Find here all our blog posts tagged with: digital health.

A single illuminated notebook on an empty conference table surrounded by rows of unlit chairs, evoking one voice claiming authority in an otherwise quiet room.

One Journal Article Is Not Yet an AI Audit Standard

A single peer-reviewed framework is being framed as the working audit standard for generative AI mental health tools, and compliance leads should treat that framing with more caution than the coverage suggests.

An illuminated paper hovers above a dim archive of closed files, symbolizing a single publication mistaken for finished regulatory guidance.

A Journal Article Is Not a Regulatory Safe Harbor

A Nature Medicine audit framework for AI mental health tools is being framed as a de facto FDA standard, but no published mechanism makes that so.

Two identical wearable devices lit differently to symbolize diverging regulatory paths for the same hardware

The New Fault Line: When Identical Hardware Faces Opposite FDA Rules

FDA's finalized wearable guidance means device classification now hinges on claims and labeling, turning product marketing into a regulatory control point.