On September 22, FDA announced the creation of a Digital Health Center of Excellence (DHCoE), which has grown out of their existing Digital Health Program. The objectives of the DHCoE include connecting and building partnerships, sharing knowledge and innovating regulatory approaches related to digital health. The landing page provides helpful links to other content on the FDA website related to digital health.
It appears that the DHCoE provides new organization for the work that the Agency has already been doing in the digital health space. DHCoE services are organized into those that empower stakeholders, connect stakeholders, share knowledge and innovate regulatory approaches. For each service, there are numerous examples of ongoing activities that the digital health team has been providing.
With its kick-off, the DHCoE focus will be to raise awareness and engage stakeholders. Starting this winter and into next year, they plan to focus on building partnerships, including creation of a digital health community of practice and assembling FDA and CDRH advisory groups. Overall, the DHCoE appears to set the stage for developing and implementing improvements to digital health policy and processes.
For those interested in learning more and asking questions related to the DHCoE, FDA is offering two listening sessions in October and November. They will also be involved in the upcoming Patient Engagement Advisory Committee Meeting on Artificial Intelligence and Machine Learning in October.