U.S. Food and Drug Administration Precertification pilot program for digital health software: weighing the benefits and risks.

Theodore T Lee; Aaron S Kesselheim

Commentary

Emerging Classic

U.S. Food and Drug Administration Precertification pilot program for digital health software: weighing the benefits and risks.

April 11, 2018

Lee TT, Kesselheim AS. Ann Intern Med. 2018;168(10):730-732.

View more articles from the same authors.

Innovation is a valuable process in health care. However, when innovations are rapidly deployed, efforts to proactively identify and address safety concerns may fall short and lead to unintended consequences. This commentary describes a new program to expedite the review of digital health software and summarizes the benefits and potential harms that could result from the program.

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