Informed consent for evolving devices

The challenge of obtaining meaningful informed consent for a device whose capabilities change after implantation — through software updates, adaptive learning, or newly decoded functions. Classical one-time consent assumes a fixed intervention; an adaptive BCI can acquire behaviors, data uses, or risks that simply did not exist when the person originally agreed.

Proposed responses include dynamic or ongoing consent — re-engaging the user as the device or its data uses evolve — tiered consent for anticipated categories of update, and clear rights to opt out of specific new functions. This intersects directly with regulatory change control: what a PCCP authorizes technically, consent must also cover ethically.