Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Medical Device Legal News with Sam Bernstein: Episode 14
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 10
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
For nearly 40 years and in more than 18,000 judicial opinions, federal courts have used the Chevron doctrine to defer to an agency's reasonable interpretation of an ambiguous statute. On June 28, 2024, the U.S. Supreme Court...more
House Energy & Commerce Health Subcommittee Holds Legislative Hearing on Improving Medicaid Access. Daniel Tsai, deputy administrator and director of the Center for Medicaid and CHIP Services (CMCS), testified. Members...more
During this election year, McDermottPlus is actively monitoring annual regulations that federal agencies are expected to release, as well as “ad hoc” regulations that will be released at the discretion of federal agencies. ...more
Once again, the U.S. Departments of Labor, Health and Human Services, and the Treasury have issued guidance on the Affordable Care Act’s (ACA) required coverage of contraception without cost sharing, clarifying the permitted...more
The Departments of Labor, Treasury, and Health and Human Services (the “Departments”) recently issued guidance for group health plans outlining a “therapeutic equivalence” medical management technique for required preventive...more
Congress Works to Meet Imminent Funding Deadlines. Speaker of the House Johnson (R-LA) and Senate Majority Leader Schumer (D-NY) announced an agreement on top-line spending levels to fund the government for the remainder of...more
The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries. Labor and Employment: Child Labor Compliance and “Hot Goods” - Many employers may...more
Artificial Intelligence, commonly known as AI, has been all over the news recently, from goofy uses (George Washington with a mullet) to apocalyptic fears (AI systems with the power to launch a missile attack without human...more
THIS WEEK’S DOSE - Uncharted Territory in the House: The House voted to remove Rep. McCarthy (R-CA) as Speaker of the House, then recessed until at least October 11, when the House is slated to reconvene to elect a new...more
The past year has seen a new star become fixed in the judicial firmament. The US District Court for the Northern District of Texas, Amarillo Division, has found new prominence, most recently retaining a challenge 26 states...more
The US Department of Health and Human Services recently updated its guide to help the private and public healthcare sectors develop cybersecurity protocols that address NIST’s Framework for Improving Critical Infrastructure...more
On July 28, 2022, in light of the United States Supreme Court’s recent decision overturning Roe v. Wade, the United States Department of Labor (DOL), in conjunction with the Departments of Health and Human Services (“HHS”)...more
With just a few short weeks left until August recess, there is no shortage of items on the congressional to-do list. The latest round of Supreme Court decisions has inspired new action within Congress to pass legislation...more
For the last few years, we have been closely monitoring and reporting on COVID-19 related fraud enforcement efforts by federal agencies. We detailed those findings in our Health Care Enforcement 2020 Year in Review & 2021...more
SCOTUS Halts OSHA’s Vax-or-Test ETS (but Greenlights CMS Rule). On January 13, 2022, the Supreme Court of the United States stayed the Occupational Safety and Health Administration’s (OSHA) COVID-19 vaccination-or-testing...more
In an effort to expand the availability of free COVID-19 testing, the Biden-Harris Administration has announced that beginning January 15, 2022, insurance companies and group health plans will be required to cover the cost of...more
President Biden announced on January 10th that the Biden-Harris Administration is requiring insurance companies and group health plans to cover the cost of over-the-counter (OTC), at-home COVID-19 tests. Beginning January 15,...more
Testing for COVID-19 certainly has evolved over the past 18 months or so. As supply and allocation continue to face challenges, guidance on serological/antibody versus viral testing, testing in the workplace, informed...more
Earlier this evening, the President of the United States announced a series of actions aimed at confronting the COVID-19 pandemic. For one thing, President Biden stated he is signing an Executive Order requiring all...more
"The overwhelming majority of courts have concluded that neither COVID-19 nor the governmental orders associated with it cause or constitute property loss or damage for purposes of insurance coverage." So concluded the...more
Below, please find a summary of recent federal government activity in response to the COVID-19 pandemic. Congress - On Tuesday, after returning from the August recess, Senate Republicans unveiled a “targeted” COVID...more
Rising unemployment rates, continued deliberations on another federal relief package, and schools implementing remote learning after on-campus spikes in case rates marked an eventful week in the COVID-19 pandemic response....more
Congress - Bipartisan negotiations on the next round of COVID-relief legislation continue, with leaders pointing to some progress over the last 24-48 hours. Administration officials have stressed the importance of reaching...more
Congress - Following negotiations over the weekend – which, according to House Speaker Pelosi (D-CA) were “more productive” than previous talks – Treasury Secretary Mnuchin and White House Chief of Staff Meadows again met...more