Denis Horgan: AI in imaging must balance innovation and ethics
Denis Horgan, Executive Director from the European Alliance of Personalised Medicine (EAPM), posted the following on LinkedIn:
“Imaging Innovation in Healthcare: Avoiding Narcissus in AI Legislation Amid Political Shifts in the EU and US
Brussels, December 2nd 2024: Artificial Intelligence (AI) is revolutionizing imaging in healthcare, promising improved diagnostics, personalized medicine, and streamlined workflows. However, as highlighted in our academic article “The Translation of In-House Imaging AI Research into a Medical Device Ensuring Ethical and Regulatory Integrity”, published in the European Journal of Radiology, legislators in the European Union and the United States face the challenge of avoiding a “Narcissus trap”—creating laws overly enamored with their own theoretical elegance but lacking applicability in real-world healthcare settings. Such self-referential legislation risks becoming an image of itself, detached from the practical needs of patients, clinicians, and healthcare systems.
This challenge is especially acute in the current political climate, with recent and upcoming elections in both the EU and the US influencing regulatory priorities. These political transitions bring both opportunities and uncertainties, as governments balance the need to foster innovation with the imperative to safeguard patient safety and equity. The EU’s AI Act and its integration with the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) exemplify the effort to create a robust regulatory framework. Meanwhile, the US is charting a more decentralized approach, focusing on principles rather than prescriptive laws.
Against this backdrop, this article examines the pathway from in-house AI research to certified medical devices in imaging, emphasizing the importance of balancing innovation with ethical and regulatory pragmatism. It advocates for adaptable governance that ensures laws not only reflect technological and clinical realities but also address the dynamic political landscape shaping healthcare priorities. For example:
Regulatory Challenges and Opportunities: Harmonize Regulations: Align the EU’s MDR, IVDR, and AI Act to ensure safety, transparency, and performance standards while mitigating AI-specific risks such as bias.
Enable In-House Pathways: Encourage healthcare institutions to innovate under the in-house exemption for AI tools, ensuring adherence to stringent safety and ethical standards.
Common-Sense Approach to Regulation: a) Balance Innovation and Safety: Establish frameworks that protect patient welfare without stifling technological advancements. Avoid overregulation or overly lenient policies and b) Ensure Flexibility: Adapt regulations to accommodate rapidly evolving AI technologies, ensuring continued relevance and support for cutting-edge tools.
The full article is below.
Thanks to Filippo Pesapane for his great work and all authors:Mathias K. Hauglid, Marzia Fumagalli PhD LLM, Lena Petersson, Anagha Parkar, Enrico Cassano. Also, Ken, Ivica, Aliki, Delia, Iñaki, France, Jasmina, Tanya, Francesco, Iwona, Hadi, Anđela, Stan.”
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