In this study, we reported a methodological framework for the development of a guideline for establishing a regulatory science system for supervising the application of artificial intelligence for traditional Chinese medicine (TCM). It introduced all of the key steps for developing the guideline as follows: the composition of the guideline expert groups, summary steps, agency, purpose, targeted population, writing, publishing, updating, dissemination, dynamic monitoring, and evaluation. The guideline will provide the basis for national authorities to effectively regulate artificial intelligence technology and enrich the supervisory system for TCM, and it will be of great significance to TCM.
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