Seminal documents on regulation of digital health software in the US.

The FDA has some seminal documents on regulation in digital health software:
Eversana's overview of 2022

Resources for getting oriented in DTx

The Digital Therapeutics Alliance (DTA) has several primers on key topics in DTx:
Exits & Outcomes
  • Exits and Outcomes - a subscription newsletter by Brian Dolan that meticulous tracks developments in digital therapeutics. Has several issues per week, plus searchable archives and detailed reports on major players in DTx.