Marcello Ienca

Laura Schopp, Ambra DImperio, Jalal Etesami et al.

While explainable AI (XAI) is often heralded as a means to enhance transparency and trustworthiness in closed-loop neurotechnology for psychiatric and neurological conditions, its real-world prevalence remains low. Moreover, empirical evidence suggests that the type of explanations provided by current XAI methods often fails to align with clinicians' end-user needs. In this viewpoint, we argue that clinically meaningful explainability (CME) is essential for AI-enabled closed-loop medical neurotechnology and must be addressed from an ethical, technical, and clinical perspective. Instead of exhaustive technical detail, clinicians prioritize clinically relevant, actionable explanations, such as clear representations of input-output relationships and feature importance. Full technical transparency, although theoretically desirable, often proves irrelevant or even overwhelming in practice, as it may lead to informational overload. Therefore, we advocate for CME in the neurotechnology domain: prioritizing actionable clarity over technical completeness and designing interface visualizations that intuitively map AI outputs and key features into clinically meaningful formats. To this end, we introduce a reference architecture called NeuroXplain, which translates CME into actionable technical design recommendations for any future neurostimulation device. Our aim is to inform stakeholders working in neurotechnology and regulatory framework development to ensure that explainability fulfills the right needs for the right stakeholders and ultimately leads to better patient treatment and care.

James Scheibner, Jean Louis Raisaro, Juan Ramón Troncoso-Pastoriza et al.

Multisite medical data sharing is critical in modern clinical practice and medical research. The challenge is to conduct data sharing that preserves individual privacy and data usability. The shortcomings of traditional privacy-enhancing technologies mean that institutions rely on bespoke data sharing contracts. These contracts increase the inefficiency of data sharing and may disincentivize important clinical treatment and medical research. This paper provides a synthesis between two novel advanced privacy enhancing technologies (PETs): Homomorphic Encryption and Secure Multiparty Computation (defined together as Multiparty Homomorphic Encryption or MHE). These PETs provide a mathematical guarantee of privacy, with MHE providing a performance advantage over separately using HE or SMC. We argue MHE fulfills legal requirements for medical data sharing under the General Data Protection Regulation (GDPR) which has set a global benchmark for data protection. Specifically, the data processed and shared using MHE can be considered anonymized data. We explain how MHE can reduce the reliance on customized contractual measures between institutions. The proposed approach can accelerate the pace of medical research whilst offering additional incentives for healthcare and research institutes to employ common data interoperability standards.

Anna Jobin, Marcello Ienca, Effy Vayena

In the last five years, private companies, research institutions as well as public sector organisations have issued principles and guidelines for ethical AI, yet there is debate about both what constitutes "ethical AI" and which ethical requirements, technical standards and best practices are needed for its realization. To investigate whether a global agreement on these questions is emerging, we mapped and analyzed the current corpus of principles and guidelines on ethical AI. Our results reveal a global convergence emerging around five ethical principles (transparency, justice and fairness, non-maleficence, responsibility and privacy), with substantive divergence in relation to how these principles are interpreted; why they are deemed important; what issue, domain or actors they pertain to; and how they should be implemented. Our findings highlight the importance of integrating guideline-development efforts with substantive ethical analysis and adequate implementation strategies.