News & Analysis as of

Covered Entities Regulatory Agenda

DarrowEverett LLP

What New Administration’s Moves at EEOC, NLRB Mean for Employers

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Times they are a-changin’ … with a flurry of moves and terminations, the new administration has signaled a reverse within the federal labor and employment landscape. These changes will have significant impacts on current...more

Troutman Pepper Locke

HIPAA Security Rule Revamp Is on the Horizon

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On January 6, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published significant proposed amendments (proposed rule) to the Security Rule under the Health Insurance Portability and...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

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

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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

Troutman Pepper Locke

New York AG Adopts Final Preclearance Rule and Prepares for the NYVRA to Take Effect

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The New York Voting Rights Act‘s (NYVRA) preclearance section takes effect on September 22, 2024. The new rule requires covered jurisdictions to seek “preclearance” of certain covered policy changes to their election and...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

Shipkevich PLLC

CFPB to Begin Tracking Offenders through National Registry

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The CFPB has issued a final rule to provide transparency and track certain covered nonbank offenders. On June 3, 2024, the CFPB introduced a significant regulatory measure known as the Registry of Nonbank Covered Persons...more

Jones Day

Here We Go Again: U.S. Congress Reintroduces New Comprehensive Federal Privacy Law

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With the bipartisan, bicameral proposed American Privacy Rights Act of 2024, the U.S. Congress seeks to adopt the first national personal data privacy and security law that would preempt comprehensive state privacy laws....more

McDermott Will & Emery

NYDFS Finalizes Amendments to Cybersecurity Regulation Impacting Financial Services Companies

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On November 1, 2023, the New York Department of Financial Services (NYDFS) amended Part 500, the cybersecurity regulation. These updates follow numerous NYDFS enforcement actions and other new cybersecurity rules, such as the...more

Jenner & Block

Client Alert: New York Issues Significant Amendments to its Forward-Leaning Cyber Regulations

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In 2017, the New York Department of Financial Services (“NYDFS”) enacted a landmark regulation requiring financial services institutions such as banks and insurance companies in the state to meet substantial cybersecurity...more

Latham & Watkins LLP

President Biden’s Executive Order on Artificial Intelligence - Initial Analysis of Private Sector Implications

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The Order marks an ambitious effort to stand up a whole-of-government approach to encouraging the benefits and managing the risks of artificial intelligence, with many of its most significant private-sector implications...more

J.S. Held

Beneficial Ownership: An Overview of the FinCEN Final Rule

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On September 30, 2022, the U.S. Department of the Treasury’s Financial Crimes Enforcement Network (FinCEN) issued a final rule implementing the beneficial ownership information (BOI) reporting requirement of the Corporate...more

Sullivan & Worcester

SEC’s Proposed Changes to Regulation S-P Would Overhaul Records and Information Requirements of Covered Institutions

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On March 15, 2023, the United States Securities and Exchange Commission (“SEC”) proposed amendments to Regulation S-P that, if finalized, would place additional burdens on covered institutions when it comes to handling...more

Wyrick Robbins Yates & Ponton LLP

Any Port in a Storm? OCR Seeks Comments on HIPAA “Safe Harbor” for Recognized Security Practices

Earlier this month, HHS’s Office for Civil Rights (OCR) issued a Request for Information (RFI) seeking comments on a statutory provision adopted last year that provides a quasi-safe harbor for entities that have voluntarily...more

Mintz - Health Care Viewpoints

HIPAA Amendments and Other Trump Regulatory Actions on Hold

In the waning days of the Trump administration, the Office for Civil Rights (“OCR”) announced a number of new initiatives, including proposed HIPAA amendments, and a very recent COVID-19 related Notice of Enforcement...more

Cozen O'Connor

NYC Council Considers Legislation to End At-Will Employment in the Fast Food Industry

Cozen O'Connor on

The New York City Council has proposed additional legislation that would have a major impact on businesses falling within the broad definition of “fast food establishments” and has scheduled a hearing on the bills for...more

Troutman Pepper Locke

IRS Issues Proposed Regulations On Section 162(M)'s Executive Compensation Deductibility Cap

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On December 20, 2019, the IRS issued proposed regulations under Section 162(m) of the Internal Revenue Code....more

Polsinelli

CY 2020 OPPS Proposed Rule – HHS Seeks Comments on 340B Payment Reductions and Remedies

Polsinelli on

This past week, CMS confirmed it will continue the 2018 and 2019 underpayment policy for certain 340B covered entities unless the D.C. Court of Appeals upholds the lower court’s ruling that it is unlawful. In that case, CMS...more

McDermott Will & Emery

OCR Corrects Past Misinterpretation of HIPAA Annual Penalty Limits, Signaling Potential Relief for Entities Facing Enforcement

McDermott Will & Emery on

On April 26, 2019, the US Department of Health and Human Services (HHS), Office for Civil Rights (OCR) issued a Notification of Enforcement Discretion Regarding HIPAA Civil Money Penalties (the Notice) to inform the public...more

Robinson+Cole Health Law Diagnosis

OCR Issues Request for Information Regarding Modification of HIPAA To Promote Care Coordination and Transition to Value-Based Care

On December 14, 2018 the Department of Health & Human Services Office for Civil Rights (OCR) published a Request for Information (RFI) soliciting public input on updates to regulations promulgated under the Health Insurance...more

Sheppard Mullin Richter & Hampton LLP

OCR Seeks Ideas on HIPAA Rule Changes to Promote Value-Based Care and Coordinated Care

The Office for Civil Rights (“OCR”) issued a request for information (“RFI”) to assist OCR in identifying provisions of the Health Insurance Portability and Accountability Act (“HIPAA”) privacy and security regulations (the...more

Polsinelli

Drug Manufacturer Pricing Under the Microscope: HRSA’s 340B Civil Monetary Penalty and Drug Pricing Final Rule

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The Health Resources and Services Administration recently surprised the 340B Drug Pricing Program community with the release of its regulations pertaining to drug manufacturer ceiling price calculations and civil monetary...more

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