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FDA's hands-off approach to digital health

The Food and Drug Administration is in no rush to regulate apps and similar digital tools that sometimes accompany prescription drugs and medical devices.

Details: The FDA rolled out a proposed framework yesterday that would treat most digital add-ons as part of a drug’s marketing, rather than as a fully regulated part of the product itself.

  • These are tools that, for example, track whether patients are taking their drugs and if they experience symptoms or side effects (potentially transmitting that information to doctors).
  • They can also gather safety and efficacy information that could help inform the FDA’s regulation of products that are already on the market.

The light touch is an effort to not stand in the way of a relatively new field that could ultimately help patients.

  • Digital tools “can promote compliance, promote collection of information that can be used to inform and engage with physicians, and promote the collection of real-world data that can be used to help inform follow-on drug development,” FDA Commissioner Scott Gottlieb said in an interview with BioCentury.
  • “The technology is ubiquitous, and I think this industry’s been slow to leverage it in large measure because of the regulatory uncertainty,” he told them.
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