Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
On May 23, 2017, the Department of Health and Human Services Office of Civil Rights (HHS OCR) announced a settlement with St. Luke’s-Roosevelt Hospital Center, part of the Mount Sinai Health System, to resolve allegations...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
5/22/2017
/ Clinical Trials ,
Department of Health and Human Services (HHS) ,
Domain Names ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Food and Drug Administration Amendments Act (FDAAA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Devices ,
Mobile Health Apps ,
PDUFA ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reporting Requirements ,
Trademarks
After a pause of nearly two months, the Department of Health and Human Services Office of Civil Rights (HHS OCR) has resumed its announcement of settlements for alleged HIPAA violations, with four new settlement agreements...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
In late March, Roger Severino was appointed to be the new Director of the Department of Health and Human Services Office of Civil Rights (HHS OCR), the office responsible for enforcing the Health Insurance Portability and...more
Expanding wage and hour obligations will continue to be a top concern for employers in 2017. As most employers are aware, in May 2016, the United States Department of Labor issued its long-awaited final rule regarding the...more
3/27/2017
/ Affordable Care Act ,
Ban the Box ,
Blockchain ,
Corporate Counsel ,
Cybersecurity ,
E-Verify ,
Employer Liability Issues ,
EU-US Privacy Shield ,
Federal Trade Commission (FTC) ,
Form I-9 ,
Non-GAAP Financial Measures ,
Popular ,
Securities and Exchange Commission (SEC) ,
Wage and Hour ,
Young Lawyers
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
With the announcements from OCR of three resolution agreements and one civil money penalty as of mid-February, OCR is off to a record start for HIPAA enforcement in 2017, with double the announcements as the same time last...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
On January 19, 2017, the U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies issued a final rule to update “Federal Policy for the Protection of Human Subjects,” also known as...more
1. With Wage and Hour Rules in Flux, Employers Need to Remain Vigilant -
Expanding wage and hour obligations will continue to be a top concern for employers in 2017. As most employers are aware, in May 2016, the United...more
1/26/2017
/ Affordable Care Act ,
Americans with Disabilities Act (ADA) ,
Ban the Box ,
Blockchain ,
Consumer Financial Protection Bureau (CFPB) ,
Copyright Infringement ,
Cybersecurity ,
Department of Labor (DOL) ,
Dodd-Frank ,
E-Verify ,
Employer Liability Issues ,
EU ,
EU-US Privacy Shield ,
European Court of Justice (ECJ) ,
Federal Trade Commission (FTC) ,
Form I-9 ,
Non-GAAP Financial Measures ,
Popular ,
Securities and Exchange Commission (SEC) ,
Tax Reform ,
UDAAP ,
USCIS ,
Wage and Hour ,
Wellness Programs
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
1/25/2017
/ 21st Century Cures Initiative ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Food and Drug Administration (FDA) ,
Foreign Corrupt Practices Act (FCPA) ,
Generic Drugs ,
Health Insurance Portability and Accountability Act (HIPAA) ,
International Arbitration ,
Medical Devices ,
OCR ,
Pharmaceutical Industry ,
Price-Fixing ,
Securities and Exchange Commission (SEC)
On January 9, 2017, the Department of Health and Human Services Office of Civil Rights (HHS OCR), which enforces the privacy requirements contained in Health Insurance Portability and Accountability Act (HIPAA), announced a...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
12/16/2016
/ 21st Century Cures Initiative ,
Business Associates ,
Covered Entities ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Devices ,
OCR ,
Orphan Drugs ,
Pharmaceutical Industry
Between June and November 2016, the Department of Health and Human Services Office of Civil Rights (HHS OCR) has announced seven high-dollar settlements to resolve alleged violations of the HIPAA privacy, security, and breach...more
The Office for Civil Rights within the U.S. Department of Health and Human Services (OCR) recently announced that it has increased its review of breaches of protected health information affecting fewer than 500 individuals....more
Even for companies accustomed to civil lawsuits, when the government is on the other side of the “v,” the prospect of litigation can be intimidating and unfamiliar. In this issue of the Litigation Newsletter, we explore how...more
Your company has experienced a data breach, and the Federal Trade Commission (“FTC”) notifies you that it is initiating a non-public investigation. How the company responds can significantly affect the course of the...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
8/23/2016
/ 510(k) RTA ,
Advertising ,
Draft Guidance ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
General Wellness Devices ,
LabMD ,
Medical Devices ,
Pharmaceutical Industry ,
Social Media ,
Software
On July 29th, the Federal Trade Commission (the Commission) issued an important opinion in its long-running data security case against LabMD, finding that the company engaged in unfair practices in violation of Section 5 of...more
On July 12th, the European Commission gave final approval to the EU US Privacy Shield program for the transfer of personal data from the European Union to the United States by companies that voluntarily choose to participate...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
Such privacy laws and regulations as the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule can have a significant impact on the development of health care data analytics in cases where those analytics...more
On February 29th, the European Commission (the “Commission”) published the details of the new EU/US Privacy Shield program (“Privacy Shield”) which is intended to replace the EU/US Safe Harbor (“Safe Harbor”) program that was...more