The End of COVID Waivers and Exceptions: What Now?
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
NGE On Demand: COVID-19 and IP Waiver for Patent Protection with Kevin O'Connor and Olivia Luk Bedi
Prohibitions on Use of Chinese Telecommunications Equipment and Services, Complying with the NDAA
COVID-19: Where are we now?
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Value-based health care: fraud & abuse laws
What patients misunderstand about their right of informed consent
Bill on Bankruptcy: ResCap Report, a Bargain at $83 Million
A new interim rule aimed at safeguarding the federal supply chain prohibits contractors from delivering or using covered articles and sources subject to exclusion or removal orders issued under the Federal Acquisition Supply...more
On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more
The Illinois Biometric Information Privacy Act (BIPA 740 ILCS 14/1 et seq.) requires businesses to notify individuals before collecting their biometric identifiers such as fingerprints (click here to read our previous client...more
Section 889(a)(1)(B) of the NDAA for Fiscal Year 2019 is now in effect. This section of the NDAA prohibits government agencies and government contractors they work with from using certain covered telecommunications equipment...more
HCCA has assembled a half-day virtual conference to help compliance professionals stay on top of the fast-moving changes caused by the COVID-19 pandemic. By participating in this event, you will hear directly from the...more
HHS Targeted by Nation-State Hackers - Evil doers know that the best time to attack is during a crisis or a time of vulnerability. As the United States, and specifically, the Department of Health and Human Services (HHS)...more
With cybercrime on the rise, organizations have increasingly found themselves subject to litigation or regulatory investigations related to breaches. Documents and information created before breaches, such as security...more
Protection of industrial control systems is crucial to the security of our country. The National Cybersecurity Center of Excellence (NCCoE) has announced a project for which it is seeking comment: Detecting and Protecting...more
Marriott International Inc. (Marriott) has released new numbers relating to its Starwood Hotel’s reservation database by stating that more than 5 million passport numbers were stolen in the database. ...more
August 24, 2018 marked a busy day for the U.S. Department of Health & Human Services' (HHS) self-designated "Regulatory Sprint to Coordinated Care," an initiative aimed at dismantling the regulatory barriers to providers...more
As Texas, Florida, and the Caribbean rebuild after the latest string of deadly hurricanes and prepare for the possibility of future storms, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR)...more
IN THE SPOTLIGHT - The CFPB Takes First Enforcement Action Related to Data Security Practices. LIFE INSURANCE - Class Certified in Unique Fixed Indexed Annuity Case. Alleged Misrepresentations to DFS Warrant...more