Last week, the U.S. Cybersecurity and Infrastructure Security Agency (“CISA”) and the U.S. Food and Drug Administration (“FDA”) released warnings about an embedded function they found in the firmware of the Contec CMS8000,...more
2/13/2025
/ Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Devices ,
Patient Privacy Rights ,
PHI ,
Risk Management
With daily media reports citing to the explosion of interest in Artificial Intelligence (“AI”), AI start-ups have attracted a huge capital influx. During the last fiscal quarter of 2024 ending on December 31st, investors...more
2/6/2025
/ Artificial Intelligence ,
Compliance ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Technology ,
Healthcare ,
Innovative Technology ,
Machine Learning ,
Regulatory Requirements ,
Risk Management
Health Care is one of the most regulated industries in the country, and for many years, one of the key administrative agencies overseeing health care in the United States, the Department of Health and Human Services’ (“HHS”)...more
As discussed in our May 6, 2024, Client Alert, earlier this year FDA issued its Final Rule for the regulation of laboratory-developed tests (LDTs) that the FDA has historically treated with enforcement discretion. A week...more
FDA’s Final Rule regulating Laboratory-Developed Tests (LDTs) has been published in the Federal Register yesterday, May 6, 2024. This follows a decades-long effort by some stakeholders to clarify the regulatory status of...more
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
Last month, the FDA’s Office of Cosmetics and Colors issued a Draft Guidance encouraging tattoo ink manufacturers and distributors to recognize situations in which these products may become contaminated with microorganisms,...more
On September 1st, the Centers for Medicare & Medicaid Services (CMS) proposed a rule offering medical device manufacturers Medicare coverage upon FDA clearance or approval when their products have been designated by the U.S....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
On November 26, 2018, FDA Commissioner Scott Gottlieb, M.D. and the Director of the Center for Devices and Radiological Health, Jeff Shuren, M.D., J.D. announced FDA’s intention to take multiple actions in the near future to...more
The FDA recently published two draft guidance documents to clarify which types of medical software, based on their functionality, are no longer considered medical devices as a result of the changes imposed under section 3060...more