Regulatory & Compliance

How Does Martha’s Rule Transform Patient Safety in the NHS?
Research & Development How Does Martha’s Rule Transform Patient Safety in the NHS?

Martha’s Rule, named in memory of 13-year-old Martha Mills who tragically lost her life to sepsis in 2021, signifies a pivotal shift in the NHS’s approach to patient safety. This initiative empowers patients and their families by allowing them to request a second medical opinion if they feel a pat

Is Patient Consent Needed for Sharing Medical Data with AI Firms?
Tech & Innovation Is Patient Consent Needed for Sharing Medical Data with AI Firms?

The recent revelation that I-MED, Australia's largest radiology provider, shared de-identified patient data with an AI company without explicit patient consent has sparked significant controversy. This sensitive information, including X-rays and CT scans, was provided to Harrison.ai to train

Public Demand for Transparent AI Use Notification in Healthcare
Tech & Innovation Public Demand for Transparent AI Use Notification in Healthcare

The integration of artificial intelligence (AI) in healthcare is rapidly advancing, promising significant improvements in patient care and operational efficiency. Nonetheless, as this technological leap transforms medical practices, it also raises critical ethical considerations, particularly

Are Montana's New Rules Truly Closing Gaps in Hospital Oversight?
Management & Regulatory Are Montana's New Rules Truly Closing Gaps in Hospital Oversight?

In an effort to crack down on perceived inadequacies in the oversight of nonprofit hospitals’ charitable activities, the state of Montana has rolled out new rules aimed at closing long-standing gaps. This move stems from a legislative audit conducted more than four years ago, which critiqued the o

EPA and FDA's Vital Role in Public Health: Recent Regulatory Actions
Management & Regulatory EPA and FDA's Vital Role in Public Health: Recent Regulatory Actions

Imagine a world where the air we breathe, the water we drink, and the food we eat are all unchecked, teeming with unseen hazards. For many, this is a nightmarish scenario, yet it highlights the importance of regulatory bodies such as the Environmental Protection Agency (EPA) and the Food and Drug

How Will FDA's New Guidance Change AI/ML Medical Device Regulation?
Tech & Innovation How Will FDA's New Guidance Change AI/ML Medical Device Regulation?

Earlier this week, the U.S. Food and Drug Administration (FDA) unveiled its much-anticipated final guidance on predetermined change control plans (PCCPs) for devices incorporating artificial intelligence and machine learning (AI/ML) software. This guidance signifies a significant milestone in the

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