Communications Medicine Review Proposes Specific Data Rights for Patients With Neuroimplants
Communications Medicine Review Proposes Specific Data Rights for Patients With Neuroimplants
On July 27, Julian Sandbrink and Michael Young published a review of data from implantable brain-computer interfaces. They propose five safeguards: protect deidentified records, give individuals control over their data, separate consent for data use from consent for surgery, restrict secondary use, and establish monetization rules in advance.
An implantable brain-computer interface, or iBCI, reads electrical activity in the brain and converts it into commands for a cursor, speech synthesizer, prosthesis, or stimulation system. For a person with paralysis, such an interface can help restore speech or movement. While operating, the device collects raw signals, features extracted from those signals, decoded intentions, and parameters from an algorithm trained on data from that particular user.
In their Communications Medicine review, Sandbrink and Young trace how these records move from the implant through the clinic and manufacturer to a cloud provider and algorithm developer. Treatment creates a lasting digital record of nervous system activity. The longer a person uses the device, the more closely this record becomes linked to their clinical record and to the decoder that identifies movement or speech.
The authors begin with deidentification. Even after conventional identifiers have been removed, patterns of neural activity may retain features specific to an individual. The review therefore proposes protecting these records as well. Patients should be able to access their data, control how it is shared, and know who uses it.
The authors propose obtaining consent for record storage, research, and algorithm training separately from consent for surgery. They also recommend setting limits in advance on secondary uses that could harm the individual, including profiling, manipulation, or discrimination. A separate issue concerns income derived from a patient’s records and the conditions under which a clinic, manufacturer, or intermediary may receive it.
In the United States, the issue has already reached the Senate through the introduced MIND Act. The bill would direct the Federal Trade Commission to examine rules for neural data, including separate consent for using records in brain models, selling them, and transferring them during corporate mergers.