Scalable Consent Management
0.1.0 - ci-build United States of America flag

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 0.1.0 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

Technical Considerations

Page standards status: Informative

Cross-Version Analysis

This is an R4 IG. None of the features it uses are changed in R4B, so it can be used as is with R4B systems. Packages for both R4 (hl7.fhir.us.consent-management.r4) and R4B (hl7.fhir.us.consent-management.r4b) are available.

Intellectual Property Statements

This publication includes IP covered under the following statements.

Global Profiles

There are no Global profiles defined

IG Dependencies

This IG Contains the following dependencies on other IGs.

IGPackageFHIRComment
.. Scalable Consent Managementhl7.fhir.us.consent-management#0.1.0R4
... HL7 Terminology (THO)hl7.terminology.r4#6.1.0R4Automatically added as a dependency - all IGs depend on HL7 Terminology
... FHIR Extensions Packhl7.fhir.uv.extensions.r4#5.1.0R4Automatically added as a dependency - all IGs depend on the HL7 Extension Pack
... US Core Implementation Guidehl7.fhir.us.core#6.1.0R4
.... HL7 Terminology (THO)hl7.terminology.r4#5.0.0R4
.... FHIR Extensions Packhl7.fhir.uv.extensions.r4#1.0.0R4
.... Bulk Data Access IGhl7.fhir.uv.bulkdata#2.0.0R4
.... SMART App Launchhl7.fhir.uv.smart-app-launch#2.1.0R4
.... VSACus.nlm.vsac#0.11.0R4
.... Structured Data Capturehl7.fhir.uv.sdc#3.0.0R4
.... PHINVadsus.cdc.phinvads#0.12.0R4
.... IHE FormatCode Vocabularyihe.formatcode.fhir#1.1.0R4
... Subscriptions R5 Backporthl7.fhir.uv.subscriptions-backport.r4#1.1.0R4
... Privacy Consent on FHIR (PCF)ihe.iti.pcf#1.1.0R4
.... HL7 Terminology (THO)hl7.terminology.r4#5.3.0R4
.... VSACus.nlm.vsac#0.9.0R4

Package hl7.fhir.uv.extensions.r4#5.1.0

This IG defines the global extensions - the ones defined for everyone. These extensions are always in scope wherever FHIR is being used (built Sat, Apr 27, 2024 18:39+1000+10:00)

Package hl7.fhir.uv.extensions.r4#1.0.0

This IG defines the global extensions - the ones defined for everyone. These extensions are always in scope wherever FHIR is being used (built Sun, Mar 26, 2023 08:46+1100+11:00)

Package hl7.fhir.uv.bulkdata#2.0.0

FHIR based approach for exporting large data sets from a FHIR server to a client application (built Fri, Nov 26, 2021 05:56+1100+11:00)

Package hl7.fhir.uv.sdc#3.0.0

The SDC specification provides an infrastructure to standardize the capture and expanded use of patient-level data collected within an EHR.
This includes two components:
* Support more sophisticated questionnaire/form use-cases such as those needed for research, oncology, pathology and other clinical domains.
*Support pre-population and auto-population of EHR data into forms/questionnaires for uses outside direct clinical care (patient safety, adverse event reporting, public health reporting, etc.). (built Tue, Mar 8, 2022 18:32+0000+00:00)

Package ihe.formatcode.fhir#1.1.0

Implementation Guide for IHE defined FormatCode vocabulary. (built Thu, Feb 24, 2022 16:55-0600-06:00)

Package hl7.fhir.us.core#6.1.0

The US Core Implementation Guide is based on FHIR Version R4 and defines the minimum conformance requirements for accessing patient data. The Argonaut pilot implementations, ONC 2015 Edition Common Clinical Data Set (CCDS), and ONC U.S. Core Data for Interoperability (USCDI) v1 provided the requirements for this guide. The prior Argonaut search and vocabulary requirements, based on FHIR DSTU2, are updated in this guide to support FHIR Version R4. This guide was used as the basis for further testing and guidance by the Argonaut Project Team to provide additional content and guidance specific to Data Query Access for purpose of ONC Certification testing. These profiles are the foundation for future US Realm FHIR implementation guides. In addition to Argonaut, they are used by DAF-Research, QI-Core, and CIMI. Under the guidance of HL7 and the HL7 US Realm Steering Committee, the content will expand in future versions to meet the needs specific to the US Realm. These requirements were originally developed, balloted, and published in FHIR DSTU2 as part of the Office of the National Coordinator for Health Information Technology (ONC) sponsored Data Access Framework (DAF) project. For more information on how DAF became US Core see the US Core change notes. (built Fri, Jun 30, 2023 14:02+0000+00:00)

Package hl7.fhir.uv.subscriptions-backport.r4#1.1.0

The Subscription R5 Backport Implementation Guide enables servers running versions of FHIR earlier than R5 to implement a subset of R5 Subscriptions in a standardized way. (built Wed, Jan 11, 2023 15:34+1100+11:00)

Package ihe.iti.pcf#1.1.0

The Privacy Consent on FHIR (PCF) Profile provides support for patient privacy consents and access control where a FHIR API is used to access Document Sharing Health Information Exchanges. (built Thu, Feb 22, 2024 13:50-0600-06:00)

Value Sets

These value sets are used in this implementation guide:

URLVersionName / TitleStatusFlagsSourceReferences
http://hl7.org/fhir/ValueSet/audit-entity-type4.0.1AuditEventEntityType
Audit event entity type
draft / trial-use / FMM3A THO, hl7.fhir.r4.coreFASTConsentAuditEvent
http://hl7.org/fhir/ValueSet/audit-event-action4.0.1AuditEventAction
AuditEventAction
draft / trial-use / FMM3A hl7.fhir.r4.coreFASTConsentAuditEvent
http://hl7.org/fhir/ValueSet/audit-event-outcome4.0.1AuditEventOutcome
AuditEventOutcome
draft / trial-use / FMM3A hl7.fhir.r4.coreFASTConsentAuditEvent
http://hl7.org/fhir/ValueSet/audit-event-sub-type4.0.1AuditEventSub-Type
Audit Event Sub-Type
active / trial-use / FMM3A E DICOM, hl7.fhir.r4.coreFASTConsentAuditEvent
http://hl7.org/fhir/ValueSet/audit-event-type4.0.1AuditEventID
Audit Event ID
active / trial-use / FMM3A E DICOM, THOFASTConsentAuditEvent
http://hl7.org/fhir/ValueSet/audit-source-type4.0.1AuditEventSourceType
Audit Event Source Type
active / trial-use / FMM3A THOFASTConsentAuditEvent
http://hl7.org/fhir/ValueSet/consent-action4.0.1ConsentActionCodes
Consent Action Codes
draft / draft / FMM1A THOFASTConsent
http://hl7.org/fhir/ValueSet/consent-category4.0.1ConsentCategoryCodes
Consent Category Codes
draft / trial-use / FMM2A E V LOINC, THOFASTConsent
http://hl7.org/fhir/ValueSet/consent-content-class4.0.1ConsentContentClass
Consent Content Class
draft / trial-use / FMM2A E V Other, hl7.fhir.r4.coreFASTConsent
http://hl7.org/fhir/ValueSet/consent-content-code4.0.1ConsentContentCodes
Consent Content Codes
draft / draft / FMM1:experimentalA LOINCFASTConsent
http://hl7.org/fhir/ValueSet/consent-data-meaning4.0.1ConsentDataMeaning
ConsentDataMeaning
draft / trial-use / FMM2A hl7.fhir.r4.coreFASTConsent
http://hl7.org/fhir/ValueSet/consent-policy4.0.1ConsentPolicyRuleCodes
Consent PolicyRule Codes
draft / trial-use / FMM2A THOFASTConsent
http://hl7.org/fhir/ValueSet/consent-provision-type4.0.1ConsentProvisionType
ConsentProvisionType
draft / trial-use / FMM2A hl7.fhir.r4.coreFASTConsent
http://hl7.org/fhir/ValueSet/consent-scope4.0.1ConsentScopeCodes
Consent Scope Codes
draft / trial-use / FMM2A THOFASTConsent
http://hl7.org/fhir/ValueSet/consent-state-codes4.0.1ConsentState
ConsentState
draft / trial-use / FMM2A hl7.fhir.r4.coreFASTConsent
http://hl7.org/fhir/ValueSet/dicm-405-mediatype4.0.1MediaTypeCode
Media Type Code
active / trial-use / FMM3E DICOMFASTConsentAuditEvent
http://hl7.org/fhir/ValueSet/languages4.0.1CommonLanguages
Common Languages
draft / trial-use / FMM3E hl7.terminology.r4FASTConsentTask, FASTConsentProvenance, FASTQuestionnaireResponse, FASTConsent, FASTConsentAuditEvent, FASTSubscription
http://hl7.org/fhir/ValueSet/mimetypes4.0.1Mime Types
MimeType
active / normative / FMM5A OtherFASTSubscription
http://hl7.org/fhir/ValueSet/network-type4.0.1AuditEventAgentNetworkType
AuditEventAgentNetworkType
draft / trial-use / FMM3A hl7.fhir.r4.coreFASTConsentAuditEvent
http://hl7.org/fhir/ValueSet/object-lifecycle-events5.1.0ObjectLifecycleEvents
ObjectLifecycleEvents
active / trial-use / FMM3A THOFASTConsentAuditEvent
http://hl7.org/fhir/ValueSet/object-role4.0.1AuditEventEntityRole
AuditEventEntityRole
draft / trial-use / FMM3A THOFASTConsentAuditEvent
http://hl7.org/fhir/ValueSet/participation-role-type4.0.1ParticipationRoleType
ParticipationRoleType
draft / trial-use / FMM3A I E DICOM, THO, THO (V3)FASTConsentAuditEvent
http://hl7.org/fhir/ValueSet/performer-role4.0.1ProcedurePerformerRoleCodes
Procedure Performer Role Codes
draft / draft / FMM1I SCTFASTConsentTask
http://hl7.org/fhir/ValueSet/provenance-activity-type4.0.1ProvenanceActivityType
Provenance activity type
draft / trial-use / FMM3A E THO (V3)FASTConsentProvenance
http://hl7.org/fhir/ValueSet/provenance-agent-type4.0.1ProvenanceParticipantType
Provenance participant type
draft / draft / FMM1A THOFASTConsentProvenance
http://hl7.org/fhir/ValueSet/provenance-entity-role4.0.1ProvenanceEntityRole
ProvenanceEntityRole
draft / trial-use / FMM3A hl7.fhir.r4.coreFASTConsentProvenance
http://hl7.org/fhir/ValueSet/questionnaire-answers4.0.1QuestionnaireAnswerCodes
Questionnaire Answer Codes
draft / draft / FMM1A SCTFASTQuestionnaireResponse
http://hl7.org/fhir/ValueSet/questionnaire-answers-status4.0.1QuestionnaireResponseStatus
QuestionnaireResponseStatus
draft / trial-use / FMM3A hl7.fhir.r4.coreFASTQuestionnaireResponse
http://hl7.org/fhir/ValueSet/request-priority4.0.1RequestPriority
Request priority
draft / trial-use / FMM3A hl7.fhir.r4.coreFASTConsentTask
http://hl7.org/fhir/ValueSet/resource-types4.0.1ResourceType
ResourceType
active / normative / FMM5A hl7.fhir.r4.coreFASTConsentProvenance
http://hl7.org/fhir/ValueSet/security-labels4.0.1All Security Labels
SecurityLabels
active / normative / FMM5V FASTConsentAuditEvent
http://hl7.org/fhir/ValueSet/security-role-type4.0.1SecurityRoleType
SecurityRoleType
draft / trial-use / FMM2A I E DICOM, THO, THO (V3)FASTConsentProvenance, FASTConsent, FASTConsentAuditEvent
http://hl7.org/fhir/ValueSet/subscription-channel-type4.0.1SubscriptionChannelType
SubscriptionChannelType
draft / trial-use / FMM3A hl7.fhir.r4.coreFASTSubscription
http://hl7.org/fhir/ValueSet/subscription-status4.0.1SubscriptionStatus
SubscriptionStatus
draft / trial-use / FMM3A hl7.fhir.r4.coreFASTSubscription
http://hl7.org/fhir/ValueSet/task-code4.0.1TaskCode
Task Codes
active / draft / FMM1A hl7.fhir.r4.coreFASTConsentTask
http://hl7.org/fhir/ValueSet/task-intent4.0.1TaskIntent
TaskIntent
draft / trial-use / FMM2A E hl7.fhir.r4.coreFASTConsentTask
http://hl7.org/fhir/ValueSet/task-status4.0.1TaskStatus
TaskStatus
draft / trial-use / FMM2A hl7.fhir.r4.coreFASTConsentTask
http://hl7.org/fhir/us/core/ValueSet/us-core-provenance-participant-type6.1.0USCoreProvenancePaticipantTypeCodes
US Core Provenance Participant Type Codes
activeA THO, hl7.fhir.us.coreFASTConsentProvenance
http://terminology.hl7.org/ValueSet/v3-PurposeOfUse3.1.0PurposeOfUse
PurposeOfUse
activeI THO (V3)FASTConsentProvenance, FASTConsent, FASTConsentAuditEvent
https://profiles.ihe.net/ITI/PCF/ValueSet/AdvancedSecurityTagVS1.1.0AdvancedSecurityTagVS
Advanced Security Tag ValueSet
activeE THO (V3)FASTConsent

Code Systems

These code systems are used in this implementation guide:

URLVersionName / TitleStatusFlagsCountReferences
http://dicom.nema.org/resources/ontology/DCM01DICOM Controlled Terminology Definitions
activeflat 3156 (complete)ParticipationRoleType, Media Type Code, SecurityRoleType, Audit Event Sub-Type, Audit Event ID
http://hl7.org/fhir/CodeSystem/task-code4.0.1TaskCode
Task Codes
active / draft / FMM1flat 7 (complete)Task Codes
http://hl7.org/fhir/audit-event-action4.0.1AuditEventAction
AuditEventAction
draft / trial-use / FMM3flat 5 (complete)AuditEventAction
http://hl7.org/fhir/audit-event-outcome4.0.1AuditEventOutcome
AuditEventOutcome
draft / trial-use / FMM3flat 4 (complete)AuditEventOutcome
http://hl7.org/fhir/consent-data-meaning4.0.1ConsentDataMeaning
ConsentDataMeaning
draft / trial-use / FMM2flat 4 (complete)ConsentDataMeaning
http://hl7.org/fhir/consent-provision-type4.0.1ConsentProvisionType
ConsentProvisionType
draft / trial-use / FMM2flat 2 (complete)ConsentProvisionType
http://hl7.org/fhir/consent-state-codes4.0.1ConsentState
ConsentState
draft / trial-use / FMM2flat 6 (complete)ConsentState
http://hl7.org/fhir/network-type4.0.1AuditEventAgentNetworkType
AuditEventAgentNetworkType
draft / trial-use / FMM3flat 5 (complete)AuditEventAgentNetworkType
http://hl7.org/fhir/provenance-entity-role4.0.1ProvenanceEntityRole
ProvenanceEntityRole
draft / trial-use / FMM35 (complete)ProvenanceEntityRole
http://hl7.org/fhir/questionnaire-answers-status4.0.1QuestionnaireResponseStatus
QuestionnaireResponseStatus
draft / trial-use / FMM3flat 5 (complete)QuestionnaireResponseStatus
http://hl7.org/fhir/request-intent4.0.1RequestIntent
RequestIntent
draft / trial-use / FMM29 (complete)TaskIntent
http://hl7.org/fhir/request-priority4.0.1RequestPriority
RequestPriority
draftflat 4 (complete)Request priority
http://hl7.org/fhir/resource-types4.0.1ResourceType
ResourceType
active / normative / FMM5flat 148 (complete)ResourceType, Audit event entity type, Consent Content Class
http://hl7.org/fhir/restful-interaction4.0.1FHIR Restful Interactions
active / normative / FMM5is-a 17 (complete)Audit Event Sub-Type
http://hl7.org/fhir/subscription-channel-type4.0.1SubscriptionChannelType
SubscriptionChannelType
draft / trial-use / FMM3flat 5 (complete)SubscriptionChannelType
http://hl7.org/fhir/subscription-status4.0.1SubscriptionStatus
SubscriptionStatus
draft / trial-use / FMM3flat 4 (complete)SubscriptionStatus
http://hl7.org/fhir/task-intent4.0.1TaskIntent
TaskIntent
draft / trial-use / FMM2flat 1 (complete)TaskIntent
http://hl7.org/fhir/task-status4.0.1TaskStatus
TaskStatus
draft / trial-use / FMM2flat 12 (complete)TaskStatus
http://hl7.org/fhir/us/core/CodeSystem/us-core-provenance-participant-type6.1.0USCoreProvenancePaticipantTypeExtensionCodes
US Core Provenance Participant Type Extension Codes
activeflat 1 (complete)US Core Provenance Participant Type Codes
http://loinc.org3.1.0LOINC
Logical Observation Identifiers, Names and Codes (LOINC)
activeflat 0 (not-present)Consent Content Codes, Consent Category Codes
http://snomed.info/sctSNOMED_CT
SNOMED CT (all versions)
activeis-a flat compositional 0 (not-present)Procedure Performer Role Codes, Questionnaire Answer Codes
http://terminology.hl7.org/CodeSystem/audit-entity-type1.0.1AuditEventEntityType
Audit event entity type
active / FMM3flat 4 (complete)Audit event entity type
http://terminology.hl7.org/CodeSystem/audit-event-type1.0.0AuditEventID
Audit Event ID
active / FMM3flat 5 (complete)Audit Event ID
http://terminology.hl7.org/CodeSystem/consentaction1.0.1ConsentActionCodes
Consent Action Codes
active / FMM1flat 5 (complete)Consent Action Codes
http://terminology.hl7.org/CodeSystem/consentcategorycodes1.0.1ConsentCategoryCodes
Consent Category Codes
active / FMM2is-a flat 9 (complete)Consent Category Codes
http://terminology.hl7.org/CodeSystem/consentpolicycodes3.0.1ConsentPolicyRuleCodes
Consent PolicyRule Codes
active / FMM2is-a flat 27 (complete)Consent PolicyRule Codes
http://terminology.hl7.org/CodeSystem/consentscope2.0.1ConsentScopeCodes
Consent Scope Codes
active / FMM2flat 4 (complete)Consent Scope Codes
http://terminology.hl7.org/CodeSystem/contractsignertypecodes1.0.1ContractSignerTypeCodes
Contract Signer Type Codes
activeflat 48 (complete)ParticipationRoleType, SecurityRoleType
http://terminology.hl7.org/CodeSystem/dicom-audit-lifecycle2.0.0DicomAuditMessageRecordLifecycleEvents
DICOM Audit Message Record Lifecycle Events
activeflat 15 (complete)ObjectLifecycleEvents
http://terminology.hl7.org/CodeSystem/extra-security-role-type1.0.1SecurityRoleType
Security Role Type
active: experimentalflat 5 (complete)ParticipationRoleType, SecurityRoleType
http://terminology.hl7.org/CodeSystem/iso-21089-lifecycle1.0.0Iso_21089_2017_Health_Record_Lifecycle_Events
ISO 21089 2017 Health Record Lifecycle Events
activeflat 27 (complete)ObjectLifecycleEvents, Audit Event ID
http://terminology.hl7.org/CodeSystem/object-role1.0.1AuditEventEntityRole
AuditEventEntityRole
active / FMM3flat 24 (complete)AuditEventEntityRole
http://terminology.hl7.org/CodeSystem/provenance-participant-type1.1.0ProvenanceParticipantType
Provenance participant type
active / FMM3is-a 12 (complete)Provenance participant type, US Core Provenance Participant Type Codes
http://terminology.hl7.org/CodeSystem/security-source-type1.0.0AuditEventSourceType
Audit Event Source Type
active / FMM3flat 9 (complete)Audit Event Source Type
http://terminology.hl7.org/CodeSystem/v3-ActCode9.0.0ActCode
ActCode
activeis-a 1302 (complete)Advanced Security Tag ValueSet, Provenance activity type
http://terminology.hl7.org/CodeSystem/v3-ActReason3.1.0ActReason
ActReason
activeis-a flat 298 (complete)PurposeOfUse
http://terminology.hl7.org/CodeSystem/v3-Confidentiality3.0.0Confidentiality
Confidentiality
activeis-a 20 (complete)Advanced Security Tag ValueSet
http://terminology.hl7.org/CodeSystem/v3-DataOperation5.0.0DataOperation
DataOperation
activeis-a 21 (complete)Provenance activity type
http://terminology.hl7.org/CodeSystem/v3-DocumentCompletion3.0.0DocumentCompletion
DocumentCompletion
activeis-a flat 9 (complete)Provenance activity type
http://terminology.hl7.org/CodeSystem/v3-ParticipationFunction3.0.0ParticipationFunction
ParticipationFunction
activeis-a 49 (complete)ParticipationRoleType, SecurityRoleType
http://terminology.hl7.org/CodeSystem/v3-ParticipationType5.0.0ParticipationType
ParticipationType
activeis-a 62 (complete)ParticipationRoleType, SecurityRoleType, Provenance activity type
http://terminology.hl7.org/CodeSystem/v3-RoleClass4.0.0RoleClass
RoleClass
activeis-a 112 (complete)ParticipationRoleType, SecurityRoleType
http://terminology.hl7.org/CodeSystem/v3-RoleCode3.0.0RoleCode
RoleCode
activeis-a flat 413 (complete)ParticipationRoleType, SecurityRoleType
urn:ietf:bcp:472.0.1Ietf3066
Tags for the Identification of Languages
activeflat 0 (not-present)Common Languages