Global AI Governance in Healthcare: A Cross-Jurisdictional Regulatory Analysis

TL;DR

This paper analyzes global regulatory approaches to AI in healthcare across 14 jurisdictions, comparing them to WHO principles, and discusses harmonization and regulation of generative AI.

Contribution

It provides a comparative analysis of international AI healthcare regulations and proposes pathways for global regulatory harmonization.

Findings

North American AI medical devices dominate 42.3% of the market

Emerging common themes in global AI healthcare regulation

Case studies of China and Singapore on generative AI policies

Abstract

Artificial Intelligence (AI) is being adopted across the world and promises a new revolution in healthcare. While AI-enabled medical devices in North America dominate 42.3% of the global market, the use of AI-enabled medical devices in other countries is still a story waiting to be unfolded. We aim to delve deeper into global regulatory approaches towards AI use in healthcare, with a focus on how common themes are emerging globally. We compare these themes to the World Health Organization's (WHO) regulatory considerations and principles on ethical use of AI for healthcare applications. Our work seeks to take a global perspective on AI policy by analyzing 14 legal jurisdictions including countries representative of various regions in the world (North America, South America, South East Asia, Middle East, Africa, Australia, and the Asia-Pacific). Our eventual goal is to foster a global conversation on the ethical use of AI in healthcare and the regulations that will guide it. We propose solutions to promote international harmonization of AI regulations and examine the requirements for regulating generative AI, using China and Singapore as examples of countries with well-developed policies in this area.