Regulatory intelligence for US exporters

Export Controls Could Harm Innovation, Use of Brain-Computer Tech, BIS Hears

If not properly tailored, export controls on brain-computer interface (BCI) technologies could stifle U.S. competitiveness and slow academic research, tech companies and universities told the Bureau of Industry and Security in comments released this month. While some commenters said certain narrow, multilateral controls may be feasible, others said BIS should avoid controls altogether to avoid impeding U.S. innovation.

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BIS in October sought feedback on the possibility of controlling exports of BCI technologies, which could empower future militaries in unmanned missions and improve the “capabilities of human soldiers” (see 2110250011). But BIS also acknowledged that the technology could have important medical uses.

New York-based Synchron said it’s developing an “implantable” BCI medical device that could help treat paralysis, specifically for people suffering from amyotrophic lateral sclerosis or a spinal cord injury. The company said it has already gone through a “rigorous” approval process with the FDA, and BIS should be careful not to impose more regulatory obstacles. The agency should instead focus its controls only on BCI technologies with nonmedical uses, Synchron said.

“The U.S. currently holds a major technology advantage over the rest of the world in the field of invasive BCI,” the company said. “Any U.S. export controls placed on implanted BCI medical technology, either hardware or software, would substantially hinder this leadership position.”

While there are “legitimate national security” concerns with the technology, BIS should make sure those concerns avoid “disrupting medical technology innovation and patient care,” said Medtronic, a medical device company. Medtronic said controls could “significantly impact our research and development efforts, our ability to conduct clinical trials, and the provision of care to patients.”

It could also hinder the company’s ability to conduct clinical trials in foreign countries and limit their cooperation with “foreign affiliates and business partners,” Medtronic said. Controls might also restrict the company from sharing the technology with its foreign employees living in the U.S. Those people might have to qualify for a deemed export license, depending on export restrictions imposed on their home country.

Blackrock Neurotech, a U.S. biotechnology company, said BIS should “carefully consider the tremendous humanitarian importance” of BCI technology-powered medical devices. The agency should specifically avoid placing restrictions on BCI tech used for “rehabilitative applications,” which can be used to treat “debilitating neurological disorders” through advanced prosthetics and other methods.

“Given the potential impact of this category of brain computer interfaces on the lives of the disabled,” Blackrock said, “such technologies have received great academic and market interest” and could be the first category of BCI technology to be commercialized. “Blackrock believes that any proposed rulemaking carefully consider the tremendous humanitarian importance of these devices, and the need for continued academic and industry collaborations to fully develop them.”

The tech could also lead to important innovations in the auto industry, the Alliance for Automotive Innovation told BIS. Carmakers are hoping to incorporate BCI into “crash avoidance systems,” specifically to help drivers with “slower reaction times,” the group said. But export controls could stunt U.S. competitiveness in this emerging technology area, it said in comments.

“Failure to craft tailored approaches to limit the transfer of BCI technologies from the U.S. could undermine the country’s leadership position in developing and deploying advanced vehicle technologies,” said the alliance, which represents Ford, Ferrari, Honda and other major car manufacturers.

BCI technology research is “well underway” in the EU and China, the alliance said. “If export controls are not multilateral and only imposed on BCI technologies in the U.S.,” it said, companies “may choose to invest in markets without such controls, elect to collaborate with technology partners outside of the U.S.” or “experience challenges in exporting U.S.-made cars and light trucks to other markets.”

Several university researchers and professors also urged BIS against imposing export controls on the technology. Allen DiPalma, a University of Pittsburgh trade compliance official, said the college feels “strongly that additional export control restrictions and market limitations will have a significant negative impact.”

Others said the controls, if imposed now, would serve little purpose. “These rules may be needed at some point, but they are premature,” said Alik Widge, a neurotechnology researcher at the University of Minnesota. There is “no functioning BCI technology that can actually augment human function in any way.”