Artificial Intelligence (AI) is rapidly transforming healthcare, from diagnostics and treatment planning to patient monitoring and administrative efficiency. The global healthcare market is projected to grow at a 5% compound annual growth rate from 2025 to 2030, reaching nearly USD 30 trillion, with inpatient and outpatient care remaining the dominant segments. Yet, the sector faces significant challenges, including fragmented regulatory landscapes, limited talent and knowledge, uneven data access, technology maturity gaps, and varying healthcare player adoption. In India, AI adoption in healthcare is accelerating; however, the regulatory framework is still evolving, with multiple agencies issuing overlapping guidelines, resulting in fragmented oversight of AI tools in healthcare.

This working paper explores and compares regulatory approaches to AI in healthcare across India, the United States, China, and the European Union. Drawing from a literature review of academic, regulatory, and policy sources, the study maps landscapes, identifies gaps, and assesses implications for patient safety, innovation, and competitiveness. By examining these jurisdictions, the study highlights lessons from different regulatory philosophies and identifies strategies that could inform India’s policy evolution.

While public health expenditure has risen and out-of-pocket costs have declined, the study argues that deeper reforms are essential—especially in regulation, health education, and equity-focused investment—to align India’s healthcare system with its demographic and epidemiological realities. By advancing regulatory efficiency and fostering innovation, both the food and healthcare sectors can serve as pillars of inclusive growth, public trust, and sustainable national development

Artificial Intelligence (AI), healthcare sector, clinical safety, regulatory landscape, government oversight