FDA’s Breakthrough Devices Program: What It Is and How It Impacts Everyday People
The U.S. Food and Drug Administration’s (FDA) Breakthrough Devices Program is a voluntary initiative designed to expedite the development, assessment,…
Category: AI Policy & Regulation
AI’s Promise and Pitfalls: Insights from Stanford Legal
A live discussion between Michelle Mello, a leading health policy expert, and Neel Guha, a JD/PhD candidate in Computer Science, highlights the…
State Legislation Leads the Way in Telehealth’s Next Chapter
Telehealth has experienced significant growth and transformation, particularly in response to the COVID-19 pandemic. This expansion has prompted various state…
First Meeting of FDA’s Digital Health Advisory Committee
The U.S. Food and Drug Administration (FDA) convened its inaugural Digital Health Advisory Committee (DHAC) meeting on November 20-21, 2024,…
Healthcare AI: FDA Urges Balance Between Progress and Patient Safety
The FDA’s role in regulating AI-based medical devices has evolved significantly since the agency first approved such a device in…
AI-Copyright Conflict in Healthcare: Barrier or Protector of Innovation?
As artificial intelligence (AI) continues to evolve, the intersection of AI development and copyright law has become a focal point…
New York State Implements New Cybersecurity Regulations For All General Hospitals
In response to escalating cyber threats targeting healthcare systems, New York State has enacted comprehensive cybersecurity regulations specifically for general…
California Mandates Disclosures for AI-Generated Patient Communications in Healthcare
California is taking a significant step toward regulating artificial intelligence (AI) in healthcare with the introduction of Assembly Bill (AB)…
California’s SB 1120: New Regulations on AI in Health Plan Utilization Review Starting January
Beginning January 1, California health care service plans and disability insurers will operate under new rules governing the use of…
Why Scrutinizing AI Vendor Security Is a Non-negotiable in Healthcare
Artificial intelligence is changing the face of healthcare, from diagnosing complex diseases to optimizing treatment plans and managing patient data.…
Understanding FDA’s Role in Regulating AI for Medical Products
New technologies are frequently hailed as transformative in healthcare, yet AI has exceeded even the loftiest expectations, emerging as a…
CMS Request Information on AI Technologies: A Call to Action for Health Innovators
The Centers for Medicare & Medicaid Services (CMS) plays a crucial role in the United States healthcare system, providing health…