Laws & Regulations

How Should the US Govern AI in Healthcare?
Digital Health How Should the US Govern AI in Healthcare?

With the Department of Health and Human Services signaling a major push to accelerate artificial intelligence in healthcare, the industry is at a critical juncture. The agency's recent Request for Information (RFI) isn't just a survey; it's an invitation to co-author the future of clinical care. To

FDA Faces Deep Divide on AI Medical Device Regulation
Regulatory & Compliance FDA Faces Deep Divide on AI Medical Device Regulation

The U.S. Food and Drug Administration (FDA) finds itself navigating a complex and fractured landscape as it endeavors to craft a regulatory framework for the real-world performance of medical devices driven by artificial intelligence (AI) and machine learning (ML). Following a call for public

Can the Government Ban Gender-Affirming Care for Minors?
Regulatory & Compliance Can the Government Ban Gender-Affirming Care for Minors?

With the administration proposing new rules that could fundamentally alter the landscape of healthcare for transgender youth, we are joined by James Maitland, a leading expert in U.S. healthcare policy and regulation. These proposals aim to restrict gender-affirming care by threatening to cut

Who Should Be Responsible for Medical AI Safety?
Regulatory & Compliance Who Should Be Responsible for Medical AI Safety?

With a background in robotics and the Internet of Things, James Maitland has spent his career at the intersection of technology and medicine. He brings a unique perspective to one of the most pressing challenges in health tech today: how to regulate the powerful, ever-evolving artificial

Who Controls Your Digital Health Records?
Regulatory & Compliance Who Controls Your Digital Health Records?

In an era defined by digital transformation in healthcare, the tension between data accessibility and patient privacy has never been more acute. With the shadow of catastrophic data breaches like the one at Change Healthcare looming large, policymakers and industry leaders are urgently reassessing

Trend Analysis: Medical Recall Modernization
Regulatory & Compliance Trend Analysis: Medical Recall Modernization

A critical vulnerability in the nation's healthcare system has been exposed, with more than 3,900 medical device recalls issued in the last four years alone, placing countless patients at direct risk from the very technologies designed to heal them. The scale of this problem has been brought into

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