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Published

Informed consent record

EM-HCP-07 · em-hcp-07

Record exactly what a patient agreed to or refused, on what information and by whose authority, so that care and data use stay within that decision.

Enterprise profiles Enterprise subject EnterpriseHCP
Bundle → Layer → Finding → QuestionsClassifiersWhat it isWhy it existsDistinguishing featuresWhat robots and AI may and may not doMoral aspectsOwnersLinks to other meta-modelsIdentity and identifiersDirect propertiesRecognitionCapabilities and actionsHazards and failure modesStandards and interfacesContext of useSources

Bundle → Layer → Finding → Questions Filled

2 bundles · 2 layers · 4 findings · 8 questions

Consent decision What was decided and on what information.

Scope and decision

Scope, decision and the information given.

Scope

What the consent covers and the decision.

  1. What treatment, procedure, research or data sharing does this consent record cover?
  2. Was the decision in this consent record to accept or to refuse, and on what date?

Information

The information given before the decision.

  1. Which version of the information sheet or form was given before this decision?
Authority and validity Who decided and whether the decision still holds.

Signatories and changes

Signatories, validity and withdrawal.

Signatories

Persons who signed, obtained or witnessed the consent.

  1. Who signed this consent, and in what capacity?
  2. Which practitioner obtained this consent, and who witnessed it where a witness is required?

Validity

Validity period, withdrawal and its effects.

  1. Until when is this consent valid, and has it been withdrawn?
  2. Which planned activities or data flows are affected by the withdrawal of this consent?
  3. Which interpreter or communication support was recorded for this consent, if any?

Classifiers Filled

Family
Enterprise profiles
Category
Enterprise subject
Entry kind
subject
Domain
EnterpriseHCP
Industry
Healthcare provider
Tags
EM-HCP-07W-INDsubjectConsentRecordConsentScopeConsentFormVersionSignatoryConsentWithdrawal

What it is Filled

A patient's or representative's recorded decision to accept or refuse a treatment, a procedure, research participation or information sharing, with its scope, form version, information given, signatories, validity and withdrawal. Legal bases for processing personal data are a separate contour.

Why it exists Filled

Record exactly what a patient agreed to or refused, on what information and by whose authority, so that care and data use stay within that decision.

Distinguishing features Filled

  • A consent record states its scope, the decision and the information given.
  • Procedure consent, research consent and data sharing consent are separate scopes.
  • A withdrawal is a new record and does not delete the original.
  • Legal bases for processing personal data are handled in a separate contour.

What robots and AI may and may not do Filled

Must not

  • Obtain consent or make a consent decision on behalf of a patient or representative.
  • Resolve ambiguous consent language or determine legal or clinical validity.
  • Treat an explicit scope match as proof of valid consent or authorization to proceed.
  • Treat a general form as specific consent.
  • Delete or alter a consent or withdrawal record.

Only with a human decision

  • Responsible staff approve consent processes appropriate to the scope and applicable requirements, including oral and electronic processes where permitted.
  • A practitioner conducts a consent conversation when the applicable process requires one.
  • Responsible clinicians or legal staff decide questions about capacity, ambiguous scope or validity.

May

  • Match explicit recorded scope fields against a planned activity using approved rules and report matches, mismatches or missing information without deciding consent meaning or validity.
  • Remind staff of consents that are about to expire.
  • Show the current consent status to authorized staff.

Moral aspects Filled

  • Consent must be voluntary and based on understandable information.
  • Representatives may have interests that differ from the patient's.

Who is affected

  • Patients
  • Legal representatives and families
  • Practitioners and researchers

Owners Filled

Steward

The medical director who answers for consent practice.

Master systems

  • Electronic health record system
  • Consent management system

Links to other meta-models Filled

neighbor

  • EM-LEG-06
  • EM-HCP-04
  • EM-HCP-05
  • EM-HCP-08
  • EM-KNW-01
  • EM-XCT-05

references

  • WM-XCT-002 - conceptual-candidate
  • WM-REC-010 - conceptual-candidate

What else AI and robots need to interact with it Filled

Identity and identifiers required Filled

  • A consent record has an identifier unique within the provider.
  • It references one patient record and the evidence of the decision, with form or information versions referenced when used.
  • Decision evidence may document an oral process or an electronic process without a signed form where applicable requirements permit.

Direct properties not applicable Not applicable

Not applicable

Enterprise record contour: physical properties belong to referenced world models.

Recognition required Filled

  • Records show a scope, a decision, a date, the decision maker, the information provided and evidence appropriate to the consent process.
  • Signatories and form or information versions are recorded when applicable to the consent process.
  • A consent record must be distinguished from a privacy notice and from an entry in a data processing register.

Capabilities and actions required Filled

  • The contour supports explicit scope matching before procedures, research use and data sharing while reserving interpretation and validity decisions for responsible humans.

Hazards and failure modes required Filled

  • Care given without valid consent harms patient autonomy and creates legal liability.
  • Ignored withdrawals lead to unauthorized data use.

Standards and interfaces optional Filled

  • HL7 International publishes the FHIR Consent resource.
  • Integrating the Healthcare Enterprise publishes privacy consent profiles for sharing documents across organizations.

Context of use required Filled

  • The contour is used before procedures, in research and in health information exchange.
  • Consent rules differ by jurisdiction and by the age of the patient.

Sources Filled

  1. HL7 FHIR: Consent resource
  2. IHE privacy consent profiles for health information exchange
  3. Research ethics and research consent practice
  4. HL7 FHIR R4 Consent resource - Checked live (HTTP 200) on 2026-10-21.
  5. HL7 FHIR R4 Provenance resource - Checked live (HTTP 200) on 2026-10-21.

Open questions

  • How is consent to a procedure distinguished from consent to data sharing?
  • Which version of the information sheet did the patient receive?
  • How does a withdrawal take effect on records and on planned activities?
  • Settle the boundary and the reuse, extend or new decision against the current specifications.
  • Confirm the semantic crosswalk, rights and source mastership.
  • Choose immutable references and run fixture checks before claiming publication readiness.

Machine files

Card as JSON Source Card backlog vercy.card/1

Provenance

enterprise research programme · published-partial

Built from: enterprise/models/em-hcp-07/brief.json, ver-cy/world-models/card-supplements/em-hcp-07.json