Bárbara Antunes Goldman (Master's student in European Union Law at the School of Law of the University of Minho)

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The Spanish Presidency of the Council of the European Union, which runs from 1 July to 31 December 2023, has expressed its commitment to the digitalisation of Europe, especially with regard to raising awareness of the need for proper regulation of non-invasive neurotechnologies in the European Union (EU) and preparing its Member States for what lies ahead.

To this end, in October 2023, an informal ministerial meeting was held in the city of León, where the Telecommunications and Digital Ministers of the EU Member States met to discuss the paths to be taken so that the EU can consolidate itself as a global reference in the protection and recognition of digital rights. This meeting resulted in the León Declaration on European Neurotechnology: A Human Centric and Rights-oriented Approach.[i]

Neurotechnology is a significant part of the current wave of technological developments that converge neuroscience, digitalisation, and artificial intelligence, promising remarkable improvements in mental health, well-being, and productivity. This novel neurotechnology offers “devices and procedures used to access, monitor, investigate, assess, manipulate, and/or emulate the structure and function of the neural systems of natural persons.”[ii]

As neurotechnology becomes more accessible in clinical and non-clinical settings, it raises ethical, legal, and societal questions concerning its disruptive and potentially human rights-violating aspects. Moreover, the boom in neurotechnology advancement is setting up an international race to innovate, scale, and secure market share.[iii]

Regarding medical treatments or clinical trials, neurotechnology is well-fitted into existing legislation and medical research codes of ethics. Besides, the problem of finding the answers to the tricky questions that neurotechnology proposes seems understandably outweighed by the wonders it offers.

For example, many of us watched in astonishment as a man paralysed from the waist down used a mind-controlled exoskeleton to kick off the 2014 FIFA World Cup.[iv] However, we certainly did not immediately delve into details about how scientists dealt with the tens of thousands of electrical signals recorded from people’s brains that allowed that breakthrough to happen. 

On the other hand, non-clinical use of neurotechnology follows legislation on electronic or well-being devices, and therein lies a big problem. It is important to acknowledge that neurotechnology not only offers a set of practices and tools for rehabilitation that can improve the lives of people struggling with mental and neurological disorders, but it also helps perfectly healthy human beings who wish to enhance brain activity.

For instance, neuro or brain stimulation can help build more effective and comprehensive education systems or provide complete and immersive entertainment experiences.[v] Furthermore, brain augmentation can also be used in warfare and other military purposes. All these non-medical fields for neurotechnology can be highly lucrative.

While mind reading is currently unachievable, improving brain performance with artificial components is no longer something in the realm of sci-fi. In addition to helping create new opportunities and developing talents, neural interfaces will play a relevant role in national economies and the job market.[vi] Unfortunately, that can also deepen social and economic inequalities.

The augmentation of brain function through non-medical and non-invasive neurotechnology is rapidly spreading to the general population, mainly through wearable devices. Like other emerging technologies, as wearable neurotechnology reaches consumer markets, the concern about its harmful use and the greed for its promised profits also increases.

It is true that wearable technologies, in general, already have a significant impact on markets and people’s lives. After all, smartwatches, fitness trackers, and Bluetooth headsets are already spread worldwide and embedded into our everyday lives. There is no reason to believe wearable neurotechnology will not go down the same path.

However, wearable neurotechnology seems like taking a step further into uncharted territory. Mainly because the brain is no ordinary organ. The brain is crucial to vital bodily functions, and it is also the fundamental enabler for the exercise of mental faculties. Undoubtedly, being alive and human largely depends on brain function.

These novel wearable neurotechnologies can create neural interfaces with little effort. They can connect brains directly to machines, creating a brain-computer interface (BCI) with a simple gadget, like a headset or earplugs, which captures electroencephalography (EEG) signals. This type of interface establishes a pathway that records and stimulates the human brain. In other words, a BCI enables bidirectional communication, simultaneously sending commands from the brain to external devices and delivering sensory signals to the brain.

Some even defend that neurotechnology is evolving towards types of brain-brain interface that connect humans not to machines but to each other, predicting, at some point, the existence of a global brain.[vii]  There is no need to go that far to promptly imagine the harm of misuse of wearable neurotechnology and BCIs once they spread among consumers in the same way that, for example, the smartphone has in the last decade.

Although it is a new and still emerging form of neurotechnology, the global BCI market size was valued at 1.74 billion USD in 2022 and is anticipated to grow at a compound annual growth rate (CAGR) of 17.5% until 2030.[viii] Around half of this growth is expected to be related to non-medical and non-military uses.[ix]

Indeed, it is key to make sure that the EU gets its share in this emergent global market. Likewise, it is of utter importance to consider and discuss neurotechnology’s potential to violate human rights and act upon it.

Therefore, the León Declaration on European Neurotechnology mentioned above is a well-timed guideline for an urgent and much-needed regulatory framework. The León Declaration acknowledges what neurotechnology is and what it can do while stating that the Council’s primary focus is on non-invasive techniques, which is precisely the kind of neurotechnology that market projections indicate will have stupendous growth among the general population.

Mainly, the León Declaration establishes a call for action from the signing Member States in a commitment to strengthen the EU’s competitiveness in neurotechnology markets while making sure to set up a sustainable system focused on its citizens that can tackle cognitive and emotional manipulation and fill the voids in legislation about data protection.

Therefore, it is not enough for the neurotechnologies available to consumers to be evaluated regarding safety and technical effectiveness. The ethical construct related to equitable access, cognitive freedom, data privacy, the right to object to automated data processing, and acceptable limits of cognitive enhancement, to name a few of the so-called neurorights, must also be considered. Nonetheless, perhaps the most important outcome of the León Declaration is helping one understand this novel neurotechnology as a new data mining technique.

The OECD Recommendation on Responsible Innovation in Neurotechnology defines personal brain data as “Data relating to the functioning or structure of the human brain of an identified or identifiable individual that includes unique information about their physiology, health, or mental states.”[x]

The amount of data generated by the current interconnected world is almost immeasurable, and it will grow exponentially once it becomes possible to read data directly from the brains connected to the internet. However, all these data must be processed to reach their potential value and utility. Therefore, data processing is essential and must be treated as such. Hence, it is crucial to understand that the adequate defence of information originating from the brain and mind is intrinsically linked to the protection  of brain data processing.

Concerning brain data, the León Declaration states that “Manipulating, collecting, retaining, processing, and storing brain data is of utmost sensitivity.”[xi] This statement reinforces that protecting personal brain data is a pressing issue and indicates that localising brain data in the GDPR is paramount. A renowned expert on the field, Marcello Ienca, argues that the GDPR is an adequate tool to mitigate risks related to what he calls “mental data processing” but recommends that “interpreters focus on processing characteristics, rather than merely on the category of data at issue”.[xii]

The data economy “is a global digital ecosystem where data is gathered, organized and exchanged to create economic value.”[xiii] Additionally, the data economy aims to highjack intention and induce consumption. Given that reality, if neural interfaces prove to be an instrument able to provide data that can be processed and, from that, generate an impact on its user’s mind, it will be a goldmine.

In such a manner, there should be no doubt about the importance of enhancing competitiveness and increasing the growth of BCI markets in the EU. Nevertheless, economic prosperity & competitiveness cannot prevail over the values on which the Union is founded (respect for human dignity, freedom, democracy, equality, the rule of law, and respect for human rights). Thus, the human-centred and rights-focused path for innovation proposed by the León Declaration seems to be the right way forward.

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[i] Spanish Presidency of the Council of the European Union, “León Declaration on European neurotechnology: a human focused and rights’ oriented approach”, Press Release, October 24, 2023, https://spanish-presidency.consilium.europa.eu/en/news/leon-declaracion-european-neurotechnology-human-rights/.

[ii] Recommendation of the Council on Responsible Innovation in Neurotechnology, adopted on  11 December 2019, OECD/LEGAL/0457, https://legalinstruments.oecd.org/en/instruments/OECD-LEGAL-0457.

[iii] Spanish Presidency of the Council of the European Union, León Declaration on European neurotechnology: a human centric and rights-oriented approach, https://spanish-presidency.consilium.europa.eu/media/o4rh53jr/le%C3%B3n-declaration.pdf.

[iv] Stephanie Smith, “Mind-controlled exoskeleton kicks off World Cup”, CNN, June 13, 2014, https://edition.cnn.com/2014/06/12/health/exoskeleton-world-cup-kickoff/index.html

[v] Spanish Presidency of the Council of the European Union, León Declaration on European neurotechnology: a human centric and rights-oriented approach, https://spanish-presidency.consilium.europa.eu/media/o4rh53jr/le%C3%B3n-declaration.pdf.

[vi]  Davide Valeriani, Francesca Santoro and Marcello Ienca, “The present and future of neural interfaces”, Front. Neurorobot, vol. 16 (2022). Doi: https://doi.org/10.3389/fnbot.2022.953968.

[vii] Marios Kyriazis, “Systems neuroscience in focus: from the human brain to the global brain?”, Front. Syst. Neurosci., vol. 9 (2015). Doi: https://doi.org/10.3389/fnsys.2015.00007.

[viii] Brain Computer Interface Market Size, Share & Trends Analysis Report By Application (Healthcare, Communication & Control), By Product (Invasive, Non-invasive), By End Use (Medical, Military), And Segment Forecasts, 2023 – 2030, Grand View Research Report, https://www.grandviewresearch.com/industry-analysis/brain-computer-interfaces-market.

[ix] Brain Computer Interface Market Size, Share & Trends Analysis Report By Application…

[x] Recommendation of the Council on Responsible Innovation in Neurotechnology, https://legalinstruments.oecd.org/en/instruments/OECD-LEGAL-0457.

[xi] Spanish Presidency of the Council of the European Union, León Declaration on European neurotechnology: a human centric and rights-oriented approach, https://spanish-presidency.consilium.europa.eu/media/o4rh53jr/le%C3%B3n-declaration.pdf.

[xii] Marcello Ienca and Gianclaudio Malgieri, “Mental data protection and the GDPR”, J Law Biosci. 25;9(1) (2022). Doi: 10.1093/jlb/lsac006.

[xiii] Andrea Sestino, Adham Kahlawi, Andrea De Mauro, “Decoding the data economy: a literature review of its impact on business, society and digital transformation”, European Journal of Innovation Management, Vol. ahead-of-print, No. ahead-of-print. (2023). DOI: doi.org/10.1108/EJIM-01-2023-0078.

Picture credits: by meo on Pexels.com.