Digital health was coming quickly prior to the coronavirus pandemic and now it is even more at the forefront. And to continue evolving the space, the U.S. Food and Drug Administration has officially launched the Digital Health Center of Excellence, a huge step in the advancement of digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and technologies used to study medical products. The new center is within the Center for Devices and Radiological Health (CDRH).
“Establishing the Digital Health Center of Excellence is part of the FDA’s work to ensure that the most cutting-edge digital health technologies are rapidly developed and reviewed in the U.S.,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s announcement marks the next stage in applying a comprehensive approach to digital health technology to realize its full potential to empower consumers to make better-informed decisions about their own health and provide new options for facilitating prevention, early diagnosis of life-threatening diseases, and management of chronic conditions outside of traditional care settings. The Digital Health Center of Excellence will provide centralized expertise and serve as a resource for digital health technologies and policy for digital health innovators, the public, and FDA staff.”
The Digital Health Center of Excellence is primarily focused on helping both internal and external stakeholders achieve their goals of getting high quality digital health technologies to patients by providing technological advice, coordinating and supporting work being done across the FDA, advancing best practices, and reimagining digital health device oversight.
A key impact will be the creation of a network of digital health experts that will engage in Collaborative Communities to share knowledge and experience concerning digital health issues and priorities with FDA staff.
This should have a significant and positive impact on the quality of healthcare worldwide and in America.