Lexology January 5, 2022
As we kick off 2022, several recent developments from FDA suggest that this year could be pivotal for the Agency’s digital health priorities. From new FDA offices and artificial intelligence guidance, to FDA’s user fee commitments and must-pass legislation in Congress, this post outlines five key issues to watch in 2022 related to FDA and digital health. For all of these issues, stakeholders should be mindful of areas where digital health can help address some of the health disparities highlighted by the pandemic (e.g., ability to reach more clinical trial participants using wearables and other technologies, use of real-world evidence to better understand treatment effects in underrepresented populations, at-home software and diagnostic solutions).
1. FDA’s Digital Transformation
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