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Health Labor & Employment

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
Manatt, Phelps & Phillips, LLP

Medicaid's Role in Empowering People with Intellectual and Developmental Disabilities

More than seven million people in the United States have an intellectual or developmental disability (I/DD), encompassing conditions like autism spectrum disorder, cerebral palsy, Down syndrome, and other developmental...more

Epstein Becker & Green

Investors, Researchers, and Business Leaders Take Note: $110M Awarded to Advance Women’s Health

Epstein Becker & Green on

On October 23, 2024, Dr. Jill Biden, first lady of the United States,  announced the winners of $110 million in awards on behalf of the Advanced Research Projects Agency for Health (ARPA-H) to accelerate transformative...more

BakerHostetler

It’s Spooky Season: HHS OCR Finalizes Two Investigations into Ransomware Incidents, Providing Nightmare Material for Acquiring...

BakerHostetler on

Before this year, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) resolved 70 breach investigations from which fines or civil monetary penalties were secured. Of those investigations, only...more

Goodwin

Accord Biopharma Announces FDA Approval of IMULDOSA (ustekinumab-srlf)

Goodwin on

​​​​​​​On October 14, 2024, Accord BioPharma, Inc. announced that the FDA has approved IMULDOSA (ustekinumab-srlf), a biosimilar to Johnson & Johnson’s STELARA (ustekinumab), indicated for the treatment of chronic...more

Littler

OSHA Issues New Inspection Guidance Targeting Animal Slaughtering and Processing Establishments

Littler on

On October 15, 2024, the U.S. Department of Labor released expanded guidance for OSHA inspections of employers in the animal slaughtering and processing industry. This guidance supersedes previous guidance issued in 2015,...more

Morris James LLP

Medical Malpractice FAQs (Updated)

Morris James LLP on

What is considered medical malpractice? Medical malpractice, also known as medical negligence, occurs when a hospital, doctor, or other health care professional fails to comply with the standard of care and causes an...more

Hogan Lovells

Getting to the point (of care): regulation for medicines manufactured at the point of care introduced before UK Parliament

Hogan Lovells on

The UK's Medicines and Healthcare products Regulatory Agency ("MHRA") has announced first-of-its-kind legislation to better facilitate the manufacture and delivery to patients of medicines that are manufactured at or near the...more

McDermott Will & Emery

Trending in Telehealth: October 14 – 21, 2024

McDermott Will & Emery on

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists, and technology companies that deliver and facilitate...more

McDermott Will & Emery

New Pharmaceutical Industry Standards Apply to the Promotion of Medicines in the United Kingdom: ABPI Code 2024 and the PMCPA...

McDermott Will & Emery on

Pharmaceutical companies promoting prescription-only medicines to health professionals and other relevant decision makers in the UK must now adhere to revised industry standards that came into operation from 1 October 2024...more

Arnall Golden Gregory LLP

The Caris MPI Decision: A Potential Turning Point in Out-of-Network Litigation Against Medicare Advantage Organizations

Nonparticipating providers have often struggled to recover fair reimbursement from vertically integrated, well-resourced Medicare Advantage Organizations (“MAOs”) through out-of-network litigation. The pattern is...more

Troutman Pepper

Precision Toxicology Agrees to Pay $27M Over Drug Testing and Kickback Allegations

Troutman Pepper on

On October 15, Maryland Attorney General Anthony G. Brown announced that his office reached a $27 million settlement with Precision Toxicology to resolve allegations that it submitted false claims to government health...more

Cooley LLP

FDA Finalizes Guidance on Use of Part 11 Electronic Systems, Records and Signatures in Clinical Investigations

Cooley LLP on

On October 1, 2024, the US Food and Drug Administration (FDA) finalized its guidance on the use of electronic records in clinical investigations of drugs, devices, biologics, foods, tobacco products and new animal drugs. The...more

McGuireWoods LLP

Recent FDA Guidance Signals Future Growth for Decentralized Clinical Trials

McGuireWoods LLP on

On Sept. 18, 2024, the U.S. Food & Drug Administration (FDA) issued a final guidance document titled “Conducting Clinical Trials With Decentralized Elements, Guidance for Industry, Investigators, and Other Interested...more

Morgan Lewis

EU High Court Allows GDPR Claims in Business Litigation, Expands Scope of ‘Health Data’ Impacting Life Sciences and Consumer...

Morgan Lewis on

The Court of Justice of the European Union (CJEU), the EU’s highest court, recently announced its significant Lindenapotheke decision, permitting companies to use the General Data Protection Regulation in business-to-business...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | September 2024 Recap

McDermott Will & Emery on

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

Morgan Lewis - Well Done

Food Safety 3.0: FDA Implements Human Foods Program Alongside Long-Awaited Reorganization

Morgan Lewis - Well Done on

On October 1, 2024, the US Food and Drug Administration (FDA) announced the implementation of its long-promised reorganization, with the establishment of the unified Human Foods Program (HFP). The HFP now oversees all FDA...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 6, October 2024

Welcome to our sixth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we take a look at the impact of AI when it comes to diverse health data, the FDA and AI medical devices, Virginia's...more

Stevens & Lee

Compare and Contrast: Key Differences Between the FTC’s Proposed Rule and Final Rule Amending Premerger Notification Requirements

Stevens & Lee on

This white paper details the significant differences between the Federal Trade Commission’s Proposed Rule and recently issued Final Rule with respect to various premerger reporting requirements under the Hart-Scott-Rodino...more

Cozen O'Connor

NJ Adopts More Transparent Prescription Drug Pricing

Cozen O'Connor on

New Jersey AG Matthew Platkin announced the adoption of new rules designed to promote greater transparency in prescription drug pricing. The new rules implement recently enacted legislation intended to control prescription...more

Constangy, Brooks, Smith & Prophete, LLP

You be the judge: Does this ADA plaintiff have a case?

Based on a real lawsuit. Names have been changed to protect the innocent. Facts may not be 100 percent accurate. PART ONE: Imagine you're the boss. You run a fast-food franchise, Flippin' Burgers. You hire Gwendolyn to...more

Holland & Hart - Employers' Lawyers

Work Absences for Fertility Treatments: Does FMLA Cover Them?

Question: We have an employee who is undergoing fertility treatments out of town and misses days sporadically. Do these absences fall under the Family and Medical Leave Act (FMLA)?...more

Stevens & Lee

FTC Voices Its Disagreement With Hospital Association in Final HSR Rule

Stevens & Lee on

In June 2023, the Federal Trade Commission (Commission) proposed major changes to its premerger notification rules that implement the Hart-Scot-Rodino Act and impact a large swath of merger and acquisition transactions each...more

King & Spalding

Medicare Finalizes Appeals Process for Reclassified Outpatient Observation Patients

King & Spalding on

On October 11, 2024, CMS issued a final rule establishing a new appeals process for Medicare beneficiaries who were initially admitted to a hospital as an inpatient but are later reclassified as an outpatient receiving...more

Saul Ewing LLP

Medical Practice Ordered to Pay HIPAA Civil Monetary Penalty Following Acquisition

Saul Ewing LLP on

In October 2024, the U.S. Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) announced the imposition of a civil monetary payment against Providence Medical Institute (“PMI”), a large medical...more

Venable LLP

Amgen Plans At-Risk Launch of EYLEA® Biosimilar Pavblu™ After Federal Circuit Lifts Temporary Injunction

Venable LLP on

On October 22, 2024, the Federal Circuit (CAFC Case No. 24-2351) denied Regeneron’s request for an injunction pending appeal for Amgen’s EYLEA® (aflibercept) biosimilar Pavblu™ (aflibercept-ayyh), concluding that “Regeneron...more

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