Enhancing Digital Therapeutics for Substance Use Disorders Through Evidence-Based Standards
New York, Thursday, 30 October 2025.
A recent article highlights the critical need for applying evidence-based medicine standards to digital therapeutics for substance use disorders, aiming to improve their credibility and patient outcomes.
The Need for Evidence-Based Standards in Digital Health
The integration of evidence-based medicine (EBM) standards into digital therapeutics for substance use disorders is increasingly recognized as vital for enhancing their effectiveness and credibility. Currently, many digital health interventions lack the rigorous evaluation seen in traditional medicine, which can undermine their potential in treating complex conditions like addiction [1].
FDA Approval and the Evidence Gap
Digital therapeutics, often approved by the FDA as medical devices, undergo a distinct approval pathway focusing on clinical performance and safety, as opposed to the chemistry-focused processes for pharmaceuticals [2]. However, a significant evidence gap persists between FDA-approved digital therapeutics and commercial apps that often lack robust clinical trial data, raising concerns about their efficacy [1].
Economic and Accessibility Benefits
Prescription digital therapeutics (PDTs) offer substantial economic value and accessibility benefits, particularly in underserved areas. By providing guideline-based care digitally, these interventions can reach populations with limited access to mental health professionals. This capability is crucial as rural areas, where only about 20% have access to behavioral health services, face severe workforce shortages [3].
Challenges and Opportunities
While digital therapeutics present promising opportunities for extending care, they also face systemic challenges such as reimbursement uncertainties, provider awareness, and integration into clinical workflows. Addressing these barriers is essential for maximizing the potential of digital tools in healthcare [1]. Furthermore, ongoing research and collaborations between tech companies and healthcare providers are expected to enhance digital therapeutic frameworks, with findings anticipated by December 2025 [4].