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Three Big Questions for Stage 3 & Patient Engagement

Chilmark Research

The definition provides only a general description, leaving a lot of possibility for interpretation and application down the road. Yet the definition above makes PGHD seem to carry more of an health risk assessment (HRA)-like utility, where patients fill out a survey and have it sent to their doctors in advance.

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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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Voice Health Summit Spotlight 2018

Consumer eHealth Engagement

patient portals) to mobile applications (mhealth) and now to voice and conversational assistants. Cedars-Sinai uses Sopris Assistant to record, summarize, approve and place the patient care note into the EHR. Real Problem Definition: Sara Holoubek, CEO Luminary Labs emphasized the importance of deciding who (e.g.

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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.