Understanding, Implementing and Operating in Compliance with Europe’s Landmark AI Regulation
Introduction: The Age of Regulated AI
- Why This Book Exists Now
- A Global Regulatory Watershed
- What You Will Learn in These Pages
Chapter 1: Genesis of the EU AI Act
- The Political Journey from Proposal to Law
- Competing Visions and Key Negotiations
- Why Risk-Based Regulation Won Out
- The Act’s Core Objectives
Chapter 2: Scope, Definitions and Territorial Reach
- What Is an AI System Under the Act
- Key Defined Terms Every Practitioner Must Know
- Territorial and Material Scope
- Exclusions and Carve-Outs
Chapter 3: The Regulatory Architecture
- Mapping the Obligations Landscape
- The Four Risk Categories Explained
- Actors in the AI Value Chain
- Governance Bodies: EU AI Office, Board and National Authorities
Chapter 4: Prohibited AI Practices
- The Unacceptable Risk Category
- Manipulation, Exploitation and Scoring Prohibitions
- Law Enforcement Exceptions and Safeguards
- Screening Your AI Practices for Prohibited Uses
Chapter 5: High-Risk AI Systems: Qualification and Requirements
- Annex I: The Product-Safety Route to High Risk
- Annex III: The Standalone High-Risk List
- Fundamental Rights Impact Assessments
- When a System Becomes High Risk (and When It Does Not)
Chapter 6: Obligations for High-Risk AI Systems: Technical Requirements
- Data Governance and Quality Requirements
- Technical Documentation and Record-Keeping
- Transparency and User Information
- Accuracy, Robustness and Cybersecurity
- Human Oversight Design
Chapter 7: Conformity Assessment and Market Surveillance
- Internal Control versus Third-Party Assessment
- The CE Marking Process for AI
- Post-Market Monitoring Obligations
- Incident Reporting and Corrective Actions
Chapter 8: General-Purpose AI Models and Systemic Risk
- Defining General-Purpose AI Under the Act
- Core Obligations for GPAI Providers
- Systemic-Risk Models and Their Enhanced Duties
- Open-Source and Foundation Model Considerations
Chapter 9: Transparency Obligations for Non-High-Risk AI
- Human-AI Interaction Disclosure Rules
- Generative AI Content Labeling
- Emotion Recognition and Biometric Categorization Transparency
- Practical Implementation of Transparency Measures
Chapter 10: Obligations for Deployers and Other Actors
- Deployer Duties Before, During and After Use
- Importers, Distributors and Authorized Representatives
- Employee Use of AI: Special Considerations
- Supply Chain and Vendor Management
Chapter 11: Regulatory Sandboxes, Innovation Support and Standards
- National AI Regulatory Sandboxes
- The European AI Sandbox Network
- Harmonized Standards and Presumption of Conformity
- Codes of Practice and Soft Law Instruments
Chapter 12: Enforcement, Penalties and Remedies
- National Supervisory Authorities and Their Powers
- Administrative Fines and Penalty Tiers
- Market Surveillance and Corrective Measures
- Private Enforcement and Individual Rights
Chapter 13: Interaction with Other EU Laws
- The AI Act and the General Data Protection Regulation
- Overlap with the Digital Services Act
- The Data Act and Data Access Obligations
- Cybersecurity, Product Safety and Sector-Specific Laws
Chapter 14: Building Your EU AI Act Compliance Program
- Phase One: Discovery and Inventory
- Phase Two: Classification and Gap Assessment
- Phase Three: Remediation and Documentation
- Phase Four: Operationalization and Monitoring
Chapter 15: Governance Structures and Organizational Design
- Designing an AI Governance Framework
- Accountability Models and Responsibility Matrices
- Integrating with ERM, Privacy and Security Programs
- Audit Readiness and Continuous Improvement
Chapter 16: Case Studies and Complex Scenarios
- A Financial Institution Deploying Credit-Score AI
- A Manufacturer Integrating AI into Medical Devices
- A SaaS Provider Offering Generative AI Tools
- A Multinational Corporation with Complex AI Supply Chains
Conclusion: The Future of AI Governance and What Comes Next
- Where We Stand Today
- Pending Delegated Acts and Evolving Interpretation
- Beyond Europe: Global Regulatory Trajectories
- What Organizations Should Prioritize
