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Governance of medical AI in the greater Bay Area in Southern China: regulatory rule of law and AI sovereignty

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  • Calvin Wai-Loon Ho

Abstract

This paper examines what the regulatory rule of law means in relation to the governance of medical devices with artificial intelligence capability (AIMDs) in China, and by extension, the Guangdong-Hong Kong-Macao Greater Bay Area (GBA). It explains how rules and processes in device-based and data-based legal regimes administered by two super-regulators (i.e. the National Medical Products Administration and the Cyberspace Administration of China) support participatory governance, which is enabled through the delineation of national sovereignty and security concerns, specification of public / societal interests and private rights and obligations. The recent shift in emphasis from technological sovereignty to more specifically AI sovereignty on the mainland could elevate the importance of the GBA in AIMD development and innovation. The links with Hong Kong SAR and Macao SAR enable the provincial government of Guangdong to collate and curate high-quality and diverse forms of data from overseas sources. This could re-enact Guangdong's historical role as a gateway to the rest of China. For the GBA to be effective as a technological and data intermediary, the regulatory rule of law on AIMDs should be strengthened by drawing on the flexibilities that the “one country, two systems and three jurisdictions” policy arrangement affords.

Suggested Citation

  • Calvin Wai-Loon Ho, 2026. "Governance of medical AI in the greater Bay Area in Southern China: regulatory rule of law and AI sovereignty," Policy Studies, Taylor & Francis Journals, vol. 47(2), pages 306-337, March.
    • Handle: RePEc:taf:cposxx:v:47:y:2026:i:2:p:306-337
    DOI: 10.1080/01442872.2025.2578435
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