Published Paper Details:

Abstract - Artificial intelligence (AI) is transforming healthcare via diagnosis algorithms, clinical decision support, medical imaging analysis, predictive analytics, and autonomous monitoring systems. Most of these systems are based on cross-national datasets, models, validation efforts, and cloud-based infrastructure. This cross-national feature raises significant legal and regulatory issues in data protection, liability, device certification, and ethical governance. This article presents a comparative legal-policy analysis of cross-border jurisdictional challenges in AI-based healthcare, with special reference to India's emerging regulatory stance in relation to established global models, specifically, the European Union (EU) and the United States (US). The examination combines official tools, regulatory documents, and scholarly work to determine friction areas: cross-border data flows and adequacy, AI medical system classification and pre-/post-market regulation, accountability and civil liability for algorithmic damage, and ethical guardrails in the form of fairness, bias reduction, and transparency. From India's policy papers and moral guidance, EU AI Act provisions and GDPR implications, and FDA guidance for AI/ML in medical devices, the paper provides realistic policy suggestions: interoperable regulatory frameworks, model contractual clauses for data trusts, harmonized liability rules, capacity building for regulators, and international sandboxing for joint validation and conformity assessment. The report ends on an implementable roadmap balancing patient safety and privacy with innovation and international collaboration.