143 posts on compliance & regulation.
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.
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.
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.
SaaS companies that embed AI features in product flows are pulled into the EU AI Act through their customers. If the customer uses the SaaS in a high-risk use case, the customer is the deployer and the SaaS company is often the provider. The mandate takes effect August 2, 2026.
A 23-item operational checklist for EU AI Act high-risk compliance, organized across scope, documentation, evidence, monitoring, and incident reporting. The mandate takes effect August 2, 2026. Items 12 to 18 are where most deployments fail.
Article 26 of the EU AI Act puts operational obligations on the deployer of a high-risk AI system. The deployer must monitor operation, suspend use under specific risk conditions, keep automatically generated logs, and inform the provider and authorities. The mandate takes effect August 2, 2026.
Article 19 of the EU AI Act sets the operational floor for log retention from high-risk AI systems at six months and specifies what the automatically generated logs must contain. The mandate takes effect August 2, 2026. Application logs fail the structural test.