AIMC Topic: European Union

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Trustworthy Artificial Intelligence in Dentistry: Learnings from the EU AI Act.

Journal of dental research
Artificial intelligence systems (AISs) gain relevance in dentistry, encompassing diagnostics, treatment planning, patient management, and therapy. However, questions about the generalizability, fairness, and transparency of these systems remain. Regu...

Implications of the novel EU AI Act for neurotechnologies.

Neuron
The EU AI Act, the first comprehensive regulation of AI, came into effect in August. Here, we provide an overview of the provisions that apply to the field of neurotechnology with respect to research and development and neuroscience practice and disc...

The EU Artificial Intelligence Act (2024): Implications for healthcare.

Health policy (Amsterdam, Netherlands)
In August 2024, the EU Artificial Intelligence Act (AI Act) entered into force. This legally binding instrument sets rules for the development, the placing on the market, the putting into service, and the use of AI systems in the European Union. As t...

The development of an EU-wide nutrition and physical activity expert knowledge base to support a personalised mobile application across various EU population groups.

Nutrition bulletin
A healthy lifestyle comprising regular physical activity and an adequate diet is imperative for the prevention of non-communicable diseases such as hypertension and some cancers. Advances in information computer technology offer the opportunity to pr...

Robotic monitoring of dunes: a dataset from the EU habitats 2110 and 2120 in Sardinia (Italy).

Scientific data
This data descriptor presents a novel dataset collected using the quadrupedal robot ANYmal C in the Mediterranean coastal dune environment of the European Union (EU) habitats 2110 and 2120 in Sardinia, Italy. The dataset mainly consists of photos, vi...

Translating the regulatory landscape of medical devices to create fit-for-purpose artificial intelligence (AI) cytometry solutions.

Cytometry. Part B, Clinical cytometry
The implementation of medical software and artificial intelligence (AI) algorithms into routine clinical cytometry diagnostic practice requires a thorough understanding of regulatory requirements and challenges throughout the cytometry software produ...

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...