The Premarket Regulation of Mobile Medical Software: The American Experience
Mobile medical software has developed rapidly in recent years which brought risks and benefits to the development of medical care. It has become an important issue about how to balance the development of the mobile health market and the control of health risks. This article observes the evolutionary process and management measures of American legal regime and finds that it presents a pattern of gradual relaxation and progressive clarify. Compared with Taiwan, the American model provides more flexibility and may be worthy of reference.