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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

A landmark clinical trial in which drugs are given solely on the basis of genetic markers identified in the cancer tissue itself is the NCI-MATCH Trial (Molecular Analysis for Therapy Choice). There are hospitals within the same healthcare system in many places with disparate EHRs which do not talk to each other or exchange information.

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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.

article thumbnail

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.

article thumbnail

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.