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FDA and Digital Health Regulation

Health Blawg

(If you’re being compliant or adherent you’ll read those three first: SaMD: Key Definitions (2013), SaMD: Possible Framework for Risk Categorization and Corresponding Considerations (2014), and SaMD: Application of Quality Management System (2015).) Comments Digital health figures in FDA's 2018 strategic roadmap.

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FDA and Digital Health Regulation

Health Blawg

(If you’re being compliant or adherent you’ll read those three first: SaMD: Key Definitions (2013), SaMD: Possible Framework for Risk Categorization and Corresponding Considerations (2014), and SaMD: Application of Quality Management System (2015).) Comments Digital health figures in FDA's 2018 strategic roadmap.

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FDA and Digital Health Regulation

Health Blawg

(If you’re being compliant or adherent you’ll read those three first: SaMD: Key Definitions (2013), SaMD: Possible Framework for Risk Categorization and Corresponding Considerations (2014), and SaMD: Application of Quality Management System (2015).) Comments Digital health figures in FDA's 2018 strategic roadmap.

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FDA and Digital Health Regulation

Health Blawg

(If you’re being compliant or adherent you’ll read those three first: SaMD: Key Definitions (2013), SaMD: Possible Framework for Risk Categorization and Corresponding Considerations (2014), and SaMD: Application of Quality Management System (2015).) Comments Digital health figures in FDA's 2018 strategic roadmap.

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FDA and Digital Health Regulation

Health Blawg

(If you’re being compliant or adherent you’ll read those three first: SaMD: Key Definitions (2013), SaMD: Possible Framework for Risk Categorization and Corresponding Considerations (2014), and SaMD: Application of Quality Management System (2015).) Comments Digital health figures in FDA's 2018 strategic roadmap.

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Unifying the Healthcare Assembly Line

Mobile Health Matters

The launch of Meaningful Use under the Affordable Care Act drove the electronic medical record (EMR) “Gold Rush,” the mass implementation of EMRs in a shift away from paper charts. Joining AirStrip in 2014 as the VP of Commercial Operations, Scott manages all commercial team operations, implementations and user training at AirStrip.

EMR 129
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Review of Mobile Devices and Health by Ida Sim in the NEJM

mHealth Insight

Mobile health — the application of sensors, mobile apps, social media, and location-tracking technology to obtain data pertinent to wellness and disease diagnosis, prevention, and management — makes it theoretically possible to monitor and intervene whenever and wherever acute and chronic medical conditions occur.