Policy & Regulation

Three Beijing agencies jointly issued a BCI action plan targeting 3-5 globally influential leaders and around 100 innovative SMEs by 2030.

California's SB 1223, enacted in 2024, amended the CCPA to classify neural data as sensitive personal information alongside genetic and biometric data.

Colorado's HB24-1058, signed in 2024, brought neural data under the state privacy act's sensitive-data protections, a first in the United States.

The US Bureau of Industry and Security announced a two-day hybrid BCI conference with industry and academic experts, following its 2021 export-control inquiry.

The FDA granted Breakthrough Device designation to Blackrock Neurotech's MoveAgain BCI System on November 16, 2021. The investigational system combines an implanted array, neural decoding and wireless output with the goal of allowing people with severe paralysis to control digital and assistive devices. The designation can expedite development and review but is not market approval.

The US Bureau of Industry and Security published a 2021 advance notice seeking comments on export controls for BCI as an emerging technology, focused on national security.

Chile's Ley 21.383, published in 2021, amended Article 19 of the Constitution to require special protection of brain activity, a world first.

The FDA issued final guidance in 2021 on implanted brain-computer interface (BCI) devices for patients with paralysis or amputation, covering nonclinical testing and clinical study design.

The OECD Council adopted the Recommendation on Responsible Innovation in Neurotechnology in December 2019, guiding governments with nine principles.