This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2025. This month features long-awaited proposed and final rules regarding the Health Insurance Portability and Accountability...more
3/3/2025
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Controlled Substances ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Executive Orders ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Reform ,
HMOs ,
Medicare ,
OIG ,
Pharmaceutical Industry ,
Physicians ,
Private Equity ,
Regulatory Agenda ,
Technology Sector ,
Telehealth ,
Telemedicine ,
Trump Administration ,
Whistleblowers
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more
2/24/2025
/ Artificial Intelligence ,
Automated Decision Systems (ADS) ,
Data Management ,
Data Privacy ,
Food and Drug Administration (FDA) ,
Healthcare ,
Labeling ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Risk Assessment ,
Risk Management ,
Technology
Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists, and technology companies that deliver and facilitate...more
11/19/2024
/ Digital Health ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Interstate Compacts ,
Legislative Agendas ,
New Legislation ,
Pharmaceutical Industry ,
Pharmacies ,
Proposed Legislation ,
Regulatory Agenda ,
Rulemaking Process ,
State and Local Government ,
Technology Sector ,
Telehealth ,
Telemedicine
On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies....more
7/16/2024
/ Clinical Trials ,
Comment Period ,
Diversity ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Life Sciences ,
Patient Privacy Rights ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation
On April 15, 2024, the US Food & Drug Administration (FDA) announced the establishment of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI will serve as the central support...more
In recent years, states have been exploring innovative avenues to address rising healthcare costs and ensure access to affordable medication for their residents. One idea gaining traction involves pursuing authorization from...more
4/8/2024
/ Department of Health and Human Services (HHS) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Imports ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Proposed Regulation ,
Regulatory Agenda ,
State and Local Government
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new Innovation in...more
2/26/2024
/ 1115 Waivers ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Medicaid ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Prior Authorization ,
Regulatory Agenda ,
Regulatory Reform ,
Self-Referral