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QUOTED. Dec. 18, 2018. Scott Gottlieb.

Executive Summary

A new report from US FDA concludes, for the most part, that the benefits of a slew of non-device software functions not regulated by the agency outweigh their risks. The report sends a signal to industry that regulators are happy with the current situation and have no incentive to expand their oversight of such products. See what FDA Commissioner Scott Gottlieb said about it here.

“While we believe that the benefits of these products generally outweigh the risks to patients, we still encourage consumers and health-care providers who use these technologies to stay informed about the benefits and risks of these and any digital health products they are considering using or recommending for their patients. Moving forward, the FDA will continue to update this report to ensure the agency is striking the right balance in our approach to digital health.” –Scott Gottlieb, commissioner, US FDA

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