"The AI-Robotic Prescription: Legal Liability When an Autonomous AI Rob" by Erika Sophia Grossbard
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University of Miami Business Law Review

Document Type

Comment

Abstract

As AI-driven healthcare accelerates, lawmakers must race against time to establish vital regulations, striving to protect patient safety in an era of increasingly autonomous medical devices. The real challenges arise when an automated AI medical device harms a patient during medical care, and the law has yet to clarify how liability should be allocated among its stakeholders. Currently, semi-autonomous robots are diagnosing medical conditions and performing surgeries. Eventually, autonomous AI medical providers will enter the market, capable of making independent medical decisions and providing treatment. These autonomous robots will function more like medical practitioners rather than merely as assistive tools for healthcare professionals.

The FDA and the legislature should preemptively address the apportionment of liability for autonomous AI medical devices before medical practitioners widely adopt this AI technology. With assistance from the FDA, federal legislation should establish a liability scheme for autonomous medical devices instead of allowing the floodgates of litigation to reactively determine liability. Such proactive regulation will enable product developers and medical providers to better understand their potential legal exposure and take measures to mitigate harm.

Moreover, individuals injured by an autonomous AI medical device should be able to recover damages under either a malpractice or product liability framework, or both, depending on the circumstances of the case. Injuries can result from human errors or machine malfunctions, so the appropriate scheme of recovery should be tailored to reflect the specific cause of harm. The complexity of assessing liability stems from the interplay between the tangible hardware and the intangible algorithms of the AI medical devices. While the AI medical devices themselves cannot be held legally responsible, a framework must be established to allocate liability among responsible parties throughout the device’s lifecycle. For instance, the AI device’s level of autonomy in a given incident should influence how liability is distributed among medical providers, manufacturers, and maintenance personnel. Finally, policymakers must integrate societal, policy, and ethical considerations to ensure that this framework achieves the objectives of tort law and medicine while also supporting continued technological innovation.

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