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Foley & Lardner LLP

Challenges in AI-Enabled Biomarker Discovery

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Patient biomarkers are now used in personalized medicine to predict disease progression, minimize side effects, and maximize therapeutic benefits in the treatment of disease. In oncology, the use of biomarkers has increased...more

Epstein Becker & Green

DOJ Criminal Fraud Section’s Annual Health Care Fraud Enforcement Action: “We Are a Target-Rich Environment”

On June 27, 2024, 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...more

Alston & Bird

Health Care Week in Review: HHS Finalizes Provider Disincentives for Information Blocking and House Ways and Means Committee...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Jackson Lewis P.C.

Minnesota Will Allow Oral Fluid Testing For Drugs, Cannabis and Alcohol

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Minnesota will amend its drug testing law to permit oral fluid testing for drugs, cannabis and alcohol, effective August 1, 2024. The Drug and Alcohol Testing in the Workplace Act (“DATWA”) currently requires employers who...more

Foley & Lardner LLP

The Basics: How Quantum Computers Work and Where the Technology is Heading

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The theoretical foundations of quantum computing emerged throughout the twentieth century, including Planck’s Quantum Hypothesis (1900), the Uncertainty Principle (1927), and Bell’s Inequality (1964). Practical applications...more

Polsinelli

Health Care Fraud and Abuse 2023 Year in Review

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Introduction - Polsinelli proudly introduces the Health Care Fraud and Abuse 2023 Year in Review, a comprehensive examination of the evolving landscape surrounding the False Claims Act (“FCA”) and fraud & abuse enforcement...more

McDonnell Boehnen Hulbert & Berghoff LLP

Biomedical Device Consultants and Laboratories of Colorado, LLC v. Vivitro Labs, Inc. (Fed. Cir. 2024)

A preliminary injunction is one of the most potent weapons in a patent plaintiff's arsenal, being capable of shutting down an accused infringer's continued infringement, prohibiting the infringing product from the stream of...more

Mintz - Health Care Viewpoints

A Mintz Health Care Roundtable: Current Trends in State Health Care Transaction Review and What to Expect in 2024

States are increasingly exercising regulatory oversight of health care transactions by enacting laws requiring prior notice or approval of certain health care transactions. Currently, 15 states have enacted health care...more

White and Williams LLP

Massachusetts Supreme Judicial Court Considers Whether University Is Prohibited from Reducing Compensation or Lab Space of Tenured...

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In Wortis v. Trustees of Tufts College, the Massachusetts Supreme Judicial Court (“Court”) held that a university’s agreement to provide academic freedom and economic security to tenured faculty in the tenure contract did not...more

Epstein Becker & Green

Making Moves – FDA’s LDT Proposed Rule Sent to OMB for Review

As of Monday March 4, 2024—just three months after the end of its comment period on December 4, 2023—FDA’s rule on regulation of laboratory developed tests (“LDTs”) as medical devices is under review by the Office of...more

Cooley LLP

Proposed Rule on Laboratory-Developed Tests Takes Center Stage

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The US Food and Drug Administration (FDA) is resolute in its quest to phase out its enforcement-discretion approach for laboratory-developed tests (LDTs). On October 3, 2023, FDA published a proposed rule to confirm that LDTs...more

Bass, Berry & Sims PLC

[Webinar] 9th Annual Nashville Healthcare Fraud Conference - December 14th - 15th, 9:00 am - 2:00 pm CST

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Please join us for the 9th Annual Nashville Healthcare Fraud Conference hosted by Bass, Berry & Sims and the Tennessee Hospital Association. Eligible for more than seven hours of CLE credit (including ethics), this...more

Bass, Berry & Sims PLC

[Event] 9th Annual Nashville Healthcare Fraud Conference - December 7th, Nashville, TN

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Please join us for the 9th Annual Nashville Healthcare Fraud Conference hosted by Bass, Berry & Sims and the Tennessee Hospital Association. Eligible for more than seven hours of CLE credit (including ethics), this...more

J.S. Held

[Webinar] How a Root Cause Failure Lab Can Help Close Complex Claims - November 14th, 2:00 pm - 3:00 pm EST

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This course will cover: - Different types of engineering analyses - Steps in root cause failure analysis - The importance of the chain of custody - How a failure analysis lab can contribute to Subrogation matters...more

Proskauer - Health Care Law Brief

OIG Reaffirms Its Concern About “Carving Out” Federal Health Care Program Business

Last month, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services reaffirmed its longstanding position that an arrangement that “carves out” Federal health care program (FHCP) business is...more

Allen Matkins

Life Sciences Real Estate Update 10.16.23

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Boston, the San Francisco Bay Area, and San Diego are once again the top markets for life sciences commercial real estate in the U.S., with plenty of opportunities for growth as biotech readies for a comeback, according to a...more

Harris Beach PLLC

OIG Kickback Opinion: Referring Labs Providing Technical Component Services Implicate Anti-Kickback Statute

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This opinion addresses a proposed agreement (“Proposed Arrangement”) between a national anatomic pathology laboratory (“Requestor”) and laboratories owned in whole or in part by physicians who may refer (“Referring...more

Allen Matkins

Life Sciences Real Estate Update 8.24.23

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The average vacancy rate for laboratory and research and development space across the top 13 U.S. life sciences markets stood at 9% in the second quarter, up more than four percentage points from a year earlier and more than...more

Genova Burns LLC

Cleaning House: New Jersey Enacts Building Service Worker Retention Law

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On July 24, 2023, Governor Phil Murphy signed into law Assembly Bill 4682/Senate Bill 2389 protecting non-managerial and non-professional service workers, who work at eligible locations, from sudden and unexpected loss of...more

ArentFox Schiff

Investigations Newsletter: Government Brings FCA Action Against Laboratory Companies

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Government Brings FCA Action Against Laboratory Companies - On July 18, 2023, the US Department of Justice (DOJ) announced it has filed a complaint against multiple laboratory companies and their owner, Patrick...more

BCLP

Five years on: EKRA's legacy

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Five years ago Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”). Aimed at combating kickbacks in the addiction treatment industry, EKRA prohibits remunerations in return for patient referrals to...more

Allen Matkins

Life Sciences Real Estate Update - 7.18.23

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California was, by January 1, 2023, home to nearly 470,000 jobs that generated $413.7 billion in total business output in 2022, according to Biocom California’s 2023 Economic Impact Report. This represents a nearly 8 percent...more

Perkins Coie

Psilocybin: Updates in Oregon and Around the Country

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Oregon is the first state in the country to offer controlled use of psilocybin to the public. As we detailed in a prior Update, the state had finalized regulations. Now, the state has licensed its first psilocybin service...more

WilmerHale

Attorneys General Bring Multistate Data Breach Settlement Against DNA Testing Lab

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On February 17, 2023, the state attorneys general of Pennsylvania and Ohio reached a settlement with Ohio-based DNA Diagnostics Center (“DDC”) for a 2021 data breach that affected 2.1 million individuals nationwide and...more

Womble Bond Dickinson

[Webinar] First Annual Health Care Fraud Symposium - March 14th, 12:00 pm - 1:30 pm ET

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Health Care fraud is a growing national issue. The National Heath Care Anti-Fraud Association estimates that health care fraud costs the nation about $68 billion annually — about 3 percent of the nation's $2.26 trillion in...more

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