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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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

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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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

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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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

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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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

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The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period).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

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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.

article thumbnail

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.