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In the last few decades, Brain-Computer Interface (BCI) research has focused predominantly on clinical applications, notably to enable severely disabled people to interact with the environment. However, recent studies rely mostly on the use of non-invasive electroencephalographic (EEG) devices, suggesting that BCI might be ready to be used outside laboratories. In particular, Industry 4.0 is a rapidly evolving sector that aims to restructure traditional methods by deploying digital tools and cyber-physical systems. BCI-based solutions are attracting increasing attention in this field to support industrial performance by optimizing the cognitive load of industrial operators, facilitating human-robot interactions, and make operations in critical conditions more secure. Although these advancements seem promising, numerous aspects must be considered before developing any operational solutions. Indeed, the development of novel applications outside optimal laboratory conditions raises many challenges. In the current study, we carried out a detailed literature review to investigate the main challenges and present criteria relevant to the future deployment of BCI applications for Industry 4.0.

Abstract Until recently the application of artificial intelligence (AI) in precision oncology was confined to activities in drug development and had limited impact on the personalisation of therapy. Now, a number of approaches have been proposed for the personalisation of drug and cell therapies with AI applied to therapy design, planning and delivery at the patient’s bedside. Some drug and cell-based therapies are already tuneable to the individual to optimise efficacy, to reduce toxicity, to adapt the dosing regime, to design combination therapy approaches and, preclinically, even to personalise the receptor design of cell therapies. Developments in AI-based healthcare are accelerating through the adoption of foundation models, and generalist medical AI models have been proposed. The application of these approaches in therapy design is already being explored and realistic short-term advances include the application to the personalised design and delivery of drugs and cell therapies. With this pace of development, the limiting step to adoption will likely be the capacity and appropriateness of regulatory frameworks. This article explores emerging concepts and new ideas for the regulation of AI-enabled personalised cancer therapies in the context of existing and in development governance frameworks.