Emergence of Robot-Assisted Surgery and the Evolving Legal Landscape in India
This article examines the emergence of robot-assisted surgery in India and the associated legal, ethical, and public policy challenges. It reviews existing regulatory mechanisms such as the Drugs and Cosmetics Act, 1940 and Medical Device Rules, 2017, while highlighting issues of informed consent, product liability, and device malfunctions. Finally, it looks at international perspectives from the US and EU to recommend comprehensive legal reforms for India's healthcare sector.
Summary and content fields are drawn from the document text and are pending editorial review.
Who issued it
Who it governs
Researchers, policymakers, and legal professionals looking for an analysis of the legal and ethical landscape of robot-assisted surgery in India.
What the document contains
The document addresses the current state of robot-assisted surgery in India, the relevant medical device laws, ethical and legal challenges like liability and informed consent, and recommendations for future legal reforms.
It lacks formal binding statutory enactments or administrative enforcement decisions, as it is an academic journal article rather than a direct legislative text.
- Robot-assisted surgery is growing in India, but the regulatory framework for medical devices needs updating to address unique technological challenges.
- Key legal issues include determining liability among surgeons, hospitals, and manufacturers in cases of medical malpractice or device malfunction.
- Informed consent must be strengthened to ensure patients understand the risks, benefits, and the legitimacy of the instruments used.
- International best practices from the US FDA and EU Medical Devices Regulation offer valuable insights for risk-based classification and liability rules in India.
· Introduction · Development and Advancements in Robot-Assisted Surgery · Legal Framework Governing Medical Devices in India · Ethical Considerations, Legal Issues and Public Policy Concerns in Robot-Assisted Surgery · Malfunction of the Robotic Device while Performing a Surgery · International Perspectives and Best Practices · Conclusion and Recommendations
How it scores
Each score is backed by a quote verified against the document text. Editorial review has not yet confirmed them.
Accountability
4/5Clear responsibility for AI outcomes
In the event of a mishap during a robot-assisted surgical procedure, determining liability can be a complex issue, given the involvement of multiple parties, including the surgeon, the hospital, and the manufacturer of the robotic surgical system.
Section 4(b)
screening score · 2026-10-23
Fairness
2/5Non-discrimination and equitable treatment
One of the primary concerns surrounding robot-assisted surgery in India is the issue of accessibility and affordability.
Section 4(e)
screening score · 2026-10-23
Human Dignity
1/5Respect for the inherent worth of persons
According to Article 21 of the Indian Constitution, the Supreme Court of India determined that protecting life is a basic right.
Section 1
screening score · 2026-10-23
Human Oversight
3/5Humans remain in control of consequential decisions
While artificial intelligence has undoubtedly improved the efficiency and accuracy of diagnosis, it should not be used to replace the surgeon’s discretion when doing surgery.
Section 5
screening score · 2026-10-23
Privacy
3/5Protection of personal data and private life
Robotic surgical systems often generate and store large amounts of data, including sensitive patient information. Ensuring the privacy and security of this data is crucial to maintaining patient trust and complying with data protection regulations
Section 4(d)
screening score · 2026-10-23
Enforcement
2/5Consequences and compliance mechanisms with real force
Litigation involving robotic surgery may be difficult to resolve, despite the fact that the legal basis for professional obligation is unchanged.
Section 4
screening score · 2026-10-23
Impact Assessment
3/5Required assessment of an AI system's risks/impacts before or during use
Before a medical device can be marketed in India, it must undergo clinical trials to establish its safety and efficacy.
Section 3(c)
screening score · 2026-10-23