The standard is based on the current actual situation of digital therapy for cognitive impairment, with reference to the content of relevant regulations and standards such as the Guiding Principles for Registration Review of Medical Device Software (2022 Revised Edition), starting from the overview, basic requirements, technical requirements, and cycle of cognitive digital therapy. Build an overall framework in terms of certification, ethics and morality. The basic requirements for cognitive digital therapy include functional requirements, training volume, training intervention effects, training programs, etc. Cognitive digital therapy technology requirements. Cognitive digital therapy technology requires standardization from six aspects: data collection and analysis, algorithm model, cognitive assessment, auxiliary diagnosis, cognitive training, and health management.
T/CECCEDA 001-2023 history
2023T/CECCEDA 001-2023 Specifications on digital therapy for cognitive function
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