Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more
4/2/2024
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Class Action ,
Continuing Legal Education ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Events ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Health Technology ,
Healthcare Facilities ,
Healthcare Fraud ,
Labeling ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
PHI ,
Popular ,
Prescription Drugs ,
Product Defects ,
Regulatory Requirements ,
Risk Management ,
State Privacy Laws ,
Sunshine Act
Speaking at CES 2024 earlier this year, U.S. Food and Drug Administration (FDA) Commissioner Robert Califf expressed significant concerns about the FDA’s ability to effectively regulate artificial intelligence (AI) in the...more
FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more
10/5/2023
/ Anti-Kickback Statute ,
Artificial Intelligence ,
Biotechnology ,
Chief Compliance Officers ,
Compliance ,
Connected Items ,
Consent ,
Continuing Legal Education ,
Cybersecurity ,
Data Collection ,
Data Privacy ,
Data Security ,
Durable Medical Equipment ,
EU ,
Events ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Technology ,
Machine Learning ,
Medical Devices ,
Medical Technology Companies ,
Pharmaceutical Industry ,
Physicians ,
Regulatory Requirements ,
Risk Management
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
12/2/2022
/ Clinical Trials ,
Compliance ,
Continuing Legal Education ,
Cybersecurity ,
Data Protection ,
Department of Justice (DOJ) ,
Documentation ,
Draft Guidance ,
EU ,
European Data Protection Board (EDPB) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Individual Accountability ,
International Data Transfers ,
Labeling ,
Manufacturers ,
Medical Device Reports (MDRs) ,
Medical Devices ,
Park Doctrine ,
Popular ,
Public Health ,
Regulatory Violations ,
Reporting Requirements ,
Risk Management ,
Schrems I & Schrems II ,
SCOTUS ,
Separation ,
Standard Contractual Clauses ,
Transparency