Addendum to: Nature Health https://doi.org/10.1038/s44360-025-00003-y, published online 15 January 2026.

On 6 January 2026, the US FDA published new guidance saying that, in many situations, clinical decision support systems which ‘inform, but are not intended to replace, a healthcare professional’s judgment’ will not be considered a medical device—changing their position on the misconceptions discussed in the article but not the current international consensus view. A note explaining this has been added to the original article.