By: Bella Hood

Unsurprisingly, inventing a novel brain implant requires navigating through a field of legal landmines. Elon Musk’s company, Neuralink, founded in 2016, continues to forge ahead in the development of a chip that the company is now calling Telepathy. Despite managing an abundance of legal hurdles and more guaranteed on the horizon, last month, Neuralink implanted the chip into a human for the first time.

Neuralink’s headlining product is the size of a quarter and designed to sit in the part of the brain that controls movement. Neuralink states that “the device is designed to interpret a person’s neural activity, so they can operate a computer or smartphone by simply intending to move – no wires or physical movement are required.” According to the company website, “the implant is powered by a small battery charged wirelessly from the outside via a compact, inductive charger that enables easy use from anywhere.” Musk, the owner and active user of X, posted on the social media site recently saying the first target users will be “those who have lost use of their limbs” and adding, “imagine if Stephen Hawking could communicate faster than a speed typist or auctioneer. That is the goal.” While Neuralink and Telepathy are getting a lot of attention, this is not the first time a brain-computer interface (BCI) has been implanted into a human. In fact, in the late 1990s, a scientist named Phil Kennedy developed a BCI that allowed a paralyzed patient to move a computer cursor using her brain.

One of the larger regulatory impediments has proven to be the U.S. Food and Drug Administration (FDA). The FDA is the federal agency responsible for ensuring the safety, efficacy, and security of medical devices, among other things. In 1976, Congress made FDA approval a requirement for medical devices to be sold in the U.S. The agency is led by the Commissioner of Food and Drugs, who is appointed by the President of the United States.

Neuralink announced in September 2023 that it received FDA approval to launch its first “in-human clinical study.”  The FDA previously denied permission in 2022 noting “major safety concerns” involving “the device’s lithium battery; the potential for the implant’s tiny wires to migrate to other areas of the brain; and questions over whether and how the device can be removed without damaging brain tissue.” The clinical trial will seek people ages 22 and older living with quadriplegia due to spinal cord injury or amyotrophic lateral sclerosis. Despite receiving approval to conduct the clinical study, Neuralink is only on step 3 of 5 on the FDA’s device development process.

Aside from FDA approval, the development of the chip has stoked anger amongst animal welfare groups and brought accusations of illegal conduct. In February 2023, the U.S. Department of Transportation conducted an investigation into alleged “unsafe transport of contaminated hardware.” Pete Buttegieg is the current Secretary of Transportation, appointed by President Biden in 2021. The Department oversees all national transportation policy. The investigation came after an animal welfare group claimed public records, including emails between Neuralink executives and the University of California, Davis, showed that Neuralink potentially violated federal hazmat law in 2019. Because UC Davis is a public institution, it is subject to public records requests. 

Neuralink’s run-ins with federal agencies do not stop there. The same animal welfare group filed a complaint with the U.S. Department of Agriculture in 2022 accusing Neuralink of violating the Animal Welfare Act which regulates the treatment of animals in research, transportation, sale, and handling.

Between 2018 and December 2022, the company killed roughly 1,500 animals, including pigs, sheep, and monkeys. Critics lament that while animal deaths are certainly not uncommon in scientific research, the process and speed of Neuralink’s research has exacerbated the mistreatment of these animals.

Yet another area of law Neuralink has exposed itself to is securities regulation. In November 2023, Four Democratic House Representatives sent a letter to the Securities Exchange Commission (SEC) demanding an investigation into Musk’s recent statements regarding the company’s handling of animals. The lawmakers are concerned that the billionaire’s statements “downplayed investor concerns about the results of its animal testing.” The Securities Act of 1933 was enacted after the stock market crash in 1929 and designed to protect investors by increasing transparency surrounding financial information and prevent misrepresentation by issuers of securities. By downplaying the animal abuse incidents, Musk may have painted a more stable picture of the private company than was accurate at the time, leading investors to increase their investments. It remains to be seen whether Musk will face further investigations over potential securities fraud.

Aside from concerns over animal welfare, transportation, and securities exchange compliance, new issues with data privacy will no doubt come to the forefront if Musk’s device continues to develop. Experts have already expressed concern over the ownership of personal data collected by the implant and who will have access to sensitive information about users. Seeing as the biggest hurdle by far, a human successfully living with and utilizing the implant, has yet to be surpassed, Neuralink’s legal team is sure to have no shortage of problems to tackle in the foreseeable future.