Nexus EMR Item Consent Profile Core Profile

Canonical	../StructureDefinition/nexus-emr-core-item-consent
Status	draft · 1.26.0
Base	Consent (constraint)
Source	FSH · JSON

Patient-level consent for one catalogue item — whether the clinic may email the patient, text the patient, or use an AI scribe during their visit. Recorded manually by clinic staff from what the patient tells them, not captured through a patient-facing flow.

TypedFhir API / Pydantic schema

The typed accessor surface Consent exposes for Consent — generated from this IG's compiled profile; each typed accessor has a validating raw-FHIR twin (xRaw) where marked. The three ports are parity-enforced.

The AI-facing shape: from typed_fhir.facade.generated.schemas import ConsentSchema — model_json_schema() is a structured-output / tool definition; instantiating validates an extraction. Generated source.

class ConsentSchema(BaseModel):
    """AI-facing shape of the Consent profile: the facade's typed accessor
    surface (curated + salient fields) as a pydantic model. `model_json_schema()` is a
    structured-output / tool schema; instantiating validates an extraction."""

    model_config = ConfigDict(extra="forbid")

    status: Literal[
        "active",
        "draft",
        "entered-in-error",
        "inactive",
        "proposed",
        "rejected",
    ] | None = Field(
        None,
        description=(
            "active | draft | inactive | entered-in-error. Required field in FHIR R4 Consent. "
            "Indicates the current state of this app consent. Note: 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. Consent.status — 1..1"
        ),
    )
    scope: Concept | None = Field(
        None,
        description=(
            "patient-privacy - Privacy consent. Required field in FHIR R4 Consent. For this app "
            "consent use case, always set to 'patient-privacy' as we're dealing with patient "
            "privacy consent for app data sharing. Consent.scope — 1..1. codes (required): adr | "
            "patient-privacy | research | treatment"
        ),
    )
    category: Concept | None = Field(
        None,
        description=(
            "Fixed: this Consent is an app consent. The family this Consent belongs to, fixed to "
            "`app`. It tells a consumer which interpretation contract governs the resource in its "
            "hand before the resource is interpreted, which is the point of carrying it on a "
            "searchable element: a mixed result can be partitioned in the search rather than "
            "after it. It says WHAT this decision governs and nothing about how to read it. The "
            "decision is `provision.type` in every family, so a reader never needs the family "
            "code to answer the dangerous question — it answers the cheap one. Note: The binding "
            "is required, not extensible: the value of this element is that a consumer can "
            "enumerate the families it knows how to interpret and refuse the ones it does not. A "
            "family minted under a deployment's own system would arrive looking like a known one, "
            "which is the failure the element exists to prevent. Consent.category — 1..1. codes "
            "(required): app | item | privacy-directive"
        ),
    )
    patient: Reference | None = Field(
        None,
        description=(
            "The patient (Patient X). The patient/healthcare consumer to whom this consent "
            "applies. Note: Commonly, the patient the consent pertains to is the author, but for "
            "young and old people, it may be some other person. Consent.patient — 1..1"
        ),
    )
    date_time: FuzzyDate | None = Field(
        None,
        description=(
            "When consent was given/withdrawn. When this Consent was issued / created / indexed. "
            "Note: This is not the time of the original consent, but the time that this statement "
            "was made or derived. Consent.dateTime — 1..1"
        ),
    )
    policy: dict | None = Field(
        None,
        description=(
            "The policy this consent is given under. A URI identifying the policy under which "
            "this consent is recorded -- the custodian's published privacy policy, or the "
            "statutory provision that governs the decision. R4's `ppc-1` invariant requires "
            "either `policy` or `policyRule`; this element satisfies it. **`policyRule` is not "
            "used, and the reason is a correction.** Earlier releases fixed `policyRule` to "
            "`consentpolicycodes#cric`. That code is 45 CFR 46 -- the United States Common Rule "
            "for informed consent in human-subjects research. It is not a "
            "communication-preference policy, not a data-sharing policy, and not Canadian. It was "
            "never the right value here, and the code system it comes from contains no Canadian "
            "concept at all: its 27 codes are US federal and state instruments plus three "
            "European ones. Rather than substitute another wrong code, this profile names the "
            "actual governing policy by URI, which is both truthful and machine-readable. "
            "Consent.policy — 1..*"
        ),
    )
    policy_rule: Concept | None = Field(
        None,
        description=(
            "Regulation that this consents to. A reference to the specific base computable "
            "regulation or policy. Note: If the policyRule is absent, computable consent would "
            "need to be constructed from the elements of the Consent resource. Consent.policyRule "
            "— 0..1. codes (extensible): at-elga | cric | dch-3927 | ga4gh | hipaa-auth | "
            "hipaa-npp | hipaa-research | hipaa-restrictions | …"
        ),
    )
    provision: dict | None = Field(
        None,
        description=(
            "The decision, and the app it is about. Carries whether the patient agreed to share "
            "with this application, and names the application. `provision.type = permit` is "
            "agreement; `deny` is refusal. A grant is now a positive statement rather than the "
            "absence of a nested denial. Consent.provision — 1..1"
        ),
    )