DTx Digest: September 27, 2024

Andy Molnar, CEO, Digital Therapeutics Alliance

It is an honor to share that I’ve been appointed to serve as an industry representative on the FDA’s newly established Digital Health Advisory Committee (DHAC), an advisory body formed to guide the agency on issues related to digital health technologies (DHTs).

This appointment is a testament to the growing influence of digital health and the role that the Digital Therapeutics Alliance (DTA) and its members are playing in shaping its future. Our involvement in the DHAC presents an opportunity for us to ensure that the voice of the entire industry—not just individual companies—is heard. It’s a chance to contribute to the regulatory framework that will determine how DHTs are evaluated, approved, and integrated into the broader health care system.

My focus within the committee will span several areas, including real-world evidence (RWE), decentralized clinical trials, digital diagnostics, and virtual/augmented reality (VR/AR). As DHTs advance, they offer new avenues to improve care coordination, manage chronic diseases, and lower health care costs. However, aligning regulatory frameworks with the pace of innovation is essential to ensuring these solutions are safe, effective, and accessible.

With the FDA taking a proactive approach to digital health, this collaboration will help streamline the approval process, creating more predictable pathways for manufacturers and ensuring payers and health systems can confidently adopt these technologies. This translates into better patient outcomes, reduced administrative burden, and, ultimately, lower costs for the health care system.

Our first meeting is slated for November, where we’ll dive into these conversations. It’s vital that we approach this responsibility with a collective mindset. The DTA will ensure that the voices of our members—representing the full spectrum of DHTs—are heard, so that we can offer the FDA a comprehensive perspective, centering efficacy and patient safety above all else.