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FDA and Digital Health Regulation

Health Blawg

These publications come as part of the FDA’s effort to improve its approach to digital health, to continue to work on drawing the line between digital health tools that are properly regulated as “devices” by the FDA and those that are not. Comments Digital health figures in FDA's 2018 strategic roadmap.

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FDA and Digital Health Regulation

Health Blawg

These publications come as part of the FDA’s effort to improve its approach to digital health, to continue to work on drawing the line between digital health tools that are properly regulated as “devices” by the FDA and those that are not. Comments Digital health figures in FDA's 2018 strategic roadmap.

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FDA and Digital Health Regulation

Health Blawg

These publications come as part of the FDA’s effort to improve its approach to digital health, to continue to work on drawing the line between digital health tools that are properly regulated as “devices” by the FDA and those that are not. Comments Digital health figures in FDA's 2018 strategic roadmap.

article thumbnail

FDA and Digital Health Regulation

Health Blawg

These publications come as part of the FDA’s effort to improve its approach to digital health, to continue to work on drawing the line between digital health tools that are properly regulated as “devices” by the FDA and those that are not. Comments Digital health figures in FDA's 2018 strategic roadmap.

article thumbnail

FDA and Digital Health Regulation

Health Blawg

These publications come as part of the FDA’s effort to improve its approach to digital health, to continue to work on drawing the line between digital health tools that are properly regulated as “devices” by the FDA and those that are not. Comments Digital health figures in FDA's 2018 strategic roadmap.

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The The Five Biggest Areas of Opportunity for Digital Health

The Digital Health Corner

I agree that traditional trials are neither practical nor necessary for most tools. Thus, the opportunity for trials utilizing digital registries, mobile clinical trial platforms, quality communications and analytics tools is significant. This should not however translate to “take my word for it” is all you need. Bring it!

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What is MHD beyond XDS-on-FHIR?

Healthcare Exchange Standards

However this solution is very hard to use if one is using programming tools more common on lightweight systems such as Mobile. So back in 2011 I wrote the first profile in IHE that was targeting ‘ease of use by lightweight application platforms such as Mobile Health Applications”.

FHIR 40