6.2 Resource Consent - Content

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: an inline attachment 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
• A reference to a document format for the original source (e.g. PDF or CDA - see the HL7 CDAR2 ConsentDirective Implementation Guide , which incorporated the IHE Basic Patient Privacy Consents (BPPC) ), either directly, or in a reference
• 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 acknowledgement or by being signed - either on paper, or digitally. Consent Signatures will be found in the Provenance resource. 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 (represented as Consent.decision) which is either permit or deny, followed by a listing of exceptions to that policy (represented as Consent.provision(s)). 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 is not in scope for the Consent resource.

6.2.4 References to this Resource

• Implements: Event
• Resource References: itself and ResearchSubject

6.2.5 Resource Content

 

Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis

6.2.5.1 Terminology Bindings

Path	ValueSet	Type	Documentation
Consent.status	ConsentState	Required	Indicates the state of the consent.
Consent.category	ConsentCategoryCodes	Example	This value set includes sample Consent Directive Type codes, including several consent directive related LOINC codes; HL7 VALUE SET: ActConsentType(2.16.840.1.113883.1.11.19897); examples of US realm consent directive legal descriptions and references to online and/or downloadable forms such as the SSA-827 Authorization to Disclose Information to the Social Security Administration; and other anticipated consent directives related to participation in a clinical trial, medical procedures, reproductive procedures; health care directive (Living Will); advance directive, do not resuscitate (DNR); Physician Orders for Life-Sustaining Treatment (POLST)
Consent.regulatoryBasis	ConsentPolicyRuleCodes	Example	This value set includes sample Regulatory consent policy types from the US and other regions.
Consent.verification.verificationType	ConsentVerificationCodes	Example	This value set includes base Consent Verification codes.
Consent.decision	ConsentProvisionType	Required	How a rule statement is applied, such as adding additional consent or removing consent.
Consent.provision.actor.role	ParticipationRoleType	Extensible	This FHIR value set is comprised of Actor participation Type codes, which can be used to value FHIR agents, actors, and other role elements. The codes are intended to express how the agent participated in some activity. Sometimes refered to the agent functional-role relative to the activity.
Consent.provision.action	ConsentActionCodes	Example	This value set includes sample Consent Action codes.
Consent.provision.securityLabel	SecurityLabelExamples	Example	A sample of security labels from Healthcare Privacy and Security Classification System as the combination of data and event codes.
Consent.provision.purpose	PurposeOfUse	Extensible	Supports communication of purpose of use at a general level.
Consent.provision.documentType	ConsentContentClass	Preferred	This value set includes the FHIR resource types, along with some other important content class codes
Consent.provision.resourceType	ResourceType	Extensible	Concrete FHIR Resource Types
Consent.provision.code	ConsentContentCodes	Example	This example value set contains all LOINC code
Consent.provision.data.meaning	ConsentDataMeaning	Required	How a resource reference is interpreted when testing consent restrictions.

6.2.6 Policies

The Consent resource has a reference to a single PolicyBasis. Many organizations will work in a context where multiple different consent regulations and policies apply. In these cases, the single 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 regulations an exception is make in regard to, the RegulatoryBasis may be used.

Policies attached to PolicyBasis should be written using positive language. For an example, a patient wanting to opt-out will be recorded with an opt-in policy where the Consent.provision[0].type indicates "deny".

6.2.7 Privacy Consent General Model

The following is the general model of Privacy Consent Directives.

There are context setting parameters:

1. Who - The patientor third-party grantor
2. What - The data - specific resources are listed, empty list means all data covered by the consent.
3. Where Required - The location boundary and authority boundary of this consent policy domain.
4. Where Accountability Lies - The organization or performer
5. When - The date issued or captured
6. When - The timeframe for which the Consent applies
7. How - The actions covered. (such as purposes of use that are covered)
8. Whom - The actor 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.

1. No consent: All settings need a policy for when no consent has been captured. Often this allows treatment only.;
2. Opt-out: No sharing allowed for the specified domain, location, actions, and purposes;
3. Opt-out with exceptions: No sharing allowed, with some exceptions where it is allowed. Example: Withhold Authorization for Treatment except for Emergency Treatment;
4. Opt-in: Sharing for some purpose of use is authorized Sharing allowed for Treatment, Payment, and normal Operations; and
5. Opt-in with restrictions: Sharing allowed, but the patient may make exceptions.

For each of these patterns (positive or negative pattern), there can be exceptions. These exceptions are explicitly recorded in the provision element.

6.2.8 Provisions

The provision structure provides a mechanism for modeling consent rules in a machine-readable and computable way. This is the FHIR Consent's native mechanism for expressing and encoding policy rules within the resource --an alternative to using an external policy language.

The default decision of the consent is stated by the decision attribute (permit or deny) and provisions state the exceptions to the base decision. Each provision may have its own sub-provisions that, in turn, state the exceptions to the rules stated in the parent provision. The following figure depicts this structure:

For example, if the base decision for a consent is permit, the first level of provisions express exceptions to this decision, therefore, the decision when matching these provisions will be a deny. The immediate child provisions to any of these provisions would express exceptions to their deny decision, therefore, their effect, when matched, will be permit.

The provision structure provides a rich mechanism to construct complex rules using logical AND and OR:

• Provisions at the same level of depth are interpreted as disjunctive (i.e., OR-ed). This means that matching any of the sibling provisions at one level constitutes an exception to the rule stated in the parent provision.
• Within a provision, the conditions implied by different attributes are interpreted conjunctively (i.e., AND-ed). This means that in order to match the provision, all the attributes must match.
• Within an attribute, if the attribute is multi-valued, the values are interpreted as disjunctive (i.e., OR-ed). This means that matching any of the values listed for the attribute is sufficient for the attribute to match. For single-valued attributes, matching is simply based on matching the value of the attribute.

If the value of an attribute is a code from a hierarchical code structure (e.g., a Confidentiality code ), the subsumption relationship between the codes in the hierarchy must be considered in the interpretation of the provision:

• If the (implicit or explicit) type of the provision is permit, all the subsumed descending codes (that are below the mentioned code in the hierarchy) are also permitted. For example, if a provision permits access to very restricted (V) data, it also permits access to restricted (R) data.
• If the (implicit or explicit) type of the provision is deny, all the subsuming parent codes (that are above the mentioned code in the hierarchy) are also denied. For example, if a provision denies access to restricted (R) data, it also denies access to very restricted (V) data.

The following figure visualizes this in the course of an example.

The base decision is a deny to which the first exception, expressed in the first provision, states that during the time period from 01/01/2020 to 31/12/2022 all access by Org A is permitted. In order to match this provision, and therefore for this permit decision to be applicable, the requestor identifier must match Org A AND the current date must be within the range 01/01/2020-31/12/2022.

The subsequent child provisions state exceptions to this base rule. Matching any of these provisions results in a deny since these are exceptions to a permit parent provision.

• access is denied if the purpose of use is marketing (HMK).
• access is denied if the requested data is restricted (R). Note that this implies access is also denied if the requested data is very restricted (V).
• access is denied if the purpose of use is payment (PAY) unless:
• content type is Claims, OR Claim Responses, OR Accounts.

6.2.9 Tracking Changes in Consent

Tracking changes in consent can be managed in two possible ways:

1. Submitting changes to the Consent resource and tracking the changes via a versioning server
2. Submitting a new Consent resource and marking the old resource as inactive

HL7 does not recommend a specific method.

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 might 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 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
Consent Directive	The legal record of a healthcare consumer's agreement or agreements made on their behalf with a party responsible for enforcing the consumer’s choices or choices made on their behalf by a third party, 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.
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

6.2.9.1 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.

6.2.10 Optimal Searching

The following steps represent the optimal path for searching for a Consent resource.

1. Request one or more Consent where status=active by Consent.scope (with patient(s), if none specified, get all). Policy will decide how to deal with multiple per patient and how to iterate through (e.g., select most recent).
2. Locally inspect Consent.provision for base policy acceptance/denial with Consent.policyRule
3. If policyRule not understandable, refer to Privacy Office
4. Locally inspect Consent.provision for contexts (e.g., provision.purpose, provision.actor, etc.) as above
5. Inspect Consent.provision.provision (et.al) for exceptions

6.2.11 Search Parameters

Search parameters for this resource. See also the full list of search parameters for this resource, and check the Extensions registry for search parameters on extensions related to this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

Name	Type	Description	Expression	In Common
action	token	Actions controlled by this rule	Consent.provision.action
actor	reference	Resource for the actor (or group, by role)	Consent.provision.actor.reference (Practitioner, Group, Organization, CareTeam, Device, Patient, PractitionerRole, RelatedPerson)
category	token	Classification of the consent statement - for indexing/retrieval	Consent.category
controller	reference	Consent Enforcer	Consent.controller (Practitioner, Organization, Patient, HealthcareService)
data	reference	The actual data reference	Consent.provision.data.reference (Any)
date	date	When consent was agreed to	Consent.date	26 Resources
grantee	reference	Who is agreeing to the policy and rules	Consent.grantee (Practitioner, Organization, CareTeam, Patient, HealthcareService, PractitionerRole, RelatedPerson)
identifier	token	Identifier for this record (external references)	Consent.identifier	65 Resources
manager	reference	Consent workflow management	Consent.manager (Practitioner, Organization, Patient, HealthcareService)
patient	reference	Who the consent applies to	Consent.subject.where(resolve() is Patient) (Patient)	65 Resources
period	date	Timeframe for this rule	Consent.provision.period
purpose	token	Context of activities covered by this rule	Consent.provision.purpose
security-label	token	Security Labels that define affected resources	Consent.provision.securityLabel
source-reference	reference	Search by reference to a Consent, DocumentReference, Contract or QuestionnaireResponse	Consent.sourceReference (Consent, Contract, QuestionnaireResponse, DocumentReference)
status	token	draft | active | inactive | entered-in-error | unknown	Consent.status
subject	reference	Who the consent applies to	Consent.subject (Practitioner, Group, Patient)
verified	token	Has been verified	Consent.verification.verified
verified-date	date	When consent verified	Consent.verification.verificationDate