医疗元宇宙技术的监管与医保准入机制:美国AR、VR医疗器械的经验与启示OA

With the rapid development of immersive technologies such as virtual reality(VR)and augmented reality(AR),the medical metaverse has become an important extension of digital healthcare.However,the regulatory approval,post-market evaluation,and medical insurance payment pathways for related products remain unclear.Focusing on AR/VR medical devices,this study reviews the experience of the United States from the perspectives of health technology assessment and full life-cycle governance.The findings show that the United States implements risk-based and classified market access through pathways such as 510(k),De Novo,and PMA,with reviews emphasizing safety,effectiveness,human factors engineering,and data security.Real-world evidence has become an important basis for continuous regulation,reassessment,and payment decision-making,while payment is mainly achieved through durable medical equipment and medical service item pathways.In comparison,China still faces challenges in product classification boundaries,evidence translation,and coordination with payment systems.It is recommended that China improve classification standards and early communication mechanisms,establish a pathway combining device approval,service pricing,and payment pilots,and develop a dynamic expansion mechanism based on real-world evidence and health technology assessment,so as to enhance patient accessibility and promote industrial innovation.