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Request For Information Rulemaking Process Department of Health and Human Services (HHS)

Venable LLP

Operation Stork Speed Update: FDA Issues RFI for Infant Formula Nutrition Review

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On May 14, as part of Operation Stork Speed (the Operation), the U.S. Food and Drug Administration (FDA) issued a request for information (RFI) to begin its review of infant formula nutrition requirements. FDA’s last...more

Mintz - Health Care Viewpoints

OCR RFI: Have You Implemented Your Recognized Security Practices?

The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) released a Request for Information (RFI) to obtain industry feedback and inform potential future rulemaking regarding information...more

Health Care Compliance Association (HCCA)

Facing Escalating Attacks, AHA Presses OCR to Expedite Security Practices Rule

Report on Patient Privacy 21, no. 12 (December, 2021) - Amid the letters of congratulations to new HHS Office for Civil Rights (OCR) Director Lisa Pino is a plea from the American Hospital Association (AHA): “victims” of...more

Akin Gump Strauss Hauer & Feld LLP

HHS Proposes to Rein In Its Use of Regulatory “Dark Matter”

- HHS is overhauling its process for developing interpretive guidance documents under a new Proposed Rule. - HHS proposes to no longer use “guidance documents” to establish broadly applicable legal obligations on the...more

Mintz - Health Care Viewpoints

Changes Ahead for HIPAA?

As we discussed last week, the Department of Health and Human Services (HHS) recently published its semi-annual regulatory agenda. In addition to the proposed rules on fraud and abuse, drug pricing, digital health, and...more

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