Are you responsible for privacy compliance at your company? Sharpen your pencils and grab your highlighters for this three-part series on critical privacy laws, DPOs and privacy officers (and when you should appoint one), and...more
5/24/2024
/ Chief Information Security Officer (CISO) ,
Chief Privacy Officer ,
Consent ,
Data Privacy ,
Data Protection ,
Data Protection Officers (DPOs) ,
Electronic Protected Health Information (ePHI) ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
PHI ,
Popular ,
Privacy Laws ,
Privacy Policy ,
Webinars ,
Websites
Are you responsible for privacy compliance at your company? Sharpen your pencils and grab your highlighters for this three-part series on critical privacy laws, DPOs and privacy officers (and when you should appoint one), and...more
5/24/2024
/ Chief Information Security Officer (CISO) ,
Chief Privacy Officer ,
Consent ,
Data Privacy ,
Data Protection ,
Data Protection Officers (DPOs) ,
Electronic Protected Health Information (ePHI) ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
PHI ,
Popular ,
Privacy Laws ,
Privacy Policy ,
Webinars ,
Websites
Are you responsible for privacy compliance at your company? Sharpen your pencils and grab your highlighters for this three-part series on critical privacy laws, DPOs and privacy officers (and when you should appoint one), and...more
5/23/2024
/ Chief Information Security Officer (CISO) ,
Chief Privacy Officer ,
Consent ,
Data Privacy ,
Data Protection ,
Data Protection Officers (DPOs) ,
Electronic Protected Health Information (ePHI) ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
PHI ,
Popular ,
Privacy Laws ,
Privacy Policy ,
Webinars ,
Websites
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
...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
The Washington My Health My Data Act ("MHMDA") may not have been written by Earth, Wind, & Fire, but it is certainly poised to make medical device and pharmaceutical manufacturers move to a new beat like a classic disco hit....more
6/14/2023
/ Consent ,
Data Security ,
Enforcement ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Manufacturers ,
Medical Devices ,
Prescription Drugs ,
Privacy Laws ,
Washington
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
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