Advancing Digital Health Innovation in the Gray Space of Evolving FDA Regulations: What to Expect in 2023 and Beyond

Over the last 47 years, since the creation of the statutory regulatory framework, we’ve evolved from the traditional hardware world of devices to newer, broad-spectrum digital health technology (DHT) solutions. This shift, coupled with the increased use of DHTs and measurement products in clinical development, has created a ”regulatory uncertainty” across the industry. As the industry continues to design and deploy these technologies in clinical trials; and evaluate and optimize their use, how can we shift our mindset to view collaborating with regulators as an opportunity, not a threat, to advancing the adoption and scale of digital measures? What regulatory uncertainty still exists and how can it be addressed? And as technology solutions and regulations continue to evolve, what lies ahead in the future of DHTs and digital measurement tools in clinical development? As the field lays the foundations to adopt and scale digital measurements to achieve the promise of digital medicine, leading experts from the field in a multistakeholder panel will share their perspectives on driving toward the next frontier of innovations.