As FDA medical device lawyers advising AI and digital health companies, Hogan Lovells lawyers have had a front-row seat to an increasingly common scenario: software platforms and mobile apps that launch with the best of intentions in the “wellness” space but, often unknowingly, edge into FDA-regulated medical device territory. Sometimes the shift is subtle—an added biometric feature here, a predictive algorithm there. But the consequences of crossing that line can be anything but subtle….
By: Hogan Lovells
By: Hogan Lovells
