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This paper examines the ethical and legal challenges encountered during the GATEKEEPER Project and how these challenges informed the development of a comprehensive framework for future Large-Scale Pilot (LSP) projects. GATEKEEPER is a LSP Project with 48 partners conducting 30 implementation studies across Europe with 50,000 target participants grouped into 9 Reference Use Cases. The project underscored the complexity of obtaining ethical approval across various jurisdictions with divergent regulations and procedures. Through a detailed analysis of the issues faced and the strategies employed to navigate these challenges, this study proposes an ethical and legal framework. This framework, derived from a comparative analysis of ethical application forms and regulations, aims to streamline the ethical approval process for future LSP research projects. By addressing the hurdles encountered in GATEKEEPER, the proposed framework offers a roadmap for more efficient and effective project management, ensuring smoother implementation of similar projects in the future. [ABSTRACT FROM AUTHOR]

Trustworthy medical AI requires transparency about the development and testing of underlying algorithms to identify biases and communicate potential risks of harm. Abundant guidance exists on how to achieve transparency for medical AI products, but it is unclear whether publicly available information adequately informs about their risks. To assess this, we retrieved public documentation on the 14 available CE-certified AI-based radiology products of the II b risk category in the EU from vendor websites, scientific publications, and the European EUDAMED database. Using a self-designed survey, we reported on their development, validation, ethical considerations, and deployment caveats, according to trustworthy AI guidelines. We scored each question with either 0, 0.5, or 1, to rate if the required information was "unavailable", "partially available," or "fully available." The transparency of each product was calculated relative to all 55 questions. Transparency scores ranged from 6.4% to 60.9%, with a median of 29.1%. Major transparency gaps included missing documentation on training data, ethical considerations, and limitations for deployment. Ethical aspects like consent, safety monitoring, and GDPR-compliance were rarely documented. Furthermore, deployment caveats for different demographics and medical settings were scarce. In conclusion, public documentation of authorized medical AI products in Europe lacks sufficient public transparency to inform about safety and risks. We call on lawmakers and regulators to establish legally mandated requirements for public and substantive transparency to fulfill the promise of trustworthy AI for health. [ABSTRACT FROM AUTHOR]

Algorithmic decision-making and other types of artificial intelligence (AI) can be used to predict who will commit crime, who will be a good employee, who will default on a loan, etc. However, algorithmic decision-making can also threaten human rights, such as the right to non-discrimination. The paper evaluates current legal protection in Europe against discriminatory algorithmic decisions. The paper shows that non-discrimination law, in particular through the concept of indirect discrimination, prohibits many types of algorithmic discrimination. Data protection law could also help to defend people against discrimination. Proper enforcement of non-discrimination law and data protection law could help to protect people. However, the paper shows that both legal instruments have severe weaknesses when applied to artificial intelligence. The paper suggests how enforcement of current rules can be improved. The paper also explores whether additional rules are needed. The paper argues for sector-specific – rather than general – rules, and outlines an approach to regulate algorithmic decision-making. [ABSTRACT FROM AUTHOR]

Aim: To develop and validate models based on logistic regression and artificial intelligence for prognostic prediction of molar survival in periodontally affected patients. Materials and Methods: Clinical and radiographic data from four different centres across four continents (two in Europe, one in the United States, and one in China) including 515 patients and 3157 molars were collected and used to train and test different types of machine‐learning algorithms for their prognostic ability of molar loss over 10 years. The following models were trained: logistic regression, support vector machine, K‐nearest neighbours, decision tree, random forest, artificial neural network, gradient boosting, and naive Bayes. In addition, different models were aggregated by means of the ensembled stacking method. The primary outcome of the study was related to the prediction of overall molar loss (MLO) in patients after active periodontal treatment. Results: The general performance in the external validation settings (aggregating three cohorts) revealed that the ensembled model, which combined neural network and logistic regression, showed the best performance among the different models for the prediction of MLO with an area under the curve (AUC) = 0.726. The neural network model showed the best AUC of 0.724 for the prediction of periodontitis‐related molar loss. In addition, the ensembled model showed the best calibration performance. Conclusions: Through a multi‐centre collaboration, both prognostic models for the prediction of molar loss were developed and externally validated. The ensembled model showed the best performance in terms of both discrimination and validation, and it is made freely available to clinicians for widespread use in clinical practice. [ABSTRACT FROM AUTHOR]

Digitization in transplantation is not a new phenomenon. Algorithms are being used, for example, to allocate organs based on medical compatibility and priority criteria. However, digitization is accelerating as computer scientists and physicians increasingly develop and use machine learning (ML) models to obtain better predictions on the chances of a successful transplant. The objective of the article is to shed light on the potential threats to equitable access to organs allocated through algorithms, whether these are the consequence of political choices made upstream of digitization or of the algorithmic design, or are produced by self-learning algorithms. The article shows that achieving equitable access requires an overall vision of the algorithmic development process and that European legal norms only partially contribute to preventing harm and addressing equality in access to organs. [ABSTRACT FROM AUTHOR]