AI Deployment in Medical Devices-Ethical and Regulaltory Reflections, Beyond Data Protection and Bias – EU perspective

Legal regulations do not eliminate existing ethical problems related to the use of modern technology in medical devices for disease diagnosis and treatment. Among these problems, some are already well analyzed in the literature - they concern the protection of personal data and the occurrence of bias and discrimination. In addition to these, however, there are several other, no less important issues involving the application of artificial intelligence technologies to medical devices. They concern how the technologies used in these devices for the purpose of diagnosis and therapy may replace human intervention and what evaluation criteria they should therefore be subject to, as well as what risks they entail.