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Regulatory Requirements Covered Entities

Maynard Nexsen

Important Updates from the Second Public Workshop on California’s Climate Disclosure Rules

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On August 21, 2025, the California Air Resources Board (“CARB”) held its second virtual public workshop on California’s climate reporting laws, Senate Bill 253 (The Climate Corporate Data Accountability Act) and Senate Bill...more

Dentons

Ep. 75 – Back to Basics: Understanding a Patient’s Right to Request an Accounting of Disclosures

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Our Back-to-Basics series celebrates back-to-school season by taking a fresh look at some basic compliance obligations....more

Vinson & Elkins LLP

CARB Hosts Public Workshop on California Climate Laws

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The California Air Resources Board (“CARB”) hosted a public workshop on August 21, 2025 to provide information on Senate Bills 253, 261 and 219 (the “California climate laws”) and solicit feedback from consumers and...more

Paul Hastings LLP

You’ve Got Mail: NYDFS Enforcement Action Highlights Cybersecurity Risk of Over-Retention and Other Risks

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On Aug. 14, 2025, the New York Department of Financial Services (NYDFS) issued a Consent Decree announcing that Healthplex, Inc. (Healthplex) has agreed to pay a $2 million fine, as a result of an investigation into a 2021...more

BakerHostetler

Texas Passes New Law Regulating Electronic Health Records and the Use of AI by Healthcare Professionals

BakerHostetler on

On June 20, Texas enacted S.B. 1188, joining only a handful of states that are taking artificial intelligence (AI) and data offshoring restrictions into their own hands. The law applies to most healthcare providers and all...more

McDermott Will & Schulte

HRSA issues 340B rebate model pilot program guidance, requests comments

The Health Resources and Services Administration (HRSA) issued a notice announcing the application process for the 340B rebate model pilot program and requesting public comment. The notice sets the parameters of 340B rebate...more

Shipman & Goodwin LLP

340B Drug Pricing Program Is on a Slippery Slope

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On July 31, 2025, notice was published in the Federal Register by the Health Resources and Services Administration (“HRSA”) of a “340B Rebate Model Pilot Program” (“340B Pilot Program”). The 340B Pilot Program’s stated...more

Husch Blackwell LLP

Federal Court Vacates 2024 HIPAA Reproductive Health Privacy Rule: Key Impacts for Covered Entities and NPP Compliance

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On June 18, 2025, the U.S. District Court for the Northern District of Texas issued a decision in Carmen Purl, et al. v. United States Department of Health and Human Services, et al., vacating nearly all of the 2024 HIPAA...more

Benesch

Texas Joins Growing State-by-State AI Regulation in Enacting Comprehensive AI System Law

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The broad applicability of Texas’s comprehensive artificial intelligence legislation and upcoming effective date will require developers and deployers of AI systems to act quickly in ensuring compliance....more

Sheppard Mullin Richter & Hampton LLP

China Initiates Mandatory Reporting Regime for Personal Information Protection Officers

On July 18, 2025, the Cyberspace Administration of China (the “CAC”) issued the Notice on Launching the Reporting Mechanism for Personal Information Protection Officers (the “Notice ”). This development marks a significant...more

WilmerHale

Texas Enacts New AI Law

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On June 22, 2025, the Texas governor signed the Texas Responsible Artificial Intelligence Governance Act (TRAIGA or the Act) into law, making Texas the second state to pass comprehensive artificial intelligence (AI)...more

Jones Day

Legal Questions for Your Sustainability Team #1

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This series of posts seeks to identify legal questions that can add definition and value to the good work that sustainability teams are doing....more

Paul Hastings LLP

NYDFS Urges Covered Entities to Review Security Practices Amidst World Turmoil

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Citing “escalating global conflict,” the New York Department of Financial Services issued an alert on Monday, June 22, 2025, to its regulated covered entities, urging them to be vigilant against potential security threats,...more

Seyfarth Shaw LLP

Time to Revisit Your HIPAA Documents After Reproductive Health Privacy Rule Vacated

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In the wake of a recent federal District Court decision, the reproductive health care HIPAA Privacy rules finalized during the Biden Administration have been vacated and plan sponsors should re-evaluate the language included...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

Holland & Knight LLP

U.S. Health Data Affected by New National Security Restrictions on International Data Transfers

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Health Insurance Portability and Accountability Act (HIPAA)-covered entities and business associates should be familiar with restrictions on the use or disclosure of protected health information (PHI) under HIPAA rules....more

Alston & Bird

Additional Cybersecurity Requirements of NYDFS Part 500 Take Effect

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On May 1, 2025, additional enhanced cybersecurity controls required by the Second Amendment to the New York Department of Financial Services (NYDFS) Cybersecurity Regulation (23 NYCRR Part 500) (the “Second Amendment”) take...more

Porter Hedges LLP

DOJ Issues Data Security Program Compliance Guide

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On April 11, 2025, the U.S. Department of Justice’s National Security Division (NSD) issued a Compliance Guide to provide additional information to assist companies and individuals in complying with the NSD’s Data Security...more

Husch Blackwell LLP

Effective Dates Draw Near for Insurance Industry to Comply with NYDFS's Cybersecurity Rules

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As part of a multiyear rollout, the New York Department of Financial Services (NYDFS) has established May 1, 2025, and November 1, 2025, as effective dates for certain amendments to its cybersecurity regulations. These...more

Hinshaw & Culbertson - Privacy, Cyber & AI...

Are Your Cybersecurity Controls Ready for the New York State Department of Financial Services' Deadlines?

In November 2023, New York State's Department of Financial Services (NYDFS) amended its cybersecurity regulation, Part 500. This legal alert provides an update for Covered Entities and Class A Businesses on the current NYDFS...more

Davis Wright Tremaine LLP

Deadline Approaching: Covered Entities Must File Certifications of Compliance With Amended NYDFS Cyber Regulation by April 15

In November 2023, the New York Department of Financial Services (NYDFS) issued its second amendment to its "Cybersecurity Requirements for Financial Services Companies (the Cybersecurity Regulation or Part 500). This was the...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 & Schulte

This Week in 340B: March 11 – 17, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Katten Muchin Rosenman LLP

NYDFS Annual Compliance Submissions Due April 15, 2025 and New Compliance Requirements Effective on May 1, 2025

As we previously reported, in 2023 the New York State Department of Financial Services (NYDFS) amended its cybersecurity regulation, 23 NYCRR 500 (or Part 500). As of November 1, 2024, Class A Companies and Covered Entities...more

Orrick, Herrington & Sutcliffe LLP

NYDFS reminds covered entities to submit notifications by April 15

On February 27, NYDFS reminded covered entities subject to the Cybersecurity Regulation to submit their annual compliance notifications for the 2024 calendar year. Covered entities must submit the compliance filing by April...more

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