Digital technology has had such a deep and profound impact on healthcare that it has spawned a new term – digital health – and an industry with multiple stakeholders, including clinicians, consumers, software and hardware vendors, labs, scientists, researchers and public health officials.

Exceedingly broad in scope, digital health includes mobile health (mHealth), telehealth and telemedicine, consumer wearable devices that track user activity and monitor vital signs such as heart rate, patient portals and personalized medicine. The vast amounts of data collected by digital devices, along with the analytics platforms, artificial intelligence (AI) and machine learning that make sense of that data, today are being used to support clinical decisions and guide public health policies.

“Digital health tools have the vast potential to improve our ability to accurately diagnose and treat disease and to enhance the delivery of healthcare for the individual,” the Food and Drug Administration (FDA) writes. The Agency has been very supportive of digital health, creating the Digital Health Center of Excellence (DHCoE) in the fall of 2020 to provide regulatory advice and support to the FDA’s regulatory reviews and to create a network of partnerships to advance and realize the potential of digital health technologies.

An emerging field in which digital tools are being used in healthcare is digital therapeutics (DTx), where software-based interventions are used to treat, manage, or prevent a disease or disorder. Today DTx companies are gathering evidence through clinical trials, studies of real-world evidence (RWE), claims data and other relevant sources and then apply for approval or clearance to the FDA’s Center for Devices and Radiological Health or other global regulatory agencies. The global DTx market is projected by Allied Market Research to reach a value of $23.6 billion by 2030, more than six times the 2020 value of $3.6 billion.

DTx have been developed to address a wide range of physical and mental health issues. There are products that deliver cognitive behavior therapy, improve medication adherence, regulate insulin doses, cope with opioid use disorder, manage musculoskeletal pain and deal with insomnia.

Unique challenges
Non-digital products are approved by the FDA in a final form, such as a pill. Should a pharmaceutical company make changes to that pill, it would have to gain approval by the FDA once again to bring it to market. But many DTx products change over time because they adapt to users. For example, Akili Interactive markets a prescription DTx video game, EndeavorRX, for children with ADHD. The game adapts to players as they use it. So Akili must evolve the gameplay experience by adding new features and functionality to retain its effectiveness as a treatment.

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