VJL - Vähiandmete juhtimislaud, published by TEHIK. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/TEHIK-EE/ig-ee-vjl/ and changes regularly. See the Directory of published versions
| Draft as of 2026-08-18 |
Definitions for the ee-vjl-clinical-trial-consent resource profile.
Guidance on how to interpret the contents of this table can be foundhere
| 0. Consent | |
| Definition | A record of a healthcare consumer’s choices or choices made on their behalf by a third party, 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. |
| Short | A healthcare consumer's or third party's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time |
| 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 consent for research participation and data sharing. |
| Control | 0..* |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Invariants | 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()) dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()) dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty()) dom-6: A resource should have narrative for robust management (text.`div`.exists()) |
| 2. 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. |
| Short | A set of rules under which this content was created |
| Comments | Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc. |
| Control | 0..1 |
| Type | uri |
| Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Must Support | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 4. Consent.contained | |
| Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning. |
| Short | Contained, inline Resources |
| Comments | This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels. |
| Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5 |
| Type | Resource |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Alternate Names | inline resources, anonymous resources, contained resources |
| 6. 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 managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them |
| Must Support | false |
| 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 |
| Invariants | 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()) |
| 8. Consent.status | |
| Definition | Indicates the current state of this Consent resource. |
| Short | draft | active | inactive | not-done | entered-in-error | unknown |
| 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. |
| Control | 1..1 |
| Binding | The codes SHALL be taken from ConsentStatehttp://hl7.org/fhir/ValueSet/consent-state-codes|5.0.0 (required to http://hl7.org/fhir/ValueSet/consent-state-codes|5.0.0)Indicates the state of the consent. |
| Type | code |
| Is Modifier | true because This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Must Support | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 10. Consent.subject | |
| Definition | The patient/healthcare practitioner or group of persons to whom this consent applies. |
| Short | Who the consent applies to |
| Control | 0..1 |
| Type | Reference(EE VJL Patient, Patient, Practitioner, Group) |
| Is Modifier | false |
| Must Support | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 12. Consent.date | |
| Definition | Date the consent instance was agreed to. |
| Short | Nõusoleku andmise kuupäev?Fully executed date of the consent |
| Control | 0..1 |
| Type | date |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Must Support | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 14. Consent.grantor | |
| Definition | The entity responsible for granting the rights listed in a Consent Directive. |
| Short | Who is granting rights according to the policy and rules |
| Control | 0..0* |
| Type | Reference(CareTeam, HealthcareService, Organization, Patient, Practitioner, RelatedPerson, PractitionerRole) |
| Is Modifier | false |
| Must Support | false |
| Summary | true |
| Alternate Names | grantor |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 16. Consent.grantee | |
| Definition | The entity responsible for complying with the Consent Directive, including any obligations or limitations on authorizations and enforcement of prohibitions. |
| Short | Who is agreeing to the policy and rules |
| Comments | In a fully computable consent, both grantee and grantor will be listed as actors within the consent. The Grantee and Grantor elements are for ease of search only. |
| Control | 0..0* |
| Type | Reference(CareTeam, HealthcareService, Organization, Patient, Practitioner, RelatedPerson, PractitionerRole) |
| Is Modifier | false |
| Must Support | false |
| Summary | true |
| Alternate Names | grantee |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 18. Consent.manager | |
| Definition | The actor that manages the consent through its lifecycle. |
| Short | Consent workflow management |
| Control | 0..0* |
| Type | Reference(HealthcareService, Organization, Patient, Practitioner) |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Alternate Names | manager |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 20. Consent.controller | |
| Definition | The actor that controls/enforces the access according to the consent. |
| Short | Consent Enforcer |
| Control | 0..0* |
| Type | Reference(HealthcareService, Organization, Patient, Practitioner) |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Alternate Names | controller |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 22. Consent.regulatoryBasis | |
| Definition | A set of codes that indicate the regulatory basis (if any) that this consent supports. |
| Short | Regulations establishing base Consent |
| Control | 0..0* |
| Binding | For example codes, see ConsentPolicyRuleCodeshttp://hl7.org/fhir/ValueSet/consent-policy|5.0.0 (example to http://hl7.org/fhir/ValueSet/consent-policy|5.0.0)Regulatory policy examples |
| Type | CodeableConcept |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 24. Consent.policyBasis | |
| Definition | A Reference or URL used to uniquely identify the policy the organization will enforce for this Consent. This Reference or URL should be specific to the version of the policy and should be dereferencable to a computable policy of some form. |
| Short | Computable version of the backing policy |
| Control | 0..01 |
| Type | BackboneElement |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 27. 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. |
| Short | Consent Verified by patient or family |
| Control | 0..0* |
| Type | BackboneElement |
| Is Modifier | false |
| Must Support | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 31. Consent.decision | |
| Definition | Action to take - permit or deny - as default. |
| Short | deny | permit |
| Control | 0..1 |
| Binding | The codes SHALL be taken from ConsentProvisionTypehttp://hl7.org/fhir/ValueSet/consent-provision-type|5.0.0 (required to http://hl7.org/fhir/ValueSet/consent-provision-type|5.0.0)Sets the base decision for Consent to be either permit or deny, with provisions assumed to be a negation of the previous level. |
| Type | code |
| Is Modifier | true because Sets context for the values in .provision |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Must Support | false |
| Summary | true |
| Invariants | 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. |
| Short | Constraints to the base Consent.policyRule/Consent.policy |
| Control | 0..0* |
| Type | BackboneElement |
| Is Modifier | false |
| Must Support | false |
| Summary | true |
| Invariants | 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 foundhere
| 0. Consent | |
| 2. Consent.category | |
| 4. Consent.category.coding | |
| Control | 1..1 |
| Pattern Value | { |
| 6. Consent.subject | |
| Type | Reference(EE VJL Patient) |
| 8. Consent.date | |
| Short | Nõusoleku andmise kuupäev? |
| 10. Consent.grantor | |
| Control | 0..0 |
| 12. Consent.grantee | |
| Control | 0..0 |
| 14. Consent.manager | |
| Control | 0..0 |
| 16. Consent.controller | |
| Control | 0..0 |
| 18. Consent.regulatoryBasis | |
| Control | 0..0 |
| 20. Consent.policyBasis | |
| Control | 0..0 |
| 22. Consent.verification | |
| Control | 0..0 |
| 24. Consent.provision | |
| Control | 0..0 |
Guidance on how to interpret the contents of this table can be foundhere
| 0. Consent | |
| Definition | A record of a healthcare consumer’s choices or choices made on their behalf by a third party, 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. |
| Short | A healthcare consumer's or third party's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time |
| 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 consent for research participation and data sharing. |
| Control | 0..* |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Invariants | 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty())dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated ( contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())dom-5: If a resource is contained in another resource, it SHALL NOT have a security label ( contained.meta.security.empty())dom-6: A resource should have narrative for robust management ( text.`div`.exists()) |
| 2. Consent.id | |
| Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. |
| Short | Logical id of this artifact |
| Comments | Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case. |
| Control | 0..1 |
| Type | id |
| Is Modifier | false |
| Must Support | false |
| Summary | true |
| 4. 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. |
| Short | Metadata about the resource |
| Control | 0..1 |
| Type | Meta |
| Is Modifier | false |
| Must Support | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 6. 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. |
| Short | A set of rules under which this content was created |
| Comments | Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc. |
| Control | 0..1 |
| Type | uri |
| Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Must Support | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 8. Consent.language | |
| Definition | The base language in which the resource is written. |
| Short | Language of the resource content |
| Comments | Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). |
| Control | 0..1 |
| Binding | The codes SHALL be taken from AllLanguages (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)IETF language tag for a human language |
| Type | code |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 10. 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. |
| Short | Text summary of the resource, for human interpretation |
| Comments | Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later. |
| Control | 0..1 This element is affected by the following invariants: dom-6 |
| Type | Narrative |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Alternate Names | narrative, html, xhtml, display |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 12. Consent.contained | |
| Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning. |
| Short | Contained, inline Resources |
| Comments | This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels. |
| Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5 |
| Type | Resource |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Alternate Names | inline resources, anonymous resources, contained resources |
| 14. 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 managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | 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()) |
| 16. 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 managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself). |
| Short | Extensions that cannot be ignored |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them |
| Must Support | false |
| 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 |
| Invariants | 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()) |
| 18. Consent.identifier | |
| Definition | Unique identifier for this copy of the Consent Statement. |
| Short | Identifier for this record (external references) |
| 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. |
| Note | This is a business identifier, not a resource identifier (see discussion) |
| Control | 0..* |
| Type | Identifier |
| Is Modifier | false |
| Must Support | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 20. Consent.status | |
| Definition | Indicates the current state of this Consent resource. |
| Short | draft | active | inactive | not-done | entered-in-error | unknown |
| 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. |
| Control | 1..1 |
| Binding | The codes SHALL be taken from ConsentState (required to http://hl7.org/fhir/ValueSet/consent-state-codes|5.0.0)Indicates the state of the consent. |
| Type | code |
| Is Modifier | true because This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Must Support | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 22. Consent.category | |
| Definition | A classification of the type of consents found in the statement. This element supports indexing and retrieval of consent statements. |
| Short | Classification of the consent statement - for indexing/retrieval |
| Control | 0..* |
| Binding | For example codes, see ConsentCategoryCodes (example to http://hl7.org/fhir/ValueSet/consent-category|5.0.0)A classification of the type of consents found in a consent statement. |
| Type | CodeableConcept |
| Is Modifier | false |
| Must Support | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 24. Consent.category.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 This element is affected by the following invariants: ele-1 |
| Type | id |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 26. Consent.category.extension | |
| Definition | May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | Additional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | 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.category.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 28. Consent.category.coding | |
| Definition | A reference to a code defined by a terminology system. |
| Short | Code defined by a terminology system |
| Comments | Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. |
| Control | 1..1 |
| Type | Coding |
| Is Modifier | false |
| Summary | true |
| Requirements | Allows for alternative encodings within a code system, and translations to other code systems. |
| Pattern Value | { |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 30. Consent.category.text | |
| Definition | A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. |
| Short | Plain text representation of the concept |
| Comments | Very often the text is the same as a displayName of one of the codings. |
| Control | 0..1 |
| Type | string |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | true |
| Requirements | The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 32. Consent.subject | |
| Definition | The patient/healthcare practitioner or group of persons to whom this consent applies. |
| Short | Who the consent applies to |
| Control | 0..1 |
| Type | Reference(EE VJL Patient) |
| Is Modifier | false |
| Must Support | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 34. Consent.date | |
| Definition | Date the consent instance was agreed to. |
| Short | Nõusoleku andmise kuupäev? |
| Control | 0..1 |
| Type | date |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Must Support | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 36. Consent.period | |
| Definition | Effective period for this Consent Resource and all provisions unless specified in that provision. |
| Short | Effective period for this Consent |
| Control | 0..1 |
| Type | Period |
| Is Modifier | false |
| Must Support | false |
| Summary | true |
| Alternate Names | period |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 38. Consent.grantor | |
| Definition | The entity responsible for granting the rights listed in a Consent Directive. |
| Short | Who is granting rights according to the policy and rules |
| Control | 0..0 |
| Type | Reference(CareTeam, HealthcareService, Organization, Patient, Practitioner, RelatedPerson, PractitionerRole) |
| Is Modifier | false |
| Must Support | false |
| Summary | true |
| Alternate Names | grantor |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 40. Consent.grantee | |
| Definition | The entity responsible for complying with the Consent Directive, including any obligations or limitations on authorizations and enforcement of prohibitions. |
| Short | Who is agreeing to the policy and rules |
| Comments | In a fully computable consent, both grantee and grantor will be listed as actors within the consent. The Grantee and Grantor elements are for ease of search only. |
| Control | 0..0 |
| Type | Reference(CareTeam, HealthcareService, Organization, Patient, Practitioner, RelatedPerson, PractitionerRole) |
| Is Modifier | false |
| Must Support | false |
| Summary | true |
| Alternate Names | grantee |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 42. Consent.manager | |
| Definition | The actor that manages the consent through its lifecycle. |
| Short | Consent workflow management |
| Control | 0..0 |
| Type | Reference(HealthcareService, Organization, Patient, Practitioner) |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Alternate Names | manager |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 44. Consent.controller | |
| Definition | The actor that controls/enforces the access according to the consent. |
| Short | Consent Enforcer |
| Control | 0..0 |
| Type | Reference(HealthcareService, Organization, Patient, Practitioner) |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Alternate Names | controller |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 46. Consent.sourceAttachment | |
| Definition | The source on which this consent statement is based. The source might be a scanned original paper form. |
| Short | Source from which this consent is taken |
| 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. |
| Control | 0..* |
| Type | Attachment |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 48. Consent.sourceReference | |
| Definition | 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. |
| Short | Source from which this consent is taken |
| 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. |
| Control | 0..* |
| Type | Reference(Consent, DocumentReference, Contract, QuestionnaireResponse) |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 50. Consent.regulatoryBasis | |
| Definition | A set of codes that indicate the regulatory basis (if any) that this consent supports. |
| Short | Regulations establishing base Consent |
| Control | 0..0 |
| Binding | For example codes, see ConsentPolicyRuleCodes (example to http://hl7.org/fhir/ValueSet/consent-policy|5.0.0)Regulatory policy examples |
| Type | CodeableConcept |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 52. Consent.policyBasis | |
| Definition | A Reference or URL used to uniquely identify the policy the organization will enforce for this Consent. This Reference or URL should be specific to the version of the policy and should be dereferencable to a computable policy of some form. |
| Short | Computable version of the backing policy |
| Control | 0..0 |
| Type | BackboneElement |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 59. Consent.policyText | |
| Definition | A Reference to the human readable policy explaining the basis for the Consent. |
| Short | Human Readable Policy |
| Control | 0..* |
| Type | Reference(DocumentReference) |
| Is Modifier | false |
| Must Support | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 61. 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. |
| Short | Consent Verified by patient or family |
| Control | 0..0 |
| Type | BackboneElement |
| Is Modifier | false |
| Must Support | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 71. Consent.decision | |
| Definition | Action to take - permit or deny - as default. |
| Short | deny | permit |
| Control | 0..1 |
| Binding | The codes SHALL be taken from ConsentProvisionType (required to http://hl7.org/fhir/ValueSet/consent-provision-type|5.0.0)Sets the base decision for Consent to be either permit or deny, with provisions assumed to be a negation of the previous level. |
| Type | code |
| Is Modifier | true because Sets context for the values in .provision |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Must Support | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
| 73. Consent.provision | |
| Definition | An exception to the base policy of this consent. An exception can be an addition or removal of access permissions. |
| Short | Constraints to the base Consent.policyRule/Consent.policy |
| Control | 0..0 |
| Type | BackboneElement |
| Is Modifier | false |
| Must Support | false |
| Summary | true |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |