Genomcore passes the first EU AI Sandbox through its spin-off, Made of Genes
Genomcore BIMS is the only B2B genomic platform to validate its AI under the new European regulatory framework of the AI Act, the world's first comprehensive AI legislation.
This testing environment has enabled the adaptation of the AI Act, the world's first comprehensive AI legislation, to the business world.
Genomcore BIMS is the only B2B genomic platform to validate its AI under the new European regulatory framework of the AI Act.
A few days ago, Laura Isus, CSO and co-founder of Made of Genes, and María Díez, QARA Lead at Genomcore, received the accreditation diploma from María González Veracruz, Secretary of State for Digitalization and Artificial Intelligence, for having successfully completed the first Artificial Intelligence (AI) Sandbox of the European Union (EU), through its spin-off, Made of Genes. The ceremony was held with the validation and presence of the AI Office of the European Commission.
Spain successfully closed the first EU AI Sandbox, a controlled testing environment designed to support companies in the process of adapting to the European Artificial Intelligence Regulation (AI Act), the world's first comprehensive AI legislation.
During the diploma ceremony, Laura Isus and María Díez had the opportunity to present what our system consists of and the technology behind it: Genomcore, with over 10 years leading the management of complex biomedical data.
From training to implementation plan
The programme was structured in several phases. The AI Act adaptation programme was organised into three phases (training, self-assessment and planning, and implementation and verification), with the support of mentors and multidisciplinary experts (legal, technical, data, and security). This participation enabled the integration of regulatory requirements into a Genomcore product that is currently in clinical validation and commercialisation phase.
Profiles involved
Participation in the sandbox has facilitated the effective integration of the AI Act requirements into our internal processes, technical documentation, and quality management system. It has also involved the collaboration of various profiles from the Genomcore and Made of Genes teams:
- Regulatory and quality team: Analysed the regulation, led the self-assessment, and integrated the AI Act requirements into the quality management system.
- Cybersecurity team: Ensured that the system's technical controls met the robustness and integrity standards for high-risk AI.
- Scientific and clinical team: Documented the technical operation, logic, and decision criteria of the MoGIA-MetCare system as required by the regulation.
- Data analyst: Worked on data traceability, quality, and governance to ensure transparency and human oversight.
