Regulation of Artificial Intelligence in Healthcare – A Global View

Abstract

As artificial intelligence (AI) becomes a cornerstone of healthcare and medicine, the global focus has shifted from innovation to regulation. Across the world, efforts to regulate AI are rapidly evolving as governments and legal systems struggle to keep pace with the advances and novel applications of AI in healthcare. To support regulators and stakeholders in this task, we have examined and evaluated global AI regulatory frameworks focusing on the efforts of international organizations (WHO, EU) and individual nations (USA, UK, Australia, and Canada) to analyze the progress made in this area. While stakeholders are advancing legislation to guide AI development and deployment, gaps persist in implementation, oversight, and long-term monitoring, especially within the healthcare sector. Despite competing economic and political realities, the dilemma between centralized and decentralized policies continues to define international efforts. However, ethical standards must guide regulation, ensuring flexible yet principled frameworks that strike a balance between autonomy and human oversight. As patient data increasingly fuels AI systems, ensuring data security and patient privacy is paramount. Regulatory fragmentation, medico-legal uncertainty, and a lack of uniform best practices challenge the safe and equitable use of AI technologies. Key concerns include preserving patient autonomy, ensuring transparency, managing bias, securing data, and maintaining human oversight in medical decision-making. We suggest that future regulatory efforts be built on collaboration between stakeholders around the globe and concentrate on providing good governance, enhancing patient safety and ensuring the responsible use of AI in healthcare and medicine.

Keywords: Artificial Intelligence, Regulation, Patient Safety, Patient-Centered Care, Medico-Legal Risk

DOI: 10.54941/ahfe1006966