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In the rapidly changing landscape of digital health, innovation has often outpaced regulations, especially for novel technologies and emerging industries. To narrow the gap, the Food and Drug Administration has acknowledged that new regulatory policies and frameworks are necessary.

To this end, the FDA has been testing new regulatory paradigms, modernizing submission approaches, updating policies, and urging legislative actions to keep up with new developments. But the time required to develop and publish regulatory guidance is out of step with the speed of advancements in digital health technologies and changes in recommendations for their clinical use. The lack of alignment in these timelines frequently leads to regulatory uncertainty among digital health innovators and developers, who often find themselves struggling to find answers to basic questions and may simply avoid or delay engaging with regulatory agencies.

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