Digital Health Liability Law in Flux

Litigation attorney Eric Alexander published a blog for Drug & Device Law discussing how product liability principles are being tested and reshaped as digital health products, software-driven medical devices and artificial intelligence (AI) become more prevalent. The post revisits predictions made in early 2023 about where litigation risk was headed, including whether courts will treat software as a "product," how the post-sale duty to warn, learned intermediary and preemption doctrines may apply when software is updated over time, and whether new targets such as software developers and contractors will be pulled into suits. Mr. Alexander also highlights the role of evolving regulation, pointing to recent U.S. Food and Drug Administration (FDA) guidance on clinical decision support, general wellness software and AI-enabled device software functions, concluding that companies should continue monitoring this fast-developing area and build risk management strategies that account for ongoing legal uncertainty.

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