Key Insights for Pharma Manufacturers Regarding the AKS -
In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more
4/29/2025
/ Abbreviated New Drug Application (ANDA) ,
Anti-Kickback Statute ,
Compliance ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
New Regulations ,
Pharmaceutical Industry ,
Popular ,
Regulatory Requirements
Last week, the US Food and Drug Administration (FDA) announced the end of a years-long shortage of semaglutide injection products — a popular glucagon-like peptide 1 (GLP-1) weight loss and diabetes medication. As a result,...more
2/27/2025
/ Compliance ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Pharmaceutical Industry ,
Pharmacies ,
Popular ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Requirements ,
Telehealth
On January 20, the US Department of Homeland Security (DHS) rescinded 2021 guidelines that prohibited immigration enforcement actions in or near medical and health care facilities and other protected areas. Hospitals and...more
2/25/2025
/ Compliance ,
Department of Homeland Security (DHS) ,
Enforcement Actions ,
FDNS ,
Foreign Nationals ,
Healthcare Facilities ,
Immigration and Customs Enforcement (ICE) ,
Immigration Procedures ,
Law Enforcement ,
Patient Privacy Rights ,
Risk Management
In the final days of the Biden Administration, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a notice of proposed rulemaking (NPRM) to modify the Security Rule under the Health...more
2/10/2025
/ Artificial Intelligence ,
Audits ,
Compliance ,
Cybersecurity ,
Data Privacy ,
Data Security ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Emerging Technologies ,
Encryption ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Security Rule ,
Notice of Proposed Rulemaking (NOPR) ,
OCR ,
Proposed Rules ,
Risk Management ,
Technology
Who will notify the potentially millions of individuals whose information might have been jeopardized by the massive cyberattack on Change Healthcare? Since the affiliate of UnitedHealth Group (UHG) first reported the...more
6/19/2024
/ Breach Notification Rule ,
Compliance ,
Cyber Attacks ,
Department of Health and Human Services (HHS) ,
Guidance Update ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Breach ,
HIPAA Privacy Rule ,
HIPAA Security Rule ,
Investigations ,
OCR ,
PHI ,
Popular
On April 26, the US Department of Health and Human Services Office for Civil Rights (OCR) published a Final Rule that adds protections under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule...more
5/29/2024
/ Attestation Requirements ,
Compliance ,
Covered Entities ,
Data Collection ,
Disclosure Requirements ,
Dobbs v. Jackson Women’s Health Organization ,
Final Rules ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Privacy Rule ,
Investigations ,
Notice Requirements ,
OCR ,
PHI ,
Popular ,
Privacy Laws ,
Reproductive Healthcare Issues ,
SCOTUS
On February 17, 2023, the US Department of Health and Human Services Office for Civil Rights (OCR) released two companion reports to Congress detailing its actions in 2021 to enforce the privacy, security, and breach...more
4/4/2023
/ Audits ,
Civil Monetary Penalty ,
Compliance ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Hackers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Information Technology ,
OCR ,
PHI
With the start of the new year, the ArentFox Schiff Hospitality Industry team reviews 10 of the most pressing legal issues for hospitality companies in 2023.
1. Potential Down Market Pressures. Interest rate increases are...more
1/5/2023
/ Artificial Intelligence ,
Brand ,
Compliance ,
Coronavirus/COVID-19 ,
Data Privacy ,
Environmental Social & Governance (ESG) ,
Franchise Agreements ,
FTC Act ,
Greenwashing ,
Hospitality Industry ,
Intellectual Property Protection ,
Interest Rate Adjustments ,
Investment ,
Labor Shortage ,
LEED Certified ,
Metaverse ,
NASAA ,
NLRB