Yesterday, the White House’s Make America Healthy Again (MAHA) Commission, led by the Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. released its inaugural health report titled, Make Our...more
On May 9, 2025, the U.S. Food and Drug Administration (FDA) granted three color additive petitions, approving two new colorings and expanding one existing approval. These approvals come after the agency’s announcement last...more
In the past week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS) announced three new initiatives related to food safety and food supply chain transparency....more
3/25/2025
/ Comment Period ,
Compliance ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food Safety ,
FSMA ,
Public Health ,
Regulatory Agenda ,
Regulatory Requirements ,
Supply Chain ,
Transparency
On January 16, 2025, the Federal Trade Commission (FTC) issued a Final Rule updating the Children’s Online Privacy Protection (COPPA) Rule, significantly expanding compliance obligations for online services that collect, use,...more
On January 15, 2025, FDA announced an order revoking the listings providing for the use of the color additive FD&C Red No. 3 in both foods (including dietary supplements) and ingested drugs. The order is in response to a 2022...more
The California Privacy Protection Agency (CPPA) announced the formal public comment period for its latest proposed rulemaking package, which includes updates to existing regulations and introduces new guidelines for automated...more
1/13/2025
/ Artificial Intelligence ,
Automated Decision Systems (ADS) ,
California ,
California Privacy Protection Agency (CPPA) ,
Consumer Privacy Rights ,
Cybersecurity ,
Data Privacy ,
Insurance Industry ,
Personal Information ,
Privacy Laws ,
Regulatory Requirements ,
Risk Assessment ,
Rulemaking Process
On November 19, 2024, FDA issued a request for information (RFI) on per-and polyfluoroalkyl substances (PFAS) in seafood. Specifically, the agency is seeking scientific data and information from the seafood industry and other...more
12/4/2024
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Contamination ,
Environmental Policies ,
Fishing Industry ,
Food and Drug Administration (FDA) ,
Food Safety ,
Food Supply ,
Hazardous Substances ,
Infrastructure ,
PFAS ,
Public Health ,
Regulatory Agenda ,
Toxic Chemicals ,
Toxic Exposure
On June 28, in Loper Bright Enterprises v. Raimondo, the Supreme Court overturned the longstanding Chevron doctrine, under which courts generally granted deference to a federal agency’s reasonable interpretation of ambiguous...more
7/9/2024
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Chevron v NRDC ,
Corner Post Inc v Board of Governors of the Federal Reserve System ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Healthcare ,
Judicial Authority ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
SCOTUS ,
Statutory Interpretation
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
4/25/2024
/ Biden Administration ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Review Act ,
Department of Health and Human Services (HHS) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
GAO ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
HRSA ,
Laboratory Developed Tests ,
Medicaid ,
Medicare ,
NIST ,
Nursing Homes ,
OIG ,
OIRA ,
OMB ,
Payment Systems ,
PHI ,
Policies and Procedures ,
Prescription Drugs ,
Presidential Elections ,
Proposed Guidance ,
Regulatory Agenda ,
Regulatory Standards ,
Rulemaking Process
On February 8, 2024, the Centers for Medicare and Medicaid Services (CMS) released a memorandum from the Quality, Safety & Oversight Group (QSOG) updating its 2018 guidance on texting patient information among healthcare...more
Multiple policy documents relating to software and digital health have been issued by the U.S. Food and Drug Administration (FDA). The documents offer: a framework for the use of digital health tools in the context of drug...more
In recent days, the U.S. Food and Drug Administration (FDA) has issued multiple policy documents relating to software and digital health. Two of them relate to software-based medical devices: draft guidance for predetermined...more
Key Points -
A new legal challenge to OIG on Medicare Beneficiaries’ ability to receive co-pay assistance has emerged. The Supreme Court has been asked to review HHS’s prohibition of co-pay assistance programs under the...more
Key Points -
Patient advocacy groups have filed suit challenging the legality of the 2020 HHS Final Rule permitting co-pay accumulator adjustment programs.
The Second Circuit has upheld HHS’ prohibition of co-pay...more
On May 17 the Senate Health, Education, Labor and Pensions (HELP) Committee released a bipartisan legislative discussion draft of the Food and Drug Administration (FDA) Safety and Landmark Advancements Act (FDASLA), which...more