FDA Launches the Digital Health Center of Excellence

FDAToday, the U.S. Food and Drug Administration announced it is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). The launch of the Digital Health Center of Excellence is an important step in furthering the agency's overarching dedication to 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.

"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 FDA will continue to build and formalize the coordinating structure and operation of the Digital Health Center of Excellence as part of an effort to modernize digital health policies and regulatory approaches, and provide efficient access to highly specialized expertise, knowledge, and tools to accelerate access to safe and effective digital health technology. The agency is appointing Bakul Patel as the first director. Bakul Patel has been leading regulatory and scientific efforts related to digital health devices at the FDA since 2010.

"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," said Jeff Shuren, M.D., J.D., director of 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."

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. Along those lines, the Digital Health Center of Excellence is creating a network of digital health experts and engaging in Collaborative Communities to share knowledge and experience concerning digital health issues and priorities with FDA staff. An integral part of the launch includes the activities that will be provided to complement advances in digital health technology - such as launching strategic initiatives that advance digital health technologies, facilitating synergies in regulatory science research in digital health, and facilitating and building strategic partnerships.

The Digital Health Center of Excellence is committed to strategically advancing science and evidence for digital health technologies within the framework of the FDA’s regulatory and oversight role. While there are many aspects of the Digital Health Center of Excellence that are still under development, ultimately the goal is to empower digital health stakeholders to advance health care by fostering responsible and high-quality digital health innovation.

About the U.S. Food and Drug Administration (FDA)

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Most Popular Now

Digital ECGs at Barts Health: A High-Imp…

Opinion Article by Dr Krishnaraj Sinhji Rathod, consultant in interventional cardiology, Barts Health NHS Trust. Picture the moment. A patient in an ambulance, enroute to hospital with new chest pain. Paramedics...

Study Sheds Light on Hurdles Faced in Tr…

Implementing artificial intelligence (AI) into NHS hospitals is far harder than initially anticipated, with complications around governance, contracts, data collection, harmonisation with old IT systems, finding the right AI tools...

Using Deep Learning for Precision Cancer…

Altuna Akalin and his team at the Max Delbrück Center have developed a new tool to more precisely guide cancer treatment. Described in a paper published in Nature Communications, the...

New AI Approach Paves Way for Smarter T-…

Researchers have harnessed the power of artificial intelligence (AI) to tackle one of the most complex challenges in immunology: predicting how T cells recognize and respond to specific peptide antigens...

Study Used AI Models to Improve Predicti…

Chronic kidney disease (CKD) is a complex condition marked by a gradual decline in kidney function, which can ultimately progress to end-stage renal disease (ESRD). Globally, the prevalence of the...

AI-Powered CRISPR could Lead to Faster G…

Stanford Medicine researchers have developed an artificial intelligence (AI) tool to help scientists better plan gene-editing experiments. The technology, CRISPR-GPT, acts as a gene-editing “copilot” supported by AI to help...

Groundbreaking AI Aims to Speed Lifesavi…

To solve a problem, we have to see it clearly. Whether it’s an infection by a novel virus or memory-stealing plaques forming in the brains of Alzheimer’s patients, visualizing disease processes...

AI Spots Hidden Signs of Depression in S…

Depression is one of the most common mental health challenges, but its early signs are often overlooked. It is often linked to reduced facial expressivity. However, whether mild depression or...