Ethical and Regulatory Challenges in Biomedical Engineering

Abstract

Biomedical engineering innovations increasingly outpace the ethical frameworks and regulatory structures designed to govern them, creating governance gaps that delay beneficial technologies and risk inadequate oversight of potentially harmful ones. We evaluated 218 biomedical engineering programmes across centres in France and Italy between 2015 and 2024, spanning five governance challenge domains: AI-based clinical decision tools, gene editing therapies, implantable neural devices, engineered living therapeutics, and patient data-intensive digital health platforms. An Ethical-Regulatory Preparedness Index (ERPI) was constructed from five sub-scores -- ethical framework completeness, regulatory pathway alignment, informed consent adequacy, data governance robustness, and post-market surveillance planning -- with weights from regression against successful regulatory milestone achievement. ERPI correlated with milestone success at r = +0.83 and discriminated successful from stalled programmes with an AUC of 0.880. AI clinical decision tools scored highest (mean ERPI 0.818), while engineered living therapeutics trailed at 0.594. Only 34.4 percent of programmes exceeded the 0.75 threshold. Regulatory pathway alignment carried the largest regression weight (beta = +0.280), followed by ethical framework completeness (beta = +0.228).