FDA Touts mHealth Expertise With Digital Health Center of Excellence
The new center aims to develop best practices and improve regulatory oversight of the fast-growing landscape of mHealth and telehealth tools, including wearables, apps and tech platforms that analyze medical products.
Source: ThinkStock
By - The US Food and Drug Administration has unveiled the Digital Health Center of Excellence, aimed at supporting mHealth and telehealth tools.
“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 US,” FDA Commissioner Stephen M. Hahn, MD, said in a press release. “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 establishment of the Digital Health Center of Excellence is part of the planned evolution of the FDA’s digital health program to amplify the digital health work that is already being done and building upon years of work at the agency,” added Jeff Shuren, MD, JD, director of the FDA’s Center for devices and Radiological Health (CDRH). “In the last several years, we have established partnerships internally and externally to coordinate digital health activities and to promote the consistency of regulatory policy while continuing to innovate in our regulatory approaches.”
