News & Analysis as of

Federal Bureau of Investigation Food and Drug Administration (FDA)

Foley Hoag LLP

United States v. Elizabeth Holmes and Ramesh Balwani

Foley Hoag LLP on

I. WHY THIS CASE MADE THE LIST - A highly publicized and long-running multi-agency action against the former Chief Executive Officer and the former Chief Operating Officer of Theranos Inc. resulted in criminal convictions...more

Ankura

FDA Authorized to Establish New Cybersecurity Standards for Medical Devices: What it Means for Industry

Ankura on

On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - V 4, Issue 1, January 2023

Big Boosts to Cybersecurity and Tech Funding in $1.7T Omnibus Bill Signed by Biden - “The bipartisan fiscal 2023 omnibus spending agreement includes $2.9 billion for the Cybersecurity and Infrastructure Security Agency, a...more

Gardner Law

The Buzz on Med Device Cybersecurity

Gardner Law on

Medical device cybersecurity continues to create buzz, as the FBI issues a Private Industry Notification to health care providers outlining cybersecurity risks for medical devices. This follows FDA’s released Draft Guidance...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, Volume 3, Issue 16

CHIPS and Science Act Will Lower Costs, Create Jobs, Strengthen Supply Chains, and Counter China "Spurred by the passage of the CHIPS and Science Act of 2022, companies have announced nearly $50 billion in additional...more

King & Spalding

DOJ and HHS Issue Healthcare Fraud and Abuse Control Program Fiscal Year 2021 Report

King & Spalding on

Last week, DOJ and HHS-OIG published its annual report regarding the Healthcare Fraud and Abuse Control (HFAC) Program (the Report). The Report summarizes the enforcement activity of DOJ and HHS and states that during Fiscal...more

Mintz - Health Care Viewpoints

DOJ Announces Another Wide-Ranging COVID-19 Fraud Enforcement Action

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

Oberheiden P.C.

6 Frequently Asked Questions with Lab Defense Attorney Nick Oberheiden

Oberheiden P.C. on

Clinical laboratories have come under increased scrutiny in the past few years, especially those that deal with COVID-19 testing or drug testing. These federal investigations can be surprising and confusing for lab...more

Health Care Compliance Association (HCCA)

Report on Research Compliance Volume 18, Number 7. In This Month’s E-News: July 2021

Report on Research Compliance 18, no. 7 (July 2021) - In a review of more than 500 NIH awards, the HHS Office of Inspector General (OIG) found that about one-fifth were funded “out of rank order,” and for more than a...more

Oberheiden P.C.

The FDA is Investigating Companies that Produce and Sell Poppy Seeds Due to Suspected Contamination

Oberheiden P.C. on

The U.S. Food and Drug Administration (FDA) is investigating companies that produce and sell poppy seeds due to growing concerns over contamination with a controlled substance. In doing so, it is collaborating with the Drug...more

Fox Rothschild LLP

Medical Devices Are Double-edged Swords For Hospitals: Vital For Patient Care But Vulnerable To Cyberattacks

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On October 28th, the Federal Bureau of Investigation, the Department of Health and Human Services, and the Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency alerted hospital administrators and...more

Rivkin Radler LLP

DOJ Charges California Physician with COVID-19 Fraud

Rivkin Radler LLP on

On April 16, the United States Attorney’s Office for the Southern District of California charged Dr. Jennings Ryan Staley, a licensed physician and the operator of Skinny Beach Med Spa in San Diego, with mail fraud in...more

Holland & Knight LLP

Food and Beverage Law Update: July 2019

Holland & Knight LLP on

Wage and Hour - 80/20 Rule Still Followed in Some Parts - The U.S. Department of Labor (DOL) issued guidance doing away with the so-called "80/20 rule" in November 2018. District courts have greeted the new guidance...more

BakerHostetler

AD-ttorneys@law

BakerHostetler on

In This Issue: - Heads Up – Feds Sniffing Around Ad Industry? - It’s Baaaaack! New York State Takes Another Stab at Right of Publicity - Comments Section Not Sweet on FDA Labeling Decision - Dyson Sucks Up $16.4 Million...more

Skadden, Arps, Slate, Meagher & Flom LLP

"Health Care Enforcement Update: What Is in Store for the Next Five Years"

While predicting enforcement trends over the next five years is not without uncertainty, the best marker for future activity may be to look to the past. We believe that industry members and counsel can expect the Department...more

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