Prescription digital therapeutics are the next stage in the evolution of medical treatments. First there were small molecules, then biologics, and more recently we’ve seen the expansion into gene therapies; each exploring different opportunities to treat diseases in new and innovative ways. We are now entering the age of digital therapeutics, where products are developed to not just deal in patient tracking and diagnostics, but to actually treat disease across a broad spectrum of indications.

With the advent of the Digital Health Innovation Action Plan in 2017, the FDA has demonstrated a commitment to reimagining its regulatory strategy for digital therapeutics, providing a potential framework that results in payor reimbursement opportunities for companies and therapeutics that are the same as any standard prescription pill or liquid medication. With the goal of assuring that only high-quality, safe and effective digital products are delivered to patients and physicians, the agency is considering how to regulate faster, iterative design and development pathways for these products. Product development, regulatory and reimbursement strategies are now driven by a pragmatic evaluation of health outcomes data and a desire to create treatments that meet rigorous regulatory standards while providing a path to reimbursement through the FDA approval process.

This panel will explore the innovation behind the exploding prescription digital therapeutics industry and the evolving regulatory standards to address the needs of this new treatment modality.

Questions addressed by the panel will include:
• What are prescription digital therapeutics and how do they work?
• Why is regulation important, and what data are needed to support approvals?
• Are digital therapeutics just alternative therapies or are they potentially better ones?
• What are the key innovations in healthcare and technology that have gotten us here, and what is needed next, both on the industry side and the regulatory side?

Ability Level: All

Session ID: 21238