Information-Directed Biomedical Intervention and the Limits of Classical Informed Consent

Contemporary biomedicine is increasingly moving from substance-oriented therapeutic intervention toward information-directed platform technologies. This development raises bioethical questions concerning whether conceptual frameworks developed within classical pharmacological medicine remain fully adequate for interventions whose effects depend upon informational sequences, platform architectures, and endogenous biological processing. This article examines the implications of information-directed biomedical intervention for uncertainty, responsibility, and informed consent. It argues that such interventions may generate forms of structural epistemic uncertainty arising from the interaction between technological scalability and biological complexity. Under these conditions, bioethical evaluation cannot be limited to the communication of measurable risks alone, but must also address the epistemic status of the intervention, the limits of prediction, and evolving knowledge conditions. The article proposes epistemic responsibility as the duty to make a conscientious effort to understand, recognise, and communicate the relevant state and limits of knowledge before acting under conditions of uncertainty. Building on this account, it introduces epistemic consent as a normative refinement of classical informed consent under conditions of platform medicine. The aim is not to reject technological innovation, but to clarify how bioethics may remain conceptually adequate when therapeutic action increasingly operates through information-directed and platform-based architectures. This manuscript is a preprint of a work currently under review at Health Care Analysis (Springer Nature). It has not undergone peer review. The present version is made publicly available to establish a time-stamped record of the conceptual framework and to invite scholarly feedback. The content may differ from the final published version following peer review and editorial revision.