As recent high-profile litigation, government investigations, and large-scale data-security incidents have shown, organizations are often thrust into crisis mode, requiring rapid responses and close collaboration with third...more
Last week, the U.S. Food and Drug Administration (FDA) issued two significant draft guidance documents concerning the use of artificial intelligence (AI) in medical devices and in drug and biological product development....more
1/16/2025
/ Artificial Intelligence ,
Bias ,
Biologics ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Premarket Approval Applications ,
Product Development Protocols ,
Regulatory Requirements ,
Risk Management ,
Software ,
Transparency
Investment in the healthcare industry requires careful consideration, as it involves numerous distinct areas of the law. Venable's Private Equity Investment in Healthcare webinar series explores the unique issues and timely...more
11/20/2024
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Department of Health and Human Services (HHS) ,
Department of Homeland Security (DHS) ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
New Guidance ,
OIG ,
Private Equity ,
Private Equity Firms ,
Risk Mitigation ,
Self-Referral ,
Stark Law ,
Strict Liability
On May 17, 2024, Governor Jared Polis signed into law Colorado Senate Bill 24-205 (SB205), pioneering a comprehensive regulatory framework for artificial intelligence (AI) systems....more
5/31/2024
/ Artificial Intelligence ,
Compliance ,
Enforcement Authority ,
Exemptions ,
Governor Polis ,
New Legislation ,
NIST ,
Regulatory Oversight ,
Regulatory Standards ,
Risk Management ,
Software Developers ,
State Attorneys General ,
Technology Sector ,
Unfair or Deceptive Trade Practices