Ethical and Regulatory Evaluation of Autonomous AI Systems in Surgical Practices

Abstract

Autonomous artificial intelligence (AI) systems are transforming surgical practice, enabling enhanced precision, efficiency, and personalization. Yet, their integration introduces critical ethical and regulatory challenges. This chapter explores current applications of AI in surgical settings—preoperative planning, intraoperative decision-making, and postoperative monitoring—highlighting clinical benefits alongside risks such as algorithmic bias and lack of explainability. Key ethical issues are examined, including informed consent, moral responsibility, and data privacy. The chapter also evaluates global regulatory responses, such as the FDA's Total Product Lifecycle model and the EU's Artificial Intelligence Act. Case studies, including the da Vinci Surgical System and the Smart Tissue Autonomous Robot, illustrate real-world implications. The chapter concludes with forward-looking recommendations emphasizing adaptive regulation, interdisciplinary collaboration, and human-centered design to responsibly guide AI's role in surgical care.

Ähnliche Arbeiten