Understanding the Regulatory Landscape in India: A Comprehensive Look at Artifical Intelligence Governance in the Healthcare Sector

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.