According to the European MDR regulation article 69, there is strict liability for injuries caused by medical devices, but in most jurisdictions, the medical malpractice rules will apply a priori, when a defect device harms patients.[2] Following the European MDR/IVDR legislation, a producer, importer, or supplier of AI technologies is liable for any damage or harm caused by a defect that is that product and must pay compensation for harmed patients. According to the medical malpractice rules, patients are only allowed to receive compensation for medical malpractice if the harm is caused by an error in the algorithm that could not be foreseen by the treatment-responsible physician, and if the injury were more serious than the patient was expected to tolerate, compared to the severity of the actual patient’s disease.[5]
Paper
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Artificial Intelligence Decision Support Systems and Liability for Medical Injuries
Semantic Scholar · Medicine · 2020
Abstract
According to the European MDR regulation article 69, there is strict liability for injuries caused by medical devices, but in most jurisdictions, the medical malpractice rules will apply a priori, when a defect device harms patients.[2] Following the European MDR/IVDR legislation, a producer, importer, or supplier of AI technologies is liable for any damage or harm caused by a defect that is that product and must pay compensation for harmed patients. According to the medical malpractice rules, patients are only allowed to receive compensation for medical malpractice if the harm is caused by an error in the algorithm that could not be foreseen by the treatment-responsible physician, and if the injury were more serious than the patient was expected to tolerate, compared to the severity of the actual patient’s disease.[5]