Ethical and regulatory challenges of Artificial Intelligence in medical research: reflections on Smart Regulation

Abstract

The article addresses the ethical and regulatory challenges of using artificial intelligence (AI) in medical research, emphasizing the importance of a regulatory framework that facilitates the ethical and safe development of technology. It explores how AI, while enabling the automation and analysis of large volumes of data with greater precision, also raises ethical concerns such as algorithmic biases and threats to patient privacy. Throughout the text, the need for a balance between innovation and ethical oversight to prevent undesired effects is highlighted. Additionally, cases are analyzed where AI contributes to drug development and microbiome studies, as well as examples of regulations in regions like the European Union and the United States, and the need for implementation in Latin America. In conclusion, the article underlines the need for smart regulation that promotes transparency and the protection of human rights, ensuring that technological progress aligns with fundamental ethical principles.