GB 3232-1982
Abolished
T/CECCEDA 001-2023
Active
Group standards
T/CECCEDA 001-2023 Cognitive Digital Therapeutics Standards。
T/CECCEDA 001-2023 Cognitive Digital Therapeutics Standards。
Price:
$ 20.00
Basic Information
Standard Code:
T/CECCEDA 001-2023
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medicine
ICS Name:
Integrated medical science and healthcare devices
Publish Date:
2023-03-01
Implement Date:
2023-03-01
Scope
Main technical content: Based on the current practical situation of cognitive digital therapy, and referring to the content of relevant regulations and standards such as the Guidelines for the Registration and Review of Medical Device Software (2022 Revised Edition), the standard establishes an overall framework from the aspects of an overview of cognitive digital therapy, basic requirements, technical requirements, evidence-based practice, and ethical and moral issues. The basic requirements of cognitive digital therapy include functional requirements, training frequency, training intervention effects, and training programs. Technical requirements of cognitive digital therapy are regulated from six aspects: data collection and analysis, algorithm models, cognitive assessment, auxiliary diagnosis, cognitive training, and health management.
Development Information
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