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FDA Unveils New Policies On Digital Health Oversight

Law360, New York (December 7, 2017, 6:21 PM EST) -- The U.S. Food and Drug Administration on Thursday unveiled new oversight policies for digital health products, including increasingly popular software used to assist doctors in making treatment decisions.

In a trio of guidance documents, the FDA described its posture on a wide array of computerized health products. They run the gamut from physician-focused software that creates customized treatment plans to consumer-focused software that reminds patients to take medications.

FDA Commissioner Scott Gottlieb heralded the guidances, saying that they will “expand our efforts to encourage innovation in...
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