Legal Issues and Countermeasures of Transcranial Magnetic Stimulation for Mental Disorders from the Perspective of Brain Science

Abstract

In the context of brain science research strategy in China, transcranial magnetic stimulation, as an input brain-computer interface technology, is able to improve the pathology of patients with mental disorders in a noninvasive way. However, new risks arising from the new technology have been ignored by the legislation, and there is a risk of privacy leaks of the neurological data presented by the patient's brain. The legal issues of physicians neglecting to inform patients of the risks of personality changes and the off-lable use of transcranial magnetic stimulation devices need to be explored. The legal issues of physicians neglecting to inform patients of the risks of personality changes and off-label use of transcranial magnetic stimulator devices need to be urgently explored. Multidisciplinary literature in the fields of trade-off between the right to health and privacy protection, principle of informed consent, data and application of off-label use for devices was searched and analyzed by using literature review and case analysis methods, to summarize the key points of the adjudication documents on off-label use for transcranial magnetic stimulation devices. It was found that the legal interpretations and value balances between the right to health and protection of privacy, physician's right of diagnosis and treatment and patient's right of informed consent, as well as the accessibility and safety of the devices, should be clarified and the adequate notification of new risks in the application of new technologies should be improved; it should be clarified that physicians and medical institutions should respect the privacy of the patients and the obligation to protect the security of neurological data, expand the scope of risk notification, clarify the risks of personality, prohibit the off-label use of the devices and establish a mechanism for risk analysis and dynamic monitoring of adverse reactions.

Keywords

• transcranial magnetic stimulation|therapeutics|brain-computer interface|brain privacy|legal liability|informed consent|devices off label use