Comparing ‘Brain-Computer Interface’ Regulations Reveals Gaps in South Korea on Neuroethics and Real-World Evidence

A comparative analysis of regulations for brain-computer interface (BCI) technology found gaps in South Korea, including in neuroethics and the use of real-world evidence.

According to a report titled “Regulatory Trends and Implications for BCI Technology,” published on the 29th by the Biotechnology Policy Research Center at the Korea Research Institute of Bioscience and Biotechnology, Professor Park Jeong-yeon of Hankyong National University made the observation while comparing regulations for BCI medical products in South Korea, the United States and the European Union (EU).

BCI technology measures and analyzes brain signals to control computers or communicate users’ intentions externally. Its applications are expanding beyond medicine and rehabilitation to include the military, education and gaming.

Under the Digital Medical Products Act, which took effect in January 2025, South Korea regulates BCI products intended for medical use as “digital medical devices.” Products that directly process brain signals and control external devices are mostly classified as high-risk Class 3 or higher and require approval from the Ministry of Food and Drug Safety.

Professor Park praised the enactment of a separate law reflecting the characteristics of digital technology as a pioneering legislative step, but noted that “specific regulations or guidelines are lacking for requirements particularly relevant to digital medical devices, such as postmarket safety management systems.”

The United States regulates BCIs as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). Invasive BCIs can pose significant risks to the human body and are classified in the most stringent category, Class Ⅲ. The report found that no invasive BCI has currently received authorization from the U.S. Food and Drug Administration (FDA).

The EU applies its Medical Device Regulation (MDR), enacted in 2017. Products that deliver electrical stimulation to the brain are subject to the MDR even if they are not intended for medical use, and invasive BCIs are generally classified in the highest category, Class Ⅲ.

Referring to the EU’s legal protection of “mental integrity” in clinical investigations, Professor Park recommended that “neuroethical perspectives should also be reflected in South Korea’s clinical trial regulations and guidelines.”

Professor Park added that although the Digital Medical Products Act provides for real-world evaluations, there is no clear indication of their specific use, and detailed guidelines for linking them to reimbursement are also lacking.

Professor Park emphasized that, because BCI technology can affect human identity, the government and companies should take a leading role in international standardization and neuroethics discussions to address gaps in South Korea’s legislation.