On January 23, 2025, President Donald Trump signed Executive Order 14179, “Removing Barriers to American Leadership in Artificial Intelligence,” which sought to revoke existing AI policies and directives that act as barriers to American AI innovation. The federal government’s push for AI development may accelerate the availability of neurotechnologies that incorporate AI, while reducing regulatory oversight and consumer protections.
Pursuant to the Executive Order, the White House released a comprehensive policy strategy entitled “Winning the Race: America’s AI Action Plan” in July of 2025. The policy includes a recommendation to remove red tape by “review[ing] all Federal Trade Commission (FTC) investigations . . . to ensure that they do not advance theories of liability that unduly burden AI innovation.” The policy also encourages the country to “establish regulatory sandboxes or AI Centers of Excellence around the country where researchers, startups, and established enterprises can rapidly deploy and test AI tools . . . enabled by regulatory agencies such as the Food and Drug Administration (FDA).” Implementing these recommendations may directly affect the development of neurotechnologies.
Brain-computer interfaces (BCIs) are neurotechnologies that allow for communication between the human brain and external output, such as a computer, mobile device, or prosthetic device. They are subject to FDA and FTC oversight, depending on their intended use. The primary FDA department responsible for regulating medical neurotechnologies is the Division of Neurological and Physical Medicine Devices (DNPMD). For direct-to-consumer technologies, the FTC oversees consumer protection and privacy. The Management of Individuals’ Neural Data Act of 2025 (the MIND Act) is proposed legislation that would direct the FTC to study how neural data are currently governed.
Neuralink and Merge Labs are companies that are eager to incorporate AI in their BCI technologies. Neuralink, headed by Elon Musk, produces a BCI that is implanted in the brain near neurons of interest. Electrodes within the BCI then detect electrical signals from neurons and decode information. The goals of Neuralink are to “restore autonomy to individuals with unmet medical needs today, and to unlock superhuman capabilities across many people in the future.” The company aims to eventually connect brain neural networks to artificially intelligent networks outside the brain.
One month before the release of America’s AI Action Plan, Neuralink received FDA breakthrough device designation to restore communication for individuals with speech impairment. Musk has also benefited from his relationship with the Trump Administration and his former position as the leader of the Department of Government Efficiency (DOGE), which has significantly reduced the federal civil service. In February of 2025, DOGE reportedly fired the FDA employees responsible for overseeing Neuralink. Ten months later, Neuralink hired the former director of the FDA office responsible for regulating the company to lead its medical affairs division.
Sam Altman, the CEO of OpenAI, has recently partnered with the Trump Administration on the Stargate Project, which “intends to invest $500 billion over the next four years building new AI infrastructure for OpenAI in the United States.” Co-founded by Altman, Merge Labs is researching a new approach that could combine gene therapy with an ultrasound device to create non-invasive BCIs. The company has a long-term mission of “bridging biological and artificial intelligence to maximize human ability, agency, and experience.” OpenAI is the largest investor in Merge Labs, which has raised $252 million of funding. Along with funding, OpenAI announced that it will collaborate with Merge Labs to accelerate progress, stating that “BCIs will create a natural, human-centered way for anyone to seamlessly interact with AI.”
Merge Labs has not yet submitted technology for FDA approval. It is unclear how the technology would be classified, especially because the company’s mission is not explicitly related to medical uses and the technology aims to be non-invasive. With the release of America’s AI Action Plan, it is also unclear whether consumers can rely on the FTC for privacy protections regarding this technology. Removing red tape and enabling AI adoption may open the door to faster development and distribution of these life-changing technologies for people with disabilities. However, brain surgery and gene therapy that incorporate AI are potentially permanent medical procedures that could put Americans at risk of long-lasting health impacts and privacy invasions.