This study explores the heightened vulnerability of patients undergoing cardiac electronic device implantation, focusing on their capacity to give informed consent. These devices, embedded within complex digital ecosystems, expose patients to cybersecurity, data privacy, and medical autonomy risks. Legal frameworks, notably the General Data Protection Regulation and French health law, offer some protection, yet fail to fully address the opacity of information and asymmetry in physician–patient relations. The paper argues for enhanced transparency, informed multi-party consent, and stronger ex ante and ex post protections. In an era of digital medicine, safeguarding patients’ rights and bodily integrity is essential to maintaining trust and ethical care.

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Remedying Vulnerability Affecting Patients’ Consent: The Case of Patients Undergoing Cardiac Electronic Device Implantation

  • Hélène Guiziou

摘要

This study explores the heightened vulnerability of patients undergoing cardiac electronic device implantation, focusing on their capacity to give informed consent. These devices, embedded within complex digital ecosystems, expose patients to cybersecurity, data privacy, and medical autonomy risks. Legal frameworks, notably the General Data Protection Regulation and French health law, offer some protection, yet fail to fully address the opacity of information and asymmetry in physician–patient relations. The paper argues for enhanced transparency, informed multi-party consent, and stronger ex ante and ex post protections. In an era of digital medicine, safeguarding patients’ rights and bodily integrity is essential to maintaining trust and ethical care.