EU AI Act Overview
The European Union Artificial Intelligence Act (EU AI Act) is the world’s first comprehensive regulatory framework for artificial intelligence. It establishes legally binding requirements for the design, development, and deployment of AI systems across the European Union, focusing on safety, transparency, accountability, and human oversight.
Adopted by the European Parliament in 2024, the EU AI Act introduces a risk-based approach to AI regulation, categorizing systems according to their potential impact on individuals, society, and fundamental rights. It represents a significant step toward harmonizing AI governance across EU member states, complementing existing laws such as the General Data Protection Regulation (GDPR) and Digital Services Act (DSA).
Purpose of the EU AI Act
The purpose of the EU AI Act is to ensure that AI systems placed on the EU market are safe, ethical, and trustworthy, while promoting innovation and competitiveness. The Act aims to prevent harm caused by opaque or biased AI models and to establish clear obligations for all actors in the AI value chain.
Key goals include:
Protecting fundamental rights: Preventing AI systems from infringing on privacy, equality, or human dignity.
Ensuring transparency and accountability: Requiring explainable and auditable AI operations.
Promoting trust in AI adoption: Establishing uniform standards for responsible use.
Encouraging innovation: Providing legal certainty for developers and businesses operating in the EU market.
Scope and Applicability
The EU AI Act applies to all AI system providers, deployers, importers, and distributors operating within the EU, regardless of where they are established.
It categorizes AI systems into four main risk tiers:
Unacceptable Risk: AI systems that pose a clear threat to human safety, rights, or democracy (e.g., social scoring or manipulative systems) are banned.
High Risk: Systems used in areas such as employment, education, credit scoring, law enforcement, or critical infrastructure must meet strict requirements before deployment.
Limited Risk: Systems with lower risk must maintain transparency obligations, such as notifying users they are interacting with AI.
Minimal or No Risk: General-purpose or entertainment AI tools face minimal compliance obligations.
Critical third-party service providers, such as model developers or data processors supporting AI systems, are also covered by the regulation.
What the Regulation Covers
The EU AI Act defines detailed requirements for the lifecycle of AI systems, particularly for high-risk applications, including:
Risk Management Framework: Ongoing identification, evaluation, and mitigation of AI-specific risks.
Data and Data Governance: Use of high-quality, unbiased, and traceable datasets.
Technical Documentation and Record-Keeping: Documentation sufficient for compliance verification by authorities.
Transparency and Information Obligations: Users must be informed when interacting with AI or when content is generated by AI.
Human Oversight: Systems must include mechanisms for human intervention and override.
Accuracy, Robustness, and Cybersecurity: High-risk systems must achieve measurable reliability and protection against attacks or manipulation.
Post-Market Monitoring: Continuous monitoring of AI performance and incident reporting to authorities.
Certification and Conformity Assessment
Compliance with the EU AI Act is verified through conformity assessments, particularly for high-risk AI systems, before market entry.
Organizations may be required to:
Conduct internal conformity evaluations based on harmonized standards.
Undergo third-party assessments by notified bodies when required.
Maintain a Declaration of Conformity and CE marking to demonstrate compliance.
Authorities across EU member states will conduct market surveillance and enforce penalties for non-compliance, which may include substantial administrative fines.
Implementation and Continuous Compliance
The EU AI Act envisions a phased implementation, with obligations becoming enforceable over several years. Organizations must:
Establish internal AI governance and compliance programs.
Maintain up-to-date documentation, risk registers, and testing results.
Perform periodic reviews and updates of high-risk AI systems.
Align AI development practices with complementary frameworks such as ISO 42001 and NIST AI RMF for structured management and oversight.
EU AI Act in DSALTA
DSALTA provides an operational foundation for managing EU AI Act compliance through mapped controls, policy alignment, and evidence tracking.
Using DSALTA, organizations can:
Document AI systems and classify them by risk level.
Track conformity assessments, approvals, and declarations.
Map transparency, data governance, and human oversight requirements.
Maintain evidence of monitoring, risk testing, and incident response activities.
While DSALTA supports the operational side of compliance, organizations should work closely with legal and data protection officers to interpret regulatory requirements and maintain coordination with EU supervisory authorities.