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The Colorado Psychedelic Mushroom Experiment Has Arrived

KFF Health News

The mushrooms are a Schedule I drug and illegal under federal law except for clinical research. The National Institute on Drug Abuse , part of the National Institutes of Health, says the risk of mental health problems caused by ingesting mushrooms in a supervised clinical setting is low, but may be higher outside of a clinical setting.

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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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act (Cures Act) (Draft). mental acuity. physical fitness. self-esteem.

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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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act (Cures Act) (Draft). mental acuity. physical fitness. self-esteem.

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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act (Cures Act) (Draft). mental acuity. physical fitness. self-esteem.

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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act (Cures Act) (Draft). mental acuity. physical fitness. self-esteem.

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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act (Cures Act) (Draft). mental acuity. physical fitness. self-esteem.

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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.