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
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 | |
Invariants | Defined 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 | |
Control | 0..? |
4. Consent.provision.extension | |
Slicing | This element introduces a set of slices on Consent.provision.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
|
5. Consent.provision.extension:diseaseUseLimitation | |
SliceName | diseaseUseLimitation |
Control | 0..1 |
Type | Extension(ResearchDiseaseUseLimitation) (Extension Type: CodeableConcept) |
6. Consent.provision.purpose | |
Binding | The 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. |
Control | 0..* |
Summary | false |
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. |
Invariants | Defined 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. |
Control | 0..1 |
Type | uri |
Is Modifier | true |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
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. |
Invariants | Defined 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). |
Control | 0..* |
Type | Extension |
Is Modifier | true |
Summary | false |
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 Names | extensions, 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. |
Invariants | Defined 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. |
Control | 1..1 |
Binding | The codes SHALL be taken from ConsentState Indicates the state of the consent. |
Type | code |
Is Modifier | true |
Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Summary | true |
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. |
Invariants | Defined 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. |
Control | 1..1 |
Binding | The 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. |
Type | CodeableConcept |
Is Modifier | true |
Summary | true |
Invariants | Defined 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. |
Control | 1..* |
Binding | The 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. |
Type | CodeableConcept |
Summary | true |
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> |
Invariants | Defined 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. | ||||
Control | 0..* | ||||
Summary | false | ||||
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. | ||||
Control | 0..1 | ||||
Type | id | ||||
Summary | true | ||||
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. | ||||
Control | 0..1 | ||||
Type | Meta | ||||
Summary | true | ||||
Invariants | Defined 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. | ||||
Control | 0..1 | ||||
Type | uri | ||||
Is Modifier | true | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | true | ||||
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. | ||||
Invariants | Defined 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. | ||||
Control | 0..1 | ||||
Binding | The codes SHOULD be taken from CommonLanguages
A human language
| ||||
Type | code | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | false | ||||
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). | ||||
Invariants | Defined 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. | ||||
Control | 0..1 | ||||
Type | Narrative | ||||
Summary | false | ||||
Alternate Names | narrative, 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. | ||||
Invariants | Defined 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. | ||||
Control | 0..* | ||||
Type | Resource | ||||
Summary | false | ||||
Alternate Names | inline 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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Summary | false | ||||
Alternate Names | extensions, 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. | ||||
Invariants | Defined 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). | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | true | ||||
Summary | false | ||||
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 Names | extensions, 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. | ||||
Invariants | Defined 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. | ||||
Note | This is a business identifier, not a resource identifier (see discussion) | ||||
Control | 0..* | ||||
Type | Identifier | ||||
Summary | true | ||||
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> | ||||
Invariants | Defined 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. | ||||
Control | 1..1 | ||||
Binding | The codes SHALL be taken from ConsentState Indicates the state of the consent | ||||
Type | code | ||||
Is Modifier | true | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | true | ||||
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. | ||||
Invariants | Defined 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. | ||||
Control | 1..1 | ||||
Binding | The 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 | ||||
Type | CodeableConcept | ||||
Is Modifier | true | ||||
Summary | true | ||||
Invariants | Defined 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. | ||||
Control | 1..* | ||||
Binding | The 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 | ||||
Type | CodeableConcept | ||||
Summary | true | ||||
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> | ||||
Invariants | Defined 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. | ||||
Control | 0..1 | ||||
Type | Reference(Patient) | ||||
Summary | true | ||||
Comments | Commonly, the patient the consent pertains to is the author, but for young and old people, it may be some other person. | ||||
Invariants | Defined 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. | ||||
Control | 0..1 | ||||
Type | dateTime | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | true | ||||
Comments | This is not the time of the original consent, but the time that this statement was made or derived. | ||||
Invariants | Defined 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. | ||||
Control | 0..* | ||||
Type | Reference(Organization|Patient|Practitioner|RelatedPerson|PractitionerRole) | ||||
Summary | true | ||||
Alternate Names | consentor | ||||
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. | ||||
Invariants | Defined 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. | ||||
Control | 0..* | ||||
Type | Reference(Organization) | ||||
Summary | true | ||||
Alternate Names | custodian | ||||
Invariants | Defined 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. | ||||
Control | 0..1 | ||||
Type | Choice of: Attachment, Reference(Consent|DocumentReference|Contract|QuestionnaireResponse) | ||||
[x] Note | See Choice of Data Types for further information about how to use [x] | ||||
Summary | true | ||||
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. | ||||
Invariants | Defined 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. | ||||
Control | 0..* | ||||
Type | BackboneElement | ||||
Summary | false | ||||
Invariants | Defined 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. | ||||
Control | 0..1 | ||||
Type | string | ||||
XML Representation | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Summary | false | ||||
Alternate Names | extensions, 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. | ||||
Invariants | Defined 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). | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | true | ||||
Summary | true | ||||
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 Names | extensions, 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. | ||||
Invariants | Defined 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. | ||||
Control | 0..1 This element is affected by the following invariants: ppc-1 | ||||
Type | uri | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | false | ||||
Invariants | Defined 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. | ||||
Control | 0..1 This element is affected by the following invariants: ppc-1 | ||||
Type | uri | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | false | ||||
Comments | This element is for discoverability / documentation and does not modify or qualify the policy rules. | ||||
Invariants | Defined 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. | ||||
Control | 0..1 This element is affected by the following invariants: ppc-1 | ||||
Binding | The codes SHALL be taken from ConsentPolicyRuleCodes; other codes may be used where these codes are not suitable Regulatory policy examples | ||||
Type | CodeableConcept | ||||
Summary | true | ||||
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. | ||||
Invariants | Defined 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. | ||||
Control | 0..* | ||||
Type | BackboneElement | ||||
Summary | true | ||||
Invariants | Defined 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. | ||||
Control | 0..1 | ||||
Type | string | ||||
XML Representation | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Summary | false | ||||
Alternate Names | extensions, 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. | ||||
Invariants | Defined 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). | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | true | ||||
Summary | true | ||||
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 Names | extensions, 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. | ||||
Invariants | Defined 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. | ||||
Control | 1..1 | ||||
Type | boolean | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | true | ||||
Invariants | Defined 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). | ||||
Control | 0..1 | ||||
Type | Reference(Patient|RelatedPerson) | ||||
Summary | false | ||||
Invariants | Defined 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. | ||||
Control | 0..1 | ||||
Type | dateTime | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | false | ||||
Invariants | Defined 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. | ||||
Control | 0..1 | ||||
Type | BackboneElement | ||||
Summary | true | ||||
Invariants | Defined 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. | ||||
Control | 0..1 | ||||
Type | string | ||||
XML Representation | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
35. Consent.provision.extension | |||||
Definition | An Extension | ||||
Control | 0..* | ||||
Type | Extension | ||||
Summary | false | ||||
Invariants | Defined 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()) | ||||
Slicing | This element introduces a set of slices on Consent.provision.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
| ||||
36. Consent.provision.extension:diseaseUseLimitation | |||||
SliceName | diseaseUseLimitation | ||||
Definition | Coding associated with limitation on what research can be performed this data. | ||||
Control | 0..1 This element is affected by the following invariants: ele-1 | ||||
Type | Extension(ResearchDiseaseUseLimitation) (Extension Type: CodeableConcept) | ||||
Invariants | Defined 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). | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | true | ||||
Summary | true | ||||
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 Names | extensions, 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. | ||||
Invariants | Defined 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. | ||||
Control | 0..1 | ||||
Binding | The codes SHALL be taken from ConsentProvisionType How a rule statement is applied, such as adding additional consent or removing consent | ||||
Type | code | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | true | ||||
Invariants | Defined 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. | ||||
Control | 0..1 | ||||
Type | Period | ||||
Summary | true | ||||
Invariants | Defined 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'). | ||||
Control | 0..* | ||||
Type | BackboneElement | ||||
Summary | false | ||||
Meaning if Missing | There is no specific actor associated with the exception | ||||
Invariants | Defined 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. | ||||
Control | 0..1 | ||||
Type | string | ||||
XML Representation | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Summary | false | ||||
Alternate Names | extensions, 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. | ||||
Invariants | Defined 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). | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | true | ||||
Summary | true | ||||
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 Names | extensions, 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. | ||||
Invariants | Defined 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. | ||||
Control | 1..1 | ||||
Binding | The 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 | ||||
Type | CodeableConcept | ||||
Summary | false | ||||
Invariants | Defined 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'). | ||||
Control | 1..1 | ||||
Type | Reference(Device|Group|CareTeam|Organization|Patient|Practitioner|RelatedPerson|PractitionerRole) | ||||
Summary | false | ||||
Invariants | Defined 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. | ||||
Control | 0..* | ||||
Binding | For example codes, see ConsentActionCodes Detailed codes for the consent action | ||||
Type | CodeableConcept | ||||
Summary | true | ||||
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 Missing | all actions | ||||
Invariants | Defined 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. | ||||
Control | 0..* | ||||
Binding | The 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 | ||||
Type | Coding | ||||
Summary | true | ||||
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. | ||||
Invariants | Defined 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. | ||||
Control | 0..* | ||||
Binding | The codes SHALL be taken from NIH Consent Code ValueSet; other codes may be used where these codes are not suitable | ||||
Type | Coding | ||||
Summary | true | ||||
Comments | When the purpose of use tag is on the data, access request purpose of use shall not conflict. | ||||
Invariants | Defined 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. | ||||
Control | 0..* | ||||
Binding | The 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 | ||||
Type | Coding | ||||
Summary | true | ||||
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. | ||||
Invariants | Defined 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. | ||||
Control | 0..* | ||||
Binding | For example codes, see ConsentContentCodes If this code is found in an instance, then the exception applies | ||||
Type | CodeableConcept | ||||
Summary | true | ||||
Comments | Typical use of this is a Document code with class = CDA. | ||||
Invariants | Defined 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. | ||||
Control | 0..1 | ||||
Type | Period | ||||
Summary | true | ||||
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. | ||||
Invariants | Defined 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. | ||||
Control | 0..* | ||||
Type | BackboneElement | ||||
Summary | true | ||||
Meaning if Missing | all data | ||||
Invariants | Defined 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. | ||||
Control | 0..1 | ||||
Type | string | ||||
XML Representation | In the XML format, this property is represented as an attribute. | ||||
Summary | false | ||||
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. | ||||
Control | 0..* | ||||
Type | Extension | ||||
Summary | false | ||||
Alternate Names | extensions, 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. | ||||
Invariants | Defined 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). | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | true | ||||
Summary | true | ||||
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 Names | extensions, 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. | ||||
Invariants | Defined 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. | ||||
Control | 1..1 | ||||
Binding | The codes SHALL be taken from ConsentDataMeaning How a resource reference is interpreted when testing consent restrictions | ||||
Type | code | ||||
Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
Summary | true | ||||
Invariants | Defined 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. | ||||
Control | 1..1 | ||||
Type | Reference(Resource) | ||||
Summary | true | ||||
Invariants | Defined 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. | ||||
Control | 0..* | ||||
Type | See ttp://hl7.org/fhir/StructureDefinition/Consent#Consent.provision | ||||
Summary | false | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |