World's first AI + brain-computer interface standard released in China.

The National Medical Products Administration today approved and released China's third brain-computer interface medical device standard, which is also the world's first product standard for brain-computer interface medical devices that uses artificial intelligence technology to process EEG data. The new standard will officially take effect on September 1 next year. It is understood that the new standard systematically specifies technical requirements and testing methods for the entire process of data collection, processing, annotation, storage, and access for brain-computer interface medical devices, helping enterprises address common issues such as inconsistent quality control standards for datasets and non-standard construction processes. The National Medical Products Administration stated that brain-computer interface medical devices are like an intelligent machine that can "read" brain signals. It needs to "learn" large amounts of EEG data and "train" artificial intelligence algorithms in order to accurately understand patients' intentions. This is not only related to treatment effectiveness, but is also closely tied to patient safety risks. In order to support major innovation in China's brain-computer interface medical devices and meet the urgent needs of industrial development, the National Medical Products Administration adopted a fast-track procedure for project initiation and approval. The new standard provides a unified "quality yardstick" for EEG datasets in the research and development and production of brain-computer interface medical devices, reaching an internationally leading level.