On July 31, 2025, the Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (OPA) issued a 340B Drug Pricing Program notice (the “Notice”) announcing the launch of a voluntary 340B rebate model pilot...more
8/4/2025
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Comment Period ,
Covered Entities ,
Drug Pricing ,
HRSA ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Pilot Programs ,
Public Comment ,
Rebates ,
Reporting Requirements ,
Section 340B
On April 26, 2024, almost a year after issuing a notice of proposed rulemaking to modify the Privacy Rule, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) finalized the HIPAA Privacy Rule to...more
6/19/2024
/ Business Associates ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Dobbs v. Jackson Women’s Health Organization ,
Final Rules ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
OCR ,
Patient Privacy Rights ,
PHI ,
Popular ,
Reproductive Healthcare Issues
On March 18, 2024, the U.S. Department of Health and Human Services Office for Civil Rights (HHS-OCR) revised its controversial December 2022 bulletin (the December 2022 Bulletin) regarding the use of tracking technologies by...more
3/28/2024
/ Business Associates ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Enforcement Priorities ,
Guidance Update ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
PHI ,
Tracking Systems ,
Web Tracking ,
Websites
The Department of Justice recently announced the launch of its new Civil Cyber-Fraud Initiative (the “Initiative”) which intends to use the False Claims Act to pursue “cybersecurity-related fraud by government contractors and...more
12/7/2021
/ Business Associates ,
Covered Entities ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Security ,
Department of Justice (DOJ) ,
Due Diligence ,
Electronic Protected Health Information (ePHI) ,
False Claims Act (FCA) ,
Federal Contractors ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Incident Response Plans ,
PHI ,
Popular ,
Privacy Laws ,
Risk Assessment