The New European Union Legal Framework on Defective Digital Medical Devices: Alleviating the Patient’s Burden of Proof

Povzetek

Digitalisation has changed the medical sector, introducing sophisticated digital medical devices (such as software as a medical device and devices assisted by Artificial Intelligence systems). Innovations in medicine present potential for improving diagnosis and treatment. Simultaneously, they raise certain questions about civil liability and the legal position of the patient who has suffered harm caused by a defective digital product. This paper examines whether the modernized EU liability rules for defective digital medical devices can alleviate the evidentiary burden patients face in civil litigation, thus strengthening their position. The author focuses on the adequacy of the new rules on disclosure of evidence and burden of proof. The key findings show that the new rules strengthen patients' position by alleviating the burden of proof and imposing an obligation to disclose relevant evidence. The author proposes drafting guidelines to resolve existing ambiguities, ensuring the new evidentiary framework is applied consistently and effectively.