Ethics and regulation of generative AI in medical device development

Abstract Medical devices are required to meet a variety of stringent regulations in markets around the world. The EU recently introduced AI legislation, and the UK government has issued AI regulatory guidance that is cascading to medical regulators. The introduction of generative AI tools into medical device development requires a detailed understanding of how these new and existing regulations may interact, as well as the underpinning ethical risks, and yet information in this area is scarce. A hypothetical medical device related use-case was created to highlight risks. A product development process was explored to elucidate the impacts of generative AI inputs and outputs. Generative AI risks are varied and prevalent across most areas of medical device businesses, particularly where traceability and reproducibility of information is key. These risks were consolidated into a UK focussed ethical framework that considered business, employee, customer, and regulator needs. The distinct approaches of different regions to generative AI regulation create challenges for businesses and regulators, which may create confusion or delays for those seeking to integrate the technology into fields with strict extant legal requirements. Simultaneously, the pace of generative AI adoption is relentless. An ethical framework that considers the key tenets of both nascent AI and established medical device guidance and regulations is necessary to protect medical device businesses and avoid significant duplication of regulatory effort. Such a framework also aids in anticipating potential future regulatory developments.