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
The HIPAA Privacy Rule sets forth provisions related to the waiver or alteration of authorization in relation to clinical research studies for circumstances in which it would be impractical or impossible to obtain...more
The Food and Drug Administration (FDA) has issued a final rule, Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations, which allows an exception from the requirement to...more
Providing medical information about a person is a highly sensitive personal matter. Asking for it as part of the hiring process raises difficulties in relation to both Israeli labor and privacy protection laws. Employers may...more
On March 17, 2020, the Office for Civil Rights’ (“OCR”) announced that—for the duration of the COVID-19 emergency—it would exercise enforcement discretion and waive any potential penalties for HIPAA violations relating to...more
For the first 72 hours after a hospital institutes its disaster protocol for the COVID-19 emergency, HIPAA sanctions and penalties will be waived for: - Failure to obtain a patient’s agreement to speak with family/friends...more
In response to the COVID-19 pandemic, on March 17, 2020, the Office for Civil Rights (“OCR”) at the Department of Health and Human Services (“HHS”) issued a notification of enforcement discretion, announcing that it would not...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
Acknowledging the “additional challenges” on health care providers following the outbreak of COVID-19, the Department of Health and Human Services (HHS) recently issued several waivers for covered entities to address the need...more
The Office of Civil Rights, U.S. Department of Health and Human Services, issued an update to its February bulletin, which outlined how the HIPAA privacy rules apply in a state of emergency....more
On March 13, 2020, the Department of Health and Human Services announced a series of limited waivers related to the HIPAA Privacy rule in response to the declaration of a national emergency related to the 2019 Novel...more
Responding to the COVID-19 national public health emergency, on March 13, 2020, the Secretary of the U.S. Department of Health and Human Services (HHS) exercised the authority granted by Section 1135 of the Social Security...more
This post provides an update on a number of HIPAA waivers that have just been made available to health care providers: (1) Waivers for hospitals in the initial 72 hours of enacting a disaster protocol; and (2) Waivers for all...more
The U.S. Department of Health and Human Services (HHS) has used its authority to waive certain provisions of HIPAA in response to Hurricane Harvey. HHS previously declared a public health emergency in Texas and Louisiana...more
Hurricane Harvey has been pummeling the Gulf Coast since Monday, with nearly 52 inches of rainfall in parts of Texas. The storm has displaced thousands of people from their homes and has resulted in over 30 reported deaths....more
The IRS recently issued draft 2015 Instructions for Forms 1094-C and 1095-C (“2015 Instructions”). These are the forms that employers with 50 or more full-time employees (including full-time equivalent employees) in the...more