Abstract

The legislative framework governing medical practice in India has gone too far in favour of therapeutic immunity. The primary legislations like the Indian Medical Councils Act, 1956, the Charter of Patients’ Rights, et al impose multifarious ethical obligations on medical practitioners but imbibe no corresponding strict penal provisions. This concern is more felt in the usage of artificial intelligence in medical procedures. The current legal infrastructure makes the apportionment of liability in artificial intelligence-assisted surgeries having unfortunate outcomes arduous. The Information Technology Act, 2000, and the Copyright Act, 1957 impose liability on the manufacturer or developer when an AI-driven technology is involved. However, given that AI has “intelligence” of its own and imitates human “thinking” and decision-making processes through the technology of Deep Machine Learning, the designer of algorithms cannot be solely held liable. This predicament is alarming, considering the dismaying statistics of the dystopia of robotic surgeries. Further, the absence of informed consent or tiered consent might connote medical malpractice in the context of AI-assisted surgeries. The practitioner being the “expert” is ethically expected to render such treatment that is best for the patient, but the patient’s right to self-determination also cannot be disregarded. The Bolam and Bolitho Tests impose liability on the medical practitioner in case of the application of unconventional treatment methods, but so far, precedents have ruled in favour of the doctors exploiting the grey area surrounding the informed nature of the consent. It is also argued that AI-assisted surgeries can be classified as clinical trials under the law. This further raises questions concerning the fundamental right to health of the patient enshrined in Article 21 of the Constitution. Therefore, it is imperative to introduce appropriate legislation regulating the use of AI in surgical procedures to address the lapses and inadequacies in the current legal infrastructure.

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