LEGAL ASPECTS OF ARTIFICIAL INTELLIGENCE IN HEALTHCARE IN INDIA: REGULATING THE UNSEEN DOCTOR

Artificial Intelligence (AI) is rapidly transforming India’s healthcare sector through advanced diagnostics, predictive analytics, and patient monitoring. With India’s doctor-patient ratio below global standards, AI tools offer vital support in bridging gaps in care delivery. However, this technological growth presents complex legal challenges. Currently, India lacks a dedicated AI law, relying instead on the Information Technology Act, 2000, Medical Devices Rules, 2017, Drugs and Cosmetics Act, 1940, and the newly enacted Digital Personal Data Protection Act, 2023. AI software used for diagnostics is treated as a medical device, requiring approval from CDSCO. Key legal issues include liability for AI errors, data protection and privacy, informed consent, and algorithmic bias. Patients’ health data is classified as sensitive, requiring explicit consent for use beyond treatment. International frameworks such as GDPR and WHO principles influence Indian regulatory approaches. While AI promises efficiency and accessibility in healthcare, robust legal safeguards are needed to ensure accountability, fairness, and ethical deployment. Clearer liability rules, stronger privacy protections, and anti-bias safeguards will be critical as India advances towards safe and inclusive AI-driven healthcare.