News & Analysis as of

Life Sciences Patients

Oberheiden P.C.

Understanding the Risks (and Costs) of Defective Abiomed Impella Heart Pumps

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Abiomed, Inc., a subsidiary of Johnson & Johnson, is facing lawsuits across the country related to the company’s Impella heart pumps. Since June of last year, the company has issued multiple recalls for these implantable...more

Arnall Golden Gregory LLP

OIG Issues Split Decision: Travel Assistance Approved, Fertility Support Under Scrutiny

On July 22, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion 24-05, evaluating two manufacturer-sponsored assistance programs under the federal Anti-Kickback...more

Arnall Golden Gregory LLP

OIG Greenlights Manufacturer’s Travel-Related Financial Assistance Offering

On June 17, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted a favorable Advisory Opinion 24-03 (“AO 24-03”) involving a pharmaceutical manufacturer’s proposed patient...more

Hogan Lovells

2024 outlook: Advancing AI innovations in patient care

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Life sciences and health care companies are heavily regulated under the rigorous standards of the U.S. Food and Drug Administration to ensure high levels of quality and patient safety. However, companies seeking to advance...more

Dentons

Ep. 4 - Ozempic, Wegovy, and the New Compliance Risks for Providers

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Diabetes and obesity drugs have skyrocketed in popularity as of late. According to a report released by Trilliant Health in September 2023, healthcare providers in the United States wrote more than 9 million prescriptions for...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 179: Obesity Effects on the Workforce & Economy with Tim...

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Recorded at SCBIO’s 2024 annual meeting, hosts Heather and Lauren welcome healthcare economist and GlobalData Director Tim Dall, who has studied the economic burden of chronic disease for over 25 years. The group discusses...more

Sheppard Mullin Richter & Hampton LLP

Digital Health to the Rescue – Improving Access to Specialized Care: A Discussion with Viveka Rydell-Anderson

The 21st-century healthcare landscape has been dramatically shaped by the rise of digitized healthcare solutions aimed at making healthcare more accessible, affordable, and personalized....more

Smart & Biggar

PMPRB publishes scoping paper for consultation on guidelines, and invites stakeholder feedback

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As we have previously reported, the Patented Medicine Prices Review Board (PMPRB) announced that it will launch the first phase of consultations on new guidelines. On November 10, 2023, the PMPRB published its Scoping Paper...more

Quarles & Brady LLP

District Court Allows for Expanded Interpretation of Eligible Patient in Impactful 340B Program Ruling

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In a decision likely to send shockwaves through the 340B Program space, the United States District Court of South Carolina recently provided a favorable ruling to 340B-participating covered entities hoping to take a more...more

Quarles & Brady LLP

HRSA Notice Provides Clarity on 340B Child Site Registration Requirements

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After months of relative uncertainty, the Health Resources and Services Administration (HRSA) published a Notice confirming the end to a COVID-19 pandemic-era flexibility that allowed unregistered child sites to utilize 340B...more

Quarles & Brady LLP

What Does Wisconsin Medical Examining Board’s New Chaperone Rule Mean for Hospitals?  Not Much.

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The new rules about chaperones for physicians in private practice (not hospitals or hospital-employed physicians) go into effect October 1, 2023. The rule is promulgated by the Medical Examining Board (MEB), which does not...more

Manatt, Phelps & Phillips, LLP

Achieving Diversity in Clinical Trials - Expanding Hospital Capacity to Offer Clinical Trials in the Community

Executive Summary - The inclusion of racial and ethnic groups in clinical trials has been a national priority for decades, but progress toward that end has been limited. When the Covid-19 pandemic threw into stark relief...more

Console and Associates, P.C.

Patients Report Extensive Injuries and Limb Loss from Potentially Unnecessary Atherectomies

As someone who cares about their health, you listen when your doctor recommends a procedure. But how can you be sure that your doctor’s suggestions are based on your own best interests rather than their own? Recent reports...more

Manatt, Phelps & Phillips, LLP

[Ongoing Program] Achieving Clinical Trial Diversity: An Overview of the Policy Landscape and Ongoing Challenges - October 12th,...

Perspectives on Life Sciences Webinar Series: Explore Key Life Sciences Issues at the Intersection of Law, Policy & Business Strategy - Although increasing representation of underserved populations in clinical trials has...more

ArentFox Schiff

Life Sciences in the Metaverse: A New Forum

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The life sciences and pharmaceutical industry is investigating potential applications in the Metaverse to reduce costs, increase efficiency, and develop novel functionalities. The Metaverse is becoming a new forum for...more

Sheppard Mullin Richter & Hampton LLP

FDA Joins Other Regulators in Focus on AI and Machine Learning

The Food and Drug Administration recently sought comments on the role of transparency for artificial intelligence and machine learning-enabled medical devices. The FDA invited comments in follow up to a recent workshop on the...more

McDermott Will & Emery

[Webinar] Life Sciences Webinar: Key Enforcement & Compliance Issues Impacting Your Business - June 17th, 1:00 pm - 2:00 pm ET

One of the few constants in the evolving government enforcement landscape is a focus on life sciences companies and their interactions and financial relationships with providers. In this final installment of our three-part...more

McDermott Will & Emery

CCPA Amendment Update: California Legislature Approves Exceptions for HIPAA De-Identified Information and Other Health Data

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On August 31, 2020, the California legislature passed California AB 713, which amends the California Consumer Privacy Act (CCPA) to except from its requirements certain health information, including information that has been...more

Robinson+Cole Health Law Diagnosis

DOJ Reaches Settlement with Patient Assistance Foundation Resolving Allegations of FCA Violations

On January 21, 2020, the Department of Justice (DOJ) announced a $3 million settlement with Patient Services, Inc. (PSI) to resolve allegations of False Claims Act (FCA) violations. The DOJ alleged that PSI enabled three...more

Manatt, Phelps & Phillips, LLP

[Webinar] Digital Health: Disruptive Technology or Just a Disruption? - October 23rd, 1:00 pm ET

The digital health market is projected to reach $536.6 billion by 2025 and transform every aspect of healthcare. Which advances hold true potential and which are just hype? Find out at a new Manatt webinar. Digital...more

Goodwin

Patients (May) Know Best: Leveraging the Patient Experience From Development to Commercialization

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With the “patient experience” becoming an increasingly important element in directing not only where industry spends its limited drug development resources but how clinical trials are designed, the U.S. Food and Drug...more

Fenwick & West Life Sciences Group

Key Digital Health Investment Trends to Watch

Our fourth annual Digital Health Summit brought together a select group of investors active in the digital health, life sciences, medical device, and healthcare industries for a one-day meeting to discuss the future of...more

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