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🇺🇸 United States · jurisdiction-aware

Three steps to decide if ReguNav fits United States.

For CFOs, COOs, Heads of Risk supervised under United States authority. Skip the architecture diagrams — see the regulator, the deliverable, and the ROI you'll quote to the board.

1. Identify your supervisorFood and Drug Administration (FDA) (+8 more on this page)2. Pick your frameworkHIPAA Security & Privacy · CCPA / CPRA · SOC 2 Type II (+4)3. Book a United States POC30-min walkthrough, real engine

Sovereign AI ready for United States.

ReguNav ships HIPAA, CCPA, SOC 2, NIST AI RMF, NIST CSF, PCI DSS — every control anchored to a US regulator. Whether you're a HIPAA-covered entity, a CCPA-supervised SaaS, or an FDA-regulated SaMD vendor, the regulator anchors are first-class on the platform.

United States regulator landscape

Every United States control on the platform is anchored to a named regulator artefact. When the regulator updates their guidance, the framework registry takes the bump and every dependent control inherits it.

Food and Drug Administration (FDA)

Medical devices · SaMD · De Novo · 510(k)official ↗

HHS Office for Civil Rights (OCR)

HIPAA Privacy + Security enforcementofficial ↗

Office of the National Coordinator for Health IT (ONC)

HTI-1 AI transparency · USCDI · TEFCAofficial ↗

National Institute of Standards and Technology (NIST)

AI RMF · CSF · 800-53 · 800-171official ↗

Securities and Exchange Commission (SEC)

Cybersecurity disclosure · Reg S-K Item 106official ↗

Commodity Futures Trading Commission (CFTC)

Derivatives · DCMs · SDRs · LabCFTCofficial ↗

Federal Trade Commission (FTC)

Consumer protection · UDAP · COPPA · Sec 5official ↗

California Attorney General

CCPA / CPRA enforcementofficial ↗

The Joint Commission

Healthcare-org accreditationofficial ↗

Frameworks anchored in United States

HIPAA Security & Privacy

2013 Omnibus20 clauses · 15 controls

US federal regulation governing the use and disclosure of Protected Health Information (PHI) by Covered Entities (health plans, health-care clearinghouses, providers transmitting health information electronically) and Business Associates. Privacy Rule (§§ 164.500-534) governs uses and disclosures of PHI; Security Rule (§§ 164.302-318) requires administrative, physical and technical safeguards for ePHI; Breach Notification Rule (§§ 164.400-414) requires notice to affected individuals, the HHS Secretary and (for breaches affecting ≥500 individuals) prominent media outlets.

CCPA / CPRA

202417 clauses · 13 controls

California state privacy law applying to for-profit businesses doing business in California that (a) had annual gross revenues over $25 million in the preceding year, (b) annually buy/sell/share the personal information of 100,000+ California consumers or households, or (c) derive 50%+ of annual revenue from selling/sharing California consumers' personal information. Establishes seven consumer rights, three opt-out mechanisms (sale, sharing, sensitive PI), a notice + transparency regime, business-purpose service-provider + contractor + third-party distinctions, and a private right of action for certain data breaches. Enforced by the California Privacy Protection Agency (CPPA) + the California Attorney General.

SOC 2 Type II

2017 TSC13 clauses · 15 controls

AICPA attestation framework for service organisations. The Common Criteria (CC1-CC9) form the security baseline that every SOC 2 engagement covers; the four additional categories (Availability, Processing Integrity, Confidentiality, Privacy) are optional and elected by the service organisation. A SOC 2 Type II engagement covers a period (typically 6-12 months) and attests to operating effectiveness of controls. Independent CPA service auditor produces the report under SSAE 18 / AT-C Section 320.

SOC 1 Type II

SSAE 18 AT-C 320 (2017)13 clauses · 14 controls

AICPA Service Organization Controls 1 (SOC 1) Type II examination — reports on the design and operating effectiveness of a service organization's controls likely to be relevant to user entities' Internal Control over Financial Reporting (ICFR). The examination is conducted by an independent service auditor under SSAE 18 AT-C 320. Type II covers a specified period (commonly 6 or 12 months) and includes the service auditor's tests of operating effectiveness. The framework captured here is the standard set of control-objective domains across the industry — logical access; change management; computer operations; system development; data transmission; physical security; data processing integrity — plus the structural requirements for the management description of the system (DC 1-8), the management assertion, CUECs (complementary user-entity controls), CSOCs (complementary subservice-organization controls), and carve-out vs inclusive-method subservice handling.

NIST AI Risk Management Framework

1.020 clauses · 14 controls

Voluntary US framework for managing risks posed by AI systems. Organises trustworthy-AI work into four core functions — GOVERN (organisational culture, policies, accountability), MAP (context, AI capabilities + use, impact identification), MEASURE (analysis, testing, tracking), MANAGE (prioritised risk response across the lifecycle). Each function decomposes into categories with subcategories. Outcomes — validity + reliability, safety, security + resilience, accountability + transparency, explainability + interpretability, privacy enhancement, fairness with managed bias — characterise trustworthy AI.

NIST CSF 2.0

2.022 clauses · 15 controls

Voluntary US framework organising cybersecurity activities into six functions — GOVERN, IDENTIFY, PROTECT, DETECT, RESPOND, RECOVER. Each function decomposes into categories with outcome-statement subcategories. Implementation Tiers (Partial, Risk-Informed, Repeatable, Adaptive) and Profiles (Current + Target) provide an organisational-maturity overlay. Suitable for use across critical infrastructure, government and the private sector at any size.

FedRAMP

Rev. 5 — 2024-0528 clauses · 18 controls

Federal Risk and Authorization Management Program — the US government programme that standardises security authorisation of cloud products and services for federal agencies. Built on the NIST SP 800-53 Rev. 5 control baseline; ReguNav indexes its three baselines (Low / Moderate / High), the 17 NIST 800-53 control families, and the FedRAMP-specific authorisation and continuous-monitoring (ConMon) obligations.

From the taxonomy · auto-derived

Connected components for United States.

Derived from @regunav/taxonomy at request time — add a new regulator / agent / framework to its source registry and it surfaces here automatically, no copy edits required.

What you get in United States.

Honest status on every capability — live means wired end-to-end in production. Pick the ones your driver requires; we'll quote a date for anything not yet live.

Framework rule packs

Live
What you get
24 framework rule packs ship populated — SOC 2, ISO 27001, PCI DSS, GDPR, HIPAA, EU AI Act, FedRAMP and more — no empty schemas to fill in.
Problem solved
Buying a compliance tool and finding the rule library empty. Six weeks lost to copy-pasting control text from PDFs before the platform produces anything useful.
ROI
6 weeks saved on first-control-to-evidence onboarding.
Assumes: compared to building one control library per framework in-house.
See all capabilities →

Evidence ranker

Live
What you get
Ranks every artefact you upload against the control it best satisfies — across 24 frameworks at once.
Problem solved
GRC manager spends 8h/week mapping evidence to controls by hand. Most artefacts satisfy 4–7 controls; manual mapping captures one.
ROIinteractive
8h/wk of compliance-manager time reclaimed
Assumes: team of 50, 3 frameworks in scope, monthly evidence refresh.
See all capabilities →

Sealed evidence packs

Live
What you get
Content-addressed (sha256) evidence bundle the auditor pulls via URL. Replayable byte-for-byte from any timestamp.
Problem solved
Auditor email chain: 'send me the December evidence again, this time with the policy header'. Three round-trips per request.
ROIinteractive
$120k audit-prep cost avoided
Assumes: 3 framework audit, $250/h loaded GRC rate, baseline ~480h of prep.
See all capabilities →

WORM hash-chained audit trail

Live
What you get
Every action against your tenant logged immutably with a per-row hash chain. Tampering with one row breaks verification of every later row.
Problem solved
Regulator asks 'who approved that change on March 4?' and the answer is a Slack search and a memory.
ROI
Zero regulator findings on access-control evidence.
Assumes: banking-grade auditor sample (typically 25 events) verified against hash chain.
See all capabilities →

Regulator + auditor report packs

Live
What you get
Seven stakeholder-shaped report packs (board, regulator, auditor, customer DPA, internal audit, …) generated from your live D1 records.
Problem solved
Four days re-formatting the same data for the board pack, the regulator submission, and the customer security questionnaire.
ROIinteractive
$96k of GRC time saved annually on report assembly
Assumes: 48 stakeholder-days/yr of report formatting at $250/h.
See all capabilities →

Code Constitution™ GitHub App

Live
What you get
Compliance checks run inline on every PR (≤90s). Findings appear as line+column annotations in the review UI.
Problem solved
Compliance review happens quarterly. By the time the auditor flags a missing model card, it has been in production for 60 days.
ROIinteractive
$110k of audit-prep + remediation time saved annually
Assumes: ~20 engineers × 220 working days × 5% PR finding rate × 2h post-hoc cost at $250/h.
See all capabilities →
What does a regulator slip cost you?

United States maximum exposure — live calculator.

Set your annual revenue. We'll show the maximum statutory penalty per regime, capped at either the percentage-of-turnover formula or the statutory floor — whichever binds. Cite shown for every line so legal can verify.

HIPAA 45 CFR 160.404
$100k

Max = min(0.2% of turnover = $100k, statutory cap = $2.1M) → capped by % of turnover. Per-violation tier; max $2.1M per identical-violation category per year.

CCPA Cal. Civ. Code §1798.155
$250k

Max = min(0.5% of turnover = $250k, statutory cap = $50.0M) → capped by % of turnover. $7,500 per intentional violation; $2,500 per negligent — at scale.

SOC 2 (audit failure) AICPA TSP-100
$500k

Max = min(1% of turnover = $500k, statutory cap = $5.0M) → capped by % of turnover. Not a regulator fine — proxy for lost enterprise deals on qualified opinion.

FedRAMP ATO revocation OMB M-22-18
$1.0M

Max = min(2% of turnover = $1.0M, statutory cap = $50.0M) → capped by % of turnover. Lost federal contract pipeline on ATO revocation or significant POA&M slippage.

Combined max exposure at this revenue
$1.9M

ReguNav addresses every regime above with a single tenant. The fine isn't hypothetical — DPA / FCA / AI Office decisions are public; we cite priors in the POC walkthrough.

How to decide for United States.

  1. 1. Identify your supervisor. Food and Drug Administration (FDA) (+ 8 more on this page).
  2. 2. Pick the framework that closes your audit. HIPAA Security & Privacy · CCPA / CPRA · SOC 2 Type II (+4).
  3. 3. Run the ROI math. Each card above shows the assumption behind the number. Plug in your team size and audit cost — if it doesn't close, neither should the deal.
  4. 4. Book a 30-min walk-through. We demo against a synthetic United States tenant — same engine that runs your production tenancy. No slide deck.

United States SaaS, fintech, healthcare-AI, or essential-service?

We work with organisations supervised by every regulator listed above. The jurisdiction-aware engine routes incident reports, DSARs, and FRIA submissions to the correct authority + timeline automatically.

Talk to United States team →

Jurisdiction codes + regulator data are sourced from @regunav/jurisdictions (Apache-2.0, open-source). Adding a new market is a single registry entry — no copy-paste regulator content. See /uk for the bespoke deep-dive template.