Fostering Medical Innovation: A Plan for Digital Health Devices

by Scott Gottlieb
Food and Drug Administration (FDA), June 2017

Read online at:
https://blogs.fda.gov/fdavoice/index.php/2017/06/fostering-medical-innovation-a-plan-
for-digital-health-devices/

FDA will soon be putting forward a broad initiative that is focused on fostering new innovation across our medical product centers. Today we want to focus on one critical aspect of this innovation initiative: A new Digital Health Innovation Plan that is focused on fostering innovation at the intersection of medicine and digital health technology. This plan will include a novel, post-market approach to how we intend to regulate these digital medical devices. According to one estimate, last year there were 165,000 health-related apps available for Apple or Android smartphones. Forecasts predict that such apps would be downloaded 1.7 billion times by 2017. From mobile apps and fitness trackers to clinical decision support software, innovative digital technologies have the power to transform health care in important ways.

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