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.

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.

Unique identifier for this copy of the Consent Statement.

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.

Indicates the current state of this Consent resource.

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.

A selector of the type of consent being presented with the base being Privacy, Treatment, or Research.

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

The patient/healthcare practitioner to whom this consent applies.

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

Date and time the consent instance was agreed to.

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.

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. Where HealthCareService is listed, some services might not be appropriate based on the type of service and if they can be segmented as an independent or dependent individual entity that might not be eligible to be a grantee.

A Consent without a listed performer may be used as a statement of preference by the subject and is not in force.

The actor that manages the consent through its lifecycle.

The actor that controls/enforces the access according to the consent.

The source on which this consent statement is based. The source might be a scanned original paper form.

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.

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.

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.

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

if policy and policyRule are not present, the resource must include the policy being agreed to, or complied with, and that policy and/or policyRule SHOULD be populated as soon as is practical to support workflows that require computability. In addition, the policy could be indicated via the sourceReference or sourceAttachment content.

Alternately, creating an invariant for individual scopes that forces one or more of the elements to be populated as part of a profile or Implementation Guide may be advisable.

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

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

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

A reference to the specific base computable regulation or policy.

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

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

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

Has the instruction been verified.

Extensible list of verification type starting with verification and re-validation.

This allows the verification element to hold multiple use cases including RelatedPerson verification of the Grantee decision and periodic re-validation of the consent.

The person who conducted the verification/validation of the Grantee decision.

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

Date(s) verification was collected.

Allows for history of verification/validation.

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

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

The timeframe in this rule is valid.

This is the bound effective time of the consent and should be in the base provision in the Consent resource.

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').

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

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').

Actions controlled by this Rule.

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'.

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

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.

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

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

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.

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.

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

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

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

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.

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

How the resource reference is interpreted when testing consent restrictions.

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

Rules which provide exceptions to the base rule or subrules.