Scalable Consent Management
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Scalable Consent Management, published by HL7 International / Community Based Collaborative Care. This guide is not an authorized publication; it is the continuous build for version 1.0.0-preview built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-consent-management/ and changes regularly. See the Directory of published versions

Artifacts Summary

This page provides a list of the FHIR artifacts defined as part of this implementation guide.

Global Profiles

There are no Global profiles defined

Requirements: Actor Definitions

The following artifacts define the types of individuals and/or systems that will interact as part of the use cases covered by this implementation guide.

Client

A system responsible for gathering patient consent decisions and filing them with a consent administration service. Typically implemented as an EHR system, patient portal, or similar application. Corresponds to the IHE-PCF Consent Recorder actor.

Consent Server

A consent server system is responsible for storing consent records and servicing requests for consent data. Implements the File Consent and Revoke Consent operations, supports consent search and subscriptions, and maintains audit events for consent access decisions. Corresponds to the IHE-PCF Consent Registry actor.

Requirements: Formal Requirements

The following artifacts describe the specific requirements to be met by systems compliant with the implementation guide.

Artifacts Summary Client

Artifacts Summary Requirements for Client

Artifacts Summary Consent Server

Artifacts Summary Requirements for Consent Server

CapStmt Client

CapStmt Requirements for Client

CapStmt Consent Server

CapStmt Requirements for Consent Server

Components Client

Components Requirements for Client

Components Consent Server

Components Requirements for Consent Server

Conformance Client

Conformance Requirements for Client

Conformance Client Consent Server

Conformance Requirements for Client Consent Server

Conformance Consent Server

Conformance Requirements for Consent Server

Conformance Expectations Client

Conformance Expectations Requirements for Client

Conformance Expectations Client Consent Server

Conformance Expectations Requirements for Client Consent Server

Conformance Expectations Consent Server

Conformance Expectations Requirements for Consent Server

Extended Operations Client Consent Server

Extended Operations Requirements for Client Consent Server

Implementation Notes Client Consent Server

Implementation Notes Requirements for Client Consent Server

Search Parameters Client Consent Server

Search Parameters Requirements for Client Consent Server

Structure Definitions Client

Structure Definitions Requirements for Client

Structure Definitions Client Consent Server

Structure Definitions Requirements for Client Consent Server

Structure Definitions Consent Server

Structure Definitions Requirements for Consent Server

Subscription Topics Client

Subscription Topics Requirements for Client

Subscription Topics Client Consent Server

Subscription Topics Requirements for Client Consent Server

Subscription Topics Consent Server

Subscription Topics Requirements for Consent Server

Technical Specification Client

Technical Specification Requirements for Client

Technical Specification Client Consent Server

Technical Specification Requirements for Client Consent Server

Technical Specification Consent Server

Technical Specification Requirements for Consent Server

Workflow Client Consent Server

Workflow Requirements for Client Consent Server

Behavior: Capability Statements

The following artifacts define the specific capabilities that different types of systems are expected to have in order to comply with this implementation guide. Systems conforming to this implementation guide are expected to declare conformance to one or more of the following capability statements.

Consent Client Capabilities

Capabilities required for a Consent Client system filing and reviewing consents.

Consent Server Capabilities

Capabilities required for a Consent Server system (consent administration service) receiving and managing consents.

Behavior: Operation Definitions

These are custom operations that can be supported by and/or invoked by systems conforming to this implementation guide.

File a Consent

This operation is used to file a consent with a consent administration service. The parameters are the Consent resource along with accompanying documentation in the form of a DocumentReference (for PDF or other forms) or QuestionnaireResponse.

Revoke a Consent

This operation is used to revoke a consent with a consent administration service. The parameters are a reference to the Consent resource along with accompanying documentation in the form of a DocumentReference (for PDF or other forms) or QuestionnaireResponse.

Behavior: Search Parameters

These define the properties by which a RESTful server can be searched. They can also be used for sorting and including related resources.

fast-consent-controller

The Consent controller reference which is defined by the Consent extension controller.

fast-consent-manager

The Consent manager reference which is defined by the Consent extension manager.

Behavior: Subscription Topics

These define the types of information that can be subscribed to on systems conforming to this this implementation guide.

FAST Consent Subscription Topic

This is the subscription topic used for ensuring Consent records are updated amongst a set of Consent Registries.

Structures: Resource Profiles

These define constraints on FHIR resources for systems conforming to this implementation guide.

FASTConsent

This profile captures the details of a Patient's Consent.

FASTConsentAuditEvent

Disclosures are recorded as FHIR AuditEvent instances. These AuditEvents reflect the Consent instance that was consulted and whether the decision to disclose data was made or not.

FASTDocumentReference

This profile records non-structured documentation that records a patient's consent.

FASTSubscription

A profile for FAST subscriptions.

File Consent Operation Parameters

A profile that indicates the parameters for the File Consent operation.

Revoke Consent Operation Parameters

A profile that indicates the parameters for the Revoke Consent operation.

Structures: Data Type Profiles

These define constraints on FHIR data types for systems conforming to this implementation guide.

FASTReference

A profile on the Reference datatype that requires the identifier and exposes a set of additional identifiers in an extension.

Terminology: Value Sets

These define sets of codes used by systems conforming to this implementation guide.

FAST Consent Statuses

The two codes that are applicable to FAST Consent instances. 'active' for active Consents, and 'inactive' for revoked Consents.

LOINC Consent Document Types

These codes are used to convey the type of consent document being referenced.

Example: Example Instances

These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.

ConsentAuditEventExample

An example of a Consent Audit Event

ConsentExample

An example of a consent.

DocumentReferenceExample

An example of a consent document.

FASTOrganizationSubscriptionExample

An example of a FAST Subscription for a specific organization (controller).

FASTPatientSubscriptionExample

An example of a FAST Subscription for a specific patient.

FASTSubscriptionNotification

An example of a FAST Subscription Notification

FASTSubscriptionNotificationParameters

An example of the parameters going back for a FAST subscription notification

FileConsentDocRefExample

An example of a $fileConsent Parameters resource with an optional DocumentReference.

FileConsentQuestionnaireExample

An example of a $fileConsent Parameters resource with an optional QuestionnaireResponse.

QuestionnaireResponseExample

An example of a consent questionnaire response.

RevokeConsentExample

An example of a $revokeConsent Parameters resource.