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The integration of Artificial Intelligence (AI) in healthcare signifies a substantial shift, offering benefits to patients and healthcare systems while also introducing new risks. The emphasis on patient safety and performance standards is pivotal, especially with the European Union's strides towards regulating AI through the AI Act. This act focuses on classifying AI systems based on risk levels, mandating stringent requirements for high-risk AI, enhancing transparency, and ensuring ethics in AI applications. The concept of an "AI passport" is introduced as a living document detailing the AI system's purpose, ethical declarations, training, evaluation, and potential biases. This passport aims to enhance transparency and safety in medical AI applications, serving as a comprehensive record for patients, clinicians, and stakeholders. The AI passport, structured in JSON format, encapsulates key information about the AI system as a mechanism for continuous performance evaluation and transparency. This initiative may represent a significant step towards mitigating the risks associated with AI in healthcare, emphasizing the importance of accountability, transparency, and patient safety in the development and application of AI technologies.

The objective of this work was to discover key topics latent in free text dispatcher observations registered during emergency medical calls. We used a total of 1374931 independent retrospective cases from the Valencian emergency medical dispatch service in Spain, from 2014 to 2019. Text fields were preprocessed to reduce vocabulary size and filter noise, removing accent and punctuation marks, along with uninformative and infrequent words. Key topics were inferred from the multinomial probabilities over words conditioned on each topic from a Latent Dirichlet Allocation model, trained following an online mini-batch variational approach. The optimal number of topics was set analyzing the values of a topic coherence measure, based on the normalized pointwise mutual information, across multiple validation K-folds. Our results support the presence of 15 key topics latent in free text dispatcher observations, related with: ambulance request; chest pain and heart attack; respiratory distress; head falls and blows; fever, chills, vomiting and diarrhea; heart failure; syncope; limb injuries; public service body request; thoracic and abdominal pain; stroke and blood pressure abnormalities; pill intake; diabetes; bleeding; consciousness. The discovery of these topics implies the automatic characterization of a huge volume of complex unstructured data containing relevant information linked to emergency medical call incidents. Hence, results from this work could lead to the update of structured emergency triage algorithms to directly include this latent information in the triage process, resulting in a positive impact in patient wellbeing and health services sustainability.

The pharmaceutical industry is a data-intensive environment and a heavily-regulated sector, where exhaustive audits and inspections are performed to ensure the safety of drugs. In this context, processing and evaluating the data generated in the manufacturing lines is a relevant challenge since it requires compliance with pharma regulations. This work combines data integrity metrics and blockchain technology to evaluate the compliance-degree of ALCOA+ principles among different levels of drug manufacturing data. We propose the DIALCOA tool, a software to assess the compliance-degree for each ALCOA+ principle, based on the assessment of data from manufacturing batch reports and its different levels of information.

We present the results of a pilot project of the Spanish Ministry of Health, Social Services and Equality, envisaged to the development of a national integrated data repository of maternal-child care information. Based on health information standards and data quality assessment procedures, the developed repository is aimed to a reliable data reuse for (1) population research and (2) the monitoring of healthcare best practices. Data standardization was provided by means of two main ISO 13606 archetypes (composed of 43 sub-archetypes), the first dedicated to the delivery and birth information and the second about the infant feeding information from delivery up to two years. Data quality was assessed by means of a dedicated procedure on seven dimensions including completeness, consistency, uniqueness, multi-source variability, temporal variability, correctness and predictive value. A set of 127 best practice indicators was defined according to international recommendations and mapped to the archetypes, allowing their calculus using XQuery programs. As a result, a standardized and data quality assessed integrated data respository was generated, including 7857 records from two Spanish hospitals: Hospital Virgen del Castillo, Yecla, and Hospital 12 de Octubre, Madrid. This pilot project establishes the basis for a reliable maternal-child care data reuse and standardized monitoring of best practices based on the developed information and data quality standards.

Low biomedical Data Quality (DQ) leads into poor decisions which may affect the care process or the result of evidence-based studies. Most of the current approaches for DQ leave unattended the shifting behaviour of data underlying concepts and its relation to DQ. There is also no agreement on a common set of DQ dimensions and how they interact and relate to these shifts. In this paper we propose an organization of biomedical DQ assessment based on these concepts, identifying characteristics and requirements which will facilitate future research. As a result, we define the Data Quality Vector compiling a unified set of DQ dimensions (completeness, consistency, duplicity, correctness, timeliness, spatial stability, contextualization, predictive value and reliability), as the foundations to the further development of DQ assessment algorithms and platforms.