From Bench to Bedside: Governing Health Care Artificial Intelligence (AI) through a “True Lifecycle Approach”

This paper addresses the comprehensive regulation of artificial intelligence ("AI") across its entire lifecycle in the health care sector. It builds on a proposal for a True Lifecycle Approach ("TLA") to address governance gaps across three phases of AI and expands the framework with detailed practical insights for governing health care AI, drawing on pioneering examples from Qatar, Saudi Arabia, and the United Arab Emirates ("UAE") as models for global implementation. Beginning with the research and development phase, it highlights the urgent need for robust guidelines and certification processes to ensure that AI technologies are developed in compliance with ethical and safety standards. Moving into the approval stage, the discussion explores how AI systems can be effectively regulated under existing medical device frameworks, emphasizing the need for tailored regulations that consider the unique challenges posed by AI. Finally, the paper delves into the deployment of AI in clinical practice, examining the gaps in current laws and the need for a coherent and consistent regulatory framework that can adapt to AI advancements. The paper argues that the existing legal structures are inadequate, often inconsistent, and fail to address the complexities of AI in health care. It argues for a broader regulatory approach focused on patient safety throughout the AI lifecycle.