New FDA Digital Health Guidance

The Food and Drug Administration (FDA) has released new guidance related to digital health technologies for remote data acquisition.

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The FDA draft report is currently open for public comments and offers recommendations about using digital health hardware to gather information from remote trial participants.

The FDA stated that digital health technology allows for frequent data collection, but stakeholders should ensure their technology is fit for its intended purpose.

Digital health technologies may be used to gather health-related information from study participants and transmit information to authorized parties. This will occur to help evaluate the safety and effectiveness of medical products.

Data that can be collected this way includes ambulation, sleep, performance of tasks, the participants location, and more. It also allows direct collection of information for participants who cannot report their experiences due to age or cognitive impairment.

The tools the FDA is referring to include sensor hardware and software applications.

The FDA’s guidance outlined considerations for study sponsors, including:

  • Technology selection
  • Verification and usability of the technology
  • Data collection tools
  • technology risks
  • Record protection and retention

Public comments are due by March 22, 2022.

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