The development and deployment of medical devices, along with most areas of healthcare, has been significantly impacted by the COVID-19 pandemic. This has had variable ethical implications, two of which we will focus on here. First, medical device regulations have been rapidly amended to expedite approvals of devices ranging from face masks to ventilators. Although some regulators have issued cessation dates, there is inadequate discussion of triggers for exiting these crisis standards, and evidence that this may not be feasible. Given (...) the relatively low evidence standards currently required for regulatory approval of devices, this further indefinite reduction in standards raises serious ethical issues. Second, the pandemic has disrupted the usual operations of device representatives in hospitals, providing an opportunity to examine and refine this potentially ethically problematic practice. In this paper we explain and critically analyse the ethical implications of these two pandemic-related impacts on medical devices and propose suggestions for their management. These include an endpoint for pandemic-related adjustments to device regulation or a mechanism for continued refinement over time, together with a review of device research conducted under crisis conditions, support for the removal and replacement of emergency approved devices, and a review of device representative credentialling. (shrink)

Ethical issues in physician-industry and academia-industry relationships have focused largely on the financial nature of these relationships. It took very little time after solutions to transparenc...

The increasing integration of artificial intelligence (AI) in healthcare presents a host of ethical, legal, social, and political challenges involving various stakeholders. These challenges prompt various studies proposing frameworks and guidelines to tackle these issues, emphasizing distinct phases of AI development, deployment, and oversight. As a result, the notion of responsible AI has become widespread, incorporating ethical principles such as transparency, fairness, responsibility, and privacy. This paper explores the existing literature on AI use in healthcare to examine how it addresses, (...) defines, and discusses the concept of responsibility. We conducted a scoping review of literature related to AI responsibility in healthcare, searching databases and reference lists between January 2017 and January 2022 for terms related to “responsibility” and “AI in healthcare”, and their derivatives. Following screening, 136 articles were included. Data were grouped into four thematic categories: (1) the variety of terminology used to describe and address responsibility; (2) principles and concepts associated with responsibility; (3) stakeholders’ responsibilities in AI clinical development, use, and deployment; and (4) recommendations for addressing responsibility concerns. The results show the lack of a clear definition of AI responsibility in healthcare and highlight the importance of ensuring responsible development and implementation of AI in healthcare. Further research is necessary to clarify this notion to contribute to developing frameworks regarding the type of responsibility (ethical/moral/professional, legal, and causal) of various stakeholders involved in the AI lifecycle. (shrink)