Health app regulators miss the middle

When it comes to healthcare apps, there is a stark divide between the nebulous wellness category and regulated digital therapies. This divide is due to national regulatory bodies such as 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 flagged as potentially dangerous or misleading. For most developers, the additional burden of evidence required to demonstrate that an app’s medical benefits 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 the stagnation of therapeutic apps likely to be approved as effective wellness apps, weakening the overall health app market.

Studies have shown that digital therapies are effective treatment tools for certain conditions, including the management of chronic diseases like diabetes or cancer, mental health (including depression or anxiety) and substance abuse, among others. Apps are powerful tools that especially help patients adopt routine behavior and stick to treatment plans. All tools that operate on these principles are simple to endorse, while other conditions require a more creative approach. The lack of approval for these creative approaches means that certain conditions are poorly met and lose candidates for consideration.

Like other medical device spaces, regulators determine if an app is low-risk and has been shown to be effective using clinical trials, which are the best way to assess whether a specific tool is capable of performing. get a positive result. Unlike other medical devices, the risk of complications when using an app is quite low, so the claimed effectiveness of a digital therapy app usually does not need to rise to the level traditional treatments. This means that positive results from a clinical study are a very strong indication that an application is ready for approval. However, conducting a clinical study is beyond the expertise of many talented app development companies, putting companies that do not yet manufacture medical devices at a disadvantage.

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

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