Placebo-Proof Digital Health: Why FDA-Grade Evidence (Still) Matters

Digital health is drowning in bold claims, so what actually counts as evidence? Paul Wicks sits down with Dr. Acacia Parks — former Chief Science Officer at Happify, now VP of Regulatory Compliance & Engineering at Avania — to unpack the toughest questions in digital therapeutics: sham comparators, placebo effects, missing data, and what the FDA really expects.

They explore why dropout is "normal" in app-based trials, why sham design is both essential and fiercely guarded, and how the evidence needed for clearance differs from the evidence needed for adoption and reimbursement — then tackle the elephant in the room: LLM "therapy" exploding at scale without regulation.

Finally, Acacia breaks down recent US shifts around wearables and the CMS TEMPO program, and makes her case for the evidence standard she'll defend every time: if you can't beat placebo, what are we doing?