BBMRI-ERIC Podcast

28 - ELSI Dialogues: Navigating the Future: Legal and IT Challenges, Risks, and Opportunities of AI in Biobanking

May 8, 2025
In this engaging discussion, Marco Montali, a leading expert in artificial intelligence, and Nikolaus Forgó, a notable IT and IP law professor, dive deep into the complex interplay of AI in biobanking. They explore how AI tools can revolutionize medical diagnostics and enhance biobank operations. The legal frameworks like the EU AI Act are dissected, revealing their implications and challenges. They highlight the importance of data quality, the ethical dimensions of integrating AI, and the necessity for collaboration to navigate the intricate landscape of regulations and technology.
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INSIGHT

AI and GDPR Framework Interaction

  • GDPR remains the fundamental regulation for data protection alongside the new AI Act and European Health Data Space Act.
  • The AI Act categorizes AI systems by risk levels, with specific obligations for high-risk systems, relevant to biobanks.
ADVICE

Start AI Compliance Early

  • Biobanks must ensure staff AI literacy immediately as the AI Act requires it now.
  • Assess AI system risk classification and prepare documentation, risk mitigation, and impact assessments especially for high-risk systems.
INSIGHT

Complexity of Horizontal Regulation

  • The AI Act's horizontal approach applies uniformly to all organizations, increasing legal complexity.
  • This creates challenges especially for smaller biobanks balancing regulatory demands and operational clarity.
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