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.
The FDA has recently moved to elevate its Office of Strategic Partnerships and Technology Innovation into a “super-office” that will be responsible for five distinct portfolio offices. This expansion demonstrates a strategic recognition of the importance of digital health and cybersecurity as part of the medical devices approvals process. It seeks to implement a more stable and communicative journey for regulated apps.
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Studies have shown that digital therapeutics are effective treatment tools for certain conditions, including the management of chronic conditions such as diabetes or cancer, mental health issues including depression or anxiety, and addiction. Apps are powerful tools that particularly help patients with routine behaviour and adherence to treatment plans. Any tools that operate on these principles are straightforward to approve, while other conditions require a more creative approach and expert judgement.
The COVID-19 pandemic saw an unprecedented shift in the healthcare landscape with a focus on enabling continued quality of care by remote means. Many digital health apps have been developed as a result of this shift in the market and subject to accelerated emergency approvals. Regulators need to move to foster working closely with this market as high interest rates limit private investment while artificial intelligence (AI) tools open entirely new possibilities.
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