Judicial Liability Deferral and Administrative Risk Management in the Regulatory Framework for AI Medical Devices -Focusing on the Limitations of Product Liability and the Asymmetry of Liability Attribution-

Key Points

• The study aims to analyze the regulatory framework and judicial liability structure concerning AI medical devices from a policy engineering perspective.
• Analysis of current laws such as the Product Liability Act and their applicability to AI medical devices.
• Examination of the asymmetric liability attribution and its implications for manufacturers and users.
• Evaluation of existing administrative regulations and proposal for improvements in liability distribution through insurance.
• Identified limitations in the Product Liability Act regarding AI medical devices, particularly in liability attribution.
• Found that current regulations favor large corporations due to high compliance costs, creating an imbalanced market.
• Proposed risk-based liability insurance and legal reforms for software defect attribution to enhance judicial equity.