Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential election year, some FDA decisions (increased...more
2/27/2024
/ Artificial Intelligence ,
Baby Products ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Healthcare ,
Labeling ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Rulemaking Process
On February 8, 2024, the U.S. Department of Health and Human Services, through its Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA), released final rule (Final Rule)...more
2/15/2024
/ CARES Act ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Breach ,
HIPAA Breach Notification Rule ,
Medical Records ,
OCR ,
Patient Rights ,
Policies and Procedures ,
SAMHSA ,
Substance Abuse
On October 6, 2023, the Drug Enforcement Agency (DEA) and the Department of Health and Human Services (HHS) issued a Second Temporary Rule, further extending the ability to prescribe controlled substances via telemedicine...more
10/12/2023
/ Controlled Substances ,
Coronavirus/COVID-19 ,
DEA ,
Electronic Prescribing ,
Health Care Providers ,
Healthcare ,
Patient Access ,
Pharmacies ,
Prescription Drugs ,
Public Health Emergency ,
Telehealth ,
Telemedicine ,
Temporary Regulations