Written by OneGuild

In the growing field of digital health, credibility is everything. As wearable technologies evolve — tracking everything from steps and sleep to glucose levels and gait — their promise is immense. But so are the risks when that promise goes unfulfilled.

Dr. Bijan Najafi, a scientist at UCLA and long-time expert in digital health and wearable technology, has publicly raised concerns that resonate across the scientific and medical communities. Writing on LinkedIn, Dr. Najafi cautioned that some manufacturers of commercial wearables are making health claims without rigorous clinical validation — echoing a troubling pattern seen in the early 2000s.

“Several wearable device manufacturers have made unsupported claims without any rigorous clinical validations,” he warned. “This situation reminds me of the early 2000s... it took two decades to rebuild trust.”

That earlier wave of overpromising and underdelivering set the field back — discouraging biopharmaceutical companies from incorporating wearables into clinical trials, even as secondary outcomes. Now, just as the field is regaining momentum with stronger algorithms and more clinical-grade applications, Najafi fears a return to mistrust.

And this time, the stakes may be even higher.

For those working at the intersection of innovation and healthcare, this moment is critical. Najafi’s warning isn’t just about science — it’s about scalability, accountability, and equity. If clinicians, researchers, and patients cannot trust wearables to deliver valid, reproducible data, these tools risk becoming novelties rather than instruments of transformation.

Building the Future Responsibly

At OneGuild, we believe scientific progress must be paired with integrity. Dr. Najafi’s reflections are a timely reminder that clinical validation is not a formality — it is the foundation of ethical innovation.

The digital health industry must move forward, but it cannot afford to repeat its past mistakes. The future — and the communities it aims to serve — depend on getting it right.