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Regulatory Requirements Cybersecurity Healthcare

Jackson Lewis P.C.

Florida AHCA Proposed Rules Would Establish New Breach Reporting, Continuity Planning Requirements

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On September 17, 2025, the Florida Agency for Health Care Administration (AHCA) will hold its first public meeting to discuss proposed rules designed to enhance transparency and preparedness around health care information...more

Troutman Pepper Locke

3 Takeaways From Recent Cyberattacks On Healthcare Cos.

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Significant data breaches have affected major players in the healthcare industry in the last year, with the methods of attack being as diverse as the affected entities themselves. Originally published in Law360 - June 4,...more

Gardner Law

Cybersecurity and the FCA: Illumina Signals "No Breach" Enforcement Risks

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A $9.8 million False Claims Act (FCA) settlement between Illumina Inc. and the U.S. Department of Justice (DOJ) is unique among cybersecurity enforcement actions because it didn’t result from a data breach, but, according to...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

Health Care Compliance Association (HCCA)

‘We Cannot Do It Alone’: Cutbacks in Federal Funds, Engagement Spur Cries for HIPAA Help, New Laws

At the very top of Fisher-Titus Medical Center’s website is a link to the Change Healthcare HIPAA notice informing visitors of the last day to register for credit monitoring related to the world’s largest breach, which...more

Arnall Golden Gregory LLP

OIG Audit Finds Cybersecurity Gaps at Large Northeastern Hospital

On July 11, 2025, the U.S. Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”) posted a report that announced the findings of a cybersecurity audit it conducted of a large Northeastern...more

DLA Piper

Proposed CY 2026 Medicare Physician Fee Schedule: Key Changes Impacting the Medicare Shared Savings Program

DLA Piper on

On July 14, 2025, the Centers for Medicare and Medicaid Services (CMS) released the 2026 calendar year (CY 2026) Medicare Physician Fee Schedule (Proposed Rule). Among the many changes proposed, the Proposed Rule includes...more

Clark Hill PLC

Right To Know - July 2025, Vol. 31

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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: Texas Limits Punitive Damage Liability For Data Security Breach...more

Morrison & Foerster LLP

NIS 2: Strengthening Europe’s Cyber Defenses

European cybersecurity risk management and reporting obligations have received a substantial facelift. The Directive (EU) 2022/2555 on measures for a high common level of cybersecurity across the EU (“NIS 2”) became effective...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 6, Issue 6, June 2025

Cybersecurity and Infrastructure Security Agency (CISA), National Security Agency’s Artificial Intelligence Security Center (NSA AISC), and the FBI have issued new AI data security guidelines. These new guidelines are aimed...more

Jones Day

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 121

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This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

Clark Hill PLC

Right To Know - May 2025, Vol. 29

Clark Hill PLC on

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

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 6, Issue 3, April 2025

Welcome to our third issue of 2025 of Decoded - our technology law insights e-newsletter. We hope you enjoy this issue and thank you for reading. SEC may Reverse Proposed Cryptocurrency Custody Rule and Ohio House...more

McDermott Will & Schulte

European Health Data Space Regulation enters into force

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

J.S. Held

2025 J.S. Held Global Risk Report: Managing Cyber Risk

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Cyber incidents such as the 2024 event involving Change Healthcare, which compromised the personal information of over 100 million people, highlight the evolving nature of cyber threats – increasingly becoming risk management...more

Gardner Law

Why Compliance Audits Are Non-Negotiable

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In today’s heightened enforcement environment, compliance auditing isn’t just a best practice—it’s a necessity. Federal and state laws and industry guidance, including the Office of Inspector General (OIG) Compliance Program...more

Latham & Watkins LLP

Week 6 in Review: Tracking Moves on Healthcare, National Security, Government Contracts, and DEI

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The administration also turned its focus to copper imports, bird flu, and a proposed new path to American citizenship....more

Gardner Law

AI Regulation and Legal Trends in the U.S and Abroad

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The Evolving Role of AI/ML in Healthcare - The use of artificial intelligence/machine learning (AI/ML) in healthcare is evolving rapidly and introducing new challenges. Not only are medical devices using AI for diagnostics,...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 6, Issue 2, February 2025

Welcome to our second issue of 2025 of Decoded - our technology law insights e-newsletter. For those of you with an interest in the Corporate Transparency Act, Brienne Marco and Joe Unger report that the recent injunction...more

Polsinelli

Generative Artificial Intelligence Leveraged to Deliver Healthcare - Legal Risks and Issues

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With daily media reports citing to the explosion of interest in Artificial Intelligence (“AI”), AI start-ups have attracted a huge capital influx. During the last fiscal quarter of 2024 ending on December 31st, investors...more

Knobbe Martens

FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development

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The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more

BakerHostetler

Healthcare Industry Team 2024 Year in Review

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As we begin a year that will once again be transformative for the industry, we are excited to present our comprehensive 2024 year-in-review, highlighting all that has happened and the trends that will shape 2025. ...more

Ankura

Enhancing Cross-Border e-Discovery and Data Breach Investigations with AI

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Today’s interconnected world presents significant challenges for managing cross-border e-discovery and data breach investigations. These processes—critical for legal proceedings and cybersecurity—are often complicated by...more

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