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
On January 3, 2023, FDA released an updated Risk Evaluation and Mitigation Strategy (REMS) for mifepristone. The updated REMS follows a December 2021 FDA announcement that it would eliminate the requirement that mifepristone...more
1/18/2023
/ Abortion ,
Dobbs v. Jackson Women’s Health Organization ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Life Sciences ,
Patient Access ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
REMS ,
Women's Rights
On January 5, 2020, President Trump signed into law H.R. 7898. This new statute amends the Health Information Technology for Economic and Clinical Health (HITECH) Act to require the Department of Health and Human Services...more
On December 10, 2020, the Department of Health and Human Services (HHS), Office for Civil Rights (OCR) issued a notice of proposed rulemaking (NPRM) to modify the Health Insurance Portability and Accountability Act (HIPAA)...more
U.S. and international health authorities continue to respond to the outbreak of the novel coronavirus (COVID-19). While originally detected in Wuhan City, Hubei Province, China, as of the date of this alert the virus has now...more
3/5/2020
/ Administrative Proceedings ,
Best Practices ,
Biologics ,
China ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
Food and Drug Administration (FDA) ,
Health and Safety ,
Infectious Diseases ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Policies and Procedures ,
Public Health ,
Risk Management ,
Supply Chain