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Digital Health Research and Partnerships

November 2, 2023: CDRH is seeking to gather more information about how digital health technologies, included those those enabled by artificial intelligence/machine learning (AI/ML), may help with early detection of risk factors for type 2 diabetes, prediabetes, and type 2 undiagnosed diabetes. Learn more: CDRH Seeks Public Comment.

Both regulatory science research and partnerships play an integral role in the Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence’s (DHCoE) mission to protect and promote public health by fostering responsible digital health innovation. 

Through digital health-focused collaborations, CDRH is fostering regulatory science research that enables FDA’s experts to understand and assess benefits and risks of new digital health technologies; and this research helps ensure the safety or reduce the harm of products used by patients and consumers by providing scientific, non-biased, and objective expertise.

On this page:

Areas of Interest 

On October 27, 2022, CDRH’s DHCoE published “Spotlight: Digital Health Regulatory Science Opportunities.” The Spotlight highlights some important research areas identified by stakeholders internal and external to the FDA. In the Spotlight, CDRH’s DHCoE describes these current regulatory science areas of interest in digital health for stakeholders to consider. Advances in digital health occur rapidly and new areas of interest are likely to arise prompting new regulatory science research focus areas throughout the ecosystem. 

Partnerships and Collaborations

Patients, researchers, health care providers, medical product manufacturers, technology companies, standards organizations, and many other stakeholders play integral roles in advancing digital health. Strategic alignment among these stakeholders can help focus efforts to optimize research and possible applications of digital health technologies. CDRH’s DHCoE fosters digital-health focused collaborations that advance public health including the following:

FDA’s Centers of Excellence in Regulatory Science and Innovation (CERSIs) are collaborations between the FDA and academic institutions to advance regulatory science through innovative research, training, and scientific exchanges.

Collaborative Communities are continuing forums in which private- and public-sector members work together on medical device challenges. These groups can invite CDRH to participate. CDRH’s DHCoE participates in the following digital health-related collaborative communities:

CDRH’s Network of Digital Health Experts is a pool of vetted experts available to share knowledge and experience regarding digital health issues with FDA staff on an as-needed basis. 

Other collaborations include CDRH’s DHCoE partnership with the Medical Device Innovation Consortium (MDIC)'s Digital Health Initiative.

Research Through Our Collaborations

Through our partnerships and collaborations, CDRH’s DHCoE is fostering regulatory science research projects in several areas important to digital health. This research includes the following topic areas:

Artificial Intelligence/Machine Learning (AI/ML)

Digital Biomarkers

Digital Health Technologies

Real World Data and Performance

Augmented Reality / Virtual Reality

Interested in Collaborating with CDRH’s Digital Health Center of Excellence?

There are several ways to collaborate with the DHCoE, including those partnerships listed in the Partnerships and Collaborations section above. 

Please visit the DHCoE webpage Ask a Question About Digital Health Regulatory Policies for information on how to collaborate with the DHCoE or to submit questions related to current digital health policies.

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