Japan plans to develop AI medical rules. Responsibility is borne by doctors.

  According to "Nikkei Business News" reported on July 3, the Japanese government will complete a series of rules on artificial intelligence (AI) medical equipment.In addition to the final responsibility for the diagnosis is borne by the doctor,The Japanese government will also clarify the specific conditions required for national reviews such as security.In addition, the Japanese government will determine how to evaluate the safety of medical devices that continue to improve with the independent learning of AI.Japan hopes to promote AI Medical, which is expected to make a significant contribution to improving the quality and efficiency of medical care, to be put into practical use as soon as possible.

  In the use of AI for medical purposes,developments aimed at practical use in the field of image diagnosis are progressing.If a medical device equipped with disease recognition AI is put into use, it is expected that a large number of medical images can be analyzed by AI, thereby making it easier to find a lesion.

  For example, NEC and the National Cancer Research Center of Japan are developing a "real-time endoscopy diagnostic aid system" to find colorectal polyps.30 images can be processed in 1 second, and the current missed diagnosis rate is 2%. The system is going to start clinical trials in 2019 and put them into use as soon as possible.

  In Japan, the sale of new medical equipment must pass the medical equipment certification review of the Ministry of Health, Labour and Welfare.However, there are currently no standards for evaluating the safety and effectiveness of AI medical devices.The enterprise is not clear about what conditions need to be met and is at the stage of exploration.

  In addition, the company is also worried that even if the application is submitted for a long time to wait for review or can not be approved, the Ministry of Health, Labour and Welfare and the Ministry of Economy, Trade and Industry will formulate a series of relevant rules.

  The Ministry of Health, Labor and Welfare of Japan will establish evaluation criteria in 2018. AI that continuously improves performance through self-learning may also experience changes in performance after being certified.Therefore, the province will formulate rules based on the characteristics of AI, such as establishing a mechanism to re-evaluate performance after After the establishment of the market.

  In addition, the responsibility for medical treatment will be clarified.Due to the possibility of misdiagnosis of AI, the Ministry of Health, Labour and Welfare will position the AI medical device as a device to assist the doctor in the diagnosis.Based on the Physician Law, “the responsibility for making the final diagnosis and determining the treatment policy is borne by the doctor”.Prevent manufacturers from reducing the development of AI medical devices by clarifying the scope of responsibility.