Authors: Mamata Gowda
Abstract: Maharani’s CollegeAs Artificial Intelligence (AI) transforms the biomedical industry, regulatory bodies face the critical task of ensuring that these innovations are safe, ethical, and effective for public use. From diagnostic algorithms and AI-enhanced drug development to robotic surgeries and personalized medicine, AI technologies are redefining clinical practices and research methodologies. However, their rapid integration raises significant regulatory challenges, particularly in areas concerning data privacy, algorithmic transparency, clinical validation, and liability. This paper provides an in-depth exploration of the current regulatory landscape governing AI in biomedical applications. It analyzes the roles of major regulatory agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others in shaping guidelines for AI deployment. Furthermore, it highlights the complexities involved in classifying AI tools, updating compliance frameworks for adaptive algorithms, and harmonizing international standards. By dissecting case studies and emerging trends, this paper offers insights into how regulatory frameworks can evolve to balance innovation with patient safety and public trust in the age of AI-powered healthcare.
DOI: http://doi.org/
