China's Hainan Free Trade Port: Medical Laws and Policy Reform.

In 2018, the government of China decided to develop Hainan Province as the country's first free trade port operating within the country's socialist system. Based on this strategy, Hainan reformed its medical laws and policies to make it freer and more open. For example, Hainan formulated policies for more rapid and convenient access of foreign medicine and sanitary equipment (MSE), allowed manufacturers to register MSE in China with real-world data (RWD), and provided legal and visa conveniences for international medical teams to carry out various activities, including: diagnosis, treatment and scientific research. Hainan's reforms are not only conducive to the improvement of local medical and public health levels, but also provide opportunities for international MSE manufacturers and medical research institutions swiftly to enter China's huge medical market. However, with opportunity comes risk: Hainan should be on guard against public health risks associated with medical tourism, and decide how to strike a reasonable balance between protecting local MSE enterprises and improving the accessibility of imported MSE through policies and legislation. Finally, the paper recommends that Hainan should improve the regulatory system as soon as possible to ensure the quality of diagnosis and treatment in its new hospitals, and deal with data and information security risks in the RWD research.