/**
 * NHS Clinical Safety Standards: DCB0129 + DCB0160 Compliance Pack
 *
 * Standards:
 *   - DCB0129 (Clinical Risk Management: its Application in the Manufacture
 *     of Health IT Systems) — applies to the MANUFACTURER (the customer
 *     building the AI agent / health IT system).
 *   - DCB0160 (Clinical Risk Management: its Application in the Deployment
 *     and Use of Health IT Systems) — applies to the DEPLOYER (the NHS
 *     trust or health organisation running the AI agent in production).
 *
 * Both standards are mandatory for any clinical IT system used in the NHS,
 * issued under the Health and Social Care Act 2012 s250. They are NOT
 * optional and they are NOT alternatives — a clinical IT system used in
 * the NHS must comply with BOTH (manufacturer evidence flows to deployer,
 * deployer adds operational evidence on top).
 *
 * Jurisdiction: GB (United Kingdom — England-led; equivalent practice
 *   followed in Scotland / Wales / Northern Ireland)
 * Authority: NHS England (publishes both standards); previously NHS Digital
 * Regulator overlap: MHRA (when the system is also a SaMD under UKCA);
 *   ICO (when personal data is processed); CQC (well-led KLOE evidence)
 *
 * Why this pack:
 *   - Required for any clinical IT system in the NHS — including AI agents
 *     issuing or supporting clinical recommendations, triage, scheduling,
 *     summarisation of clinical content, or any decision affecting patient
 *     care.
 *   - The Clinical Safety Officer (CSO) role is a contractual gate: a
 *     suitably qualified clinician must be named for the manufacturer side
 *     AND for each deployer organisation.
 *   - Unblocks Pack 4 (MHRA UK SaMD) per F-NEW-TIER-10-UK-WAVE1-ROADMAP —
 *     MHRA SaMD evidence inherits the DCB0129 clinical-safety-case spine.
 *   - Depends on Pack 5 (NHS DSPT, PR #395) for the NHS-data classification
 *     substrate (NHS Number, SNOMED-CT, ICD-10).
 *
 * Key obligations encoded in this pack:
 *   1. Clinical Safety Officer (CSO) named for both manufacturer and each
 *      deployer; sign-off captured on the Clinical Safety Case Report.
 *   2. Hazard log: every clinical hazard identified, scored (likelihood ×
 *      severity → risk level), mitigated, residual-risk assessed, and
 *      reviewed at every release / configuration change.
 *   3. Clinical Safety Case Report (CSCR) — the single document that
 *      assembles hazards, mitigations, residual risk, deployment context,
 *      training and operational instructions, and the CSO sign-off. CSCR
 *      is the contractual artefact a deploying NHS organisation requires
 *      before procuring or going live with a clinical IT system.
 *   4. Change-control gate: any change to a clinical IT system requires
 *      hazard-log re-review and CSCR update before deployment.
 *   5. Incident response: clinical safety incidents reported to the CSO,
 *      logged in the hazard log, and where harm reached or could reach a
 *      patient, escalated to the deploying organisation's Patient Safety
 *      Incident Response Framework (PSIRF) and (if applicable) MHRA Yellow
 *      Card / Field Safety Notice.
 *   6. Manufacturer-deployer evidence handoff: the manufacturer's CSCR is
 *      the deployer's input; the deployer's DCB0160 evidence layers on
 *      operational context (local config, training records, integration
 *      hazards).
 *   7. AI-specific overlays: model-version logging, drift monitoring as a
 *      named hazard, prompt / output sample retention for forensic review.
 *
 * Out of scope:
 *   - MHRA SaMD UKCA marking (separate pack: forthcoming Wave 1 Pack 4)
 *   - NHS DSPT data security baseline (separate pack: nhs-dspt PR #395)
 *   - Cyber Essentials technical-control evidence (separate pack:
 *     cyber-essentials PR #397)
 *   - UK GDPR personal-data handling (separate pack: uk-gdpr)
 *
 * @connexum/ai-governance
 */
import { CompliancePack } from './index';
import { CategoryClassifiers } from '../classification/pack-driven-classifier';
/**
 * DCB0129/DCB0160 category classifiers.
 *
 * Pack scope is clinical-safety evidence: hazards, mitigations, CSCR
 * artefacts, CSO sign-off records, change-control reviews, and AI-model
 * audit metadata. Personal-data classification is delegated to nhs-dspt
 * and uk-gdpr packs which a clinical-IT customer must run alongside.
 */
export declare const NHS_CLINICAL_SAFETY_CATEGORY_CLASSIFIERS: CategoryClassifiers;
export declare const NHS_CLINICAL_SAFETY_PACK: CompliancePack & {
    categoryClassifiers: CategoryClassifiers;
};
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