Brent Savoie, MD, JD, vice chair for radiology informatics, section chief of cardiovascular imaging, Vanderbilt University, explains who will get sued when there is a misdiagnosis due to artificial intelligence (AI). He spoke on this topic at the Society of Cardiovascular Computed Tomography (SCCT) 2022 meeting.
“The answer is everyone will get sued,” Savoie explained. "It's a big hairy issue."
He said this is mainly because there is a not a good regulatory framework for AI in the U.S. at this time. This means there is no guidance on how to deploy the technology safely and there are no clear protections from law suites that say "if you do this" you are not at risk, he explained.
He outlined that the physician could share responsibility when AI fails, since they are ultimately responsible for diagnosis and reporting. The AI vendor could be liable if the algorithm has a bug, or a built in bias or missing information. The IT department and hospital could be liable if the AI was not updated or there is a glitch caused by interactions with other software on the system. Savoie said the most likely result is everyone gets sued and it will be up to the courts to sort it out.
"This is all kind of a downer message I feel like I am giving, but I really am optimistic about the future of AI and I think creating these processes is essential for preserving that future, Savoie explained. "If you are at an institution and install something and you face an adverse outcome and it comes to litigation, it's going to be really difficult to get approval for a budget request for the next application."
Savoie said it needs to be stressed it hospital IT departments that AI applications are not just another imaging system software that is not FDA regulated, which is what most IT departments are more accustomed to. AI applications are FDA approved medical devices. This is important because he said IT departments need to prioritize updates and QA for AI apps because they might have a direct impact on clinical care.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: dfornell@innovatehealthcare.com