“The European Commission has shown its ambition in the area of artificial intelligence (AI) in its recent White Paper on Artificial Intelligence – a European approach to excellence and trust. This White Paper is at the same time a precursor of possible legislation of AI in products and services in the European Union. However, COCIR sees no need for novel regulatory frameworks for AI-based devices in Healthcare, because the requirements of EU MDR and EU IVDR in combination with GDPR are adequate to ensure that same excellence and trust.” (COCIR paper).
“This book provides a thorough overview of the ongoing evolution in the application of artificial intelligence (AI) within healthcare and radiology, enabling readers to gain a deeper insight into the technological background of AI and the impacts of new and emerging technologies on medical imaging”.
The objective of this guideline is to provide medical device manufacturers and notified bodies instructions and to provide them with a concrete checklist to understand what the expectations of the notified bodies are, to promote step-by-step implementation of safety of medical devices, that implement artificial intelligence methods, in particular machine learning, to compensate for the lack of a harmonized standard (in the interim) to the greatest extent possible.
This paper contributes the first human-centered observational study of a deep learning system deployed directly in clinical care with patients. Through field observations and interviews at eleven clinics across Thailand, we explored the expectations and realities that nurses encounter in bringing a deep learning model into their clinical practices. First, we outline typical eye-screening workflows and challenges that nurses experience when screening hundreds of patients. Then, we explore the expectations nurses have for an AI-assisted eye screening process. Next, we present a human-centered, observational study of the deep learning system used in clinical care, examining nurses’ experiences with the system, and the socio-environmental factors that impacted system performance. Finally, we conclude with a discussion around applications of HCI methods to the evaluation of deep learning algorithms in clinical environments.
Artificial intelligence and machine learning technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated during the delivery of health care every day. Medical device manufacturers are using these technologies to innovate their products to better assist health care providers and improve patient care. The FDA is considering a total product lifecycle-based regulatory framework for these technologies.
FDA need to widen their scope from evaluating medical AI/ML-based products to assessing systems. This shift in perspective—from a product view to a system view—is central to maximizing the safety and efficacy of AI/ML in health care, but it also poses significant challenges for agencies like the FDA who are used to regulating products, not systems. We offer several suggestions for regulators to make this challenging but important transition