Healthcare IT News January 3, 2022
The draft report offers recommendations for stakeholders about using digital health hardware and software to gather information from remote trial participants.
The U.S. Food and Drug Administration has released a draft guidance focused on using digital health technologies to acquire data remotely from participants in clinical investigations of medical products.
“Compared to intermittent trial visits, the use of DHTs to remotely collect data from trial participants may allow for continuous or more frequent data collection,” said FDA officials. “This may provide a broader picture of how participants feel or function in their daily lives.”
At the same time, it said, sponsors and stakeholders should ensure their technology of choice is fit for its intended purpose.
“Sponsors are...
Today's Sponsors
Today's Sponsor