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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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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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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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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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BioLab fire: Patchwork response exposes shortfalls in emergency planning, environmental safety

HEALTHBEAT

Public health, explained: Sign up to receive Healthbeat’s free Atlanta newsletter here. But questions remain about what steps local and state regulators took to prevent a fire at a facility with a track record of environmental violations, including similar accidents in 2020. Rockdale County says it will file a federal lawsuit.

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How would you like to change HIPAA?

Health Blawg

The first RFI to issue was the one seeking input on the regulations implementing the Stark law and the federal anti-kickback statute (See: Stark and AKS RFI and public comments ). A digression: As the health wonks and policy nerds reading this are already aware, HIPAA is a horse of a different color.