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Intelligence Series · 2026 Edition

The AI Compliance Books
the World Has Been Waiting For

Written by the founders of the world's only pure-play independent AI certification body. No vendor relationships. No conflicts of interest. Pure regulatory intelligence.

EU deadlines aligned to the AI Omnibus
14+ Global Frameworks
Every Major Jurisdiction
Read Online · 2026 Editions
New · Read Online, Revised as the Rules Move

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The Library · Included With Your Subscription

Five Volumes to Read Today. A Sixth in Preparation.

The most current, most comprehensive AI compliance intelligence available — from an independent body with zero financial stake in any AI vendor or platform. Every published title opens inside the secure online reader, page by page, with nothing to download. One monthly subscription unlocks them all.

In final preparation
THE EU AI ACT ARTICLE BY ARTICLE REGULATION (EU) 2024/1689 ANNOTATED REFERENCE · 2026 O. PINZARU · A. KIMMIG © COPYRIGHT PROTECTED
EU AI Act Prohibited Practices High-Risk Systems GPAI Models Enforcement
Annotated Reference · 13 Chapters, 113 Articles

The EU AI Act: Article by Article

In final preparation — not yet in the reader. The complete article-by-article decode of Regulation (EU) 2024/1689 — the world's first comprehensive, binding AI law — as amended by the Digital Omnibus on AI, Regulation (EU) 2026/1744. Every one of its 113 articles translated into plain language: what it says, who it applies to, what it requires, and the deadline that governs it.

  • All 113 articles across 13 chapters — plain-English, obligation by obligation
  • Article 5's prohibited practices — in force since February 2, 2025, with two added from December 2, 2026
  • The December 2, 2027 high-risk deadline, as set by the in-force Omnibus — what it covers and who must comply
  • GPAI and systemic-risk model obligations under the August 2025 rules
  • €35M / 7% of global turnover — the enforcement and penalty tiers decoded
JP KR CN IN SG AU AI COMPLIANCE IN ASIA PACIFIC REGIONAL EDITION · 2026 O. PINZARU · A. KIMMIG © COPYRIGHT PROTECTED
South Korea Singapore ISO 42001 EU AI Act NIST
Asia-Pacific Edition · 9 Chapters

AI Compliance in Asia-Pacific 2026

The complete jurisdiction-by-jurisdiction guide to AI compliance across the Asia-Pacific region — South Korea, Singapore, Japan, China, India, and Australia. Includes a 90-day multi-jurisdiction sprint plan.

  • South Korea AI Basic Act — in force January 22, 2026
  • Singapore AI Verify, MAIGF and Agentic AI Framework
  • China CAC enforcement — strictest penalties globally
  • Japan AI Promotion Act and APPI obligations
  • 90-day APAC multi-jurisdiction compliance sprint
New · Vol. 3
THE AGENTIC AI GOVERNANCE HANDBOOK ENTERPRISE EDITION · 2026 O. PINZARU · A. KIMMIG © COPYRIGHT PROTECTED
Agentic AI Singapore MAIGF EU AI Act NIST AI RMF ISO 42001
Enterprise Edition · 12 Chapters + Appendix

The Agentic AI Governance Handbook

The first definitive framework for governing AI that acts on its own — calling tools, executing transactions and coordinating other agents without a human approving each step. Grounded in Singapore's landmark Agentic AI Framework (January 2026), the WEF foundations, and the Agentic Operating Model.

  • $139B agentic AI market by 2034 — why governance cannot wait
  • Agent Identity Cards per Singapore's January 2026 standard
  • Five-tier autonomy taxonomy with requirements at each level
  • HITL / HOTL / HOOTL and the 60-second meaningful-oversight test
  • Six-phase roadmap, Agent Risk Register and Decision Rights Matrix
New · Vol. 4
AI IN HEALTHCARE THE COMPLIANCE COMMAND CENTER HEALTHCARE EDITION · 2026 O. PINZARU · A. KIMMIG © COPYRIGHT PROTECTED
FDA HIPAA EU AI Act & MDR ISO 42001 US State Laws
Healthcare Edition · 14 Chapters + Appendix

AI in Healthcare: The Compliance Command Center

The most comprehensive single-volume guide to healthcare AI compliance — synthesizing HIPAA, HITECH, FDA clinical-decision-support and SaMD guidance, 21 CFR Part 11, the EU AI Act, EU MDR and ISO 42001 into one usable framework. Written from primary sources, researched to June 2026, with EU deadlines aligned to the Digital Omnibus on AI — including the August 2, 2028 deadline for medical-device AI under Annex I.

  • $7.4M average breach cost and HHS OCR's active enforcement posture
  • 14-framework regulatory stack mapped to a single system
  • FDA CDS four-part test with six worked device / non-device examples
  • FDA AI/ML SaMD 2026 guidance — TPLC, PCCP, GMLP and QMSR
  • AI-specific BAA clause library and 18-item compliance checklist
What's Inside

Every Chapter, Every Jurisdiction

The full table of contents of all five published volumes — written from primary regulatory sources, with EU deadlines aligned to the Digital Omnibus on AI.

The AI Compliance Command Center

Global Edition · 10 Chapters + Appendix
  • 01The Global AI Compliance Landscape — why every organization needs a strategy
  • 02The Foundational Frameworks — ISO 42001, NIST AI RMF, ISO 23894
  • 03Europe (EU / UK) — full EU AI Act analysis, the world's strictest law
  • 04North America — NIST AI RMF, Colorado SB 189, FedRAMP, state patchwork
  • 05Asia-Pacific — South Korea, Singapore, Japan, China, India, Australia
  • 06Latin America — Brazil, Chile, Colombia, Argentina
  • 07Middle East & Africa — UAE, Saudi Arabia, African Union strategy
  • 08The Eight Dimensions of AI Compliance — what auditors actually assess
  • 09Building Your Compliance Program — the AxiLayer readiness methodology
  • 10The Independent Certification Advantage
  • AAppendix — global penalty reference, framework crosswalk, glossary

AI Compliance in Asia-Pacific

Regional Edition · 9 Chapters
  • 01APAC at a Glance — a regulatory landscape unlike any other
  • 02South Korea — the AI Basic Act, in force January 22, 2026
  • 03Singapore — AI Verify, MAIGF and the 2026 Agentic AI Framework
  • 04China — CAC generative-AI rules, the world's strictest enforcer
  • 05Japan — the AI Promotion Act and APPI obligations
  • 06India — MeitY AI guidelines and the DPDP Act
  • 07Australia — safety-focused, sector-led governance
  • 08Emerging Markets — Vietnam, Indonesia, Thailand, Taiwan
  • 09The 90-Day APAC Sprint — an integrated multi-jurisdiction plan

The Agentic AI Governance Handbook

Enterprise Edition · 12 Chapters + Appendix
  • 01The Agentic Revolution — what changed and why traditional governance fails
  • 02Anatomy of an AI Agent — perception, memory, tools, multi-agent coordination
  • 03The Governance Gap — why EU AI Act and NIST AI RMF were not built for agents
  • 04The Agentic Operating Model — three layers of enterprise governance
  • 05Agent Identity and Access Control — identity cards, least privilege, authentication
  • 06Human Oversight in an Agentic World — HITL, HOTL, HOOTL, meaningful oversight
  • 07Multi-Agent Coordination Governance — trust, delegation chains, liability
  • 08Risk Classification — the five-tier autonomy taxonomy
  • 09Technical Safeguards — prompt injection, data poisoning, supply chain, containment
  • 10Regulatory Application — EU AI Act, NIST AI RMF, ISO 42001, Singapore MAIGF
  • 11Building Your Governance Program — six-phase implementation roadmap
  • 12Metrics and Continuous Control — behavioral, process, and outcome metrics
  • AAppendix — Agent Risk Register, Decision Rights Matrix, glossary

AI in Healthcare: The Compliance Command Center

Healthcare Edition · 14 Chapters + Appendix
  • 01The Healthcare AI Compliance Crisis — why now and what is at stake
  • 02The Complete Regulatory Stack — all 14 frameworks, one system
  • 03HIPAA and HITECH — the foundation that AI inherits
  • 04FDA Clinical Decision Support — the device / non-device boundary
  • 05FDA AI/ML SaMD — the 2026 guidance landscape (TPLC, PCCP, GMLP)
  • 0621 CFR Part 11 — electronic records in AI-assisted regulated environments
  • 07The EU AI Act in Healthcare — high-risk classification and device intersection
  • 08EU Medical Device Regulation — AI-enabled devices and CE marking
  • 09ISO 42001 for Healthcare — AI management system implementation
  • 10US State AI Laws in Healthcare — Colorado, California, NYC, Texas, Washington
  • 11Business Associate Agreements for AI Vendors — the contract that governs everything
  • 12The Joint Commission-CHAI — seven governance domains
  • 13Building Your Healthcare AI Governance Program — the six-phase roadmap
  • 14The Healthcare AI Compliance Audit — what independent assessors examine
  • AAppendix — 18-item compliance checklist, BAA clause library, glossary

The Board & C-Suite AI Governance Playbook

Board & C-Suite Edition · 10 Chapters
  • 01Foreword — the call you do not want to receive
  • 02The Governance Emergency — why AI is now a board-level duty
  • 03Personal Accountability — CEO, board, General Counsel and CAIO roles
  • 04The Questions Every Board Must Ask — and why each one matters
  • 05The Regulatory Landscape — jurisdiction, framework and director exposure
  • 06Investor & Shareholder Expectations — governance as a value driver
  • 07AI Governance Structures — committees, reporting lines, decision rights
  • 08When AI Goes Wrong — incident response and the General Counsel
  • 09A Culture of Responsible AI — the culture test for leadership
  • 10The 90-Day Board AI Governance Sprint — a practical action plan
The Authors

Written by the Founders

The series is authored by the founding partners of AxiLayer AI, Inc. — an independent body with zero commercial relationships with any AI vendor or platform. The technical volumes are written by Ovi Pinzaru; the law, regulation and compliance volumes are co-authored by Ovi Pinzaru and Anisa Kimmig.

Ovi Pinzaru
Chief Executive Officer · AxiLayer AI, Inc.

Co-founder of AxiLayer AI and architect of its structural-independence model. He leads the firm's research into global AI regulation and its eight-dimension independent audit methodology, and is the author of the series' technical volumes.

Anisa Kimmig
Chief Financial Officer · AxiLayer AI, Inc.

Co-founder of AxiLayer AI, focused on the commercial and governance frameworks that make independent certification credible to enterprise procurement and insurance underwriters. She co-authors the series' law, regulation and compliance volumes with Ovi Pinzaru.

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AxiLayer AI is pursuing ISO/IEC 17020 and ISO/IEC 42001 accreditation through a U.S.-based signatory to the ILAC MRA and IAF MLA. Accreditation not yet granted.
These publications are for informational and educational purposes only and do not constitute legal advice. Regulations change frequently — verify current requirements with qualified legal counsel in your jurisdiction.