4.2AIAug 27, 2024
Aligning XAI with EU Regulations for Smart Biomedical Devices: A Methodology for Compliance AnalysisFrancesco Sovrano, Michael Lognoul, Giulia Vilone
Significant investment and development have gone into integrating Artificial Intelligence (AI) in medical and healthcare applications, leading to advanced control systems in medical technology. However, the opacity of AI systems raises concerns about essential characteristics needed in such sensitive applications, like transparency and trustworthiness. Our study addresses these concerns by investigating a process for selecting the most adequate Explainable AI (XAI) methods to comply with the explanation requirements of key EU regulations in the context of smart bioelectronics for medical devices. The adopted methodology starts with categorising smart devices by their control mechanisms (open-loop, closed-loop, and semi-closed-loop systems) and delving into their technology. Then, we analyse these regulations to define their explainability requirements for the various devices and related goals. Simultaneously, we classify XAI methods by their explanatory objectives. This allows for matching legal explainability requirements with XAI explanatory goals and determining the suitable XAI algorithms for achieving them. Our findings provide a nuanced understanding of which XAI algorithms align better with EU regulations for different types of medical devices. We demonstrate this through practical case studies on different neural implants, from chronic disease management to advanced prosthetics. This study fills a crucial gap in aligning XAI applications in bioelectronics with stringent provisions of EU regulations. It provides a practical framework for developers and researchers, ensuring their AI innovations advance healthcare technology and adhere to legal and ethical standards.
An Empirical Study on Compliance with Ranking Transparency in the Software Documentation of EU Online PlatformsFrancesco Sovrano, Michaël Lognoul, Alberto Bacchelli
Compliance with the European Union's Platform-to-Business (P2B) Regulation is challenging for online platforms, and assessing their compliance can be difficult for public authorities. This is partly due to the lack of automated tools for assessing the information (e.g., software documentation) platforms provide concerning ranking transparency. Our study tackles this issue in two ways. First, we empirically evaluate the compliance of six major platforms (Amazon, Bing, Booking, Google, Tripadvisor, and Yahoo), revealing substantial differences in their documentation. Second, we introduce and test automated compliance assessment tools based on ChatGPT and information retrieval technology. These tools are evaluated against human judgments, showing promising results as reliable proxies for compliance assessments. Our findings could help enhance regulatory compliance and align with the United Nations Sustainable Development Goal 10.3, which seeks to reduce inequality, including business disparities, on these platforms.
13.1AIJul 10, 2020
Impact of Legal Requirements on Explainability in Machine LearningAdrien Bibal, Michael Lognoul, Alexandre de Streel et al.
The requirements on explainability imposed by European laws and their implications for machine learning (ML) models are not always clear. In that perspective, our research analyzes explanation obligations imposed for private and public decision-making, and how they can be implemented by machine learning techniques.