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By: Troy Tazbaz, Director, Digital Health Center of Excellence, Center for Devices and Radiological Health, U.S. Food and Drug Administration

One of my highest priorities for the Digital Health Center of Excellence (DHCoE) is to foster collaboration as we seek to understand and assess the rapid advances occurring in the digital health ecosystem. I see patients, researchers, health care providers, medical product manufacturers, technology companies, standards organizations, and many other stakeholders as playing integral roles in advancing digital health, and ultimately improving health care.

Our collective sharing of knowledge can increase awareness of digital health advancements and reveal opportunities for synergy. DHCoE's collaborative regulatory science research in the areas of artificial intelligence/machine learning (AI/ML), digital biomarkers, and digital health technologies continues to demonstrate how we can advance responsible innovation together.

The Opportunity for Digital Health to Improve Diabetes Prevention and Early Detection

Today I want to share with you an area of interest and an opportunity for digital health collaboration that touches the lives of so many people: diabetes. One in 10 Americans has diabetes—37 million people—and one in five do not know they have it. As President Biden's proclamation for National Diabetes Month recommits us as a nation to do more to prevent and manage this disease, we at the DHCoE are asking, "What role can digital health technology play?"

With this ability to facilitate prevention, early diagnosis, and management of chronic conditions outside of traditional health care settings, digital health technologies (DHTs) also have the potential to reach underserved populations and advance health equity. There are many examples of socioeconomically disadvantaged or geographically isolated communities that lack access to health care services and have a higher risk of developing diabetes or diabetes-related complications. This highlights the opportunity for digital health to identify diabetes earlier and to help people live healthier lives.

Together—as the whole of government and as a community of researchers and innovators—we can work hand in hand with the people most impacted by type 2 diabetes to extend the reach of the health care system beyond the clinic, and to advance the use of DHTs to help people better measure, understand, and manage their health.

We need your help. CDRH previously announced that we are seeking comment from the public on a number of questions related to diabetes prevention and detection, and a docket is open for the public to submit comments. Please share your insights on how digital health technologies may help with early detection of risk factors for type 2 diabetes, prediabetes, and type 2 undiagnosed diabetes now through January 31, 2024. We invite you to answer these and other important questions:

• How can DHTs extend care into people's homes and communities, to play a role in early detection, prevention, or disease reversal of type 2 diabetes?
• How can DHTs be used to advance health equity and help people in impacted communities avoid the burden and disability from diabetic-related conditions such as blindness or stroke, and cardiovascular, kidney, and peripheral vascular disease?

This is our opportunity to make significant strides in advancing safe and effective DHTs and reducing the diabetes epidemic's effect on individuals and society.

Opportunities to Collaborate with the DHCoE

I welcome you to collaborate with our DHCoE through our ongoing regulatory science research projects, as well as our Centers of Excellence in Regulatory Science and Innovation (CERSI), and Collaborative Communities, in which private- and public-sector members work together on medical device challenges.

We are here to help you navigate the FDA's current policies on digital health products and to provide informal feedback on the possible regulatory status of products in development. We welcome your questions and look forward to your continued partnership.