352 KB47 KB2026Proso, Majaletnik:19številka:2str. 309–325DOI:10.18690/mls.19.2.309-326.2026ISSN:2463-7955COBISSID_HOST:294767875URN:URN:NBN:SI:doc-73V9BMUBenUniversity of Maribor PressMedicine, law & societyburden of proofdefective digital medical deviceDirective (EU) 2024/2853 on liability for defective productsdisclosure of evidencepatientThe new European Union legal framework on defective digital medical devices| alleviating the patient’s burden of proof|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 effectivelyDigitalizacija je spremenila zdravstveni sektor z uvedbo naprednih digitalnih medicinskih pripomočkov (kot so npr. programska oprema, medicinski pripomočki in pripomočki, ki jih podpirajo sistemi umetne inteligence). Inovacije v medicini ponujajo potencial za izboljšanje diagnoze in zdravljenja. Hkrati pa sprožajo določena vprašanja o civilni odgovornosti in pravnem položaju pacienta, ki je utrpel škodo zaradi okvarjenega digitalnega izdelka. Članek preučuje, ali lahko posodobljena pravila EU o odgovornosti za okvarjene digitalne medicinske pripomočke olajšajo dokazno breme, s katerim se pacienti soočajo v civilnih sporih, in s tem okrepijo njihov položaj. Avtor se osredotoča na ustreznost novih pravil o razkritju dokazov in dokaznem bremenu. Ključne ugotovitve kažejo, da nova pravila krepijo položaj pacientov z zmanjšanjem dokaznega bremena in uvedbo obveznosti razkritja relevantnih dokazov. Avtor predlaga pripravo smernic za rešitev obstoječih nejasnosti, s čimer bi se zagotovila dosledna in učinkovita uporaba novega dokaznega okviraTEXTznanstveno časopisjejournalsSlovenian National E-content AggregatorNational and University Library of SloveniaUniverza v Mariboru, Pravna fakulteta