Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 233: Prioritizing Women’s Health Through Innovation with Lindsey Calcutt of Incora Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 228: Designing & Manufacturing Auto-Injectors with Kimberlee Steele of SHL Medical
Building a Business at the Intersection of Neurodata and Innovation With Rob Cooley
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 209: North Carolina’s Life Sciences Industry with Laura Gunter of NCLifeSci
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 208: Extended Reality Technology and the ThinkReality Headset with Mattney Beck of Lenovo
AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Meet Meaghan Luster: Patent Litigation Associate at Wolf Greenfield
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 177: Brain Health and Research with Dr. Fridriksson, Neuroscientist, Professor, & Vice President of Research at the Universit
Transparency and the Open Payments Program
Medical Device Legal News with Sam Bernstein: Episode 19
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
Health + Tech - Improving Cancer Care With Digital Health Tools
Medical Device Legal News with Sam Bernstein: Episode 14
The US Department of Justice’s settlement with Illumina, Inc. is a first-of-its-kind involving alleged cybersecurity deficiencies causing violations of the False Claims Act (FCA) based on FDA quality standards. The...more
With the first half of 2025 in the rearview mirror, the government’s continued focus on False Claims Act (FCA) enforcement shows no signs of slowing. In fact, the Department of Justice recently announced the results of a...more
On July 31, the U.S. Department of Justice (DOJ) announced a settlement in United States ex rel. Lenore v. Illumina, Inc, the first case in which underlying cybersecurity issues formed the basis of a settlement under the...more
On July 7, 2025, the Office of Inspector General (“OIG”) for the Department of Health and Human Services published Advisory Opinion 25-08 (“AO 25-08”), an unfavorable and strongly worded opinion interpreting the “arranging...more
The United States Department of Health and Human Services, Office of Inspector General (“OIG”) recently released two unfavorable advisory opinions, OIG Advisory Opinion No. 25-04 and -08 (the “Opinions”) to medical device...more
On July 2, 2025, the U.S. Department of Justice (DOJ) and U.S. Department of Health and Human Services (HHS) announced the reestablishment of the DOJ-HHS False Claims Act Working Group. Originally formed in December 2020 at...more
The wound care industry faces unprecedented scrutiny as Medicare Part B expenditures for skin substitutes exceeded $1.6 billion in the fourth quarter of 2023 alone. The spending surge has triggered a wave of skin substitute...more
On July 2, 2025, the Departments of Justice and Health & Human Services announced a joint working group aimed at “strengthening their ongoing collaboration to advance priority enforcement areas” under the False Claims Act...more
A large health system implements an Artificial Intelligence (AI)-powered clinical decision support tool that promises to ensure “complete and accurate” diagnosis documentation. Within six months, the system’s Medicare...more
The U.S. Department of Health and Human Services (HHS) and the Department of Justice (DOJ) have jointly announced the launch of a reinvigorated DOJ-HHS False Claims Act Working Group aimed at enhancing interagency...more
The Department of Justice and the Department of Health and Human Services announced the reinvigoration of a False Claims Act (“FCA”) Working Group, a joint effort between the two agencies. ...more
The U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced on July 2 their formation of a False Claims Act Working Group. The announcement and the formation of the Working Group...more
On July 2, 2025, the U.S. Department of Justice (DOJ) announced the formation of a new working group in collaboration with the U.S. Department of Health and Human Services (HHS) focused on the enforcement of the False Claims...more
On July 2, 2025, the Department of Health and Human Services (HHS) and the Department of Justice (DOJ) announced the reinvigoration of their False Claims Act (FCA) enforcement efforts through the formation of a joint FCA...more
On July 2, 2025, the Department of Justice (“DOJ”) and the Department of Health and Human Services (“HHS”) announced a joint DOJ-HHS False Claims Act Working Group (the “Working Group”) that will focus on enhanced enforcement...more
Despite much recent attention to the new administration's plans to deploy the False Claim Act (FCA) to advance other policy objectives, a July 2, 2025 Department of Justice (DOJ) press release announcing a DOJ-HHS False...more
On July 2, 2025, the U.S. Department of Justice (“DOJ”) and the Department of Health and Human Services (“HHS”) announced the formation of the DOJ-HHS False Claims Act Working Group, signaling a continued and coordinated...more
Key Points - - The Office of Inspector General of the Department of Health and Human Services (OIG) has issued Advisory Opinion No. 25-04 (AO 25-04), its first advisory opinion of the year addressing a proposed arrangement...more
The U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services (“HHS”) have announced the formation of a newly strengthened False Claims Act (“FCA”) Working Group, signaling a more coordinated and...more
In a joint announcement, the U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) unveiled the formation of the new DOJ-HHS False Claims Act Working Group (Working Group) – a strategic...more
On Wednesday, July 2, 2025, the U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) announced the creation of a DOJ-HHS False Claims Act Working Group. The Working Group is a procedural...more
Now in its sixth month, the second Trump administration has made clear that the False Claims Act (FCA) will remain a central tool in its efforts to combat fraud, waste, and abuse across federal programs....more
On June 20, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-04, in which it declined to approve a proposal by a medical device company (Requestor) to pay the...more
On July 2, 2025, the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced the creation of the DOJ-HHS False Claims Act Working Group, a high-level interagency initiative aimed at...more
On June 20, 2025, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued an unfavorable advisory opinion - OIG Advisory Opinion 25-04 (“AO 25-04”)....more