eHealth Infrastructure
3.4.1 - release Denmark flag

eHealth Infrastructure, published by Den telemedicinske infrastruktur (eHealth Infrastructure). This guide is not an authorized publication; it is the continuous build for version 3.4.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/fut-infrastructure/implementation-guide/ and changes regularly. See the Directory of published versions

Resource Profile: ehealth-consent

Official URL: http://ehealth.sundhed.dk/fhir/StructureDefinition/ehealth-consent Version: 3.4.1
Active as of 2025-03-14 Computable Name: ehealth-consent

Introduction

A Consent resource is a record of a healthcare consumer’s policy choices, which permits or denies identified actors(s) or identified role(s) to perform one or more actions within a given policy context, for specific purpose(s) and period of time.

Scope and Usage

In the eHealth infrastructure a Consent resource is used

  1. as a record of the fact that a Patient has given a Consent and
  2. to enforce data policies that require Consent to be given and recorded for a Patient.

When a Patient gives a consent, this consent must be recorded as a Consent resource. This resource can be created by the Patient herself or by a Practitioner as a result of conversations or correspondence with the Patient.

eHealth operates with two categories of consents:

  1. Category PITEOC: Consent given by a Patient to be enrolled into a telemedical EpisodeOfCare. This Consent is interpretated to also apply to all CarePlan instances related to the consented EpisodeOfCare.

  2. Category SSLPCI: Consent given by a Patient to have his/her contact information (physical address and telecommunication endpoints) being disclosed to a specified actor supplying device(s) and service(s) to the Patient as part of an EpisodeOfCare and related CarePlan(s).

Consents of category PITEOC are expressed by creating a Consent resource with:

  • Consent.category.coding.system = "http://ehealth.sundhed.dk/cs/consent-category"
  • Consent.category.coding.code = "PITEOC".

Consents of category SSLPCI are expressed by creating a Consent resource with:

  • Consent.category.coding.system = "http://ehealth.sundhed.dk/cs/consent-category"
  • Consent.category.coding.code = "SSLPCI".

Business rules are built into eHealth infrastructure to ensure that data can only be processed or forwarded to other systems and actors when the proper Consent is given.

This means, that:

  1. An EpisodeOfCare can only change status to active if a Consent with category PITEOC has been given.
  2. An SSL Order can only change status to submitted if a Consent with category SSLPCI has been given.

In addition to the Consent.category element, the following elements must be set on a Consent resource for the policy enforcing business logic to take effect:

  • Consent.patient - the patient who is the subject of this consent (must coincide with the EpisodeOfCare.patient referenced by Consent.data.reference)
  • Consent.data.reference - the EpisodeOfCare for which this Consent is in force.
  • Consent.actor - the actor (Organization, CareTeam, Practitioner) whose behaviour is controlled by this consent.
  • Consent.status - the status of this consent (only active consents are considered to be in force)
  • Consent.period - the (possibly open-ended) period for which this consent is in force.

For more information see the element descriptions in the snapshot table on this page and also see the example Consent resources on the Examples tab.

Remarks on operations

Update

The update operation on Consent only accepts changes to the patient, category, data.reference, actor, status, and period contents.

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

NameFlagsCard.TypeDescription & Constraintsdoco
.. Consent C 0..* Consent A healthcare consumer's choices to permit or deny recipients or roles to perform actions for specific purposes and periods of time
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
dom-6: A resource should have narrative for robust management
ppc-1: Either a Policy or PolicyRule
ppc-2: IF Scope=privacy, there must be a patient
ppc-3: IF Scope=research, there must be a patient
ppc-4: IF Scope=adr, there must be a patient
ppc-5: IF Scope=treatment, there must be a patient
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
ele-1: All FHIR elements must have a @value or children
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
... status ?!Σ 1..1 code draft | proposed | active | rejected | inactive | entered-in-error
Binding: ConsentState (required): Indicates the state of the consent.


ele-1: All FHIR elements must have a @value or children
... category Σ 1..* CodeableConcept Classification of the consent statement - for indexing/retrieval
Binding: Consent Category (required)
ele-1: All FHIR elements must have a @value or children
... patient Σ 1..1 Reference(ehealth-patient) {r} Who the consent applies to
ele-1: All FHIR elements must have a @value or children
... organization Σ 0..* Reference(ehealth-organization) {r} Custodian of the consent
ele-1: All FHIR elements must have a @value or children
... Slices for source[x] Σ 0..1 Source from which this consent is taken
Slice: Unordered, Open by type:$this
ele-1: All FHIR elements must have a @value or children
.... sourceAttachment Attachment
.... sourceReference Reference(Consent | DocumentReference | Contract | QuestionnaireResponse)
.... source[x]:sourceReference Σ 0..1 Reference(ehealth-consent | ehealth-documentreference | Contract | ehealth-questionnaireresponse) Source from which this consent is taken
ele-1: All FHIR elements must have a @value or children

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Consent.statusrequiredConsentState
http://hl7.org/fhir/ValueSet/consent-state-codes|4.0.1
from the FHIR Standard
Consent.scopeextensibleConsentScopeCodes
http://hl7.org/fhir/ValueSet/consent-scope
from the FHIR Standard
Consent.categoryrequiredConsentCategory (a valid code from Consent Category)
http://ehealth.sundhed.dk/vs/consent-category
from this IG

 

Other representations of profile: CSV, Excel, Schematron