Mind the Gap

Governance at Neuron Speed

The electrodes are already mapping thoughts while ethics committees are still finding the conference room. Precision Neuroscience received FDA clearance in March 2025. By the time France assembled its eight-person monitoring committee, the devices were translating intention into action. Governance remained under construction. Technology moves at neuron speed. Oversight moves at committee speed. The implant is already in a patient’s brain while the committee drafts guidance. This isn’t just a timing issue. It’s a structural advantage for those who move first.

The governance gap isn’t new. What’s new is the infrastructure we’re building while the gap stays open. Neural data collection systems. Ownership ambiguity that creates tradeable rights before anyone agrees who owns what. Regulatory arbitrage opportunities that let companies shop for favorable jurisdictions. The gap itself has become a feature of the market. We’ve built a market for thoughts before we’ve decided who owns them.

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Neural implants occupy a regulatory nowhere land. They’re part medical device, part data harvester, part cognitive modifier. The FDA cleared Precision Neuroscience’s electrode array under rules designed for pacemakers. Not devices that translate intention into action. It’s like regulating spacecraft with traffic laws. The clearance covers the hardware. Questions dangle like loose threads. Who owns the thoughts these devices capture? Firmware updates change how you think. The GAO report documents patients losing access once trial support ends. Having a neural implant that becomes obsolete is like having a pacemaker that stops working when the manufacturer discontinues the app.

In Europe, existing frameworks emerged before devices that monitor brain activity existed. The Medical Devices Regulation, GDPR, and the AI Act all predate this technology. The EU has significant blind spots regarding brain data. It’s like writing privacy laws without mentioning photographs. The framework isn’t just inadequate. It’s anachronistic before it’s even implemented.

France piloted a national charter in January 2025. It established a monitoring committee of eight experts. A committee to monitor the committees. Meta confirmation that we’re building governance structures as quickly as we’re building the problems they’re meant to solve. The monitoring committee in France meets quarterly. That means three meetings before the next wave of neural devices makes their entire framework obsolete.

Consumer neurotechnology devices often avoid medical regulation entirely. Wellness headsets, gaming BCIs, neurofeedback systems fall through the cracks. Neither GDPR nor U.S. state data laws address neural data with clarity. A 2024 analysis of 30 consumer neurotechnology companies found a striking pattern. 96.67% give themselves access to users’ neural data. Only one company offered meaningful restrictions on data use or sale. Medical law may cover implants. But governance frameworks haven’t caught up to long-term use, software updates, and the shift from therapy to enhancement.

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Ethics committees are assembling with yesterday’s frameworks. They’re trying to solve tomorrow’s problems. Institutional Review Boards emerged during the pacemaker era. Not for devices that capture intention before the user is consciously aware of it. BCIs bring novel ethical issues. They monitor brain activity. They potentially modulate cognition. They capture data about thoughts and intentions. They interact with AI algorithms. They upgrade hardware inside the skull. All through devices that continuously update via firmware changes.

One commentary emphasizes that BCIs pose challenges around informed consent. Also cognitive liberty, vulnerability, and identity. A user consents once. The implant stays for years. Its firmware changes. The neural data gets sold. The conditions of consent shift continuously.

France’s solution? A monitoring committee of eight “personalities with complementary expertise.” This hints at a model. Cross-disciplinary review committees combining ethics, neuroscience, patient voices and regulatory representation.

Governance frameworks emerge at the intersection of innovation and rights. They protect neural privacy, cognitive liberty, and human identity. These frameworks attempt to span both medical devices and non-medical neurotechnologies. Many remain non-binding guidelines rather than enforceable law. Ethics committees use yesterday’s blueprints. Technology builds tomorrow’s realities at neuron speed.

On the policy front, neurotechnology gets viewed through a dual-use lens. Not just a medical innovation but a potential security challenge. A March 2025 analysis from the German Council on Foreign Relations frames neurotechnology in Europe as both prosperity and security issue. This framing shifts the governance question. BCIs that decode neural patterns could enable medical breakthroughs. Or surveillance tools. It depends on who controls the data and how someone uses it.

The tension is real. Neural data could be health information. That’s protected but accessible to medical providers. Or consumer data, regulated under privacy frameworks. Or sensitive national security information, subject to export controls. Different jurisdictions answer differently. This creates regulatory arbitrage opportunities. A company blocked from deploying a consumer BCI in one jurisdiction simply relocates to another with looser standards.

However, data-privacy bodies expand the governance lens into consumer protection. Ethics and governance boards must collaborate with data regulators and consumer-rights bodies, not simply medical device boards.

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Four dilemmas emerge when technology that reads minds meets governance that moves at glacial speed. These play out now in hospitals and labs. Patients with neural implants navigate questions that ethics boards haven’t finished formulating. The gap between what we can do and what we’ve thought through has become a chasm. We’re already crossing it without a bridge.

BCIs capture neural signals. Electrical activity. Brain states. Emotional markers. Patterns that correlate with actions you haven’t even decided to take yet. The ownership framework depends on jurisdiction, device category, and who you ask. For implants approved under medical device rules, ownership remains unclear. Patient, hospital, device maker, or software owner? Health-privacy laws like HIPAA or consumer data rules might cover it. BCIs involve machine learning, remote servers, and firmware upgrades. Patients don’t know what rights they have over their own brain-machine streams.

According to that 2024 analysis, 96.67% of neurotech companies reserve access to users’ neural data. Only one company offers meaningful restrictions. This creates a market structure. Companies that give users control over their neural data compete against companies that monetize it. The monetization pathways exist: Training data for AI models. Behavioral prediction systems. Attention metrics for advertisers. Cognitive performance benchmarking. Neural data ownership varies by jurisdiction and device category. Some manufacturers claim ownership of raw signals. Others claim processed outputs. Others still claim AI-derived insights. GDPR grants EU patients data access rights. But applying those rights to continuous neural streams remains untested. U.S. frameworks offer even less clarity. Neural data fits uneasily into HIPAA categories and state privacy laws written before BCIs existed.

The current landscape looks like this. Manufacturers write terms-of-service suggesting data ownership. Patients assume the thoughts remain theirs. The courts haven’t settled it because the cases haven’t been filed yet. The implants are too new. The data collection too recent. The precedents nonexistent. Meanwhile, the infrastructure for neural data markets is already operational. The ownership question will be settled by whoever builds the most valuable dataset first. Not by whoever drafts the most elegant legal framework.

An implanted BCI fails. Electrode drift. Software bug. Hacking. Unintended stimulation. The liability chain is complex. BCIs interact with AI, adapt over time, and networks connect them. The GAO report noted patients may lose access to support after trial or manufacturer withdrawal. Who is responsible then? Manufacturer, hospital, insurer, or patient? A user’s sense of agency gets mediated through the implant. It malfunctions. No governance mechanisms for reparative rights exist yet.

The line between “treatment” and “enhancement” isn’t blurry. It disappeared. Like a coastline in rising waters, leaving behind a landscape where the old maps no longer apply. A device for paralysis later enables memory boost or mood modulation. Regulatory frameworks adapted for medical devices don’t suit enhancement use targeting healthy individuals. Who oversees trial quality and adverse event reporting in those cases? Ethics boards are still forming consensus.

The question is not merely academic. A BCI approved for treating paralysis gets marketed for cognitive enhancement. Does it need re-approval? Can insurers refuse to cover “enhancement” uses while paying for “treatment”? Who decides whether a given use counts as treatment or enhancement when the same device serves both?

Implants mean brain surgery. Semi-permanence. Unknown long-term effects. Evolving firmware. Surgical candidates may be vulnerable. They rely on the device for function in ways that compromise voluntary risk evaluation. Firmware changes alter mood, personality, or agency. Consent forms don’t disclose upgrade paths. Governance committees don’t revisit consent when conditions change. Many bioethics boards are only beginning to ask these questions.

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Companies deploy at neuron speed. Committees convene at conference room speed. The speed differential creates market opportunities. First-movers capture user bases before governance frameworks constrain their terms of service. Early adoption becomes a defensive position. Once millions have implants under specific terms, changing those terms retroactively becomes politically difficult. The gap between deployment and governance isn’t just timing. It’s a window. Network effects lock in favorable conditions before regulation can alter them.

Companies accelerate clinical-trial milestones. Manufacturers implant BCIs in human subjects. Regulators grant clearances. Precision’s March 30, 2025 clearance is just one example. Meanwhile, policymakers draft ethics charters that remain non-binding. Descriptive rather than prescriptive. Review committees assemble slowly. Manufacturers proliferate consumer neurotech devices faster than regulators can build oversight frameworks. Non-medical BCIs multiply. Neural-data regulation lags. Gaps in U.S. and EU data law prompt calls for expanded consumer protections. Yet liability, long-term monitoring, and upgrade obligations remain fuzzy. The GAO report documents this clearly.

The result? Patients with implants navigate questions that haven’t been fully formulated. Governance frameworks chase technology already in use. Neural data gets captured before we’ve decided who owns it. By the time governance catches up, the market structure is already set. The early movers have built their datasets. They’ve established their terms. They’ve captured their users. Retroactive governance becomes negotiation with entrenched interests, not establishment of baseline rules.

Emerging practices remain optional. They vary across jurisdictions. Multi-party charters. Public consultations. Cross-discipline monitoring. This variability itself creates value. Companies can optimize their regulatory environment by choosing favorable jurisdictions. This creates competitive pressure for regions to maintain “innovation-friendly” frameworks. Read: permissive.

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The FDA clears implantable devices. Companies launch trials. Hospitals collect neural data. Governance infrastructures remain under construction. Patients get implanted before full frameworks are in place. Committees form after deployment begins. We’re building the plane while flying it through turbulence. The passengers don’t know there’s no pilot.

Some governance mechanisms emerge. France’s monitoring committee. Cross-party consultations. Regulator-legislator engagement in the U.S. Open questions persist. The U.S. has no dedicated neurotech regulator. The line between therapy and enhancement blurs. An implant shifts from medical to enhancement use. No one knows what governance applies.

Device upgrades raise longitudinal issues. So do firmware modifications and AI decoding algorithms. Review boards can’t monitor them over time. Neural data creates value chains. Pressure for monetization and algorithmic training builds. A user’s sense of agency gets mediated by a device. It fails. No one knows who is responsible. Some jurisdictions have begun recognizing neurorights. Chile amended its constitution in 2021 to protect “mental integrity.” Its Supreme Court applied these protections in a 2023 ruling against Emotiv, finding the company violated constitutional rights by collecting neural data without proper consent. Many regimes remain fragmented.

For patients and users, the stakes compound. Data about brain activity. Thoughts. Intentions. Devices that may influence agency, personality, communication. The question is whether ethics boards can catch up. And how they operate when the technology is already in use.

The pattern? We’re deploying intimate neurological interventions before establishing basic frameworks. Ownership, liability, and consent remain undefined. The companies moving fastest have the strongest incentive to deploy before frameworks solidify. Regulatory ambiguity favors first-movers. Uncertainty about ownership creates opportunities to establish data rights through terms of service. This happens before courts or legislatures define them. Liability uncertainty means companies aren’t yet responsible for long-term support obligations. The gap isn’t random. It’s valuable.

The committees will convene. Guidelines will get drafted. By then, the technology will have evolved into something the original frameworks never anticipated. Like trying to regulate smartphones with telegraph laws. Except this time it’s not communication devices. It’s the interface between human consciousness and digital systems.

Picture it: 2027. A lawsuit filed by the first wave of neural implant users. Not because the devices failed, but because they succeeded too well. The plaintiff’s lawyer holds up a Terms of Service agreement signed three years earlier. “My client consented to have their paralysis treated,” she says. “They did not consent to have their emotional responses logged, analyzed, and sold to insurance companies who then determined they were too ‘neurologically risky’ for coverage.” The defense will argue the terms were clear. They were. What wasn’t clear was what those terms would mean once someone else owned a continuous record of your brain’s activity patterns.

The FDA clearance letter for Precision Neuroscience’s array runs to forty-three pages. Page eleven describes the electrode materials. Platinum-iridium alloy. Medical-grade polymer. Adhesive biocompatible with cortical tissue. Page twenty-seven outlines the testing protocol for signal fidelity and electrode durability. Page thirty-nine addresses sterility assurance and shelf life. Nowhere in those forty-three pages does the word “ownership” appear. Not once. Not in reference to the neural signals the device will capture. The patterns it will decode. The intentions it will translate into action before the patient fully articulates them to themselves.

The technical specifications are exhaustive. The framework for who owns what gets recorded inside your skull doesn’t exist yet. The device is already approved. Patients are already being implanted. The terms of service are already being signed. And somewhere, the first neural datasets are already being monetized under contractual terms that courts haven’t reviewed. Terms that regulators haven’t examined. By the time governance defines the rules, the market will have already defined the defaults.

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