Digital Therapeutics as Prescription: Navigating Regulatory Pathways and Provider Adoption

Digital therapeutics are evolving from experimental interventions to FDA-cleared prescription solutions, yet the pathway from regulatory approval to widespread provider adoption remains complex and uncertain. While several DTx have achieved regulatory milestones and demonstrated clinical efficacy, translating these achievements into routine clinical practice requires navigating unfamiliar prescribing workflows, reimbursement challenges, and provider education needs.

The prescription model for digital therapeutics introduces unique considerations that differ significantly from traditional software applications or wellness tools, requiring healthcare providers to understand new therapeutic categories while patients adapt to app-based treatments with the same rigor as pharmaceutical interventions. Success depends on creating seamless integration points between regulatory compliance, clinical workflows, and patient engagement strategies.

Join us to discuss:

• What regulatory pathways and evidence requirements are proving most effective for digital therapeutics seeking prescription status, and how are these evolving based on early market experience?
• How are healthcare providers adapting their prescribing practices and patient management approaches to incorporate FDA-cleared digital therapeutics into routine care?
• What implementation strategies are proving most successful for driving provider adoption and patient adherence with prescription digital therapeutics across different therapeutic areas?