.png)
5 myths about biopharma Digital Health Tech (DHTs) that I hear far too often
After years of working at the intersection of digital health and drug development, I've noticed the same misconceptions keep resurfacing in boardrooms, protocol reviews, and conference hallways. Let's clear a few up.
Myth 1: "Regulators aren't ready for digital endpoints." They are, and they have been for a while. FDA and EMA have both published frameworks, qualification pathways, and guidance on digital health technologies in clinical investigations. The bottleneck is usually the sponsor's evidence package, not the regulator's willingness.
Myth 2: "Wearables are consumer gadgets, not clinical tools." The device is not the endpoint. The endpoint is the validated measure derived from it, with documented verification, analytical validation, and clinical validation behind it. Do that work rigorously and a sensor becomes a scientific instrument.
Myth 3: "Digital tools burden patients." Poorly designed ones do. Well-designed ones reduce site visits, replace tedious paper diaries, and capture how people actually live between appointments. Burden is a design choice, not an inherent property.
Myth 4: "More data is always better." Continuous data streams are only valuable if you know what question you're answering. Fit for purpose beats volume every time.
Myth 5: "This is a pilot project, not core strategy." Sponsors who treat digital as a side experiment keep re-learning the same lessons. The ones building it into their measurement strategy early are the ones getting to meaningful, patient-relevant endpoints faster.
Which of these do you still hear most? And which ones did I miss?
Comments