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Oberheiden P.C.

Insulin Overpricing Lawsuits: 6 Things to Know

Oberheiden P.C. on

Anyone who needs insulin to treat diabetes knows that the cost of the drug has skyrocketed in the last few years. The reason for the sharp increase seems to be simple: corporate greed. Recently, though, the high price of...more

Fenwick & West LLP

Key Takeaways from Digital Health Counsel 2024 AI Summit

Fenwick & West LLP on

Walking away from Digital Health Counsel 2024 AI Summit, the stunning impact that AI and data-powered innovation are making on healthcare is undeniable. Organized by Ogden Murphy Wallace and sponsored by Fenwick, the summit...more

Fish & Richardson

Women’s Health Tech Entrepreneurs Combat Period Poverty and Increase Representation at the USPTO

Fish & Richardson on

Roughly half the world’s population menstruates at some point in their lives. While menstruation is essential for human life and a critical indicator of health, it is plagued with stigma. Around the world people who...more

Smith Anderson

Update on Regulatory Relief for North Carolina Long-Term Care Facilities After Hurricane Helene

Smith Anderson on

The North Carolina Division of Health Service Regulation (“DHSR”) has issued guidance to Adult Care Home (ACH), Family Care Home (FCH), and Skilled Nursing Facility (SNF) providers regarding temporary waivers or modification...more

Epstein Becker & Green

Unpacking Averages: CDRH Recognition of Consensus Standards Appears to Overlook Software

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For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical device submissions....more

Hinckley Allen

Massachusetts’ Highest Court Issues Landmark Decision Dismissing Wiretap Class Action Based Upon Website Tracking Tools

Hinckley Allen on

In a long-awaited decision affecting the scope of privacy protections in Massachusetts, on October 24, 2024, the Massachusetts Supreme Judicial Court (“SJC”) held that collecting and transmitting user browsing activities,...more

Foley & Lardner LLP

Medicare Overpayments: CMS Issues Final Regulations Implementing Changes to 60-day Refund Rule

Foley & Lardner LLP on

On Friday, November 1, 2024, the Center for Medicare & Medicaid Services (CMS) issued the display copy of the final rule interpreting the 60-day Refund Rule for Medicare Parts A/B (Traditional Medicare) and C/D (Medicare...more

Ropes & Gray LLP

Hospital and Health Systems Reimbursement Check - NOVEMBER 2024

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Ropes & Gray attorneys share their analysis of administrative and court litigation, regulatory developments, key developments affecting federal program payments to hospitals and health systems, and other reimbursement-related...more

Goodwin

New Momentum for a Time-Limited Conditional Approval Pathway for Rare Disease Drugs

Goodwin on

On October 4, 2024, a US House version of the revised Promising Pathway Act (PPA) 2.0 was introduced, sponsored by Rep. Bruce Westerman (R-AR). ...more

Patrick Malone & Associates P.C. | DC Injury...

Better Health Care Newsletter - November 2024

For decades, the U.S. Surgeon General has shined a light on hazards to the health of Americans, both for individuals and society at large. The beacons have worked to persuade lots of people to improve health habits....more

Foley Hoag LLP - Cannabis and the Law

ALJ Hearing on Rescheduling Faces Delay Over Witness Standing

The U.S. Drug Enforcement Administration (DEA) is facing a minor delay in a crucial hearing initially scheduled for December 2, 2024, regarding the rescheduling of cannabis under federal law. Chief Administrative Law Judge...more

Sheppard Mullin Richter & Hampton LLP

CMS Continues to Plan AHEAD Amid Rising Healthcare Costs

On October 28, 2024, the Centers for Medicare & Medicaid Services (“CMS”) announced the latest states to participate in the voluntary state total cost of care (“TCOC”) model: the All-Payer Health Equity Approaches and...more

Ropes & Gray LLP

DOJ Issues Notice of Proposed Rulemaking to Restrict Flow of Bulk Sensitive Personal Data to China and other Countries of Concern

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On October 29, 2024, the Department of Justice (“DOJ”) published its Notice of Proposed Rulemaking (“NPRM”) to implement President Biden’s Executive Order 14117, “Preventing Access to Americans’ Bulk Sensitive Personal Data...more

Perkins Coie

FDA Human Foods Priority Deliverables for FY 2025

Perkins Coie on

On October 30, 2024, the U.S. Food and Drug Administration’s (FDA) newly minted Human Foods Program (HFP) published a list of priority deliverables for Fiscal Year 2025.  By way of brief background, FDA designed the HFP to...more

Robins Kaplan LLP

Exeltis USA, Inc. v. Lupin Ltd. - Slynd® (drospirenone)

Robins Kaplan LLP on

Case Name: Exeltis USA, Inc. v. Lupin Ltd., Civ. No. 22-434-RGA, 2024 WL 4040470 (D. Del. Sept. 4, 2024) (Andrews, J.)....more

Foley & Lardner LLP

New HCPCS for Advanced Primary Care Management

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The Center for Medicare & Medicaid Services (CMS) issued the display copy of the final Calendar Year 2025 Physician Fee Schedule on November 1, 2024, which included three new Healthcare Common Procedure Coding System (HCPCS)...more

Foley & Lardner LLP

Cancer Drugs: Clinical Trial Issues for Antibody Drug Conjugates (ADCs)/Antibody Therapeutics

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Antibody Drug Conjugates (ADCs) are a class of small molecule drugs (also known as a payload) and an antibody conjugated together by a chemical linker. ADCs are designed to target specific cells, such as cancer cells, while...more

McDermott Will & Emery

New Fact Sheet Highlights ASTP’s Concerns About Certified API Practices

McDermott Will & Emery on

On October 29, 2024, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy (ASTP) released a fact sheet titled “Information Blocking Reminders Related to API Technology.” The fact...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 213: AI Transformations in Life Sciences and Beyond with...

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Recorded at NC Life Sciences Organization’s Annual Meeting, Heather and Matthew welcome Igor Jablokov, an entrepreneur, former IBM director, and pioneer of the artificial intelligence industry who has been involved in several...more

Jackson Lewis P.C.

Massachusetts’ Earned Sick Time Law Now Covers Pregnancy Loss: What Employers Need to Know

Jackson Lewis P.C. on

As of Nov. 21, 2024, Massachusetts employees may use earned sick time to address physical and mental health needs following a pregnancy loss or failed assisted reproduction, adoption, or surrogacy under an amendment to the...more

Holland & Knight LLP

The Evolving Landscape of Behavioral Health Transactions: Insights from Industry Professionals

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In this episode of "Counsel That Cares," healthcare attorney John Arnold and Erika Haanpaa, a managing director at Cain Brothers, discuss mergers and acquisitions (M&A) trends in the behavioral health industry. Mr. Arnold and...more

Ius Laboris

Things Are Hotting Up: Wildfires in Brazil and the Law in Brazil and Elsewhere

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Wildfires in Brazil have been a recurring and worrying phenomenon since 2022, with devastating impacts. The fires have impacted the environment, biodiversity, farming, cattle ranching, and human health as a whole,...more

Weber Gallagher Simpson Stapleton Fires &...

Understanding Senate Bill 365: Expanded Workers’ Comp Benefits for First Responders’ PTSD

In a bi-partisan effort, both Pennsylvania legislative houses and the Pennsylvania Governor have come together to lower the burden of proof for our Commonwealth’s first responders, when those men and women have witnessed a...more

Goodwin

Four Steps to Maximize AI Innovation in Medtech

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Investment in artificial intelligence (AI) is rising fast. The International Data Corporation projects global spending on AI R&D will reach $632 billion by 2028, more than twice the expected total for 2024....more

Foley Hoag LLP - Cannabis and the Law

A Trip Into the Fine Print of Ballot Question 4: MA’s Proposal to Legalize Certain Natural Psychedelic Substances

With election day less than 24 hours away, we wanted to provide a primer on Massachusetts Ballot Question 4, which, if you believe recent voter polls, may soon make the Commonwealth just the second state in the nation to...more

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