Ethical Considerations in the Development and Deployment of AI-powered Medical Device Software: Balancing Innovation with Patient Welfare

Abstract

The integration of artificial intelligence (AI) into medical device software holds immense promise for revolutionizing healthcare delivery, with the potential to improve diagnosis, treatment, and patient outcomes. However, alongside the benefits, the development and deployment of AI-powered medical device software raise significant ethical considerations. This abstract provides an overview of the ethical challenges inherent in the intersection of AI and healthcare, focusing on the need to balance innovation with patient welfare. It explores issues such as data privacy, transparency, accountability, bias, and equity, highlighting the importance of ethical frameworks and regulatory oversight in guiding AI development and deployment. Drawing on case studies and real-world examples, this abstract examines the ethical dilemmas faced by developers, healthcare providers, regulators, and patients in navigating the complexities of AI-powered medical device software. It underscores the importance of interdisciplinary collaboration, stakeholder engagement, and ongoing ethical reflection to ensure that AI-driven innovations prioritize patient safety, dignity, and autonomy. Ultimately, this abstract aims to stimulate dialogue and critical thinking around the ethical challenges associated with AI in healthcare, fostering responsible innovation and equitable access to advanced medical technologies.