Related papers: Semi-automated checking for regulatory compliance …
The enactment of the General Data Protection Regulation (GDPR) in 2018 forced any organization that collects and/or processes EU-based personal data to comply with stringent privacy regulations. Software organizations have struggled to…
Organizations need to manage numerous business processes for delivering their services and products to customers. One important consideration thereby lies in the adherence to regulations such as laws, guidelines, or industry standards. In…
The transparent and decentralized characteristics associated with blockchain can be both appealing and problematic when applied to a healthcare use-case. As health data is highly sensitive, it is also highly regulated to ensure the privacy…
As deep learning (DL) technologies advance, their application in automated visual inspection for Class III medical devices offers significant potential to enhance quality assurance and reduce human error. However, the adoption of such…
We address the problem of complying with the GDPR while processing and transferring personal data on the web. For this purpose we introduce an extensible profile of OWL2 for representing data protection policies. With this language, a…
As electronic data becomes the lifeline of modern society, privacy concerns increase. These concerns are reflected by the European Union's enactment of the General Data Protection Regulation (GDPR), one of the most comprehensive and robust…
We present an end-to-end pipeline that converts healthcare policy documents into executable, data-aware Business Process Model and Notation (BPMN) models using large language models (LLMs) for simulation-based policy evaluation. We address…
Ensuring compliance of norms and policies when working on administrative law cases can be difficult to manage for government organisations. Automating this process could save a lot of time, effort and ensure compliance. Prior research…
Checking the compliance of software against laws, regulations and contracts is increasingly important and costly as the embedding of software into societal practices is becoming more pervasive. Moreover, the digitalised services provided by…
The General Data Protection Regulation (GDPR) is a European Union regulation that will replace the existing Data Protection Directive on 25 May 2018. The most significant change is a huge increase in the maximum fine that can be levied for…
Electronic Health Records (EHR) are crucial for the success of digital healthcare, with a focus on putting consumers at the center of this transformation. However, the digitalization of healthcare records brings along security and privacy…
Purpose: The introduction of artificial intelligence / machine learning (AI/ML) products to the regulated fields of pharmaceutical research and development (R&D) and drug manufacture, and medical devices (MD) and in-vitro diagnostics (IVD),…
This paper addresses the critical challenge of ensuring healthcare policy compliance in the context of Electronic Health Records (EHRs). Despite stringent regulations like HIPAA, significant gaps in policy compliance often remain undetected…
Electronic Health Records (EHRs) are integral for storing comprehensive patient medical records, combining structured data (e.g., medications) with detailed clinical notes (e.g., physician notes). These elements are essential for…
Ensuring compliance with international data protection standards for privacy and data security is a crucial but complex task, often requiring substantial legal expertise. This paper introduces LegiLM, a novel legal language model…
The rise of electronic health records (EHRs) has unlocked new opportunities for medical research, but privacy regulations and data heterogeneity remain key barriers to large-scale machine learning. Federated learning (FL) enables…
Artificial intelligence is rapidly encroaching on the field of service regulation. However, existing AI-based regulation techniques are often tailored to specific application domains and thus are difficult to generalize in an automated…
The EU General Data Protection Regulation (GDPR), enforced from 25th May 2018, aims to reform how organisations view and control the personal data of private EU citizens. The scope of GDPR is somewhat unprecedented: it regulates every…
Background: More than half (57%) of pharma clinical research spend is in support of clinical trials. One reason is that Electronic Health Record (EHR) systems and HIPAA privacy rules often limit how broadly patient information can be…
The healthcare environment is commonly referred to as "information-rich" but also "knowledge poor". Healthcare systems collect huge amounts of data from various sources: lab reports, medical letters, logs of medical tools or programs,…