Introduction

Brain-Computer Interfaces (BCIs) are rapidly evolving technologies that allow direct communication between the human brain and external devices. While they hold immense potential in medical applications – such as restoring mobility, communication, or treating neurological conditions – they also introduce serious cybersecurity concerns. Unlike traditional medical devices, BCIs deal directly with neural data, making them uniquely sensitive and potentially vulnerable to exploitation.

Regulatory frameworks and data protection

Currently, there is no unified regulation or standard specifically for BCIs, but both the United States and the European Union have existing laws that partially apply to them. Since BCIs are considered medical devices, frameworks like the EDR, NIS2, and the AI Act are relevant – especially as artificial intelligence plays an increasingly critical role in decoding brain signals. These developments raise urgent questions about data privacy.

Who has access to brain-derived data, and when? Where is it stored, and for how long? What happens if the data processed by these devices goes beyond personal information and begins to reveal thoughts or intentions? As BCIs evolving, these questions become central to ethical, legal, and technical discussions.

A new milestone in data protection: The Neurodata

The world’s first and most significant court ruling on BCIs data privacy emerged in South America. The case involved a U.S.-based neurotechnology company and its portable device, Insight, which records brain activity and stores the data in the cloud. The plaintiff argued that the device failed to protect users neural data, violating constitutional privacy rights in Chile.

What made this case groundbreaking was the legal recognition of neurodata as a new, distinct category of data. The court acknowledged that neurodata can qualify as both personal and sensitive, especially when used for health purposes or identity recognition. More importantly, it emphasized that neurodata can reveal deeply intimate aspects such as thoughts, emotions, and intentions. For this reason, the court ruled that neurodata must be treated as a fundamental part of human rights.

The Peak of BCIs: Neuralink

Neuralink, founded by Elon Musk in 2016, is currently the most influential company in the development of BCIs. Their chip, the size of a coin, connects to the brain via ultra-thin wires and transmits brain signals wirelessly to a computer.

The Neuralink system enhances not only physical function but also psychological well-being by restoring a sense of autonomy, self-confidence, and access to leisure. The chip is implanted using a robotic arm, which avoids damaging blood vessels in the brain, making the procedure safer and more precise.

Unlike earlier BCIs, Neuralink’s device is wireless, using Bluetooth for communication. This eliminates physical vulnerabilities associated with wires, such as accidental disconnection or deliberate damage, though it introduces new cybersecurity concerns.

Potential Medical Applications of Neuralink BCIs:

• Motor Rehabilitation:
  Restores lost movement in limbs through brain-controlled robotic arms or legs.
• Communication for Nonverbal Patients:
  Enables individuals who cannot speak to express thoughts through brain signals translated into text or speech by AI.
• Mental Health Support:
  Helps patients regain access to activities like gaming, positively affecting emotional and psychological health.

Bluetooth vulnerabilities of the BCIs

BCIs, such as those developed by Neuralink, rely on Bluetooth for wireless data transmission. While this enables seamless brain-to-device communication, it also exposes BCIs to various cyber threats. Below are the key Bluetooth-based vulnerabilities that may affect BCIs:

• Bluebugging:
  Allows attackers within 10 meters to gain unauthorized access to a BCI device, potentially intercepting neural signals or altering its functions. Though physical proximity is required, an insider (e.g. hospital staff) could pose a risk.
• Bluejacking:
  Sends unsolicited messages to Bluetooth-enabled devices. While not inherently dangerous, it may disrupt BCI data transmission and affect signal quality.
• Bluesnarfing:
  Enables data theft from unsecured Bluetooth connections over distances up to 100 meters. In BCI applications, this could lead to massive neurodata leaks without user awareness.
• BlueBorne:
  A highly aggressive attack that allows full takeover of a Bluetooth-enabled device. In BCIs, it could lead to complete control, data theft, or injection of malicious commands.
• KNOB Attack:

Breaks Bluetooth encryption by manipulating key negotiation protocols. Attackers can intercept and decrypt neural data or send fake signals to the BCI device.

• BLE Spoofing (BLESA):
  Fools devices into trusting a malicious Bluetooth Low Energy source. In BCI settings, this could result in life-threatening misinformation (e.g., incorrect drug delivery).
• BCI Whispering:
  Hijacks Bluetooth audio connections to eavesdrop or manipulate signals.
• Bluetooth DoS:
  Overloads the BCI system, draining battery or halting neural data transmission, compromising device availability.
• Bluetooth Tracking:
  Locates BCI users via Bluetooth signals, exposing their real-time location and privacy.
• Man-in-the-Middle (MITM):
  Intercepts communication between BCI and connected devices, secretly stealing or altering sensitive neural data over time.

Foundations of a legal framework

Security must be integrated from the start (Security by Design), especially given BCIs critical role in assisting people with severe conditions. Developers have a responsibility to ensure robust protection throughout the product lifecycle.

BCIs handle highly sensitive neurodata. This data should be legally recognized as personal or sensitive data and protected accordingly. It must be encrypted during storage and transmission, with strict access controls.

“Privacy by Design” principles must be applied, ensuring data protection from collection through to deletion. Systems should feature encryption, anonymization, and user-controlled access.

Users must retain full control of their neurodata. They alone should decide if, when, and how it is shared or deleted. Additional concerns include:

• Protecting thought privacy from unauthorized access,
• defining limits on law enforcement access to neural data,
• preventing third-party use of neurodata for advertising.

Comprehensive risk management is essential. Developers should follow international standards (e.g., ISO/IEC 31000:2018) to identify and mitigate risks.

Rapid-response teams must be in place to address incidents such as data breaches or system failures that affect users health or privacy.

Training and awareness programs should be tailored to users, clinicians, and data handlers to ensure understanding of risks and protection measures.

Finally, legal frameworks must ensure:

• User ownership of neurodata,
• specific BCI cybersecurity regulations,
• ethical safeguards,
• global standardization aligned with GDPR, MDR, and IVDR.

Summary

The future faces several cybersecurity challenges without complete solutions yet. Existing regulations, especially in the EU and US are promising but do not cover every cyber risk. Brain-computer interfaces represent a major healthcare advancement, but their wireless Bluetooth communication faces proven threats. A clear legal and regulatory framework is needed to protect electronic medical devices, such as BCIs, with a strong focus on data privacy, ethics, risk management and education.