RP37 - Ethical and Regulatory Dimensions of AI in Disease Diagnosis

Integrating artificial intelligence (AI) with multimodal data offers new possibilities for identifying markers and refining clinical decision-making in melanoma. However, these advancements require thorough exploration of ethical, legal, and regulatory considerations to ensure responsible and equitable use. Drawing on Obioma Pelka’s extensive involvement in the “AI Governance and Ethics Framework” project, this project aims to investigate these dimensions, focusing on the ethical application of AI to identify biomarkers for melanoma using diverse data sources, such as radiological imaging, genetic data, and patient history. It addresses critical issues such as critically appraising claims of predictive accuracy and their ethical weight, the ethical implications of early diagnosis including its psychological burden, and the responsible handling of sensitive diagnostic information. The research project will also tackle the regulatory challenges in deploying clinical decision support systems that utilise multimodal datasets, including investigating the approval processes required for such systems and establishing protocols for ongoing monitoring and updates. Moreover, the project addresses the ethical implications of long-term, longitudinal data use, legal concerns related to multimodal radiological data, and strategies for mitigating biases in AI systems. Finally, the project aims to develop comprehensive ethical frameworks for using AI in melanoma diagnosis. These frameworks will cover consent, data ownership, and patient autonomy, ensuring that integrating various data sources respects patient rights and adheres to ethical principles. Methodologically, the project is conceptual, normative, and regulatory in nature and draws on existing multimodal datasets and models developed within the consortium, rather than collecting new clinical data, keeping the demand on clinical partners limited to targeted advisory input. By addressing these critical issues, this project advances technological and clinical understanding and ensures that these advancements are implemented ethically, legally compliant, and equitably.