eng Oriental Scientific Publishing Company Biosciences Biotechnology Research Asia 0973-1245 2026-10-10 23 3 59907 article Rahul Shamota 1 Govind Yadav 1 Department of Law, Manipal University, Jaipur, India The speed at which AI is being used in health care and the making of clinical decisions leads to legal, ethical, and regulatory dilemmas on data protection, informed consent, clinical responsibility, and the explanation of clinical decision-making. This paper focuses on health care AI and addresses biotechnology in the context of genomic, diagnostic, drug development, and clinical services and/or health data processing. Using doctrinal and comparative legal analysis of laws, cases, regulations, policies, and relevant literature published in the European Union, the United States, India, the United Kingdom, and China, this study uses the legal cut-off date of June 30, 2026. The comparison focuses on data protection, medical liability, transparency, informed consent, and institutional accountability. It differentiates primary law from non-binding law and policy. The analysis did not find such a comprehensive health care AI system in these jurisdictions, and found remaining gaps in informed consent, distributed liability, explainability, and institutional control. It proposes providing more information to the patient, oversight by humans, and greater control over response allocations, but acknowledges that the content and the nature of the legal obligations will vary in each jurisdiction. https://www.biotech-asia.org/vol23no3/regulating-ai-in-healthcare-data-protection-consent-accountability-and-transparency/ Algorithmic Accountability; Artificial Intelligence; Data Protection; Health Data Governance; Healthcare Law; Patient Consent