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
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
When conducting due diligence of an FDA-regulated company, there are several important questions that should be posed. These include questions relating to regulatory, compliance, and privacy matters. For example, questions...more
8/8/2023
/ Anti-Kickback Statute ,
Audits ,
Buyers ,
CMP Law ,
Compliance ,
Due Diligence ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
FTC Act ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Policies and Procedures ,
Privacy Laws ,
Regulatory Requirements ,
Sellers ,
Stark Law ,
Sunshine Act
Are you licensed to sell in these states?
Most U.S. states require manufacturers to register, and gain a state-issued licensure, to sell or manufacture products within state boundaries. In fact, the following states...more
7/20/2023
/ Distributors ,
Filing Requirements ,
Healthcare ,
Licenses ,
Manufacturers ,
Marketing ,
Registration Requirement ,
Regulatory Requirements ,
Sellers ,
State and Local Government ,
State Legislatures