Two very distinct types of apps focus on healthcare: the nebulous wellness category and regulated digital therapeutics. This divide is due to national regulatory bodies such as the US Food and Drug Administration (FDA) that oversee the approval of apps that may qualify as medical devices, but only step in to address wellness apps that are reported as potentially dangerous or misleading. Regulators have been working to ensure there is a pathway to approval for a few years, but the lack of a strategic emphasis and limited resources has been a pain point for developers.
