/**
 * NICE Evidence Standards Framework for Digital Health Technologies
 * Compliance Pack
 *
 * Framework: NICE (National Institute for Health and Care Excellence)
 *   Evidence Standards Framework for Digital Health Technologies (ESF
 *   for DHT). Originally published 2018; updated 2022 + 2024 to address
 *   AI-driven digital health technologies. Used by NHS England,
 *   Department of Health and Social Care, integrated care systems, and
 *   commissioners as the de-facto UK reimbursement evidence bar for
 *   digital health technologies, including AI-based products.
 *
 * Jurisdiction: GB — England-led; equivalent practice in Scotland (SHTG
 *   Scottish Health Technologies Group), Wales, and Northern Ireland
 *   under their devolved health-technology-assessment bodies.
 * Authority: NICE + NHS England (commissioning) + DHSC (policy) +
 *   integrated care systems (commissioners)
 *
 * Why this pack:
 *   - The UK healthcare-AI assessment stack has FOUR distinct layers:
 *     1. **Regulatory approval** — MHRA UKCA / SaMD (separate pack:
 *        `mhra-samd-ukca`)
 *     2. **Clinical safety case** — DCB0129/0160 (separate pack:
 *        `nhs-clinical-safety`)
 *     3. **Data security baseline** — DSPT (separate pack: `nhs-dspt`)
 *     4. **HTA / reimbursement evidence** — this pack
 *   - NICE ESF for DHT is the "is this AI product worth NHS funding?"
 *     gate. Distinct from MHRA's "is it safe to sell?" gate.
 *   - Replaces Australian TGA slot in Thomas's UK-16 list (UK doesn't
 *     have a TGA — TGA is the Australian Therapeutic Goods Admin; the
 *     UK equivalent regulatory body is MHRA, already covered. The
 *     missing piece in the UK healthcare-AI stack is HTA evidence).
 *   - Pairs with `mhra-samd-ukca` (regulatory approval), `nhs-clinical-
 *     safety` (clinical safety case), `nhs-dspt` (data security),
 *     `nhs-dtac` (composite assessment).
 *
 * NICE ESF for DHT three evidence tiers (current 2024 framework):
 *   - **Tier A**: digital tools with no measurable user benefit (e.g.,
 *     system services). Minimal evidence required.
 *   - **Tier B**: products that inform users (e.g., information apps,
 *     diagnostic aids). Functional evidence + accuracy.
 *   - **Tier C**: products that drive behaviour change or treatment
 *     decisions. Highest evidence bar — clinical effectiveness +
 *     economic impact + real-world data.
 *
 * Evidence categories per NICE ESF:
 *   - **Effectiveness evidence** — clinical outcomes; AI accuracy +
 *     calibration metrics; comparator data
 *   - **Economic impact evidence** — cost-effectiveness analysis;
 *     budget impact; QALY gain
 *   - **Real-world performance** — post-deployment monitoring;
 *     equity-of-access metrics; subgroup performance
 *   - **Health inequalities impact** — Equality Act 2010 protected-
 *     characteristic subgroup analysis
 *   - **Data and analytics** — model lineage; training data
 *     provenance; UK-applicability evidence
 *
 * Out of scope:
 *   - MHRA UKCA / SaMD regulatory approval (separate pack)
 *   - DCB0129/0160 clinical safety case (separate pack)
 *   - SHTG Scotland equivalent (devolved, separate pack to follow)
 *   - General clinical-trial regulation (separate regime)
 *
 * @connexum/ai-governance
 */
import { CompliancePack } from './index';
import { CategoryClassifiers } from '../classification/pack-driven-classifier';
export declare const NICE_ESF_DHT_CATEGORY_CLASSIFIERS: CategoryClassifiers;
export declare const NICE_ESF_DHT_PACK: CompliancePack & {
    categoryClassifiers: CategoryClassifiers;
};
//# sourceMappingURL=nice-esf-dht.d.ts.map