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Spain's Sandbox IA — the EU's First National AI Regulatory Sandbox Under the AI Act

Spain · Madrid · See the Spain profile

Under Royal Decree 817/2023, Spain became the first EU country to run a live AI Act regulatory sandbox: a 2025 cohort tested 12 high-risk systems — biometric age checks, medical diagnostics, hiring tools — feeding AESIA's 16 public compliance guides published in December 2025.

Details

Promoter
Agencia Española de Supervisión de la Inteligencia Artificial (AESIA)
Period
2023–2026
Keywords
AI regulation, compliance, public administration, EU AI Act

Description

Royal Decree 817/2023, published 9 November 2023, created Spain's national AI regulatory sandbox, run by the Spanish Agency for the Supervision of Artificial Intelligence (AESIA) under the State Secretariat for Digitalisation and Artificial Intelligence. It lets providers and deployers test high-risk AI systems under regulatory supervision ahead of the EU AI Act's enforcement deadlines, coordinating with the European AI Office.

The first public call opened in December 2024, and on 3 April 2025 AESIA provisionally selected 12 high-risk AI systems for the inaugural cohort, spanning biometric age verification, healthcare diagnostic tools, employment-screening systems and critical-infrastructure monitoring. By 2026 the programme had reached a third call cycle.

The sandbox's practical output arrived on 16 December 2025, when AESIA published 16 compliance guides in Spanish and English — covering risk management, data governance, transparency and human oversight — drawn directly from the sandbox's first cohort and described by legal observers as among the first structured interpretative criteria issued by any EU public authority under the AI Act. The honest caveat: as of mid-2026, no independent outcome evaluation of the 12 tested systems themselves — error rates, harm reduction, or comparable measures — has been published, and the guidance remains non-binding.

Read the full analysis: https://digital.gob.es/en/digitalizacion/areas-interes/sandbox-ia

Implementation

Implementation detail (cost, timeline, staffing, conditions for success) is not yet available for this practice.

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