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Bulletin of Chinese Academy of Sciences (Chinese Version)

Keywords

brain-computer interface；technology assessment；evidence hierarchy；clinical translation；regulatory approval

Abstract

Brain-computer interface systems are emerging neurotechnologies that are gradually moving from laboratory research toward clinical application. However, their inherent features, including small sample sizes, heterogeneous technical pathways, and rapid product iteration, make it difficult to integrate safety and efficacy data across studies or to conduct meaningful cross-study comparisons. These challenges not only hinder the cumulative development of evidence in evidence-based medicine, but also complicate the assessment of clinical access and regulatory review. In addition, subjective evidence, such as patient experience, remains insufficiently captured in existing evaluation frameworks. It is therefore necessary to examine the structure of evidence for brain-computer interface and its challenges. Drawing on the idea of clinical pragmatism, this study proposes a three-axis evidence framework that places engineering performance, clinical function, and patient experience on equal footing. It further specifies differentiated evidence requirements for three stages of development, namely exploratory research, limited dissemination, and routine application, and discusses possible pathways for implementing clinical review of brain-computer interface, with the aim of supporting the governance of such emerging technologies.

First page

1959

Last Page

1969

Language

Chinese

Publisher

Bulletin of Chinese Academy of Sciences

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