What Are Digital Therapeutics?

Digital therapeutics (DTx) first entered clinical discussions in the 1990s. The idea was that technology could improve healthcare access. It could help overcome barriers of location, time, and resources. This is important as more people need healthcare as people live longer.

DTx is part of “digital health,” which also includes telehealth. But it is different from other forms of digital health. DTx products must be evidence-based. They must also aim to prevent or manage a certain condition.

What are digital therapeutics?

DTx includes software-based therapies that prevent or treat medical conditions. People can use DTx alone or with other types of care. The goal is to deliver care outside traditional doctor’s offices. Some benefits of DTx include:^1,2

• Increasing access to safe and effective therapies
• Lowering stigma by offering at-home convenience and privacy
• Providing therapies in different languages
• Personalizing goals and outcomes
• Reducing the burden on healthcare resources and personnel

The most common applications of DTx are in the treatment of:¹

• Diabetes
• Chronic obstructive pulmonary disorder (COPD)
• Post-traumatic stress disorder (PTSD)
• Substance addiction and mental health disorders

How are digital therapeutics different from digital health?

Digital health includes technologies used for wellness or health purposes. These do not need to provide evidence of their benefits. The government does not regulate them as medical devices. Examples of digital health include:¹

• Health information technologies
• Telehealth systems
• Systems that use consumer health information

DTx is a separate part of digital health. DTx technology must have evidence of preventing or managing a disease. In other words, DTx must target specific diseases. A wellness application on your phone is a type of digital health. An application designed to treat diabetes with diet changes is a type of DTx.^1,3

Examples of digital therapeutics

In some cases, DTx complements traditional healthcare. An example is mobile device reminders to take medicines. In other cases, DTx may replace existing healthcare. An example is using sensory stimuli instead of medicine.¹

DTx is used to treat conditions with behavior changes or therapy. Some examples include:^4,5

• A behavior program to manage type 2 diabetes
• Self-care programs to treat mental health disorders
• Artificial intelligence that encourages people to take medicines
• An ingestible sensor to monitor people with type 2 diabetes and hepatitis C
• Virtual reality that treats PTSD, depression, and other disorders

How are digital therapeutics regulated?

As DTx platforms and devices grow, governing groups must ensure they meet certain standards. The U.S. Food and Drug Administration (FDA) regulates DTx technologies as “mobile medical applications.” This includes anything other than a drug that can diagnose, treat, or prevent a disease.⁴

Medical devices can harm people if they do not work as intended. Each DTx technology goes through different levels of regulation by the FDA.^1,4

The FDA can waive the need to regulate products with low risk. This includes applications that help with diet and exercise. DTx devices similar to existing therapies do not need as much evidence as new devices. Brand-new DTx techniques must submit a “randomized controlled trial” to the FDA. This can take many years, which may be too slow for the digital world.¹

The FDA updated guidelines in 2017 to reduce the regulation time. Companies that have gone through a per-certification process can now go through a faster approval process.^1,4

What is the future of digital therapeutics?

DTx techniques have the potential to transform our healthcare system. Some digital therapies have already been approved and are in use for certain health conditions. As more digital therapies are studied and approved, they will continue to be integrated into medical care.