AI prescription systems automation: Regulatory and educational challenges in the USA and Europe

Abstract

Western healthcare systems face escalating pressures from chronic disease prevalence, aging populations, increasing healthcare demands, and rising costs. Artificial Intelligence (AI) solutions offer transformative potential by enhancing clinical decision-making and healthcare management, optimizing resource allocation, improving patient outcomes, and accelerating innovation. However, the integration of AI into healthcare raises unresolved questions regarding transparency, algorithmic accountability, legal liability, and data governance, highlighting significant systemic risks. The regulatory frameworks adopted by the European Union (EU) and the United States (US) differ significantly, shaped by contrasting legal traditions and policy objectives. This paper critically examines these divergent regulatory approaches, focusing on the recent Healthy Technology Act 2025 proposal in the US, which would enable AI to prescribe medications autonomously. We discuss legal, ethical, and educational challenges arising from this regulatory divergence, ultimately providing insights and recommendations for policymakers, healthcare organizations, and technology developers.

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