
Arize Compliance Audit
- 1.6k installs
- 41 repo stars
- Updated August 5, 2026
- arize-ai/arize-skills
arize-compliance-audit provides documented workflows for INVOKE THIS SKILL when auditing an AI agent or LLM app for regulatory compliance. Covers EU AI Act, GPAI Code of Practice, GDPR, NIST AI RMF, Colorado AI Act, H
About
The arize-compliance-audit skill iNVOKE THIS SKILL when auditing an AI agent or LLM app for regulatory compliance. Covers EU AI Act, GPAI Code of Practice, GDPR, NIST AI RMF, Colorado AI Act, HIPAA, and ISO 42001. Scans the codebase for compliance gaps, cross-references Arize instrumentation for audit trail coverage, and produces an actionable remediation checklist tailored to the selected frameworks. # Arize Compliance Audit Skill Use this skill when the user wants to **audit their AI agent or LLM application for regulatory compliance**. The skill scans the codebase for compliance gaps, cross-references Arize instrumentation for audit trail coverage, and produces a tailored checklist with optional remediation. **Triggers:** "audit my app for compliance", "EU AI Act requirements", "NIST AI RMF checklist", "GDPR for AI", "is my AI app compliant", "compliance checklist", "regulatory audit", "ISO 42001", "AI management system", "AIMS certification". ## Disclaimer **Before doing anything else, present this disclaimer verbatim to the user:** --- > ⚠️ **Legal disclaimer** > > This audit is for **guidance only** and does **not** constitute legal advice or a complete compliance assessment.
- **Prefer inspection over mutation** - understand the codebase before suggesting changes.
- **Be practical, not legal** - produce developer-actionable items, not legal opinions.
- **Tailor to jurisdiction and use case** - a chatbot has different obligations than a hiring tool. Do not dump the enti
- **Cross-reference instrumentation** - compliance requires audit trails; check whether Arize tracing captures what regu
- **Offer remediation, always confirm** - after presenting the checklist, offer to implement specific fixes, but never m
Arize Compliance Audit by the numbers
- 1,623 all-time installs (skills.sh)
- +75 installs in the week ending Aug 5, 2026 (Skillselion tracking)
- Ranked #321 of 2,203 Security skills by installs in the Skillselion catalog
- Data as of Aug 5, 2026 (Skillselion catalog sync)
arize-compliance-audit capabilities & compatibility
- Capabilities
- **prefer inspection over mutation** understand · **be practical, not legal** produce developer · **tailor to jurisdiction and use case** a chat · **cross reference instrumentation** compliance · **offer remediation, always confirm** after pr
- Use cases
- documentation
What arize-compliance-audit says it does
# Arize Compliance Audit Skill Use this skill when the user wants to **audit their AI agent or LLM application for regulatory compliance**.
The skill scans the codebase for compliance gaps, cross-references Arize instrumentation for audit trail coverage, and produces a tailored checklist with optional remediation.
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| Installs | 1.6k |
|---|---|
| repo stars | ★ 41 |
| Last updated | August 5, 2026 |
| Repository | arize-ai/arize-skills ↗ |
How do I use arize-compliance-audit for the task described in its SKILL.md triggers?
INVOKE THIS SKILL when auditing an AI agent or LLM app for regulatory compliance. Covers EU AI Act, GPAI Code of Practice, GDPR, NIST AI RMF, Colorado AI Act, HIPAA, and ISO 42001. Scans the codebase.
Who is it for?
Teams invoking arize-compliance-audit when the user request matches documented triggers and prerequisites.
Skip if: Skip when cached docs are missing, the request is a negative trigger, or another sibling skill owns the workflow.
When should I use this skill?
INVOKE THIS SKILL when auditing an AI agent or LLM app for regulatory compliance. Covers EU AI Act, GPAI Code of Practice, GDPR, NIST AI RMF, Colorado AI Act, HIPAA, and ISO 42001. Scans the codebase for compliance gaps,
What you get
Step-by-step guidance grounded in arize-compliance-audit documentation and reference files.
- Compliance gap report
- Remediation checklist
By the numbers
- Covers 7 named regulatory and standards frameworks
Files
Arize Compliance Audit Skill
Use this skill when the user wants to audit their AI agent or LLM application for regulatory compliance. The skill scans the codebase for compliance gaps, cross-references Arize instrumentation for audit trail coverage, and produces a tailored checklist with optional remediation.
Triggers: "audit my app for compliance", "EU AI Act requirements", "NIST AI RMF checklist", "GDPR for AI", "is my AI app compliant", "compliance checklist", "regulatory audit", "ISO 42001", "AI management system", "AIMS certification".
Disclaimer
Before doing anything else, present this disclaimer verbatim to the user:
---
⚠️ Legal disclaimer
>
This audit is for guidance only and does not constitute legal advice or a complete compliance assessment. It identifies common technical patterns and gaps based on publicly available regulatory frameworks, but cannot assess your organisation's specific legal obligations, contractual commitments, data processing agreements, or operational processes.
>
Do not rely on this output as a substitute for qualified legal counsel. Regulatory compliance is a complex, jurisdiction-specific, and fact-dependent determination. Always engage a qualified attorney or compliance specialist for binding assessments.
---
Core principles
- Prefer inspection over mutation — understand the codebase before suggesting changes.
- Be practical, not legal — produce developer-actionable items, not legal opinions.
- Tailor to jurisdiction and use case — a chatbot has different obligations than a hiring tool. Do not dump the entire regulatory framework.
- Cross-reference instrumentation — compliance requires audit trails; check whether Arize tracing captures what regulators expect.
- Offer remediation, always confirm — after presenting the checklist, offer to implement specific fixes, but never modify code without explicit user confirmation.
- Keep output concise and production-focused — do not generate extra documentation or summary files unless requested.
- Never embed literal credential values — always reference environment variables.
Phase 0: Framework selection and use case
Before scanning code, determine which compliance frameworks apply.
Step 1 — Framework selection
Use the AskUserQuestion tool to ask the user which frameworks apply. Do not infer or auto-select — always ask explicitly.
Ask:
Which compliance frameworks should this audit cover?
Select all that apply (reply with numbers, e.g. "1, 3"):
1. EU frameworks — EU AI Act, GPAI Code of Practice, GDPR
(choose if end-users or data subjects are located in the EU)
2. US frameworks — NIST AI RMF, state laws (Colorado AI Act, NYC LL144),
HIPAA (if processing health data)
(choose if operating in the United States)
3. ISO 42001 — International AI Management System standard
(choose if pursuing ISO 42001 certification, operating globally,
or wanting an internationally recognised baseline)
You can select any combination. If unsure, select all that seem relevant
and we can narrow down during the audit.Based on the selection:
- 1 selected — EU AI Act, GPAI Code of Practice, GDPR apply. See references/eu-ai-act-gpai.md.
- 2 selected — NIST AI RMF, Colorado AI Act, NYC LL144, HIPAA may apply. See references/us-ai-compliance.md.
- 3 selected — ISO 42001 AIMS controls apply. See references/iso-42001.md. Note: ISO 42001 is an organisational management system — the audit will cover technically-auditable controls only; purely organisational clauses (leadership review, internal audits) are flagged separately.
- Multiple selected — all selected frameworks apply; the audit covers the union of requirements, with cross-references where frameworks overlap.
Step 2 — Determine use case category
Use the AskUserQuestion tool to ask: What does your AI application do?
- General chatbot / assistant — Limited risk (EU), general obligations (US)
- Hiring / HR — High risk (EU Art. 6, Annex III); Colorado AI Act applies; NYC LL144 applies if NYC
- Healthcare — High risk (EU); HIPAA applies if processing PHI
- Credit / financial — High risk (EU); Colorado AI Act applies
- Education — High risk (EU)
- Content generation — Limited risk (EU Art. 50 transparency); general obligations (US)
- GPAI model provider — GPAI Code of Practice applies (EU)
Step 3 — Determine risk tier
Based on the use case and selected frameworks:
- EU selected: Classify as Unacceptable / High / Limited / Minimal per references/eu-ai-act-gpai.md
- US selected: Classify as High-risk (consequential decisions per Colorado AI Act) or General
- ISO 42001 selected: Risk tier is not a formal classification in ISO 42001, but note whether the system is high-stakes (which elevates the priority of impact assessment and bias controls)
Phase 0 output
Present a brief summary:
Frameworks selected: {EU / US / ISO 42001 / combination}
Use case: {category}
Risk tier: {EU tier if applicable} / {US tier if applicable}
Applicable: {list of specific regulations and standards}
ISO 42001 note: {if selected} Audit covers technically-auditable controls only;
organisational clauses will be flagged but not code-audited.Then proceed directly to Phase 1.
Phase 1: Codebase audit (read-only)
Do not write any code or create any files during this phase.
Systematically scan the codebase for evidence of compliance and gaps across seven domains. For each domain, run the listed searches and record findings.
A. Transparency and disclosure
What to look for:
- User-facing strings disclosing AI involvement: search for terms like
AI,artificial intelligence,automated,bot,machine learning,generated by,powered byin UI templates, API responses, and user-facing code - Content labelling: markers on AI-generated output (text, images, audio)
- Terms of service, privacy policy references in the codebase
Signals of concern: Absence of any AI disclosure in user-facing code, especially if the application generates content or makes recommendations.
B. Data protection and privacy
What to look for:
- PII field names in code:
email,phone,ssn,social_security,date_of_birth,address,namein prompts, context, or retrieved documents - PII in trace span attributes: check if
input.valueoroutput.valuecould contain personal data sent to Arize without redaction - Consent mechanisms:
consent,opt-in,opt-out,gdpr,ccpareferences - DPIA or privacy assessment references
- Data retention and deletion handlers
- Data subject rights:
right_to_access,right_to_erasure,data_subject_request,data_protection_officer
C. Security
What to look for:
- Prompt injection defences: input validation, guardrail libraries (
guardrails-ai,nemo-guardrails,rebuff,lakera), content filtering, system prompt protection - Data loss prevention: output scanning before returning to users, sensitive data detection
- Tool/function calling controls: permission boundaries, allowlists, sandboxing for tool execution
- Rate limiting and authentication on AI endpoints
- Hardcoded secrets:
api_key,secret,password,tokenliterals in source files (not env var references)
D. Testing and evaluation
What to look for:
- Bias and fairness testing: references to demographic parity, impact ratios, fairness metrics
- Red teaming or adversarial test suites: prompt injection tests, jailbreak tests
- Evaluation frameworks: Arize evaluators, custom eval scripts,
pytest-based evals, experiment infrastructure - A/B testing or model comparison infrastructure
E. Documentation
What to look for:
- Model cards:
MODEL_CARD.md,model_card.json,model_card.yaml, or similar - System architecture documentation
- Change logs or version tracking for prompts and model updates
- Incident response documentation
F. Monitoring and observability
What to look for:
- Arize tracing setup:
arize-otel,register(),TracerProvider,opentelemetry,openinferenceimports - If tracing exists, check coverage:
- All LLM calls traced (not just some)
- Session IDs for conversation continuity
- User IDs for data subject request support
- Error tracking and exception spans
- Alerting and drift detection configuration
- Trace retention configuration
G. Vendor management
What to look for:
- Third-party AI API usage: OpenAI, Anthropic, Google, Azure, Bedrock, Cohere imports or client instantiation
- Model versioning: are specific model versions pinned (e.g.,
gpt-4-0613) or usinglatest/ unversioned identifiers - Fallback and failover logic between providers
Phase 1 output
Present a two-part report:
Part 1 — Summary table
| Domain | Evidence found | Gaps identified | Rating |
|---|---|---|---|
| A. Transparency | {findings} | {gaps} | Compliant / Partial / Non-compliant / N/A |
| B. Data protection | {findings} | {gaps} | ... |
| C. Security | {findings} | {gaps} | ... |
| D. Testing | {findings} | {gaps} | ... |
| E. Documentation | {findings} | {gaps} | ... |
| F. Monitoring | {findings} | {gaps} | ... |
| G. Vendor management | {findings} | {gaps} | ... |
Part 2 — Gap detail (required for every Non-compliant or Partial rating)
For each domain rated Non-compliant or Partial, write a dedicated subsection that includes:
1. The exact code path — file path(s), line number(s), and the relevant code snippet showing where the gap exists. Do not paraphrase; quote the actual code. 2. Why it matters in this specific app — explain the concrete risk in the context of this codebase (e.g. which tools could be abused, which data flows are exposed, what an attacker or regulator would find). 3. What is missing — a precise description of the control or code that should exist but does not (e.g. "a span attribute processor that hashes user_email before the OTLP exporter fires", not just "add PII redaction").
Minimum one subsection per Non-compliant/Partial domain. Do not omit this section — it is the primary value of the audit for engineering teams.
Then proceed directly to Phase 2.
Phase 2: Compliance checklist
Using the Phase 1 findings and the template in references/compliance-checklist-template.md, generate a tailored compliance checklist.
Rules for checklist generation
1. Only include relevant sections. If the user is US-only, skip GDPR-specific items. If not healthcare, skip HIPAA. If not hiring in NYC, skip LL144. 2. Mark items from Phase 1. Items where evidence was found: mark as Compliant. Items with gaps: mark as Non-compliant with a concrete remediation suggestion. 3. Prioritise correctly. Critical = enforcement risk or system prohibition. High = required by regulation. Medium = recommended by framework. Low = best practice. 4. Be specific in remediation. Instead of "implement input validation", say "add a guardrail library like guardrails-ai to validate LLM inputs and outputs against your content policy". 5. Include the instrumentation cross-reference table from the template. If Arize tracing is not set up, flag this as a Critical gap — audit trails are required by EU Art. 12 and NIST MAN-2.1.
Final report
Present a single consolidated report with four sections:
Section 1 — Audit scope (Phase 0 summary)
- Frameworks selected, use case, risk tier, applicable regulations
Section 2 — Codebase findings (Phase 1 summary table)
- The domain table (A–G) with evidence, gaps, and ratings
Section 3 — Gap detail (Phase 1 expanded)
- One subsection per Non-compliant or Partial domain, each containing: exact file paths and line numbers, quoted code snippets, app-specific risk explanation, and a precise description of what is missing. This section is mandatory — never omit it.
Section 4 — Compliance checklist (Phase 2)
- The tailored checklist with status and remediation suggestions, instrumentation cross-reference table, priority summary, and recommended next steps
When the user asks for a report file, write a single markdown file to /tmp/<app-name>-compliance-audit-<YYYY-MM-DD>.md containing all four sections.
After presenting the report, offer Phase 3 remediation.
Phase 3: Remediation (optional)
After presenting the checklist, offer to implement specific fixes. Always use the `AskUserQuestion` tool to confirm before making any changes.
Remediation categories
Add dependencies — offer to install:
- Guardrail libraries for input/output validation (e.g.,
guardrails-ai,nemo-guardrails) - PII detection/redaction packages (e.g.,
presidio-analyzer,scrubadub) - Content safety classifiers
Insert code — offer to add:
- AI disclosure strings in user-facing output (templates, API responses)
- PII redaction filters on span attributes before export to Arize
- Input validation/sanitisation on AI endpoints
- User ID attributes on trace spans for data subject request support
Create documentation templates — offer to scaffold:
- Model card template (markdown file with standard sections)
- Incident response plan template
- Data processing record template
Configure monitoring — offer to set up via related skills:
- Arize evaluators for bias detection and content safety (via
arize-evaluatorskill) - Tracing for audit trail coverage (via
arize-instrumentationskill)
Remediation rules
- Present each remediation as a discrete, confirmable action. Never batch-apply changes.
- Show exactly what will change (file, code diff concept) then use the
AskUserQuestiontool to get confirmation before applying. - Follow existing code style and project conventions.
- Never embed credentials — always use environment variables.
- Test that the application still builds after changes.
Skill orchestration
When gaps identified in Phase 1 or 2 require capabilities from other Arize skills, offer to invoke them. Always use the `AskUserQuestion` tool to ask before invoking another skill and explain why it is relevant to the compliance gap.
| Gap | Skill to invoke | Why |
|---|---|---|
| No tracing / incomplete audit trail | arize-instrumentation | EU Art. 12 and NIST MAN-2.1 require event logging; Arize tracing provides this |
| No bias or safety evaluation | arize-evaluator | Create LLM-as-judge evaluators for fairness, content safety, or quality monitoring |
| Need trace export for compliance evidence | arize-trace | Export spans for regulatory documentation or incident investigation |
| Need human review for high-risk decisions | arize-annotation | Set up annotation queues for human oversight per EU Art. 14 |
| Need deep link to share compliance evidence | arize-link | Generate URLs to specific traces, spans, or evaluations for stakeholder review |
Instrumentation cross-reference
If Arize tracing is already set up, verify it meets compliance requirements:
| Compliance need | Required trace data | What to check |
|---|---|---|
| Audit trail for AI decisions | All LLM spans with input/output | Verify all LLM client calls are instrumented, not just some |
| Data subject access requests | User ID attribute on spans | Check for user.id or custom user identifier attribute |
| PII in traces | Sensitive data in input.value/output.value | Check if PII passes through unredacted — flag if so |
| Incident investigation | Error spans with full context | Check for exception tracking and error status on spans |
| Retention requirements | Trace data retained for required period | EU: appropriate period (min 6 months for high-risk); HIPAA: 6 years |
| Bias monitoring | Demographic or group attributes | Check for metadata attributes that enable fairness analysis |
If Arize tracing is not set up, this is a significant compliance gap. Offer: "Shall I run the arize-instrumentation skill to set up audit-trail tracing? Regulatory frameworks (EU AI Act Art. 12, NIST AI RMF MAN-2.1) require event logging for AI systems."
Reference links
| Resource | URL |
|---|---|
| EU AI Act full text | https://eur-lex.europa.eu/eli/reg/2024/1689/oj |
| GPAI Code of Practice | https://digital-strategy.ec.europa.eu/en/policies/contents-code-gpai |
| Code of Practice portal | https://code-of-practice.ai/ |
| NIST AI RMF | https://www.nist.gov/artificial-intelligence/ai-risk-management-framework |
| Colorado AI Act (SB24-205) | https://leg.colorado.gov/bills/sb24-205 |
| NYC Local Law 144 | https://www.nyc.gov/site/dca/about/automated-employment-decision-tools.page |
| HIPAA | https://www.hhs.gov/hipaa/index.html |
| ISO/IEC 42001:2023 | https://www.iso.org/standard/42001.html |
| Arize AX Docs | https://arize.com/docs/ax |
Reference files
- references/eu-ai-act-gpai.md — EU AI Act and GPAI Code of Practice developer guide
- references/us-ai-compliance.md — US compliance landscape (NIST AI RMF, Colorado, NYC LL144, HIPAA)
- references/iso-42001.md — ISO/IEC 42001:2023 AI Management Systems developer guide (technically-auditable controls only)
- references/compliance-checklist-template.md — Reusable checklist template for Phase 2 output
Compliance Checklist Template
Use this template to generate the Phase 2 compliance checklist. Fill in the status and notes columns based on Phase 1 audit findings. Only include sections relevant to the user's jurisdiction and use case — do not dump the entire template.
Header
| Field | Value |
|---|---|
| Application name | {app_name} |
| Frameworks selected | {EU / US / ISO 42001 / combination} |
| Risk classification | {Unacceptable / High / Limited / Minimal (EU) or High-risk / General (US)} |
| Use case category | {General chatbot / Hiring / Healthcare / Credit / Education / Other} |
| Applicable regulations | {EU AI Act, GPAI CoP, GDPR, NIST AI RMF, Colorado AI Act, NYC LL144, HIPAA, ISO 42001} |
| Audit date | {date} |
Priority legend
| Priority | Meaning |
|---|---|
| Critical | Blocking — non-compliance carries enforcement risk or system prohibition |
| High | Required by applicable regulation; remediate before production |
| Medium | Recommended by frameworks; strengthens compliance posture |
| Low | Best practice; implement when resources allow |
---
1. Governance and documentation
| # | Item | Regulation | Priority | Status | Remediation |
|---|---|---|---|---|---|
| 1.1 | AI governance policy documented | NIST GOV-1, ISO 42001 cl.5.2 | Medium | ||
| 1.2 | Accountable individuals assigned for AI risk | NIST GOV-1.1, Colorado, ISO 42001 A.6.1 | High | ||
| 1.3 | Model card or technical documentation exists | EU Art. 11, Colorado, ISO 42001 A.6.2 | High | ||
| 1.4 | Intended purpose and limitations documented | EU Art. 13, NIST MAP-1.1, ISO 42001 A.8 | High | ||
| 1.5 | Change log for model/prompt updates maintained | EU Art. 11, NIST GOV-5, ISO 42001 cl.8.4 | Medium | ||
| 1.6 | Documentation retained for required period (10yr EU, 6yr HIPAA) | EU Art. 11, HIPAA | High | ||
| 1.7 | AI impact assessment conducted and documented | ISO 42001 cl.8.3, A.5.2 | High | ISO 42001 only. Create an impact assessment document covering intended use, potential harms, and affected stakeholders. May be combined with a GDPR DPIA. | |
| 1.8 | AI risk assessment process documented | ISO 42001 cl.6.1.2 | High | ISO 42001 only. Document the process for identifying and assessing AI-specific risks (bias, safety, privacy, security). | |
| 1.9 | Supplier AI policy documented (third-party AI providers) | ISO 42001 A.10 | Medium | ISO 42001 only. Document all third-party AI APIs used and confirm vendor obligations (no training on your data, data residency, etc.). | |
| 1.10 | Organisational clauses (leadership, internal audit, management review) | ISO 42001 cl.5.1, 9.2, 9.3 | — | Organisational — not code-auditable | These clauses require evidence from outside the codebase. Flag for the compliance team. |
2. Data protection and privacy
| # | Item | Regulation | Priority | Status | Remediation |
|---|---|---|---|---|---|
| 2.1 | Lawful basis for processing documented | GDPR Art. 6 | Critical | ||
| 2.2 | Data Protection Impact Assessment conducted | GDPR Art. 35, ISO 42001 cl.8.3 | High | ||
| 2.3 | Data Processing Agreements with all AI vendors | GDPR Art. 28 | Critical | ||
| 2.4 | PII redacted from traces and span attributes | GDPR Art. 5(1)(c) | High | ||
| 2.5 | Data subject rights handlers implemented (access, deletion, portability) | GDPR Art. 15-22 | High | ||
| 2.6 | User ID on spans to support data subject lookups | GDPR Art. 15 | Medium | ||
| 2.7 | Consent or opt-out mechanism for AI processing | State privacy laws | High | ||
| 2.8 | International data transfer safeguards (SCCs/DPF) | GDPR Art. 44-49 | Critical | ||
| 2.9 | Breach detection and 72-hour notification workflow | GDPR Art. 33 | High | ||
| 2.10 | PHI handling compliant (BAAs, min. necessary, encryption) | HIPAA | Critical |
3. Security
| # | Item | Regulation | Priority | Status | Remediation |
|---|---|---|---|---|---|
| 3.1 | Prompt injection defences implemented | EU Art. 15, NIST MEA-2.7, ISO 42001 A.4.2 | High | ||
| 3.2 | Output filtering / guardrails in place | NIST MAN-1.2, ISO 42001 A.4.2 | High | ||
| 3.3 | Data loss prevention for sensitive output | NIST MAN-1.2, HIPAA, ISO 42001 A.7.4 | High | ||
| 3.4 | Tool/function access controls (least privilege) | NIST MAN-1.2 | High | ||
| 3.5 | Rate limiting on AI endpoints | NIST MAN-1.2 | Medium | ||
| 3.6 | Authentication on AI endpoints | NIST MAN-1.2 | High | ||
| 3.7 | No hardcoded secrets in source | General security | Critical | ||
| 3.8 | Incident response plan documented | NIST MAN-3.1 | Medium |
4. Testing and evaluation
| # | Item | Regulation | Priority | Status | Remediation |
|---|---|---|---|---|---|
| 4.1 | Bias and fairness testing across demographic groups | NIST MEA-2.1, Colorado, NYC LL144, ISO 42001 A.4.2 | High | ||
| 4.2 | Adversarial / red team testing conducted | NIST MEA-2.5, GPAI CoP | High | ||
| 4.3 | Evaluation pipeline for accuracy and quality | NIST MEA-1.1, ISO 42001 cl.9.1 | Medium | ||
| 4.4 | Regression test suite for AI behaviour | EU Art. 15 | Medium | ||
| 4.5 | Impact assessment (annual for Colorado) | Colorado AI Act | High | ||
| 4.6 | Independent bias audit (annual for NYC LL144) | NYC LL144 | Critical |
5. Transparency and user communication
| # | Item | Regulation | Priority | Status | Remediation |
|---|---|---|---|---|---|
| 5.1 | Users informed they are interacting with AI | EU Art. 50, Colorado, ISO 42001 A.8 | Critical | ||
| 5.2 | AI-generated content labelled | EU Art. 50(2) | High | ||
| 5.3 | Explanation provided for AI-driven decisions | EU Art. 13-14, GDPR Art. 22 | High | ||
| 5.4 | Opt-out mechanism for automated profiling | State privacy laws | High | ||
| 5.5 | Capabilities and limitations communicated to users | EU Art. 13, Colorado, ISO 42001 A.9 | Medium |
6. Monitoring and continuous compliance
| # | Item | Regulation | Priority | Status | Remediation |
|---|---|---|---|---|---|
| 6.1 | Arize tracing captures all LLM calls | EU Art. 12, NIST MAN-2.1, ISO 42001 cl.8.6 | High | ||
| 6.2 | Error and exception tracking on spans | NIST MAN-2.1, ISO 42001 cl.9.1 | Medium | ||
| 6.3 | Drift detection and alerting configured | NIST MEA-3.1, ISO 42001 cl.9.1 | Medium | ||
| 6.4 | Trace retention meets regulatory requirements | EU Art. 12, HIPAA | High | ||
| 6.5 | Periodic re-audit schedule defined | NIST GOV-5, Colorado, ISO 42001 cl.9.2 | Medium |
7. Vendor management
| # | Item | Regulation | Priority | Status | Remediation |
|---|---|---|---|---|---|
| 7.1 | All third-party AI APIs documented | NIST MAP-3.1, GOV-6, ISO 42001 A.10 | Medium | ||
| 7.2 | Model versions pinned (not using "latest") | NIST MAP-3.2, ISO 42001 cl.8.4 | Medium | ||
| 7.3 | Data Processing Agreements with all processors | GDPR Art. 28 | Critical | ||
| 7.4 | Vendor does not train on your data (confirmed in writing) | HIPAA, GDPR, ISO 42001 A.10 | High | ||
| 7.5 | Fallback and failover logic implemented | NIST MAN-1.1 | Low |
---
Instrumentation cross-reference
| Compliance need | Required trace data | Status |
|---|---|---|
| Audit trail for AI decisions | All LLM spans with input/output | |
| Data subject access requests | User ID attribute on spans | |
| PII exposure prevention | PII redaction on span attributes | |
| Incident investigation | Error spans with full context | |
| Retention requirements | Trace retention configured for required period | |
| Bias monitoring | Demographic or group attributes on spans |
Next steps
1. Address all Critical items immediately 2. Remediate High items before production deployment 3. Schedule Medium items for the next development cycle 4. Track Low items in backlog 5. Schedule next compliance audit for: {date + 3 months or per regulatory requirement} 6. Consult qualified legal counsel for binding compliance assessment
EU AI Act and GPAI Code of Practice — Developer Reference
This reference covers the EU AI Act (Regulation 2024/1689) and the Code of Practice for General-Purpose AI (GPAI). It is written for developers building AI agents and LLM applications, not for legal professionals. Always consult qualified legal counsel for binding compliance assessments.
Official sources:
- EU AI Act full text: https://eur-lex.europa.eu/eli/reg/2024/1689/oj
- GPAI Code of Practice: https://digital-strategy.ec.europa.eu/en/policies/contents-code-gpai
- Code of Practice portal: https://code-of-practice.ai/
Risk classification
The EU AI Act classifies AI systems into four risk tiers. Your obligations depend on which tier your application falls into.
Unacceptable risk (prohibited — Art. 5)
These AI uses are banned outright:
- Social scoring by public authorities
- Real-time remote biometric identification in public spaces (with narrow exceptions)
- Exploitation of vulnerabilities of specific groups (age, disability)
- Subliminal manipulation causing harm
- Emotion recognition in workplaces and educational institutions (with exceptions)
- Untargeted scraping of facial images for facial recognition databases
High risk (Art. 6–7, Annex III)
Subject to the strictest requirements. Includes AI used for:
- Employment: recruitment, CV screening, interview evaluation, promotion decisions, task allocation
- Credit scoring and loan decisions
- Education: student assessment, admissions, exam proctoring
- Healthcare: diagnostic assistance, treatment recommendations, triage
- Law enforcement: risk assessment, evidence evaluation
- Migration and border control: document authentication, risk assessment
- Critical infrastructure: energy, water, transport management
Limited risk (Art. 50 — transparency obligations)
AI systems that interact with people or generate content must:
- Disclose to users that they are interacting with AI
- Label AI-generated content (text, audio, image, video) as such
- Label deepfakes clearly
This tier covers most chatbots, virtual assistants, and content-generation tools.
Minimal risk
No specific obligations. Includes spam filters, AI-enhanced video games, inventory management systems.
High-risk system requirements (Art. 8–15)
If your application is classified as high-risk, you must implement:
Risk management system (Art. 9)
- Continuous, iterative risk identification and mitigation throughout the AI system lifecycle
- Testing with metrics appropriate to the intended purpose
- Evaluation of risks from foreseeable misuse
- Risk mitigation measures that cannot be fully eliminated must be communicated to deployers
Data governance (Art. 10)
- Training, validation, and testing datasets must be relevant, sufficiently representative, and as error-free as possible
- Statistical properties including biases must be examined
- Data must be appropriate for the geographic, contextual, and functional setting
Technical documentation (Art. 11)
- General description of the AI system and its intended purpose
- Design specifications, development methodology, and development choices
- Monitoring, functioning, and control of the system
- Risk management documentation
- Description of changes made throughout the lifecycle
- Must be drawn up before the system is placed on the market and kept up to date
Record-keeping (Art. 12)
- Automatic logging of events ("logs") throughout the system's lifecycle
- Logs must enable tracing of the system's operation to identify risks
- Logging must be appropriate to the intended purpose
- Retention: Logs must be kept for a period appropriate to the intended purpose, at least 6 months unless provided otherwise by law
Transparency and information to deployers (Art. 13)
- Clear, adequate information to deployers about the system's capabilities and limitations
- Intended purpose, level of accuracy, robustness, and cybersecurity
- Known or foreseeable circumstances that may lead to risks
- Performance metrics including for specific persons or groups
- Technical capabilities and limitations (input data specifications, output interpretation guidance)
Human oversight (Art. 14)
- Designed to allow effective oversight by natural persons during use
- Deployers must assign human oversight to competent individuals
- Individuals must be able to: understand the system, detect anomalies, decide not to use the system, intervene or stop the system
Accuracy, robustness, cybersecurity (Art. 15)
- Appropriate level of accuracy declared in documentation
- Resilience to errors, faults, and inconsistencies
- Resilience against manipulation by unauthorised third parties
- Technical redundancy solutions where appropriate
GPAI Code of Practice obligations
The GPAI Code of Practice applies to providers of general-purpose AI models. If you are building on top of a GPAI model (e.g., using OpenAI, Anthropic, or open-source LLMs), these obligations primarily fall on the model provider, but you should understand them for your own documentation and risk management.
Transparency (Commitments 1–7)
- Prepare and maintain a Model Documentation Form covering model capabilities, limitations, training data summaries, and contact information
- Publish a sufficiently detailed summary of training data content
- Provide documentation to downstream providers and deployers
- Retention: Documentation must be maintained for a minimum of 10 years after the model is placed on the market
Copyright (Commitments 8–11)
- Establish a copyright compliance policy aligned with EU copyright law (Directive 2019/790)
- Implement measures to mitigate risk of copyright-infringing outputs
- Implement a complaints-handling process for rights holders
- Document how training data was sourced and validated for copyright compliance
Safety and security (Commitments 12–22, for systemic risk models)
- Implement a Safety and Security Framework (SSF) covering governance, risk assessment, and technical mitigations
- Identify and evaluate systemic risks before major deployment decisions
- Conduct model evaluations (capability, safety, societal risk)
- Implement safeguards for identified risks
- Conduct adversarial testing (red teaming)
- Report serious incidents to the AI Office within prescribed timelines
- Track and document model capabilities over time
GDPR intersection
If your AI application processes personal data of EU residents, GDPR applies regardless of where you are based.
When AI processing triggers GDPR
- Prompts or context containing personal data (names, emails, health info)
- User conversation logs stored for fine-tuning or evaluation
- Retrieval-augmented generation (RAG) over documents containing personal data
- Trace data sent to observability platforms containing PII in span attributes
Key GDPR requirements for AI developers
- Lawful basis (Art. 6): Consent, contract, legitimate interest, or other lawful basis for processing
- Data Protection Impact Assessment (Art. 35): Required for high-risk processing, including systematic profiling and large-scale processing of sensitive data
- Data Processing Agreements (Art. 28): Required with every processor (LLM providers, cloud infrastructure, observability platforms)
- Data subject rights (Art. 15–22): Right to access, rectification, erasure, restriction, portability, and to object. For automated decision-making: right to human intervention and explanation
- Data minimisation (Art. 5(1)(c)): Only process data that is adequate, relevant, and limited to what is necessary
- Breach notification (Art. 33–34): Notify supervisory authority within 72 hours; notify affected individuals without undue delay if high risk
- International transfers (Art. 44–49): Standard Contractual Clauses or Data Privacy Framework for transfers outside EEA
Developer action mapping
| Requirement | Article | Developer action |
|---|---|---|
| AI disclosure | Art. 50 | Add UI/API indicators that content is AI-generated or user is interacting with AI |
| Content labelling | Art. 50(2) | Label AI-generated text, images, audio, video with machine-readable markers |
| Technical documentation | Art. 11 | Maintain model card and system architecture docs |
| Record-keeping | Art. 12 | Implement trace logging (Arize tracing covers this) with appropriate retention |
| Transparency to deployers | Art. 13 | Document capabilities, limitations, accuracy metrics, known risks |
| Human oversight | Art. 14 | Implement human-in-the-loop for high-risk decisions; build override/stop mechanisms |
| Accuracy and robustness | Art. 15 | Implement evaluation pipelines, adversarial testing, error handling |
| Risk management | Art. 9 | Continuous risk identification, testing, mitigation documentation |
| Data governance | Art. 10 | Audit training/RAG data for bias, representativeness, errors |
| GDPR — lawful basis | Art. 6 | Document and implement consent or legitimate interest for data processing |
| GDPR — DPIA | Art. 35 | Conduct impact assessment for high-risk AI processing |
| GDPR — DPA | Art. 28 | Execute data processing agreements with all AI vendors |
| GDPR — data subject rights | Art. 15–22 | Implement access, deletion, portability handlers; user ID on traces for lookup |
| GDPR — PII minimisation | Art. 5(1)(c) | Redact PII in prompts, traces, and logs where not strictly necessary |
| GDPR — breach notification | Art. 33 | Implement breach detection and 72-hour notification workflow |
Penalties
| Violation | Maximum fine |
|---|---|
| Prohibited AI practices (Art. 5) | EUR 35 million or 7% of global annual turnover |
| High-risk non-compliance (Art. 8–15) | EUR 15 million or 3% of global annual turnover |
| Incorrect information to authorities | EUR 7.5 million or 1.5% of global annual turnover |
| GDPR violations | EUR 20 million or 4% of global annual turnover |
Timeline
| Date | Milestone |
|---|---|
| 1 August 2024 | EU AI Act entered into force |
| 2 February 2025 | Prohibited practices apply |
| 2 August 2025 | GPAI obligations apply to new models |
| 2 August 2026 | Full enforcement begins — high-risk requirements, Commission can request info, model access, and order recalls |
| 2 August 2027 | Existing GPAI models (released before Aug 2025) must comply |
ISO/IEC 42001:2023 — AI Management Systems Developer Reference
This reference covers ISO/IEC 42001:2023, the international standard for Artificial Intelligence Management Systems (AIMS). It is written for developers building AI agents and LLM applications, not for legal or audit professionals.
Official source: https://www.iso.org/standard/42001.html
Scope note: ISO 42001 is primarily an organisational management system standard. Many of its requirements (leadership commitment, internal audits, management reviews) cannot be verified from code alone. This reference focuses on clauses and annex controls that produce code or documentation artifacts — things a codebase audit can actually find evidence of or flag as missing.
What ISO 42001 is
ISO 42001 is to AI what ISO 27001 is to information security: a framework for establishing, implementing, maintaining, and continually improving an AI management system. It applies to any organisation that develops, provides, or uses AI systems.
Unlike the EU AI Act or NIST AI RMF, ISO 42001 is a certifiable standard — organisations can be independently audited and certified. It is internationally applicable (not jurisdiction-specific) and complements other frameworks rather than replacing them.
Relationship to other frameworks
| Framework | Type | Scope |
|---|---|---|
| ISO 42001 | Management system standard (certifiable) | Organisational + technical |
| EU AI Act | Regulation (mandatory, EU) | Technical + procedural |
| NIST AI RMF | Voluntary framework (US) | Risk management, technical |
| GDPR | Regulation (mandatory, EU) | Data protection |
ISO 42001 Annex C maps the standard's controls to the EU AI Act and NIST AI RMF. If you comply with EU AI Act Art. 8–15, you satisfy most ISO 42001 technical requirements.
Clause structure overview
| Clause | Topic | Code-auditable? |
|---|---|---|
| 4 — Context | Organisational context, interested parties | No |
| 5 — Leadership | Management commitment, AI policy | Partially (policy doc) |
| 6 — Planning | Risk assessment, objectives | Partially (impact assessment docs) |
| 7 — Support | Resources, awareness, documentation | Partially (model cards, changelogs) |
| 8 — Operation | AI system lifecycle, impact assessment | Yes (lifecycle docs, impact register) |
| 9 — Performance evaluation | Monitoring, measurement, internal audit | Partially (monitoring config) |
| 10 — Improvement | Nonconformity, continual improvement | No |
| Annex A — Controls | 38 controls across 9 categories | Partially |
Technically auditable clauses and controls
Clause 5.2 — AI policy
Requirement: The organisation shall establish an AI policy that includes commitments to satisfy applicable requirements and to continual improvement.
Code artifact to look for: A policy document referenced in the codebase (AI_POLICY.md, docs/ai-policy.md, GOVERNANCE.md) or a link to a policy in README.md or CONTRIBUTING.md.
Gap signal: No policy document or reference found anywhere in the repository.
Clause 6.1.2 — AI risk assessment
Requirement: Documented process for identifying and assessing AI-specific risks (bias, safety, privacy, security).
Code artifact to look for: Risk assessment or DPIA documents, risk register files, or references to a risk management process.
Gap signal: No risk or impact assessment documentation.
Clause 8.3 — AI impact assessment
Requirement: Conduct and document an impact assessment for AI systems, covering intended use, potential harms, and affected stakeholders.
Code artifact to look for: AI_IMPACT_ASSESSMENT.md, docs/impact-assessment.*, or similar. May be combined with a DPIA for GDPR overlap.
Gap signal: No impact assessment document found.
Clause 8.4 — AI system lifecycle
Requirement: Manage the AI system through a documented lifecycle: design, development, testing, deployment, monitoring, decommission. Changes are documented and controlled.
Code artifact to look for:
- Changelog or version history for models and prompts
- Model card (
MODEL_CARD.md,model_card.json) - Pinned model versions (not
latest) in code - Deployment notes or release documentation
Gap signal: No model card, no changelog, or model versions unpinned.
Clause 8.6 — AI system operation and monitoring
Requirement: Monitor AI system performance, detect degradation, and act on findings.
Code artifact to look for:
- Arize tracing and evaluation setup
- Drift detection configuration
- Alerting rules
- Periodic re-evaluation schedule
Gap signal: No monitoring or evaluation infrastructure.
Clause 9.1 — Monitoring, measurement, analysis, evaluation
Requirement: Determine what needs to be monitored, methods, when to analyse, when to report results.
Code artifact to look for: Evaluation pipelines, Arize evaluators, scheduled jobs for performance review, dashboards.
Gap signal: No evaluation or measurement infrastructure beyond basic logging.
Annex A controls (technically auditable subset)
A.2.2 — Policies for AI use (organisational AI use policy)
Policies governing acceptable AI use, including approved use cases, prohibited uses, and responsible use guidelines.
Artifact: docs/ai-use-policy.md, ACCEPTABLE_USE.md, or policy links in README.
A.3.2 — Internal audit of the AIMS
Documented audit programme and results.
Artifact: Audit log files, scheduled audit tooling config. Usually organisational — note as not code-auditable.
A.4.2 — Addressing bias
Documented processes for identifying, assessing, and mitigating bias in training data and model outputs.
Artifact: Bias testing scripts, fairness metric definitions, Arize evaluators for fairness, demographic parity tests.
A.5.2 — AI system impact assessment
See clause 8.3 above.
A.6.1 — Allocation of AI roles and responsibilities
Accountable owners for AI systems identified and documented.
Artifact: CODEOWNERS, README.md ownership sections, or GOVERNANCE.md with role assignments.
A.6.2 — AI system lifecycle management
Processes for managing the full lifecycle. See clause 8.4.
A.7 — Data for AI systems
A.7.1 — Data governance: Processes ensuring data quality, provenance, and fitness for purpose.
A.7.2 — Data acquisition and collection: Documented data sources, collection methods, consent basis.
A.7.3 — Data preparation: Data cleaning, preprocessing, and validation documented.
A.7.4 — Data quality: Data quality checks implemented in pipeline.
Code artifact to look for: Data validation scripts, schema definitions, data provenance documentation, data quality checks.
A.8 — Information for interested parties
Requirements for transparency to users and stakeholders — overlaps with EU AI Act Art. 13 and 50.
Artifact: User-facing disclosures, model documentation, capability and limitation statements.
A.9 — Use of AI systems
Guidance for users of AI systems, including known limitations and appropriate use. Often in user documentation.
Artifact: User guide, USAGE.md, or in-app help text describing limitations.
A.10 — Third-party and supplier relationships
Requirement: Supplier AI policy covering third-party AI providers and data processors.
Code artifact to look for: Documented AI vendor list, vendor risk assessments, DPA references, supplier questionnaires.
Gap signal: Third-party AI APIs used (OpenAI, Anthropic, etc.) with no vendor documentation.
Organisational-only requirements (not code-auditable)
These clauses require organisational evidence that cannot be found in a codebase. Flag them for the user to address outside the technical audit:
| Clause | Requirement |
|---|---|
| 5.1 | Leadership and commitment — management sign-off |
| 5.3 | Roles and responsibilities assigned |
| 6.2 | AI objectives and planning to achieve them |
| 7.2 | Competence — staff training records |
| 7.3 | Awareness — staff awareness of AI policy |
| 9.2 | Internal audit — conducted by qualified auditors |
| 9.3 | Management review — periodic leadership reviews |
| 10.1 | Continual improvement programme |
Checklist priority guidance
| Priority | Meaning in ISO 42001 context |
|---|---|
| Critical | Certification blocker or significant nonconformity |
| High | Required control with no documented evidence |
| Medium | Control partially evidenced; needs strengthening |
| Low | Best practice; documentation gap only |
US AI Compliance Landscape — Developer Reference
This reference covers US regulatory frameworks applicable to AI agent and LLM application development. The US does not have a single comprehensive federal AI law; compliance is a patchwork of federal frameworks, state laws, and sector-specific regulations. Always consult qualified legal counsel for binding compliance assessments.
Official sources:
- NIST AI RMF: https://www.nist.gov/artificial-intelligence/ai-risk-management-framework
- Colorado AI Act (SB24-205): https://leg.colorado.gov/bills/sb24-205
- NYC Local Law 144: https://www.nyc.gov/site/dca/about/automated-employment-decision-tools.page
- HIPAA: https://www.hhs.gov/hipaa/index.html
NIST AI Risk Management Framework (AI RMF 1.0)
The NIST AI RMF is voluntary but increasingly the de facto standard for AI governance. Federal agencies require alignment for AI procurement (OMB M-24-10), and state laws like the Colorado AI Act reference NIST-aligned frameworks. Aligning with NIST AI RMF is the strongest foundation for US compliance.
Govern function
Establish organisational AI governance. Developer actions:
| Sub-function | What to implement |
|---|---|
| GOV-1 | Define an AI governance policy covering accountability, roles, and escalation paths |
| GOV-1.1 | Assign individuals or teams responsible for AI risk management |
| GOV-1.2 | Document the organisation's risk tolerance for AI systems |
| GOV-2 | Establish accountability structures — who is responsible when the AI produces harmful output |
| GOV-3 | Define processes for workforce diversity and domain expertise in AI development |
| GOV-4 | Implement organisational processes for feedback, appeals, and override of AI decisions |
| GOV-5 | Establish processes for continuous improvement based on monitoring data |
| GOV-6 | Define policies for third-party AI components (model providers, APIs, data sources) |
Map function
Identify and contextualise AI risks. Developer actions:
| Sub-function | What to implement |
|---|---|
| MAP-1.1 | Document the intended purpose and known limitations of the AI system |
| MAP-1.2 | Identify the interdependencies and downstream impacts of the system |
| MAP-1.5 | Document assumptions and constraints of the AI system |
| MAP-2.1 | Identify who is affected by the system (users, subjects of decisions, bystanders) |
| MAP-2.2 | Document potential benefits and harms for each stakeholder group |
| MAP-2.3 | Assess risks of the AI system in its real-world deployment context |
| MAP-3.1 | Identify risks from the AI supply chain (model provider, training data, third-party tools) |
| MAP-3.2 | Assess risks of bias, inaccuracy, or unreliability in data and models |
| MAP-5.1 | Document the system's fitness for its intended purpose through testing |
Measure function
Quantify and test AI risks. Developer actions:
| Sub-function | What to implement |
|---|---|
| MEA-1.1 | Define and track performance metrics appropriate to the system's purpose |
| MEA-2.1 | Test for bias and fairness across demographic groups and use cases |
| MEA-2.2 | Evaluate the system's robustness under adversarial conditions |
| MEA-2.3 | Test for privacy risks — data leakage, PII exposure, membership inference |
| MEA-2.5 | Conduct red teaming and adversarial testing for safety and security |
| MEA-2.6 | Evaluate the AI system's environmental impact (compute, energy) |
| MEA-2.7 | Evaluate the AI system's security posture (prompt injection, data exfiltration) |
| MEA-3.1 | Track metrics over time to detect drift, degradation, and emerging risks |
| MEA-4.1 | Document measurement methodology and results |
Manage function
Implement controls and mitigation. Developer actions:
| Sub-function | What to implement |
|---|---|
| MAN-1.1 | Implement risk treatment plans for identified risks |
| MAN-1.2 | Deploy technical controls: input validation, output filtering, guardrails |
| MAN-2.1 | Implement monitoring for deployed systems (drift, performance, incidents) |
| MAN-2.2 | Establish mechanisms for user feedback and incident reporting |
| MAN-3.1 | Define incident response procedures for AI-related incidents |
| MAN-3.2 | Implement escalation and notification workflows |
| MAN-4.1 | Implement decommissioning procedures for AI systems |
| MAN-4.2 | Document and apply lessons learned from incidents |
Colorado AI Act (SB24-205)
Scope
Applies to developers and deployers of "high-risk AI systems" — those making or substantially assisting consequential decisions in:
- Employment, promotion, termination
- Education admissions and opportunities
- Financial services (lending, credit, insurance)
- Healthcare services
- Housing
- Legal services
- Government services
Developer obligations (effective 1 February 2026)
| Requirement | What to implement |
|---|---|
| Reasonable care | Exercise reasonable care to protect consumers from algorithmic discrimination |
| Impact assessment | Conduct and document annual impact assessments covering performance, bias, and discrimination risks |
| Risk management | Implement a risk management programme aligned with a recognised framework (NIST AI RMF, ISO 42001) |
| Documentation | Make available: a general description of the system, known limitations, the type of data used, how the system was evaluated, mitigation measures |
| Disclosure to deployers | Provide deployers with documentation needed for their own compliance |
| Discrimination prevention | Test for and mitigate algorithmic discrimination based on protected classes (race, colour, ethnicity, sex, religion, age, disability, sexual orientation, veteran status) |
Safe harbour
Compliance with a recognised risk management framework (NIST AI RMF or ISO 42001) establishes a rebuttable presumption of reasonable care.
NYC Local Law 144 — Automated Employment Decision Tools (AEDT)
Scope
Applies to employers and employment agencies in New York City using AI for hiring, promotion, or other employment decisions.
Requirements
| Requirement | What to implement |
|---|---|
| Annual bias audit | Conduct an independent bias audit before use and annually thereafter |
| Audit scope | Assess scoring rates and impact ratios for sex, race/ethnicity, and intersectional categories |
| Transparency | Publish a summary of the most recent bias audit on the employer's website |
| Notice to candidates | Notify candidates at least 10 business days before use; describe the job qualifications evaluated; allow alternatives |
| Data disclosure | Disclose what data is collected and its retention period |
Audit methodology
- Calculate selection/scoring rates for each demographic category
- Calculate impact ratios (selection rate of each group vs the most-selected group)
- Flag categories with impact ratios below 0.8 (four-fifths rule) for further analysis
HIPAA for AI applications
Applies if your AI application processes Protected Health Information (PHI). This includes clinical data, diagnostic information, treatment records, or any data linkable to a specific patient.
When HIPAA applies to AI
- AI system processes, stores, or transmits PHI
- AI system is used by or on behalf of a covered entity (healthcare provider, health plan, healthcare clearinghouse)
- AI system is provided by a business associate of a covered entity
Requirements
| Requirement | What to implement |
|---|---|
| Business Associate Agreement (BAA) | Execute BAAs with every vendor that touches PHI (LLM provider, cloud, observability) |
| No training on PHI | Verify LLM providers do not use your data for model training — get written confirmation |
| Minimum necessary | Limit PHI in prompts and context to what is strictly necessary for the task |
| Access controls | Implement role-based access control (RBAC) or attribute-based access control (ABAC) for PHI |
| Audit logs | Maintain immutable audit logs of all PHI access: who, what, when, why |
| Encryption | Encrypt PHI in transit (TLS 1.2+) and at rest (AES-256) |
| De-identification | Use Safe Harbor or Expert Determination methods to de-identify data where possible |
| Breach notification | Notify affected individuals within 60 days; notify HHS; notify media if 500+ individuals affected |
PHI in traces and spans
If using Arize tracing in a healthcare context:
- Ensure PHI is redacted from
input.valueandoutput.valuespan attributes before export - Verify Arize's BAA covers trace data storage
- Implement PII/PHI detection filters on span data before it leaves the application
- Configure trace retention to meet HIPAA's 6-year retention requirement for audit logs
State privacy laws intersection
Several state privacy laws impose additional obligations when AI processes personal data:
| Law | Scope | Key AI provisions |
|---|---|---|
| CCPA/CPRA (California) | Businesses serving CA residents | Right to opt out of automated decision-making; right to access information about the logic involved |
| Virginia CDPA | Businesses serving VA residents | Right to opt out of profiling in furtherance of automated decisions; data protection assessments required |
| Connecticut Data Privacy Act | Businesses serving CT residents | Right to opt out of profiling; data protection assessments for targeted advertising and profiling |
| Texas Data Privacy Act | Businesses serving TX residents | Data protection assessments for processing that presents a heightened risk of harm |
| Oregon Consumer Privacy Act | Businesses serving OR residents | Right to opt out of profiling; children's data protections |
Common obligations across state privacy laws:
- Data protection assessments for AI-driven profiling
- Opt-out mechanisms for automated decision-making
- Transparency about automated processing
- Data minimisation in AI contexts
Developer action summary
| Compliance area | Framework | Concrete developer action |
|---|---|---|
| Governance policy | NIST GOV-1 | Document AI governance policy, roles, accountability |
| Risk identification | NIST MAP-1–3, Colorado | Document intended purpose, limitations, stakeholder impact, supply chain risks |
| Bias testing | NIST MEA-2.1, Colorado, NYC LL144 | Test output fairness across demographic groups; compute impact ratios |
| Adversarial testing | NIST MEA-2.5, MEA-2.7 | Red team for prompt injection, jailbreak, goal hijacking, data exfiltration |
| Input/output validation | NIST MAN-1.2 | Implement guardrails, content filtering, DLP |
| Monitoring | NIST MAN-2.1, MEA-3.1 | Deploy Arize tracing with drift detection and alerting |
| Incident response | NIST MAN-3.1 | Define and document AI incident response procedures |
| Documentation | Colorado, NIST MAP-1 | Maintain model card, system docs, impact assessments |
| Transparency | Colorado, state privacy laws | Disclose AI use to users; provide opt-out for profiling |
| PHI protection | HIPAA | BAAs, PII/PHI redaction, audit logs, encryption, minimum necessary |
| Privacy assessments | State privacy laws | Conduct DPAs for AI processing involving personal data |
Related skills
FAQ
What does arize-compliance-audit do?
INVOKE THIS SKILL when auditing an AI agent or LLM app for regulatory compliance. Covers EU AI Act, GPAI Code of Practice, GDPR, NIST AI RMF, Colorado AI Act, HIPAA, and ISO 42001. Scans the codebase for compliance gaps,
When should I use arize-compliance-audit?
INVOKE THIS SKILL when auditing an AI agent or LLM app for regulatory compliance. Covers EU AI Act, GPAI Code of Practice, GDPR, NIST AI RMF, Colorado AI Act, HIPAA, and ISO 42001. Scans the codebase for compliance gaps,
What are common prerequisites?
--- name: arize-compliance-audit description: "INVOKE THIS SKILL when auditing an AI agent or LLM app for regulatory compliance.