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Manatt, Phelps & Phillips, LLP

CMMI Transforming Maternal Health (TMaH) Model Applications Due Soon

On June 26, the Centers for Medicare & Medicaid Services (CMS) released the Notice of Funding Opportunity (NOFO) for the Transforming Maternal Health (TMaH) Model. TMaH is ten-year delivery and payment model designed to test...more

Robinson+Cole Data Privacy + Security Insider

Lehigh Valley Health Network Settle Class Action Case for $65M

Lehigh Valley Health Network (LVHN) has agreed to settle a class action filed against it following a February 2023 ransomware attack that compromised personal information of patients, including medical and treatment...more

Manatt, Phelps & Phillips, LLP

Government Will Seek Supreme Court Review of Preventive Services Decision

On August 27, the government filed a motion indicating that it intends to seek Supreme Court review of the U.S. Court of Appeals for the Fifth Circuit’s decision in Braidwood Management v. Becerra. In June, the Fifth Circuit...more

Robinson+Cole Data Privacy + Security Insider

CMS Notifies 946,801 Medicare Recipients of Data Breach

The Centers for Medicare & Medicaid Services (CMS) and the Wisconsin Physicians Insurance Corporation have announced that 946,801 current Medicare recipients are being notified that their personal information may have been...more

Holland & Knight LLP

Holland & Knight Health Dose: September 10, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Alston & Bird

California Joins the Neural Data Bandwagon

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On August 31, the California assembly passed SB1223, which amends the CCPA/CPRA to include “neural data” as a type of sensitive data.  SB1223, which is likely to become law, defines “neural data” as “information that is...more

Cooley LLP

Artificial Intelligence/Machine Learning Medical Device Regulatory Handbook

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Even before the Biden administration issued a landmark executive order on October 30, 2023, establishing new standards for artificial intelligence (AI) safety and security, the US Food and Drug Administration (FDA) had been...more

Goldberg Segalla

National Science and Technology Council’s PFAS R&D Strategy Plan Highlights Substantial Deficiencies

Goldberg Segalla on

Recently, as part of the Joint Subcommittee on Environment, Innovation, and Public Health, the PFAS Strategy Team of the National Science and Technology Council released a report titled the “Per- and Polyfluoroalkyl...more

Knobbe Martens

FDA Approves Colony Stimulating Factor-1 Receptor (Csf-1R) Blocking Antibody for Treatment of Chronic Graft-Versus-Host Disease...

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On August 14, 2024, the U.S. Food and Drug Administration (FDA) approved a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody, NIKTIMVO (axatilimab-csfr) developed by Incyte Corporation (and in-licensed from...more

McAfee & Taft

Gavel to Gavel: OSHA turns up the heat on workplace safety

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On August 30, 2024, the Occupational Safety and Health Administration published a proposed rule to protect millions of workers from a leading cause of weather-related deaths in the United States: heat. You know, that weather...more

Cozen O'Connor

California and New York Pass Workplace Violence Laws: Is Federal OSHA Next?

Cozen O'Connor on

When CA’s Workplace Violence Prevention Law took effect on July 1, 2024, it joined a handful of other states including CT, IL, MD, MN, NJ, OR and WA with some type of similar law. On September 4, 2024, Governor Hochul signed...more

Health Care Compliance Association (HCCA)

[Webinar] The Compliance Officer's Challenge: Riding the Technological Wave in Healthcare - September 17th, 12:00 pm CT

Learning Objectives: - It's crucial to be aware of the areas where technology and AI are present in healthcare, and equally important not to overlook your EHR. A comprehensive understanding is key - Acquiring knowledge...more

Troutman Pepper

Texas AG Challenges HHS Privacy Rules

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On September 4, Texas Attorney General (AG) Ken Paxton filed a lawsuit against the Department of Health and Human Services (HHS) Office for Civil Rights (OCR), challenging two key Health Insurance Portability and...more

Mintz - Health Care Viewpoints

Texas Challenges HHS’s HIPAA Rule Protecting Reproductive Health Information from State Investigative Bodies

Last week, Texas Attorney General Ken Paxton filed a complaint in federal district court against HHS and the Office for Civil Rights (OCR) challenging a recently issued rule strengthening protection of protected health...more

Proskauer - Proskauer For Good

Pro Bono Work and the Impact of Growing Inequality

Pro bono work regularly makes a meaningful difference in people’s lives, whether by securing a favorable outcome for an individual or resolving a class action case affecting thousands. While it’s important to recognize and...more

Wilson Sonsini Goodrich & Rosati

California Passes Law Requiring Attorney General Approval for Certain Healthcare Investments and Emphasizes Requirements for...

Pre-Closing Notice or Consent: If signed by Governor Newsom, Assembly Bill 3129 (AB 3129) will mandate that, starting January 1, 2025, certain healthcare investors provide a 90-day written notice to, or obtain consent from,...more

Vicente LLP

DEA Conducts Joint Raid in Texas on Vape Shops Selling High-THC Products

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On August 27, 2024, nine vape shops operating in Allen, Texas were shut down after the Allen Police Department executed warrants in coordination with the Collin County Sheriff’s Office and the Federal Drug Enforcement...more

Baker Donelson

Health Plan Compliance Concerns for Year-End 2024

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As employers look toward open enrollment for their group health plans, now is a good time to review action items needed for those plans by year-end, as well as upcoming deadlines in the near future. While fully-insured health...more

Manatt, Phelps & Phillips, LLP

Johnson & Johnson Announces Rebate Model for Certain 340B Drugs; HRSA Pushes Back

On August 23, Johnson & Johnson (J&J) issued a written notice to disproportionate share hospitals that participate in the prescription drug discount program established under section 340B of the federal Public Health Service...more

Manatt, Phelps & Phillips, LLP

CMS Issues Guidance on Renewal Timeliness Post-Unwinding

On August 29, 2024, the Centers for Medicare & Medicaid Services (CMS) released a Center for Medicaid & Children’s Health Insurance Program (CHIP) Services (CMCS) Informational Bulletin (CIB) and an accompanying slide deck to...more

Morrison & Foerster LLP

When Your Life Sciences Are on the Line: Product Liability and Mass Torts

Morrison Foerster Investigations + White Collar Defense partner Nate Mendell, former Acting U.S. Attorney for the District of Massachusetts, hosted the fourth episode of When Your Life Sciences Are on the Line, where leading...more

Nelson Mullins Riley & Scarborough LLP

Biden Administration Finalizes Stronger Rules On Mental Health Coverage Parity

Summary: Under a final rule released by the Biden administration on Sept. 9, 2024, health insurers will be required to cover mental health care and addiction services on par with other medical conditions. This rule is part of...more

McDermott+

Biden Administration Issues Final Reg on Mental Health Parity Requirements

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Biden Administration Issues Final Reg on Mental Health Parity Requirements McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. Click here to subscribe to future blog posts....more

Bradley Arant Boult Cummings LLP

It’s Getting Hot in Here: OSHA Proposes New Heat Hazard Rules

Did you know that OSHA does not currently have a specific standard covering heat stress hazards? Rather, OSHA uses the General Duty Clause, Section 5(a)(1) of the Occupational Safety and Health Act, to impose requirements...more

Troutman Pepper

9th Circ. Clarifies ERISA Preemption for Healthcare Industry

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On May 31, the U.S. Court of Appeals for the Ninth Circuit published an opinion in Bristol SL Holdings Inc. v. Cigna Health and Life Insurance Co., which has significant implications for the healthcare industry. Originally...more

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