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

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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Publication Details

Journal
SSM - Health Systems
Published
2025-08-12
DOI
https://doi.org/10.1016/j.ssmhs.2025.100115
Primary Topic
Ethics and Social Impacts of AI
Type
article
Field-Weighted Citation Impact
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article

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

Francesco Andrea Causio, Simone Palazzo, Alice Ravizza, Davide Golinelli et al.
SSM - Health Systems
Ethics and Social Impacts of AI
article

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

Francesco Andrea Causio, Simone Palazzo, Alice Ravizza, Davide Golinelli, Ciro Pappalardo, Chiara Barneschi, Francesca Aurora Sacchi
article en

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.

SSM - Health SystemsVol. 5
Università Cattolica del Sacro Cuore (IT), Azienda Ospedaliera di Cosenza (IT), Italian Society of Physiotherapy (IT), Monroe County Department of Public Health (US), Dipartimento della Protezione Civile (IT), Link Campus University (IT)
Openalex Percentile: Top 80%
Ethics and Social Impacts of AI
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