This year, thousands of individuals in Southern California were impacted by the Palisades Fire and Eaton Fire. The fires were the second and fourth most destructive in the state’s history.[1] In 2024, millions of individuals in the southeastern United
On December 17, 2024, the House Task Force on Artificial Intelligence (Task Force) released a highly-anticipated report titled, “Bipartisan House Task Force Report on Artificial Intelligence,” (the Report) which establishes guiding principles and issues recommendations to guide U.S. innovation in
On November 21st, the Food and Drug Administration (FDA) released final guidance for the 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review processes, which clarifies how the FDA will use third party review organizations (ROs)
FDA approved drugs and medical devices are often studied further by sponsors and other firms to generate additional scientific information around other potential benefits and uses of those products. Providing the results of this additional scientific activity to health care
On October 18, 2024, the American Medical Association’s (AMA’s) Current Procedural Terminology (CPT) Editorial Panel released a Summary of Panel Actions from its September 2024 Panel Meeting, which includes six new remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM)
Federal policy efforts to advance health data exchange and interoperability are continuing to change rapidly. The latest changes are the publication of two final rules by the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology
Federal policy efforts to advance health data exchange and interoperability through the Trusted Exchange Framework and Common Agreement (TEFCA) have advanced rapidly in the past several months. Since TEFCA became operational in December 2023, the seven designated Qualified Health Information
On October 2, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS) released final guidance outlining the process for the second cycle of negotiations through the Medicare Drug Price Negotiation Program.
On October 9, the Centers for Medicare & Medicaid Services (CMS) Innovation Center, issued a Request for Information (RFI) about the Innovation Center’s proposed Medicare $2 Drug List Model (the M2DL Model), which aims to test whether offering low-cost, clinically
The FDA recently provided its opinion on a pharmaceutical television ad that should help other pharmaceutical companies in their own advertisements. The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) informed pharmaceutical company AbbVie