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Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 207: Long COVID Research & Treatments with Dr. Kashyap...

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This episode, we welcome back one of our favorite guests, Dr. Kashyap Patel, a renowned practicing physician, author, and healthcare thought leader. Dr. Patel has been dedicating much of his attention to analyzing long COVID...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 196: Regulation Trends in Healthcare and Certificate of...

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This week, Heather and Matthew welcome the Maynard Nexsen health care team’s newest addition, Rebecca Thornhill, an experienced health care attorney who guides clients through regulatory, transactional, and litigation...more

Manatt, Phelps & Phillips, LLP

Manatt Health: Health AI Policy Tracker

The purpose of this quarterly tracker is to identify key federal and state health AI policy activity. Below reflects federal legislative and regulatory activity to date related to AI, and state legislative activity introduced...more

Epstein Becker & Green

Last Call for Comments on Bipartisan Discussion Draft SUSTAIN Act: Shaping 340B for the Future

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Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more

Polsinelli

Florida Legislative Session 2024: Health Care Highlights

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The Florida Regular Legislative Session began on January 9, 2024, and ended on March 8, 2024. Below is a summary of relevant health care laws that will be effective July 1, 2024, if they are approved by Governor DeSantis....more

Epstein Becker & Green

Time Runs Out in the Oregon State Senate for Hb 4130, but Will Likely Return in 2025

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Oregon’s Proposed HB 4130, which passed the Oregon House of Representatives on February 22, 2024, was at the desk of the Senate president when the 82nd Legislative Assembly adjourned sine die on March 7, 2024, thereby ending...more

Mayer Brown

Private Equity in Healthcare: Increased Scrutiny from FTC, DOJ, and HHS

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Private equity acquisitions in healthcare will likely face increased scrutiny from multiple federal departments, as well as from state antitrust enforcement officials....more

Quarles & Brady LLP

Indiana Lawmakers Continue to Take Aim at Health Care Organization Mergers

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On February 27, 2024, the Indiana House of Representatives (“House”) voted to pass legislation that would call for increased scrutiny regarding mergers between health care organizations. More specifically, the implementation...more

Manatt, Phelps & Phillips, LLP

Georgia Proposes a Bill to Regulate Physician and Insurer AI Use

The health care industry, like most industries, is exploring how to reap the benefits of increasingly powerful artificial intelligence-based technologies while managing the risks they pose. Federal and state policymakers are...more

Quarles & Brady LLP

The Lower Costs More Transparency Act of 2023

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The Lower Costs More Transparency Act of 2023, passed by the House 320-71 on Monday, December 11, 2023, would institute new transparency and pricing rules on pharmacy benefit managers (PBMs) and hospitals. The bill would...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | October 2023 Recap

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

Nelson Mullins Riley & Scarborough LLP

FDA Revises Guidance Concerning Scientific Communications to HCPs about Unapproved Uses of Approved/Cleared Medical Products

The U.S. Food and Drug Administration (FDA) issued a long-awaited revised draft guidance on October 23, 2023, which focuses on communications to healthcare providers (HCPs) regarding scientific information on unapproved uses...more

McDermott Will & Emery

Investing in Healthcare & Life Sciences - An International Guide to Regulatory and Transactional Issues Across the Sector -...

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As macroeconomic forces and geopolitical dynamics continue to shape the M&A and investment climate globally, health and life sciences transactions continue to remain high priority sectors presenting both high growth and...more

Polsinelli

Proposed Regulatory Oversight on the Emerging Use of Artificial Intelligence in Digital Health

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Recent months have seen a heightened interest in artificial intelligence (“AI”)-based technology solutions. Although AI is derived from neural networks that date back to the 1940s, new technologies such as generative AI...more

Jones Day

Vital Signs: Digital Health Law Update Winter 2022

Jones Day on

Note From the Editors With 2022 well underway, the rapid pace of statutory, regulatory, policy, and industry activities in digital health continues in force. We bring you Vital Signs, a curated, one-stop resource on the most...more

Latham & Watkins LLP

European Healthcare & Life Sciences Market Update - H1 2022

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Welcome to the first edition of our European Healthcare & Life Sciences Market Update, a new report summarising key emerging trends, opportunities, and challenges facing the market in 2022. During the last 12 months, the...more

Vicente LLP

Psychedelics and Mental Health Therapy in Colorado: DORA and Potential Regulatory Response

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Recent psilocybin studies have generated significant interest due to the unparalleled positive results for individuals suffering from major depressive disorders and substance abuse disorders. In an era where once-illicit...more

Latham & Watkins LLP

A Look Ahead at the Biden Administration’s Regulatory and Enforcement Priorities

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With the new administration poised to take office, public and private companies will need to consider how President Biden’s regulatory, enforcement, and legislative priorities will affect their businesses. During this...more

Morgan Lewis

Telehealth in the United Kingdom: Considerations for Providers

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With telehealth surging around the globe due to the COVID-19 pandemic, the UK National Health Services has released guidance that provides a set of good practice principles for third-party partners to follow....more

McDermott Will & Emery

Special Report - The Future of AI Regulation: The Government as Regulator and Research & Development Participant - Part 1 of 2

Artificial intelligence (AI) systems have raised concerns in the public—some speculative and some based in contemporary experience. Some of these concerns overlap with concerns about privacy of data, some relate to the...more

Hogan Lovells

CMS Innovation Center seeks input on Oncology Care Model sequel

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In a late-night announcement on Friday, 1 November, the Center for Medicare and Medicaid Innovation (CMMI) gave cancer providers the first look at a possible sequel to the Oncology Care Model (OCM). ...more

Hogan Lovells

A bit more Sunshine: CMS proposes collecting additional information on manufacturer payments under the Open Payments program

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Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services (CMS) – among many other things, the...more

Hogan Lovells

CMS proposes changes to new-technology add-on payment amounts and criteria in the inpatient prospective payment system proposed...

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On 23 April 2019 the Centers for Medicare & Medicaid Services (CMS) issued the inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system proposed rule for fiscal year (FY) 2020...more

Hogan Lovells

Regulatory Insights for Life Sciences and Health Care Investments: Value-based purchasing

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Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product’s success or failure could cost you millions of dollars....more

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