For the first time ever, the Federal Trade Commission (FTC) is seeking enforcement under the Health Breach Notification Rule. This regulation requires certain businesses not covered by the Health Insurance Portability and...more
2/3/2023
/ Breach Notification Rule ,
Consent ,
Corporate Counsel ,
Data Breach ,
Data-Sharing ,
Electronic Protected Health Information (ePHI) ,
Enforcement ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Health Technology ,
HIPAA Breach ,
HIPAA Breach Notification Rule ,
Mobile Apps
New federal regulations have been proposed that will affect licensure of wholesale drug distributors and third-party logistics providers (3PLs). The Drug Supply Chain Security Act became law in 2013. The U.S. Food and Drug...more
Kathryn Isted In Harbor Healthcare System, L.P. v. United States, 5 F.4th 593 (5th Cir. 2021), the court of appeals ruled that the district court abused its discretion in refusing to exercise its equitable jurisdiction over a...more
10/18/2021
/ Abuse of Discretion ,
Anti-Kickback Statute ,
Appeals ,
Attorney-Client Privilege ,
Comment Period ,
Criminal Investigations ,
Discovery ,
Draft Guidance ,
Evidence ,
Failure To State A Claim ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Kickbacks ,
Managed Care Contracts ,
Medicaid ,
Medicare ,
Patient Referrals ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Qui Tam ,
Scienter
Neurosurgeons' Compensation in Top 10 Percent Nationwide Gives Rise to Stark Act and FCA Claims -
In United States ex re. Bookwalter v. UPMC, 946 F. 3d 162 (3d Cir. 2019), the court ruled that the relators stated a Stark...more
2/25/2020
/ Americans with Disabilities Act (ADA) ,
Anti-Kickback Statute ,
Assisted Living Facilities (ALFs) ,
Centers for Medicare & Medicaid Services (CMS) ,
Diagnostic Tests ,
DMEPOS ,
Durable Medical Equipment ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Grants ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Hospitals ,
Medicare ,
Objective Falsity ,
Ownership Interest ,
Physicians ,
Protected Activity ,
Stark Law
In recent years, the healthcare industry has been turning greater attention to the need to engage or involve patients in developing new technologies and systems to improve healthcare delivery. These patient engagement...more
10/15/2019
/ Administrative Procedure Act ,
Affordable Care Act ,
Anti-Kickback Statute ,
Article III ,
Attorney-Client Privilege ,
Centers for Medicare & Medicaid Services (CMS) ,
Criminal Convictions ,
Dismissals ,
Disproportionate Share Adjustments ,
Draft Guidance ,
Enforcement Actions ,
European Medicines Agency (EMA) ,
False Advertising ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Lanham Act ,
Medical Devices ,
Medicare ,
Patient Engagement Advisory Committee (PEAC) ,
Patient Referrals ,
Physicians ,
Prescription Drugs ,
Standing ,
Stark Law
• The U.S. Department of Health and Human Services on Dec. 28, 2018, announced the release of the "Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients" that provides a "Call to Action" to make...more
1/14/2019
/ Best Practices ,
Cyber Attacks ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Data Loss Prevention ,
Data Privacy ,
Data Protection ,
Data Security ,
Data Theft ,
Department of Health and Human Services (HHS) ,
Department of Homeland Security (DHS) ,
Food and Drug Administration (FDA) ,
Hackers ,
Health Care Providers ,
Health Clinics ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HITECH Act ,
Hospitals ,
Information Technology ,
Medical Devices ,
NIST ,
Patient Safety ,
Personally Identifiable Information ,
PHI ,
Phishing Scams ,
Popular ,
Ransomware ,
Risk Mitigation ,
Standard of Care
Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security...more
10/2/2018
/ Comment Period ,
Deadlines ,
Draft Guidance ,
Drug Compounding ,
Drug Distribution ,
DSCSA ,
Food and Drug Administration (FDA) ,
Grandfathering Rules ,
Manufacturers ,
New Guidance ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Product Identifiers ,
Product Packaging ,
Public Comment ,
Regulatory Requirements ,
Suppliers ,
Supply Chain ,
Wholesale
Medicaid -
Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law -
By Eddie Williams -
In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more
6/7/2017
/ Anti-Kickback Statute ,
Antitrust Violations ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
DSM ,
Enforcement Actions ,
Failure To Warn ,
False Claims Act (FCA) ,
Federal v State Law Application ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicaid ,
Medicaid Act ,
Misrepresentation ,
Noerr-Pennington Doctrine ,
OCR ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmacies ,
Preemption ,
Prescription Drugs ,
Sherman Act ,
Stark Law ,
Third-Party Liability ,
Unfair or Deceptive Trade Practices ,
Warning Labels
When food and beverage companies think of their largest risks, data breaches have not historically come to mind, but this is changing because of reports in the past few months of major breaches by companies such as Noodles &...more
8/2/2016
/ COPPA ,
Cyber Insurance ,
Cybersecurity ,
Data Breach ,
Defined Contribution Plans ,
Employee Benefits ,
ESOP ,
Fair Labor Standards Act (FLSA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
FSMA ,
IRS ,
Minimum Salary ,
Over-Time ,
Personally Identifiable Information ,
Popular ,
Registration Requirement ,
Restaurant Industry ,
Retailers ,
Selling a Business ,
Tipped Employees ,
Tips ,
Wage and Hour ,
White-Collar Exemptions
Long-term care companies in Florida need to dust off their regulatory compliance plans to see if updates are needed in light of several bills that passed during the regular legislative session of 2015. If they are signed by...more
5/28/2015
/ Assisted Living Facilities (ALFs) ,
Biologics ,
Continuing Care Retirement Communities ,
Food and Drug Administration (FDA) ,
Healthcare ,
Hospitals ,
Long Term Care Facilities ,
Medicaid ,
Medicare ,
Nursing Homes ,
Ombudsman ,
Skilled Nursing Facility ,
Vaccinations
On December 19, 2012, the U.S. Food and Drug Administration (FDA) held a public meeting, broadcast live on the Internet, to discuss the respective roles of the federal and state governments in regulating pharmacy compounding....more