This paper analyzes the impact of Brain-Computer Interface (BCI) technologies in the medical and healthcare fields, highlighting their extraordinary therapeutic and rehabilitative opportunities, as well as the significant ethical and legal risks involved. By enabling direct communication between the human brain and external devices, these interfaces allow for the restoration of motor and sensory functions, but they also raise complex issues related to self-determination, privacy (neural and mental), and the emergence of a new form of “technological vulnerability” for patients. Through a systematic review, the study reconstructs the European regulatory framework applicable to medical BCIs and further explores the emerging doctrinal debate on the category of so-called “neuro-rights.” The focus is on the need for a multi-level regulatory approach that combines binding legislation (hard law) with non-binding legislation (soft law), as well as technical standardization and compliance by design, in order to steer neurotechnological innovation toward high levels of safety and adequate safeguards for human rights.
Il presente contributo analizza l'impatto delle tecnologie di Brain-Computer Interface (BCI) in ambito medico-sanitario, evidenziandone le straordinarie opportunità terapeutiche e riabilitative, nonché i significativi rischi di natura etico-giuridica. Tali interfacce, consentendo una comunicazione diretta tra il cervello umano e dispositivi esterni, permettono il ripristino di funzioni motorie e sensoriali, ma sollevano complesse questioni legate all'autodeterminazione, alla privacy (neurale e mentale) e all'emergere di una nuova "vulnerabilità tecnologica" in capo ai pazienti. Attraverso un'indagine sistematica, lo studio ricostruisce il quadro normativo europeo applicabile alle BCI di area medica ed esplora, inoltre, il nascente dibattito dogmatico sulla categoria dei c.d. "neurodiritti". L'attenzione è posta sulla necessità di un approccio regolatorio multilivello che coniughi la normazione cogente (hard law) a quella non vincolante (soft law) e alla standardizzazione tecnica e alla compliance by design, al fine di orientare l'innovazione neurotecnologica verso elevati livelli di sicurezza e adeguate garanzie di tutela dei diritti umani.
Le tecnologie di brain computer interface in medicina tra regolamentazione e prospettive future
Gaeta M. C.
2025-01-01
Abstract
This paper analyzes the impact of Brain-Computer Interface (BCI) technologies in the medical and healthcare fields, highlighting their extraordinary therapeutic and rehabilitative opportunities, as well as the significant ethical and legal risks involved. By enabling direct communication between the human brain and external devices, these interfaces allow for the restoration of motor and sensory functions, but they also raise complex issues related to self-determination, privacy (neural and mental), and the emergence of a new form of “technological vulnerability” for patients. Through a systematic review, the study reconstructs the European regulatory framework applicable to medical BCIs and further explores the emerging doctrinal debate on the category of so-called “neuro-rights.” The focus is on the need for a multi-level regulatory approach that combines binding legislation (hard law) with non-binding legislation (soft law), as well as technical standardization and compliance by design, in order to steer neurotechnological innovation toward high levels of safety and adequate safeguards for human rights.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
