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Abstract

This article examines the emerging medical technology of deep brain stimulation (DBS), a type of brain implant, to determine its ethical and legal ramifications. Lawyers, philosophers, and ethicists have labored to define the conditions under which individuals are to be judged legally and morally responsible for their actions. But where does responsibility lie if a person acts under the influence of her brain implant? Do we hold the individual solely responsible for her actions? Can we attribute any blame to the device? What about the engineers who designed it, or the manufacturer? The neurosurgeon who implanted it, or the neurologist who programmed the device parameters? Do these causes of action lie in traditional actions of medical malpractice and products liability, or do we hold physicians and device developers to direct criminal or tort liability for the individual's actions? If multiple actors share responsibility, the question regarding how to distribute responsibility among multiple actors must also be considered. Adding an additional layer is the potential for malicious interference with these implants by criminals. Finally, all these legal and ethical issues exist within a regulatory landscape wherein medical devices must have approval to be sold. How do we define the criteria for approval to limit these issues? And how do those regulations impact the liabilities for the various parties in up and down the chain of development and use?

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