Digital therapeutics (DTx) are health softwares intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient’s health.
DTx products deliver medical interventions directly to patients or integrate with other digital health technologies, medications, or in-person therapies to:
“I knew the main thing I needed was to have a companion, someone I could tell my worries to, and who could be there for me. I found Woebot and when I opened it up to use it, I had a sense of calm like someone was there for me.”
Brian C, United States
“My mental health is way up thanks to Sleepio. I feel like myself again – the issues of anxiety and depression are gone, my work productivity is up, my personal health and relationships have improved, and my sense of who I am and wellbeing is completely restored.”
Wendy, United States
Digital therapeutic products must be proven as effective via rigorous testing such as Randomized Control Trials (RCT). Published results must include clinical trials results demonstrating that each technology is safe, effective, credible, and delivers clinically meaningful results.
DTx companies collect, analyze, and apply ongoing real-world evidence generation and analysis of product performance data to demonstrate ongoing clinical impact, product usability, and value.
Additionally, DTx products align with industry best practices which include well-established Good Clinical Practice protocols.
DTx manufacturers are expected to design products using a human-centered approach and account for the user’s core needs, their environment, and the types of devices that will be used. While some digital therapeutics are purely software-based, others are paired with hardware components, such as wearable and wireless devices, sensors, diagnostic products, and virtual reality systems.
No matter how many components are integrated into a DTx product, all product developers must engage end users – including patients, caregivers, and clinicians – every step of the way. This patient-centered focus enables digital therapeutics to more seamlessly blend into clinical guidelines, care delivery systems, and patient lifestyles from the privacy of their own environments.
Digital therapeutic products improve patient outcomes for a wide range of diseases and disorders with clinically proven technologies that are accessible through devices such as smartphones and personal tablets.
DTx products may expand access to proven therapies, offer treatment options for un- or undertreated conditions, and empower patients with self-management tools. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes.
Yes. DTx products are subject to national and regional privacy rules which define strict standards for the protection of personal health information (e.g., HIPAA, GDPR).
Compared to products that track fitness, encourage medication adherence, or monitor patient activity, DTx products deliver medical interventions directly to patients. As such, digital therapeutics undergo rigorous testing and are held to the same standards of evidence and regulatory requirements as traditional medical treatments.
Wellness and fitness apps that consumers download to their smartphones are not typically regulated, nor do they need to prove product claims by scientific testing or clinical evidence.
Patient access to DTx products is generally granted through a prescription by a qualified healthcare provider, a referral or authorization from a clinician, or through the delivery of a product activation code via a payor or employer.
“I had a stroke which left my left side fully paralyzed. JOGO helped me fully recover in the comfort of my own home after the initial rehab failed. I am now able to walk, my range of motion improved dramatically, I am now able to open a water bottle and even drive a car”
"My COPD has been under control a whole lot more with having Propeller. I don't have nearly as many attacks as I used to since I've been using Propeller for three years now."
"Dario has helped me manage my diabetes, because I now know how my body reacts to different foods and meals. Before Dario, my A1c was 9.7. Now it's 5.7."
“I was an aggravated mess, short tempered for no reason, and always on edge. That edge was very sharp and when people got close I would ‘cut’ them with my behavior. The breathing causes me to stop and slow down. It’s like my edge is dull now instead of sharp and people can get close to me. My children really noticed that there has been a change. I am so glad my doctor suggested I do this.”
"In the past 20 months, because BlueStar and following the directions of my physicians, I have lost 40 pounds. The program has helped me get a handle on diabetes."