Regulatory policies research on digital intelligence medical equipment in metaverse in medicine

Metaverse in medicine forges a novel paradigm of digitized and intelligent healthcare services using AR/VR technology and the Internet of Medical Things (IoMT), transcending the spatial and temporal constraints of conventional medical practice and unveiling significant prospects in medical training, surgical support, and chronic disease management, among others. Concurrently, the ascent of metaverse in medicine poses challenges, including technology dependency, regulatory gaps, and a shortage of skilled professionals, particularly concerning data security and privacy protection. This article scrutinizes the regulatory demands and hurdles associated with digital medical devices, encompassing the oversight of hardware, software applications, and intelligent algorithms, and reviews regulatory strategies for digital health products in leading markets such as the FDA, MDR, and NMPA guidelines. In conclusion, the paper proffers strategic recommendations for businesses to navigate forthcoming regulatory obstacles, underscores the imperative of compliance management, and anticipates the influence of nascent technologies on the trajectory of regulatory evolution. 

Key Words: metaverse in medicine; digital intelligence medical equipment; regulatory policy; data security; personal privacy protection