@connexum/ai-governance 1.0.0-beta.11

package/dist/packs/us-nih-dms.d.ts

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+/**
+ * NIH 2023 Data Management and Sharing Policy -- Pack
+ *
+ * Split notice: All four NIH policy instruments were previously bundled in
+ * `src/packs/nih-data-sharing.ts`. Split per Thomas's 2026-04-24 principle:
+ * one country, one regulation, one pack. The four NIH instruments have
+ * different effective dates, different scope triggers, and different
+ * compliance obligations. Reference the original Vera brief at
+ * `docs/compliance-research/2026-04-24-pack-brief-nih-data-sharing.md`
+ * which documented all four instruments.
+ *
+ * Cross-pack interactions (all 4 NIH packs typically activate together):
+ *   - us-nih-dms requires data sharing to the maximum extent possible.
+ *   - us-nih-coc may RESTRICT sharing of CoC-protected identifiable data.
+ *     Resolution: CoC governs the disclosure side; DMS governs the deposit
+ *     side. When both apply, CoC-protected data goes to controlled-access
+ *     repositories (not public), satisfying DMS deposit while respecting CoC.
+ *   - us-nih-gds governs the controlled-access repository deposit workflow
+ *     (dbGaP). DMS and GDS run simultaneously for genomic NIH research.
+ *   - us-nih-it-security provides the FISMA Moderate baseline required for
+ *     systems processing controlled-access data under both DMS and GDS.
+ *   - When all 4 packs are active, strictest-wins resolves conflicts. CoC
+ *     blocking typically governs over DMS sharing obligations.
+ *
+ * NIH 2023 Data Management and Sharing (DMS) Policy (NOT-OD-21-013):
+ * Effective January 25, 2023. Applies to all NIH-funded research generating
+ * scientific data. Requires a Data Management and Sharing Plan (DMSP)
+ * submitted with grant application; requires sharing of scientific data to
+ * the maximum extent possible.
+ *
+ * @connexum/ai-governance
+ */
+import { CompliancePack } from './index';
+import { CategoryClassifiers } from '../classification/pack-driven-classifier';
+/**
+ * NIH DMS category classifiers.
+ */
+export declare const NIH_DMS_CATEGORY_CLASSIFIERS: CategoryClassifiers;
+export declare const NIH_DMS_PACK: CompliancePack & {
+    categoryClassifiers: CategoryClassifiers;
+    subjectKeyedCategories: string[];
+};
+//# sourceMappingURL=us-nih-dms.d.ts.map

package/dist/packs/us-nih-dms.d.ts.map

@@ -0,0 +1 @@
+{"version":3,"file":"us-nih-dms.d.ts","sourceRoot":"","sources":["../../src/packs/us-nih-dms.ts"],"names":[],"mappings":"AAAA;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;GA+BG;AAEH,OAAO,EAAE,cAAc,EAAE,MAAM,SAAS,CAAC;AACzC,OAAO,EAAE,mBAAmB,EAAE,MAAM,0CAA0C,CAAC;AAE/E;;GAEG;AACH,eAAO,MAAM,4BAA4B,EAAE,mBAwB1C,CAAC;AAEF,eAAO,MAAM,YAAY,EAAE,cAAc,GAAG;IAAE,mBAAmB,EAAE,mBAAmB,CAAC;IAAC,sBAAsB,EAAE,MAAM,EAAE,CAAA;CAuLvH,CAAC"}

package/dist/packs/us-nih-dms.js

@@ -0,0 +1,244 @@
+"use strict";
+/**
+ * NIH 2023 Data Management and Sharing Policy -- Pack
+ *
+ * Split notice: All four NIH policy instruments were previously bundled in
+ * `src/packs/nih-data-sharing.ts`. Split per Thomas's 2026-04-24 principle:
+ * one country, one regulation, one pack. The four NIH instruments have
+ * different effective dates, different scope triggers, and different
+ * compliance obligations. Reference the original Vera brief at
+ * `docs/compliance-research/2026-04-24-pack-brief-nih-data-sharing.md`
+ * which documented all four instruments.
+ *
+ * Cross-pack interactions (all 4 NIH packs typically activate together):
+ *   - us-nih-dms requires data sharing to the maximum extent possible.
+ *   - us-nih-coc may RESTRICT sharing of CoC-protected identifiable data.
+ *     Resolution: CoC governs the disclosure side; DMS governs the deposit
+ *     side. When both apply, CoC-protected data goes to controlled-access
+ *     repositories (not public), satisfying DMS deposit while respecting CoC.
+ *   - us-nih-gds governs the controlled-access repository deposit workflow
+ *     (dbGaP). DMS and GDS run simultaneously for genomic NIH research.
+ *   - us-nih-it-security provides the FISMA Moderate baseline required for
+ *     systems processing controlled-access data under both DMS and GDS.
+ *   - When all 4 packs are active, strictest-wins resolves conflicts. CoC
+ *     blocking typically governs over DMS sharing obligations.
+ *
+ * NIH 2023 Data Management and Sharing (DMS) Policy (NOT-OD-21-013):
+ * Effective January 25, 2023. Applies to all NIH-funded research generating
+ * scientific data. Requires a Data Management and Sharing Plan (DMSP)
+ * submitted with grant application; requires sharing of scientific data to
+ * the maximum extent possible.
+ *
+ * @connexum/ai-governance
+ */
+Object.defineProperty(exports, "__esModule", { value: true });
+exports.NIH_DMS_PACK = exports.NIH_DMS_CATEGORY_CLASSIFIERS = void 0;
+/**
+ * NIH DMS category classifiers.
+ */
+exports.NIH_DMS_CATEGORY_CLASSIFIERS = {
+    NIH_SCIENTIFIC_DATA: {
+        references: ['NOT-OD-21-013 -- NIH DMS Policy; definition of scientific data'],
+        classifier: (input) => {
+            if (/\b(?:nih.award|nih.grant|r01|r21|u01|t32|nih.scientific.data|NIH_SCIENTIFIC_DATA)\b/i.test(input))
+                return true;
+            // Award number pattern (standard NIH grant identifier format)
+            if (/\b[1-9][A-Z]\d{2}[A-Z]{2}\d{6}-\d{2}\b/i.test(input))
+                return true;
+            return false;
+        },
+    },
+    DMSP_RESTRICTED_DATA: {
+        references: ['NOT-OD-21-013 -- Data Management and Sharing Plan scope'],
+        classifier: (input) => {
+            if (/\b(?:DMSP.restricted|dmsp.approved.scope|data.management.sharing.plan.limit|outside.dmsp|DMSP_RESTRICTED_DATA)\b/i.test(input))
+                return true;
+            return false;
+        },
+    },
+    PRE_PUBLICATION_RESEARCH_DATA: {
+        references: ['NOT-OD-21-013 -- timely sharing; pre-publication sensitivity'],
+        classifier: (input) => {
+            if (/\b(?:pre.publication|unpublished.research|embargo.period.data|pre-pub.data|PRE_PUBLICATION_RESEARCH_DATA)\b/i.test(input))
+                return true;
+            return false;
+        },
+    },
+};
+exports.NIH_DMS_PACK = {
+    categoryClassifiers: exports.NIH_DMS_CATEGORY_CLASSIFIERS,
+    /**
+     * P3.5: Scientific data bound to a DMSP is subject-keyed to satisfy
+     * NOT-OD-21-013 audit trail requirements (NIH award number linkage).
+     */
+    subjectKeyedCategories: ['NIH_SCIENTIFIC_DATA'],
+    id: 'us-nih-dms',
+    name: 'NIH Data Management and Sharing Policy (2023)',
+    version: '1.0.0',
+    description: 'NIH Data Management and Sharing Policy (NOT-OD-21-013, effective January 25, 2023). Applies to all NIH-funded research generating scientific data. Requires DMSP submission with grant; data sharing to maximum extent possible; AI must operate within DMSP-approved scope. Activate alongside us-nih-gds, us-nih-coc, and us-nih-it-security for complete NIH research compliance.',
+    authority: 'National Institutes of Health (NIH), HHS; enforced through NIH Program Officers and Grants Policy',
+    industries: ['clinical-research', 'academic-research', 'higher-education', 'biotech', 'federal-grantee'],
+    requiredModules: [
+        {
+            name: 'governance-runtime',
+            required: true,
+            reason: 'DMSP scope enforcement gate; de-identification-for-avoidance prohibition; consent-scope enforcement before sharing',
+            reference: 'NOT-OD-21-013 (DMSP scope)',
+        },
+        {
+            name: 'audit-integrity',
+            required: true,
+            reason: 'Per-access tamper-evident log with NIH award number and timestamp; DMSP compliance audit trail for NIH and institution',
+            // OPERATOR_VERIFICATION_REQUIRED (F-NEW-VERA-PACK-C2-03, 2026-05-03):
+            // NIH GPS is updated periodically; verify current section at grants.nih.gov
+            reference: 'NOT-OD-21-013; NIH GPS Section 8.4.1 -- audit trail and records retention (verify current GPS edition at grants.nih.gov)',
+        },
+        {
+            name: 'data-classifier',
+            required: true,
+            reason: 'Classify NIH scientific data, DMSP-restricted data, and pre-publication research data',
+            reference: 'NOT-OD-21-013 (scientific data definition)',
+        },
+        {
+            name: 'session-persistence',
+            required: true,
+            reason: 'Per-session DMSP approval status; NIH award number context persistence',
+            reference: 'NOT-OD-21-013',
+        },
+        {
+            name: 'supply-chain',
+            required: true,
+            reason: 'No-training-on-research-data attestation; US data residency commitment',
+            reference: 'NOT-OD-21-013',
+        },
+        {
+            name: 'approval-queue',
+            required: true,
+            reason: 'DMSP scope deviation escalation; human confirmation before sharing outside DMSP terms',
+            reference: 'NOT-OD-21-013 (DMSP scope gate)',
+        },
+        {
+            name: 'attestation-manager',
+            required: true,
+            reason: 'DMSP documentation; NIH audit rights acknowledgment',
+            // OPERATOR_VERIFICATION_REQUIRED (F-NEW-VERA-PACK-C2-03, 2026-05-03):
+            // 45 CFR 74.53 redesignated under 2 CFR Part 200 (Uniform Guidance).
+            // Current citation: 2 CFR §200.334. Verify applicable CFR for your award type.
+            reference: '2 CFR §200.334 (Uniform Guidance record retention); NIH GPS (verify current edition at grants.nih.gov); NOT-OD-21-013',
+        },
+        {
+            name: 'event-bus',
+            required: true,
+            reason: 'DMSP scope deviation events; NIH Program Officer notification stream',
+            reference: 'NOT-OD-21-013',
+        },
+        {
+            name: 'anomaly-detector',
+            required: true,
+            reason: 'Detection of AI processing outside DMSP-approved scope; format incompatibility with repository submission requirements',
+            reference: 'NOT-OD-21-013 (AI must not impede sharing compliance)',
+        },
+    ],
+    moduleConfig: {
+        'governance-runtime': {
+            dmspApprovalRequired: true,
+            dataSharingComplianceMonitored: true,
+            retentionPolicyBoundToNihGps: true,
+        },
+        'data-classifier': {
+            enabledCategories: ['NIH_SCIENTIFIC_DATA', 'DMSP_RESTRICTED_DATA', 'PRE_PUBLICATION_RESEARCH_DATA'],
+        },
+        'supply-chain': {
+            providerTrainingProhibitionAttested: true,
+            dataResidencyUSRequired: true,
+        },
+        'approval-queue': {
+            dmspScopeDeviationEscalationRequired: true,
+        },
+        'attestation-manager': {
+            dmspDocumentationRequired: true,
+            nihAuditRightsAcknowledged: true,
+        },
+        'event-bus': {
+            researchDataAuditEnabled: true,
+            nihAwardNumberRequiredInEvents: true,
+        },
+        'anomaly-detector': {
+            dmspScopeDeviationDetectionActive: true,
+            repositoryFormatCompatibilityMonitoringActive: true,
+        },
+    },
+    providerPolicy: {
+        blockedProviders: [],
+        requiredCapabilities: [
+            'DATA-RESIDENCY-US',
+            'ZERO-TRAINING-ON-NIH-RESEARCH-DATA',
+        ],
+        blockReasons: {},
+    },
+    dataPolicy: {
+        scanCategories: ['NIH_SCIENTIFIC_DATA', 'DMSP_RESTRICTED_DATA', 'PRE_PUBLICATION_RESEARCH_DATA'],
+        categoryActions: {
+            NIH_SCIENTIFIC_DATA: 'LOG',
+            DMSP_RESTRICTED_DATA: 'BLOCK',
+            PRE_PUBLICATION_RESEARCH_DATA: 'WARN',
+        },
+        encryptionRequired: true,
+        encryptionStandard: 'AES-256',
+        minimumClassification: 'CONFIDENTIAL',
+    },
+    retentionPolicy: {
+        sovereignty: ['US'],
+        auditLogRetentionDays: 2555, // 7 years (NIH clinical research standard)
+        sessionRetentionDays: 2555,
+        incidentRetentionDays: 2555,
+        // OPERATOR_VERIFICATION_REQUIRED (F-NEW-VERA-PACK-C2-03, 2026-05-03):
+        // NIH GPS is updated annually. Verify current section at grants.nih.gov.
+        reference: 'NOT-OD-21-013 (DMS Policy); NIH GPS Section 8.4.1 (verify current edition at grants.nih.gov); retain until published/deposited per DMSP; institution policy typically 3-7 years post-publication',
+    },
+    incidentPolicy: {
+        notificationDeadlineHours: 72,
+        reference: 'NOT-OD-21-013; NIH Program Officer notification required promptly for DMSP compliance failures',
+        requiredRecipients: ['nih-program-officer', 'institution-research-compliance'],
+        formalNotificationRequired: true,
+    },
+    validators: [
+        {
+            id: 'nih-dms-dmsp-scope-check',
+            description: 'AI processing within scope of approved DMSP',
+            reference: 'NOT-OD-21-013 (DMSP compliance requirement)',
+            check: 'nih_dms_dmsp_scope_check',
+            failSeverity: 'CRITICAL',
+        },
+        {
+            id: 'nih-dms-no-training-on-research-data',
+            description: 'Provider attestation: no model training on NIH scientific data',
+            reference: 'NOT-OD-21-013; FTC guidance on research data training prohibition',
+            check: 'nih_dms_no_training_on_research_data',
+            failSeverity: 'CRITICAL',
+        },
+        {
+            id: 'nih-dms-audit-log-per-access',
+            description: 'Every access to NIH scientific data logged with award number and timestamp',
+            // OPERATOR_VERIFICATION_REQUIRED (F-NEW-VERA-PACK-C2-03): verify GPS section at grants.nih.gov
+            reference: 'NOT-OD-21-013; NIH GPS Section 8.4.1 (verify current edition at grants.nih.gov)',
+            check: 'audit_trail_exists',
+            failSeverity: 'HIGH',
+        },
+        {
+            id: 'nih-dms-behavioral-dmsp-scope',
+            description: 'Runtime blocks DMSP_RESTRICTED_DATA category outside approved scope',
+            reference: 'NOT-OD-21-013 (DMSP scope)',
+            check: 'behavioralValidator_us_nih_dms',
+            failSeverity: 'CRITICAL',
+        },
+        {
+            id: 'nih-dms-dmsp-documentation',
+            description: 'DMSP documentation and NIH audit rights acknowledged',
+            reference: '45 CFR 74.53; NIH GPS; NOT-OD-21-013',
+            check: 'nih_dms_no_training_on_research_data',
+            failSeverity: 'HIGH',
+        },
+    ],
+};
+//# sourceMappingURL=us-nih-dms.js.map

package/dist/packs/us-nih-dms.js.map

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package/dist/packs/us-nih-gds.d.ts

@@ -0,0 +1,41 @@
+/**
+ * NIH Genomic Data Sharing Policy -- Pack
+ *
+ * Split notice: All four NIH policy instruments were previously bundled in
+ * `src/packs/nih-data-sharing.ts`. Split per Thomas's 2026-04-24 principle:
+ * one country, one regulation, one pack. Reference the original Vera brief at
+ * `docs/compliance-research/2026-04-24-pack-brief-nih-data-sharing.md`
+ * which documented all four instruments.
+ *
+ * Cross-pack interactions (all 4 NIH packs typically activate together):
+ *   - us-nih-dms requires sharing of scientific data broadly; GDS governs
+ *     the controlled-access repository workflow for genomic data specifically.
+ *     Both run simultaneously for genomic NIH research.
+ *   - us-nih-coc may restrict sharing of CoC-protected identifiable genomic
+ *     data. CoC governs the disclosure side; GDS governs the deposit side.
+ *     CoC-protected genomic data routes to controlled-access repositories only.
+ *   - us-nih-it-security provides the FISMA Moderate baseline required for
+ *     systems processing controlled-access genomic data.
+ *   - When all 4 packs are active, strictest-wins resolves conflicts.
+ *
+ * NIH Genomic Data Sharing (GDS) Policy (NOT-OD-14-124):
+ * Effective January 25, 2015. Applies to NIH-funded research generating
+ * large-scale genomic data. Requires deposit of genomic data in NIH-
+ * designated repositories (dbGaP for controlled-access; public repositories
+ * for unrestricted data). AI systems processing controlled-access genomic
+ * data require an active Data Use Certificate (DUC) from the relevant
+ * Data Access Committee (DAC).
+ *
+ * @connexum/ai-governance
+ */
+import { CompliancePack } from './index';
+import { CategoryClassifiers } from '../classification/pack-driven-classifier';
+/**
+ * NIH GDS category classifiers.
+ */
+export declare const NIH_GDS_CATEGORY_CLASSIFIERS: CategoryClassifiers;
+export declare const NIH_GDS_PACK: CompliancePack & {
+    categoryClassifiers: CategoryClassifiers;
+    subjectKeyedCategories: string[];
+};
+//# sourceMappingURL=us-nih-gds.d.ts.map

package/dist/packs/us-nih-gds.d.ts.map

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