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Keyword: risk-based approach

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Institutional Review Boards as Soft Governance Mechanisms of R&D: journal article free

Governing the R&D of AI-based Medical Products

Antoni Lorente

Journal of AI Law and Regulation, Volume 1 (2024), Issue 1, Page 40 - 49

Risk-based approaches to governance bear an ambiguous stance regarding the R&D stages of AI, for they the possibility of explicit risks before they are posed by a given finalised product. In this context, Institutional Review Boards (IRBs) stand as unique governance mechanisms, capable of addressing the step from general research to concrete product development. However, IRBs face several challenges in governing AI-based medical products, including: (a) achieving consistency, (b) being exhaustive, (c) ensuring process transparency, and (d) reducing the existing capacity and knowledge asymmetry between different stakeholders. This article explores four governance levers that can be used to effect change, four governance entry-points throughout a product’s lifecycle, and five different behaviours that IRBs should try to advance to ensure the effective governance of the R&D stages of AI-based medical projects. In doing so, IRBs can seize the unique opportunity they present to bring principles into practice, increase research quality, reduce governance costs, and bridge the knowledge gap between stakeholders. Keywords: AI governance; research and development; risk-based approach; research ethics

The EU Artificial Intelligence Act: journal article free

Advancing Innovation for Trustworthy AI

Tatjana Evas

Journal of AI Law and Regulation, Volume 1 (2024), Issue 1, Page 98 - 101

The European Union’s Artificial Intelligence Act (AI Act)1 is one of the most widely discussed and anticipated pieces of upcoming legislations, capturing global attention with its approach to governing uses of AI technologies. Following intense preparatory work,2 and almost three years of complex political negotiations, culminating in political agreement on 8 December 2023, the AI Act is set to shape global regulatory space on how we innovate, manage, and perceive AI technologies. This opinion, drawing upon first-hand experience from the AI Act’s conceptualisation, legal drafting, and negotiations, offers a reflection on key decisions and the overall rationale behind this innovative and pioneering regulation. Keywords: EU AI Act; trustworthy AI; risk-based approach; horizontal framework; product safety

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