Algorithmic Conceptions: Regulating Artificial Intelligence in Assisted Reproductive Technologies through an Ethical and Legal Lens

Abstract

Artificial intelligence is increasingly integrated into assisted reproductive technology (ART), with regulator-approved systems now assessing embryo viability through time-lapse imaging and multimodal clinical data. This review investigates whether current legal frameworks sufficiently regulate algorithmic decision-making in reproductive practices. Employing a comparative doctrinal methodology, it examines the European Union’s Artificial Intelligence Act (Regulation (EU) 2024/1689), the General Data Protection Regulation, the Medical Device Regulation, and India’s Assisted Reproductive Technology (Regulation) Act, 2021, alongside relevant technical literature on operational embryo-assessment systems. The analysis reveals a structural deficiency: each regulatory framework treats algorithmic embryo selection as incidental to other primary regulatory objectives, namely, product safety, data processing, or clinic licensing, and thus fails to address the technology's reproductive and intergenerational implications directly. The review advocates a rights-based governance model grounded in algorithmic transparency, compulsory human oversight, bias auditing, sui generis reproductive-data protection, and a legally enforceable right to an explanation.