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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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mHealth13: Lots Going On, But Few New Developments

Chilmark Research

Another year, another mHealth Summit. HIMSS’ younger sibling has slowly grown over the last five years, a period that has seen a Precambrian explosion of companies and advances in mobile tech. However, despite some early hints of maturity, the mHealth Summit revealed the mobile healthcare market’s overall identity confusion.

mHealth 60
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The Most Important Trends For Health in Mary Meeker’s 2019 Internet Report Aren’t About Health Care

Health Populi

For health care privacy, Americans’ HIPAA provisions surely don’t cover personal information that informs health beyond the healthcare claim the way Europeans’ GDPR or the soon-to-be-implemented California Consumer Privacy Act of 2020 do. 2015 – Musings with Mary Meeker on the Digital/Health Nexus.

eHealth 264