Current Legislative Landscape and Proposed Regulatory Approaches

While solving the technical challenges of brain-computer interface (BCI) technology is important, it does not resolve the accompanying ethical and legal uncertainties. For example, many of these technologies are developed and sold by private tech companies rather than medical professionals, raising the question of whether they are subject to regulations like the Health Insurance Portability and Accountability Act (HIPAA), which governs medical data. This ambiguity highlights the need for clearer regulatory frameworks, as BCIs currently operate in a “gray area” where the line between consumer technology and health care is blurred, leaving significant gaps in oversight and accountability.

The legal landscape surrounding BCI technology in the United States is currently fragmented and lacks comprehensive federal regulation, especially outside the medical context. The regulatory gap for consumer neurotechnology products leaves a vast area vulnerable to potential exploitation and misuse, as the market for nonmedical BCIs continues to expand and these devices may be used for wide-ranging purposes such as entertainment, wellness, or personal enhancement.

There is an unresolved legal question regarding whether the Food and Drug Administration (FDA)—or any federal agency—has the authority to regulate nonmedical BCIs without explicit congressional authorization. This uncertainty has been reinforced by the Supreme Court’s decision in West Virginia v. Environmental Protection Agency (2022), which limited federal agency power by ruling that agencies cannot regulate major economic and political issues without clear congressional authorization. This ruling applied the major questions doctrine, meaning that if a regulatory issue is of significant national importance, agencies like the FDA cannot unilaterally assert authority unless Congress has explicitly granted them the power to do so.

“Without federal oversight, there is a risk that consumer BCI products could be sold with misleading claims, inadequate security protections, and unclear data privacy standards.”

Congress has not yet passed legislation explicitly granting the FDA, Federal Trade Commission, or any other federal agency jurisdiction over consumer BCIs. If federal legislators do not act to explicitly authorize regulation, the FDA may not be able to extend its authority to these products, leaving them to be developed and marketed with minimal scrutiny. Without federal oversight, there is a risk that consumer BCI products could be sold with misleading claims, inadequate security protections, and unclear data privacy standards. This regulatory gap highlights the urgency of legislative action to ensure that neurotechnology is not left unregulated in areas where it could pose risks to consumers.

Because of the legal uncertainty surrounding whether the federal government can regulate nonmedical BCIs, much of the responsibility for addressing neural data privacy and security has shifted to individual states. Some states have begun to develop their own legal frameworks for BCI oversight. Notably, Colorado and California have pioneered legislation specific to neural data. Colorado’s laws are the strongest to date, requiring explicit consent for data collection and granting users rights to access and delete their neural data. In August last year, the California assembly passed SB1223, which amends the California Consumer Privacy Act to include neural data as a type of sensitive data.¹

These state-level initiatives are significant as they begin to fill the regulatory void left by federal inaction. However, they are not without their challenges. There are gaps in the scope of their application, particularly regarding smaller entities or individual developers who may handle neural data without falling under the purview of these regulations. Additionally, the enforcement mechanisms in place lack the necessary detail for proactive monitoring, enforcement, and auditing, which are crucial for ensuring compliance. This is compounded by the fact that current legislation may not be adaptable enough to address future technological advancements or new methods of data manipulation, potentially leaving consumers unprotected against emerging threats.

California’s SB1223 also excludes inferences made from “non-neural information” from the definition of “neural data,” but since “non-neural information” is not clearly defined, it creates confusion about what qualifies as neural data. If non-neural information refers in this context to anything not produced by the central or peripheral nervous system, that runs into the uncertainty about what exactly constitutes nervous system activity. A key debate in neuro privacy is the blurred line between muscle movements and the nervous system’s role in controlling them. For instance, eye-tracking technology raises questions: While eye movements result from muscle contractions, they are controlled by a cranial nerve in the peripheral nervous system. TechNet, opposing SB1223, pointed out that systems monitoring eye movements could be considered measurements of the nervous system, underscoring the uncertainty around what legally counts as neural data.²

This highlights the need for more research and the development of standards. Without clear definitions, companies and regulators will struggle to implement effective protections, and the risk remains that certain categories of neural-adjacent data could be exploited outside the scope of existing privacy laws. The lack of a standardized regulatory approach highlights the necessity of further legislative refinement to ensure neural data privacy protections are comprehensive and enforceable.