India: Artificial Intelligence (Human Health and Medical Education) Regulation Act 2026 (Bill No. XIII of 2026) was introduced to Parliament

On 6 February 2026, the Artificial Intelligence (Human Health and Medical Education) Regulation Bill, 2026 (Bill No. XIII of 2026) was introduced to the Council of States. The Bill proposes a statutory framework governing the development, deployment, and use of artificial intelligence systems in healthcare, clinical research, and medical education, and would provide for the establishment of the National Authority for Artificial Intelligence in Human Health and Medical Education as a central regulatory and supervisory body. It would permit Government and private healthcare institutions to use artificial intelligence systems for diagnostic support, treatment planning, patient monitoring, prescription review, clinical audit, and operational management, subject to human oversight and informed consent. It would prohibit autonomous prescription or final clinical decision-making. Accountability for diagnosis, prescription, and treatment decisions would remain with qualified medical professionals. The proposed Authority would register and approve systems, classify high-risk applications, set technical and ethical standards, and oversee validation and post-deployment monitoring. Furthermore, the Bill proposes the creation of an Artificial Intelligence Harm Compensation Fund and would provide for fines of up to INR 50'000'000 for serious violations and up to INR 100'000'000 or imprisonment of up to 7 years where violations result in death.