News & Analysis as of

Covered Entities Regulatory Requirements

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 & Emery

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

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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

McDermott Will & Emery

This Week in 340B: January 21 – 27, 2025

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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

Baker Donelson

OCR Issues "Dear Colleagues" Letter Regarding AI in Medicine

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On May 6, 2024, OCR published the final rule interpreting and implementing Section 1557 at 45 C.F.R. § 92 (the Final Rule). The Final Rule regulates the use of patient care decision support tools, including AI algorithms for...more

McDermott Will & Emery

Section 1557 Patient Care Decision Support Tools, Anti-Discrimination Compliance: 12 Things to Consider

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In April 2024, the US Department of Health and Human Services (HHS) issued a final rule reinterpreting Section 1557 of the Affordable Care Act, which prohibits discrimination on the basis of race, color, national origin, sex,...more

Epstein Becker & Green

Recent Developments in Health Care Cybersecurity and Oversight: 2024 Wrap Up and 2025 Outlook

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As Cyberattacks targeting the health care sector have continued to intensify over the past year, including ransomware attacks that have resulted in major data breaches impacting health care organizations, the protection of...more

Sheppard Mullin Richter & Hampton LLP

HHS’ Last-Minute Holiday Gift: Proposed Changes to the HIPAA Security Rule

The U.S. Department of Health and Human Services (“HHS”) issued a Notice of Proposed Rulemaking (the “Proposed Rule”) on December 27, 2024, to significantly amend HIPAA’s Security Rule, which sets forth the security standards...more

Foley Hoag LLP - Security, Privacy and the...

HHS Office for Civil Rights Proposes Measures to Strengthen Cybersecurity in Health Care Under HIPAA

The Department of Health and Human Services (HHS) has proposed significant modifications to the HIPAA Security Rule and the HITECH Act in an attempt to strengthen cybersecurity protections for electronic protected health...more

White & Case LLP

NYDFS Releases Artificial Intelligence Cybersecurity Guidance For Covered Entities

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On October 16, 2024, the New York State Department of Financial Services (the "DFS"), under its Cybersecurity Regulation—23 NYCRR Part 500—issued a memorandum providing guidance on the risks posed by artificial intelligence...more

Health Care Compliance Association (HCCA)

Recognized Security Practices ‘Saved’ Covered Entity $60K of $300K Fine, But Which Ones Remain a Mystery

Covered entities (CEs) and business associates (BAs) may receive a “discount” for having recognized security practices (RSPs) in place when the HHS Office for Civil Rights (OCR) calculates financial penalties for Security...more

Vorys, Sater, Seymour and Pease LLP

Action Required for HIPAA Covered Entities Regarding Reproductive Health Care Compliance

On April 22, 2024, the Department of Health and Human Services (HHS) Office of Civil Rights (OCR) issued a Final Rule titled HIPAA Privacy Rule to Support Reproductive Health Care Privacy (Final Rule)....more

Eversheds Sutherland (US) LLP

AI at the gate: NYDFS issues guidance on addressing new AI-driven cybersecurity risks under existing cybersecurity requirements

On October 16, 2024, the New York State Department of Financial Services (DFS) issued an industry letter providing guidance on how DFS-regulated entities (covered entities) should be evaluating and responding to artificial...more

A&O Shearman

Cyber and AI: NYDFS has entered the chat

A&O Shearman on

On October 16, 2024, the New York Department of Financial Services (“NYDFS”) released an Industry Letter—entitled Cybersecurity Risks Arising from Artificial Intelligence and Strategies to Combat Related Risks (the “Letter”)....more

McDermott Will & Emery

NYDFS Issues Letter Highlighting Cybersecurity Risks of AI

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On October 16, 2024, the New York State Department of Financial Services (NYDFS) published a letter to covered entities that calls attention to the risks posed by artificial intelligence (AI). This non-binding guidance letter...more

Health Care Compliance Association (HCCA)

2nd Settlement Triggered by 2017 Ransomware Attack Costs WA Practice $100K; ‘Not a Breach’

Let’s review for a moment. It’s not a HIPAA violation to be a victim of ransomware. It’s not a HIPAA violation to pay a ransom. It’s up to the covered entity (CE) to determine if a security or privacy incident is a...more

Proskauer - Health Care Law Brief

Shortly After its Online Tracking Technologies Bulletin is Declared Unlawful, HHS-OCR Stands Down, Withdraws Appeal

On August 29, 2024, the Office for Civil Rights of the United States Department of Health and Human Services (“HHS-OCR”) withdrew its appeal of an order by the United States District Court for the Northern District of Texas’...more

Sheppard Mullin Richter & Hampton LLP

OHCA Proposes Amendments to its Cost and Market Impact Review Program

Only two months after California’s cost and market impact review (CMIR) regime began to require notice of certain healthcare-related transactions, the Office of Health Care Affordability (OHCA) has already proposed several...more

Seward & Kissel LLP

SEC Adopts Data Privacy Rule Amendments to Regulation S-P

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Who may be interested: Investment Companies; Investment Advisers; Broker-Dealers; Transfer Agents - The SEC adopted amendments to Regulation S-P imposing new data privacy and security requirements on broker-dealers,...more

Ward and Smith, P.A.

Navigating the National Practitioner Data Bank: A Guide for Healthcare Professionals (NPDB or Data Bank).

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Few aspects of the healthcare regulatory apparatus evoke more confusion and dread for healthcare practitioners than the National Practitioner Data Bank (NPDB or Data Bank).  Being reported to the Data Bank is often regarded...more

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