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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.

article thumbnail

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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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.

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