Regulations For the Ethical and Safe Use of Artificial Intelligence in Healthcare

Abstract

Digital transformation is rapidly impacting the healthcare sector, driven in particular by advances in artificial intelligence, a technology used in many areas, such as diagnosis, treatment, patient monitoring, and health systems management, which has been promoting gains in efficiency and precision for clinical decision-making. The incorporation of artificial intelligence into public healthcare contexts demands attention to ethical, legal, and governance aspects, as its use involves risks related to privacy, data security, and possible discriminatory biases. In light of this scenario, the World Health Organization and the Pan American Health Organization have developed, over the last decade, regulations aimed at ensuring the ethical and safe use of these technologies, based on principles such as transparency, equity, responsibility, data protection, privacy and security. In this article, the authors present a survey and analysis of key regulations issued by these organizations concerning the use of artificial intelligence in healthcare, with a focus on their  applicability to health systems in developing countries. Through a systematic documentary review, it was sought to identify the central elements of these guidelines, discuss their implications, and reflect on the challenges for their practical implementation. The analysis highlighted the importance of regulatory governance, the responsible use of sensitive data, and the prevention of bias in algorithms, as well as the need for a multi-stakeholder and collaborative approach involving governments, the private sector, academia, and civil society. Despite the existence of robust regulatory instruments, gaps remain in the practical adoption of these guidelines, especially in contexts with limited infrastructure. Strengthening national public policies, continuing to train healthcare professionals, and expanding the debate on the risks and benefits of artificial intelligence are seen as fundamental steps toward a safe, ethical, and equitable digital transformation in global health.