The Regulatory Trilemma of Medical AI: A New Framework for Navigating Innovation, Rights, and Sovereignty in Global Governance

Abstract

The rapid rise of medical AI has outpaced global governance, with the US, EU, and China taking divergent regulatory paths. Existing theories such as regulatory competition and techno-nationalism cannot fully explain this fragmentation. This paper proposes the Regulatory Trilemma of Medical AI, which posits that no system can simultaneously maximize innovation velocity, rights protection, and national sovereignty. Using comparative case studies and framework analysis, we show that the US prioritizes innovation speed, the EU emphasizes rights and safety, and China asserts sovereignty through state-led data control. These choices generate systemic trade-offs, leading to a “Balkanization” of global medical AI markets, creating barriers to trade, complicating standard-setting by bodies like the WHO, and threatening health equity. The framework offers a more integrated lens to understand these dynamics and calls for a new global compact to establish baseline principles of safety, efficacy, and ethics in medical AI governance.