AIMC Topic: European Union

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[Regulatory classification of AI-enabled products for medical use on the basis of the EU AI Act and MDR/IVDR].

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz Jul 4, 2025
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...
Equipment and Supplies Germany Artificial Intelligence Europe European Union Medical Device Legislation Device Approval Equipment Safety Humans
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The case for homebrew AI in diagnostic pathology.

The Journal of pathology Jul 4, 2025
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...
Artificial Intelligence United States Humans European Union Pathology, Clinical United States Food and Drug Administration Image Interpretation, Computer-Assisted
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Reevaluating feature importance in machine learning: concerns regarding SHAP interpretations in the context of the EU artificial intelligence act.

Water research Mar 18, 2025
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...
Artificial Intelligence Machine Learning European Union
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Estimating the causal impact of non-pharmaceutical interventions on COVID-19 spread in seven EU countries via machine learning.

Scientific reports Mar 17, 2025
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...
European Union SARS-CoV-2 Europe Humans Machine Learning Pandemics COVID-19
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Quantitative trend analysis of well-established use mutual recognition and decentralised products indicates codified disharmonisation in the European Economic Area.

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...
European Union Pattern Analysis, Machine
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The EU project Real4Reg: unlocking real-world data with AI.

Health research policy and systems Feb 27, 2025
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...
Artificial Intelligence Algorithms Decision Making Technology Assessment, Biomedical Humans Pharmacovigilance European Union
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Regulatory approaches towards AI Medical Devices: A comparative study of the United States, the European Union and China.

Health policy (Amsterdam, Netherlands) Feb 1, 2025
The swift progression of AI within the realm of medical devices has precipitated an imperative for stringent regulatory oversight. The United States, the European Union, and China stand as vanguard entities in the regulatory landscape for AI-enhanced...
European Union Medical Device Legislation Government Regulation China Humans United States Artificial Intelligence Equipment and Supplies Device Approval
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Do circular innovations and carrying capacity of natural environment enhance circular economy in the European Union? Evidence from simulation and machine learning methods.

Journal of environmental management Dec 27, 2024
The longevity of the natural environment is fundamental for sustainable production and consumption. The circular economy conserves natural resources, ensures sustainable production and consumption, and protects the natural environment. The role of ci...
Natural Resources Machine Learning Recycling Conservation of Natural Resources European Union
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Generative artificial intelligence (GenAI) and decision-making: Legal & ethical hurdles for implementation in mental health.

International journal of law and psychiatry Oct 19, 2024
This article argues that significant risks are being taken with using GenAI in mental health that should be assessed urgently. It recommends that guidelines for using generative artificial intelligence (GenAI) in mental health care must be establishe...
Mental Health Services Decision Making Artificial Intelligence Mental Health Humans Liability, Legal European Union
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The legal regulation of artificial intelligence in the European Union: A practical guide for radiologists.

Radiologia Sep 24, 2024
The European Union is taking the lead globally on the regulation of Artificial Intelligence (AI) and developing important legislation, namely the AI Act. The purpose of this article is to describe this regulation and examine three implications that w...
Radiologists Liability, Legal European Union Artificial Intelligence Radiology Humans
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