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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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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.

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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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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.

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The Most Important Trends For Health in Mary Meeker’s 2019 Internet Report Aren’t About Health Care

Health Populi

For health care privacy, Americans’ HIPAA provisions surely don’t cover personal information that informs health beyond the healthcare claim the way Europeans’ GDPR or the soon-to-be-implemented California Consumer Privacy Act of 2020 do. 2015 – Musings with Mary Meeker on the Digital/Health Nexus.

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