Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
Changes in FDA, Cannabis Policies and AI Developments
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 181: South Carolina’s Life Sciences Economy with Ashely Teasdel, Deputy Secretary of SC Department of Commerce
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 166 — Christine Vannais, COO of Fujifilm Diosynth Biotechnologies
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Episode 150 - Jane Pine Wood, Senior Vice President & Chief Legal Officer, BioReference
Jones Day Talks Health Care: The Eliminating Kickbacks in Recovery Act
In December 2024, we published an alert highlighting the FDA’s final rule on Laboratory Developed Tests (LDTs) and the compliance countdown to May 2025. The rule, issued in May 2024, sought to phase out the agency’s...more
On January 10, 2025, China’s State Administration for Market Regulation (“SAMR”) put into effect its Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (“Compliance Guidelines”)....more
Compared with other issues, healthcare enforcement during President-elect Donald Trump’s upcoming second term has received little attention. When he takes office again on January 20, should industry actors like pharmaceutical...more
Recently, Holland & Knight healthcare attorneys have received questions as to whether the Eliminating Kickback in Recovery Act (EKRA) is still in effect, given the recent expiration of many provisions of the Substance...more
Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more
On June 28, 2023, the U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services, Office of Inspector General (“HHS-OIG”), along with other federal and state law enforcement partners, announced a...more
Recently, we were invited to speak on a panel at the Executive War College on Diagnostics, Clinical Laboratory and Pathology Management. We spoke about the federal information blocking rules, and highlighted how some actors...more
On February 17, 2023, the state attorneys general of Pennsylvania and Ohio reached a settlement with Ohio-based DNA Diagnostics Center (“DDC”) for a 2021 data breach that affected 2.1 million individuals nationwide and...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between November 21 and December 31, 2022, including recent enforcement activity and a summary of the Office of Inspector...more
Please join us for the 8th Annual Nashville Healthcare Fraud Conference hosted by Bass, Berry & Sims and the Tennessee Hospital Association. Eligible for more than seven hours of CLE credit (including ethics), this...more
What To Do When The Government Knocks On Your Lab’s Door - The volume of federal enforcement actions involving laboratories has increased dramatically over the last few years. Not a month seems to pass without a press...more
Enacted in 2018, the Eliminating Kickbacks Recovery Act (EKRA) remains a source of anxiety and confusion in the clinical laboratory industry. In the four years since EKRA's enactment, U.S. Department of Justice (DOJ)...more
On April 28, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-09, declining to approve a laboratory company’s proposal to pay hospitals a fair market...more
The U.S. Department of Justice (DOJ) recently intervened in an action filed in Texas against two laboratory CEOs, one hospital CEO, and numerous other executives, employees, and recruiters, seeking civil penalties and treble...more
The U.S. Department of Justice (“DOJ”) recently announced that over $5.6 billion in False Claims Act (“FCA”) settlements and judgments had been reached during the 2021 fiscal year, with over $5 billion of those settlements...more
Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance. This year’s seminar will take place virtually on March 15, March 17, March 22, and...more
A False Claims Act case can easily turn into a criminal prosecution. The Federal Bureau of Investigation often initiates criminal investigations as part of its commitment to reducing health care fraud....more
In Connecticut General Life Ins. Co. v. BioHealth Labs., Inc., No. 20-2312-CV, — F.3d –, 2021 WL 476111 (2d Cir. Feb. 10, 2021), Cigna, as administrator of employee health plans, sued six out-of-network lab companies for...more
Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance... Registrants will have the option of selecting the sessions they would like to...more