On April 15, 2025, the Centers for Medicare & Medicaid Services (“CMS”) published the Contract Year 2026 Policy and Technical Changes Final Rule which amends the regulations governing various Medicare programs, including the...more
4/24/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Final Rules ,
Health Insurance ,
Healthcare ,
Manufacturers ,
Medicare ,
Medicare Part D ,
Pharmacies ,
Prescription Drugs ,
Reimbursements
As the Trump administration stakes dramatically new positions on matters across the federal government, we are waiting to learn its view on the HIPAA Privacy Rule to Support Reproductive Health Care Privacy Final Rule,...more
2/10/2025
/ Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Enforcement Actions ,
Final Rules ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
Patient Privacy Rights ,
Regulatory Agenda ,
Reproductive Healthcare Issues ,
State Privacy Laws ,
Trump Administration
A recent Securities and Exchange Commission (“SEC”) settlement with DMK Pharmaceuticals Corporation (“DMK Pharmaceuticals”) and its Chief Financial Officer (“CFO”) serves as a good reminder that SEC-regulated entities...more
1/31/2025
/ Anti-Kickback Statute ,
Corporate Governance ,
Enforcement Actions ,
Fraud ,
Healthcare ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Securities and Exchange Commission (SEC) ,
Securities Regulation ,
Securities Violations ,
Settlement ,
Veterinarians
‘Tis the season for holiday baking and the elves at the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), have been diligently crafting their own holiday treat. On December 27,...more
1/2/2025
/ Cybersecurity ,
Data Breach ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Breach ,
HIPAA Security Rule ,
HIPAA Violations ,
Life Sciences ,
NPRM ,
OCR ,
PHI ,
Regulatory Agenda ,
Rulemaking Process
December 23, 2024, was the compliance deadline for HIPAA covered entities and business associates to apply the protections of the HIPAA Privacy Rule to support Reproductive Health Care Privacy Final Rule—that is all covered...more
On December 2, 2024, the U.S. Department of Health and Human Services Office for Civil Rights (HHS OCR) announced a settlement with Holy Redeemer Family Medicine, a Pennsylvania covered entity, regarding an alleged violation...more
12/5/2024
/ Data Breach ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Privacy Rule ,
OCR ,
Patient Privacy Rights ,
PHI ,
Settlement
On September 18, 2024, the Attorney General (AG) of Texas announced a settlement with an artificial intelligence-focused healthcare technology company to resolve allegations of false and misleading statements about the...more
10/16/2024
/ Artificial Intelligence ,
Electronic Protected Health Information (ePHI) ,
Enforcement Actions ,
False Statements ,
Health Care Providers ,
Health Technology ,
Life Sciences ,
Misleading Statements ,
Settlement ,
State Attorneys General ,
Texas
As we settle into spooky season, let’s take a minute to consider a recent development in health care privacy as we ask ourselves, is this a trick or a treat?...more
10/11/2024
/ Data Management ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
Patient Privacy Rights ,
PHI ,
Reproductive Healthcare Issues ,
State Attorneys General ,
Statutory Authority ,
Texas
The Federal Trade Commission (“FTC”) recently published its Final Rule amending the Health Breach Notification Rule (“HBNR”). The updated HBNR, which regulates entities that handle certain personal health information, other...more