Published August 3, 2026 | Version v1.0

The Regulatory Asymmetry of Biological Wetware: Lineage Continuity and Intent Capture at the Bio-Digital Frontier

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Contemporary biomedical regulation displays a striking asymmetry when confronted with two interventionsthat share the same underlying substance — human biological wetware. Human germline genome editing is met with exceptionally strict restriction within several mature biomedical regulatory traditions, mostprominently the European path represented by the Oviedo Convention, while highly engineered in vitrobrain-organoid computing systems are smoothly reclassified as matters of intellectual property, researchoversight, or ordinary tangible property. Mainstream scholarship on the legal status of organoids has soughta doctrinal foothold for these entities by asking whether they satisfy the criteria of natural or juridical personhood, leaving unexplained why the legal system is able to reach a stable classification without ever settlingthe question of consciousness. This paper argues that the operative variables are not personhood criteriaat all, but two implicit filters embedded in legal doctrine: a lineage continuity filter, which asks whetheran entity is anchored in a socially recognized genealogical chain, and an intent-capture filter, which askswhether an entity’s causal architecture retains a reflective gap not wholly commandeered by external engineering purpose. Germline editing triggers both filters simultaneously and is blocked accordingly; organoidcomputing reaches neither filter as an active subject-status inquiry, because the lineage filter is pre-emptedby the property-law fiction of Moore v. Regents and the intent-capture filter is interpreted as foreclosed byan architecture whose strategic objectives remain externally specified. Read through Luhmann’s autopoietic systems theory, this is not a failure of bioethical reasoning but a demonstration of how the legal systemmaintains normative closure without ever resolving the ontology of consciousness.

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Preprint: 10.5281/zenodo.21452297 (DOI)