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Holland & Knight
U.S. Health and Human Services Office for Civil Rights Director Melanie Fontes Rainer speaks at length on the growing threat of ransomware cyberattacks upcoming rule changes and enforcement priorities.
Jones Day
The California Court of Appeal allowed the plaintiffs' negligence claim to proceed.
Goodwin Procter LLP
As we previously reported, the Judicial Panel on Multidistrict Litigation recently granted Regeneron Pharmaceutical's ("Regeneron") motion to establish a multi-district litigation ("MDL")...
Foley Hoag LLP
On April 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited favorable Advisory Opinion (AO 24-02) for a charitable...
Manatt, Phelps & Phillips LLP
On April 2, the Centers for Medicare and Medicaid Services (CMS) published the most significant set of eligibility regulations since the initial rule implementing the Affordable Care Act (ACA).
Venable LLP
On December 26, 2023, the Food and Drug Administration (FDA) issued a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements...
Foley & Lardner
The Centers for Medicare & Medicaid Services (CMS) published two significant updates to its Medicaid regulations on May 10, 2024.
Crowell & Moring LLP
In reality, HIPAA only applies to a narrow set of covered entities—health care clearinghouses, health plans, and most health care providers—as well as their business associates.
Proskauer Rose LLP
The Office for Civil Rights at the Department of Health and Human Services recently issued final regulations under the Health Insurance Portability and Accountability Act of 1996 that narrow the permitted uses and disclosures of protected health information.
Goodwin Procter LLP
Rapid advancement in life sciences technologies has made keeping up with the legal implications more important than ever. Join the Berkeley Center for Law and Technology...
Foley & Lardner
Udofa et al. provides valuable guidelines for adapting ADCs in a clinical setting, which are also useful for analyzing ADC technology and formulating effective patent strategies.
Greenberg Traurig, LLP
On May 6, 2024, the U.S. Food and Drug Administration published its anticipated final rule concerning oversight of laboratory-developed tests (LDTs).
Venable LLP
According to a May 1, 2024 press release, the high-concentration (100 mg/mL), citrate-free formulation of Boehringer Ingelheim's Cyltezo® (adalimumab-adbm) was approved by the FDA on May 1...
Sheppard Mullin Richter & Hampton
On April 4, 2024, the Centers for Medicare & Medicaid Services ("CMS") issued the contract year 2025 (CY2025) Medicare Advantage and Part D final rule (the "Final Rule").
Sheppard Mullin Richter & Hampton
First-step recommendations are: Do the basics, as in following HIPAA security-rule compliance and doing a security-risk analysis, says Carolyn Metnick, partner at Sheppard Mullin and member of their Healthcare...
Holland & Knight
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.
Goodwin Procter LLP
On April 29th, the district court for the district of New Jersey granted summary judgment for the Government in two cases, brought by BMS and Janssen, challenging the IRA's Drug Price Negotiation Program.
Arnold & Porter
On 6 May 2024, the U.S. Food and Drug Administration (FDA) published its highly anticipated final rule, revising the regulatory definition of an in vitro diagnostic (IVD) to explicitly capture IVDs manufactured by laboratories.
Sheppard Mullin Richter & Hampton
Most Medicare Advantage ("MA") beneficiaries rely on agents and brokers to help them navigate the complex process of selecting a health plan that will meet their needs.
Sheppard Mullin Richter & Hampton
In the rapidly evolving landscape of digital health, gamification has emerged as a powerful tool to enhance patient engagement and improve health outcomes.
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