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type: resourceresource: Consent

Consent

Introduction

Scope and Usage

The purpose of this Resource is to be used to express a Consent regarding Healthcare. There are three 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:

This resource is scoped to cover all three uses and specified via the Category element, but at this time, only the privacy use case is fully modeled, others are being used but no formal modelling exists. Other use cases are possible through the use of the use of other category codes. The scope of the resource may change when the other possible scopes are investigated, tested, or profiled. It is possible to have multiply scoped consent in one Consent resource (e.g., Privacy and Research, or Research and Treatment, etc.) by having multiple provision trees paired.

Usage of the Provenance resource may be the best way to manage the tracking of the changes to Consent. In addition, the DocumentReference may be used as an attachment to show the stages of consent ceremony with additional or updated document(s) attached at each stage. Contract may also be used in this fashion where as signatures are gathered or conditions applied, the Contract resource can be updated and attached to the Consent.

In its simplest form, the Consent resource provides the means to record the content and the metadata of a consent (either implicit consent as an event or an explicit consent document). At this level of implementation, basic metadata about the Consent (e.g., status, data and time, patient, and organization) is recorded in the corresponding attributes of the Consent resource to enable consent discovery by indexing, searching, and retrieval of consents based on this metadata. The sourceAttachment and/or sourceReference elements can be used to record the original consent document either in the form of a pointer to another resource or in the form of an attachment.

In a more advanced usage of the Consent resource, in addition to recording the metadata and potentially the original content, the privacy preferences stated in the consent are encoded directly in the form of machine-readable rules. These rules can be processed by a decision engine to adjudicate whether the consent permits a specific given activity (e.g., sharing the patient information with a requester or enrolling the patient in a research project). In other words, the Consent resource is used directly to record rules that can be used by a rules engine to understand and enforce the preferences expressed by the consenter as they were intended.

The current version of the Consent resource provides two different mechanisms for recording computable rules:

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:

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.

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.

Notes

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".

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.

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:

consent provisions

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:

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:

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

consent provisions 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.

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:

ConsentThe 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 DirectiveThe 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 FormHuman 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 DerivativeConsent Content that conveys the minimal set of information needed to manage Consent Directive workflow, including providing Consent Directive content sufficient to:

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 time. A 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 |

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.

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

StructureDefinition

Elements (Simplified)

Mappings

Implementation Guide

<?xml version="1.0" encoding="UTF-8"?>

<ImplementationGuide xmlns="http://hl7.org/fhir">
  <id value="Consent-core"/>
  <version value="0.01"/>
  <name value="ConsentHL7Extensions"/>
  <title value="Consent  H L7  Extensions"/>
  <status value="draft"/>
  <date value="1970-01-01T10:00:00+10:00"/>
  <publisher value="Health Level Seven, Inc. - CBCC WG"/>
  <description value="Defines common extensions used with or related to the Consent resource"/>
</ImplementationGuide>

Resource Packs

<?xml version="1.0" encoding="UTF-8"?>

<List xmlns="http://hl7.org/fhir">
  <id value="Consent-packs"/>
  <status value="current"/>
  <mode value="working"/>
  <entry>
    <item>
      <reference value="ImplementationGuide/Consent-core"/>
    </item>
  </entry>
</List>

Search Parameters

Full Search Parameters

Examples

Full Examples

Mapping Exceptions

Divergent Elements

Unknown does not represent "other" - one of the defined statuses must apply. Unknown is used when the authoring system is not sure what the current status is. | 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.

Unmapped Elements

Unmapped Elements