Complete guide to EU AI Act compliance in Spain. AESIA (first dedicated EU AI agency), enforcement timeline, and impact on tourism, banking, and healthcare.
Agencia Española de Supervisión de Inteligencia Artificial (AESIA)
Spain created AESIA — the Spanish Agency for the Supervision of Artificial Intelligence — making it the first EU member state to establish a dedicated national AI supervisory agency. Based in A Coruña, AESIA was operational before the EU AI Act even entered into force, demonstrating Spain’s commitment to being at the forefront of AI governance in Europe.
Spain’s proactive stance with AESIA signals strong enforcement ambitions. As the first EU country with a dedicated AI agency, Spain is setting the standard for national AI oversight. AESIA is building regulatory sandboxes for AI innovation and developing sector-specific guidance. Companies operating in Spain should expect well-organized and thorough enforcement.
EU AI Act (Regulation EU 2024/1689) officially entered into force.
Banned AI practices and Article 4 AI literacy obligation now enforceable.
General-purpose AI model obligations and national authority designations.
High-risk AI system rules, conformity assessments, and transparency requirements fully apply.
Existing Annex I high-risk AI systems must fully comply.
Top 3 industries affected
Spain is the world’s second most-visited country. AI is transforming the tourism sector through smart hotel management, automated customer service, dynamic pricing, and personalized travel recommendations. AI systems profiling tourists or making automated booking decisions face transparency requirements.
Major Spanish banks (Santander, BBVA, CaixaBank) are European leaders in AI adoption for credit scoring, customer analytics, and fraud prevention. These AI applications fall squarely under high-risk classification. AESIA works with the Bank of Spain on financial AI oversight.
Spain’s national health system (SNS) is integrating AI for diagnostics, hospital management, and patient prioritization. AI-powered medical devices and diagnostic tools face high-risk classification under both the EU AI Act and medical device regulations. Regional health authorities are preparing compliance frameworks.
For a typical Spain SMB with EUR 2M revenue:
For SMEs, fines are capped at the lower of the fixed amount or turnover percentage.
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