Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
7/26/2021
/ Cybersecurity ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Home Health Care ,
Life Sciences ,
Medical Devices ,
Medicare ,
OPDP ,
Pharmaceutical Industry ,
Pharmacies ,
Popular ,
Prescription Drugs ,
State Privacy Laws
With the recent enactment of Virginia’s Consumer Data Privacy Act (VCDPA), and similar bills under consideration in several state legislatures, healthcare and life sciences companies are considering how these new laws are...more
CISA, FBI, & HHS Warn of Ransomware Activity Targeting the Healthcare Sector - On October 28, 2020, the Cybersecurity and Infrastructure Security Agency (CISA), the Federal Bureau of Investigation (FBI), and the Department of...more
11/11/2020
/ Cyber Attacks ,
Cyber Threats ,
Cybersecurity ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
FBI ,
Hackers ,
Health Care Providers ,
Homeland Security Cybersecurity & Infrastructure Security Agency (CISA) ,
Office of Foreign Assets Control (OFAC) ,
Popular ,
Ransomware
The next phase of New York’s cybersecurity rules entered into force on September 4, 2018, requiring Covered Entities, including insurance companies, banks, and other financial services companies regulated by the New York...more
On December 28th, the Department of Health and Human Services Office of Civil Rights (OCR) announced a $2.3 million settlement with 21st Century Oncology Inc. (21st Century) to settle potential violations of the HIPAA privacy...more
In recent years, the CFPB has struck fear into the C-suites of financial services companies. The agency was extraordinarily active in rulemaking that addresses every aspect of lending, prepaid cards and arbitration clauses in...more
1/17/2018
/ Civil Investigation Demand ,
Consumer Financial Protection Bureau (CFPB) ,
Cybersecurity ,
Department of Labor (DOL) ,
Employer Liability Issues ,
Enforcement Actions ,
EU ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
Popular ,
Sexual Harassment ,
Tax Cuts and Jobs Act ,
Tax Reform ,
Wage and Hour
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
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
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
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
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
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
The increasing amounts of health information being generated, stored and collected have heightened the special risks medical device manufacturers have long faced. In addition to the nexus to patient health and safety, if a...more
8/21/2015
/ Contract Terms ,
Data Breach ,
Data Collection ,
Data Privacy ,
Data Security ,
De-Identified Protected Health Information ,
Department of Health and Human Services (HHS) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Internet Privacy ,
Medical Devices ,
Mobile Medical Applications ,
Passwords ,
Patient Privacy Rights ,
Personally Identifiable Information ,
Popular