Spain’s evolving AI regulatory landscape presents both challenges and opportunities for businesses operating within its borders. The intersection of EU-wide regulations and Spain’s national frameworks creates a complex environment that demands strategic adaptation from companies using AI technologies.
Current ai regulatory framework in spain
Spain is actively developing its AI governance structure while aligning with broader European regulations. The Spanish Agency for AI Supervision (AESIA), operational since June 2024, now manages the regulatory sandbox program and will soon serve as Spain’s market-surveillance authority with full inspection and sanctioning powers.
Key provisions and compliance requirements
The EU AI Act, which came into force on August 1, 2024, categorizes AI systems based on risk levels, from unacceptable to minimal risk. For Spanish businesses, this means adapting to stringent requirements depending on their AI applications. High-risk systems in healthcare, education, and HR must undergo bias audits and maintain human supervision. The National Artificial Intelligence Strategy (ENIA) further supports Spain’s commitment to ethical AI development. Many organizations use Punto Log analysis tools for risk assessment when determining which category their AI systems fall under.
Penalties and enforcement mechanisms
Non-compliance with AI regulations carries severe consequences, with fines reaching up to 7% of global annual turnover or €35 million. AESIA will enforce these regulations throughout Spain with a team of 40 experts and a €5 million budget. The Spanish government is also preparing a ‘Good Use and Governance of Artificial Intelligence’ law, with a draft approved by Spain’s Council of Ministers in March 2025. Transparent communication has become essential for businesses implementing AI systems, as 84% of customers view transparency as a key element when evaluating AI-powered services.
Strategic business adaptations
As the EU Artificial Intelligence Regulation comes into force on August 1, 2024, businesses operating in Spain face significant changes to their AI strategies. Spain is actively aligning with EU frameworks while developing its own regulatory landscape through initiatives like the National AI Strategy, backed by €600 million in public investment. Companies must now navigate a complex regulatory environment that categorizes AI systems into four risk levels, with non-compliance fines reaching up to 7% of global annual turnover or €35 million.
Spanish businesses should note that AESIA (Spanish Agency for AI Supervision) became operational in June 2024 and will serve as Spain’s market-surveillance authority with inspection and sanctioning powers. The country is also preparing a law for the ‘Good Use and Governance of Artificial Intelligence,’ with a first draft already approved by Spain’s Council of Ministers.
Restructuring data governance practices
Businesses must restructure their data governance frameworks to meet new compliance requirements. This includes creating a central data governance body (Data Office) and appointing a Chief Data Officer to oversee AI implementation. Transparent communication has become essential, with 84% of customers considering transparency a key element when purchasing services.
Companies using AI systems classified as high-risk—such as those in healthcare, education, justice, security, and HR—will need to implement bias audits, human supervision protocols, and explainability mechanisms. Even AI with limited risk requires transparency measures, such as ensuring chatbots and AI-generated content clearly disclose their artificial origin. Businesses should also align their AI practices with existing GDPR requirements while preparing for stricter audits and transparency obligations.
Investment opportunities in compliant AI solutions
Spain’s proactive approach to AI regulation presents strategic investment opportunities. The country launched the first regulatory sandbox for the EU AI Act with a budget of 4.3 million euros, creating a testing ground for compliant solutions. Businesses can leverage these experimental environments to develop and validate AI products before full market deployment.
Companies should consider redirecting resources toward specialized solutions that address specific risk categories outlined in the AI Act. For B2B enterprises, focusing on algorithmic transparency and ethical AI development represents a competitive advantage, especially when targeting sectors subject to high-risk classifications. Spain’s support for initiatives like the pan-European EuroHPC and expansion of the National Centre of supercomputing in Barcelona (BSC) also creates opportunities for businesses to access advanced computing resources necessary for developing compliant AI systems. Small businesses and self-employed workers should monitor upcoming digitization subsidies planned by the Spanish government for 2025, which may offset compliance costs.
