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Who will regulate mHealth? Patient Engagement at Crossroads; New Alliance Takes On Interoperability

Chilmark Research

mHealth, known for rapid innovation and iteration, has a tendency to buck at the snail’s pace of FDA regulation. This could herald a new age of credibility for mHealth. They will need to tread carefully to maintain their objectivity in both certifying apps while at the same time providing a marketplace for mHealth apps.

mHealth 60
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The The Five Biggest Areas of Opportunity for Digital Health

The Digital Health Corner

Electronic health records (EHRs) and personal fitness trackers have helped create awareness through use. According to most recent statistics from the Office of the National Coordinator, use of EHRs has increased from 20% in 2004 to 87% in 2015. We need EHRs which are clinically oriented with good user interfaces.

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HIMSS14: Patiently Waiting for Progress

Chilmark Research

EHRs Look Inward. EHR vendors are at last developing moderate to advanced functionality with their portals (refills, secure communication, education, scheduling), with improved UX/UI that is starting to conform to consumer tech standards. HIEs Look Backward.

HIE 60
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FDA and Digital Health Regulation

Health Blawg

The IMDRF recognizes that the regulated community touched by this guidance is more software-focused than hardware-focused (and is not the traditional medical device regulated community), thus requiring some new approaches to data gathering and analysis. Comments Digital health figures in FDA's 2018 strategic roadmap.

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FDA and Digital Health Regulation

Health Blawg

The IMDRF recognizes that the regulated community touched by this guidance is more software-focused than hardware-focused (and is not the traditional medical device regulated community), thus requiring some new approaches to data gathering and analysis. Comments Digital health figures in FDA's 2018 strategic roadmap.

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FDA and Digital Health Regulation

Health Blawg

The IMDRF recognizes that the regulated community touched by this guidance is more software-focused than hardware-focused (and is not the traditional medical device regulated community), thus requiring some new approaches to data gathering and analysis. Comments Digital health figures in FDA's 2018 strategic roadmap.

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FDA and Digital Health Regulation

Health Blawg

The IMDRF recognizes that the regulated community touched by this guidance is more software-focused than hardware-focused (and is not the traditional medical device regulated community), thus requiring some new approaches to data gathering and analysis. Comments Digital health figures in FDA's 2018 strategic roadmap.