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
Overview - On December 10th, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) announced significant proposed changes to the Health Insurance Portability and Accountability Act...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
On April 21, 2020, the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG) issued a Proposed Rule amending civil money penalty (CMP) regulations. This Proposed Rule seeks to address three...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
On June 15th, New York Attorney General Eric Schneiderman announced a settlement with CoPilot Provider Support Services Inc. to resolve allegations that the company improperly delayed notice to more than 220,000 consumers of...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 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
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
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
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