Introduction

Until recently, the idea of someone controlling their environment through thought was confined to science fiction. But technological advancements have shifted this concept into the realm of possibility. Today, humans can harness electrical signals produced by brain activity to interact with, influence, and modify their surroundings. The rapidly evolving field of brain-computer interface (BCI) technology offers transformative potential, particularly for individuals with speech and mobility impairments, by allowing them to communicate or operate assistive devices through the power of thought. The potential applications of these technologies are vast. Examples include enabling speech for individuals like Casey Harwell, who was overjoyed to communicate with his family again after losing his ability to speak due to amyotrophic lateral sclerosis (ALS).¹

The integration of BCIs into everyday life raises significant privacy and security concerns. As companies gather and analyze the resulting data, often without explicit consent or knowledge from users, the potential for misuse or unintended consequences becomes pressing. The platforms that utilize BCIs will capture and record individuals’ neural activity data at an unprecedented scale as researchers continue to integrate the power of BCI technologies into more applications.

When neural data is collected from a BCI device, it can be analyzed by companies, allowing them to gather information about users that was not volunteered or directly related to the device itself. The neural activity data captured by these devices is deeply personal and, in many cases, could reveal intimate details about an individual’s thoughts, emotions, and cognitive states. This concern is exacerbated by the current lack of comprehensive federal regulation governing the use of BCIs outside of medical contexts, as well as the absence of robust data privacy and security laws.

While the U.S. Food and Drug Administration (FDA) regulates medical devices, including those incorporating BCI technology for therapeutic purposes, its rulemaking authority does not extend to commercial uses of BCI technology.² The FDA’s guidance on cybersecurity protections for medical devices does not apply in the context of commercial neurotechnology applications because those are typically categorized as consumer electronics rather than medical devices.³ This leaves a significant gap in protections for consumer neurotechnology products, making their users particularly vulnerable to privacy breaches and data exploitation.

Companies like Snap and Apple are exploring BCI applications for consumer use, from enhancing augmented and virtual reality experiences to developing new communication tools.⁴ These companies are actively researching and developing BCI technologies, often leveraging the neural data they collect to refine their products and services. Beyond what consumers expect, the data collected through neurotechnology applications could be used for more troubling purposes, such as manipulative behavioral profiling, unauthorized cognitive monitoring, or even influencing decision-making processes. In more extreme cases, there is potential for misuse in surveillance, law enforcement, and military contexts.

“Data collected through neurotechnology applications could be used for more troubling purposes, such as manipulative behavioral profiling, unauthorized cognitive monitoring, or even influencing decision-making processes.”

The need for regulation becomes even more urgent considering the legislative landscape. While several federal comprehensive privacy bills have been introduced in Congress that could include BCI oversight, none have been enacted into law. Some states are beginning to address these concerns: Recent legislation in Colorado and California specifically targets neurotechnology, imposing restrictions on the collection and use of neural data.⁵ Colorado’s legislation requires companies to obtain explicit consent before collecting neural data and provides users with the right to access and delete their data. Similarly, California has introduced regulations emphasizing transparency and user control over neurodata. These state-level initiatives highlight a growing recognition of the need to protect individuals’ neural privacy and may serve as a model for future federal regulations.

Nonetheless, without a unified national framework, inconsistencies in legal protections across states could leave many consumers vulnerable. In addition to regulatory measures, efforts to enhance public education and awareness of BCI technology are crucial to ensuring that individuals understand how their neural data is collected, used, and protected.

To address these challenges, it is imperative to establish a regulatory framework that encompasses all BCI technologies, regardless of their intended use. This framework should ensure that consumers are fully informed about how their neural data is collected, used, and protected. It should also establish clear guidelines for companies on data handling and set stringent penalties for violations. The framework should include guidelines for secure software development, ensuring that BCI technologies are built and maintained with strong cybersecurity measures. Additionally, appropriate regulatory bodies should be designated to oversee the implementation and enforcement of these regulations.

Given its expertise in medical device regulation, the FDA could play a central role in this oversight, possibly in conjunction with other agencies like the Cybersecurity and Infrastructure Security Agency (CISA) and the Federal Trade Commission (FTC), which is experienced in consumer protection and data privacy issues. This holistic approach would help safeguard user data and maintain public trust in these emerging technologies.

To fully address the challenges and opportunities presented by neurotechnology, this report will explore key areas essential for establishing a robust regulatory framework. Following this section, we will first delve into the fundamentals of BCIs, examining their applications in both medical and commercial contexts. Next, we will analyze the privacy and security challenges unique to BCI technology, highlighting the ethical concerns and potential risks associated with neural data collection and usage. Building on these insights, we will evaluate the current legislative landscape, including state-level initiatives and gaps in federal oversight. Finally, the report will propose a comprehensive regulatory approach that incorporates secure-by-design principles, defines clear accountability for software manufacturers, and establishes a unified federal framework to ensure consumer protection while fostering innovation. By outlining these critical elements, this report aims to provide a roadmap for policymakers, technologists, and stakeholders in navigating the evolving landscape of neurotechnology regulation.