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Track N: Legal & Regulatory Operations

Priority: MEDIUM — Continuous regulatory compliance Agent: regulatory-change-monitor, compliance-framework-specialist Sprint Range: S5-S8 Reference: docs/compliance/20-regulatory-compliance-matrix.md, docs/operations/64-security-architecture.md

Status Summary​

Progress: 0% (0/26 tasks)

SectionTitleStatusTasks
N.1Terms of Service & Privacy PolicyPending0/4
N.2GDPR/CCPA Compliance EnginePending0/5
N.3Contract Lifecycle ManagementPending0/6
N.4Regulatory Change MonitoringPending0/6
N.5IP & Vendor CompliancePending0/5

N.1: Terms of Service & Privacy Policy​

Sprint: S5 | Priority: P0 | Depends On: None (legal drafting) Goal: Version-controlled legal documents with customer acceptance tracking

  • N.1.1: Draft platform Terms of Service
    • Scope: multi-tenant SaaS terms, data ownership, liability limitations
    • Addenda: regulated industry addenda (FDA, HIPAA carve-outs)
    • Versioning: version-controlled with change notification to customers
  • N.1.2: Draft Privacy Policy
    • Coverage: data collection, processing, sharing, retention
    • Cookie policy: consent management
    • Data subject rights: procedures
  • N.1.3: Create Acceptable Use Policy
    • Prohibited uses: compliance with regulatory requirements
    • Data classification: responsibilities
    • Incident reporting: obligations
  • N.1.4: Build policy version management
    • Tracking: policy change tracking with diff view
    • Notification: customer notification on material changes
    • Acceptance: tracking per tenant (click-through on login)

N.2: GDPR/CCPA Compliance Engine​

Sprint: S6-S7 | Priority: P0 | Depends On: C.1, D.3 Goal: Data Subject Request processing, consent management, DPIA, and cross-border controls

  • N.2.1: Build Data Subject Request (DSR) processing engine
    • Right of access: export all tenant data (JSON + CSV)
    • Right to rectification: audit-trailed corrections
    • Right to erasure: anonymization (regulatory retention takes precedence)
    • Right to portability: structured data export
    • SLA: 30 days (GDPR), 45 days (CCPA)
  • N.2.2: Implement consent management
    • Granular: consent tracking per processing purpose
    • Withdrawal: consent withdrawal workflow
    • Audit trail: who, when, what purpose
  • N.2.3: Build DPIA (Data Protection Impact Assessment) tool
    • Templates: assessment per processing activity
    • Scoring: risk scoring and mitigation tracking
    • Review: DPO review workflow
  • N.2.4: Create cookie and tracking consent
    • Banner: cookie banner with granular categories
    • Preferences: consent preference center
    • Integration: with analytics (J.1) for consent-aware tracking
  • N.2.5: Implement cross-border data transfer controls
    • TIA: Transfer Impact Assessment per doc 64
    • SCCs: Standard Contractual Clauses management
    • Encryption: region-specific encryption keys
    • Logging: cross-region access logging

N.3: Contract Lifecycle Management​

Sprint: S7 | Priority: P1 | Depends On: I.4 Goal: Template library, contract tracking, and BAA management

  • N.3.1: Build contract template library
    • Templates: MSA, Order Form, SOW, BAA, NDA, DPA
    • Clause library: compliance-approved variants
    • Regional: adaptations (US, EU, UK)
  • N.3.2: Implement contract tracking system
    • Status: contract status, renewal dates, termination clauses
    • Obligations: tracking per contract
    • Notifications: auto-renewal and expiry notifications
  • N.3.3: Create BAA (Business Associate Agreement) management
    • Records: BAA record per HIPAA-covered tenant
    • Dashboard: status dashboard for compliance team
    • Renewals: 90-day renewal notifications (per D.3.3)
  • N.3.4: Build BAA execution workflow
    • Drafting: auto-populate BAA from tenant profile and service configuration
    • Negotiation: redline tracking with version comparison
    • Execution: DocuSign/HelloSign integration for e-signature
    • Storage: executed BAA linked to tenant record with immutable archive
  • N.3.5: Implement BAA compliance monitoring
    • Obligations: extract and track obligations from each executed BAA
    • Breach notification: automated breach notification timeline tracking (60-day HIPAA)
    • Subcontractor: BAA chain management for downstream processors
    • Reporting: BAA compliance status per tenant for audit readiness
  • N.3.6: Create BAA termination and breach handling
    • Termination: formal BAA termination workflow with data return/destruction
    • Breach response: BAA-specific breach response procedures
    • Documentation: breach investigation documentation with regulatory filing support
    • Archival: post-termination BAA archival per retention policy (6 years)

N.4: Regulatory Change Monitoring​

Sprint: S7-S8 | Priority: P1 | Depends On: D.2-D.4 Goal: Regulatory intelligence feed, impact assessment, and compliance calendar

  • N.4.1: Build regulatory intelligence feed
    • Agencies: FDA, EMA, MHRA, ANVISA guidance monitoring
    • Privacy: HIPAA, GDPR, LGPD updates
    • Audit: SOC 2 criteria updates from AICPA
  • N.4.2: Implement impact assessment workflow
    • Flow: new regulation → impact analysis → required changes → implementation plan
    • Cross-reference: with existing compliance controls
    • Customer notification: for regulation-affecting changes
  • N.4.3: Create compliance calendar
    • Dates: audit dates, renewal dates, training deadlines
    • Submissions: regulatory submission deadlines
    • Reviews: compliance review cadence (monthly, quarterly, annual)
  • N.4.4: Build compliance intelligence aggregation
    • Sources: FDA Federal Register, EMA regulatory news, MHRA alerts, ICH guidelines
    • AI parsing: NLP extraction of actionable requirements from regulatory text
    • Relevance scoring: auto-score regulation relevance to tenant's product types
    • Digest: weekly compliance intelligence digest for regulatory affairs team
  • N.4.5: Implement FDA engagement coordination
    • Pre-submission: Type II Pre-Submission meeting request preparation
    • Correspondence: FDA correspondence tracking (510(k), PMA, De Novo)
    • Timeline: submission timeline management with milestone tracking
    • Templates: regulatory submission cover letter and response templates
  • N.4.6: Create regulatory audit preparation automation
    • Readiness: pre-audit readiness checklist generation per framework
    • Evidence: automated evidence collection and packaging
    • Mock audit: simulated audit walkthrough with finding prediction
    • Response: audit finding response template library with deadline tracking

N.5: IP & Vendor Compliance​

Sprint: S9 | Priority: P2 | Depends On: None Goal: Open source license compliance, vendor risk assessment, and IP protection

  • N.5.1: Build open source license compliance
    • SBOM: Software Bill of Materials generation
    • Compatibility: license compatibility matrix (no GPL contamination)
    • CI: automated license scanning in CI
  • N.5.2: Create vendor risk assessment process
    • Questionnaire: third-party vendor security questionnaire
    • SOC 2 review: report collection and review
    • Access audit: vendor access audit (who has access to what)
  • N.5.3: Implement IP protection measures
    • Trade secrets: identification and protection
    • Patents: monitoring for AI/QMS innovations
    • Clearance: competitor IP clearance for new features
  • N.5.4: Build vendor SLA monitoring and prediction
    • Tracking: vendor SLA compliance tracking per contract
    • Prediction: ML-based vendor risk scoring from performance trends
    • Escalation: automated escalation when vendor SLA at risk
    • Reporting: vendor performance scorecard for quarterly reviews
  • N.5.5: Create supply chain compliance management
    • Mapping: critical vendor dependency mapping
    • Continuity: vendor continuity planning (backup vendor identification)
    • Certification: vendor certification tracking (ISO, SOC 2, HITRUST)
    • Audit: vendor audit scheduling and finding tracking

Updated: 2026-02-14 Compliance: CODITECT Track Nomenclature Standard (ADR-054)