Regulatory & Compliance

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

Virginia Urology Silent on Massive Data Breach
Regulatory & Compliance Virginia Urology Silent on Massive Data Breach

A significant data breach has allegedly compromised the highly sensitive personal and medical information of countless patients at Virginia Urology, a major Richmond-based medical practice, yet the organization has remained completely unresponsive to all inquiries. This profound silence creates a

FDA and CMS Fast-Track Digital Health for Medicare
Regulatory & Compliance FDA and CMS Fast-Track Digital Health for Medicare

Bridging the Gap How Federal Agencies are Revolutionizing Digital Health Adoption A groundbreaking collaboration between the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) is set to reshape the digital health landscape for millions of Americans. By

Does Epic's Data Monopoly Harm Healthcare?
Regulatory & Compliance Does Epic's Data Monopoly Harm Healthcare?

In an era where personal health information is one of the most valuable digital assets, the question of who controls this data has become a critical battleground for innovation, competition, and patient rights. The immense power wielded by the companies that create and manage electronic health

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