Digital Therapeutics

Digital therapeutics (DTx) deliver therapeutic interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of behavioral, mental, and physical diseases and disorders. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes.


What is a digital therapeutic?

Digital therapeutics deliver clinical-grade therapeutic interventions to patients. DTx products may be used independently or in tandem with in-person or remote clinician-delivered therapy to optimize patient outcomes. These products:

  • Increase remote access to therapies that are clinically demonstrated as safe and effective.
  • Provide care independent of a patient’s schedule and in the privacy and safety of their home environment.
  • Are easily scalable and often accessible through patient-owned devices (e.g., smartphones, tablets).
  • Generate actionable, real world insights that enable intelligent data-driven care management and clinical decision making.

Digital therapeutics undergo clinical trials, collect real world outcomes, and are based on patient-centered core principles and product development best practices, including product design, usability, data security, and privacy standards.

Is there a difference between DTx products and wellness apps?

Not all digital health products are the same. But what are their differences? How should each product be used? What should expectations be about product outcomes? How much clinical evidence or regulatory oversight is needed to go to market?

Digital health includes technologies, platforms, and systems that engage consumers for lifestyle, wellness, and health-related purposes; capture, store or transmit health data; and/or support life science and clinical operations. These products typically do not require clinical evidence or regulatory oversight.

Digital medicine includes evidence-based software and/or hardware products that measure and/or intervene in the service of human health. Clinical evidence is required for all digital medicine products and requirements for regulatory oversight vary.

Digital therapeutic products deliver evidence-based therapeutic interventions to prevent, manage, or treat a medical disorder or disease. Clinical evidence and real world outcomes are required for all DTx products. They are reviewed by regulatory bodies as required to support product claims of risk, efficacy, and intended use.

What are examples of digital therapeutics?

The products developed by member companies address a wide variety of diseases and deliver an equally diverse array of interventions.

While DTA does not endorse, certify, or accredit products, we are glad to provide examples of DTx products from member companies that attest to aligning with DTx Industry Core Principles.

This list will continue to be updated with additional member company products that have advanced through the pipeline development process and are aligned with DTA’s core principles.

What benefits do DTx products provide?

DTx products are increasingly able to provide broad access to evidence-based therapy options for conditions that previously have been untreated or undertreated by traditional medications and therapies.

As the digital therapeutics industry grows, patients, providers, and payors can expect to see an increasingly comprehensive network of therapy options for physical, mental, and behavioral disease states.

Accounting for the diversity of products across the DTx industry, individual digital therapeutics have the potential to:

  • Provide patients, clinicians, and payors with novel therapy options for unmet medical needs
  • Be used independently or in conjunction with other therapies
  • Enhance, support, or optimize current medical treatments
  • Integrate into medical guidelines and best practices
  • Enable the expansion of care outside of a traditional clinic setting

What constitutes a ‘high quality’ DTx product?

DTA Members are committed to ensuring that all DTx products align with industry core principles and advanced technology best practices, including product quality and design, end user engagement, usability, clinical evaluation, regulatory oversight, privacy, and security.

As companies within the digital therapeutic industry work to deliver medical interventions directly to patients through software, it is important for end users to know that the companies working to develop, evaluate, and market these products are acting in end users’ best interests.

The industry Code of Ethics and Best Practices demonstrate DTA Member Companies’ dedication to developing and bringing DTx products to market in a responsible way.

What types of clinical trials do DTx products undergo?

Digital therapeutics are a novel modality of medicine in which software delivers therapeutic interventions directly to a patient, usually targeting a specific disease, to generate a measurable clinical outcome. In the same way that active ingredients in pharmaceuticals are responsible for the drug’s mechanism of action, software content and algorithms in digital therapeutics are used to prevent, manage, or treat a medical disorder or disease. DTA advocates that digital therapeutics be held to the same standards of evidence as other medical therapies. This includes selection of the proper trial design, utilization of standardized endpoints, alignment with Good Clinical Practices (GCP), appropriate reporting of outcomes, publication of results in peer-reviewed journals, and the generation and application of Real World Evidence (RWE).

Digital therapeutics must be subject to recognized standards of evidence in the field of medicine if they are to: a) demonstrate safety and efficacy; b) establish credibility to sustain the trust of patients, clinicians, and healthcare organizations; c) offer clinically meaningful patient benefits; and d) be integrated into and/or adopted as standard-of-care. A product without an evidence base should not, therefore, be put forth as a digital therapeutic.

Links

How are DTx products regulated?

Regulatory jurisdictions most frequently regulate digital therapeutics as Software as a Medical Device (SaMD), as a medical device, or as a combination product.

Digital therapeutics are categorized based on the level of risk associated with each product’s claim. Best practices all digital therapeutics should adhere to include:

  • Be compliant with oversight provided by each national regulatory agency or notified body, including review of safety and efficacy medical claims.
  • Register with the applicable regulatory agency or notified body in each jurisdiction the product is being used.
  • Be compliant with regional manufacturing requirements.
  • Ensure that product claims are appropriate to clinical validation, regulatory status, and marketing authorization.
  • Adhere to labeling and advertising regulations under appropriate authorities, including all labels and other written, printed, or graphic matter accompanying or associated with the product.

How are DTx products paid for?

In order to address growing mental health needs, provide remote care for patients with chronic conditions, and optimize clinician-delivered care, it is crucial for patients to be given access to evidence-based digital therapies from the safety and privacy of their home environment.

Healthcare decision makers may expect digital therapeutics to:

  • Deliver clinical, service efficiency, and health economic benefits at the patient and population levels for a broad range of disorders and diseases
  • Be used independently or in tandem with remote or in-person clinician-delivered therapy
  • Increase therapy access without potentially requiring an equivalent workforce expansion
  • Achieve commercial scale through partnerships between DTx companies and industry partners
  • Optimize patient outcomes and prevent exacerbations, thus reducing chronic disease-related hospitalizations
  • Decrease the economic burden of medical conditions by reducing overall costs

National coverage frameworks for digital health that include DTx products are currently being implemented in Germany and Belgium, while France and the United Kingdom have been financing DTx products regionally for more than three years.

In the United States, DTx products most frequently receive third-party payment by employers, PBMs, or insurers. Digital therapeutics are not currently reimbursed by Medicare or most state Medicaid programs.

What are patients saying about digital therapeutics?

Digital therapeutic manufacturers are expected to design DTx 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, biometric sensors, and diagnostic products.

No matter how many components are integrated into a DTx product, it is crucial for product developers to engage end users – including patients, caregivers, and healthcare providers – every step of the way.

This patient-centered focus enables digital therapeutics to more seamlessly blend into clinical guidelines, care delivery systems, and patient lives in the privacy of their own environment.