The EU AI Act, a groundbreaking regulation by the European Commission, is set to transform artificial intelligence’s role and regulation globally, with significant implications for projects like SYNTHEMA. This comprehensive legal framework categorizes AI systems based on their risk levels, ranging from unacceptable to limited risk, to ensure their safe and ethical use.

Unacceptable risk AI systems, which pose a threat to public safety and rights, will be banned. This includes technologies that manipulate behavior or use real-time biometric identification, with strict exceptions under certain conditions.

High-risk AI systems, impacting safety or fundamental rights, fall into two categories. The first includes AI in products covered by EU safety legislation, such as medical devices, aligning closely with SYNTHEMA’s focus on healthcare. The second covers AI in critical areas like law enforcement and legal interpretation, requiring thorough assessments and registration in an EU database.

Generative AI, akin to what is used in SYNTHEMA for synthetic data generation, faces specific transparency requirements under the Act. These include mandatory disclosure of AI-generated content, designing AI to prevent illegal content, and publishing data training summaries. These requirements resonate with SYNTHEMA’s mission to create reliable, high-quality synthetic data for rare hematological diseases, emphasizing the need for transparent and responsible AI development.

Limited risk AI systems must meet basic transparency requirements, allowing users to make informed decisions about their use. This aspect is crucial for SYNTHEMA, aiming to establish a cross-border hub for AI techniques in anonymization and synthetic data generation, ensuring data used in developing virtual patients for diagnostics and treatment assessment in rare diseases is both ethical and compliant with the new regulations.

In summary, the EU AI Act fosters an environment where projects like SYNTHEMA can thrive under ethical guidelines, ensuring that AI advancements in healthcare, particularly in rare hematological diseases, are safe, transparent, and beneficial for all stakeholders.

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