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Health Information Technology Policy Under the Trump Administration

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Patient engagement. Information blocking. Interoperability. These buzz words are flying around the health information technology (HIT) world as the Trump administration starts to make its mark on the HIT policy landscape....more

Sheppard Mullin Richter & Hampton LLP

The One Big Beautiful Bill Act’s Proposed Moratorium on State AI Legislation: What Healthcare Organizations Should Know

Congress is weighing a sweeping proposal that could significantly reshape how artificial intelligence (AI) is regulated across the United States. At the end of May, the United States House of Representatives passed, by a vote...more

McDermott Will & Emery

McDermott HealthEx 2025: McKinsey Key Takeaways

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McDermott HealthEx convened more than 1,300 of the most influential leaders in healthcare and life sciences. The event emphasized creativity, transformation, and growth, with sessions dedicated to innovation, AI-powered...more

Sheppard Mullin Richter & Hampton LLP

Montana Amends Law to Cover Collection and Use of Neural Data

Montana recently revised its Genetic Information Privacy Act to address neural data. The law went into effect in 2023, and applies to both entities that offer genetic testing services as well as entities that use genetic...more

Skadden, Arps, Slate, Meagher & Flom LLP

A 20-Minute Speech Provides the Clearest Road Map Yet for FDA Policy

Key Points - - Who is impacted: Manufacturers of pharmaceutical, biotechnology, medical device and food products. - What is changing: The agency is prioritizing user fee reauthorization, the MAHA initiative and a push for...more

Sheppard Mullin Richter & Hampton LLP

Guarding Against the Unknown: M&A Due Diligence of AI Companies in Data-Sensitive Sectors

M&A in the AI sector is redefining deal risk, especially when sensitive data is involved. As AI companies power breakthroughs in biotech, healthcare, defense, and critical infrastructure, the stakes for companies acquiring...more

McDermott Will & Emery

Colorado Fails to Amend Groundbreaking AI Law: What Happened and What’s Next

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On May 5, 2025, the Colorado Senate rejected an attempt by state lawmakers to amend Colorado’s landmark artificial intelligence (AI) law, known as Senate Bill (SB) 205. Colorado State Senator Robert Rodriguez and State...more

Clark Hill PLC

Right To Know - May 2025, Vol. 29

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Welcome to your monthly rundown of all things cyber, privacy, and technology, where we highlight all the happenings you may have missed. State Action: Virginia Governor Signs Bill Restricting Minor’s Use of Social Media:...more

Bradley Arant Boult Cummings LLP

Colorado’s Artificial Intelligence Act (CAIA) Updates: A Summary of CAIA’s Consumer Protections When Interacting with Artificial...

During the 2024 legislative session, the Colorado General Assembly passed Senate Bill 24-205, which is known as the Colorado Artificial Intelligence Act (CAIA). This law will take effect on February 1, 2026, and requires...more

Bradley Arant Boult Cummings LLP

DEA Proposed Rule for Special Registrations for Telemedicine and Limited State Telemedicine Registrations

On January 17, 2025, the Drug Enforcement Administration (DEA) released the proposed rule, “Special Registrations for Telemedicine and Limited State Telemedicine Registrations.” The proposed rule marks a significant first...more

White & Case LLP

Life Science Private Equity Risk

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Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more

Knobbe Martens

Boston Scientific Agrees to Acquire Sonivie Ltd. For up to $540 Million

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Boston Scientific recently announced it entered into a definitive agreement to acquire SoniVie Ltd. According to the press release, SoniVie is a privately held medical device company that developed the TIVUS Intravascular...more

McDermott Will & Emery

FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances

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Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...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

Woods Rogers

HHS Updates Its Guidance on Online Tracking Technologies – Controversy Remains

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The U.S. Department of Health and Human Services, Office of Civil Rights (OCR) recently updated its controversial, year-old guidance document on the use of online tracking technologies by healthcare providers and other...more

Sheppard Mullin Richter & Hampton LLP

Artificial Intelligence Highlights from FTC’s 2024 PrivacyCon

This is the second post in a two-part series on PrivacyCon’s key-takeaways for healthcare organizations. The first post focused on healthcare privacy issues. This post focuses on insights and considerations relating to the...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

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 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

McDermott Will & Emery

Landmark Executive Order on AI: What Does It Mean for Healthcare?

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On October 30, 2023, the White House released a long-awaited Executive Order (EO) on the “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence.” The EO acknowledges the transformative potential of AI...more

Proskauer - Health Care Law Brief

OIG Issues Final Information Blocking Enforcement Rule and Highlights the Potential for Referrals to the FTC and FCA Liability

On June 27, 2023, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) released its final rule (“Final Rule”) implementing penalties for information blocking....more

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