policy.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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
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.

InvariantsDefined on this element
ele-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())
23. Consent.policy.authority
Definition

Entity or Organization having regulatory jurisdiction or accountability for enforcing policies pertaining to Consent Directives.

Control0..1 This element is affected by the following invariants: ppc-1
Typeuri
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
24. Consent.policy.uri
Definition

The references to the policies that are included in this consent scope. Policies may be organizational, but are often defined jurisdictionally, or in law.

Control0..1 This element is affected by the following invariants: ppc-1
Typeuri
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Comments

This element is for discoverability / documentation and does not modify or qualify the policy rules.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
25. Consent.policyRule
Definition

A reference to the specific base computable regulation or policy.

Control0..1 This element is affected by the following invariants: ppc-1
BindingThe codes SHALL be taken from ConsentPolicyRuleCodes; other codes may be used where these codes are not suitable Regulatory policy examples
TypeCodeableConcept
Summarytrue
Requirements

Might be a unique identifier of a policy set in XACML, or other rules engine.

Comments

If the policyRule is absent, computable consent would need to be constructed from the elements of the Consent resource.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
26. Consent.verification
Definition

Whether a treatment instruction (e.g. artificial respiration yes or no) was verified with the patient, his/her family or another authorized person.

Control0..*
TypeBackboneElement
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
27. Consent.verification.id
Definition

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

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
28. Consent.verification.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 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.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
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.

InvariantsDefined on this element
ele-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())
29. Consent.verification.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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
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.

InvariantsDefined on this element
ele-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())
30. Consent.verification.verified
Definition

Has the instruction been verified.

Control1..1
Typeboolean
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
31. Consent.verification.verifiedWith
Definition

Who verified the instruction (Patient, Relative or other Authorized Person).

Control0..1
TypeReference(Patient|RelatedPerson)
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
32. Consent.verification.verificationDate
Definition

Date verification was collected.

Control0..1
TypedateTime
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
33. Consent.provision
Definition

An exception to the base policy of this consent. An exception can be an addition or removal of access permissions.

Control0..1
TypeBackboneElement
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
34. Consent.provision.id
Definition

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

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
35. Consent.provision.extension
Definition

An Extension

Control0..*
TypeExtension
Summaryfalse
InvariantsDefined on this element
ele-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())
SlicingThis element introduces a set of slices on Consent.provision.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
36. Consent.provision.extension:diseaseUseLimitation
SliceNamediseaseUseLimitation
Definition

Coding associated with limitation on what research can be performed this data.

Control0..1 This element is affected by the following invariants: ele-1
TypeExtension(ResearchDiseaseUseLimitation) (Extension Type: CodeableConcept)
InvariantsDefined on this element
ele-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())
37. Consent.provision.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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
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.

InvariantsDefined on this element
ele-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())
38. Consent.provision.type
Definition

Action to take - permit or deny - when the rule conditions are met. Not permitted in root rule, required in all nested rules.

Control0..1
BindingThe codes SHALL be taken from ConsentProvisionType How a rule statement is applied, such as adding additional consent or removing consent
Typecode
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
39. Consent.provision.period
Definition

The timeframe in this rule is valid.

Control0..1
TypePeriod
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
40. Consent.provision.actor
Definition

Who or what is controlled by this rule. Use group to identify a set of actors by some property they share (e.g. 'admitting officers').

Control0..*
TypeBackboneElement
Summaryfalse
Meaning if MissingThere is no specific actor associated with the exception
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
41. Consent.provision.actor.id
Definition

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

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
42. Consent.provision.actor.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 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.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
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.

InvariantsDefined on this element
ele-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())
43. Consent.provision.actor.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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
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.

InvariantsDefined on this element
ele-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())
44. Consent.provision.actor.role
Definition

How the individual is involved in the resources content that is described in the exception.

Control1..1
BindingThe codes SHALL be taken from SecurityRoleType; other codes may be used where these codes are not suitable How an actor is involved in the consent considerations
TypeCodeableConcept
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
45. Consent.provision.actor.reference
Definition

The resource that identifies the actor. To identify actors by type, use group to identify a set of actors by some property they share (e.g. 'admitting officers').

Control1..1
TypeReference(Device|Group|CareTeam|Organization|Patient|Practitioner|RelatedPerson|PractitionerRole)
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
46. Consent.provision.action
Definition

Actions controlled by this Rule.

Control0..*
BindingFor example codes, see ConsentActionCodes Detailed codes for the consent action
TypeCodeableConcept
Summarytrue
Comments

Note that this is the direct action (not the grounds for the action covered in the purpose element). At present, the only action in the understood and tested scope of this resource is 'read'.

Meaning if Missingall actions
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
47. Consent.provision.securityLabel
Definition

A security label, comprised of 0..* security label fields (Privacy tags), which define which resources are controlled by this exception.

Control0..*
BindingThe codes SHALL be taken from All Security Labels; other codes may be used where these codes are not suitable Security Labels from the Healthcare Privacy and Security Classification System
TypeCoding
Summarytrue
Comments

If the consent specifies a security label of "R" then it applies to all resources that are labeled "R" or lower. E.g. for Confidentiality, it's a high water mark. For other kinds of security labels, subsumption logic applies. When the purpose of use tag is on the data, access request purpose of use shall not conflict.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
48. Consent.provision.purpose
Definition

The context of the activities a user is taking - why the user is accessing the data - that are controlled by this rule.

Control0..*
BindingThe codes SHALL be taken from NIH Consent Code ValueSet; other codes may be used where these codes are not suitable
TypeCoding
Summarytrue
Comments

When the purpose of use tag is on the data, access request purpose of use shall not conflict.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
49. Consent.provision.class
Definition

The class of information covered by this rule. The type can be a FHIR resource type, a profile on a type, or a CDA document, or some other type that indicates what sort of information the consent relates to.

Control0..*
BindingThe codes SHALL be taken from ConsentContentClass; other codes may be used where these codes are not suitable The class (type) of information a consent rule covers
TypeCoding
Summarytrue
Comments

Multiple types are or'ed together. The intention of the contentType element is that the codes refer to profiles or document types defined in a standard or an implementation guide somewhere.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
50. Consent.provision.code
Definition

If this code is found in an instance, then the rule applies.

Control0..*
BindingFor example codes, see ConsentContentCodes If this code is found in an instance, then the exception applies
TypeCodeableConcept
Summarytrue
Comments

Typical use of this is a Document code with class = CDA.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
51. Consent.provision.dataPeriod
Definition

Clinical or Operational Relevant period of time that bounds the data controlled by this rule.

Control0..1
TypePeriod
Summarytrue
Comments

This has a different sense to the Consent.period - that is when the consent agreement holds. This is the time period of the data that is controlled by the agreement.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
52. Consent.provision.data
Definition

The resources controlled by this rule if specific resources are referenced.

Control0..*
TypeBackboneElement
Summarytrue
Meaning if Missingall data
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
53. Consent.provision.data.id
Definition

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

Control0..1
Typestring
XML RepresentationIn the XML format, this property is represented as an attribute.
Summaryfalse
54. Consent.provision.data.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 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.

Control0..*
TypeExtension
Summaryfalse
Alternate Namesextensions, user content
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.

InvariantsDefined on this element
ele-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())
55. Consent.provision.data.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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

Control0..*
TypeExtension
Is Modifiertrue
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
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.

InvariantsDefined on this element
ele-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())
56. Consent.provision.data.meaning
Definition

How the resource reference is interpreted when testing consent restrictions.

Control1..1
BindingThe codes SHALL be taken from ConsentDataMeaning How a resource reference is interpreted when testing consent restrictions
Typecode
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
57. Consent.provision.data.reference
Definition

A reference to a specific resource that defines which resources are covered by this consent.

Control1..1
TypeReference(Resource)
Summarytrue
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))
58. Consent.provision.provision
Definition

Rules which provide exceptions to the base rule or subrules.

Control0..*
TypeSee ttp://hl7.org/fhir/StructureDefinition/Consent#Consent.provision
Summaryfalse
InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count()))