In its August 2024 issue, the journal Environmental International published an article called Tampons as a Source of Exposure to Metal(loid)s. The article reports on the results of a recent study by researchers from Columbia,...more
On June 28, 2024, the Food and Drug Administration (FDA) released draft guidance for industry, titled Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies (the...more
In summer of 2023, New York City Mayor Eric Adams signed Intro. 844-A (Local Law 844-A) and amended the New York City Charter. Local Law 844-A directs Mayor Adams to establish an Office of Healthcare Accountability that will...more
In a defining moment for reproductive rights in America, the Supreme Court’s decision in Dobbs v. Jackson Women's Health Organization (2022) marked a pivotal turning point. This ruling, revoking the constitutional right to...more
A year has passed since Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA) and enhanced the Food and Drug Administration’s (FDA) authority to regulate the cosmetics industry. Although MoCRA implementation...more
1/3/2024
/ Cosmetics ,
Food and Drug Administration (FDA) ,
GAO ,
Manufacturers ,
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) ,
Product Labels ,
Regulatory Requirements ,
Reporting Requirements ,
Responsible Party ,
Risk Management ,
Serious Harm Standard
On November 13, 2023, Governor Kathy Hochul announced plans to regulate cybersecurity for New York general hospitals regulated under Article 28 of the Public Health Law. As proposed, the regulations will provide an additional...more
11/29/2023
/ Audits ,
Chief Information Security Officer (CISO) ,
Confidential Information ,
Cybersecurity ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
Incident Response Plans ,
Infrastructure ,
Medical Records ,
New York ,
PHI ,
Policies and Procedures ,
Popular ,
Proposed Regulation ,
Public Health ,
Reporting Requirements ,
Risk Assessment ,
State Health Departments ,
Vulnerability Assessments
Since the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law (see our previous blog post detailing the law here), cosmetics companies have spent the past year preparing to comply with its...more
Public Act No. 23-171: An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs (Act) took effect in Connecticut on October 1, 2023. Under the Act, a pharmaceutical manufacturer (PM) that employs...more
11/10/2023
/ Cosmetics ,
Disclosure Requirements ,
Drug Compounding ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Costs ,
Manufacturers ,
Medical Devices ,
New Legislation ,
Pharmaceutical Industry ,
Pharmacist ,
Prescription Drugs ,
Reporting Requirements ,
Trademarks
On August 21, 2023, the New York State Office of the Medicaid Inspector General (OMIG) issued updated guidance regarding its Self-Disclosure Program (Updated Guidance). In the final days of 2022, New York’s Department of...more
On August 7, 2023, the Food and Drug Administration (FDA) published Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products (the Draft Guidance), which provides much-needed...more
Since the federal No Surprises Act took effect in January 2022, many pieces of legislation have been, and continue to be, geared toward promoting price transparency in health care. One such example is seen in the momentum of...more
7/21/2023
/ Connecticut ,
Fees ,
Healthcare ,
Healthcare Facilities ,
Healthcare Reform ,
Hospitals ,
New Legislation ,
New York ,
No Surprises Act (NSA) ,
Notice Requirements ,
Regulatory Agenda ,
Regulatory Reform ,
State Legislatures ,
Telehealth
On May 3, 2023, New York joined Connecticut, Delaware, Massachusetts, Nevada, New Jersey, Oregon, Rhode Island, Washington, and California in enacting legislation that increases oversight over certain health care...more
Since the late December 2022 seismic shift in the legal landscape for cosmetic companies – when Congress passed and President Biden signed the Modernization of Cosmetics Regulation Act, or MOCRA, into law (see our prior post...more
With less than two weeks left until the end of the federal COVID-19 Public Health Emergency (PHE), which is set to expire on May 11, 2023, the Department of Health and Human Services (HHS) is preparing to transition certain...more
4/28/2023
/ Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Emergency Use Authorization (EUA) ,
Families First Coronavirus Response Act (FFCRA) ,
Food and Drug Administration (FDA) ,
Medicaid ,
Medicare ,
Public Health Emergency ,
Telehealth ,
Waivers