Hainan Launches Call for Digital Therapeutics Products to Be Included in Commercial Insurance

VCBeat has learned that the Hainan Provincial Health Commission released"Notice of the Hainan Provincial Health Commission on Recommending the Inclusion of Digital Therapeutics Products in Commercial Insurance", initiating the collection of digital therapeutics products within the province that are proposed for inclusion in commercial health insurance. The notice requires subordinate units to complete the "Digital Therapeutics Product Recommendation Form," andSubmit feedback by 12:00 PM on Friday, October 28.。

Screenshot from the official website of the Hainan Provincial Health Commission

Since the release of Hainan’s Several Measures to Accelerate the Development of the Digital Therapeutics Industry (hereinafter referred to as the “Measures”) on October 10, Hainan has been steadily advancing progress across multiple fronts in accordance with the Measures, fully demonstrating the unique acceleration of development in the Hainan Free Trade Port!

On October 14, the Hainan Provincial Health Commission issued the “Notice of the Hainan Provincial Health Commission on Organizing Applications for the Establishment of the Hainan Digital Therapeutics Clinical Trial Center.”, we have begun applying to establish the Hainan Provincial Digital Therapeutics Clinical Trial Center, focusing on key therapeutic areas such as respiratory diseases, neurological disorders, endocrine, nutritional and metabolic diseases, circulatory system diseases, mental, behavioral and cognitive disorders (including sleep disorders), ophthalmic diseases, and oncology.

Subsequently,On October 19, the Hainan Provincial Center for Drug and Medical Device Evaluation and Service released the “Notice of the Hainan Provincial Center for Drug and Medical Device Evaluation and Service on the Summary Opinions Regarding the Classification Determination of ‘Digital Therapeutics’ Software Medical Devices.”, in conjunction with the relevant classification guidance documents issued by the National Medical Products Administration (NMPA), the "Medical Device Classification Catalog" (No. 104 of 2017), the publicly available classification determination results from the National Center for Medical Device Standardization Administration, as well as national and industry standards, a consolidated summary of opinions on the classification determination of software medical devices under the category of "Digital Therapeutics" has been compiled.

Today, the Hainan Provincial Health Commission issued the “Notice of the Hainan Provincial Health Commission on Recommending the Inclusion of Digital Therapeutics Products in Commercial Insurance.”, commence the application for digital therapeutics products proposed for inclusion in commercial health insurance within the province.

Notably, in addition to company information, the "Recommended Digital Therapeutics Products List" also includes indications for the recommended digital therapeutics products, dates of regulatory approval and certification, and their application status across China. This implies that a prerequisite for inclusion in commercial health insurance coverage is that the relevant products must have obtained medical device registration certificates.

According to the timeline of the Measures,Hainan will also complete the accelerated development of a public service and management platform for digital therapeutics by October 31.Establish a special channel for registration guidance of Class II medical device digital therapeutics products,Implementation of Three Measures to Include Digital Therapeutics in the Priority Review Channel for Class II Medical Devices. Warrants significant attention from the industry.