In today’s heightened enforcement environment, compliance auditing isn’t just a best practice—it’s a necessity. Federal and state laws and industry guidance, including the Office of Inspector General (OIG) Compliance Program…
more
/ Administrative Law, Health, Privacy
A HIPAA compliance assessment is an evaluation of an organization's practices, policies, and procedures to ensure that they align with requirements from the Health Insurance Portability and Accountability Act (“HIPAA”). It…
more
/ Administrative Law, Health, Privacy
Celebrity Endorsements -
As companies continue to seek effective advertising strategies, celebrity endorsements remain a powerful tool, particularly in reaching broad and receptive audiences through social media platforms…
more
/ Administrative Law, Communications & Media Law, Health
The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, seafood, poultry, meat and dairy (excluding plant-based milk, e.g. oat milk). FDA is…
more
/ Administrative Law, Consumer Protection
The Evolving Role of AI/ML in Healthcare -
The use of artificial intelligence/machine learning (AI/ML) in healthcare is evolving rapidly and introducing new challenges. Not only are medical devices using AI for diagnostics,…
more
/ Health, Intellectual Property, Science, Computers, & Technology
In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many of whom had been hired to fill roles left by retirees or to bolster the agency’s staffing during the…
more
/ Administrative Law, Labor & Employment Law, Health, Science, Computers, & Technology
Medical device, drug, food, cosmetic, and other FDA-regulated product manufacturers face the constant threat of product liability lawsuits. Claims of injuries from allegedly defective products can lead to significant financial…
more
/ Administrative Law, Consumer Protection, Health, Products Liability
On December 27, 2024, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM) to modify the HIPAA Security Rule and strengthen cybersecurity protections for electronic protected…
more
/ Administrative Law, Health, Science, Computers, & Technology
Securing FDA clearance or approval is a major accomplishment for medical device and pharmaceutical companies, but it’s not the final step. Before selling your products in most states, you must navigate state licensing…
more
/ Administrative Law, Health, Mergers & Acquisitions
Artificial intelligence already is positively affecting health, according to Mark Gardner, MBA, Esq., Founder and Managing Partner, Gardner Law, which represents clients subject to Food and Drug Administration regulations…
more
/ Administrative Law, Health, Science, Computers, & Technology
Clinical trial agreements (CTAs) form the foundation of any clinical research initiative, establishing the legal and operational framework essential for a study's success. Crafting, reviewing, and negotiating CTAs require…
more
/ Commercial Law & Contracts, Health, Intellectual Property, Science, Computers, & Technology
The clock is ticking for medical device and pharmaceutical companies to fulfill their obligations under the Physician Payments Sunshine Act (the "Sunshine Act"). With the reporting deadline of March 31 looming and CMS actively…
more
/ Administrative Law, Health
In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement certain pre-approved…
more
/ Administrative Law, Health, Science, Computers, & Technology
Artificial intelligence already is positively affecting health, according to Mark Gardner, MBA, Esq., Founder and Managing Partner, Gardner Law, which represents clients subject to Food and Drug Administration…
more
/ Administrative Law, Health, Science, Computers, & Technology
The recent announcement of the Department of Justice’s (DOJ) M&A Safe Harbor policy has significant implications for companies involved in mergers and acquisitions (M&A) within the healthcare industry. This new policy…
more
/ Antitrust & Trade Regulation, Health, Mergers & Acquisitions
