Opinion: Where do we go from here on digital therapeutics?
Where do we go from here on digital therapeutics?
South Korea is the only country to officially recognize digital therapeutics as a category. Nevertheless, the concept of software-based tools designed to manage or treat medical conditions has received enormous attention in the U.S. as proponents tout their potential to both widen access to care and improve patient outcomes. This optimism has driven significant financial investment in the sector, which ballooned to $3.4 billion in 2021.
However, recent setbacks and billions of dollars in bankruptcies in 2023 indicate that the field is stagnating. Though industry voices point to regulatory hurdles as the culprit, deeper structural challenges threaten the future of “software as a medical device” and other digital health technologies, as categorized by the Food and Drug Administration.
What's Your Reaction?
