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Ranking Member Sanders Warns of Massive Coverage Losses, Premium Spikes, and Health System Instability Under H.R. 1

Yesterday, Sen. Bernie Sanders (I-VT), Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a report warning of the projected impact of health care cuts in H.R. 1 (press release; report). Last week, Ranking Member Sanders invited people across the country to share how cuts to Medicaid and the Affordable Care Act (ACA) would affect them,… (Eisen, October 7, 2025) #Affordable Care Act, #Budget, #Costs, #Insurance Coverage

Agency Seeks Public Input on Measuring and Evaluating Real-World Performance of AI-Enabled Medical Devices; Comments Due December 1

The Food and Drug Administration (FDA) issued a Request for Public Comment (RFC) to gather input on how AI-enabled medical devices perform in clinical settings after deployment. The agency notes that the RFC is for discussion purposes only and is not intended to set policy or guidance, but rather seeks early feedback from the public to inform future FDA discussions… (Colocho, October 7, 2025) #Artificial Intelligence, #Health Information Technology, #Medical Devices, #Transparency

Agency Approves New Generic Version of Mifepristone Amid Federal Scrutiny

This week, the Food and Drug Administration (FDA) approved another generic version of mifepristone, one of the two drugs used in medication abortion. With this approval, three U.S. companies are now authorized to manufacture the medication: Danco Laboratories, which first received FDA approval in 2000; GenBioPro, which secured approval of the first generic in 2019; and now Evita Solutions. The… (Eisen, October 3, 2025) #Generic Drugs, #Women’s Health

Sen. Peters Urges DOGE Shutdown After Investigation Into Violation of Federal Privacy and Security Laws

Sen. Gary Peters (D-MI), Ranking Member of the Senate Homeland Security and Governmental Affairs Committee, released a report revealing that the Department of Government Efficiency (DOGE) is operating outside federal law with unchecked access to Americans’ personal data. The investigation, backed by whistleblower accounts across the Social Security Administration (SSA), the General Services Administration (GSA), and the Office of Personnel… (Colocho, October 3, 2025) #Health Information Technology, #Privacy, #Transparency

Federal Proposal Could Reopen New DACA Applications with Restrictions for Texas Residents; Case on Hold During Shutdown

The Trump administration has outlined a proposal that, if approved by a federal judge, would allow immigration officials to resume processing new applications for Deferred Action for Childhood Arrivals (DACA) after a four-year pause. The plan was filed late Monday by the Department of Justice (DOJ) in federal court in Brownsville, Texas, as part of a long-running lawsuit led by… (Colocho, October 2, 2025) #Health Equity

Agency Memo Clarifies Survey & Certification Operations Amid Shutdown

Today, the CMS Center for Clinical Standards and Quality released a memo (QSO-26-01-ALL) outlining which survey and certification functions will continue during the federal government shutdown, which will pause, and how state agencies and contractors should proceed. The agency emphasized that protecting beneficiaries from immediate harm remains the top priority. Enforcement and immediate jeopardy investigations will continue, but routine surveys… (Testa, October 1, 2025) #Clinical Labs, #Grants, #Hospice, #Quality

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