Join Gardner Law for a half-day CLE event in person at Loft on Two in Boston, MA or attend virtually. Industry experts will decode the intricacies of regulatory scrutiny and strategic decision-making in acquisitions. Gain...more
8/20/2024
/ Acquisitions ,
Continuing Legal Education ,
Cybersecurity ,
Data Breach ,
Department of Justice (DOJ) ,
Due Diligence ,
Events ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Loper Bright Enterprises v Raimondo ,
Mergers ,
Safe Harbors ,
Statutory Interpretation
...Innovation in connected medical devices is critical to advances in health care outcomes, user experience, and reducing costs. These exciting technologies also can be challenging when it comes to navigating the complex...more
12/5/2023
/ Artificial Intelligence ,
California Consumer Privacy Act (CCPA) ,
Connected Items ,
Cybersecurity ,
Data Collection ,
Durable Medical Equipment ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
FTC Act ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Machine Learning ,
Med Tech ,
Medical Devices ,
PHI ,
Popular ,
Privacy Laws ,
Technology Sector
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
To set the stage, it is important we review the current privacy and cybersecurity landscape. New privacy laws and regulations are emerging at both the state and federal levels, not to mention internationally, imposing...more
6/6/2023
/ Acquisitions ,
California Consumer Privacy Act (CCPA) ,
Cybersecurity ,
Data Breach ,
Data Security ,
Enforcement ,
General Data Protection Regulation (GDPR) ,
Medical Devices ,
Mergers ,
Prescription Drugs ,
Privacy Laws ,
Remediation ,
Risk Allocation ,
State Privacy Laws ,
Valuation
Join Gardner Law and colleagues live from Lord Fletcher's on Lake Minnetonka, Minnesota for a complimentary CLE event. Hear from a panel of experts on compliance, data breaches, FDA regulations, privacy, and more....more
4/24/2023
/ Acquisitions ,
Best Practices ,
Biotechnology ,
Chief Compliance Officers ,
Continuing Legal Education ,
Corporate Counsel ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Due Diligence ,
Enforcement Actions ,
Events ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Technology ,
Mergers ,
Pharmaceutical Industry ,
Third-Party Risk
Medical device cybersecurity continues to create buzz, as the FBI issues a Private Industry Notification to health care providers outlining cybersecurity risks for medical devices. This follows FDA’s released Draft Guidance...more
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
If you have been following recent privacy news, you know that the pace of new state laws has not slowed from warp speed, even with the specter of a possible federal privacy law looming. ...more
9/6/2022
/ California Consumer Privacy Act (CCPA) ,
California Privacy Rights Act (CPRA) ,
Canada ,
CDPA ,
Cybersecurity ,
Data Collection ,
Data Security ,
Enforcement ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
General Data Protection Regulation (GDPR) ,
Individual Accountability ,
Personal Information Protection Law (PIPL) ,
Privacy Laws ,
Securities and Exchange Commission (SEC) ,
State Privacy Laws ,
Transparency ,
UK GDPR