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Healthcare app regulators are missing the middle

September 27, 2022


When it comes to healthcare apps, there is a very clear divide between the nebulous wellness category and regulated digital therapeutics. This divide is due to national regulatory bodies like the US Food and Drug Administration (FDA), which oversee the approval of apps that may qualify as medical devices and step in to address wellness apps that are reported as potentially dangerous or misleading. For most developers, the extra burden of evidence required to demonstrate that the medical benefits of an app outweigh its risks is often not worth pursuing.

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