News & Analysis as of

Proposed Legislation Life Sciences

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

Jones Day

U.S. Senate Unanimously Passes Bill Limiting Number of Patents Asserted Against Biosimilar Applicants

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The Situation: Senate Bill 150 ("S.B. 150")—the Affordable Prescriptions for Patients Act of 2023—unanimously passed the Senate and would amend 35 U.S.C. § 272(e) to limit, under certain circumstances, the number of patents...more

Fenwick & West LLP

Update on the BioSecure Act

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The BioSecure Act is a bipartisan bill introduced in both the U.S. House of Representatives and Senate earlier this year that would effectively stop companies that are doing business with the U.S. government from using...more

McDermott Will & Emery

FDA Pushes to Diversify Clinical Studies, Releases Draft Industry Guidance

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On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies....more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

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...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

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Polsinelli

California’s AB 3129 Continues National Trend of Scrutinizing Private Equity Investments in the Health Care Industry

Polsinelli on

The California legislature is considering a bill that could severely impact the ability for private equity companies and hedge funds to operate in the California health care industry. AB 3129, introduced by Assembly Member...more

Foley Hoag LLP

Planning for the BIOSECURE Act

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Members from both parties in the House and Senate have introduced legislation in both houses (H.R. 7085 / S. 3558) to bar federal agencies from entering into: Contracts, loans, or grant agreements for biotechnology...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: April 2024

Arguing that the National Science Foundation (NSF) was “intricately involved” when it made a $1.125 million fixed amount subaward, Oklahoma University (OU) objected to a recent finding by auditors for the NSF Office of...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

Fenwick & West LLP

The BIOSECURE Act: Too Early to Call?

Fenwick & West LLP on

A congressional proposal to sever ties between United States and Chinese biopharmaceutical companies is far from a done deal, but its bipartisan support is a concrete reminder to consider options for supply chain...more

Quarles & Brady LLP

340B Developments in 2024 – Litigation and Legislation

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Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts....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

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

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

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

A&O Shearman

Senate Bill Introduced to Examine Bayh-Dole Reporting Requirements

A&O Shearman on

On January 10, 2024, Senators Chris Coons and Thom Tillis introduced a bill titled Improving Efficiency to Increase Competition Act (“IEICA”). The IEICA would require that the Comptroller General provide a report to certain...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

McDermott Will & Emery

Trending in Telehealth: December 14, 2023 – December 20, 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

Troutman Pepper

New Amendments and Pending Legislation Impact SEC Beneficial Ownership Reporting: What Foreign Private Issuers Need to Know

Troutman Pepper on

On November 7, the U.S. Securities and Exchange Commission (SEC) published amendments to the beneficial ownership reporting rules under Sections 13D and 13G of the Securities Exchange Act of 1934 (the Exchange Act). These...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

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