FDA launches new center of excellence to develop, fine-tune digital health solutions

The FDA announced Tuesday, Sept. 22, its plans to launch a new center of excellence focused on the development and refinement of high-quality digital health solutions.

The Digital Health Center of Excellence, set to be operated within the agency’s Center for Devices and Radiological Health (CDRH), is designed to help stakeholders get their digital health products in the hands of patients. Experts in the field will be available to offer advice, organize strategic initiatives and build partnerships.

Considering the massive potential for mobile health applications, wearable devices and other digital technologies to help diagnose, monitor and treat various cardiovascular ailments, it’s likely that cardiologists will become quite familiar with the new center in the years ahead.

“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.,” FDA Commissioner Stephen M. Hahn, MD, said in a prepared statement. “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.”

Bakul Patel, a longtime digital health specialist for the FDA, will serve as the center’s first director. Some details are still under development, the agency wrote in its statement, but “ultimately the goal is to empower digital health stakeholders to advance health care by fostering responsible and high-quality digital health innovation.”