The Challenges of Regulating Brain-Machine Interfaces

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Scholar highlights the fragmented regulatory environment governing advanced neurological technology.

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With news stories of pigs with microchips inserted in their brains and humans controlling prosthetic limbs with only their minds, the blurring of biology and technology today seems to approach the realm of science fiction.

One remarkable development of this fusion has been the creation of increasingly sophisticated brain-machine interfaces (BMI)—technologies that connect a person’s nervous system to a computer or machine.

According to Walter G. Johnson, a doctoral scholar at the Australian National University, oversight of brain-machine technologies is important because of their potential to cause harm. In his article, Johnson argues that BMIs pose challenges to government regulators given the technologies’ unique risks and the fragmented regulatory framework that governs them.

Johnson proposes that BMIs present diverse risks to consumers because they integrate different technological and scientific fields.

Scientists’ failure to understand how the brain works, for instance, could result in a user experiencing chronic debilitation if a device is misplaced. Furthermore, the materials used in a piece of directly implanted hardware may prove incompatible with the human body.

BMIs also present cybersecurity risks to users. Individuals’ use of a BMI could enable a hacker or industry actor to steal their biological data or even meddle with the function of their devices.

Beyond safety and performance risks, the use of BMIs also raises broader ethical questions. For example, Johnson suggests that the data collected by device manufacturers might—as technological advances occur—provide invasive insights into users’ thoughts. In addition, BMIs’ potential to enhance human performance may widen the wealth gap if accessible only to the wealthy. This potential could also, if used in a military setting, present national security risks.

Johnson argues that because BMIs do not fit neatly into the current regulatory schemes of federal agencies, the U.S. government may experience difficulty in mitigating these risks. Johnson highlights two agencies in the United States that currently have authority to oversee BMIs: the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).

FDA has the power to review a device for its safety and effectiveness in situations where a specific health-related claim is made. Generally speaking, the riskier a device, the higher the regulatory scrutiny FDA will exert.

Although BMIs are likely to fall into higher risk categories, Johnson argues that FDA will face difficulties in regulating them effectively. He worries that because BMIs have both software and hardware components that present risks to users, FDA must expend resources performing two separate safety and effectiveness reviews. A device’s connectivity to the internet would also force FDA to factor in cybersecurity risks when contemplating its safety and effectiveness.

Furthermore, Johnson finds it problematic that FDA can only oversee products that make specific health-related claims because many future BMIs—such as a device that translates a person’s brain signals into text messages—would fall out of the agency’s jurisdiction.

The FTC could fill part of this jurisdictional gap. Unlike FDA, the FTC is empowered to review nonmedical claims made by BMI manufacturers when they constitute “unfair or deceptive acts or practices.” For example, the FTC could review a manufacturer’s claims about the extent a device protects users’ biological data.

Johnson argues that the presence of multiple administrative agencies with partial power to regulate BMIs creates potential governance problems that may chill innovation or reduce agencies’ legitimacy.

For instance, BMI manufacturers may be subject to increased costs due to inconsistent or duplicative standards for regulatory approval. Agencies may also expend unnecessary resources developing relevant regulatory expertise independent from one another.

Johnson claims that improved interagency coordination could combat the issues created by fragmented governance of BMIs. He proposes the consolidation of multiple agencies into a larger department or another administrative unit. Alternatively, agencies could engage in joint policymaking or draft interagency agreements to help them navigate the shared regulatory space.

In addition, Johnson proposes that technology assessment programs designed to inform policymakers directly about issues posed by BMIs could enable lawmakers to manage them proactively. Although technology assessment programs are rarely used, Johnson argues that the U.S. Government Accountability Office and the Congressional Research Service may be able to fill this void.

Johnson notes the importance that public awareness advocacy will play in spurring effective regulation of BMIs. Accordingly, he urges civil society organizations and entities from the neurotechnology industry to advocate proactive action on BMIs from agencies such as FDA and the FTC.

In May 2021, FDA released guidance on the establishment of experimental trials for certain categories of BMIs. The FTC has not acted on BMIs so far, but Johnson admits that this is unsurprising given the relative novelty of BMI technology and the agency’s use of adjudication.

Although federal efforts so far fall short of Johnson’s recommendations for substantial regulatory coordination and action, it remains to be seen how lawmakers and the public will react once BMI technologies become increasingly commonplace.