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Robins Kaplan LLP

Allergan USA, Inc. v. MSN Labs. Private Ltd. - Viberzi® (eluxadoline)

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Case Name: Allergan USA, Inc. v. MSN Labs. Private Ltd., 111 F.4th 1358, 2024 WL 3763599 (Fed. Cir. Aug. 13, 2024) (Circuit Judges Lourie, Dyk, and Reyna presiding; Opinion by Lourie, J.; Opinion concurring-in-part and...more

Holland & Knight LLP

Regulation of AI in Healthcare Utilization Management and Prior Authorization Increases

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Over the past two years, federal and state government agencies have moved to regulate the deployment of artificial intelligence (AI) in the healthcare setting, including in the utilization management (UM) and prior...more

McDermott Will & Emery

Trending in Telehealth: October 21 – 28, 2024

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Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists, and technology companies that deliver and facilitate...more

Gardner Law

Navigating Government Investigations: A Guide for FDA-Regulated Companies

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Government investigations are an ever-present reality for companies operating in FDA-regulated industries. Whether you're in pharmaceuticals, medical devices, biologics, laboratories, food, cosmetics, veterinary, or cannabis,...more

Gardner Law

Responding to Letters from FDA

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There are several forms of communications FDA may send to signify an issue. FDA may send a company a notice of a violation in the form of a Warning Letter, an Untitled Letter, or an “It Has Come to Our Attention” Letter. Any...more

Ropes & Gray LLP

[Podcast] Health Care Transaction Laws Unwrapped: Recent Developments on the West Coast

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On this fourth episode of Ropes & Gray’s Health Care Transaction Laws Unwrapped podcast series, health care attorneys Ranee Adipat, Jenn Romig and Jaclyn Freshman discuss the latest updates to state health care transaction...more

Cooley LLP

Certain Stem Cell Products Require FDA Premarket Approval

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On September 27, 2024, in USA v. California Stem Cell Treatment Center, Inc., the US Court of Appeals for the Ninth Circuit issued a decision agreeing with the US Food and Drug Administration (FDA) that the defendants’ stem...more

McGuireWoods LLP

Senior Living Alert: How 2024 State Elections Could Impact Future of Senior Care

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State election outcomes can fundamentally reshape policies governing senior living facilities, as evidenced by how executives such as Gov. Glenn Youngkin of Virginia wielded veto power over industry-specific legislation and...more

Kilpatrick

E.D.N.Y. deals blow to plaintiffs’ claims – including mislabeling, false advertising and RICO claims – in multidistrict litigation...

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Takeaway: When it comes to mislabeling and related claims, and especially when human safety is not implicated, express preemption under the federal Food, Drug and Cosmetic Act (FDCA) remains a powerful tool in the hands of...more

Maynard Nexsen

Health Infrastructure Security and Accountability Act: A New Era for Healthcare Cybersecurity

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In September 2024, Senators Ron Wyden (D-OR) and Mark Warner (D-VA) introduced the Health Infrastructure Security and Accountability Act, which is new legislation aimed to improve healthcare cybersecurity by imposing greater...more

Fox Rothschild LLP

Changing Landscape: Increasing Scrutiny and Regulation of Health Care Transactions Despite the California AB 3129 Veto

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California Assembly Bill 3129 (“AB 3129”) would have targeted private equity and hedge fund investment in health care entities specifically. It would have required private equity and hedge fund groups to provide 90 days...more

EDRM - Electronic Discovery Reference Model

Dario Amodei’s Essay on AI, ‘Machines of Loving Grace,’ Is Like a Breath of Fresh Air

While almost everyone is panicking about a potential robot apocalypse, Dario Amodei, the CEO and co-founder of Anthropic (“Claude”), is explaining how AI might compress 100 years of medical progress into a decade, cure mental...more

Vorys, Sater, Seymour and Pease LLP

Just Say No!  HIPAA and Requests for Reproductive Health Information

On April 22, 2024, the Office of Civil Rights issued a Final Rule titled HIPAA Privacy Rule to Support Reproductive Health Care Privacy (2024 Final Privacy Rule). Originally Published by the American Bar Association....more

Cozen O'Connor

[Event] Health Care & Life Sciences 2025 - December 5th, Philadelphia, PA

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Cozen O'Connor will host Health Care & Life Sciences 2025, our annual in-person seminar exploring critical issues impacting health care and life sciences businesses. Join attorneys and professionals from our Health Care &...more

Health Care Compliance Association (HCCA)

What is the priority?

In organizations, there are many competing priorities among different departments. Everyone may track the organization’s priorities and their individual tasks differently, i.e., through “to-do” lists, action plans, etc....more

Jackson Lewis P.C.

Conjuring Health Plan Hygiene: The Final Chapter

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As we conclude our “Health Plan Hygiene” blog series, we reflect on the important insights shared about fiduciary responsibilities under the Employee Retirement Income Security Act of 1974 (ERISA) and highlight the risk posed...more

Husch Blackwell LLP

Americans’ Growing Appetite for Risk and Shrinking Responsiveness to Potential Product Issues

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Over one-third of Americans (36%) now report that they would continue to use products even after a recall, according to recent data collected by MasterControl, a provider of quality management and manufacturing software. The...more

Health Care Compliance Association (HCCA)

BAAs: If and when third parties receiving PHI for research qualify as BAs under HIPAA

A business associate agreement (BAA) is a written contract between a covered entity (CE) and a business associate (BA) that—among other requirements—(1) establishes the permitted and required uses and disclosures of protected...more

Davidoff Hutcher & Citron LLP

Sparks Fly: The E-Bike Ban Tango in New York City Apartments

The integration of e-bikes and e-scooters into the urban fabric of New York City has raised questions about the potential risks they pose within the confines of multi-unit apartment buildings. Landlords, tasked with ensuring...more

Cozen O'Connor

Connecticut’s $39 Million Award a Bitter Bill for Pharmacy to Swallow

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Connecticut AG William Tong obtained a judgment in his favor in his office’s lawsuit against Assured Rx, LLC (“Assured”), which alleged that the pharmacy engaged in a kickback scheme in violation of state false claims and...more

Whiteford

Preparing For 2025 Stark Enforcement Regarding Compensation and Productivity Bonuses

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In 2024, Stark enforcement remains a critical focus for healthcare providers and regulatory bodies, with a continued focus on excessive compensation and productivity bonuses. Compliance with Stark Law is essential to avoid...more

Littler

UK: Menopause Awareness in the Workplace

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Menopause awareness continues to be a growing focus for employers in the UK. In light of World Menopause Day 2024, we wanted to provide a recap on the developments and updates that have been made in the space this year. ...more

Littler

Ontario, Canada: Bill 190, Working for Workers Five Act, 2024 Receives Royal Assent

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On October 28, 2024, Ontario’s Bill 190, Working for Workers Five Act, 2024 (Bill 190), received Royal Assent. Among other things, Bill 190 amends the Employment Standards Act, 2000 (ESA), Occupational Health and Safety...more

Manatt, Phelps & Phillips, LLP

How States Support Safety Net Hospitals through Innovative Funding Approaches

Key Takeaways: Importance of Safety Net Hospitals: Safety net hospitals are crucial for health equity, providing essential services to marginalized communities – including behavioral health and trauma care – despite...more

Manatt, Phelps & Phillips, LLP

Administration Proposes Rules on OTC Contraception and Utilization Management in Preventive Care

On October 21, the Departments of Health and Human Services (HHS), Labor, and the Treasury (the Departments) issued a proposed rule on permissible utilization management techniques for preventive services and the required...more

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