BAIC and BHC Launch TRUST-OSAI, a Pioneering Platform for AI Validation and Certification in Healthcare

Euskadi Positions Itself as a European Benchmark in Safe, Ethical, and Regulated Artificial Intelligence for Health

Bilbao, 23rd December 2025

The Basque Artificial Intelligence Center (BAIC) and Basque Health Cluster (BHC) have launched TRUST-OSAI, a strategic project aimed at the early validation of Artificial Intelligence solutions in healthcare, ensuring safety, data protection, and regulatory compliance from the initial design stages.

The project, part of the ELKARTEK 2025 program by the Basque Government, addresses one of the main challenges of the biosanitary sector: accelerating the market introduction of AI-based medical products without compromising European regulatory requirements, such as the Medical Devices Regulation (MDR), the European Artificial Intelligence Act (AI Act), and the General Data Protection Regulation (GDPR).

TRUST-OSAI is designed to reduce regulatory barriers that currently slow down innovation, especially for SMEs and startups, by creating a knowledge platform and an early validation environment that allows companies, technology centers, and research agents to test their developments in controlled conditions aligned with current regulations.

Key project outcomes include the development of regulatory toolkits, methodological guides, self-assessment frameworks, and the design of a regulatory sandbox pilot, as well as a digital AI-based platform that will serve as a reference point for the Basque health and AI ecosystem. These tools will support projects from early research phases (TRL 3–5) to advanced stages of implementation and market deployment (TRL 8–9).

With TRUST-OSAI, Euskadi strengthens its position as a leading region in responsible AI innovation applied to healthcare, anticipating future European regulatory frameworks and generating a competitive advantage for its industrial ecosystem. The project also opens the door to scaling the model to other strategic sectors, such as industry, energy, or mobility, which face similar regulatory challenges in the use of Artificial Intelligence.