Value of DTx  /  Clinicians

Trustworthy and Effective Therapy Options

DTx products represent a new category of evidenced-based therapeutic technologies that support clinicians in the delivery of high-quality patient care. They address a range of disease states and provide a wide variety of software-based interventions. DTx products are used independently or in concert with other medical therapies to:

  • Directly impact disease state measures and clinical outcomes
  • Expand access to safe, confidential, and effective medical treatments
  • Provide therapies for previously un- or undertreated conditions
  • Extend clinicians’ ability to care for patients
  • Maximize patient engagement
  • Close gaps in care
  • Lower overall healthcare costs

Because of their easy accessibility, record of improving outcomes, ability to integrate into care management workflows, delivery of real-world insights, and increased reimbursement by payors, DTx products are becoming critically important tools for clinicians and their care teams.

"I can go to the doctor on a good day and show him all the bad days. The information has helped fine-tune my treatment plan. Asthma is a horrible disease with no cure, but Propeller is a tool that has helped improve my daily quality of life."

Dawn, United States

“I suffered with Dystonia of my fingers due to a childhood stroke for more than 9 years. With JOGO, I am able to write now.”

Ms. Ananya, India

Frequent Questions

When evaluating whether to prescribe or authorize a DTx product, consider the following:

  • Which disease, disorder, condition or injury is the DTx product indicated to treat or alleviate?
  • What is the appropriate timing, duration, and frequency of therapy use?
  • Should the DTx product be used independently, or with medications, devices, or other therapies?
  • Does the product enable greater access to care and align with the patient’s current care?
  • Is the product content available in a familiar language for the patient?
  • What actionable outcomes are collected by the product and shared with patients, caregivers, and clinicians?

Digital therapeutics undergo robust clinical trials and are held to similar standards of safety and clinical evidence as traditional medical treatments. These include the proper trial design, utilization of standardized endpoints, alignment with Good Clinical Practices, appropriate reporting of outcomes, publication of results in peer-reviewed journals, and the generation and application of real-world evidence. This rigorous process enables DTx products to:

  • Demonstrate safety and efficacy across the relevant and target populations
  • Establish credibility
  • Deliver clinically meaningful results
  • Be considered as or among current standards-of-care

Digital therapeutics are regulated as medical devices. Regulatory oversight is based on product risk levels and includes:

  • Compliance with national regulatory agencies, notified bodies, and manufacturing requirements
  • Registration with the applicable product regulatory agency or notified body
  • Affirmation that product claims are factual and supported by clinical validation, regulatory status, and marketing authorization
  • Adherence to appropriate labeling and advertising regulations

Patient access to DTx products may be granted through:

  • Prescription from a qualified healthcare provider
  • Authorization or referral by a clinician or payor
  • Eligibility determination via a validated screening tool or clinical guideline
  • Delivery of an activation code via a payor or employer

DTx products are designed to generate and assess patient engagement and clinical outcomes. Data related to how many patients are accessing the technology, how often a product is used, and relevant clinical data may be delivered as appropriate to the treating clinician or payor in accordance with privacy measures. Well-established industry standards for a particular disease or disorder are used to define all relevant metrics for measuring and assessing meaningful clinical improvements.

In the United States, DTx products are increasingly covered by private payors, employers, and health systems. Public programs such as Medicare and Medicaid are still working to determine how to formally recognize and provide patients with access to DTx products.

Frameworks for national or regional payments are currently being implemented in Belgium, Germany, France, Japan, South Korea and the United Kingdom.

DTx products provide a wide range of valuable information that can be used to optimize patient outcomes, support data-driven care management, and drive clinical decision making such as:

  • Patient engagement and adherence to therapy
  • Clinical responses and overall therapy progress
  • Patient-generated insights
  • Real-world outcomes

Data captured by DTx products can be seamlessly integrated into health system practice settings, electronic health records, formularies, and coding systems to evaluate and optimize patient health.

"Even with medication for her ADHD, Freah still wasn't able to focus enough to do her school work. Since she started using EndeavorRx, she's been able to focus and pay attention long enough to do multiple pages of homework without my help. That has really boosted her confidence!"

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United States

"I tried Woebot and I just felt better. I've noticed a big difference in myself, and Woebot has really helped me to think differently. I never would have gone to a psychologist, Woebot kind of pushed me towards it. I realized how much I benefited from it."

United States

“I love TALi. It struck a beautiful balance between challenging and reassuring the targeted age group. The graphics are engaging, and the tasks are well explained. For the parents, the reports are well written, providing enough detail without being too overwhelming."

Monique, Cognitive Trainer

"We strongly believe that Dario's RPM offering fills a major unmet need by helping practices achieve meaningful improvements in medical outcomes while potentially increasing efficiency and reducing healthcare costs."

Hugh Hamer
Williams Medical

“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.”

United States

"Since introducing Freespira as a treatment option, we’ve seen tremendous patient quality of life improvements in a very short time. Many of these patients had been in therapy for years and struggled with ongoing panic attacks. After using Freespira, most were completely panic free.”

Kevin Caridad, LCSW, PhD
Cognitive Behavior Institute

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