Artificial Intelligence (AI) is rapidly transforming healthcare, from diagnostics andtreatment planning to patient monitoring and administrative efficiency. The globalhealthcare market is projected to grow at a 5% compound annual growth rate from 2025to 2030, reaching nearly USD 30 trillion, with inpatient and outpatient care remaining thedominant segments. Yet, the sector faces significant challenges, including fragmentedregulatory landscapes, limited talent and knowledge, uneven data access, technologymaturity gaps, and varying healthcare player adoption. In India, AI adoption in healthcare isaccelerating; however, the regulatory framework is still evolving, with multiple agenciesissuing overlapping guidelines, resulting in fragmented oversight of AI tools in healthcare.This working paper explores and compares regulatory approaches to AI in healthcareacross India, the United States, China, and the European Union. Drawing from a literaturereview of academic, regulatory, and policy sources, the study maps landscapes, identifiesgaps, and assesses implications for patient safety, innovation, and competitiveness. Byexamining these jurisdictions, the study highlights lessons from different regulatoryphilosophies and identifies strategies that could inform India’s policy evolution.