Governance of Artificial Intelligence in Healthcare Policy and Legislative Approaches to Balancing Innovation and Data Protection

Abstract

The transformative potential of artificial intelligence in healthcare has generated substantial enthusiasm among researchers, clinicians, and policymakers. AI applications in diagnosis, treatment, monitoring, and research promise significant benefits for patient care, health outcomes, and scientific discovery. However, the realization of these benefits depends critically on the development of policy and legislative frameworks capable of balancing innovation with the protection of individual rights and public interests. Current regulatory frameworks, including the GDPR, provide foundational protections for data privacy and individual rights. However, these frameworks were not designed specifically for AI applications in healthcare and may inadequately address the unique challenges presented by AI. Gaps in legislation and policy include insufficient attention to formal regulation, limited international coordination, inadequate consumer education, and insufficient ethical-legal support for researchers. This article examines policy and legislative challenges in AI healthcare applications, analyzing current regulatory gaps and proposing recommendations for reform. The analysis draws on contemporary scholarship to identify critical policy issues and develop a comprehensive policy framework. The GDPR is considered as a foundation for data protection that must be extended and refined to address the specific challenges of AI in healthcare.