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Regulatory Requirements Digital Health

Polsinelli

Regulatory Trend: Safeguarding Mental Health in an AI-Enabled World

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Key Takeaways: New York is the first state to enact mental health-focused statutory provisions for “AI Companions,” requiring user disclosures and suicide prevention measures for emotionally interactive AI systems....more

MoFo Life Sciences

Key Developments in MedTech M&A: Momentum Despite Macroeconomic Uncertainty

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2024 was a challenging year for M&A activity in the medical technology (“MedTech”) industry. Although some sectors experienced a rebound in deal volume, MedTech dealmakers were disproportionately affected by a difficult...more

Hogan Lovells

AI wellness or regulated medical device? A lawyer's guide to navigating FDA rules—and what could change next

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As FDA medical device lawyers advising AI and digital health companies, Hogan Lovells lawyers have had a front-row seat to an increasingly common scenario: software platforms and mobile apps that launch with the best of...more

Morgan Lewis

Navigating Uncertainty in US FDA’s Center for Devices and Radiological Health Regulation of Medical Devices

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The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and Radiological Health have seen a fluctuating workforce size, a slew of new executive...more

McGuireWoods LLP

Insights From the 21st Annual McGuireWoods Healthcare Private Equity and Finance Conference Part 5: Digital Health

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The McGuireWoods Healthcare Private Equity and Finance Conference brings together leading investors, operators and advisers to explore trends shaping the healthcare deal making landscape. With a focus on actionable insights...more

Clark Hill PLC

Beyond HIPAA: How state laws are reshaping health data compliance

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We are in an era where smartphones track sleep patterns, fitness apps monitor heart rates, and online searches reveal sensitive medical inquiries. As a result, the notion of “health data” has expanded dramatically. This...more

McDermott+

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

Epstein Becker & Green

HealthBench: Advancing the Standard for Evaluating AI in Health Care

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The Evolution of Health Care AI Benchmarking - Artificial Intelligence (AI) foundation models have demonstrated impressive performance on medical knowledge tests in recent years, with developers proudly announcing their...more

McDermott Will & Emery

Trending in Telehealth: May 2025

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Trending in Telehealth highlights monthly state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report – June 2025

This latest edition features articles on succeeding in the current life sciences funding market, strategic and legal considerations in digital health combinations, the corporate practice of medicine and guidance for...more

Gardner Law

Are FDA Review Timelines Slipping? What Companies Need to Know

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As noted in our earlier alert, the FDA continues to face mounting internal pressure, ranging from staffing reductions and document backlogs to operational restructuring. While core review functions are still running, early...more

Stikeman Elliott LLP

Ontario’s More Convenient Care Act, 2025: A New Strategy for the Healthcare Sector

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On May 5, 2025, the Ontario government introduced Bill 11, the proposed More Convenient Care Act, 2025 (“MCCA”), a legislative initiative aimed at supporting the province’s long-term healthcare goals for first reading. Bill...more

Foley & Lardner LLP

The Intersection of AI, Digital Health, and the TCPA: What You Need to Know

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Artificial intelligence (AI) is widely transforming digital health, including by automating certain patient communications. However, as health care companies consider deploying AI-driven chatbots, texting platforms, and...more

Baker Donelson

DOJ Bulk Data Rule: Key Takeaways for Healthcare and Life Sciences

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The Data Security Program (DSP), implemented by the Department of Justice's National Security Division (DOJ/NSD) under Executive Order 14117 (Preventing Access to Americans' Bulk Sensitive Personal Data and United States...more

A&O Shearman

The future of the robotics metaverse in the healthcare sector

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On 26 February 2025, the European Economic and Social Committee (EESC) adopted an opinion addressing the integration of robotics and the metaverse in healthcare. This forward-looking document outlines the opportunities and...more

Foley & Lardner LLP

HIPAA Compliance for AI in Digital Health: What Privacy Officers Need to Know

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Artificial intelligence (AI) is rapidly reshaping the digital health sector, driving advances in patient engagement, diagnostics, and operational efficiency. However, for Privacy Officers, AI’s integration into digital health...more

Hogan Lovells

Life Sciences & Health Care Horizons 2025

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Our 2025 Life Sciences and Health Care Horizons edition is now live! Explore the latest global insights from the U.S., Asia-Pacific, Europe, Latin America, and the Middle East on the key issues and emerging trends shaping the...more

Bass, Berry & Sims PLC

Healthcare Trends & Transactions Q1 2025

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The healthcare mergers and acquisitions (M&A) market began 2025 with a slower start than expected given the easing headwinds and building momentum at the end of last year, with the number of deals reported in Q1 lower than...more

Wilson Sonsini Goodrich & Rosati

Utah Enacts Mental Health Chatbot Law

On March 25, 2025, Utah Governor Spencer Cox signed HB 452, which establishes new rules for the use of artificial intelligence (AI) mental health chatbots accessible to any “Utah user,” defined as, “an individual located in...more

Pagefreezer

HIPAA Regulations & Business Associate Agreements In The Age Of Digital Collaboration

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The healthcare industry has come up against unprecedented pressure in recent years. Digital transformation has had a significant role to play when it comes to creating the efficiency needed to deal with the challenges of a...more

McDermott Will & Emery

European Health Data Space Regulation enters into force

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March 26, 2025, marked a pivotal moment in the EU with the European Health Data Space Regulation, (EU) 2025/327 (“EHDS Regulation”), coming into force. The EHDS represents a transformative initiative by the European Union...more

Epstein Becker & Green

Telehealth Cliff Averted, for Now (But September is Six Months Away)

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The potential plunge off the telehealth cliff that we warned you about in our March 3, 2025, blog post has been averted, for now....more

Ropes & Gray LLP

[Podcast] Women @ RopesTalk: Conversation with Jan Sbarbaro, Lyric

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On this episode of Women @ RopesTalk hosted by IP transactions and licensing partner Megan Baca, IP transactions partner Emily Karlberg returns for another engaging conversation, this time with Jan Sbarbaro, the chief legal &...more

Husch Blackwell LLP

Structuring the Right Deals for Growth in Life Sciences

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Innovation in life sciences isn’t just about scientific breakthroughs—it’s about making the right business decisions. Whether a company is developing AI-driven diagnostics, biotech therapies, connected medical devices, or...more

McDermott Will & Emery

Five Questions With a Health Lawyer: Stacey L. Callaghan

What is your favorite part about practicing healthcare law at McDermott? My favorite part about practicing healthcare law here at McDermott is the phenomenal team. There are thought leaders in every sub-specialty you can...more

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