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:
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.
Analytical feedback suggests SilverCloud is working just as well as more traditional methods of care.
Luke Raymond, Manager, Behavioral Health Services, OSF Health, United States
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:
Digital therapeutics are regulated as medical devices. Regulatory oversight is based on product risk levels and includes:
Patient access to DTx products may be granted through:
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 Germany, Belgium, France, and the United Kingdom.
When evaluating whether to prescribe or authorize a DTx product, consider the following:
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:
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.
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"Analytical feedback suggests SilverCloud is working just as well as more traditional methods of care."