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. Companies with existing medical device products, clinical experience and a relationship with regulators have a distinct advantage when navigating approval. This leads to therapeutic apps that might qualify for approval stagnating as effective wellness apps, weakening the overall healthcare app market.      

Studies have shown that digital therapeutics are effective treatment tools for certain conditions, including the management of chronic conditions like diabetes or cancer, mental health (including depression or anxiety), and addiction among others. 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. The lack of approval for these creative approaches means that certain conditions are being under-served and losing out on study candidates.

Similar to other medical device spaces, regulatory bodies determine whether an app is low risk and has demonstrated efficacy by using clinical trials, which are the best way to evaluate whether a specific tool is able to achieve a positive result. Unlike other medical devices, the risk of complications when using an app is quite low, so the displayed efficacy of a digital therapeutic app does not generally need to rise to the level of traditional treatments. This means that positive results from a clinical study are a very strong indication that an app is ready for approval. However, running a clinical study is outside the expertise of many talented app development companies, putting the companies that do not already manufacture medical devices at a disadvantage.

There is a strong consumer preference for apps over using a dedicated device, so this market is expected to continue developing rapidly. Regulators will become more familiar with the nuance of using apps as a medical device as more are approved each year. Care must be taken so that this familiarity does not only benefit large global medical device manufacturers, as innovation is just as often driven by smaller, dedicated companies with particular expertise in niche conditions. Regulatory bodies should work to establish policies that will ensure that a variety of approved apps covering a wide range of diseases can gain approval.

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