CITIC SEC: The top-level design of the brain-machine interface standard system has been further improved, focusing on relevant targets in three major directions.

CITIC SEC published a research report stating that the "Guideline for the Construction of National Brain-Computer Interface Industry Standards System (2026 Version)" establishes a standardized roadmap covering the entire industry chain for brain-computer interfaces. This is expected to enhance the normative development of the industry, and companies with core technologies, engineering capabilities, clinical validation, and compliance capabilities will establish core competitiveness. The standard construction is expected to accelerate technology validation and product finalization, promoting specialized division of labor within the industry chain. It is recommended to focus on three main areas: 1) Hardware: autonomous control of core hardware such as electrodes and chips; 2) Algorithm: rich data accumulation with leading algorithm development capabilities; 3) Application: breakthroughs in clinical translation in the medical field, and clear practical scenarios and commercialization channel advantages in non-medical fields. The main views of CITIC SEC are as follows: The top-level design of the brain-computer interface standard system has been further improved, and the normative development of the industry is expected to accelerate. On August 25, the Science and Technology Department of the Ministry of Industry and Information Technology publicly solicited opinions on the "Guideline for the Construction of National Brain-Computer Interface Industry Standards System (2026 Version)" (draft for consultation), hereinafter referred to as the "Guideline." The "Guideline" proposes that by 2028, more than 40 standards in the field of brain-computer interfaces will be formulated or revised, leading and participating in the formulation of more than 10 international standards, and promoting over 100 companies to carry out standard promotion and implementation; by 2030, a total of more than 80 standards will be developed, and the brain-computer interface standard system will be basically formed. It is believed that clear goals for standard development, implementation promotion, and internationalization are expected to provide clearer norms for technological innovation, product development, and application scenarios in brain-computer interface technology, promoting high-quality industrial development. Seven standard sections cover the entire industry chain, expected to establish a unified industry "measurement system." The "Guideline" constructs a standard system consisting of seven parts: common foundations, hardware, software and algorithms, data and communication, products and systems, industry applications, and safety/governance, covering terminology classification, reference architecture, typical paradigms, testing and evaluation, as well as product research and development and application governance. Brain-computer interfaces integrate multiple fields including neuroscience, materials, chips, algorithms, and clinical medicine, creating a unified standard demand across different technical routes in interfaces, data, and performance evaluation. It is anticipated that related standards will improve the comparability of research and development results as well as hardware-software compatibility, reduce upstream and downstream adaptation costs, and promote specialized division of labor and collaborative innovation in the industrial chain. The layout of core hardware standards has become clearer, with electrodes, chips, modular components, and key instruments expected to benefit significantly. The "Guideline" proposes standard construction directions for electrode materials, biocompatibility, chemical stability, safety under magnetic resonance conditions, corrosion resistance, mechanical properties, and conductivity; chip standards cover sampling signal-to-noise ratio, stimulation accuracy, resistance to biological interference, temperature control, packaging, and bus interfaces; modular components cover sealing, power consumption, reliability, and safety. Additionally, the standard system also includes key instruments such as multi-modal detection, electrical stimulation control, and electrode implantation. It is believed that as the standards for electrodes, chips, modular components, and hardware interfaces become progressively clearer, the performance evaluation of related products and upstream and downstream adaptations are expected to be more standardized, with hardware companies possessing core technologies, engineering capabilities, and reliable verification abilities likely to benefit significantly. Software, algorithms, and data standards are expected to promote interoperability, enhancing platform development and data utility value. The "Guideline" covers brain-computer interface data formats, long-term storage, real-time communication, multi-modal fusion, data visualization, as well as encoding and decoding model architecture, training processes, validation methods, and performance evaluation directions, and proposes regulations for algorithm and model interfaces, interoperability, and compatibility. It is believed that a unified data format and software interface will promote collaboration among different devices, algorithms, and execution devices, enhancing interoperability and compatibility of brain-computer interface systems, and providing clearer technical specifications for the development and utilization of EEG data, real-time encoding and decoding algorithms, general software platforms, and data security. The layout of standards for medical devices and medical applications has become clearer, and product standardization research and clinical translation are expected to accelerate. The "Guideline" separately lists brain-computer interface products and systems classified as medical devices, covering both invasive and non-invasive systems, electrodes, signal acquisition and processing controllers, execution devices, and specialized implantation devices. Typical uses include diagnosis and treatment, compensation, functional reconstruction, rehabilitation training, and closed-loop neural stimulation for central nervous system disorders; specific applications involve the reconstruction of movement, sensation, speech, and vision functions, as well as diseases such as epilepsy, Parkinson's disease, stroke, spinal cord injuries, and depression. Meanwhile, the "Guideline" clarifies that brain-computer interface products that meet the definition of medical devices must still adhere strictly to laws and regulations, as well as standard system specifications in the medical device field. It is anticipated that relevant standards will provide clearer technical dimensions for product design, performance validation, and clinical evaluation, facilitating collaboration among medical institutions, enterprises, and testing organizations, and supporting the standardized research and clinical translation of brain-computer rehabilitation devices, neural modulation devices, as well as invasive and non-invasive systems. The standards for testing and evaluation have become clearer, and diverse application scenarios are expected to accelerate standardized development. The "Guideline" proposes standards for signal simulation, physiological environment simulation, structural characterization and measurement, animal experimental evaluation, electromagnetic compatibility, and environmental adaptability, and plans application standards for medical, industrial, transportation, health, education, gaming, and virtual reality. It is believed that the formulation and implementation of related standards are expected to drive the construction of testing equipment, third-party inspection and testing, and standardized public service platforms; in terms of applications, directions such as industrial safety monitoring, driver state monitoring, sleep health, elderly assistance, exoskeleton enhancement, and brain-controlled interaction are also expected to gain clearer bases for product development and scenario implementation. Risk factors: The progress of standard formulation and promotion is not as expected; the research and engineering progress of core technologies is not as expected; the progress of clinical trials and registrations for medical devices is not as expected; the safety, effectiveness, and commercialization performance of products are not as expected; changes in data security and ethical governance requirements.