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Regulatory Requirements Digital Health

McDermott Will & Schulte

HHS announces information blocking enforcement “crackdown”

The US Department of Health and Human Services (HHS) announced its intent to begin actively enforcing the information blocking regulations adopted under the 21st Century Cures Act, in a press release on September 3, 2025, and...more

McDermott Will & Schulte

Trending in Telehealth: August 2025

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

Coblentz Patch Duffy & Bass

Updates to U.S. Health-Data Privacy and Wearable Tech

This year marks a pivotal shift from the era of rapid, unregulated health-tech innovation to one of stringent governance. The proliferation of wearable devices, health applications and remote monitoring tools has led to an...more

Robinson+Cole Health Law Diagnosis

OIG Shines Spotlight on Billing for Remote Patient Monitoring

On August 25, 2025, the Department of Health and Human Services Office of Inspector General (OIG) issued a new report (Report) highlighting trends in remote patient monitoring (RPM) Medicare billing, recommending stronger...more

McDermott Will & Schulte

New Illinois law updates physical therapy standards for telehealth providers

On August 15, 2025, Illinois enacted Senate Bill (SB) 2153, which became effective on the date of signature. The legislation amends the Illinois Physical Therapy Act to remove various provisions that previously limited the...more

Hogan Lovells

2025 Horizons Life Sciences and Health Care

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In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more

Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

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The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Wilson Sonsini Goodrich & Rosati

The FDA and WHOOP Debate Challenges the Line Between Wellness Products and Medical Devices

In July 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter to WHOOP, Inc. (WHOOP), asserting that the company is marketing its wearable blood pressure product, or Blood Pressure Insights (BPI), in the...more

Foley & Lardner LLP

CY 2026 Medicare PFS Proposed Rule: Telehealth Takeaways

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In July 2025, the Centers for Medicare & Medicaid Services (CMS) released the CY 2026 Medicare Physician Fee Schedule (PFS) proposed rule (the Proposed Rule), which included several proposed changes that aim to expand...more

Knobbe Martens

Cardiosense Obtains FDA Clearance for Wearable Cardiac Sensor

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Cardiovascular disease is a leading cause of death, with over 900,00 deaths reported in the United States in 2023. In this context many companies have pursued products to help diagnose or sense heart activity. In the last few...more

Morrison & Foerster LLP

A MoFo Privacy Minute: Neural Data Added to Montana’s Genetic Information Privacy Act

Question: How does Montana’s amendment to its Genetic Information Privacy Act (“GIPA”) regulate neurotechnology data, and what obligations might my business face compared to the amendments that were passed in Colorado and...more

Epstein Becker & Green

The AI Doctor Is Out? How California’s AB 489 Could Limit AI Development in Healthcare

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California’s Assembly Bill 489 (“AB 489”) signals more than just a tweak to existing healthcare law—it’s a glimpse into how the next generation of regulation may shape the future of AI development and deployment in...more

Baker Donelson

Illinois Passes Extensive Law Regulating AI in Behavioral Health

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On August 4, 2025, Illinois enacted the Wellness and Oversight for Psychological Resources Act (HB 1806) (the Act), imposing sweeping restrictions on the use of Artificial intelligence (AI) in the delivery of therapy and...more

Sheppard Mullin Richter & Hampton LLP

Telehealth and “In-Person Visits”: Tracking Federal and State Updates to Pandemic Era Telehealth Exceptions

I. Overview of Telehealth and Tele-Prescribing Landscape Since the end of the Public Health Emergency (“PHE”) exceptions in 2023, states have continued to re-evaluate the broad telehealth and tele-prescribing flexibilities...more

Orrick, Herrington & Sutcliffe LLP

Structuring Tips for Scaling: Unpacking PC-MSOs

Jeremy Sherer and Alexandra Wood offer tips on: How to establish a PC-MSO How PC-MSO considerations vary from state to state. Alexandra: What are structuring considerations for early-stage healthtech companies? Jeremy: It...more

Orrick, Herrington & Sutcliffe LLP

Will FDA’s Warning Letter to WHOOP Put a Chill on Wearables?

FDA’s Warning Letter to WHOOP, a manufacturer of cutting-edge, wellness wearable tech, has sent shivers through an industry enjoying exponential growth in the health and wellness space. “Wellness technology”, a result of the...more

Sheppard Mullin Richter & Hampton LLP

What to Watch: WHOOP Warning Letter

On July 14, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued a warning letter (the “Warning Letter”) to WHOOP, Inc. (“WHOOP”), rejecting WHOOP’s claim that its wearable “Blood Pressure Insights” product...more

Holland & Knight LLP

Podcast - Regulating AI in Healthcare: The Road Ahead

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In this episode of "Counsel That Cares," Public Policy & Regulation attorney John Vaughan, Healthcare attorney Dan Silverboard and Public Affairs Advisor Sarah Starling Crossan discuss the rapidly evolving landscape of...more

Foley & Lardner LLP

Remote Patient Monitoring (RPM) and Remote Therapeutic Monitoring (RTM): What You Need to Know About CMS’ Proposed Changes

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On July 14, 2025, the Centers for Medicare and Medicaid Services (CMS) proposed key changes to remote patient monitoring (RPM) and remote therapeutic monitoring (RTM) services reimbursed under the Medicare program. The...more

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

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