On January 22, the New York State Legislature passed Senate Bill S929, titled the New York Health Information Privacy Act (NYHIPA), which is poised to redefine how businesses handle health and wellness-related data in and...more
2/10/2025
/ Consumer Privacy Rights ,
Data Privacy ,
Data Protection ,
Health Insurance Portability and Accountability Act (HIPAA) ,
New Legislation ,
Pending Legislation ,
Personal Data ,
PHI ,
Privacy Laws ,
Sensitive Personal Information ,
State Privacy Laws
On January 15, 2025, the Department of Health and Human Services (HHS) and Drug Enforcement Administration (DEA) issued a series of rules relating to the telemedicine prescribing of controlled substances, including a proposed...more
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products. The document clarifies how sponsors,...more
On January 7, 2025, FDA announced the availability of a final guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more
1/17/2025
/ Communication Restrictions ,
Compliance ,
Disclosure Requirements ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Devices ,
New Guidance ,
Off-Label Promotion ,
Off-Label Use ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Requirements
On November 15, 2024, the Department of Health and Human Services (HHS) and the US Drug Enforcement Agency (DEA) issued a joint regulations further extending the flexibilities that have been in place relating to prescribing...more
1/14/2025
/ Compliance ,
Controlled Substances ,
Controlled Substances Act ,
DEA ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Final Rules ,
Health Care Providers ,
Prescription Drugs ,
Telehealth ,
Telemedicine ,
Time Extensions
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
The BIOSECURE Act passed the House of Representatives on September 9, 2024, with a bipartisan vote of 306–81. It has now moved to the Senate, which has its own version of the BIOSECURE Act already in play. If passed by the...more
On May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory developed tests (LDTs), the U.S. Food and Drug Administration (FDA) published its...more
5/21/2024
/ CLIA ,
Clinical Laboratories ,
Compliance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Life Sciences ,
Medical Devices ,
Prescription Drugs ,
Regulatory Requirements
On April 29, 2024, the U.S Food and Drug Administration (FDA) announced its final rule on Laboratory Developed Tests (LDTs). This final ruling amends the FDA’s regulations to make explicit that in vitro diagnostic products...more