Understanding FDA Guidance on Digital Health Technologies

What healthcare companies need to know—straight from a legal lens.
Digital health is no longer the future—it’s the present. From wearable sensors to software that supports clinical trials, Digital Health Technologies (DHTs) are transforming how healthcare is delivered and regulated. The FDA’s latest guidance aims to bring clarity, but for many businesses, it also raises new questions.
As a law firm that works closely with FDA-regulated companies, we’ve put together a breakdown of what this guidance means—and how to stay ahead of it.