npj Digital Medicine (Apr 2023)
The proposed EU Directives for AI liability leave worrying gaps likely to impact medical AI
Abstract
Abstract Two newly proposed Directives impact liability for artificial intelligence in the EU: a Product Liability Directive (PLD) and an AI Liability Directive (AILD). While these proposed Directives provide some uniform liability rules for AI-caused harm, they fail to fully accomplish the EU’s goal of providing clarity and uniformity for liability for injuries caused by AI-driven goods and services. Instead, the Directives leave potential liability gaps for injuries caused by some black-box medical AI systems, which use opaque and complex reasoning to provide medical decisions and/or recommendations. Patients may not be able to successfully sue manufacturers or healthcare providers for some injuries caused by these black-box medical AI systems under either EU Member States’ strict or fault-based liability laws. Since the proposed Directives fail to address these potential liability gaps, manufacturers and healthcare providers may have difficulty predicting liability risks associated with creating and/or using some potentially beneficial black-box medical AI systems.