This page is part of the FHIR Specification (v3.0.2: STU 3). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5R4BR4R3R2
A record of a healthcare consumer’s policy 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.
6.2.1 Scope and Usage
The purpose of this Resource is to be used to express a Consent regarding Healthcare. There are four
anticipated uses for the Consent Resource, all of which are written or verbal agreements by a
healthcare consumer [grantor] or a personal representative, made to an authorized entity [grantee]
concerning authorized or restricted actions with any limitations on purpose of use, and
handling instructions to which the authorized entity must comply:
Privacy Consent Directive: Agreement to collect, access, use or disclose (share) information.
Medical Treatment Consent Directive: Consent to undergo a specific treatment (or record of refusal to consent).
Research Consent Directive: Consent to participate in research protocol and information sharing required.
Advance Care Directives: Consent to instructions for potentially needed medical treatment (e.g. DNR).
This resource is scoped to cover all four uses, but at this time, only the privacy use case is modeled.
The scope of the resource may change when the other possible scopes are investigated, tested, or profiled.
A FHIR Consent Directive instance is considered the encoded legally binding Consent Directive if it meets
requirements of a policy domain requirements for an enforceable contract. In some domains, electronic
signatures of one or both of the parties to the content of an encoded representation of a Consent Form
is deemed to constitute a legally binding Consent Directive. Some domains accept a notary’s electronic
signature over the wet or electronic signature of a party to the Consent Directive as the additional
identity proofing required to make an encoded Consent Directive legally binding. Other domains may
only accept a wet signature, or may not require the parties’ signatures at all.
Whatever the criteria are for making an encoded FHIR Consent Directive legally binding, anything less
than a legally binding representation of a Consent Directive must be identified as such, i.e., as a
derivative of the legally binding Consent Directive, which has specific usage in Consent Directive workflow management.
Definitions:
Consent
The record of a healthcare consumer’s policy 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
Consent Directive
The legal record of a healthcare consumer's agreement with a party responsible for enforcing the consumer’s choices, which permits or denies identified actors or roles to perform actions affecting the consumer within a given context for specific purposes and periods of time
Consent Form
Human readable consent content describing one or more actions impacting the grantor for which the grantee would be authorized or prohibited from performing. It includes the terms, rules, and conditions pertaining to the authorization or restrictions, such as effective time, applicability or scope, purposes of use, obligations and prohibitions to which the grantee must comply. Once a Consent Form is “executed” by means required by policy, such as verbal agreement, wet signature, or electronic/digital signature, it becomes a legally binding Consent Directive.
Consent Directive Derivative
Consent Content that conveys the minimal set of information needed to manage Consent Directive workflow, including providing Consent Directive content sufficient to:
Represent a Consent Directive
Register or index a Consent Directive
Query and respond about a Consent Directive
Retrieve a Consent Directive
Notify authorized entities about Consent Directive status changes
Determine entities authorized to collect, access, use or disclose information about the Consent Directive or about the information governed by the Consent Directive.
Derived Consent content includes the Security Labels encoding the applicable privacy and security policies. Consent Security Labels inform recipients about specific access control measures required for compliance.
Consent Statement
A Consent Directive derivative has less than full fidelity to the legally binding Consent Directive from which it was "transcribed". It provides recipients with the full content representation they may require for compliance purposes, and typically include a reference to or an attached unstructured representation for recipients needing an exact copy of the legal agreement.
Consent Registration
The legal record of a healthcare consumer's agreement with a party responsible for enforcing the consumer’s choices, which permits or denies identified actors or roles to perform actions affecting the consumer within a given context for specific purposes and periods of timeA Consent Directive derivative that conveys the minimal set of information needed to register an active and revoked Consent Directive, or to update Consent status as it changes during its lifecycle.
Consent Query/Response Types
The FHIR Consent Resource specifies multiple Consent Search parameters, which support many types of queries for Consent Resource content. There are several Query/Response patterns that are typically used for obtaining information about consent directive content for the following use cases:
Find Active Consent Directive: A query that includes sufficient consent directive content to determine whether a specific party is authorized to share information governed by a consent directive with another specific party. The Response is either:
“Yes” meaning that both parties are authorized to share the information with one another.
“No” meaning that the authorized querier is not permitted to share with another specific party
“No information found” meaning that there is no active Consent Directive in which the querier is authorized to share the governed information.
Find Consent Directive Authorized Entities: A query that includes sufficient consent directive content to return a list of entities with which the querier is authorized to share governed information. The response to an authorized querier is the list of any authorized entities with which the querier is permitted to share governed information. The response to an unauthorized querier is that “no information is found”.
Find Consent Directive(s): A query that includes sufficient consent directive content to return a list of Consent Directive metadata for an authorized querier to determine what Consent Directives are available, and to locate and retrieve one or more of those Consent Directives as needed.
Policy context
Any organizational or jurisdictional policies, which may limit the consumer’s policy choices, and which includes the named range of actions allowed
Healthcare Consumer
The individual establishing his/her personal consent (i.e. Consenter). In FHIR, this is referred to as the 'Patient' though this word is not used across all contexts of care
6.2.1.1 Privacy Consent Directive (PCD)
Privacy policies define how Individually Identifiable Health Information
(IIHI) is to be collected, accessed, used and disclosed. A Privacy Consent
Directive as a legal record of a patient's (e.g. a healthcare consumer)
agreement with a party responsible for enforcing the patient's choices,
which permits or denies identified actors or roles to perform actions
affecting the patient within a given context for specific purposes and
periods of time. All consent directives have a policy context, which is
any set of organizational or jurisdictional policies which may limit the
consumer’s policy choices, and which include a named range of actions allowed.
In addition, Privacy Consent Directives provide the ability for a healthcare consumer
to delegate authority to a Substitute Decision Maker who may act on behalf of that individual.
Alternatively, a consumer may author/publish their privacy preferences as a self-declared Privacy Consent Directive.
The Consent resource on FHIR provides support for alternative representations for expressing
interoperable health information privacy consent directives in a standard form for the
exchange and enforcement by sending, intermediating, or receiving systems of privacy policies
that can be enforced by consuming systems (e.g., scanned documents, of computable structured
entries elements, FHIR structures with optional attached, or referenced unstructured representations.)
It may be used to represent the Privacy Consent Directive itself, a Consent Statement, which
electronically represents a Consent Directive, or Consent Metadata, which is the minimum
necessary consent content derived from a Consent Directive for use in workflow management.
6.2.2 Boundaries and Relationships
Consent management - particularly privacy consent - is complicated by the fact that consent to share
is often itself necessary to protect. The need to protect the privacy of the privacy statement itself
competes with the execution of the consent statement. For this reason, it is common to deal with
'consent statements' that are only partial representations of the full consent statement that the
patient provided.
For this reason, the consent resource contains two elements that refer back to the source: a master
identifier, and a direct reference to content from which this Consent Statement was derived. That
reference can be one of several things:
A reference to another consent resource from which this limited statement was derived
The source can be included in the consent as an attachment
The consent statements represent a chain that refers back to the original source consent
directive. Applications may be able to follow the chain back to the source, but should
not generally assume that they are authorized to do this.
Consent Directives are executed by verbal acknowledge or by being signed - either on paper, or digitally. Consent Signatures will
be found in the Provenance resource (example consent and
signature). Implementation Guides will generally
make rules about what signatures are required, and how they are to be shared and used.
6.2.3 Background and Context
The Consent resource is structured with a base policy which is either opt-in or opt-out,
followed by a listing of exceptions to that policy. The exceptions can be additional positive
or negative exceptions upon the base policy. The set of exceptions include a list of data objects,
list of authors, list of recipients, list of Organizations, list of purposeOfUse, and Date Range.
The enforcement of the Privacy Consent Directive is not included, but is expected that
enforcement can be done using a mix of the various Access Control enforcement methodologies (e.g. OAuth, UMA, XACML).
This enforcement includes the details of the enforcement meaning of the elements of the Privacy Consent Directive,
such as the rules in place when there is an opt-in consent would be specific about which
organizational roles have access to what kinds of resources (e.g. RBAC, ABAC).
The specification of these details are not in scope for the Consent resource.
A healthcare consumer's policy choices to permits or denies recipients or roles to perform actions for specific purposes and periods of time + Either a Policy or PolicyRule Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
A healthcare consumer's policy choices to permits or denies recipients or roles to perform actions for specific purposes and periods of time + Either a Policy or PolicyRule Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
ppc-1: Either a Policy or PolicyRule (expression : policy.exists() or policyRule.exists())
6.2.5 Policies
This specification defines 2 magic values for consent policyRule:
URI
Description
http://hl7.org/fhir/ConsentPolicy/opt-out
The basic 'deny' policy is to grant no authority for data access or use. No actions are approved, unless they are explicitly detailed in the exceptions
http://hl7.org/fhir/ConsentPolicy/opt-in
The basic 'permit' policy is to grant generally acceptable authority for data access and use. All generally acceptable actions are approved, unless they are explicitly detailed in the exceptions
Other jurisdictions (e.g. HL7 Affiliates) may define their additional lists of consent policy URI values that represent consent policies established by law or regulation
The Consent resource has a reference to a single policyRule. Many organizations will work in a context where multiple different consent regulations and policies apply.
In these cases, the single policy rule reference refers to a policy document that resolves and reconciles the various policies, and presents a single policy for patient
consent. If it is still necessary to track which of the underlying policies an exception is make in regard to, the policy may be used.
6.2.6 General Model
The following is the general model of Privacy Consent Directives.
There are context setting parameters:
Who - The
patient
What - The
data
- specific resources are listed, empty list means all data covered by the consent.
Where - The
domain
and
authority
- what is the location boundary and authority boundary of this consent
When - The
issued
or captured
When - The timeframe for which the Consent
applies
How - The
actions
covered. (such as purposes of use that are covered)
Whom - The
recipient
are grantees by the consent.
A Privacy Consent may transition through many states including: that no consent has been sought, consent has been proposed,
consent has been rejected, and consent approved.
There are set of patterns.
No consent: All settings need a policy for when no consent has been captured. Often this allows treatment only.;
Opt-in with restrictions: Sharing allowed, but the patient may make exceptions (See the Canadian examples).
For each of these patterns (positive or negative pattern), there can be exceptions.
These exceptions are explicitly recorded in the
except
element.
6.2.7 Realm specifics
6.2.7.1 US Realm sample Use-Cases
Five categories of Privacy Consent Directives are described in the Office of the National Coordinator for
Health Information (ONC) Consent Directives Document released March 31, 2010, and include the following
US-specific “Core consent options” for electronic exchange:
No consent: Health information of patients is automatically included—patients cannot opt out;
Opt-out: Default is for health information of patients to be included automatically, but the patient can opt out completely;
Opt-out with exceptions: Default is for health information of patients to be included, but the patient can opt out completely or allow only select data to be included;
Opt-in: Default is that no patient health information is included; patients must actively express consent to be included, but if they do so then their information must be all in or all out; and
Opt-in with restrictions: Default is that no patient health information is made available, but the patient may allow a subset of select data to be included.
A common exception is to explicitly exclude or explicitly include a period of time.
6.2.7.2 Canada Realm sample Use-Cases
The following scenarios are based on existing jurisdictional policy and are realized in existing systems in
Canada. The default policy is one of implied consent for the provision of care, so these scenarios all deal
with withdrawal or withholding consent for that purpose. In other jurisdictions, where an express consent
model is used (Opt-In), these examples would contain the phrase "consent to" rather than "withhold"
or "withdraw" consent for.
Withhold or withdraw consent for disclosure of records related to specific domain (e.g. DI, LAB, etc.)
Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.
Security and Privacy
. Page versions: R5 R4B R4 R3 R2
Consent 
identifier 
status 
patient 
actor 
source[x] 
<!-- from Resource: id, meta, implicitRules, and language --> <!-- from DomainResource: text, contained, extension, and modifierExtension --> <identifier><!-- 0..1 Identifier Identifier for this record (external references) --></identifier> <status value="[code]"/><!-- 1..1 draft | proposed | active | rejected | inactive | entered-in-error --> <category><!-- 0..* CodeableConcept Classification of the consent statement - for indexing/retrieval --></category> <patient><!-- 1..1 Reference(Patient) Who the consent applies to --></patient> <period><!-- 0..1 Period Period that this consent applies --></period> <dateTime value="[dateTime]"/><!-- 0..1 When this Consent was created or indexed --> <consentingParty><!-- 0..* Reference(Organization|Patient|Practitioner| RelatedPerson) Who is agreeing to the policy and exceptions --></consentingParty> <actor> <!-- 0..* Who|what controlled by this consent (or group, by role) --> <role><!-- 1..1 CodeableConcept How the actor is involved --></role> <reference><!-- 1..1 Reference(Device|Group|CareTeam|Organization|Patient| Practitioner|RelatedPerson) Resource for the actor (or group, by role) --></reference> </actor> <action><!-- 0..* CodeableConcept Actions controlled by this consent --></action> <organization><!-- 0..* Reference(Organization) Custodian of the consent --></organization> <source[x]><!-- 0..1 Attachment|Identifier|Reference(Consent|DocumentReference| Contract|QuestionnaireResponse) Source from which this consent is taken --></source[x]> <policy> <!-- 0..* Policies covered by this consent --> <authority value="[uri]"/><!--
0..1 Enforcement source for policy --> <uri value="[uri]"/><!--
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