Physician viewpoint: If healthcare AI makes a mistake, who is legally responsible?

As artificial intelligence becomes increasingly integrated into healthcare delivery, and especially in the field of radiology, the industry must determine who — or what — is liable if an algorithm leads to a mistaken diagnosis or treatment, according to Saurabh Jha, MD.

In an op-ed for Stat, Dr. Jha, a radiologist at Philadelphia-based Penn Medicine, discussed the many challenges associated with pursuing medical malpractice lawsuits in situations that involve the use of AI. For example, if a hospital or health system built a faulty algorithm in-house, they will likely be found liable. But if they outsourced the AI from an external vendor, Dr. Jha wrote, "the distribution of liability is more complex."

In those cases, Dr. Jha explains, a court will need to rule on whether FDA approval protects an algorithm and its vendor from malpractice allegations; while this federal preemption has protected some medical devices from lawsuits in the past, it may not apply to AI that is continuously learning and updating, potentially rendering it completely different from the version approved by the FDA within just a few uses.

Additionally, Dr. Jha pointed out, physicians could also be held liable if they opt out of using AI that could have resulted in better outcomes for a patient.

"The adoption of artificial intelligence in radiology will certainly be influenced by science. But it will also be shaped by the courts and defensive medicine. Once a critical mass of radiologists use AI clinically, it could rapidly diffuse and, in a few years, reading chest x-rays, mammograms, head CTs, and other imaging without AI will seem old-fashioned and dangerous," he concluded. "Ironically, the courts will keep both AI and radiologists tethered to each other, granting neither complete autonomy."

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