Documentation Index
Fetch the complete documentation index at: https://docs.encoreos.io/llms.txt
Use this file to discover all available pages before exploring further.
42 CFR Part 2 Electronic Consent & Redisclosure — Compliance Evidence
Feature ID: CL-11-EN-01
Regulation: 42 CFR Part 2 (Confidentiality of SUD Patient Records)
Status: ✅ Implemented
Date: 2026-04-10
Spec: CL-11-EN-01
1. Regulatory Requirements Addressed
§ 2.31 — Consent Requirements
| Requirement | Implementation | Evidence |
|---|
| Written consent with specific elements | ConsentCaptureSheet wizard with Zod validation (consent-capture-schema.ts) | Schema enforces all required fields before submission |
| Granular consent categories | consent_categories JSONB: treatment, payment, operations, providers, research | ConsentCategories type in electronic-consent.ts |
| Patient identification | patient_id UUID required on all consent records | DB NOT NULL constraint |
| Purpose specification | Category-level granularity (treatment/payment/operations/providers/research) | Checkbox UI with at-least-one validation |
| Expiration date | expiration_date DATE column with 30/14/7-day alert thresholds | consent-expiration.ts utility |
| Right to revoke | RevokeConsentDialog with irreversibility warning; status → ‘revoked’ | Permission-gated (cl.electronic-consent.revoke) |
§ 2.32 — Prohibition on Redisclosure
| Requirement | Implementation | Evidence |
|---|
| Notice must accompany disclosures | generateRedisclosureNotice() in redisclosure-notice.ts | Full federal prohibition language generated |
| Notice includes federal confidentiality citation | Notice text references “42 CFR Part 2” and prohibition language | Unit tests verify presence of key phrases |
| Notice includes recipient, date, purpose | Parameterized notice generation with all fields | RecordDisclosureSheet shows preview before submission |
§ 2.13(d) — Accounting of Disclosures
| Requirement | Implementation | Evidence |
|---|
| Who disclosed | disclosed_by UUID in cl_redisclosure_log | NOT NULL FK to pf_profiles |
| When disclosed | disclosed_at TIMESTAMPTZ | NOT NULL, set at creation |
| To whom | recipient TEXT | NOT NULL |
| Purpose | purpose TEXT | NOT NULL |
| What records | records_disclosed JSONB | Structured record type/date range metadata |
2. Data Model Evidence
Tables Created
| Table | Purpose | Immutability |
|---|
cl_electronic_consents | Signed consent records with e-signature and categories | Standard CRUD (revocation via status change) |
cl_redisclosure_log | Append-only disclosure audit trail | UPDATE/DELETE revoked + immutability trigger |
RLS Enforcement
- Both tables use
cl_has_org_access() SECURITY DEFINER helper
cl_redisclosure_log: SELECT + INSERT only policies; no UPDATE/DELETE policies- Privilege revocation:
REVOKE UPDATE, DELETE ON cl_redisclosure_log FROM authenticated
- Defense-in-depth:
trg_cl_redisclosure_log_immutable trigger raises exception on UPDATE/DELETE
3. Permission Controls
| Permission Key | Purpose | Roles |
|---|
cl.electronic-consent.view | View consent records | org_admin, manager, staff |
cl.electronic-consent.create | Create new consents | org_admin, manager, staff |
cl.electronic-consent.revoke | Revoke active consents | org_admin only |
cl.redisclosure-log.view | View disclosure audit trail | org_admin, manager, staff |
cl.redisclosure-log.create | Record new disclosures | org_admin, manager, staff |
cl.compliance_report.view | View compliance dashboard | org_admin |
4. UI Controls
| Component | Permission Gate | Description |
|---|
ElectronicConsentPage | cl.electronic-consent.view | Two-tab layout (Consents + Redisclosure Audit) |
ConsentCaptureSheet | cl.electronic-consent.create | Wizard with e-signature and attestation |
RevokeConsentDialog | cl.electronic-consent.revoke | Destructive action with irreversibility warning |
RecordDisclosureSheet | cl.redisclosure-log.create | Disclosure recording with § 2.32 notice preview |
Part2ComplianceDashboardPage | cl.compliance_report.view | Aggregate-only statistics (no patient IDs) |
5. Test Evidence
| Test Suite | Tests | Coverage |
|---|
consent-expiration.test.ts | 12 | 30/14/7-day thresholds, status logic |
redisclosure-notice.test.ts | 8 | § 2.32 prohibition language validation |
electronic-consent-workflow.test.ts | 16 | Full lifecycle: draft → active → revoke; disclosure blocking |
electronic-consent-compliance.test.ts | 20 | § 2.31 elements, § 2.32 notices, § 2.13(d) accounting |
| Total | 56 | All passing |
6. Route Registration
- Path:
/cl/electronic-consents
- Lazy loaded via
React.lazy
- Permission guard:
RequirePermission('cl.electronic-consent.view')
7. References
