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Leading AI Strategy: The EU AI Act and the Rise of High-Risk AI Systems Across the Life Science Value Chain
AI is rapidly transforming life sciences and healthcare, powering applications in drug development, diagnostics and clinical decision support. With many technologies now likely to fall within the EU AI Act’s high-risk category, companies must implement robust governance and oversight mechanisms while navigating complex interactions with medical device frameworks and emerging product liability rules.
This session will examine how the EU AI Act’s high risk framework is shaping AI deployment across the industry, and explore the implications of the landmark legislation for your legal governance structures, technology validation and liability risk.
-Which life science technologies are most likely to fall within the EU AI Act’s high-risk classification?
- What governance, transparency and human oversight obligations will companies need to implement when deploying high-risk AI systems?
- How will the AI Act interact with existing MDR and IVDR frameworks, particularly for AI-enabled diagnostics and medical device software?
- Could overlapping requirements between the AI Act, MDR/IVDR and product liability frameworks create new litigation risks and challenges for technology validation?
- What practical steps should legal teams take to ensure their high-risk AI governance frameworks are fit for purpose?
