This study advances a novel multilayer network model to explore the connection between different aspects of Technological Innovation in European Union (EU) countries. We follow a fuzzy clustering approach and consider three variables: Research and De...
The AI Act advances a risk-based approach to the legal regulation of AI systems in the European Union. While we support this development, we argue that adequate AI governance requires paying attention to the broader implications of AI systems on the ...
British journal of hospital medicine (London, England : 2005)
Aug 20, 2025
The integration of artificial intelligence (AI) in healthcare offers the potential to play a critical role in reshaping clinical practice. However, it also brings regulatory, ethical, implementation, social, and technical challenges that healthcare s...
The use of artificial intelligence (AI) in healthcare offers great potential but also presents regulatory challenges. The EU Artificial Intelligence Act (AIA), the Medical Device Regulation (MDR), and the Regulation on in vitro diagnostic medical dev...
Artificial intelligence (AI) methods for digital pathology have tremendous potential to improve cancer diagnostics, biomarkers, and ultimately patient care. These AI methods, if marketed and sold, require authorisation or clearance as in vitro diagno...
Regulatory toxicology and pharmacology : RTP
Jun 6, 2025
The toxicity of nanomaterials(NMs) is closely tied to their physicochemical properties, such as size, shape, surface chemistry, stability in biological medium, and state of agglomeration as well to their uptake by cells. Key deficiencies in standardi...
This paper critically examines the analysis conducted by Maußner et al. on AI analysis, particularly their interpretation of feature importances derived from various machine learning models using SHAP (SHapley Additive exPlanations). Although SHAP ai...
During the COVID-19 pandemic, Non-Pharmaceutical Interventions (NPIs) were imposed all over Europe with the intent to reduce infection spread. However, reports on the effectiveness of those measures across different European countries are inconclusiv...
Health policy (Amsterdam, Netherlands)
Mar 6, 2025
The growing number of well-established use (WEU) applications was reported by the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh). The procedures from the CMDh annual statistics and products from the Mutual Recog...
BACKGROUND: The use of real-world data is established in post-authorization regulatory processes such as pharmacovigilance of drugs and medical devices, but is still frequently challenged in the pre-authorization phase of medicinal products. In addit...
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