@connexum/ai-governance 1.0.0-beta.11

package/dist/esm/packs/nice-esf-dht.js

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+/**
+ * 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
+ */
+export const NICE_ESF_DHT_CATEGORY_CLASSIFIERS = {
+    ESF_TIER_DESIGNATION: {
+        references: [
+            'NICE ESF for DHT (2024) — three-tier evidence framework',
+        ],
+        classifier: (input) => {
+            if (/\b(?:nice\s+esf\s+(?:tier\s*[abc]|designation)|esf\s+dht\s+tier|tier\s+[abc]\s+digital\s+health)\b/i.test(input))
+                return true;
+            if (/\b(?:nice\s+evidence\s+standards\s+framework|nice\s+digital\s+health\s+evidence)\b/i.test(input))
+                return true;
+            return false;
+        },
+    },
+    EFFECTIVENESS_EVIDENCE: {
+        references: [
+            'NICE ESF for DHT — clinical effectiveness + AI accuracy / calibration metrics',
+        ],
+        classifier: (input) => {
+            if (/\b(?:clinical\s+effectiveness|clinical\s+outcome\s+study|ai\s+(?:accuracy|calibration|sensitivity|specificity)\s+report)\b/i.test(input))
+                return true;
+            if (/\b(?:auc\s+roc\s+(?:report|nice|clinical)|comparator\s+study\s+nice|head[\s-]?to[\s-]?head\s+evaluation)\b/i.test(input))
+                return true;
+            return false;
+        },
+    },
+    ECONOMIC_IMPACT_EVIDENCE: {
+        references: [
+            'NICE ESF for DHT — cost-effectiveness, budget impact, QALY gain',
+        ],
+        classifier: (input) => {
+            if (/\b(?:cost[\s-]?effectiveness\s+(?:analysis|model)|qaly\s+(?:gain|analysis)|budget\s+impact\s+model)\b/i.test(input))
+                return true;
+            if (/\b(?:icer\s+nice|incremental\s+cost\s+effectiveness\s+ratio|hta\s+economic\s+model)\b/i.test(input))
+                return true;
+            return false;
+        },
+    },
+    REAL_WORLD_PERFORMANCE: {
+        references: [
+            'NICE ESF for DHT — post-deployment real-world performance monitoring',
+        ],
+        classifier: (input) => {
+            if (/\b(?:real[\s-]?world\s+(?:evidence|performance|data\s+nice|monitoring\s+nice)|rwe\s+nice)\b/i.test(input))
+                return true;
+            if (/\b(?:post[\s-]?deployment\s+(?:monitoring|evaluation\s+nice)|rwd\s+report\s+nice)\b/i.test(input))
+                return true;
+            return false;
+        },
+    },
+    HEALTH_INEQUALITIES_IMPACT: {
+        references: [
+            'NICE ESF for DHT — health inequalities + subgroup performance; Equality Act 2010 overlay',
+        ],
+        classifier: (input) => {
+            if (/\b(?:health\s+inequalities\s+(?:impact|assessment|nice)|core20plus5)\b/i.test(input))
+                return true;
+            if (/\b(?:subgroup\s+performance\s+(?:nice|esf)|equity\s+of\s+access\s+(?:nice|esf))\b/i.test(input))
+                return true;
+            if (/\b(?:protected\s+characteristic\s+subgroup\s+nice|imd\s+decile\s+(?:nice|esf))\b/i.test(input))
+                return true;
+            return false;
+        },
+    },
+    MODEL_PROVENANCE_RECORD: {
+        references: [
+            'NICE ESF for DHT — model lineage + training data provenance + UK applicability',
+        ],
+        classifier: (input) => {
+            if (/\b(?:model\s+(?:lineage|provenance|card)\s+nice|training\s+data\s+(?:provenance|origin)\s+esf)\b/i.test(input))
+                return true;
+            if (/\b(?:uk\s+applicability\s+evidence|uk\s+population\s+representativeness|domain\s+shift\s+nice)\b/i.test(input))
+                return true;
+            return false;
+        },
+    },
+    CREDENTIALS: {
+        references: ['Cross-pack secrets safety; NICE ESF artefacts must not embed credentials'],
+        classifier: (input) => {
+            if (/\b(?:api[_-]?key|apikey)\s*[=:]\s*["']?[A-Za-z0-9_\-\/+]{16,}["']?/i.test(input))
+                return true;
+            if (/\bpassword\s*[=:]\s*["']?[A-Za-z0-9!@#$%^&*_\-]{8,}["']?/i.test(input))
+                return true;
+            if (/-----BEGIN\s+(?:RSA\s+)?PRIVATE\s+KEY-----/.test(input))
+                return true;
+            return false;
+        },
+    },
+};
+export const NICE_ESF_DHT_PACK = {
+    categoryClassifiers: NICE_ESF_DHT_CATEGORY_CLASSIFIERS,
+    id: 'nice-esf-dht',
+    aliases: [
+        'nice-esf',
+        'nice-evidence-standards-framework',
+        'nice-dht',
+        'esf-dht',
+        'nice-digital-health',
+        'uk-hta-dht',
+    ],
+    name: 'NICE Evidence Standards Framework for Digital Health Technologies',
+    version: '1.0.0',
+    description: 'NICE Evidence Standards Framework for Digital Health Technologies (2018; updated 2022 + 2024). The UK\'s de-facto reimbursement evidence bar for digital health technologies, including AI-based products. Three-tier framework: Tier A (no measurable user benefit, minimal evidence), Tier B (informs users, functional + accuracy evidence), Tier C (drives behaviour change or treatment decisions, full clinical effectiveness + economic + real-world evidence). Evidence categories: effectiveness, economic impact, real-world performance, health inequalities impact, model provenance / UK applicability. Replaces "TGA" slot in Thomas\'s UK-16 list — UK has no TGA equivalent (MHRA covers regulatory approval, this pack covers HTA / reimbursement).',
+    authority: 'NICE (National Institute for Health and Care Excellence) + NHS England (commissioning) + DHSC + integrated care systems',
+    industries: ['healthcare', 'pharma', 'digital-health', 'medical-devices', 'public-sector', 'clinical-research'],
+    requiredModules: [
+        {
+            name: 'attestation-manager',
+            required: true,
+            reason: 'NICE ESF tier designation (A / B / C) recorded with rationale; per-tier evidence bundle attestation; UK-applicability declaration; model-card publication.',
+            reference: 'NICE ESF for DHT 2024',
+        },
+        {
+            name: 'governance-runtime',
+            required: true,
+            reason: 'Default-deny on commissioning / reimbursement claims where the required-tier evidence bundle is incomplete; tier-aware gate (Tier C requires the highest evidence bar).',
+            reference: 'NICE ESF tier evidence requirements',
+        },
+        {
+            name: 'audit-integrity',
+            required: true,
+            reason: 'Tamper-evident audit chain for evidence-bundle revisions, NICE submission revisions, real-world performance reports, model-update events — required for NICE assessment + commissioner due-diligence.',
+            reference: 'NICE submission evidentiary integrity',
+        },
+        {
+            name: 'event-bus',
+            required: true,
+            reason: 'Real-world performance drift alerts; subgroup performance disparity alerts; model-update events that may shift evidence bundle; NICE re-assessment cycle reminders.',
+            reference: 'NICE ESF real-world performance monitoring',
+        },
+        {
+            name: 'data-classifier',
+            required: true,
+            reason: 'Surface ESF-specific evidence categories for the audit chain and the dashboard (tier designation, effectiveness, economic, real-world, health inequalities, model provenance).',
+            reference: 'NICE ESF evidence categorisation',
+        },
+        {
+            name: 'attestation-manager',
+            required: true,
+            reason: 'Per-evidence-category bundle status (collected / submitted / accepted) tracked for NICE submission state machine.',
+            reference: 'NICE submission lifecycle',
+        },
+        {
+            name: 'session-persistence',
+            required: true,
+            reason: 'Evidence retained for the product lifecycle plus 6 years (Limitation Act 1980 baseline; NICE may request historic evidence in re-assessment cycles).',
+            reference: 'Limitation Act 1980; NICE re-assessment practice',
+        },
+        {
+            name: 'bias-monitor',
+            required: true,
+            reason: 'Subgroup performance monitoring across protected characteristics (Equality Act 2010 overlap); IMD-decile and Core20PLUS5 subgroup analysis for health inequalities impact evidence.',
+            reference: 'NICE ESF health inequalities; Equality Act 2010',
+        },
+        {
+            name: 'transparency-injector',
+            required: true,
+            reason: 'Public-facing model card; commissioner-facing evidence summary; clinician-facing decision-support uncertainty display.',
+            reference: 'NICE ESF transparency expectations',
+        },
+        {
+            name: 'supply-chain',
+            required: true,
+            reason: 'Sub-supplier model / component evidence chain; training-data provenance flow-down; UK-applicability cascade.',
+            reference: 'NICE ESF model provenance',
+        },
+    ],
+    moduleConfig: {
+        'attestation-manager': {
+            esfTierDesignationRequired: true,
+            perTierEvidenceBundleAttestationRequired: true,
+            ukApplicabilityDeclarationRequired: true,
+            modelCardPublicationRequired: true,
+            perEvidenceCategoryBundleStatusTracked: true,
+        },
+        'governance-runtime': {
+            tierAwareEvidenceGateRequired: true,
+            defaultDenyOnIncompleteEvidenceBundle: true,
+        },
+        'audit-integrity': {
+            niceSubmissionEvidenceTrackingRequired: true,
+        },
+        'event-bus': {
+            realWorldPerformanceDriftAlertsRequired: true,
+            subgroupDisparityAlertsRequired: true,
+            modelUpdateEventsRequired: true,
+            niceReassessmentRemindersRequired: true,
+        },
+        'data-classifier': {
+            enabledCategories: [
+                'ESF_TIER_DESIGNATION',
+                'EFFECTIVENESS_EVIDENCE',
+                'ECONOMIC_IMPACT_EVIDENCE',
+                'REAL_WORLD_PERFORMANCE',
+                'HEALTH_INEQUALITIES_IMPACT',
+                'MODEL_PROVENANCE_RECORD',
+                'CREDENTIALS',
+            ],
+            credentialsAction: 'BLOCK',
+        },
+        'session-persistence': {
+            retentionDaysAfterProductEol: 2190, // 6 years
+        },
+        'bias-monitor': {
+            subgroupCoverageRequired: true,
+            protectedCharacteristicSubgroupAnalysisRequired: true,
+            core20Plus5OverlayRequired: true,
+            imdDecileSubgroupRequired: true,
+        },
+        'transparency-injector': {
+            modelCardPublicationRequired: true,
+            commissionerEvidenceSummaryRequired: true,
+            clinicianUncertaintyDisplayRequired: true,
+        },
+        'supply-chain': {
+            subSupplierEvidenceChainRequired: true,
+            trainingDataProvenanceFlowDownRequired: true,
+        },
+    },
+    providerPolicy: {
+        blockedProviders: ['deepseek', 'baidu', 'alibaba'],
+        requiredCapabilities: ['DATA-RESIDENCY-UK-OR-EU', 'PROCESSOR-CONTRACT', 'MODEL-CARD-PUBLICATION', 'UK-APPLICABILITY-EVIDENCE'],
+        blockReasons: {
+            deepseek: 'PRC jurisdiction. NICE ESF requires UK-applicability evidence + data-residency that excludes PRC routing for digital health technologies.',
+            baidu: 'PRC jurisdiction. Inadequate UK-applicability evidence chain.',
+            alibaba: 'PRC jurisdiction. Inadequate UK-applicability evidence chain.',
+        },
+    },
+    dataPolicy: {
+        scanCategories: [
+            'ESF_TIER_DESIGNATION',
+            'EFFECTIVENESS_EVIDENCE',
+            'ECONOMIC_IMPACT_EVIDENCE',
+            'REAL_WORLD_PERFORMANCE',
+            'HEALTH_INEQUALITIES_IMPACT',
+            'MODEL_PROVENANCE_RECORD',
+            'CREDENTIALS',
+        ],
+        categoryActions: {
+            ESF_TIER_DESIGNATION: 'WARN',
+            EFFECTIVENESS_EVIDENCE: 'WARN',
+            ECONOMIC_IMPACT_EVIDENCE: 'WARN',
+            REAL_WORLD_PERFORMANCE: 'WARN',
+            HEALTH_INEQUALITIES_IMPACT: 'WARN',
+            MODEL_PROVENANCE_RECORD: 'WARN',
+            CREDENTIALS: 'BLOCK',
+        },
+        encryptionRequired: true,
+        encryptionStandard: 'AES-256-GCM',
+        minimumClassification: 'RESTRICTED',
+    },
+    retentionPolicy: {
+        auditLogRetentionDays: 2190, // 6 years
+        sessionRetentionDays: 2190,
+        incidentRetentionDays: 2190,
+        reference: 'NICE re-assessment practice; Limitation Act 1980',
+        forceDelete: false,
+        requiresLegalHoldSupport: true,
+        sovereignty: ['gb', 'eu'],
+    },
+    incidentPolicy: {
+        notificationDeadlineHours: 168, // 7-day baseline; NICE practical timing
+        reference: 'NICE re-assessment cooperation; commissioner due-diligence cadence',
+        requiredRecipients: ['commissioner-sponsor', 'clinical-safety-officer', 'medical-director', 'data-protection-officer'],
+        formalNotificationRequired: false,
+    },
+    validators: [
+        {
+            id: 'nice-esf-tier-designation',
+            description: 'NICE ESF tier (A / B / C) designated with rationale documented; per-tier evidence bundle expectation set.',
+            reference: 'NICE ESF for DHT 2024 three-tier framework',
+            check: 'attestation_active',
+            failSeverity: 'CRITICAL',
+        },
+        {
+            id: 'nice-esf-effectiveness-evidence',
+            description: 'Clinical effectiveness evidence captured at the tier-required depth (clinical outcomes, AI accuracy + calibration, comparator).',
+            reference: 'NICE ESF effectiveness evidence',
+            check: 'attestation_active',
+            failSeverity: 'CRITICAL',
+        },
+        {
+            id: 'nice-esf-economic-impact',
+            description: 'Economic impact evidence captured (cost-effectiveness, budget impact, QALY) at the tier-required depth.',
+            reference: 'NICE ESF economic impact',
+            check: 'attestation_active',
+            failSeverity: 'HIGH',
+        },
+        {
+            id: 'nice-esf-real-world-performance',
+            description: 'Post-deployment real-world performance monitoring active; NICE re-assessment cycle reminders configured.',
+            reference: 'NICE ESF real-world performance',
+            check: 'monitoring_active',
+            failSeverity: 'HIGH',
+        },
+        {
+            id: 'nice-esf-health-inequalities',
+            description: 'Subgroup analysis across protected characteristics (Equality Act overlay), IMD deciles, and Core20PLUS5 captured.',
+            reference: 'NICE ESF health inequalities; Equality Act 2010',
+            check: 'bias_monitor_active',
+            failSeverity: 'HIGH',
+        },
+        {
+            id: 'nice-esf-model-provenance',
+            description: 'Model lineage + training-data provenance + UK-applicability evidence captured; model card published.',
+            reference: 'NICE ESF model provenance',
+            check: 'attestation_active',
+            failSeverity: 'HIGH',
+        },
+        {
+            id: 'nice-esf-evidence-gate',
+            description: 'Default-deny on commissioning / reimbursement claims when required-tier evidence bundle is incomplete.',
+            reference: 'NICE ESF evidence-gate practice',
+            check: 'governance_active',
+            failSeverity: 'CRITICAL',
+        },
+        {
+            id: 'nice-esf-evidence-audit-trail',
+            description: 'Tamper-evident audit chain covers evidence-bundle revisions, NICE submission revisions, real-world performance reports, model-update events.',
+            reference: 'NICE submission evidentiary integrity',
+            check: 'audit_trail_exists',
+            failSeverity: 'HIGH',
+        },
+        {
+            id: 'nice-esf-supplier-flow-down',
+            description: 'Sub-supplier evidence chain captured; training-data provenance flow-down recorded.',
+            reference: 'NICE ESF model provenance flow-down',
+            check: 'subservice_registry_active',
+            failSeverity: 'MEDIUM',
+        },
+        {
+            id: 'nice-esf-credential-block',
+            description: 'Plaintext credentials blocked from NICE ESF evidence artefacts and audit chain entries.',
+            reference: 'NICE ESF evidence integrity',
+            check: 'data_classifier_active',
+            failSeverity: 'CRITICAL',
+        },
+    ],
+};
+//# sourceMappingURL=nice-esf-dht.js.map

package/dist/esm/packs/nice-esf-dht.js.map

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