Understanding AI and Machine Learning’s Effect on Regulation and Litigation Risk

Product liability and mass torts attorneys Hannah Anderson, Christine Kain, Kevin Morrow and Theodore O’Reilly coauthored an article for the Defense Research Institute (DRI)’s For the Defense magazine titled “Understanding AI and Machine Learning’s Effect on Regulation and Litigation Risk.”

The article highlights the growing use of Artificial Intelligence (AI) and Machine Learning (ML) in medical applications and the Food and Drug Administration (FDA)’s evolving regulatory approach to AI and ML, including the FDA’s “Software as a medical device (SaMD) Action Plan.”

The authors also address the potential personal injury litigation risks for device manufacturers, noting that the potential allegations of software failures, inaccuracies, risk of hacking, and challenges must be weighed against the potential benefits of the devices.