Following negotiations between the EU institutions, an updated text for the Product Liability Directive has now been agreed, giving Member States until late 2026 to arrange for transposition into national law. The Directive expands the current definition of a product to include software. Therefore, claims for damage allegedly caused by AI-enabled digital health products and services will fall within the scope of the Product Liability Directive, leading to an increase in product liability claims in the medical sector. Digital health products and services delivered using AI-enabled technologies, such as wearable devices, telemedicine platforms, scan interpretation software and health apps will be very significantly affected, from a potential liability perspective. Most significantly, this will have a substantial impact on insurers and insured hospitals and healthcare settings/clinics which are using and/or investing in AI devices, platforms and software.