Related papers: Semi-automated checking for regulatory compliance …
Machine Learning on Big Data gets more and more attention in various fields. Even so privacy-preserving techniques become more important, even necessary due to legal regulations such as the General Data Protection Regulation (GDPR). On the…
Although the goal of achieving semantic interoperability of electronic health records (EHRs) is pursued by many researchers, it has not been accomplished yet. In this paper, we present a proposal that smoothes out the way toward the…
Methods to ensure factual accuracy of text generated by large language models (LLM) in clinical medicine are lacking. VeriFact is an artificial intelligence system that combines retrieval-augmented generation and LLM-as-a-Judge to verify…
Electronic health records (EHRs) contain vast amounts of complex data, but harmonizing and processing this information remains a challenging and costly task requiring significant clinical expertise. While large language models (LLMs) have…
De-identification of electronic health records (EHR) is a vital step towards advancing health informatics research and maximising the use of available data. It is a two-step process where step one is the identification of protected health…
The European General Data Protection Regulation (GDPR) brings new challenges for companies who must ensure they have an appropriate legal basis for processing personal data and must provide transparency with respect to personal data…
Medical Artificial Intelligence (AI) involves the application of machine learning algorithms to biomedical datasets in order to improve medical practices. Products incorporating medical AI require certification before deployment in most…
The proliferation of Large Language Models (LLMs) has demonstrated remarkable capabilities, elevating the critical importance of LLM safety. However, existing safety methods rely on ad-hoc taxonomy and lack a rigorous, systematic…
Technological advances in information sharing have raised concerns about data protection. Privacy policies contain privacy-related requirements about how the personal data of individuals will be handled by an organization or a software…
Healthcare data are generated in many different formats, which makes it difficult to integrate and reuse across institutions and studies. Standardisation is required to enable consistent large-scale analysis. The OMOP-CDM, developed by the…
Regulatory compliance is a well-studied area, including research on how to model, check, analyse, enact, and verify compliance of software. However, while the theoretical body of knowledge is vast, empirical evidence on challenges with…
Compliance checking is the process of determining whether a regulated entity adheres to these regulations. Currently, compliance checking is predominantly manual, requiring significant time and highly skilled experts, while still being…
The medical device products at the European Union market must be safe and effective. To ensure this, medical device manufacturers must comply to the new regulatory requirements brought by the Medical Device Regulation (MDR) and the In Vitro…
The robust development of Electronic Health Records (EHRs) causes a significant growth in sharing EHRs for clinical research. However, such a sharing makes it difficult to protect patient's privacy. A number of automated de-identification…
Understanding how data quality aligns with regulatory requirements in machine learning (ML) systems presents a critical challenge for practitioners navigating the evolving EU regulatory landscape. To address this, we first propose a…
Cloud computing adoption across industries has revolutionized enterprise operations while introducing significant challenges in compliance management. Organizations must continuously meet evolving regulatory requirements such as GDPR and…
Background: The integration of the General Data Protection Regulation (GDPR) and the Medical Device Regulation (MDR) creates complexities in conducting Data Protection Impact Assessments (DPIAs) for medical devices. The adoption of…
No one can dispute the disruptive impact of blockchain technology, which has long been considered one of the major revolutions of contemporary times. Its integration into the healthcare ecosystem has helped overcome numerous difficulties…
General Data Protection Regulation (GDPR) becomes a standard law for data protection in many countries. Currently, twelve countries adopt the regulation and establish their GDPR-like regulation. However, to evaluate the differences and…
Trust and Reputation Management Systems (TRMSs) are critical for the modern web, yet their reliance on subjective user ratings or narrow Quality of Service (QoS) metrics lacks objective grounding. Concurrently, while regulatory frameworks…