Abstract| Volume 16, ISSUE 1, P116, January 2023

Brain Stimulation Law: Legal issues raised by current and emerging neuromodulation therapies

      This presentation addresses the legal context for neuromodulation therapy. Many of these rules will apply during the research phase and are also useful to have in mind during the development of devices, as the legal context may suggest certain design choices are advisable. Among the rules to be discussed are the laws in various jurisdictions that impose specific eligibility, consent, and oversight procedures for certain forms of neurosurgery for psychiatric disorders, sometimes including deep brain stimulation. Other legal issues to be covered are questions about the collection and use of neurophysiological and other data collected in adaptive DBS, rules regarding telemedicine applicable for remote programming of DBS, and legal arguments regarding rights of access to neuromodulation therapy and discrimination. The applicable laws vary by jurisdiction and so it will be impossible to cover all legal approaches, but the presentation will present each issue with examples of how one or more jurisdictions address it.