President Biden recently issued on Executive Order (EO) on Strengthening Access to Affordable, High-Quality Contraception and Family Planning Services.  The EO directs the Treasury, Labor, and Health and Human Services (HHS) Secretaries to “consider new guidance to ensure private health …

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The U.S. Federal Trade Commission (FTC) is proposing to amend its Health Breach Notification Rule (HBNR; 16 C.F.R. 318).  The HBNR currently requires vendors of personal health records (PHR) and related entities not covered by the Health Insurance Portability and …

FTC Proposed Amendments to Health Breach Notification Rule Read more »

The U.S. Food and Drug Administration (FDA) “is proposing to amend its human prescription drug labeling regulations to require a new type of Medication Guide – ‘Patient Medication Information’ – for prescription drug products used, dispensed, or administered on an …

FDA Proposed Rule on “Patient Medication Information” Guide Read more »

With the 5/11/2023 end of the COVID-19 national emergency and public health emergency (PHE) declarations, there will be changes to the US healthcare system.  The US Centers for Medicare & Medicaid Services (CMS) website provides a comprehensive Coronavirus Disease 2019 …

Healthcare Changes Coming After End of COVID-19 National & Public Health Emergencies Read more »

The U.S. Food & Drug Administration (FDA) recently released an Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market.  The Food and Drug Omnibus Reform Act of 2022 directed the FDA to work with the Department …

FDA National Strategy to Further Increase U.S. Infant Formula Market Resiliency Read more »