Transforming Healthcare in India: The Role of Artificial Intelligence and Regulatory Frameworks for Sustainable Growth

ABSTRACT Artificial intelligence (AI) has quickly emerged as a game changer in healthcare, providing innovative ways to improve patient care, enhance processes, and reduce expenses. AI could solve important healthcare issues in India, including increasing service demand, a lack of trained medical personnel, and notable geographical differences, especially in rural areas. AI can aid in addressing this gap by offering scalable, affordable regulatory framework that enhance diagnosis, treatment planning, and suitable resource allocation. This paper examines the impact of AI on healthcare, considering its benefits, challenges, and ethical implications for improving the healthcare delivery system. The paper also explores global regulatory frameworks and their implications for AI in healthcare, focusing on the roles of the United States, United Kingdom, European Union, India, and other prominent organizations. Additionally, the paper explores the opportunity to develop a robust AI policy framework for healthcare in India, drawing from global approaches. The study emphasizes ethical, interoperable AI and outlines a roadmap for India's healthcare sector‐integrating risk‐based regulations, enhanced digital infrastructure, ethical AI policies, and private entrepreneurship via public–private partnerships—to position India as a leader in AI‐driven healthcare regulation. As India continues to invest in digital health infrastructure, a comprehensive, ethically sound regulatory framework will be crucial in ensuring that AI‐powered healthcare is accessible, affordable, and inclusive for all citizens. By learning from global best practices and focusing on equitable healthcare, India can lead the way in AI‐driven healthcare innovation.