The MIND Act would direct the Federal Trade Commission (FTC), in consultation with the Office of Science and Technology Policy (OSTP), the FDA, and other agencies, to study the collection, use, storage, and transfer of neural data. Neural data is defined as information obtained by measuring activity of the central or peripheral nervous system through neurotechnology.

The Act applies broadly to devices that access, monitor, record, analyze, predict, stimulate, or alter nervous system activity, including consumer wearables and brain–computer interfaces (BCIs). Within one year, the FTC would submit a report recommending a regulatory framework for neural data, including categorization by sensitivity, sector-specific safeguards, cybersecurity protections, and potential prohibitions on manipulative or discriminatory uses.

In Girardi Lavín v. Emotiv Inc., the Supreme Court of Chile reviewed a constitutional challenge brought by Senator Guido Girardi Lavín against Emotiv Inc., a U.S.-based neurotechnology company headquartered in San Francisco. The case concerned the company’s “Insight” EEG headset, a consumer neurotechnology device that collects users’ brain activity data (neurodata) and stores it in the company’s cloud infrastructure.

The claimant argued that the device violated constitutional guarantees and Chile’s Personal Data Protection Law (Law No. 19.628), particularly Article 11 (controller due diligence) and Article 13 (right to cancel/block personal data). Alleged risks included reidentification, hacking, commercialization, unauthorized reuse, and surveillance. Emotiv contended that users provided explicit consent, that neurodata were pseudonymized or anonymized, and that the product was non-medical and compliant with Chilean and GDPR standards.

The case centered on whether brain data qualifies as personal data and whether existing privacy protections adequately safeguard neurodata.

SB 1223 amends the California Consumer Privacy Act (CCPA), as modified by the CPRA, to classify neural data as “sensitive personal information.” Neural data includes information generated by measuring activity of a consumer’s central or peripheral nervous system and excludes data inferred from nonneural information.

Businesses collecting neural data must meet heightened transparency, consent, retention limitation, and security obligations. Enhanced protections apply particularly when neural data is used to infer characteristics about a consumer.

Chile amended Article 19 of its Constitution to require that scientific and technological development respect life and physical and psychological integrity. The amendment specifically mandates legal protection of brain activity and information derived from it.

The provision states that the law shall regulate requirements, conditions, and restrictions for technological use on persons and shall “especially protect brain activity and the information derived from it.”

Commentary:
Chile became the first country to constitutionally recognize protections for brain activity and neural data. This formalizes neurorights within constitutional doctrine rather than statutory privacy law.

SB 163 amends Montana’s Genetic Information Privacy Act to include “neurotechnology data.” Neurotechnology is defined as devices capable of recording, interpreting, or altering responses of the central or peripheral nervous system, including BCIs and EEG devices.

The law imposes strict consent requirements, data localization constraints, security program obligations, and limitations on transfers to insurers and employers. It prohibits storage in sanctioned or foreign adversary countries and requires consent for cross-border transfer. It also imposes warrant requirements for government access.

However, the amendment does not expand the scope of regulated entities, meaning it primarily applies to organizations already covered under GIPA.

Establishes:

- A uniform set of definitions for neurotechnology governance
- A structured methodology to assess ethical and socio-technical considerations
- Lifecycle coverage across design, development, deployment, and use

Applies to developers, researchers, manufacturers, users, and regulators involved in neurotechnology systems.

The standard operationalizes an RRI-based methodology, enabling stakeholders to:

- Anticipate ethical and sociocultural implications
- Identify and mitigate unintended negative consequences
- Promote transparency and accountability in development practices
- Increase community engagement and public trust
- Support responsible commercialization and deployment

Key Risk Domains Addressed (Non-Exhaustive):

- Cognitive liberty and mental autonomy
- Informed consent in neurodata contexts
- Data governance and neurodata protection
- Human enhancement and non-therapeutic use
- Social equity and access
- Dual-use concerns

Compliance Mechanism:

Voluntary self-assessment framework; may be adopted internally by organizations as part of governance, risk, and compliance (GRC) programs.

No direct enforcement mechanism.

However, potential indirect relevance in litigation where:

- Ethical design standards are cited as industry benchmarks
- Plaintiffs argue deviation from recognized best practices
- Courts assess foreseeability of harm
- Regulatory agencies incorporate IEEE standards by reference


May serve as:

- Evidence of industry-standard duty of care
- Benchmark for negligence analysis in product liability claims
- Reference framework in disputes involving neurodata misuse, informed consent, or unsafe design practices

Neuronetics filed litigation against BrainsWay in the U.S. District Court for the District of Delaware, alleging unfair competition under the Lanham Act and state law. The dispute centered on BrainsWay’s alleged use of efficacy data related to the treatment of anxious depression associated with Neuronetics’ NeuroStar® Advanced Therapy for Mental Health.

While a motion to dismiss filed by BrainsWay was pending, the parties agreed to settle the case on mutually agreeable terms without any admission of liability or wrongdoing. Under the settlement agreement, BrainsWay agreed to cease using the NeuroStar efficacy data referenced in the complaint. Additional terms of the settlement were kept confidential.

Commentary:
The dispute highlights emerging governance challenges in the commercialization of neurotechnology-based medical treatments. As neurostimulation therapies such as transcranial magnetic stimulation (TMS) become more widely marketed, questions surrounding the use, interpretation, and competitive deployment of clinical efficacy data are likely to become more prominent. The case illustrates how existing legal frameworks may be used to regulate claims about neurotechnology performance in the absence of neurotechnology-specific regulation.

The European Charter for the Responsible Development of Neurotechnologies seeks to address governance gaps that remain despite existing European regulations and international recommendations. The charter recognizes that neurotechnologies raise unique ethical, legal, and societal challenges due to the central role of the brain in cognitive processes and personal identity.

Key governance concerns include:

- The need for stronger protections for personal neural data, including transparency in data collection, processing, sharing, and use.
- The development of clear guidelines for direct-to-consumer neurotechnology devices, particularly with respect to informed consent and mental privacy.
- Robust cybersecurity standards for connected neurotechnology devices, including hardware, software, and data security safeguards.
- Ensuring life-long continuity of care for individuals with implanted neurotechnologies or neuroprostheses.

The charter also emphasizes the need for transparent and accessible consent processes, requiring clear, plain-language explanations of neurotechnology use, potential risks, benefits, operational mechanisms, and possible secondary effects. Signatories commit to providing evidence-based educational materials before obtaining consent.

The charter reinforces compliance with several European regulatory regimes, including:

- General Data Protection Regulation (GDPR) principles such as proportionality, data minimization, accuracy, transparency, and fairness in neural data processing.
- EU Artificial Intelligence Act, particularly:
- Prohibitions on AI systems using subliminal manipulation techniques.
- Restrictions on systems exploiting vulnerabilities of individuals.
- Bans on social scoring and emotional inference in workplace and education settings.
- Transparency obligations for AI system providers and deployers.
- Compliance with high-risk AI requirements when AI-enabled neurotechnology is deployed in regulated domains such as healthcare, biometrics, education, employment, or justice.

The charter outlines a set of guiding commitments for neurotechnology developers and deployers:

- Protection of neural data and mental privacy
- Transparent and informed consent practices
- Reliability, safety, and cybersecurity of neurotechnology systems
- Long-term care and support for neurotechnology users
- Prevention of misuse, malicious applications, and manipulation
- Oversight and monitoring mechanisms
- Protection of vulnerable populations
- Ethical communication about neurotechnologies
- Education and awareness regarding neurotechnology risks and benefits
- Alignment of innovation with societal values

In 2019, the Organisation for Economic Co-operation and Development (OECD) adopted the Recommendation on Responsible Innovation in Neurotechnology. The instrument promotes responsible research, development, and deployment of neurotechnology, particularly in health contexts.

It defines:

- Personal brain data as data relating to the functioning or structure of the brain of an identified or identifiable individual, including information about physiology, health, or mental states; and
- Neurotechnology as devices and procedures used to access, monitor, assess, manipulate, or emulate neural systems.

The Recommendation calls on adherents to promote safety assessment, inclusivity in health applications, scientific collaboration across sectors and countries, public deliberation, strengthened oversight capacity, safeguards for personal brain data, stewardship cultures, and monitoring of unintended uses or misuse.

Although not legally binding, OECD Recommendations represent political commitments by member states to implement their principles.

The León Declaration, signed by the Telecommunications and Digital Affairs Ministers of all EU Member States at an informal ministerial meeting in León under the Spanish Presidency of the Council of the EU, outlines the European Union’s commitment to developing human-centric neurotechnologies that respect fundamental rights while strengthening Europe’s technological competitiveness.

The declaration emphasizes that neurotechnology development should align with European democratic values and digital governance principles. It highlights several key priorities, including:

- Protection of fundamental rights and human dignity in neurotechnology development.
- Promotion of digital inclusion and accessibility.
- Development of a secure and trustworthy digital ecosystem.
- Support for innovation and investment in neurotechnology across the EU.

The declaration frames neurotechnology as a strategic sector for Europe’s digital future and positions the EU as a potential global leader in responsible neurotechnology development.

The declaration calls for a range of coordinated actions by Member States and EU institutions, including:

- Public–Private Collaboration
- Innovation and Investment Ecosystem
- Strategic Autonomy and Competitiveness
- Regulatory and Policy Assessment
- Human-Centred Design Principles
- Public Engagement and Transparency
- Standardisation

HB24-1058 amends the Colorado Privacy Act to classify neural data as a subtype of “biological data” and therefore as “sensitive data.” Neural data is defined as information generated by measuring the activity of an individual’s central or peripheral nervous system that can be processed by or with a device.

Businesses must obtain opt-in consent before processing neural data and conduct data protection assessments when engaging in high-risk processing.

Commentary:
Colorado became the first U.S. state to explicitly protect neural data under a comprehensive consumer privacy law.

In November 2025, UNESCO adopted the first global normative framework addressing the ethics and governance of neurotechnology. The Recommendation applies to both medical and non-medical uses of neurotechnology and adopts a broad, technology-neutral definition of neural data. It includes not only direct neurological measurements but also indirect neural data and non-neural data capable of generating mental inferences.

Although not legally binding, the Recommendation calls on Member States, research institutions, and private sector actors to align neurotechnology development, deployment, and disposal with international human rights principles. It articulates high-level values—including human dignity, health and well-being, sustainability, diversity, and professional integrity—and sets forth ethical principles such as proportionality, protection of freedom of thought, privacy safeguards, transparency and accountability, equity, and special protections for children and vulnerable populations.

The Recommendation also proposes policy actions for Member States, including oversight mechanisms, lifecycle impact assessments, strengthened data protection and cybersecurity frameworks, energy sustainability measures, restrictions on manipulative uses of neural data (e.g., neuromarketing, behavioral nudging), and prohibitions on coercive neuroenhancement.

This instrument establishes the first comprehensive international normative baseline for neurotechnology governance. Its broad conception of neural data anticipates emerging AI-driven inference risks and avoids narrow technical definitions that may become obsolete.

Commentary:
While non-binding, UNESCO recommendations have historically influenced binding regulatory instruments (e.g., AI governance frameworks). The Recommendation positions neurotechnology squarely within international human rights doctrine and may serve as persuasive authority in legislative drafting, regulatory guidance, and judicial interpretation.

The framework aims to:

- Define and describe the landscape of neurotechnologies
- Identify ELSCI considerations relevant across the full neurotechnology lifecycle
- Provide structured guidance for multiple stakeholder groups

Although particularly useful for researchers and developers, it explicitly applies to:

- Device regulators
- Research ethics committees (IRBs/RECs)
- Scientific funding bodies
- Clinicians
- Employers and institutional adopters
- End users


Framework architecture:

- Establishes a matrix of technology modalities × application domains.
- Each application domain includes:
- Analysis of ELSCI considerations specific to that context
- References to applicable regulatory regimes and related guidelines

Application Contexts Considered (Non-Exhaustive):

- Medical
- Wellness
- Work and employment
- Legal and criminal justice
- Education
- Entertainment
- Marketing
- Sports and competition