Related papers: Regulating radiology AI medical devices that evolv…
As deep learning (DL) technologies advance, their application in automated visual inspection for Class III medical devices offers significant potential to enhance quality assurance and reduce human error. However, the adoption of such…
While the pace of development of AI has rapidly progressed in recent years, the implementation of safe and effective regulatory frameworks has lagged behind. In particular, the adaptive nature of AI models presents unique challenges to…
Medical Artificial Intelligence (AI) involves the application of machine learning algorithms to biomedical datasets in order to improve medical practices. Products incorporating medical AI require certification before deployment in most…
In December 2023, the European Parliament provisionally agreed on the EU AI Act. This unprecedented regulatory framework for AI systems lays out guidelines to ensure the safety, legality, and trustworthiness of AI products. This paper…
The discussions around Artificial Intelligence (AI) and medical imaging are centered around the success of deep learning algorithms. As new algorithms enter the market, it is important for practicing radiologists to understand the pitfalls…
In August 2024, the EU Artificial Intelligence Act (AIA) came into force, marking the world's first large-scale regulatory framework for AI. Central to the AIA is a risk-based approach, aligning regulatory obligations with the potential…
Despite the immense potential of AI-powered medical devices to revolutionize healthcare, concerns regarding their safety in life-critical applications remain. While the European regulatory framework provides a comprehensive approach to…
AI agents - i.e. AI systems that autonomously plan, invoke external tools, and execute multi-step action chains with reduced human involvement - are being deployed at scale across enterprise functions ranging from customer service and…
This article provides a critical overview of the recently approved Artificial Intelligence Act. It starts by presenting the main structure, objectives, and approach of Regulation (EU) 2024/1689. A definition of key concepts follows, and…
The General Data Protection Regulation (GDPR) is a European Union regulation that will replace the existing Data Protection Directive on 25 May 2018. The most significant change is a huge increase in the maximum fine that can be levied for…
There is a growing demand for the use of Artificial Intelligence (AI) and Machine Learning (ML) in healthcare, particularly as clinical decision support systems to assist medical professionals. However, the complexity of many of these…
A global challenge in artificial intelligence (AI) regulation lies in achieving effective risk management without compromising innovation and technical progress. The European Union (EU) Artificial Intelligence Act represents the first…
Assessments of trustworthiness have become a cornerstone of responsible AI development. Especially in high-stakes fields like healthcare, aligning technical, evidence-based, and ethical practices with forthcoming legal requirements is…
Machine learning is expected to fuel significant improvements in medical care. To ensure that fundamental principles such as beneficence, respect for human autonomy, prevention of harm, justice, privacy, and transparency are respected,…
With the Proposal for a Regulation laying down harmonised rules on Artificial Intelligence (AI Act) the European Union provides the first regulatory document that applies to the entire complex of AI systems. While some fear that the…
Advances in computing power, deep learning architectures, and expert labelled datasets have spurred the development of medical imaging artificial intelligence systems that rival clinical experts in a variety of scenarios. The National…
Increasing demands on medical imaging departments are taking a toll on the radiologist's ability to deliver timely and accurate reports. Recent technological advances in artificial intelligence have demonstrated great potential for…
Machine learning systems deployed in medical devices require governance frameworks that ensure safety while enabling continuous improvement. Regulatory bodies including the FDA and European Union have introduced mechanisms such as the…
The rapid advancements in artificial intelligence (AI) present unique challenges for policymakers that seek to govern the technology. In this context, the Delphi method has become an established way to identify consensus and disagreement on…
The explosion in the performance of Machine Learning (ML) and the potential of its applications are strongly encouraging us to consider its use in industrial systems, including for critical functions such as decision-making in autonomous…