Source: White & Case LLP

White & Case LLP provides an insight alert on the new European Union (EU) responsibility and liability landscape for smart medical devices, placing it within a global context. The article details how the EU is adapting its legal framework to address the complexities introduced by Artificial Intelligence (AI) and interconnected technologies in healthcare. This evolving regulatory environment aims to ensure patient safety and assign clear lines of accountability for devices that incorporate AI, machine learning, and other advanced digital functionalities.

The alert explains that traditional product liability laws are often insufficient to cover the dynamic and adaptive nature of AI-powered medical devices, where issues such as algorithmic errors, data security breaches, and software updates can significantly alter device performance post-market. The new regulations seek to clarify who is responsible when a smart medical device causes harm, encompassing manufacturers, software developers, and even data providers. The article highlights the significant implications for companies operating in the health tech sector, requiring them to reassess their design, development, and risk management strategies to comply with these stringent new EU standards and ensure responsible innovation in smart medical devices.