Extraordinary claims in digital health require extraordinary evidence

By Paul Wicks, Independent Consultant at Wicks Digital Health.

Digital health is full of bold proclamations: AI that makes doctors into “superhumans”. An app that replaces physiotherapy. A headset that treats major depressive disorder with low power electrical impulses. These are not just incremental features, they have the potential to be paradigm-shifting claims but as Carl Sagan taught us, paradigm shifts demand evidence that is equally extraordinary. I believe that because for the past 20+ years I’ve been helping digital health companies generate, structure, and communicate the kind of evidence that convinces skeptical clinicians, regulators, payers, and pharma to give new technologies a chance to flourish.

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