In Japan, patient safety has been promoted at all levels since the 1999 landmark adverse medical event at Yokohama City University Hospital (YCUH). However, patients do not believe that health care is becoming safer. Furthermore, two university hospitals (UHs) that were designated as “advanced treatment hospitals” had their status revoked by the Health Ministry as of June 1, 2015 due to patient safety problems. The history of patient safety in Japan can be roughly divided into two terms: 1999-2009 and since 2010. In the first term, a basic patient safety system was established that included the creation of a patient safety division and an incident-reporting system from the perspective of systems error rather than individual responsibility. Additionally, many companies have promoted the improvement and development of drugs and medical devices in collaboration with health care providers. The two recent serious medical errors at UHs seemed to occur partially due to a lack of medical ethics. Unlike in the United States (US), in Japan, there is no medical license renewal system, the organizations that govern physicians are weak, and the framework of lifelong education is inadequate. Therefore, the second term involves a mindset of quality-driven patient safety. It requires health care providers and policy makers to change their mindset toward medical ethics and patient safety by learning from the US and demands a strong organization and framework to govern physicians in Japan.