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FDA and Digital Health Regulation

Health Blawg

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Since some digital health tools will inevitably be subject to regulation while many will not, the agency has previously issued a high-level plan for streamlining its processes.

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The Digital Consumer, Increasingly Connected to Health Devices; Parks Associates Kicking Off #CES2021

Health Populi

But the coronavirus era also saw broadband households spending more on connecting health devices, with 42% of U.S. consumers owning digital health tech compared with 33% in 2015, according to research discussed in Supporting Today’s Connected Consumer from Parks Associates. In 2020, the COVID-19 pandemic drove U.S.

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The Digital Transformation of Patients – Update from Rock Health and Stanford

Health Populi

But another patient side-effect of COVID-19 has been the digital transformation of many patients , documented by data gathered by Rock Health and Stanford Center for Digital Health and analyzed in their latest report explaining how the public health crisis accelerated digital health “beyond its years,” noted in the title of the report.

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FDA and Digital Health Regulation

Health Blawg

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Since some digital health tools will inevitably be subject to regulation while many will not, the agency has previously issued a high-level plan for streamlining its processes.

article thumbnail

FDA and Digital Health Regulation

Health Blawg

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Since some digital health tools will inevitably be subject to regulation while many will not, the agency has previously issued a high-level plan for streamlining its processes.

article thumbnail

FDA and Digital Health Regulation

Health Blawg

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Since some digital health tools will inevitably be subject to regulation while many will not, the agency has previously issued a high-level plan for streamlining its processes.

article thumbnail

FDA and Digital Health Regulation

Health Blawg

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Since some digital health tools will inevitably be subject to regulation while many will not, the agency has previously issued a high-level plan for streamlining its processes.