Colloquium: Regulating Generative AI in Healthcare: A Systematic Review and Policy Mapping Across Six Jurisdictions with a Market Landscape Analysis

Abstract: 
Generative AI systems, including large language models and LLM-based agents, are entering clinical and patient-facing health settings faster than dedicated regulatory frameworks can develop. I will present a project that combines three components. First, a systematic review of the academic literature on regulation of generative AI in healthcare. Second, a systematic policy mapping of the regulatory instruments themselves across six jurisdictions: the UK, USA, Germany, Australia, South Korea, and Sweden, including non-binding guidance and official regulatory communications, since binding generative AI-specific statutory law remains scarce. Third, a non-systematic market layer describing 10 to 15 companies with a documented regulatory footprint in one of the six jurisdictions. An empirical entry point is the FDA 510(k) clearance of UpDoc V1.0 in December 2025, the first identified patient-facing generative AI health device worldwide, cleared without a clinical study requirement and absent from the FDA's own AI-Enabled Medical Device List.