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McDermott Will & Emery

Texas AG’s Landmark AI Settlement: A Wake-Up Call for Health Tech & AI Companies

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The Texas Attorney General (AG) recently announced a “first-of-its-kind” settlement with a healthcare generative artificial intelligence (AI) company, Pieces Technologies, Inc., resolving allegations that the company made a...more

Health Care Compliance Association (HCCA)

Hackers Increasingly Leveraging Threats to Patients to Pressure Health Organizations to Pay Ransom

Cyberhackers—potentially frustrated by their limited ability to extort ransom from health care entities in attacks—have started extorting the patients themselves, threatening them with the release of information or...more

Health Care Compliance Association (HCCA)

Employees’ Misdeeds, Lack of Risk Analysis Cost NY Hospital $4.75M; OCR Issues Warning

Although the HHS Office for Civil Rights (OCR) described its recent $4.75 million agreement with a Bronx, New York, hospital as settling a “malicious insider cybersecurity investigation,” the agency considered a total of 11...more

Manatt, Phelps & Phillips, LLP

Federal Antitrust Enforcement in Health Care: 2023 Year in Review–Part 3

In 2023, the DOJ continued its aggressive criminal antitrust enforcement agenda in health care, with mixed results in labor markets. In speeches, the DOJ asserted that its commitment to labor market cases has not diminished,...more

Manatt, Phelps & Phillips, LLP

Federal Antitrust Enforcement in Health Care: 2023 Year in Review – Part 2

Editor’s Note: This article is the second in our three-part series, Federal Antitrust Enforcement in Health Care: 2023 Year in Review.  (Click here to read part 1.) The series is based on our recent webinar, 2023 Health Care...more

Health Care Compliance Association (HCCA)

Hospital Settles CMP Case Over Free APPs; 'Bona Fide' Use Shouldn't Inspire Fear, Lawyer Says

In a case that may hit a raw compliance nerve, Ascension Macomb Oakland Hospital in Michigan has agreed to pay $100,000 in a settlement with the HHS Office of Inspector General (OIG) over free services provided to certain...more

Mintz - Health Care Viewpoints

Health Care Privacy and Security In 2024: Six Critical Topics to Watch

As we reflect on the flurry of activity in the health care data privacy and security space in 2023 and look ahead to what will continue to be a busy 2024, we are seeing the early stages of federal agency movement to align the...more

Quarles & Brady LLP

Indianapolis Health System to Pay $345 Million to Settle Stark Law Allegations

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Community Health Network, Inc. (“Community Health”) is a non-profit healthcare system with more than 200 hundred affiliated sites throughout central Indiana. As such, Community Health is one of the larger Midwest...more

Sheppard Mullin Richter & Hampton LLP

Overview of Recent Anti-Corruption Enforcement Actions in the Pharmaceutical Industry in China

On May 8, 2023, the National Health Commission of the People’s Republic of China (the “PRC”), along with 13 other government departments of the PRC, issued the “Key Highlights for Combating Corruption in the Medicine Purchase...more

Jones Day

DOJ Obtains First Divestitures in a Criminal Antitrust Case

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The U.S. Department of Justice Antitrust Division ("DOJ") recently resolved a criminal case with Teva Pharmaceuticals and Glenmark Pharmaceuticals via deferred prosecution agreements ("DPAs"), which include a novel remedy for...more

Epstein Becker & Green

The 2023 DOJ Health Care Fraud Enforcement (f/k/a “Takedown”): Big Dollars or Clever Packaging?

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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

Carlton Fields

7th Cir. Holds Insurance Coverage Applies to Settlement Payments for Alleged Anti-Kickback and False Claims Act Violations

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On May 3, 2023, the Seventh Circuit Court of Appeals, in Astellas US Holding Inc. v. Federal Insurance Co., held that a liability insurer was required to contribute its limits toward its insured’s payment to settle potential...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - V 4, Issue 5, May 2023

Cyber Resilience Programs Falling Short on Preparing Workers for a Crisis- “At two-thirds of organizations, there is a fear that almost all employees, 95%, will not understand how to recover following a cyberattack.” ...more

Akerman LLP

False Claims Act 2022 in Review

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The U.S. government continued to earn its longstanding reputation for its vigorous enforcement of the False Claims Act (FCA) in 2022, either directly or through relator proxies. The Department of Justice (DOJ) recorded the...more

Wyrick Robbins Yates & Ponton LLP

Not What the Doctor Ordered: GoodRx to Pay $1.5 Million in FTC’s First Enforcement of the Health Breach Notification Rule

The Federal Trade Commission earlier this month undertook an enforcement action against online pharmacy and telehealth provider GoodRx, in the latest example of the agency seriously pursuing its role as the nation’s de facto...more

Foley Hoag LLP - White Collar Law &...

False Claims Act Enforcement: Looking Back and What to Expect in 2023

This is the first in our 2023 series examining important trends in white collar law and investigations. Up next: criminal tax enforcement. The False Claims Act (or “FCA”) continued to drive significant enforcement...more

Cadwalader, Wickersham & Taft LLP

State Attorney General Insider – Winter 2023: Notable Cases

Here are some of the cases that dominated the headlines in the state Attorney General space. Grubhub − District of Columbia Attorney General Karl Racine secured $3.5M in a settlement with the food delivery company for...more

Bradley Arant Boult Cummings LLP

FTC Proposes Rule to Strike Noncompete Agreements Nationwide

On January 5, 2023, the Federal Trade Commission (FTC) announced a proposed new rule that would effectively prohibit employers from requiring employees to agree to noncompete clauses. The public is invited to submit comments...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | December 2022

LEGISLATION, REGULATIONS & STANDARDS - Former FDA Commissioners, Industry Groups Show Support for Modernized FDA Regulatory Framework - In recent months, two former U.S. Food and Drug Administration (FDA) commissioners and...more

Skadden, Arps, Slate, Meagher & Flom LLP

Inside the Courts – An Update From Skadden Securities Litigators - December 2022

Cornerstone Research reports that during the first six months of 2022, plaintiffs filed 110 securities class actions, a pace that is generally in line — 2.8% higher — with what we saw in the second half of 2021. Looking...more

Bass, Berry & Sims PLC

What Does the DOJ’s New Civil Cyber-Fraud Initiative Mean for You?

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As discussed in a previous post, the Department of Justice (DOJ) has announced a new Civil Cyber-Fraud Initiative to utilize one of the strongest tools in its toolbox—the False Claims Act—to hold entities receiving federal...more

Foley Hoag LLP - White Collar Law &...

False Claims Act Enforcement in 2021: A Look Ahead

This is the sixth in our First 100 Days series examining important trends in white collar law and investigations in the early days of the Biden administration. Our previous entry discussed ESG initiatives by the SEC. Up next...more

A&O Shearman

Global Healthcare Company To Enter DPA, Pay $345 Million To DOJ And SEC, To Resolve FCPA Claims

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On June 25, 2020, Novartis AG, a global healthcare company headquartered in Switzerland, and two of its subsidiaries (one current and one former) agreed to pay a total of $345 million in disgorgement and fines to the U.S....more

The Volkov Law Group

Three Pharmaceutical Companies Pay a Total of $122 Million to Settle Kickback Allegations Involving Co-Pay Assistance Foundations

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In a significant False Claims Act enforcement action, DOJ announced settlements with three pharmaceutical companies – Jazz Pharmaceuticals, Lundbeck, and Alexion Pharmaceuticals – under which they agreed to pay $122 million...more

Cadwalader, Wickersham & Taft LLP

White Collar Crime Law Enforcement in a Trump Justice Department - 8 Predictions

After a conventional presidential campaign, determining the policy priorities and direction of the incoming administration with respect to the Justice Department’s white collar law enforcement responsibilities can be a...more

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