Risks and benefits of BCI call for clear eye

Editor's note: Brain-computer interfaces are among the new drivers of economic growth mentioned in the outline of the 15th Five-Year Plan (2026-30). China Times spoke to Liu Fang, head of Beijing Medical Ethics Association, about their potential and the challenges they present. Below are excerpts of the interview. The views don't necessarily represent those of China Daily.

Brain-computer interfaces are medical devices or technologies that measure and decode neural signals generated by the central nervous system, using either invasive or non-invasive methods. They enable real-time, bidirectional interaction or closed-loop feedback between patients and external assistive or therapeutic systems. The goal is to improve, restore or even replace certain neurological functions.

The inclusion of BCIs in the national development plan is not only a recognition of their technological value, but also a forward-looking, systemic move for China's future industrial landscape, innovation-driven development model and capacity for smart social governance. It reflects a firm commitment to advancing technological self-reliance and securing a leading position in future global competition.

But clinical research on BCI raises a range of ethical concerns. The key questions are whether research institutions and teams are properly qualified and accountable, whether study designs — including inclusion and exclusion criteria, interventions and data management — are scientifically sound, safe and effective. Ensuring that informed consent is both meaningful in content and properly obtained in practice is another critical issue.

Researchers must assess the potential risks and benefits, ensure fairness in procedures and opportunities, and protect vulnerable groups, while disclosing any conflict of interest.

The risks associated with BCI research fall into three broad categories. First are the general risks, such as surgical complications in invasive procedures or device malfunctions during long-term use of non-invasive systems. Second are specific BCI risks. Given the current limits in understanding neural signals, these technologies may capture or interpret brain activity beyond the scope of intent, potentially leading to unintended intervention in or even control of certain brain functions. Third are the unknown risks, including unforeseen changes in neural activity and the long-term effects of continuous BCI interaction.

In order to establish proper ethical frameworks, it is important to know how to build standardized systems and align them with real-world practice. Efforts should be made to regulate clinical data management and verify safety and efficacy through real-world studies over the long term.

Another issue is market access and regulatory approval. The transition from laboratory research to a mature product that can be included in the national medical insurance system depends on regulatory review and sufficient real-world clinical evidence.

Therefore, unified technical standards, transparent pricing mechanisms, accessible insurance coverage and standardized procedures for equipment maintenance, upgrades and recycling are essential. It also requires breaking down the barriers between universities, research institutes and enterprises to better integrate innovation with clinical applications.

From a policy perspective, the potential of BCIs should be fully recognized and supported, while the ethical challenges and societal risks must be addressed with caution and foresight.

The pathway to industrialization also requires clearer regulatory coordination. A cross-sector governance framework tailored to the technology's characteristics is needed, alongside synchronized development of legal and ethical standards. It is necessary to strengthen ethical oversight across the entire technology lifecycle, including the establishment of ethical review standards, the standardization of approval procedures and the dynamic supervision of clinical trials and real-world applications.

In this context, data privacy stands out as a central concern. Ensuring users' rights to informed consent, control over their neural data and anonymization must be at the core of ethical governance.