Document paper AI Product Liability Directive

Liability challenges in AI medical technologies

AI in healthcare can bring enormous benefits to patients, healthcare professionals as well as
improving patient safety, effectiveness of treatment and increasing of healthcare systems.
Given the specificities of AI, new legal questions may present themselves when assessing liability
for harm caused by AI technology. The legal framework regulating liability of AI (medtech) products
must allow claims by injured parties without hindering access to innovation for patients and
healthcare systems.

The specific roles and responsibilities in the healthcare ecosystem must be considered (e.g.
healthcare professionals, healthcare organisations and producer).

In Europe, despite the complexity of this ecosystem, risks of personal injury are comprehensively
covered by a range of liability regimes, whether through national contract and tort law or the
Product Liability Directive (PLD).

Find more about liability challenges in AI medical technologies on the document below.

Posted on 13.10.2022

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