Brain-computer interfaces can dramatically improve the lives of people with disabilities, but they can also suck up sensitive information about what goes on in a person’s brain. Questions and concerns about how that information might be used could delay the transformative technology from reaching the market, according to a new government report.
These devices, including wearables as well as ones that are implanted, help people with severe disabilities communicate or use robotic limbs. The Government Accountability Office’s report suggests three areas that the field will need to address: protecting implantee’s neural data, providing them with support after implantation, and working with Centers for Medicare and Medicaid Services to determine coding, coverage, and payment for the devices.
“This is not something that fell off the turnip truck,” said Amy Kruse, a former neuroscientist and the chief investment officer at Texas-based investment firm, Satori Neuro. “The science has been well-established and the methodologies and processes have really been a building almost like a crescendo, right to the moment that we are in right now.”
The report, a response to a Congressional request, comes at an inflection point, said industry experts. The Food and Drug Administration has awarded “breakthrough device” designation to devices from many firms, including Paradromics, Synchron and Precision Neuroscience. Clinical trials with a few participants are expanding to confirm their efficacies. And Neuralink founder Elon Musk is poised to become a top advisor in the incoming Trump administration.
“We need to take the progress we’ve made today and say, ‘OK, what products can we actually make to start to help people and improve their quality of life,” said Jennifer Collinger, past president of the BCI Society and associate professor in the Department of Physical Medicine and Rehabilitation at the University of Pittsburgh.
Conducting human trials with brain-computer interfaces is difficult, according to the report’s authors. Recruitment is tough, measuring brain signals can be tricky, and the industry hasn’t developed a reliable manufacturer for devices. But companies are moving past these obstacles toward new challenges.
Consumer neurotech devices rarely include protections or restrictions detailing how companies can employ or sell a user’s neural data. While some states have passed or are pursuing regulations to plug this privacy gap, the GAO suggests Congress pass legislation that could accelerate these piecemeal protections. As the authors show, nonmedical products, such as Neuralink’s N1 Implant, do not have as many consumer protections sewn into their existence across the federal health apparatus.
Insufficient consumer protections can have dramatic consequences. Second Sight was a neurotechnology startup that sold retinal implants to hundreds of people. Then, without warning, they went bankrupt, leaving their consumers stranded with obsolete gadgets in their eyes. While BCI industry professionals are eager to move past that fiasco, the nascent field does not afford patients many protections.
To avoid another Second Sight and to share knowledge, researchers, industry leaders and FDA officials recently formed a collaborative community to plot the industry’s future. Many of their conversations have centered around the need to develop usable outcome measures for clinical trials that can accurately capture the device’s functioning and a patient’s needs.
While BCI developers have worked in concert with FDA officials to develop these measures, Centers for Medicare and Medicaid Services officials have only just gotten involved. Securing the cooperation of CMS represents a “major junction” for the industry, but experts told the authors that “it can be challenging to interact with CMS about BCIs.” To boost communication, CMS officials suggested companies contact the CMS Ombudsman program or apply for the new Transitional Coverage for Emerging Technologies pathway, which simplifies securing Medicare coverage for devices that receive the FDA’s breakthrough device designation. However, only five devices can enter the program and many BCI devices are too far along the pathway to qualify.
While the communication challenges are legitimate, the authors suggest that they could spur the development of outcome measures that will improve the quality of life for people with disabilities who receive these implants. This report is also a partial snapshot of BCI technology, as it only discusses devices that measure brain activity and deploy it to control phones, computers or other devices. Many industry experts believe the field’s true potential resides in devices that can stimulate the brain to move limbs or create sensations.
“These discussions will help to facilitate continuous innovation toward wide, equitable access to implantable BCIs with the potential to improve communication, mobility, and other functions for people with neurological conditions,” said Leigh Hochberg, a neurologist at Massachusetts General Hospital and the director of BrainGate clinical trials.