AIMC Topic: European Union

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A Natural Language Processing Approach Towards Harmonized Communication of Uncertainties Identified During the European Medicine Authorization Process.

Clinical pharmacology and therapeutics
Within the European Union, the European Medicines Agency's (EMA's) European Public Assessment Report (EPAR) is an important source of information for healthcare professionals and patients that allows them to understand important risks and uncertainti...

The Proposal for a Directive on Defective Products: A Game Changer for Innovative Medicinal Products.

European journal of health law
At the end of 2022, the European Commission published a proposal for a directive to revise the strict liability regime introduced in 1985. Although the main goal of this new proposal is to adapt the regulations to information technologies such as art...

Artificial intelligence in medicine: A comprehensive survey of medical doctor's perspectives in Portugal.

PloS one
Artificial Intelligence (AI) is increasingly influential across various sectors, including healthcare, with the potential to revolutionize clinical practice. However, risks associated with AI adoption in medicine have also been identified. Despite th...

A Case for Synthetic Data in Regulatory Decision-Making in Europe.

Clinical pharmacology and therapeutics
Regulators are faced with many challenges surrounding health data usage, including privacy, fragmentation, validity, and generalizability, especially in the European Union, for which synthetic data may provide innovative solutions. Synthetic data, de...

Artificial intelligence in medical device software and high-risk medical devices - a review of definitions, expert recommendations and regulatory initiatives.

Expert review of medical devices
INTRODUCTION: Artificial intelligence (AI) encompasses a wide range of algorithms with risks when used to support decisions about diagnosis or treatment, so professional and regulatory bodies are recommending how they should be managed.

Learning From Experience and Finding the Right Balance in the Governance of Artificial Intelligence and Digital Health Technologies.

Journal of medical Internet research
Artificial intelligence (AI) and machine learning medical tools have the potential to be transformative in care delivery; however, this change will only be realized if accompanied by effective governance that ensures patient safety and public trust. ...

Application of a developed triple-classification machine learning model for carcinogenic prediction of hazardous organic chemicals to the US, EU, and WHO based on Chinese database.

Ecotoxicology and environmental safety
Cancer, the second largest human disease, has become a major public health problem. The prediction of chemicals' carcinogenicity before their synthesis is crucial. In this paper, seven machine learning algorithms (i.e., Random Forest (RF), Logistic R...

Legal Protection of Revenge and Deepfake Porn Victims in the European Union: Findings From a Comparative Legal Study.

Trauma, violence & abuse
The use of images of persons in a pornographic context (without the prior consent of the person concerned) on the internet is an increasingly widespread infringement. Unlawful activities carried out with the use of generated images and artificial int...

Digital skills of therapeutic radiographers/radiation therapists - Document analysis for a European educational curriculum.

Radiography (London, England : 1995)
INTRODUCTION: It is estimated that around 50% of cancer patients require Radiotherapy (RT) at some point during their treatment, hence Therapeutic Radiographers/Radiation Therapists (TR/RTTs) have a key role to play in patient management. It is essen...

Achieving a 'Good AI Society': Comparing the Aims and Progress of the EU and the US.

Science and engineering ethics
Over the past few years, there has been a proliferation of artificial intelligence (AI) strategies, released by governments around the world, that seek to maximise the benefits of AI and minimise potential harms. This article provides a comparative a...