The EU Product Liability Directive has long been studied to make it fit for new technologies. However, with the advent of AI, IoT, and robotics, the European Council finally decided that a complete rework of the legislation was needed. Hence, in October 2024, they adopted a proposal for updating the Directive, and, in November 2024, that proposal was enacted into law. The main difference between the old and the new Directive is that the new rules consider software to be a product, irrespective of whether it is interconnected to some hardware. This includes AI. Hence, the research question to be discussed in this chapter is: What now? How will a general directive that still applies to traditional consumer products be adapted to more refined devices and systems, such as the Internet of Medical Things? This chapter takes the new generation of active prostheses, such as the lower-limb prosthetics described in Chapter 11, as an example. As interconnected devices that can use AI systems for security, these prostheses lie at the intersection of liability law, (regulatory) health law, and different technologies working at the same time (e.g., IoT and AI). As such, this assessment will evaluate how the new Product Liability Directive will affect the manufacturers of these devices.

错误:搜索内容不能为空,请输入英文关键词
错误:关键词超出字数限制,请精简
高级检索

(Product) Liability in the Medical Internet of Things. What Now?

  • Francesca Gennari

摘要

The EU Product Liability Directive has long been studied to make it fit for new technologies. However, with the advent of AI, IoT, and robotics, the European Council finally decided that a complete rework of the legislation was needed. Hence, in October 2024, they adopted a proposal for updating the Directive, and, in November 2024, that proposal was enacted into law. The main difference between the old and the new Directive is that the new rules consider software to be a product, irrespective of whether it is interconnected to some hardware. This includes AI. Hence, the research question to be discussed in this chapter is: What now? How will a general directive that still applies to traditional consumer products be adapted to more refined devices and systems, such as the Internet of Medical Things? This chapter takes the new generation of active prostheses, such as the lower-limb prosthetics described in Chapter 11, as an example. As interconnected devices that can use AI systems for security, these prostheses lie at the intersection of liability law, (regulatory) health law, and different technologies working at the same time (e.g., IoT and AI). As such, this assessment will evaluate how the new Product Liability Directive will affect the manufacturers of these devices.