유럽 MDR, IVDR

[Emergo, UL] The European AI Act is Here

MD우야 2024. 5. 30. 12:30
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This is the second in our series of regulatory updates on the EU AI Act.

 

We discussed AIA in our first regulatory update, the EU Artificial Intelligence Act. The EU AIA introduces a comprehensive framework for AI-enabled device regulation in the EU. In this regulatory update we discuss key elements of the regulation and best practices, enforcement and oversight, AI regulatory sandboxes and real-world testing.

AI regulatory best practices

While the AIA is the world’s first comprehensive regulation for AI systems, it is based on established AI best practices. The EU has previously had soft law approaches via guidelines for developing these products. One such guideline is the Ethics Guidelines for Trustworthy Artificial Intelligence. Presented by the High-Level Expert Group on AI on April 8, 2019, this best practice outlined seven requirements for assuring trustworthy AI across the AI system’s entire life cycle.

Established best practices for AI:

  • Human agency and oversight
  • Technical robustness and safety
  • Privacy and data governance
  • Transparency
  • Diversity, non-discrimination and fairness
  • Environmental and societal well-being
  • Accountability

 

The EU AI Act is Here | Emergo by UL

 

The European AI Act is Here

Medical device makers will want to read the second story in our series covering the implications of the EU Artificial Intelligence Act.

www.emergobyul.com


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