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Jones Day

Vital Signs: Digital Health Law Update | Winter 2024

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more

Harris Beach PLLC

New York Medical and Life Sciences: Year in Review 2023

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From pharmaceuticals to cosmetics, preemption to expert preclusion, New York state and federal courts issued decisions in 2023, which further shaped the landscape in the medical and life sciences legal world. To prepare the...more

Alston & Bird

Health Care Week in Review: Biden Administration Issued Final Rule on Fees for IDR Process Under NSA; W&M Democrats Release Report...

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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

Alston & Bird

Health Care Week in Review: House E&C Subcommittee on Health Held a Hearing on Healthcare and AI; CMS Extended the Application...

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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

Akin Gump Strauss Hauer & Feld LLP

President Biden's AI EO: Key Takeaways for Health Care & Life Sciences

Key Points - President Biden’s eagerly-awaited executive order (EO) on artificial intelligence (AI) tasks the Department of Health & Human Services (HHS) with promoting responsible AI innovation, development and use,...more

Alston & Bird

Alston & Bird Health Care Week in Review - March 2022 #3

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

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Oversight of Laboratory-Developed Tests Continues To Evolve

On August 19, 2020, the Trump administration made a major announcement that marks the latest development in the ever-evolving saga of the Food and Drug Administration’s (FDA) oversight of laboratory-developed tests (LDTs)....more

Skadden, Arps, Slate, Meagher & Flom LLP

Novartis’ $678 Million Settlement Sets Guideposts for Life Sciences Industry Speaker Programs

Novartis Pharmaceuticals Corporation (Novartis) recently entered into a civil settlement agreement with the Department of Justice (DOJ) to resolve allegations that the company paid health care practitioners (HCPs) who spoke...more

Jones Day

Vital Signs: Digital Health Law Update | Winter 2020

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NOTE FROM THE EDITORS - Welcome to the first issue of "Vital Signs"—a refreshed and reframed revival of Jones Day's Digital Health Law Update, given our long-standing commitment, experience, and leadership in digital...more

Akin Gump Strauss Hauer & Feld LLP

MedTech Update 2020: Legal and Regulatory Issues to Watch For in the Medical Technology Industry in the New Year

Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more

McDonnell Boehnen Hulbert & Berghoff LLP

United States v. Gilead Sciences, Inc.

Last month, the United States government, acting on behalf of its Department of Health and Human Services (HHS), filed suit in Delaware against Gilead Sciences, Inc. and Gilead Sciences Ireland UC for infringing four patents...more

Polsinelli

Genetic Testing Fraud Gains Concern of Congress and Multiple Government Agencies

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Since the United States Department of Health and Human Services Office of Inspector General (HHS-OIG) alerted the industry about genetic testing scams two months ago, the public, multiple government agencies, and Congress...more

Wilson Sonsini Goodrich & Rosati

Sitting Here on Capitol Hill: Congressional Developments on Life Science and Consumer Product Issues - July 2019 #2

Legislation - Consumer Product Safety: House Committee Approves Six Bills - Responding to what they claim has been a failure of the Consumer Product Safety Commission (CPSC) to act in recent years, the House Energy and...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

A&O Shearman

Cybersecurity in life sciences: what is your duty of care?

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Cybersecurity continues to be headline-grabbing news, particularly following recent reports of high-profile cyber attacks on a number of major well-known corporations. Conscious of their fiduciary duties, boardrooms of global...more

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