Abstract

With focus on the development and use of artificial intelligence (AI) systems in the digital health context, we consider the following questions: How does the European Union (EU) seek to facilitate the development and uptake of trustworthy AI systems through the AI Act? What does trustworthiness and trust mean in the AI Act, and how are they linked to some of the ongoing discussions of these terms in bioethics, law, and philosophy? What are the normative components of trustworthiness? And how do the requirements of the AI Act relate to these components? We first explain how the EU seeks to create an epistemic environment of trust through the AI Act to facilitate the development and uptake of trustworthy AI systems. The legislation establishes a governance regime that operates as a socio-epistemological infrastructure of trust which enables a performative framing of trust and trustworthiness. The degree of success that performative acts of trust and trustworthiness have achieved in realising the legislative goals may then be assessed in terms of statutorily defined proxies of trustworthiness. We show that to be trustworthy, these performative acts should be consistent with the ethical principles endorsed by the legislation; these principles are also manifested in at least four key features of the governance regime. However, specified proxies of trustworthiness are not expected to be adequate for applications of AI systems within a regulatory sandbox or in real-world testing. We explain why different proxies of trustworthiness for these applications may be regarded as ‘special’ trust domains and why the nature of trust should be understood as participatory.