Regulating AI In Healthcare: Legal Frameworks And Challenges
- IJLLR Journal
- Dec 28, 2025
- 2 min read
M Kalaivani, Guest Lecturer, Government Law College, Vellore
ABSTRACT
The integration of Artificial Intelligence (AI) into healthcare systems has significantly transformed medical diagnosis, treatment planning, patient monitoring, and health data management. AI-driven technologies promise enhanced efficiency, accuracy, and accessibility in healthcare delivery; however, their rapid deployment raises complex legal, ethical, and regulatory concerns. This research paper critically examines the existing legal frameworks governing the use of AI in healthcare and analyses the challenges associated with regulating such technologies in a rights-based legal system. The AI applications intersect with core legal principles such as patient consent, data protection, medical negligence, and accountability. In the Indian context, the paper evaluates the applicability of existing laws, including healthcare regulations, information technology laws, and the Digital Personal Data Protection Act, 2023, highlighting the absence of AI- specific legislation in the medical sector. It further examines the role of regulatory authorities and policy guidelines in overseeing AI-enabled healthcare practices. A comparative perspective is adopted by analysing international regulatory approaches such as the European Union’s AI Act, World Health Organization guidelines, and regulatory standards followed in the United States, to identify best practices and regulatory gaps. The addresses key challenges posed by AI in healthcare, including algorithmic bias, lack of transparency, data security risks, and the difficulty of attributing liability for AI-induced medical errors. These challenges raise serious concerns regarding patient safety, autonomy, and the protection of fundamental rights such as privacy and human dignity. Through doctrinal and comparative analysis, the development of a comprehensive legal framework that ensures accountability, transparency, and ethical deployment of AI technologies in healthcare. The effective regulation of AI in healthcare requires a balanced approach that promotes innovation while safeguarding patient rights, ensuring legal certainty, and maintaining public trust in AI- driven medical systems.
Keywords: Artificial Intelligence (AI), Healthcare Regulation, Data Protection, Medical Liability, Ethical AI.
