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Elon Musk Wants to Hack Your Brain

How will the FDA manage that?

In July, Elon Musk made a highly anticipated announcement about his secretive brain-computer interface company, Neuralink. The big reveal: a new set of thin electrodes in “threads” and a “sewing machine for the brain” designed to implant the electrodes through small holes in the skull. Musk envisions using brain-computer interfaces, or BCIs, to control smartphones—imagine using an app or typing a text message without moving your fingers—but technologies like Neuralink’s could also become groundbreaking tools for medicine and surgery.

The company laid out plans to test its tech in humans with authorization from the Food and Drug Administration next year. Musk is certainly known for pushing aggressive deadlines for his technologies, but this rushed timeline may signal that he might not really understand the complexity of the FDA process. And it’s not just Musk who is getting into this space. Facebookjust announced that it wants to create mind-reading technology to control virtual reality, while Braintree founder Bryan Johnson’s BCI company Kernel explicitly aims to advance human cognition. A sector trying to “move fast and break things” might not have the patience to comply with FDA regulations. Instead, the clash between the FDA’s legal lag and an overzealous BCI industry could lead to real patient harm and damage the agency’s ability to oversee cutting-edge technologies.

In the past, our limited understanding of the brain’s electrical system has made managing neurological disease and trauma difficult. But utilizing the power of artificial intelligence, BCIs could potentially diagnose and treat complex neurological conditions. If BCI technology works as hoped, it could grant patients with motor impairments the chance to walk, stimulate breakthroughs in treating mental illness, or reverse degenerative brain diseases such as Parkinson’s. “Revolutionary” would be an understatement.

On the other hand, using BCIs in patients or ostensibly healthy people could pose some serious concerns. Inserting objects into the brain, even via a harmless-sounding “sewing machine,” creates obvious safety issues like damaging neural tissue or causing an immune reaction or infection in the brain. BCIs also raise privacy and security issues because of their digital component. Who will get to collect and use the data created by patients’ brains? How will BCIs be protected from cyberattacks? Will they be available only to the wealthy? Might patients become dependent on companies who implant them?

Unanswered questions about which FDA rules would apply to BCI software and whether developers are protected from lawsuits (as other implantable device developers are) could push BCI companies to develop their devices in places U.S. rules and lawsuits cannot reach—and where fewer protections might be available for test subjects. Medical tourism, safety and consent concerns, data protection, and access for only the wealthy could quickly follow.

With Neuralink and other BCI companies pressing forward, the time has come for both regulators to take the technology seriously and industry to place patient protection at the center of innovation. Rather than uncontrollably accelerate innovation, the BCI industry will need to make a good faith effort to work with device regulators to protect patients. In turn, the FDA may need to pursue more flexible programs for speedy, yet safe innovation. Failure to compromise could instead lead to patient harm or exploitation under the guise of progress.

Future Tense is a partnership of SlateNew America, and Arizona State University that examines emerging technologies, public policy, and society.


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