Author(s)
VARSHA G NAIR, DR JAMEELA KC
- Manuscript ID: 121191
- Volume 2, Issue 7, Jul 2026
- Pages: 56–66
Subject Area: Law and Legal Studies
Abstract
Artificial Intelligence (AI) has emerged as one of the most transformative technologies in modern healthcare, fundamentally altering the diagnosis, treatment, management, and delivery of medical services. AI-powered applications such as predictive analytics, machine learning algorithms, robotic-assisted surgeries, clinical decision support systems, and telemedicine have significantly improved healthcare efficiency and patient outcomes. India, with its rapidly expanding digital health ecosystem and initiatives such as the National Digital Health Mission (NDHM), Ayushman Bharat Digital Mission (ABDM), and the adoption of electronic health records, has increasingly embraced AI to bridge gaps in healthcare accessibility and quality.
Despite these advancements, the integration of AI into healthcare raises significant legal and ethical concerns. Issues relating to patient privacy, informed consent, algorithmic bias, accountability for medical negligence, cybersecurity vulnerabilities, ownership of health data, and transparency of AI decision-making pose substantial regulatory challenges. India's existing legal framework—including the Information Technology Act, 2000, the Digital Personal Data Protection Act, 2023, the National Medical Commission Act, 2019, and various ethical guidelines—provides only fragmented governance mechanisms and lacks a comprehensive legal framework specifically regulating AI in healthcare.
This article critically examines the legal and ethical challenges associated with AI-enabled healthcare in India. It analyses existing legislation, judicial precedents, policy initiatives, and international regulatory models, including the European Union AI Act, the United States Food and Drug Administration framework, the United Kingdom's regulatory approach, and China's AI governance mechanisms. The article argues that India requires a dedicated, risk-based regulatory framework that balances technological innovation with patient rights, medical ethics, and constitutional guarantees. It concludes by proposing legislative and policy reforms aimed at ensuring responsible, transparent, accountable, and human-centric AI governance within India's healthcare ecosystem.