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Australian Privacy Regulator Commences Penalty Proceedings Against Medibank

On 5 June 2024, the Australian Information Commissioner commenced civil penalty proceedings in the Australian Federal Court against Medibank Private Limited (an Australian health insurance provider) in relation to an October 2022 data breach. On 25 October 2022, Medibank notified the Office of the Australian Information Commissioner (OAIC) of a data breach concerning sensitive personal … Continue Reading

Are you Ready for Washington and Nevada’s Consumer Health Data Laws?

Washington’s My Health My Data Act (“MHMDA”) and Nevada’s SB 370 (“NV CHD Law”) (collectively, “CHD Laws”) went into effect at the end of last month, on March 31, 2024 (as many know, MHMDA’s geofencing prohibition went into effect last summer). Unlike the Health Insurance Portability and Accountability Act (“HIPAA”), a federal law which governs privacy and security … Continue Reading

President Biden Announces Groundbreaking Restrictions on Access to Americans’ Sensitive Personal Data by Countries of Concern

On February 28, 2024, President Biden issued a groundbreaking executive order (EO) establishing the framework for new restrictions on transactions involving US persons’ sensitive personal data and “countries of concern,” including China, or related parties.… Continue Reading

FEPA: the New Tool in the DOJ’s Fight Against Corruption

Members of our Government Investigations & White Collar team recently presented a timely webinar on the new Foreign Extortion Prevention Act (FEPA).  The Act, which has been referred to as  “the most consequential anti-foreign-bribery law passed in almost 50 years,” allows the DOJ to prosecute foreign officials who demand or accept a bribe from a … Continue Reading

The End of “Chevron” or Its Rebirth?

Fishermen in the small town of Cape May, New Jersey, are at the epicenter of a legal challenge that could reshape the landscape of agency authority. The fishermen are challenging the entrenched “Chevron” doctrine, which for years has afforded deference to government agencies with respect to reasonable interpretation of ambiguous statutes. Once again, the US … Continue Reading

Webinar:  The New Foreign Extortion Prevention Act – What It Means for US Companies

On Tuesday January 30, we hope you will join a seasoned team of former Department of Justice (DOJ) prosecutors for what will certainly be a robust a discussion on “the most consequential anti-foreign-bribery law passed in almost 50 years”: the Foreign Extortion Prevention Act (FEPA). Passed as part of the National Defense Authorization Act (NDAA), … Continue Reading

US Antitrust Agencies Release 2023 Merger Guidelines

On December 18, 2023, the US Department of Justice (DOJ) and Federal Trade Commission (FTC) (collectively, the “government”) released the final 2023 Merger Guidelines (the “Guidelines”) which set forth factors and frameworks the government will use when assessing mergers and acquisitions. While the Guidelines are not legally binding, they provide important guidance on how the … Continue Reading

Federal Courts Continue to Grapple with Causation in Anti-Kickback-Based False Claims Act Cases

Courts around the country continue to disagree on the causation standard to be applied in False Claims Act cases based on alleged Anti-Kickback Statute violations.  Two recent federal district court decisions out of the District of Massachusetts, United States v. Regeneron Pharms., Inc., No. 20-11217-FDS, 2023 WL 7016900 (D. Mass. Oct. 25, 2023) and United … Continue Reading

Considering DPF Certification? It May be Worth Considering APEC Certifications, Too

It has become commonplace to talk about compliance becoming more and more of a challenge amidst the increasing complexities and fragmentation of regulations worldwide. Data protection compliance is no exception. As new requirements continue to mushroom across the globe with escalating frequency and accompanied by heightened repercussions for any failure to meet expected standards, global … Continue Reading

Join us on September 28 for a Webinar on Washington’s My Health My Data Act and other Consumer Health Data Regulation

With its private right of action and expansive scope – extending far beyond Washington state’s borders and applying to a wide swath of health- and non-health-oriented companies alike – Washington’s My Health My Data Act is poised to be more ground-shifting than any other consumer privacy law that came before it. Join Kyle Fath, Bola … Continue Reading

Supreme Court Clarifies Knowledge Requirement for False Claims Act Liability

In April, we previewed two significant False Claims Act (FCA) cases before the U.S. Supreme Court, United States ex. rel. Schutte v. SuperValu, Inc., No. 21-1326 (“SuperValu”), and United States ex. Rel. Proctor v. Safeway, Inc., No. 22-111 (“Safeway”).  The FCA provides that “any person who knowingly presents, or causes to be presented, a false or fraudulent claim” to the United … Continue Reading

Healthcare Companies and Companies Doing Business with the US Government – Supreme Court Appears Likely to Clarify False Claims Act (FCA) Knowledge Requirements

The Supreme Court recently heard oral argument in the appeal of two False Claims Act (FCA) cases from the Seventh Circuit that called into question the level of intent, or scienter, required to establish corporate liability under the FCA for “knowingly” overbilling the government for goods or services.  The Court’s eventual decision may have widespread … Continue Reading

Sixth Circuit Limits Anti-Kickback Claims Brought Under False Claims Act

Recently, the Sixth Circuit issued an important decision limiting the scope of claims alleging violations of the Anti-Kickback Statute that are brought under the False Claims Act. In Shannon Martin, M.D., et al. v. Hathaway, et al., No. 22-1463 (March 28, 2023), the court clarified the meaning of remuneration under the Anti-Kickback Statute. Squire Patton … Continue Reading

The U.S. Department of Justice Loses Another Labor-related Antitrust Case with Jury’s Acquittal of Four Home-Health Operators

In a blow to the Biden Administration’s goal to heighten enforcement of labor-related competitor agreements, a Maine jury on Wednesday acquitted four home-health operators who were accused of conspiring to fix the wages of home-health workers in the Spring of 2020.  The U.S. Department of Justice (“DOJ”) had alleged that the operators violated Section 1 … Continue Reading

Bankruptcy Court Doors Swing Open For Cannabis Companies, But Just Slightly

Are bankruptcy doors now opening for cannabis companies?  A recent decision from a California bankruptcy court indicates perhaps so, at least for cannabis companies that are no longer operating. Squire Patton Boggs partner Mark Salzburg discusses this case and its implications on our Restructuring GlobalView blog, available at this link.… Continue Reading

Revamping of Cosmetics Regulation and Safety

President Biden signed into law the “Consolidated Appropriations Act, 2023” on December 29, 2022 (the enactment date). The Act includes the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) which increases the authority of the United States Food and Drug Administration (“FDA”) to regulate cosmetics and provide enhanced protections for consumers. The new law includes … Continue Reading

Dobbs Puts New Emphasis on Proactive Provider Transparency in Care Offerings

Months following the Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization, the reproductive health climate remains clouded with terms lawyers—not to mention patients—never like to hear: “wait and see,” “to be decided,” “gray area,” “it depends.” Perhaps nowhere is the information gap of more crucial import than at the moment a patient walks through … Continue Reading

California’s Senate Bill 1019 Seeks to Expand Access to Mental Health Benefits for Medicaid Enrollees

In an effort to expand access to mental health services, on September 30, 2022, California’s Governor approved Senate Bill 1019, which modifies the California Welfare & Institutions Code as it relates to Medi-Cal managed care plans (“MMCP”). No later than January 1, 2025, MMCPs must develop and implement an annual outreach and education plan for … Continue Reading

Healthcare Non-Competes in 2022: Status Following Recent Developments

For healthcare entities that use non-compete agreements, the landscape has changed as much recently as it has at any point in recent memory.  Several developments at the federal level have created a potential pitfall that did not materially exist until recently, i.e., a non-compete agreement violating antitrust law.  Further, several recent state laws have heightened … Continue Reading

Judge Strikes Down Part Of Administration’s Surprise Billing Rules In Win For Physicians

The Biden Administration’s Interim Final Rule implementing provisions of the No Surprises Act suffered its first major legal setback yesterday.  Judge Kernodle of the Eastern District of Texas issued a decision vacating portions of the Rule relating to the independent dispute resolution (“IDR”) process that the Act creates. As we’ve previously reported, the No Surprises … Continue Reading

Healthcare Research: A Transatlantic and Trans-European Dialogue Seminar

On November 23rd, a Squire Patton Boggs partner will lead a panel of industry thought leaders in a discussion of transcontinental health research and data issues.  Topics to be explored include: What are the challenges that companies need to face in order to promote research with health data? What should evolve in the legal framework … Continue Reading

COVID-19 Vaccine Mandate Fundamentals for Healthcare Employers

Now that OSHA has issued its emergency temporary standard and CMS has issued its own emergency rule, the landscape has changed once again for healthcare employers in terms of addressing employees’ vaccination status.  Fortunately, they now have much more certainty, which allows for more specific and detailed planning to address the myriad vaccination-related requirements that … Continue Reading

OSHA and CMS to Require Employers to Mandate Vaccines or Weekly Negative Tests

The Occupational Safety and Health Administration, as well as the Centers for Medicare & Medicaid Services, are preparing to issue new requirements that will have a major impact on healthcare employers, as well as other employers across the U.S.  On Thursday, the executive branch announced its plans to have OSHA require employers to ensure that … Continue Reading

Will Patents Become More Political? The PTO Begins to Implement Arthrex

In United States v Arthrex, the Supreme Court held that 35 U.S.C. §6(c), which sets forth the authority of Patent Trial & Appeal Board (“PTAB”) Administrative Patent Judges (“APJs”), is unconstitutional because APJs effectively wield the power of principal officers (who require Senate confirmation) while being appointed as inferior officers (who do not require Senate confirmation). … Continue Reading
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