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As smartphone apps that treat mental health conditions become more common, the companies making them are grappling with a growing imperative: If they want to succeed, they need to get a lot better at producing more compelling evidence.

Interest in the mental health tech space has boomed as more stakeholders warm to the idea that software could be used to meet unmet demand for mental health treatment at a reasonable cost. Developers, fueled by unprecedented investment, are pursuing swelling product pipelines and putting out a steady flow of research papers claiming to show clinical efficacy and economic savings. But by and large, that evidence hasn’t been enough to convince highly skeptical health insurers and providers, who are still cautious to prescribe or pay for the products, broadly known as digital therapeutics.


There are several reasons why the evidence still falls far short of convincing: The regulatory landscape means strong research isn’t always required to go to market, disincentivizing such studies. It’s also challenging to design comprehensive clinical studies, especially for novel treatment approaches, and expensive to run them.

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