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Life Sciences Regulatory Requirements Healthcare

McDermott Will & Emery

Trending in Telehealth: July 30 – August 12, 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

McDermott Will & Emery

Trending in Telehealth: July 16 – 22, 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

McDermott Will & Emery

Trending in Telehealth: July 2 – 8, 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

McDermott Will & Emery

2024 Health Report - Government Actions Affecting Food, Drug and Medical Device Industries

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The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more

McDermott Will & Emery

International News: Spotlight on Innovation - Issue 60

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Innovation fuels business growth and ushers in success, yet it brings its own set of challenges. In our latest issue, we explore innovative products and processes including: - The EU’s new Unified Patent Court...more

McDermott Will & Emery

Trending in Telehealth: May 14 – May 20, 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

McDermott Will & Emery

Trending in Telehealth: May 7 – May 13, 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

McDermott Will & Emery

Trending in Telehealth: April 30 – May 6, 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

Quarles & Brady LLP

HHS’ Long-Awaited 340B Alternative Dispute Resolution Rule Is Finalized

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In a move long anticipated by 340B Program participants, the Department of Health and Human Services (HHS) recently published its finalized 340B Administrative Dispute Resolution (ADR) rule, establishing formal processes for...more

Robinson & Cole LLP

Health Law Diagnosis - April 2024

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Additional States Implement Notice Requirements for Healthcare Transactions - In a prior blog post, we noted the trend of states enacting legislation implementing reporting requirements for certain healthcare transactions....more

Troutman Pepper

New FDA Guidance on AI and Medical Products

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n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - March 2024

Welcome to the March edition of Akin Intelligence. This month, the EU AI Act was approved by the European Parliament, moving one step closer to becoming the first major AI law. In the U.S., the DOJ brought criminal charges...more

Epstein Becker & Green

Indiana Senate Enrolled Act 9 Requires Written Notice of Health Care Entities’ Mergers or Acquisitions

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On March 13, 2024, Indiana Governor Eric J. Holcomb signed Senate Enrolled Act No. 9 (“SEA 9”) which will amend the Indiana Code with respect to notice of health care entity mergers and acquisitions....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

Husch Blackwell LLP

Avoiding the Landmines on the Path to HealthTech Innovation

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Every year, I look forward to the SXSW Interactive Health & MedTech Track, which showcases and explores the future of healthcare technology being created by innovators, entrepreneurs, and tech enthusiasts. This year is no...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

ArentFox Schiff

Top Legal Considerations for the GCs and CFOs in the Life Sciences Industry in 2024

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The top legal issues in 2024 for the life sciences field reflect the complex and changing legal landscape that the industry is navigating, encompassing drug pricing, regulatory challenges, and broader societal and governance...more

McDermott Will & Emery

Trending in Telehealth: February 5 – 12, 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

Health Care Compliance Association (HCCA)

In This Month’s E-News: February 2024

The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...more

McDermott+

Organ Procurement and Transplantation Network: What’s Next in Oversight and Reform

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The Organ Procurement and Transplantation Network (OPTN) is a public-private partnership that manages the US organ donation and transplantation system. Today, more than 100,000 people are on the organ transplant waiting list,...more

Quarles & Brady LLP

Are You Ready for Alabama’s New Designated Representative Requirements?

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In a previous update, Quarles discussed a new Alabama law that requires individuals serving as the designated representative for an Alabama-licensed facility to register with the Alabama Board of Pharmacy ("the Board”) as of...more

Epstein Becker & Green

Warning - Transaction Delays Expected. State Notice Requirements Ahead for Health Care M&A!

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An increasing number of states are requiring advance notice of health care transactions.  These requirements may delay transactions or result in confidential information becoming accessible to the public. Effective August 1,...more

McDermott Will & Emery

Trending in Telehealth: November 8 – 14, 2023

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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

Bass, Berry & Sims PLC

Healthcare Trends & Transactions Q3 2023

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After steadying during Q2, it appears the overall volume of deals in the healthcare industry declined in Q3 compared with Q2, and year-to-date 2023 is still down from last year. A slumping economy has no doubt played a large...more

McDermott Will & Emery

Trending in Telehealth: October 24 – 31, 2023

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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

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