Implications of An Evolving Regulatory Landscape on the Development of AI and ML in Medicine.

Abstract

The rapid advancement of artificial intelligence and machine learning (AI/ML) technologies in healthcare presents significant opportunities for enhancing patient care through innovative diagnostic tools, monitoring systems, and personalized treatment plans. However, these innovative advancements might result in regulatory challenges given recent Supreme Court decisions that impact the authority of regulatory agencies like the Food and Drug Administration (FDA). This paper explores the implications of regulatory uncertainty for the healthcare industry related to balancing innovation in biotechnology and biocomputing with ensuring regulatory uniformity and patient safety. We examine key Supreme Court cases, including Loper Bright Enterprises v. Raimondo, Relentless, Inc. v. Department of Commerce, and Corner Post, Inc. v. Board of Governors of the Federal Reserve System, and their impact on the Chevron doctrine. We also discuss other relevant cases to highlight shifts in judicial approaches to agency deference and regulatory authority that might affect how science is handled in regulatory spaces, including how biocomputing and other health sciences are governed, how scientific facts are applied in policymaking, and how scientific expertise guides decision making. Through a detailed analysis, we assess the potential impact of regulatory uncertainty in healthcare. Additionally, we provide recommendations for the medical community on navigating these challenges.