The US Food and Drug Administration (FDA) has issued draft guidance for regulating the testing of brain-computer interface devices, an emerging field of medical technology.
The guidance follows an FDA public workshop and centres around recommendations for industry on procedures for non-clinical testing and clinical trial design when developing brain-computer interface devices. The aim is to ensure the safety and effectiveness of research output in this field.
Further support for these emerging devices will be carried out by the newly created Emerging Sciences Working Group to observe and report back about the status of this and similar technology.
What are brain-computer interface devices?
Using neuron silicon interfaces, brain-computer interface devices create a direct communication pathway between the brain and an external device.
Simply put, these technologies allow patients to use an external device to help restore function to sensory organs and limbs; the FDA defines them as “neuroprostheses that interfaces with the central or peripheral nervous system to restore lost motor and/or sensory capabilities in patients with paralysis or amputation.”
This communication can potentially provide “benefit to people with severe disabilities by increasing their ability to interact with their environment, and consequently, providing new independence in daily life.”
Examples of medical brain-computer interface devices are giving blind people the sensation of seeing light and simulating the movement of limbs in paralysed patients. This second use has been expanded to include direct brain control over moving robotic prosthetic limbs.
Moreover, this technology is being trialled to allow paralysed patients to move a computer cursor or fly a virtual helicopter by controlling their own brainwaves.
In a statement, former FDA Commissioner Scott Gottlieb said: “This is a critical area of development for the millions of people who suffer from conditions that inhibit their mobility.
“Today, we’re issuing draft guidance to help spur development of BCI devices for patients with paralysis or amputation, including our nation’s veterans.”
Despite the immense promise of these devices for drastically improving the lives of patients, the impact of the device’s direct linkage to the brain is not fully understood.
For this reason, the FDA’s recent advice is a so-called ‘leap frog’ guidance, which means it will be updated and altered as brain-computer interface technology develops.
Vulnerability to hacking and the question of data privacy
A major challenge for regulators will be to resolve issues around data and the threat of malicious hacking. Research has found that brain-computer interface devices could be vulnerable to cybercrime; termed ‘neurocrime’ and ‘brain hacking’ by ETH Zurich research fellow Dr Marcello Ienca and Radboud University Nijmegen associate professor Pim Haselager.
Scientists from the Belgian Catholic University of Leuven proved how easy brain-computer interface devices were to hack by using a laptop, a USB-6351 data acquisition system and two home-made antennas to take control of an implanted neurostimulator.
Neurocrime from brain-computer interface devices could include disrupting the devices even physically harming the patient by increasing the voltage of signals delivered to the brain, as well as depriving them of their computer-enhanced motor abilities, which causes psychological distress.
In their paper, the Belgian researchers said reprogramming the device could allow hackers to “prevent the patient from speaking or moving, cause irreversible damage to his brain, or even worse, be life-threatening.”
Hacking of brain-computer interface devices is also particularly concerning because of the implications it has in breaching patient’s personal, medical data records. Freedom of privacy is a universal right, which should be not violated because a person relies on a medical device.
The data privacy issue was identified by the Morningside Group of neuroscientist, clinicians, ethicists and machine-intelligence engineers from global academic and research institutions.
The group suggested that technology used in other industries to protect user privacy, such as blockchain and open-source code, could be implemented to protect user privacy.
The Belgian team echoed these proposals in their paper stating a touch-to-access policy and encryption could be used to improve security; they had found that the communication pathway between the brain and the device was not encoded or authenticated.
Inability to meet patient expectations
Issues with the efficacy, reliability and usability of brain-computer interface devices have been identified by many researchers. For example, a study by the American Academy of Neurology in 2018 found that in a home setting, rather than a research or clinical setting with expert support, it was common for patients to lose interest in the device.
The research showed that 14% of amyotrophic lateral sclerosis patients using an EEG-based brain-computer interface device at home lost interest in the device over the 12 to 18 month study period.
These findings have meant the devices struggle to meet the expectations of patients using them, which researchers associate with causing actual psychological harm as the patient’s desired actions cannot be achieved despite the medical device.
This is a serious concern for regulators whose core responsibility is to ensure medicines and medical devices do not prevent harm to vulnerable patients. Therefore, they need to support innovations that seek to improve the efficacy and usability of the devices, as well reduce any harm caused by them, such as through managing patient expectations of the device, including educating patients on the limitations of the brain-device interface.
The low strength of the signal obtained by the device from the brain are the reason for the high error rate with this technology, noted by a report by Nigerian researchers.
Usability is an issue because of the device’s aesthetics, battery life, and weight, as well as fatigue of users since it involves significant concentration on a particular task.