By , and -

Elon Musk’s Neuralink recently livestreamed a video of Noland Arbaugh, the paralysed first recipient of a brain-implant developed by the company, playing chess on his laptop by thought alone. Whilst brain-computer interfaces are not new, Musk’s backing underscores the commercial potential many other investors now appreciate.

Arbaugh has already discussed the capacity of the device to restore autonomy to himself and others, underscoring the very significant upside of neurotech. However, the technology’s human rights implications also need consideration and some countries have undertaken a legislative response or the beginnings of one.

The emerging field of neurotechnology

For centuries the brain has been a tantalizing black box. Over recent decades, however, it has begun to reveal some of its secrets to neuroscientists. This understanding of the brain has led to new technologies and the first modern neurotech device to become fairly widely available is the cochlear implant (CI). Since the 1970s, more than one million CIs have provided profoundly deaf people with the ability to hear. CIs don’t interface directly with the brain, however, and the first deep brain stimulators (DBS), which interface with neurons within the brain, were approved for use in the late 1990s for people with conditions such as Parkinsons’ Disease. More complex devices such as Blackrock Neurotech’s Utah Array has been used since the early 1990s to allow quadriplegics to interface with computers and accomplish physical tasks with robotic limbs using only thoughts.

Turning now to newer forms of neurotech, Neuralink’s device operates somewhat similarly to other DBSs with the aim of improving brain-device connectivity. The Synchron implant is based on a stent and complex neurosurgery is not required thus the risk of brain damage is significantly reduced.

While BCIs and DBS have been used for many years as research tools and last-resort therapeutics for people with severe disease or injury, these implants damage the brain. While devices which only read brain signals are far less damaging, scar tissue, tissue damage, and resulting neuropathologies are side-effects of all invasive BCIs. Often the cases where such devices have been used are severe enough to warrant that form intervention but as neurotech becomes more mainstream understanding risks will be essential for users and their families.

Beyond therapy

Some neurotechnologies are not invasive and are forms of wearable that are currently available for purchase over the internet. For example, Emotiv, a company that has its origins in Australia offers various headsets for sale in support of a variety aims including workplace wellness, customer research, scientific research, and education.

Some military and criminal justice institutions have engaged with this emerging technology. The Defence Advanced Research Projects Agency (an American military organisation) has a longstanding interest in neurotech, including brain-computer interfaces used to control drones by thought alone rather through manual control of a joystick, and the company Brainwave Science offers a product which it suggests enables police to monitor the brains of suspects who are being interrogated in order to get extra information about the suspect’s responses directly from their neural activity.

These forms of neurotechnology involve connecting humans to technology but the Australian company, Cortical Labs is engaged in a different form of neurotechnology that uses laboratory-grow neurons (rather than actual human beings) fused with silicon in order create hybrid forms of intelligence.

The upside of neurotechnology

Perhaps the most obvious upside of neurotech its ability to restore function for people with serious brain or nervous system-related injuries or neurological diseases. Additionally, neurotechnology is used extensively in animal studies and has expanded our understanding of the nervous system and neurophysiology. Human recipients of this technology also provide data which has added to scientific understanding.

Non-therapeutic invasive applications are probably still many years away given the potential side effects and our limited understanding of biological neural networks. Wearable devices or products in development such as that of Synchron that are invasive but less so than forms of DBS are almost certainly the short and medium-term answer for consumer or wellness applications.

Despite advances in technology and in our understanding of the brain since the first cochlear implantation almost 50 years ago, the biggest challenge in this field is interfacing reliably and safely with the human body and particularly the human brain. The computational advancements of the last decades allow high-bandwidth interfacing with a brain and this will continue to improve, however, connecting seamlessly to a brain without damage or interference is the real challenge. Advancements in material science and biocompatible materials are likely to be the way forward to making neurotech more widely available.

Commercial excitement and venture capital

Neurotechnology has now clearly moved beyond research into a commercialisation phase and the emerging technologies are becoming mature enough that markets are slowly becoming willing to buy into the risk-return trade-off.

There are enormous return prospects for neurotech, and global venture capital activity is responding to that. The major brain-computer interface companies are all venture backed and US$ 1.5 billion in venture capital was raised last year for neurotech. Fuelling the momentum, is the growing acceptance from providers (such as hospital networks) and payers (such as the state or private insurance).

From a commercial perspective the risks are significant partly because neurotechnology doesn’t live in free markets, it lives in regulated markets, and in respect of therapeutic devices the medical device regulator can have significant impact on commercial outcomes. An investor might spend a large amount of money and fail to meet the primary goals of a pivotal study or succeed, only to be met by a delay in approval or unsuccessful coverage. Uncertainty concerning the regulator and reimbursement deters many venture capitalists, in particular generalists from investing in neurotechnology but this may change as the commercial upsides of neurotechnology become more evident.

Whilst Australia has some interesting and successful neurotech companies (and a very early success with Cochlear) its market is far behind the US in terms of neurotech commercialisation. Australia might be thought to lack sufficient domestic capital and population to allow the technology to mature however that should not negate the role of Australian research in the success of BCI. Otherwise we risk killing the incentives for researchers to found ground-breaking technologies like  recent success Synchron and Saluda Medical.

Ethics and law

Excitement about neurotech needs to be tempered by a consideration of ethical and legal issues. One issue with respect to novel therapeutic interventions is informed consent and given the novelty of emerging forms of brain-implants it is not clear what the long-term impact on the brain might be. Of course, the degree of risk a person may be prepared to assume will vary and a person who is paralysed below the neck might have a very different risk profile from someone with a less debilitating condition. Another issue relates to human trials – sometimes they are discontinued and we need to ask what provision there is for patients who are faced with such an eventuality.

But as devices improve in their capacity to detect neural activity, human rights thinking has turned towards the issue of mental privacy. So for example should police or security services be allowed to employ devices such as the company Brainwave Science’s brain monitoring headset which purports to detect ‘guilty knowledge’ in suspects during interrogations or should drivers of heavy goods vehicles have their brains monitored by their employees to prevent attention slips and accidents? What about offenders in the community having their brains monitored?

Questions in relation to equality emerge from a consideration of neurotech. What if cognitive enhancement were to become feasible so that there was a class of transhuman that were much smarter than ordinary humans? What kind of social issues might emerge and would such a society be inherently unfair?

Turning to a different form of neurotechnology -laboratory-grown neurons derived from human stem cells- one might ask at what point would making use of such synthetic biological intelligence be unethical. Might some of these brain organoids be conscious and have the capacity to suffer?

Finally, we need to consider some of the more traditional problems of the law such as punches thrown in anger and contracts entered into unfair circumstances. What if a neurotechnological malfunction where to explain an impulsive punch or purchase? We well might ask how the law should respond and will no doubt gain some guidance from precedent and legislation, but the novel neurotechnological environment might put strain on the existing legal sources.

Action

The current set of legal responses to neurotechnology began in Chile in 2022 with their constitutional change which added these words to section 19: Scientific and technological development will be at the service of people and will be carried out with respect for life and physical and mental integrity. The law will regulate the requirements, conditions and restrictions for its use in people, having to protect especially the brain activity, as well as the information coming from it.

Many countries in Latin America are now also considering constitutional reform. At the international level organisations such the OECD, the Council of Europe and the UN either have or are in the process of producing reports on what to do about neurotechnology.

A recent addition to this activity comes from the Australian Human Rights Commission, who in March 2024 released their report Protecting Cognition: Background Paper on Human Rights and Neurotechnology. Whilst Latin America is leading the world in respect of the consideration of human rights implications of neurotechnology, Australia is now significant with respect to common law nations insofar as it is the first such country to have its national human rights body produce a report on the implications of neurotechnology (reports from other common law countries have not made human rights the primary focus). The Human Rights Commission also leads the way within Australian government, being the first Australian institution to demonstrate a proper consideration of neurotechnology.

In the USA, the state of Colorado, whilst not having engaged in a comprehensive survey of neurotechnology and human rights, might be thought of as having gone a step further than Australia insofar as it now has a bill which aims to modify their privacy laws in light neurotechnology.

But neurotechnology raises a host of issues for law and many go beyond human rights. Bodies such as medical device and consumer regulators, data and privacy commissioners, and law reform commissions in Australia and around the world need to consider the emerging issues and to form a preliminary view of what might done in response.

However, it is vital that the wonderful therapeutic upside not be thwarted by a regulatory environment that is unnecessarily inhospitable to development. Law can have a role in guiding neurotechnology but not it should have not impede beneficial advancements. The restoration of autonomy to Noland Arbaugh and hopefully many others in the future must be kept firmly in mind when thinking about regulating how we merge with technology or respond to the legally significant conduct of those who have merged.


Allan McCay is an Academic Fellow at the University of Sydney Law School and Deputy Director of Sydney Institute of Criminology. Harikesh Pushpapathan is General Partner at Stoic Venture Capital. Tara Hamilton is CEO at Advanced PS Clocking, Chief Scientist as Cuvos, and Adjunct Associate Professor at UTS