@zanii/health 0.1.2 → 0.1.3

package/README.md

@@ -111,6 +111,8 @@ enforce — we make **ignoring it undeniable**. A regulator can *require* review
   signed — never that the treatment was *right*.
 
 ## Changelog
+
+- **0.1.3** — FHIR `toFhirAuditEvent` export (no clinical content), AI medical-device change logs against the change-control plan (`deviceChange` / `changeControlReport`), clinical-trial `trialAuditTrail`, consent to AI-assisted care with `aiUseWithoutConsent`, `secondOpinion`, prescriptions with pharmacist checks, device-signed readings, `claimEvidence` for insurers, outbreak counts that hide each facility's number (on `@zanii/zk`) and secondary-use permits.
 - **0.1.2** — now depends on `@zanii/core` 0.5 (protocol 1.2), so it shares one core with `@zanii/sdk` 0.5 instead of pulling in a second, older copy. No API change.
 - **0.1.0** — initial release: `episodeSeed`/`episodeTag`/`episodeTags` (unlinkable per-episode identity), `buildAccessReceipt`, `buildRecommendation` (protocol required), `buildClinicianConfirmation`, `buildBreakGlass` + `pendingBreakGlass`/`markReviewed`, `protocolTrail` (**not** `ruleConsistency`), `fetchEpisodes`.
 

package/dist/clinical.d.ts

@@ -0,0 +1,269 @@
+/**
+ * More clinical accountability: FHIR AuditEvent export, change logs for AI medical devices
+ * against their predetermined change-control plan, clinical-trial audit trails, consent to
+ * AI-assisted care, second opinions, prescription checks, device-signed readings, claim
+ * evidence without clinical content, outbreak counts that hide each facility's number, and
+ * secondary-use permits.
+ *
+ * Nothing here holds clinical content: episodes are pseudonymous tags and content stays as
+ * salted commitments. Regulatory names (FDA PCCP, ICH E6, EHDS) describe what each record
+ * supports, not a certification.
+ */
+import { type SignedObject } from '@zanii/core';
+import { type Commitment } from '@zanii/zk';
+type Payload = Record<string, unknown>;
+/** A health payload as a FHIR AuditEvent resource (R4/R5 core fields) for an EHR's audit repository. */
+export declare function toFhirAuditEvent(payload: Payload, episodeTag: string): {
+    extension: {
+        url: string;
+        valueString: string;
+    }[];
+    purposeOfEvent?: {
+        text: string;
+    }[] | undefined;
+    resourceType: string;
+    type: {
+        system: string;
+        code: string;
+        display: string;
+    };
+    action: string;
+    recorded: unknown;
+    agent: {
+        who: {
+            identifier: {
+                value: string;
+            };
+        };
+        requestor: boolean;
+    }[];
+    source: {
+        observer: {
+            display: string;
+        };
+    };
+    entity: {
+        what: {
+            identifier: {
+                value: string;
+            };
+        };
+        description: string;
+    }[];
+};
+/** A change to an AI medical device, declared as inside or outside its predetermined change-control plan. */
+export declare function deviceChange(input: {
+    device: string;
+    fromVersion: string;
+    toVersion: string;
+    description: string;
+    validationHash: string;
+    withinPlan: boolean;
+    ts: string;
+}): {
+    target: string;
+    payload: {
+        device: string;
+        fromVersion: string;
+        toVersion: string;
+        description: string;
+        validationHash: string;
+        withinPlan: boolean;
+        ts: string;
+        _zr_kind: string;
+        _zr_domain: string;
+        v: number;
+        kind: string;
+    };
+};
+/** Changes made outside the plan (which need their own submission) and changes with no validation evidence. */
+export declare function changeControlReport(payloads: Payload[]): {
+    changes: number;
+    outsidePlan: unknown[];
+    unvalidated: unknown[];
+};
+/** A clinical-trial event for a pseudonymous participant (enrolment, dosing, adverse event, withdrawal). */
+export declare function trialEvent(input: {
+    trial: string;
+    participantTag: string;
+    event: 'enrolment' | 'consent' | 'dose' | 'assessment' | 'adverse-event' | 'withdrawal';
+    detailsHash: string;
+    ts: string;
+}): {
+    target: string;
+    subjectTag: string;
+    payload: {
+        trial: string;
+        participantTag: string;
+        event: "enrolment" | "consent" | "dose" | "assessment" | "adverse-event" | "withdrawal";
+        detailsHash: string;
+        ts: string;
+        _zr_kind: string;
+        v: number;
+        kind: string;
+    };
+};
+/** Audit-trail checks per participant: consent before enrolment, nothing before enrolment, nothing after withdrawal. */
+export declare function trialAuditTrail(payloads: Payload[]): {
+    participants: number;
+    ok: boolean;
+    issues: string[];
+};
+/** The patient's consent (or refusal) to AI-assisted care in an episode. */
+export declare function aiCareConsent(input: {
+    episodeTag: string;
+    granted: boolean;
+    scope: string[];
+    ts: string;
+}): {
+    target: string;
+    subjectTag: string;
+    payload: {
+        episodeTag: string;
+        granted: boolean;
+        scope: string[];
+        ts: string;
+        _zr_kind: string;
+        v: number;
+        kind: string;
+    };
+};
+/** Were recommendations in an episode made only while AI consent was in force? */
+export declare function aiUseWithoutConsent(payloads: Payload[], episodeTag: string): string[];
+/** Two models (or a model and a clinician) on the same question: whether they agreed, with both commitments. */
+export declare function secondOpinion(input: {
+    episodeTag: string;
+    first: {
+        by: string;
+        commitment: string;
+    };
+    second: {
+        by: string;
+        commitment: string;
+    };
+    agree: boolean;
+    ts: string;
+}): {
+    target: string;
+    subjectTag: string;
+    risk: "medium" | "high";
+    payload: {
+        episodeTag: string;
+        first: {
+            by: string;
+            commitment: string;
+        };
+        second: {
+            by: string;
+            commitment: string;
+        };
+        agree: boolean;
+        ts: string;
+        _zr_kind: string;
+        v: number;
+        kind: string;
+    };
+};
+/** A prescription, marked when an AI suggested it, and the pharmacist's check. */
+export declare function prescription(input: {
+    episodeTag: string;
+    rxId: string;
+    drugCode: string;
+    prescriber: string;
+    aiSuggested: boolean;
+    ts: string;
+}): {
+    target: string;
+    subjectTag: string;
+    payload: {
+        episodeTag: string;
+        rxId: string;
+        drugCode: string;
+        prescriber: string;
+        aiSuggested: boolean;
+        ts: string;
+        _zr_kind: string;
+        v: number;
+        kind: string;
+    };
+};
+export declare function pharmacistCheck(input: {
+    episodeTag: string;
+    rxId: string;
+    pharmacist: string;
+    outcome: 'dispensed' | 'queried' | 'refused';
+    ts: string;
+}): {
+    target: string;
+    subjectTag: string;
+    payload: {
+        episodeTag: string;
+        rxId: string;
+        pharmacist: string;
+        outcome: "dispensed" | "queried" | "refused";
+        ts: string;
+        _zr_kind: string;
+        v: number;
+        kind: string;
+    };
+};
+/** AI-suggested prescriptions that no pharmacist has checked. */
+export declare function uncheckedAiPrescriptions(payloads: Payload[]): unknown[];
+export type DeviceReading = SignedObject<{
+    v: 1;
+    type: 'health.device_reading';
+    episodeTag: string;
+    metric: string;
+    value: number;
+    unit: string;
+    ts: string;
+}>;
+/** A wearable or bedside device signs its own reading (the device key is the trust root). */
+export declare function deviceReading(input: {
+    episodeTag: string;
+    metric: string;
+    value: number;
+    unit: string;
+    ts: string;
+}, devicePrivateKey: Uint8Array): DeviceReading;
+export declare function verifyDeviceReading(r: DeviceReading, trustedDevices: string[]): boolean;
+/** For an insurer: what kind of care events happened in an episode, under which protocols. No clinical content. */
+export declare function claimEvidence(payloads: Payload[]): {
+    events: number;
+    counts: Record<string, number>;
+    protocols: string[];
+    confirmedByClinician: boolean;
+};
+/** Each facility commits to its case count; the ministry learns the regional total, not any facility's number. */
+export declare function facilityCaseCount(count: number): Commitment;
+export declare function regionalTotal(commitments: string[], openings: Commitment['opening'][]): {
+    total: number;
+    verified: boolean;
+};
+export type SecondaryUsePermit = SignedObject<{
+    v: 1;
+    type: 'health.permit';
+    permit: string;
+    dataUser: string;
+    purposes: string[];
+    datasets: string[];
+    exp: string;
+    ts: string;
+}>;
+/** A data-access permit for secondary use (research, policy), issued by the health-data access body. */
+export declare function secondaryUsePermit(input: {
+    permit: string;
+    dataUser: string;
+    purposes: string[];
+    datasets: string[];
+    exp: string;
+    ts?: string;
+}, bodyPrivateKey: Uint8Array): SecondaryUsePermit;
+export declare function secondaryUseAllowed(p: SecondaryUsePermit, access: {
+    dataUser: string;
+    purpose: string;
+    dataset: string;
+    ts: string;
+}, trustedBodies: string[]): boolean;
+export {};
+//# sourceMappingURL=clinical.d.ts.map

package/dist/clinical.d.ts.map

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package/dist/clinical.js

@@ -0,0 +1,130 @@
+/**
+ * More clinical accountability: FHIR AuditEvent export, change logs for AI medical devices
+ * against their predetermined change-control plan, clinical-trial audit trails, consent to
+ * AI-assisted care, second opinions, prescription checks, device-signed readings, claim
+ * evidence without clinical content, outbreak counts that hide each facility's number, and
+ * secondary-use permits.
+ *
+ * Nothing here holds clinical content: episodes are pseudonymous tags and content stays as
+ * salted commitments. Regulatory names (FDA PCCP, ICH E6, EHDS) describe what each record
+ * supports, not a certification.
+ */
+import { jcsHash, signObject, verifySignedObject } from '@zanii/core';
+import { commit, sumOpenings, verifyAggregate } from '@zanii/zk';
+/** A health payload as a FHIR AuditEvent resource (R4/R5 core fields) for an EHR's audit repository. */
+export function toFhirAuditEvent(payload, episodeTag) {
+    const access = payload.kind === 'access' || payload.kind === 'break-glass';
+    return {
+        resourceType: 'AuditEvent',
+        type: { system: 'http://terminology.hl7.org/CodeSystem/audit-event-type', code: 'rest', display: 'RESTful Operation' },
+        action: access ? 'R' : 'E',
+        recorded: payload.ts,
+        agent: [{ who: { identifier: { value: String(payload.actor ?? payload.model_id ?? payload.clinician ?? 'unknown') } }, requestor: true }],
+        source: { observer: { display: 'Zanii transparency log' } },
+        entity: [{ what: { identifier: { value: episodeTag } }, description: String(payload.kind) }],
+        ...(payload.purpose ? { purposeOfEvent: [{ text: String(payload.purpose) }] } : {}),
+        extension: [{ url: 'https://ledger.zanii.agency/fhir/receipt-payload', valueString: jcsHash(payload) }],
+    };
+}
+/** A change to an AI medical device, declared as inside or outside its predetermined change-control plan. */
+export function deviceChange(input) {
+    return { target: 'health.device.change', payload: { _zr_kind: 'health', _zr_domain: 'health', v: 1, kind: 'device-change', ...input } };
+}
+/** Changes made outside the plan (which need their own submission) and changes with no validation evidence. */
+export function changeControlReport(payloads) {
+    const changes = payloads.filter((p) => p.kind === 'device-change');
+    return { changes: changes.length, outsidePlan: changes.filter((c) => !c.withinPlan).map((c) => c.toVersion), unvalidated: changes.filter((c) => !c.validationHash).map((c) => c.toVersion) };
+}
+/** A clinical-trial event for a pseudonymous participant (enrolment, dosing, adverse event, withdrawal). */
+export function trialEvent(input) {
+    return { target: `health.trial.${input.event}`, subjectTag: input.participantTag, payload: { _zr_kind: 'health', v: 1, kind: 'trial', ...input } };
+}
+/** Audit-trail checks per participant: consent before enrolment, nothing before enrolment, nothing after withdrawal. */
+export function trialAuditTrail(payloads) {
+    const issues = [];
+    const by = new Map();
+    for (const p of payloads.filter((x) => x.kind === 'trial'))
+        by.set(String(p.participantTag), [...(by.get(String(p.participantTag)) ?? []), p]);
+    for (const [tag, list] of by) {
+        const e = [...list].sort((a, b) => String(a.ts).localeCompare(String(b.ts)));
+        const at = (ev) => e.find((x) => x.event === ev)?.ts;
+        const consent = at('consent');
+        const enrol = at('enrolment');
+        const withdraw = at('withdrawal');
+        if (!consent || (enrol && consent > enrol))
+            issues.push(`${tag}: no consent before enrolment`);
+        for (const x of e) {
+            if (enrol && x.event !== 'consent' && x.event !== 'enrolment' && String(x.ts) < enrol)
+                issues.push(`${tag}: ${x.event} before enrolment`);
+            if (withdraw && x.event !== 'withdrawal' && String(x.ts) > withdraw)
+                issues.push(`${tag}: ${x.event} after withdrawal`);
+        }
+    }
+    return { participants: by.size, ok: issues.length === 0, issues };
+}
+/** The patient's consent (or refusal) to AI-assisted care in an episode. */
+export function aiCareConsent(input) {
+    return { target: input.granted ? 'health.consent.ai.grant' : 'health.consent.ai.refuse', subjectTag: input.episodeTag, payload: { _zr_kind: 'health', v: 1, kind: 'ai-consent', ...input } };
+}
+/** Were recommendations in an episode made only while AI consent was in force? */
+export function aiUseWithoutConsent(payloads, episodeTag) {
+    const events = payloads.filter((p) => (p.kind === 'ai-consent' && p.episodeTag === episodeTag) || p.kind === 'recommendation').sort((a, b) => String(a.ts).localeCompare(String(b.ts)));
+    let consent = false;
+    const bad = [];
+    for (const e of events) {
+        if (e.kind === 'ai-consent')
+            consent = !!e.granted;
+        else if (!consent)
+            bad.push(String(e.ts));
+    }
+    return bad;
+}
+/** Two models (or a model and a clinician) on the same question: whether they agreed, with both commitments. */
+export function secondOpinion(input) {
+    return { target: 'health.second-opinion', subjectTag: input.episodeTag, risk: input.agree ? 'medium' : 'high', payload: { _zr_kind: 'health', v: 1, kind: 'second-opinion', ...input } };
+}
+/** A prescription, marked when an AI suggested it, and the pharmacist's check. */
+export function prescription(input) {
+    return { target: 'health.rx.issue', subjectTag: input.episodeTag, payload: { _zr_kind: 'health', v: 1, kind: 'rx', ...input } };
+}
+export function pharmacistCheck(input) {
+    return { target: 'health.rx.check', subjectTag: input.episodeTag, payload: { _zr_kind: 'health', v: 1, kind: 'rx-check', ...input } };
+}
+/** AI-suggested prescriptions that no pharmacist has checked. */
+export function uncheckedAiPrescriptions(payloads) {
+    const checked = new Set(payloads.filter((p) => p.kind === 'rx-check').map((p) => p.rxId));
+    return payloads.filter((p) => p.kind === 'rx' && p.aiSuggested && !checked.has(p.rxId)).map((p) => p.rxId);
+}
+/** A wearable or bedside device signs its own reading (the device key is the trust root). */
+export function deviceReading(input, devicePrivateKey) {
+    if (!Number.isFinite(input.value))
+        throw new Error('health: reading must be finite');
+    return signObject({ v: 1, type: 'health.device_reading', ...input }, devicePrivateKey);
+}
+export function verifyDeviceReading(r, trustedDevices) {
+    return verifySignedObject(r) && trustedDevices.includes(r.signer);
+}
+/** For an insurer: what kind of care events happened in an episode, under which protocols. No clinical content. */
+export function claimEvidence(payloads) {
+    const counts = {};
+    for (const p of payloads)
+        counts[String(p.kind)] = (counts[String(p.kind)] ?? 0) + 1;
+    const protocols = [...new Set(payloads.filter((p) => p.manifest_hash).map((p) => String(p.manifest_hash)))];
+    return { events: payloads.length, counts, protocols, confirmedByClinician: payloads.some((p) => p.kind === 'clinician-confirmation') };
+}
+/** Each facility commits to its case count; the ministry learns the regional total, not any facility's number. */
+export function facilityCaseCount(count) {
+    return commit(count);
+}
+export function regionalTotal(commitments, openings) {
+    const total = sumOpenings(openings);
+    return { total: Number(total.value), verified: verifyAggregate(commitments, total) };
+}
+/** A data-access permit for secondary use (research, policy), issued by the health-data access body. */
+export function secondaryUsePermit(input, bodyPrivateKey) {
+    return signObject({ v: 1, type: 'health.permit', ...input, ts: input.ts ?? new Date().toISOString() }, bodyPrivateKey);
+}
+export function secondaryUseAllowed(p, access, trustedBodies) {
+    return verifySignedObject(p) && trustedBodies.includes(p.signer) && p.dataUser === access.dataUser && p.purposes.includes(access.purpose) && p.datasets.includes(access.dataset) && access.ts <= p.exp;
+}
+//# sourceMappingURL=clinical.js.map

package/dist/clinical.js.map

@@ -0,0 +1 @@
+{"version":3,"file":"clinical.js","sourceRoot":"","sources":["../src/clinical.ts"],"names":[],"mappings":"AAAA;;;;;;;;;;GAUG;AACH,OAAO,EAAE,OAAO,EAAE,UAAU,EAAE,kBAAkB,EAAqB,MAAM,aAAa,CAAC;AACzF,OAAO,EAAE,MAAM,EAAE,WAAW,EAAE,eAAe,EAAmB,MAAM,WAAW,CAAC;AAIlF,wGAAwG;AACxG,MAAM,UAAU,gBAAgB,CAAC,OAAgB,EAAE,UAAkB;IACnE,MAAM,MAAM,GAAG,OAAO,CAAC,IAAI,KAAK,QAAQ,IAAI,OAAO,CAAC,IAAI,KAAK,aAAa,CAAC;IAC3E,OAAO;QACL,YAAY,EAAE,YAAY;QAC1B,IAAI,EAAE,EAAE,MAAM,EAAE,wDAAwD,EAAE,IAAI,EAAE,MAAM,EAAE,OAAO,EAAE,mBAAmB,EAAE;QACtH,MAAM,EAAE,MAAM,CAAC,CAAC,CAAC,GAAG,CAAC,CAAC,CAAC,GAAG;QAC1B,QAAQ,EAAE,OAAO,CAAC,EAAE;QACpB,KAAK,EAAE,CAAC,EAAE,GAAG,EAAE,EAAE,UAAU,EAAE,EAAE,KAAK,EAAE,MAAM,CAAC,OAAO,CAAC,KAAK,IAAI,OAAO,CAAC,QAAQ,IAAI,OAAO,CAAC,SAAS,IAAI,SAAS,CAAC,EAAE,EAAE,EAAE,SAAS,EAAE,IAAI,EAAE,CAAC;QACzI,MAAM,EAAE,EAAE,QAAQ,EAAE,EAAE,OAAO,EAAE,wBAAwB,EAAE,EAAE;QAC3D,MAAM,EAAE,CAAC,EAAE,IAAI,EAAE,EAAE,UAAU,EAAE,EAAE,KAAK,EAAE,UAAU,EAAE,EAAE,EAAE,WAAW,EAAE,MAAM,CAAC,OAAO,CAAC,IAAI,CAAC,EAAE,CAAC;QAC5F,GAAG,CAAC,OAAO,CAAC,OAAO,CAAC,CAAC,CAAC,EAAE,cAAc,EAAE,CAAC,EAAE,IAAI,EAAE,MAAM,CAAC,OAAO,CAAC,OAAO,CAAC,EAAE,CAAC,EAAE,CAAC,CAAC,CAAC,EAAE,CAAC;QACnF,SAAS,EAAE,CAAC,EAAE,GAAG,EAAE,kDAAkD,EAAE,WAAW,EAAE,OAAO,CAAC,OAAgB,CAAC,EAAE,CAAC;KACjH,CAAC;AACJ,CAAC;AAED,6GAA6G;AAC7G,MAAM,UAAU,YAAY,CAAC,KAA+I;IAC1K,OAAO,EAAE,MAAM,EAAE,sBAAsB,EAAE,OAAO,EAAE,EAAE,QAAQ,EAAE,QAAQ,EAAE,UAAU,EAAE,QAAQ,EAAE,CAAC,EAAE,CAAC,EAAE,IAAI,EAAE,eAAe,EAAE,GAAG,KAAK,EAAE,EAAE,CAAC;AAC1I,CAAC;AAED,+GAA+G;AAC/G,MAAM,UAAU,mBAAmB,CAAC,QAAmB;IACrD,MAAM,OAAO,GAAG,QAAQ,CAAC,MAAM,CAAC,CAAC,CAAC,EAAE,EAAE,CAAC,CAAC,CAAC,IAAI,KAAK,eAAe,CAAC,CAAC;IACnE,OAAO,EAAE,OAAO,EAAE,OAAO,CAAC,MAAM,EAAE,WAAW,EAAE,OAAO,CAAC,MAAM,CAAC,CAAC,CAAC,EAAE,EAAE,CAAC,CAAC,CAAC,CAAC,UAAU,CAAC,CAAC,GAAG,CAAC,CAAC,CAAC,EAAE,EAAE,CAAC,CAAC,CAAC,SAAS,CAAC,EAAE,WAAW,EAAE,OAAO,CAAC,MAAM,CAAC,CAAC,CAAC,EAAE,EAAE,CAAC,CAAC,CAAC,CAAC,cAAc,CAAC,CAAC,GAAG,CAAC,CAAC,CAAC,EAAE,EAAE,CAAC,CAAC,CAAC,SAAS,CAAC,EAAE,CAAC;AAC/L,CAAC;AAED,4GAA4G;AAC5G,MAAM,UAAU,UAAU,CAAC,KAA0K;IACnM,OAAO,EAAE,MAAM,EAAE,gBAAgB,KAAK,CAAC,KAAK,EAAE,EAAE,UAAU,EAAE,KAAK,CAAC,cAAc,EAAE,OAAO,EAAE,EAAE,QAAQ,EAAE,QAAQ,EAAE,CAAC,EAAE,CAAC,EAAE,IAAI,EAAE,OAAO,EAAE,GAAG,KAAK,EAAE,EAAE,CAAC;AACrJ,CAAC;AAED,wHAAwH;AACxH,MAAM,UAAU,eAAe,CAAC,QAAmB;IACjD,MAAM,MAAM,GAAa,EAAE,CAAC;IAC5B,MAAM,EAAE,GAAG,IAAI,GAAG,EAAqB,CAAC;IACxC,KAAK,MAAM,CAAC,IAAI,QAAQ,CAAC,MAAM,CAAC,CAAC,CAAC,EAAE,EAAE,CAAC,CAAC,CAAC,IAAI,KAAK,OAAO,CAAC;QAAE,EAAE,CAAC,GAAG,CAAC,MAAM,CAAC,CAAC,CAAC,cAAc,CAAC,EAAE,CAAC,GAAG,CAAC,EAAE,CAAC,GAAG,CAAC,MAAM,CAAC,CAAC,CAAC,cAAc,CAAC,CAAC,IAAI,EAAE,CAAC,EAAE,CAAC,CAAC,CAAC,CAAC;IAC/I,KAAK,MAAM,CAAC,GAAG,EAAE,IAAI,CAAC,IAAI,EAAE,EAAE,CAAC;QAC7B,MAAM,CAAC,GAAG,CAAC,GAAG,IAAI,CAAC,CAAC,IAAI,CAAC,CAAC,CAAC,EAAE,CAAC,EAAE,EAAE,CAAC,MAAM,CAAC,CAAC,CAAC,EAAE,CAAC,CAAC,aAAa,CAAC,MAAM,CAAC,CAAC,CAAC,EAAE,CAAC,CAAC,CAAC,CAAC;QAC7E,MAAM,EAAE,GAAG,CAAC,EAAU,EAAE,EAAE,CAAC,CAAC,CAAC,IAAI,CAAC,CAAC,CAAC,EAAE,EAAE,CAAC,CAAC,CAAC,KAAK,KAAK,EAAE,CAAC,EAAE,EAAwB,CAAC;QACnF,MAAM,OAAO,GAAG,EAAE,CAAC,SAAS,CAAC,CAAC;QAC9B,MAAM,KAAK,GAAG,EAAE,CAAC,WAAW,CAAC,CAAC;QAC9B,MAAM,QAAQ,GAAG,EAAE,CAAC,YAAY,CAAC,CAAC;QAClC,IAAI,CAAC,OAAO,IAAI,CAAC,KAAK,IAAI,OAAO,GAAG,KAAK,CAAC;YAAE,MAAM,CAAC,IAAI,CAAC,GAAG,GAAG,+BAA+B,CAAC,CAAC;QAC/F,KAAK,MAAM,CAAC,IAAI,CAAC,EAAE,CAAC;YAClB,IAAI,KAAK,IAAI,CAAC,CAAC,KAAK,KAAK,SAAS,IAAI,CAAC,CAAC,KAAK,KAAK,WAAW,IAAI,MAAM,CAAC,CAAC,CAAC,EAAE,CAAC,GAAG,KAAK;gBAAE,MAAM,CAAC,IAAI,CAAC,GAAG,GAAG,KAAK,CAAC,CAAC,KAAK,mBAAmB,CAAC,CAAC;YAC1I,IAAI,QAAQ,IAAI,CAAC,CAAC,KAAK,KAAK,YAAY,IAAI,MAAM,CAAC,CAAC,CAAC,EAAE,CAAC,GAAG,QAAQ;gBAAE,MAAM,CAAC,IAAI,CAAC,GAAG,GAAG,KAAK,CAAC,CAAC,KAAK,mBAAmB,CAAC,CAAC;QAC1H,CAAC;IACH,CAAC;IACD,OAAO,EAAE,YAAY,EAAE,EAAE,CAAC,IAAI,EAAE,EAAE,EAAE,MAAM,CAAC,MAAM,KAAK,CAAC,EAAE,MAAM,EAAE,CAAC;AACpE,CAAC;AAED,4EAA4E;AAC5E,MAAM,UAAU,aAAa,CAAC,KAA4E;IACxG,OAAO,EAAE,MAAM,EAAE,KAAK,CAAC,OAAO,CAAC,CAAC,CAAC,yBAAyB,CAAC,CAAC,CAAC,0BAA0B,EAAE,UAAU,EAAE,KAAK,CAAC,UAAU,EAAE,OAAO,EAAE,EAAE,QAAQ,EAAE,QAAQ,EAAE,CAAC,EAAE,CAAC,EAAE,IAAI,EAAE,YAAY,EAAE,GAAG,KAAK,EAAE,EAAE,CAAC;AAC/L,CAAC;AAED,kFAAkF;AAClF,MAAM,UAAU,mBAAmB,CAAC,QAAmB,EAAE,UAAkB;IACzE,MAAM,MAAM,GAAG,QAAQ,CAAC,MAAM,CAAC,CAAC,CAAC,EAAE,EAAE,CAAC,CAAC,CAAC,CAAC,IAAI,KAAK,YAAY,IAAI,CAAC,CAAC,UAAU,KAAK,UAAU,CAAC,IAAI,CAAC,CAAC,IAAI,KAAK,gBAAgB,CAAC,CAAC,IAAI,CAAC,CAAC,CAAC,EAAE,CAAC,EAAE,EAAE,CAAC,MAAM,CAAC,CAAC,CAAC,EAAE,CAAC,CAAC,aAAa,CAAC,MAAM,CAAC,CAAC,CAAC,EAAE,CAAC,CAAC,CAAC,CAAC;IACxL,IAAI,OAAO,GAAG,KAAK,CAAC;IACpB,MAAM,GAAG,GAAa,EAAE,CAAC;IACzB,KAAK,MAAM,CAAC,IAAI,MAAM,EAAE,CAAC;QACvB,IAAI,CAAC,CAAC,IAAI,KAAK,YAAY;YAAE,OAAO,GAAG,CAAC,CAAC,CAAC,CAAC,OAAO,CAAC;aAC9C,IAAI,CAAC,OAAO;YAAE,GAAG,CAAC,IAAI,CAAC,MAAM,CAAC,CAAC,CAAC,EAAE,CAAC,CAAC,CAAC;IAC5C,CAAC;IACD,OAAO,GAAG,CAAC;AACb,CAAC;AAED,gHAAgH;AAChH,MAAM,UAAU,aAAa,CAAC,KAAgJ;IAC5K,OAAO,EAAE,MAAM,EAAE,uBAAuB,EAAE,UAAU,EAAE,KAAK,CAAC,UAAU,EAAE,IAAI,EAAE,KAAK,CAAC,KAAK,CAAC,CAAC,CAAE,QAAkB,CAAC,CAAC,CAAE,MAAgB,EAAE,OAAO,EAAE,EAAE,QAAQ,EAAE,QAAQ,EAAE,CAAC,EAAE,CAAC,EAAE,IAAI,EAAE,gBAAgB,EAAE,GAAG,KAAK,EAAE,EAAE,CAAC;AACjN,CAAC;AAED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package/dist/index.d.ts

@@ -187,4 +187,5 @@ export declare function fetchEpisodes(seed: EpisodeSeed, opts?: {
     from?: number;
     to?: number;
 }): Promise<EpisodeHistory>;
+export * from './clinical.js';
 //# sourceMappingURL=index.d.ts.map

package/dist/index.d.ts.map

@@ -1 +1 @@
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package/dist/index.js

@@ -244,4 +244,5 @@ export async function fetchEpisodes(seed, opts = {}) {
         protocols: protocolTrail(all),
     };
 }
+export * from './clinical.js';
 //# sourceMappingURL=index.js.map

package/dist/index.js.map

@@ -1 +1 @@
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package/package.json

@@ -1,6 +1,6 @@
 {
   "name": "@zanii/health",
-  "version": "0.1.2",
+  "version": "0.1.3",
   "description": "Medical audit trails without leaking the pattern: per-episode unlinkable tags (the patient supplies the tag, never the seed), plus who accessed the record, which model recommended what under which protocol, and which named clinician took responsibility. Break-glass is loud, not impossible.",
   "license": "Apache-2.0",
   "homepage": "https://ledger.zanii.agency",
@@ -31,7 +31,8 @@
     "vitest": "^3.0.9"
   },
   "dependencies": {
-    "@zanii/core": "^0.5.2",
+    "@zanii/core": "^0.5.4",
+    "@zanii/zk": "^0.1.0",
     "@zanii/subject": "^0.1.2"
   },
   "scripts": {

package/src/clinical.ts

@@ -0,0 +1,145 @@
+/**
+ * More clinical accountability: FHIR AuditEvent export, change logs for AI medical devices
+ * against their predetermined change-control plan, clinical-trial audit trails, consent to
+ * AI-assisted care, second opinions, prescription checks, device-signed readings, claim
+ * evidence without clinical content, outbreak counts that hide each facility's number, and
+ * secondary-use permits.
+ *
+ * Nothing here holds clinical content: episodes are pseudonymous tags and content stays as
+ * salted commitments. Regulatory names (FDA PCCP, ICH E6, EHDS) describe what each record
+ * supports, not a certification.
+ */
+import { jcsHash, signObject, verifySignedObject, type SignedObject } from '@zanii/core';
+import { commit, sumOpenings, verifyAggregate, type Commitment } from '@zanii/zk';
+
+type Payload = Record<string, unknown>;
+
+/** A health payload as a FHIR AuditEvent resource (R4/R5 core fields) for an EHR's audit repository. */
+export function toFhirAuditEvent(payload: Payload, episodeTag: string) {
+  const access = payload.kind === 'access' || payload.kind === 'break-glass';
+  return {
+    resourceType: 'AuditEvent',
+    type: { system: 'http://terminology.hl7.org/CodeSystem/audit-event-type', code: 'rest', display: 'RESTful Operation' },
+    action: access ? 'R' : 'E',
+    recorded: payload.ts,
+    agent: [{ who: { identifier: { value: String(payload.actor ?? payload.model_id ?? payload.clinician ?? 'unknown') } }, requestor: true }],
+    source: { observer: { display: 'Zanii transparency log' } },
+    entity: [{ what: { identifier: { value: episodeTag } }, description: String(payload.kind) }],
+    ...(payload.purpose ? { purposeOfEvent: [{ text: String(payload.purpose) }] } : {}),
+    extension: [{ url: 'https://ledger.zanii.agency/fhir/receipt-payload', valueString: jcsHash(payload as never) }],
+  };
+}
+
+/** A change to an AI medical device, declared as inside or outside its predetermined change-control plan. */
+export function deviceChange(input: { device: string; fromVersion: string; toVersion: string; description: string; validationHash: string; withinPlan: boolean; ts: string }) {
+  return { target: 'health.device.change', payload: { _zr_kind: 'health', _zr_domain: 'health', v: 1, kind: 'device-change', ...input } };
+}
+
+/** Changes made outside the plan (which need their own submission) and changes with no validation evidence. */
+export function changeControlReport(payloads: Payload[]) {
+  const changes = payloads.filter((p) => p.kind === 'device-change');
+  return { changes: changes.length, outsidePlan: changes.filter((c) => !c.withinPlan).map((c) => c.toVersion), unvalidated: changes.filter((c) => !c.validationHash).map((c) => c.toVersion) };
+}
+
+/** A clinical-trial event for a pseudonymous participant (enrolment, dosing, adverse event, withdrawal). */
+export function trialEvent(input: { trial: string; participantTag: string; event: 'enrolment' | 'consent' | 'dose' | 'assessment' | 'adverse-event' | 'withdrawal'; detailsHash: string; ts: string }) {
+  return { target: `health.trial.${input.event}`, subjectTag: input.participantTag, payload: { _zr_kind: 'health', v: 1, kind: 'trial', ...input } };
+}
+
+/** Audit-trail checks per participant: consent before enrolment, nothing before enrolment, nothing after withdrawal. */
+export function trialAuditTrail(payloads: Payload[]) {
+  const issues: string[] = [];
+  const by = new Map<string, Payload[]>();
+  for (const p of payloads.filter((x) => x.kind === 'trial')) by.set(String(p.participantTag), [...(by.get(String(p.participantTag)) ?? []), p]);
+  for (const [tag, list] of by) {
+    const e = [...list].sort((a, b) => String(a.ts).localeCompare(String(b.ts)));
+    const at = (ev: string) => e.find((x) => x.event === ev)?.ts as string | undefined;
+    const consent = at('consent');
+    const enrol = at('enrolment');
+    const withdraw = at('withdrawal');
+    if (!consent || (enrol && consent > enrol)) issues.push(`${tag}: no consent before enrolment`);
+    for (const x of e) {
+      if (enrol && x.event !== 'consent' && x.event !== 'enrolment' && String(x.ts) < enrol) issues.push(`${tag}: ${x.event} before enrolment`);
+      if (withdraw && x.event !== 'withdrawal' && String(x.ts) > withdraw) issues.push(`${tag}: ${x.event} after withdrawal`);
+    }
+  }
+  return { participants: by.size, ok: issues.length === 0, issues };
+}
+
+/** The patient's consent (or refusal) to AI-assisted care in an episode. */
+export function aiCareConsent(input: { episodeTag: string; granted: boolean; scope: string[]; ts: string }) {
+  return { target: input.granted ? 'health.consent.ai.grant' : 'health.consent.ai.refuse', subjectTag: input.episodeTag, payload: { _zr_kind: 'health', v: 1, kind: 'ai-consent', ...input } };
+}
+
+/** Were recommendations in an episode made only while AI consent was in force? */
+export function aiUseWithoutConsent(payloads: Payload[], episodeTag: string) {
+  const events = payloads.filter((p) => (p.kind === 'ai-consent' && p.episodeTag === episodeTag) || p.kind === 'recommendation').sort((a, b) => String(a.ts).localeCompare(String(b.ts)));
+  let consent = false;
+  const bad: string[] = [];
+  for (const e of events) {
+    if (e.kind === 'ai-consent') consent = !!e.granted;
+    else if (!consent) bad.push(String(e.ts));
+  }
+  return bad;
+}
+
+/** Two models (or a model and a clinician) on the same question: whether they agreed, with both commitments. */
+export function secondOpinion(input: { episodeTag: string; first: { by: string; commitment: string }; second: { by: string; commitment: string }; agree: boolean; ts: string }) {
+  return { target: 'health.second-opinion', subjectTag: input.episodeTag, risk: input.agree ? ('medium' as const) : ('high' as const), payload: { _zr_kind: 'health', v: 1, kind: 'second-opinion', ...input } };
+}
+
+/** A prescription, marked when an AI suggested it, and the pharmacist's check. */
+export function prescription(input: { episodeTag: string; rxId: string; drugCode: string; prescriber: string; aiSuggested: boolean; ts: string }) {
+  return { target: 'health.rx.issue', subjectTag: input.episodeTag, payload: { _zr_kind: 'health', v: 1, kind: 'rx', ...input } };
+}
+
+export function pharmacistCheck(input: { episodeTag: string; rxId: string; pharmacist: string; outcome: 'dispensed' | 'queried' | 'refused'; ts: string }) {
+  return { target: 'health.rx.check', subjectTag: input.episodeTag, payload: { _zr_kind: 'health', v: 1, kind: 'rx-check', ...input } };
+}
+
+/** AI-suggested prescriptions that no pharmacist has checked. */
+export function uncheckedAiPrescriptions(payloads: Payload[]) {
+  const checked = new Set(payloads.filter((p) => p.kind === 'rx-check').map((p) => p.rxId));
+  return payloads.filter((p) => p.kind === 'rx' && p.aiSuggested && !checked.has(p.rxId)).map((p) => p.rxId);
+}
+
+export type DeviceReading = SignedObject<{ v: 1; type: 'health.device_reading'; episodeTag: string; metric: string; value: number; unit: string; ts: string }>;
+
+/** A wearable or bedside device signs its own reading (the device key is the trust root). */
+export function deviceReading(input: { episodeTag: string; metric: string; value: number; unit: string; ts: string }, devicePrivateKey: Uint8Array): DeviceReading {
+  if (!Number.isFinite(input.value)) throw new Error('health: reading must be finite');
+  return signObject({ v: 1 as const, type: 'health.device_reading' as const, ...input }, devicePrivateKey);
+}
+
+export function verifyDeviceReading(r: DeviceReading, trustedDevices: string[]): boolean {
+  return verifySignedObject(r) && trustedDevices.includes(r.signer);
+}
+
+/** For an insurer: what kind of care events happened in an episode, under which protocols. No clinical content. */
+export function claimEvidence(payloads: Payload[]) {
+  const counts: Record<string, number> = {};
+  for (const p of payloads) counts[String(p.kind)] = (counts[String(p.kind)] ?? 0) + 1;
+  const protocols = [...new Set(payloads.filter((p) => p.manifest_hash).map((p) => String(p.manifest_hash)))];
+  return { events: payloads.length, counts, protocols, confirmedByClinician: payloads.some((p) => p.kind === 'clinician-confirmation') };
+}
+
+/** Each facility commits to its case count; the ministry learns the regional total, not any facility's number. */
+export function facilityCaseCount(count: number): Commitment {
+  return commit(count);
+}
+
+export function regionalTotal(commitments: string[], openings: Commitment['opening'][]) {
+  const total = sumOpenings(openings);
+  return { total: Number(total.value), verified: verifyAggregate(commitments, total) };
+}
+
+export type SecondaryUsePermit = SignedObject<{ v: 1; type: 'health.permit'; permit: string; dataUser: string; purposes: string[]; datasets: string[]; exp: string; ts: string }>;
+
+/** A data-access permit for secondary use (research, policy), issued by the health-data access body. */
+export function secondaryUsePermit(input: { permit: string; dataUser: string; purposes: string[]; datasets: string[]; exp: string; ts?: string }, bodyPrivateKey: Uint8Array): SecondaryUsePermit {
+  return signObject({ v: 1 as const, type: 'health.permit' as const, ...input, ts: input.ts ?? new Date().toISOString() }, bodyPrivateKey);
+}
+
+export function secondaryUseAllowed(p: SecondaryUsePermit, access: { dataUser: string; purpose: string; dataset: string; ts: string }, trustedBodies: string[]): boolean {
+  return verifySignedObject(p) && trustedBodies.includes(p.signer) && p.dataUser === access.dataUser && p.purposes.includes(access.purpose) && p.datasets.includes(access.dataset) && access.ts <= p.exp;
+}

package/src/index.ts

@@ -364,3 +364,4 @@ export async function fetchEpisodes(
     protocols: protocolTrail(all),
   };
 }
+export * from './clinical.js';