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Dentons

Ep. 34 – Implementing Changes to Part 2 Regulations Governing Substance Use Disorder Records

Dentons on

On March 27, 2020, Congress enacted the Coronavirus Aid, Relief & Economic Security Act (CARES Act) which included provisions requiring the U.S. Department of Health & Human Services (“HHS”) to better align the federal...more

TNG Consulting

Tip of the Week: BIT Standards for Higher Education – Standard 9 

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In this series, we continue to explore the updated NABITA Industry Standards for Behavioral Intervention Teams. These standards offer proactive guidance to BITs in developing effective approaches for preventing harm and...more

Epstein Becker & Green

OCR Withdraws Appeal of District Court Order Declaring Unlawful and Vacating the “Proscribed Combination” Portion of Its HIPAA...

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On March 18, 2024, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued updated guidance regarding the use of online tracking technologies by entities and business associates subject to...more

Baker Donelson

Temporary Regulatory Relief for South Carolina Health Care Providers Responding to Hurricane Helene

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South Carolina Governor Henry McMaster declared a State of Emergency on September 25, 2024, to prepare for Hurricane Helene. On September 29, 2024, the Federal Emergency Management Agency (FEMA) issued a Federal Major...more

Robinson+Cole Health Law Diagnosis

Middle District of Florida Judge Finds False Claims Act’s Qui Tam Provision Unconstitutional

On September 30, 2024, Judge Kathryn Kimball Mizelle of the U.S. District Court for the Middle District of Florida issued an order in United States ex rel. Clarissa Zafirov v. Florida Medical Associates, LLC, holding that the...more

Littler

Massachusetts Expands Reasons for Use of Earned Sick Time

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The Massachusetts legislature has expanded the reasons employees can use Massachusetts Earned Sick Time through provisions in a larger bill entitled, “An Act Promoting Access to Midwifery Care and Out-of-Hospital Birth...more

Sheppard Mullin Richter & Hampton LLP

Women’s Health on the Ballot in November: What the Election Could Mean for Reproductive Care and Beyond

Over two years into the post-Dobbs era, women’s health is taking center stage in the presidential election. In Dobbs v. Jackson, the Supreme Court overturned protections relating to abortion established in Roe v. Wade. Since...more

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q3 2024

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The third quarter of this year brought numerous high-dollar False Claims Act (FCA) settlements involving a variety of industries and alleged conduct. Below are noteworthy resolutions that reflect recent enforcement trends....more

Sheppard Mullin Richter & Hampton LLP

CFPB Issues Guidelines for Medical Debt Collection

On October 1, the CFPB issued an advisory opinion highlighting that debt collectors engaging in certain practices with respect to the collection of medical debts are strictly liable under the FDCPA and Regulation F....more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | August 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for August 2024. We discuss several enforcement actions pertaining to healthcare fraud, including alleged violations under the False...more

Hogan Lovells

Rare pediatric disease Priority Review Voucher program renewed through Dec. 20

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U.S. President Biden signed a bill last Thursday postponing the sunset date of the rare pediatric disease Priority Review Voucher (PRV) program from September 30, 2024, to December 20, 2024. The bill, the “Continuing...more

Robinson+Cole Data Privacy + Security Insider

OCR Settles Fourth Ransomware Investigation

The Office for Civil Rights of the Department of Health and Human Services (OCR) announced on September 26, 2024, that it had entered a settlement with Cascade Eye and Skin Centers (together, Cascade) for $250,000 following...more

Alston & Bird

Health Care Week in Review: HHS Released Final Guidance for the Second Cycle of Medicare Drug Price Negotiations; CMS Released...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

J.S. Held

Inside the Healthcare Industry: The Impact of Human Factors & User Experience in Healthcare

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Human Factors and User Experience testing play an important role in healthcare settings and in the development of healthcare products. They can greatly impact the delivery of care, and the patient experience delivered by...more

Morgan Lewis - As Prescribed

Are PDABs Pushing the Limit Drug Pricing Complexities Collide with Implementation

In response to rising prescription costs and overall state-level healthcare spending, numerous states, including Maryland and Oregon, have established prescription drug affordability review boards (PDABs) to review certain...more

Wilson Sonsini Goodrich & Rosati

California Governor Gavin Newsom Vetoes Law Requiring Attorney General Approval for Certain Healthcare Investments

Last weekend, California Governor Gavin Newsom vetoed Assembly Bill (AB) 3129, which would have required healthcare investors to notify and obtain written consent from the California Attorney General (AG) before investing in...more

Ankura

Navigating the Fallout: Essential Insights for Healthcare Companies in Light of the Change Healthcare Cyber Breach

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The cyber breach at Change Healthcare in 2024 stands out as one of the most significant cyber-attacks in recent memory. Its repercussions extend far beyond immediate industry disruptions, resonating deeply in regulatory...more

ArentFox Schiff

Investigations Newsletter: Florida Federal Judge Strikes Down FCA’s Qui Tam Provision as Unconstitutional

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Florida Federal Judge Strikes Down FCA’s Qui Tam Provision as Unconstitutional - On September 30, US District Judge Kathryn Kimball Mizelle of the Middle District of Florida held in a historic decision that the federal...more

Lippes Mathias LLP

The Proposed OSHA Heat Standard: Key Changes and Responsibilities for Employers

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Recently, the Occupational Safety and Health Administration (OSHA) officially published its long-awaited rule proposal to establish a workplace heat standard to address a leading cause of weather-related deaths in the U.S....more

Littler

Pittsburgh Ordinance Bans Tests for Many Prospective and Current Employees Who Use Medical Marijuana

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On September 24, 2024, the Pittsburgh City Council passed a new ordinance prohibiting discrimination against an individual’s status as a medical marijuana patient. Mayor Ed Gainey signed the ordinance the same day, making it...more

Epstein Becker & Green

As the Window for Comments Closes on ONC/ASTP’s HTI-2 Proposed Rule: What’s in HTI-2 and What Does It Mean for You?

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On August 5, 2024, the Office of the National Coordinator for Health Information Technology— now known as the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (“ASTP/ONC”) within the...more

DLA Piper

California Governor Vetoes Further Legislative Efforts to Restrict Healthcare Investments and Management Relationships

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On September 28, 2024, California Governor Gavin Newsom vetoed AB 3129, which would have required qualifying private equity groups, hedge funds, and any associated portfolio companies to notify and obtain written consent from...more

DLA Piper

California Implements New AI and Software Regulations for Insurers

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On September 28, 2024, California enacted SB 1120, which regulates the use of artificial intelligence (AI), an algorithm, or “other software tool” in utilization review and utilization management (UR/UM) functions by...more

Fisher Phillips

California’s Healthcare Minimum Wage Increase Is Finally Here: What Employers Need to Know + 3 Steps You Should Take Now

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After months of delay, California’s healthcare minimum wage increase will finally take effect on October 16, immediately hiking wages to $21 per hour for workers at many healthcare facilities and as high as $23 per hour for...more

Orrick, Herrington & Sutcliffe LLP

U.S. States Begin Regulating Generative Artificial Intelligence in Health Care

The health care industry has utilized artificial intelligence for decades, but the recent expansion of AI’s capabilities into generative AI models is raising questions about how and to what extent to regulate the technology....more

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