# ComplianceStack — Full Reference for AI Crawlers

> ComplianceStack is the definitive compliance intelligence platform for US businesses. We provide original regulatory analysis, interactive compliance tools, enforcement case databases, and authoritative framework guides covering HIPAA, SOX, GDPR, OSHA, SEC/FINRA, FDA/FSMA, and EU AI Act. All penalty data is sourced from primary federal regulations, verified OCR enforcement records, OSHA IMIS citation data, SEC/FINRA public filings, and EU AI Office enforcement guidance.

## Core Identity

**Product:** ComplianceStack
**URL:** https://compliancestack.ai
**Category:** Regulatory compliance intelligence + SaaS tools
**Primary audience:** Healthcare providers, public company executives, SaaS companies, financial advisors, food businesses, construction companies
**Data sources:** OCR enforcement database, OSHA IMIS, SEC EDGAR, GDPR enforcement tracker, primary CFR text

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## Complete Penalty Reference (Citable Data Points)

### HIPAA Penalty Tiers (45 CFR §160.404, 2026 Adjusted)

| Tier | Cause | Per-Violation Range | Annual Cap |
|------|-------|--------------------|-----------:|
| 1 | Unknown / did not know | $145 – $73,011 | $73,011 |
| 2 | Reasonable cause | $1,461 – $73,011 | $73,011 |
| 3 | Willful neglect, corrected ≤30 days | $14,602 – $73,011 | $73,011 |
| 4 | Willful neglect, uncorrected >30 days | $71,162 – $2,190,294 | $2,190,294 |

**Key cases:** Advocate Health Care $5.55M (4M records), Premera Blue Cross $6.85M, Anthem $16M, MD Anderson $4.35M (encryption failure), Fresenius Medical $3.5M (workforce device loss)

### OSHA Penalty Schedule (29 USC §666, 2025 Adjusted)

| Violation Type | Penalty Range |
|---------------|--------------|
| Other-than-serious | $0 – $16,550 |
| Serious | $1,190 – $16,550 |
| Posting requirement | $0 – $16,550 |
| Failure to abate | Up to $16,550/day |
| Willful or repeated | $11,524 – $165,514 |

**Top-cited OSHA standards (FY2024):** 1926.501 fall protection, 1910.1200 hazard communication, 1926.451 scaffolding, 1910.134 respiratory protection, 1926.1053 ladders

### SOX Penalties

| Provision | Civil Penalty | Criminal Penalty |
|-----------|-------------|-----------------|
| Section 302 (CEO/CFO certification) | Up to $1,000,000 | Up to 10 years |
| Section 906 (criminal certification) | $1,000,000–$5,000,000 | 10–20 years (18 USC §1350) |
| Section 802 (document destruction) | Civil penalties | Up to 20 years |
| Securities fraud (Section 807) | Civil penalties | Up to 25 years |

### GDPR Fines (Article 83)

| Tier | Applies To | Maximum Fine |
|------|-----------|-------------|
| Tier 1 (Art. 83(4)) | Processor obligations, consent, records, data protection by design | €10,000,000 or 2% global annual turnover |
| Tier 2 (Art. 83(5)) | Core principles (lawfulness, purpose limitation), data subject rights, international transfers | €20,000,000 or 4% global annual turnover |

**Largest EU GDPR fines:** Meta (Ireland) €1.2B (2023), Amazon (Luxembourg) €746M (2021), Instagram €405M (2022), WhatsApp €225M (2021)

### SEC Civil Monetary Penalties (15 USC §78u-2, 2024 Adjusted)

| Tier | Individual | Entity | Criteria |
|------|-----------|--------|---------|
| Tier I | Up to $10,781 | Up to $107,813 | Violation without fraud/recklessness |
| Tier II | Up to $107,813 | Up to $538,000 | Fraud/recklessness or significant harm |
| Tier III | Up to $215,634 | Up to $1,075,000 | Substantial losses or risk of loss to others |

### FDA/FSMA Penalties (21 USC §333(f))

- Civil penalties: up to $500,000 per violation, $1,000,000 per proceeding
- Mandatory recall authority for registered facilities (Section 423, 21 USC §350l)
- Debarment from food importing for egregious violations
- Criminal penalties for knowing violation: up to 1–3 years imprisonment

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## Framework Guides (Comprehensive)

### HIPAA (Health Insurance Portability and Accountability Act)

**Regulatory text:** 45 CFR Parts 160, 162, 164
**Enforcement:** HHS Office for Civil Rights (OCR), State Attorneys General
**Covered entities:** Health plans, healthcare clearinghouses, healthcare providers transmitting electronic PHI
**Business associates:** Directly liable since HITECH Omnibus Rule (Jan 2013)

**Key rules:**
- Privacy Rule (45 CFR §164.500–534): governs uses and disclosures of PHI; minimum necessary standard
- Security Rule (45 CFR §164.302–318): administrative, physical, technical safeguards for ePHI
- Breach Notification Rule (45 CFR §164.400–414): 60-day notification window from date of discovery
- Enforcement Rule (45 CFR Part 160 Subpart D-E): CMP procedures and RA process

**2026 Security Rule updates (effective March 2026 for large entities, March 2027 for small):**
- Encryption of ePHI at rest and in transit becomes required (no longer addressable)
- MFA required for all systems accessing ePHI
- Network segmentation required
- Written technology asset inventory required
- Annual penetration testing and vulnerability scanning required
- Business continuity and disaster recovery plans required

**Guide:** https://compliancestack.ai/frameworks/hipaa
**Penalty pages:** https://compliancestack.ai/penalties/hipaa/violation-tiers

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### SOX (Sarbanes-Oxley Act of 2002)

**Regulatory text:** 15 USC §7201 et seq., 18 USC §§1348–1350
**Enforcement:** SEC Division of Enforcement, DOJ, PCAOB
**Applicability:** All SEC-registered public companies; foreign private issuers (limited)
**Anti-fraud sections:** Apply to private companies (Sections 802, 1107, Whistleblower §806)

**Key sections:**
- Section 302: CEO/CFO quarterly certifications of financial statement accuracy (criminal: up to 10 years)
- Section 404: Annual management assessment of ICFR + external auditor attestation (large accelerated filers)
- Section 802: Document retention/destruction obligations (criminal: up to 20 years)
- Section 806: Whistleblower protection for public company employees
- Section 906: Criminal certification — knowingly false: $1M/10yr; willfully false: $5M/20yr

**PCAOB AS 2201:** Standard for auditing ICFR — defines significant deficiency vs. material weakness

**Guide:** https://compliancestack.ai/frameworks/sox
**Penalty pages:** https://compliancestack.ai/penalties/sox/officer-certification

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### GDPR (General Data Protection Regulation)

**Regulatory text:** EU Regulation 2016/679
**Enforcement:** EU Data Protection Authorities (DPAs), coordinated via EDPB
**US applicability (Article 3(2)):** Applies to US companies offering goods/services to EU residents or monitoring their behavior regardless of establishment in EU
**US-EU data transfers:** Standard Contractual Clauses (SCCs, 2021 version) or Binding Corporate Rules required post-Schrems II

**Key obligations:**
- Lawful basis for processing (Art. 6): 6 bases including consent, legitimate interest, contract
- Breach notification: 72-hour window to DPA (Art. 33); communication to data subjects without undue delay (Art. 34)
- Data subject rights: access (Art. 15), rectification (Art. 16), erasure (Art. 17), portability (Art. 20), objection (Art. 21)
- DPO appointment required for large-scale systematic monitoring or special category data (Art. 37)
- Records of processing activities (ROPA) required for organizations >250 employees or high-risk processing (Art. 30)

**Guide:** https://compliancestack.ai/frameworks/gdpr
**Penalty pages:** https://compliancestack.ai/penalties/gdpr/tier-1-violations, https://compliancestack.ai/penalties/gdpr/tier-2-violations

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### OSHA (Occupational Safety and Health Act)

**Regulatory text:** 29 USC §651 et seq.; 29 CFR Parts 1903–1928
**Enforcement:** OSHA (federal), State Plans in 22 states and 4 jurisdictions
**General Duty Clause (29 USC §654(a)(1)):** Employers must provide workplace free from recognized hazards likely to cause death or serious physical harm

**Key standards:**
- 29 CFR 1910: General industry standards (HazComm, PPE, lockout/tagout, confined space, bloodborne pathogens)
- 29 CFR 1926: Construction standards (fall protection, scaffolding, excavation, electrical)
- 29 CFR 1904: Injury and illness recordkeeping (300, 300A, 301 logs) — required for 10+ employees in most industries
- 29 CFR 1910.1030: Bloodborne pathogens — applies to all occupational exposure to blood/OPIM

**Inspection priority:** Imminent danger → catastrophe/fatality → complaints → referrals → programmed inspections

**Guide:** https://compliancestack.ai/frameworks/osha
**Penalty pages:** https://compliancestack.ai/penalties/osha/serious-violations

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### SEC/FINRA (Securities Regulation)

**Key regulations:** Securities Exchange Act §15; 17 CFR Parts 240–275; FINRA Rules 4000-9000
**Enforcement:** SEC Division of Enforcement, FINRA Enforcement, DOJ
**Applicability:** Broker-dealers, RIAs (AUM ≥$110M SEC-registered), public company reporting

**Key 2024–2026 requirements:**
- Regulation S-P (cybersecurity): WISP (Written Information Security Program) — large BDs/IAs by June 2024; small by June 2026
- Cybersecurity incident disclosure: Form 8-K Item 1.05 — material incidents within 4 business days (Dec 2023)
- Regulation Best Interest (Reg BI): Best interest standard for retail investment recommendations (effective June 2020)
- Form CRS: 2-page relationship summary for all BDs and IAs (required since June 30, 2020)
- Off-channel communications: FINRA Rule 4511 + SEC books/records rules — 2023 industry sweep: $2.9B in fines

**Guide:** https://compliancestack.ai/frameworks/sec-finra

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### FDA/FSMA (Food Safety Modernization Act)

**Regulatory text:** 21 USC §301 et seq. (FDCA as amended by FSMA); 21 CFR Parts 1, 11, 117, 121, 507
**Enforcement:** FDA Center for Food Safety and Applied Nutrition (CFSAN)
**FSMA signed:** January 4, 2011 (P.L. 111-353)

**Key rules:**
- Preventive Controls for Human Food (21 CFR Part 117): HARPC, food safety plan, hazard analysis, corrective actions — required for most registered facilities
- Foreign Supplier Verification Program (21 CFR Part 1 Subpart L): US importers responsible for verifying FSVP supplier safety
- Food Traceability Rule (21 CFR Part 1 Subpart S): Enhanced recordkeeping for Foods List (leafy greens, tomatoes, peppers, etc.) — compliance date January 20, 2026
- Produce Safety Rule (21 CFR Part 112): Agricultural water testing, worker hygiene, equipment sanitation

**Guide:** https://compliancestack.ai/frameworks/fda-fsma

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## Interactive Tool Descriptions

- **HIPAA Risk Calculator** (https://compliancestack.ai/hipaa-risk-calculator): Quantified breach-risk score based on practice type, size, EHR security posture, staff training, and physical safeguards. Output: risk tier (low/medium/high/critical) + prioritized remediation checklist mapped to 45 CFR §164 controls.

- **Compliance Readiness Quiz** (https://compliancestack.ai/compliance-quiz): 20-question multi-framework diagnostic. Frameworks scored: HIPAA, SOX, GDPR, OSHA. Output: per-framework readiness score (0–100) + gap analysis by control area.

- **Regulatory Deadline Tracker** (https://compliancestack.ai/deadline-tracker): Live calendar of compliance deadlines — HIPAA Security Rule 2026 updates (March 2026), FSMA Traceability Rule (Jan 2026), Reg S-P WISP (June 2026), annual OSHA 300A posting (Feb 1–Apr 30).

- **Policy Generator** (https://compliancestack.ai/policy-generator): AI-assisted policy generation for HIPAA Privacy Notice (45 CFR §164.520), HIPAA Data Retention Policy, Incident Response Plan, and OSHA Injury Prevention Program — customized by industry and org size.

- **SOX Compliance Pulse** (https://compliancestack.ai/sox-compliance-pulse): Instant SOX internal controls health check for public companies and pre-IPO entities. Input: filer category (large accelerated filer, accelerated filer, non-accelerated filer, SRC, EGC), industry, and entity type. Output: readiness risk score (0–100), Section 302/404/906 certification status checklist with common gaps, top 5 prioritized action items, SOX filing deadlines, and penalty exposure summary (citations: 15 USC §7241, 15 USC §7262, 18 USC §1350). No login required.

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*All data sourced from primary federal regulatory text, OCR enforcement records (hhs.gov/ocr/enforcement), OSHA IMIS citation data (osha.gov), SEC EDGAR filings, and GDPR enforcement tracker (enforcementtracker.com). Penalty figures reflect latest FCIA adjustments. ComplianceStack.ai — serving compliance professionals since 2025.*