77 posts on compliance & regulation.
Article 12 of the EU AI Act mandates that high-risk AI systems automatically record events over the system lifetime. The logs must reconstruct what happened, who initiated it, and what data was involved. Penalties reach 15M EUR. Most AI deployments produce zero compliant records today.
SOC 2 reports cover five Trust Services Criteria: security, availability, processing integrity, confidentiality, and privacy. AI deployments touch all five. The audit evidence that AICPA expects has to be operational, not architectural. Application logs and policy documents fail. The records that pass are per request.
NIST AI RMF is a voluntary US framework. The EU AI Act is binding law with penalties reaching 35M EUR or 7% of global turnover. The two frameworks converge on the same operational evidence: per-request records that capture identity, classification, policy state, and decision outcome.
NIST AI RMF 1.0 defines four functions: Govern, Map, Measure, Manage. The framework is voluntary, but federal procurement and state AI laws increasingly cite it as the baseline. Implementation runs to dozens of decisions across identity, classification, policy enforcement, and audit. Most deployments stop at Govern.
NIS2 took effect at the Member State level by October 18, 2024. The directive covers essential and important entities across 18 sectors. AI used in those operations falls under Article 21 cybersecurity risk management and Article 23 incident reporting. Audit trail expectations are operational.
ISO 27001 is the information security management system standard. ISO 42001 is the AI management system standard published December 2023. The two standards integrate at the controls layer. Annex A controls in ISO 27001:2022 cover the same evidence ISO 42001 expects for AI-specific risk treatment.
EU AI Act compliance breaks into six operational workstreams: scope classification, technical documentation, conformity assessment, runtime evidence, deployer monitoring, and incident reporting. The mandate takes effect August 2, 2026. Most organizations are running three of the six and missing the rest.
HIPAA requires that PHI is redacted or de-identified before disclosure to entities outside a Business Associate Agreement. AI prompts routinely contain PHI. Inline redaction at the AI request boundary is the only architecture that produces the per-request evidence HHS expects under a HIPAA audit.
A Business Associate Agreement with an AI vendor transfers HIPAA obligations under specific conditions. OpenAI, Anthropic, Microsoft, AWS, and Google offer BAAs to enterprise tiers. The agreement covers what the vendor does with PHI; it does not eliminate the covered entity duty to record disclosures.
HIPAA Security Rule audit controls require recording activity in systems that contain PHI. AI deployments produce that activity at the prompt layer. OCR audits request per-request records of PHI exposure to AI services. Application logs fail. The architecture that survives is independent of the application.
GDPR governs the processing of personal data. The EU AI Act governs the operation of AI systems. The two regimes overlap on automated decision-making and divergent on per-decision evidence. GDPR records describe what data is processed. AI Act records describe what an AI system did with a specific request.
Article 6 of the EU AI Act establishes a two-branch test for classifying an AI system as high-risk. Branch one covers safety components of regulated products. Branch two covers the Annex III use cases. The classification triggers the full operational regime from August 2, 2026.