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Alston & Bird

Health Care Week In Review: Biden Administration Released FY2025 Budget; Bill Introduced to Make Telehealth Permanent

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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

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Enforcement and Regulatory Updates

In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | August 2023 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for August 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more

Knobbe Martens

Venture Capitalist Funding in Medtech Increasing

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Recent reports, including one by PitchBook, indicate that both venture capitalist funding for medtech companies and the variety of medtech companies receiving venture capitalist funding has increased since the first quarter...more

Epstein Becker & Green

FDA Issues Draft Recommendations for Implementing Decentralized Clinical Trials

On May 2, 2023, the U.S. Food and Drug Administration (FDA) took additional steps to support the use of decentralized clinical trials (DCTs) by releasing a new draft guidance titled “Decentralized Clinical Trials for Drugs,...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - May 2023 #5

News Briefs - Inflation Causes Many Patients to Skip Doctors' Appointments - As prices go up generally, patients stay away from their physicians, according to federal analysts. In 2022, 28 percent of adults went without some...more

Alston & Bird

Health Care Week in Review: Congress Passes Omnibus, HHS Releases Hospital Data

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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

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 118: Matthew Roberts and Darra Coleman, Health Care...

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Hosts Matthew Roberts, Darra Coleman, and Tina Emerson sit down together for a compelling conversation about health care hot topics currently impacting the industry. They discuss everything from behavioral health issues and...more

Alston & Bird

Alston & Bird Health Care Week in Review - May 2022 #1

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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

Knobbe Martens

Pfizer Australia Announces Deal to Acquire ResApp Health

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ResApp Health recently announced its planned sale to Pfizer Australia, a wholly owned subsidiary of Pfizer Inc. Pfizer agrees it would acquire 100% of the shares for AUD $0.115 / share, for a total equity value of...more

Goodwin

DOJ False Claims Act Recoveries Exceed $5.6 Billion in 2021

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The U.S. Department of Justice (“DOJ”) recently announced that over $5.6 billion in False Claims Act (“FCA”) settlements and judgments had been reached during the 2021 fiscal year, with over $5 billion of those settlements...more

Morgan Lewis

Digital Health Trends to Watch in 2022

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In the digital health market, new trends reveal future opportunities for innovators and shape healthcare investors’ strategies. Trends for 2022 include regulatory developments regarding digital health, telehealth expansion,...more

Fenwick & West Life Sciences Group

Economic Conditions Changing, but Digital Health Still Strong

The digital health sector emerged as a juggernaut during the COVID-19 pandemic, with almost $15 billion invested in privately-held digital health companies in 2020 and nearly $30 billion invested last year, according to our...more

Mintz - Health Care Viewpoints

Health Care Enforcement Year In Review & 2022 Outlook

STATISTICAL TRENDS IN FALSE CLAIMS ACT LITIGATION - FCA case activity for 2021 reveals seemingly contrary trends. For the federal fiscal year (FY) that ended September 30, 2021, the DOJ annual report on FCA enforcement...more

Smart & Biggar

New CADTH Report on Health Technology Trends in 2021

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The Canadian Agency for Drugs and Technologies in Health (CADTH) published an interesting new report on January 29, 2021 about Health Technology Trends to Watch. The report identifies the following list of emerging trends...more

McDermott Will & Emery

HHS Finalizes Sweeping Changes to Stark Law, Anti-Kickback Statute Regulations

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On November 20, 2020, the US Department of Health and Human Services (HHS) released final rules amending the regulations to the physician self-referral law (Stark Law) (Stark Rule) and the Anti-Kickback Statute (AKS) and...more

Wilson Sonsini Goodrich & Rosati

Digital Health Report - Q4 2020

In this issue, we discuss how real-world evidence can be an important component of satisfying drug approval and post-approval study requirements and also, can provide other tangible advantages to drug sponsors. We also look...more

Mayer Brown Free Writings + Perspectives

Healthcare Financing Trends

CBInsights recently hosted a webcast, The State of Healthcare Q2 2020. Capital raising by companies in the global healthcare sector yielded a historic high of $18.1 billion in the second quarter of 2020, and deal volume rose...more

Jones Day

Vital Signs: Digital Health Law Update | Summer 2020

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Note From the Editors - With this Summer 2020 issue of Vital Signs, we take a moment to again applaud the remarkable actions of all the health care and life science organizations around the globe working tirelessly on our...more

Hogan Lovells

Helping companies navigate the COVID-19 pandemic

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Our Medical Device and Technology team has been at the forefront of the COVID-19 legal response since the pandemic swept across the globe. In just a few short months, our team has taken on nearly 200 matters, ranging from...more

Jones Day

JONES DAY PRESENTS® Digital Health: Current Trends and Legal Issues

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The adoption of digital health technologies introduces a new range of efficiencies for health care delivery and marks a significant breakthrough in research and development capabilities for the life sciences industry. Jones...more

Stinson LLP

FDA Allows Modification of Certain Ophthalmic Devices, Expanding Use for Telehealth and Remote Assessment

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In the ongoing effort to reduce in-person contact and exposure during the coronavirus pandemic, this week FDA released the guidance document "Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During...more

Wilson Sonsini Goodrich & Rosati

The Cares Act Brings Changes for Drug and Medical Device Oversight and New Options for Telehealth Services

On March 27, 2020, President Trump signed Public Law 116-136, the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act), the federal government's latest and most ambitious response to the COVID-19 crisis. As yet,...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

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We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

Downs Rachlin Martin PLLC

Vermont Health Care Update 02-17-2020 - An analysis from DRM's Health Law Team

Push to end surprise medical billing - The Senate Finance Committee heard from providers and health insurers on S.309, a bill that prohibits certain provisions in contracts between health insurers and health care...more

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