The GDPR, the EU’s data protection regulation, is the bloc’s most famous tech export, and it has been copied everywhere from California to India.
The approach to AI the EU has taken, which targets the riskiest AI, is one that most developed countries agree on. If Europeans can create a coherent way to regulate the technology, it could work as a template for other countries hoping to do so too.
“US companies, in their compliance with the EU AI Act, will also end up raising their standards for American consumers with regard to transparency and accountability,” says Marc Rotenberg, who heads the Center for AI and Digital Policy, a nonprofit that tracks AI policy.
The bill is also being watched closely by the Biden administration. The US is home to some of the world’s biggest AI labs, such as those at Google AI, Meta, and OpenAI, and leads multiple different global rankings in AI research, so the White House wants to know how any regulation might apply to these companies. For now, influential US government figures such as National Security Advisor Jake Sullivan, Secretary of Commerce Gina Raimondo, and Lynne Parker, who is leading the White House’s AI effort, have welcomed Europe’s effort to regulate AI.
“This is a sharp contrast to how the US viewed the development of GDPR, which at the time people in the US said would end the internet, eclipse the sun, and end life on the planet as we know it,” says Rotenberg.
Despite some inevitable caution, the US has good reasons to welcome the legislation. It’s extremely anxious about China’s growing influence in tech. For America, the official stance is that retaining Western dominance of tech is a matter of whether “democratic values” prevail. It wants to keep the EU, a “like-minded ally,” close.
What are the biggest challenges?
Some of the bill’s requirements are technically impossible to comply with at present. The first draft of the bill requires that data sets be free of errors and that humans be able to “fully understand” how AI systems work. The data sets that are used to train AI systems are vast, and having a human check that they are completely error free would require thousands of hours of work, if verifying such a thing were even possible. And today’s neural networks are so complex even their creators don’t fully understand how they arrive at their conclusions.
Tech companies are also deeply uncomfortable about requirements to give external auditors or regulators access to their source code and algorithms in order to enforce the law.
Leggett told researchers that she “became one” with her device. It helped her to control the unpredictable, violent seizures she routinely experienced, and allowed her to take charge of her own life. So she was devastated when, two years later, she was told she had to remove the implant because the company that made it had gone bust.
The removal of this implant, and others like it, might represent a breach of human rights, ethicists say in a paper published earlier this month. And the issue will only become more pressing as the brain implant market grows in the coming years and more people receive devices like Leggett’s. Read the full story.
—Jessica Hamzelou
You can read more about what happens to patients when their life-changing brain implants are removed against their wishes in the latest issue of The Checkup, Jessica’s weekly newsletter giving you the inside track on all things biotech. Sign up to receive it in your inbox every Thursday.
If you’d like to read more about brain implants, why not check out:
+ Brain waves can tell us how much pain someone is in. The research could open doors for personalized brain therapies to target and treat the worst kinds of chronic pain. Read the full story.
+ An ALS patient set a record for communicating via a brain implant. Brain interfaces could let paralyzed people speak at almost normal speeds. Read the full story.
+ Here’s how personalized brain stimulation could treat depression. Implants that track and optimize our brain activity are on the way. Read the full story.
Burkhart’s device was implanted in his brain around nine years ago, a few years after he was left unable to move his limbs following a diving accident. He volunteered to trial the device, which enabled him to move his hand and fingers. But it had to be removed seven and a half years later.
His particular implant was a small set of 100 electrodes, carefully inserted into a part of the brain that helps control movement. It worked by recording brain activity and sending these recordings to a computer, where they were processed using an algorithm. This was connected to a sleeve of electrodes worn on the arm. The idea was to translate thoughts of movement into electrical signals that would trigger movement.
Burkhart was the first to receive the implant, in 2014; he was 24 years old. Once he had recovered from the surgery, he began a training program to learn how to use it. Three times a week for around a year and a half, he visited a lab where the implant could be connected to a computer via a cable leading out of his head.
“It worked really well,” says Burkhart. “We started off just being able to open and close my hand, but after some time we were able to do individual finger movements.” He was eventually able to combine movements and control his grip strength. He was even able to play Guitar Hero.
“There was a lot that I was able to do, which was exciting,” he says. “But it was also still limited.” Not only was he only able to use the device in the lab, but he could only perform lab-based tasks. “Any of the activities we would do would be simplified,” he says.
For example, he could pour a bottle out, but it was only a bottle of beads, because the researchers didn’t want liquids around the electrical equipment. “It was kind of a bummer it wasn’t changing everything in my life, because I had seen how beneficial it could be,” he says.
At any rate, the device worked so well that the team extended the trial. Burkhart was initially meant to have the implant in place for 12 to 18 months, he says. “But everything was really successful … so we were able to continue on for quite a while after that.” The trial was extended on an annual basis, and Burkhart continued to visit the lab twice a week.
“A patient should not have to undergo forcible explantation of a device,” says Nita Farahany, a legal scholar and ethicist at Duke University in North Carolina, who has written a book about neuro rights.
“If there is evidence that a brain-computer interface could become part of the self of the human being, then it seems that under no condition besides medical necessity should it be allowed for that BCI to be explanted without the consent of the human user,” says Ienca. “If that is constitutive of the person, then you’re basically removing something constitutive of the person against their will.” Ienca likens it to the forced removal of organs, which is forbidden in international law.
Mark Cook, a neurologist who worked on the trial Leggett volunteered for, has sympathy with the company, which he says was “ahead of its time.” “I get a lot of correspondence about this; a lot of people inquiring about how wicked it was,” he says. But Cook feels that outcomes like this are always a possibility in medical trials of drugs and devices. He stresses that it’s important for participants to be fully aware of these possibilities before they take part in such trials.
Ienca and Gilbert, however, think something needs to change. Companies should have insurance that covers the maintenance of devices should volunteers need to keep them beyond the end of a clinical trial, for example. Or perhaps states could intervene and provide the necessary funding.
Burkhart has his own suggestions. “These companies need to have the responsibility of supporting these devices in one way or another,” he says. At minimum, companies should set aside funds that cover ongoing maintenance of the devices and their removal only when the user is ready, he says.
Burkhart also thinks the industry could do with a set of standards that allow components to be used in multiple devices. Take batteries, for example. It would be easier to replace a battery in one device if the same batteries were used by every company in the field, he points out. Farahany agrees. “A potential solution … is making devices interoperable so that it can be serviced by others over time,” she says.
“These kinds of challenges that we’re now observing for the first time will become more and more common in future,” says Ienca. Several big companies, including Blackrock Neurotech and Precision Neuroscience, are making significant investments in brain implant technologies. And a search for “brain-computer interface” on an online clinical trials registry gives more than 150 results. Burkhart believes around 30 to 35 people have received brain-computer interfaces similar to his.
Leggett has expressed an interest in future trials of brain implants, but her recent stroke will probably render her ineligible for other studies, says Gilbert. Since the trial ended, she has been trying various combinations of medicines to help manage her seizures. She still misses her implant.
“To finally switch off my device was the beginning of a mourning period for me,” she told Gilbert. “A loss—a feeling like I’d lost something precious and dear to me that could never be replaced. It was a part of me.”
