NEW DELHI: India must adopt a robust legal framework to ensure the safe, ethical and accountable use of artificial intelligence in healthcare, clinical research and medical education, where errors can have serious consequences for patients and medical professionals.With the objective to establish a science-based, patient-centric statutory framework that keeps AI under meaningful human control while safeguarding patient safety, informed consent and data governance, Rajya Sabha MP Ajeet Gopchade has urged govt to take up the Artificial Intelligence (Human Health and Medical Education) Regulation Bill, 2026.The objective of this private member Bill is to facilitate responsible and trustworthy innovation, aligned with India’s national priorities, by providing legal clarity, regulatory and confidence in the deployment of artificial intelligence in sectors where human life and dignity are paramount, Gopchade told TOI.The Bill provides for the establishment of an independent regulator, National Authority for Artificial Intelligence in Human Health and Medical Education, with powers to register, scrutinise and approve AI systems, classify risks, establish standards, monitor performance and take enforcement action.“When an AI system causes harm, responsibility must not disappear between hospitals, developers and technology providers. A regulatory authority is needed to oversee system approval, audits, compliance, liability and appropriate compensation’’, Gopchade said.The Bill, a copy of which is available with TOI, empowers the Authority to identify high-risk AI systems based on potential harm, complexity, autonomy and impact on human safety, ethics and rights. Those systems capable of causing death, serious bodily injury, psychological harm, unethical experimentation or other grave consequences would face heightened regulatory scrutiny, it adds.
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It requires AI systems covered by the Bill to undergo scientific validation in clinical, research or educational settings in India, followed by continuous post-deployment monitoring, bias assessment and performance review.At present, there are existing guidelines covering certain aspects of AI in healthcare, but they may not be legally binding. Earlier, the Indian Council of Medical Research released ethical guidelines to address issues including patient safety, informed consent, transparency and ethical review of AI-based biomedical research and healthcare applications. While the Medical Devices Rules, 2017, cover AI-enabled software that qualifies as a medical device, including safety and performance requirements.
