Artificial intelligence (“AI”) is revolutionizing the healthcare industry, offering innovations that enhance diagnostics, treatment, and patient care. AI’s capabilities range from analyzing medical imaging with greater accuracy to predicting disease outbreaks. However, the increasing reliance on AI in healthcare has also raised complex legal questions, particularly concerning liability.[i] When a medical error occurs due to AI’s involvement, determining who is accountable becomes a critical issue. As AI systems continue to play a larger role in medical decision-making, healthcare providers, developers, and policymakers are grappling with how to navigate this evolving landscape of responsibility.
AI technologies are being integrated into various aspects of healthcare, from diagnostics to treatment recommendations, fundamentally transforming the way medical professionals approach patient care. AI systems can sift through vast amounts of data, identifying patterns and correlations that may be beyond human detection, leading to more personalized and precise treatments. For example, AI algorithms are being deployed to analyze radiology images with greater accuracy, reducing the risk of oversight and to suggest treatment plans based on a patient’s unique medical history and genetic profile. AI even assists in surgeries, enhancing the precision of complex procedures. These applications promise to not only improve the accuracy and efficiency of medical care but also to reduce human error, increase the speed of decision-making, and significantly lower healthcare costs over time.
However, the introduction of AI also creates new challenges. While the technology can enhance decision-making, it is not infallible. Traditionally, liability in healthcare is governed by the legal concept of medical malpractice. A healthcare provider may be held liable if they breach the standard of care owed to a patient, and that breach results in harm.[ii] The standard of care is typically defined as the level of competence that a reasonably skilled healthcare professional would provide under similar circumstances.
Nonetheless, the introduction of AI may complicate this framework. AI systems may perform tasks autonomously or in conjunction with human doctors, making it difficult to pinpoint the source of a medical error. Is the physician at fault for relying on the AI system? Or is the fault with the software developer who designed the AI tool? These questions challenge the traditional notions of medical malpractice and force a reconsideration of liability.
Thus, one of the central debates surrounding AI in healthcare is the distribution of liability between the human operator (physician) and the AI developer.[iii] It can be argued that physicians should still bear ultimate responsibility for patient outcomes, as they are the ones making the final decisions about diagnosis and treatment. In this view, AI is simply a tool that aids doctors, much like a stethoscope or an MRI machine. If a physician misuses an AI tool or fails to question its recommendations, they could be held liable for any resulting harm.
On the other hand, AI developers could be held liable under the theory of product liability.[iv] If an AI system malfunctions due to a design flaw, inadequate testing, or a failure to provide appropriate warnings about the system’s limitations, the developer could be sued for damages. Courts may need to decide whether AI systems are more akin to medical devices (subject to product liability laws) or professional services (subject to malpractice standards).
Given the growing use of AI in healthcare, regulatory bodies play a crucial role in defining liability standards. In the U.S., the Food and Drug Administration (“FDA”) is responsible for regulating medical devices, including certain AI systems.[v] The FDA has created a framework for approving AI tools based on their safety and efficacy, but this framework is still evolving. As AI becomes more sophisticated and autonomous, the FDA will likely need to update its regulations to account for the unique risks posed by these systems.
Integrating AI into healthcare presents both tremendous opportunities and significant legal challenges. Determining liability when AI causes harm is a complex issue that requires rethinking traditional frameworks of medical malpractice and product liability. Physicians, AI developers, and regulatory bodies must work together to establish clear guidelines for the use of AI in healthcare and ensure that patients are protected.
As AI technology continues to evolve, the legal system must adapt to address new forms of liability and ensure that healthcare providers and developers are held accountable for AI’s safe and effective use. Ultimately, the goal should be to harness AI’s potential while safeguarding patients’ rights and ensuring that ethical and legal standards keep pace with technological innovation.
[i] See generally Nithesh Naik et al., Legal and Ethical Consideration in Artificial Intelligence in Healthcare: Who Takes Responsibility?, Nat’l Libr. of Medicine (Mar. 14, 2022), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8963864/ (discussing the potential issue of AI and medical malpractice cases).
[ii] See generally B. Sonny Bal, An Introduction to Medical Malpractice in the United States, Nat’l Libr. of Medicine (2009), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2628513/#Sec6title (explaining the legal framework of a medical malpractice suit).
[iii] See generally The Role of AI in Healthcare: Who’s to Blame When Things Go Wrong, Bell L. Firm (June 26, 2023), https://www.belllawfirm.com/ai-in-healthcare/ (discussing the current discourse regarding liability with AI use in the healthcare field).
[iv] See generally Product Liability Considerations for AI-Enabled MedTech, Sidley (Jan. 10, 2024), https://www.sidley.com/en/insights/publications/2024/01/product-liability-considerations-for-ai-enabled-medtech (discussing possible product liability framework in relation to AI in medical technology).
[v] See generally How FDA Regulates Artificial Intelligence in Medical Products, Pew (Aug. 5, 2021), https://www.pewtrusts.org/en/research-and-analysis/issue-briefs/2021/08/how-fda-regulates-artificial-intelligence-in-medical-products (discussing the FDA’s role in the regulation of AI).
