Indian MP proposes new bill to regulate AI in healthcare and medical education

The push for a legal framework

India is facing a growing conversation regarding how to manage artificial intelligence in sensitive sectors like healthcare and medical training. Rajya Sabha MP Ajeet Gopchade has introduced a private member bill titled the Artificial Intelligence (Human Health and Medical Education) Regulation Bill, 2026. This move comes as the government looks for ways to ensure that technology remains safe and ethical.

The primary goal of the bill is to create a science-based, patient-centric statutory framework. This would move the country beyond voluntary guidelines toward enforceable laws. The proposal emphasizes that AI must remain under meaningful human control to protect the dignity and safety of patients.

Gopchade stated that the bill aims to provide legal clarity and confidence for those deploying AI in areas where human life is at stake. By establishing clear rules, the government hopes to facilitate responsible innovation that aligns with national priorities. The bill seeks to balance the benefits of new technology with the necessity of safeguarding informed consent and data governance.

Establishing a national authority

A central component of the proposed legislation is the creation of a new regulatory body. This would be the National Authority for Artificial Intelligence in Human Health and Medical Education. This independent regulator would have the power to register, scrutinize, and approve various AI systems used in the medical field.

The Authority would be responsible for classifying different types of risks associated with these technologies. It would also have the power to establish specific standards, monitor how systems perform in real-world settings, and take enforcement actions when necessary. This structure is intended to provide a single point of oversight for complex digital tools.

The bill highlights the need for accountability when technology fails. Gopchade noted that responsibility must not disappear between hospitals, developers, and technology providers. The proposed authority would oversee system audits, compliance, and the determination of liability and appropriate compensation for those affected by errors.

Identifying high-risk systems

Not all AI applications will face the same level of oversight under the proposed bill. The Authority would be empowered to identify high-risk systems based on factors like their complexity, autonomy, and potential impact on human rights. Systems that could cause grave consequences would face the strictest rules.

Specifically, the bill targets AI capable of causing death, serious bodily injury, or psychological harm. It also covers tools used in unethical experimentation or other situations that could lead to significant harm. These high-risk systems would be subject to heightened regulatory scrutiny to ensure they meet safety requirements.

To ensure these tools work as intended, the bill requires AI systems to undergo scientific validation. This validation must occur in clinical, research, or educational settings within India. Once approved, the systems would still need to be monitored continuously after they are deployed to check for bias and performance issues.

Current landscape vs. new rules

The move toward a formal bill comes because current regulations in India are somewhat limited. While there are existing guidelines for AI in healthcare, they are often not legally binding. This means that while they provide a moral compass, they may not offer a clear path for legal recourse in the event of a failure.

Previously, the Indian Council of Medical Research released ethical guidelines to address patient safety and transparency. These guidelines were meant to oversee AI-based biomedical research and healthcare applications. However, they do not carry the same weight as a statutory framework like the one proposed by Gopchade.

Additionally, the Medical Devices Rules of 2017 do cover some AI-enabled software that qualifies as a medical device. These rules include certain safety and performance requirements. The new bill would build upon these existing structures by creating a more comprehensive and specific set of rules for the unique challenges of AI in medicine.

Impact on developers and patients

For medical professionals and patients, the bill aims to create a safer environment for adopting new tools. By ensuring that AI systems are validated and monitored, the framework seeks to build trust in digital diagnostics and educational aids. It ensures that the human element remains central to medical decision-making.

For developers and technology providers, the bill provides a roadmap for innovation. Instead of navigating a gray area of ethics, companies would have a clear set of standards to meet. This could potentially make it easier for trustworthy AI products to enter the Indian market by providing a clear path to approval.

Ultimately, the bill seeks to ensure that the benefits of AI do not come at the cost of safety. By addressing liability and data governance, it aims to protect the rights of individuals while allowing the medical field to advance. The focus remains on creating a system where technology serves human health without compromising accountability.