Emergence of Robot-Assisted Surgery and the Evolving Legal Landscape in India

Abstract

The emergence of robot-assisted surgery has brought about significant advancements in surgical techniques and improved patient outcomes. This technology, however, also raises several legal, ethical, and public policy concerns that must be addressed in order to ensure its responsible and equitable development and use in India. This article provides an overview of the current state of robot-assisted surgery in India, the legal framework governing medical devices, and the various legal and ethical issues surrounding the technology, including informed consent, liability, intellectual property rights, and accessibility. The legal framework governing medical devices in India primarily consists of the Medical Device Rules, 2017, and the Drugs and Cosmetics Act, 1940. These regulations, although providing a foundation for the regulation of robotic surgical systems, must be updated and expanded to accommodate the unique challenges posed by this technology. Key legal issues include obtaining informed consent from patients, determining liability in cases of medical malpractice, and protecting intellectual property rights. Ethical considerations and public policy concerns include the accessibility and affordability of robot-assisted surgery, training and certification of surgeons, the impact on traditional surgical practices, and balancing patient safety with medical innovation. To address these concerns, this article proposes a series of legal reforms and recommendations. By examining international perspectives and best practices from the United States and the European Union, India can draw valuable insights to inform the development of its legal framework for robot-assisted surgery.