FDA Touts mHealth Expertise With Digital Health Center of Excellence

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.”

Established within the CDRH, the center will focus on standards and guidelines for the development of devices, software as a medical device (SaMD) wearables that are used as devices, and technology platforms used to study medical products. Its first director will be Bakul Patel, the CDRH’s current director for digital health.

The center’s primary function will be to improve the process for regulating mHealth and telemedicine devices. To that end, officials said the center is creating a network of digital health experts to network with FDA staff.

The FDA has in the past drawn criticism from telehealth and mHealth advocates, who have said officials haven’t kept abreast of advances in digital health technology that affect clinical outcomes and have been slow to react to new technologies.

The new center drew praise from the Connected Health Initiative (CHI), a consortium developed by ACT | The App Association.

“The Digital Health Center of Excellence (DHCE) will play a critical role to play in gathering and analyzing data from the skyrocketing use of the range of digital tools being developed, including those in the wake of the COVID-19 pandemic,” CHI Executive Director Morgan Reed said in a press release. “The FDA has the experience to analyze the effectiveness of digital health solutions and improve both outcomes and patient safety.”

“The DHCE is also well positioned to bring together industry, government, and academia as part of larger collaborations to advance digital health,” he added. “We look forward to the opportunity to work with DHCE to continue to advance the use of digital health technologies.”