Centre for Human Factors and Sociotechnical Systems, University of the Sunshine Coast, Australia.
Centre for Human Factors and Sociotechnical Systems, University of the Sunshine Coast, Australia; School of Health, University of the Sunshine Coast, Australia. Electronic address: https://twitter.com/gemma_read.
Appl Ergon. 2023 Sep;111:104028. doi: 10.1016/j.apergo.2023.104028. Epub 2023 May 4.
Brain-computer interface (BCI) technologies are progressing rapidly and may eventually be implemented widely within society, yet their risks have arguably not yet been comprehensively identified, nor understood. This study analysed an anticipated invasive BCI system lifecycle to identify the individual, organisational, and societal risks associated with BCIs, and controls that could be used to mitigate or eliminate these risks. A BCI system lifecycle work domain analysis model was developed and validated with 10 subject matter experts. The model was subsequently used to undertake a systems thinking-based risk assessment approach to identify risks that could emerge when functions are either undertaken sub-optimally or not undertaken at all. Eighteen broad risk themes were identified that could negatively impact the BCI system lifecycle in a variety of unique ways, while a larger number of controls for these risks were also identified. The most concerning risks included inadequate regulation of BCI technologies and inadequate training of BCI stakeholders, such as users and clinicians. In addition to specifying a practical set of risk controls to inform BCI device design, manufacture, adoption, and utilisation, the results demonstrate the complexity involved in managing BCI risks and suggests that a system-wide coordinated response is required. Future research is required to evaluate the comprehensiveness of the identified risks and the practicality of implementing the risk controls.
脑机接口 (BCI) 技术正在迅速发展，最终可能会在社会中广泛应用，但它们的风险尚未得到全面识别和理解。本研究分析了预期的侵入性 BCI 系统生命周期，以确定与 BCI 相关的个人、组织和社会风险，以及可用于减轻或消除这些风险的控制措施。开发了一个 BCI 系统生命周期工作领域分析模型，并由 10 名主题专家进行了验证。随后，该模型被用于采用系统思维的风险评估方法，以识别在功能未得到优化或完全未执行时可能出现的风险。确定了 18 个广泛的风险主题，这些风险可能以各种独特的方式对 BCI 系统生命周期产生负面影响，同时还确定了针对这些风险的更多控制措施。最令人担忧的风险包括对 BCI 技术的监管不足以及对 BCI 利益相关者（如用户和临床医生）的培训不足。除了指定一套实用的风险控制措施来为 BCI 设备的设计、制造、采用和使用提供信息外，研究结果还展示了管理 BCI 风险所涉及的复杂性，并表明需要进行系统范围的协调响应。未来需要研究来评估已确定风险的全面性和实施风险控制的实用性。
