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Three Big Questions for Stage 3 & Patient Engagement

Chilmark Research

The final rule is expected to drop sometime in Q1-Q2 of 2015 – just one year away. A popular example as of late is with biometric data: If a panel of diabetic patients are all given Bluetooth glucometers that input into respective EHRs, then what – Will someone monitor each of them?

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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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#WWBR Week of July 27, 2015

Chilmark Research

“Confusion about HIPAA privacy and security is one thing. HIPAA is often cited as a reason for not sharing patient data in contexts where HIPAA does not apply. The post #WWBR Week of July 27, 2015 appeared first on Chilmark Research. Paula Span for The New York Times. Feigned confusion is another.

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