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

Lee TT, Kesselheim AS. U.S. Food and Drug Administration Precertification Pilot Program for Digital Health Software: Weighing the Benefits and Risks. Ann Intern Med. 2018;168(10):730-732. doi:10.7326/M17-2715.

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April 11, 2018
Lee TT, Kesselheim AS. Ann Intern Med. 2018;168(10):730-732.

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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Lee TT, Kesselheim AS. U.S. Food and Drug Administration Precertification Pilot Program for Digital Health Software: Weighing the Benefits and Risks. Ann Intern Med. 2018;168(10):730-732. doi:10.7326/M17-2715.