New FDA guidance means that digital therapeutics could get to at-risk patients faster amid the Covid-19 pandemic, and healthcare stakeholders are already reacting.
Digital therapeutics — software-based disease prevention, management, and treatment solutions — has been gaining more interest in recent years.
As an emerging area of digital health, it holds potential for new avenues in patient care — the market is expected to reach nearly $9B by 2025. However, its role remains uncertain as industry adoption is up in the air.
In April, the FDA released a guidance document that waived some of its regulatory requirements for digital health devices — including digital therapeutics — supporting psychiatric disorders (like major depressive disorder, schizophrenia, or substance use disorder). This may help demonstrate how digital therapeutics could be integrated into the current care model.