The subject of the study is the legal regulation of informed voluntary consent (IVC) of a patient to medical intervention in the context of digital transformation of healthcare. The digitalization of medicine has given rise to legal relationships not covered by the traditional IVC framework, which was developed for facetoface doctorpatient interaction. The analysis focuses on three technological contexts. The first is telemedicine: Order No. 193n of the Ministry of Health of the Russian Federation dated April 11, 2025 leaves the information mechanism to the discretion of each medical organization. The second is AI in diagnostics: by signing an IVC form, the patient does not realize that their data will be processed by an algorithm, whereas the law does not oblige disclosure of this fact. The third is the collection of neurophysiological data (EEG, MRI and other biomarkers) by means of AI: such data constitute biometric identifiers capable of revealing the subject's emotional states and intentions, but Russian law does not provide a special regime for them. The following methods are applied: formallegal, comparativelegal and systemic. The analysis covers regulatory legal acts of the Russian Federation (20172025), the legislation of Chile, the European Union, the United States, and the DPRK (Democratic People's Republic of Korea), as well as materials of judicial practice. Scientific novelty consists in a comprehensive identification of legal gaps in the regulation of IVC in relation to the three technological contexts of digital medicine, taking into account the acts of 20212025 that have not previously been subjected to joint systemic analysis. It is established that Order No. 193n (2025) reproduces a fundamental flaw of the previous regulation: no uniformity of the information mechanism in remote interaction has been achieved. No effective act obliges disclosure to the patient of the fact that their data are processed algorithmically, nor does it provide for the right of dynamic withdrawal of consent. The norms of Federal Law No. 152FZ do not account for the nature of neurophysiological data as biometric identifiers. About 80% of patients sign the IVC form automatically – the institution has de facto turned into a protective mechanism for medical organizations. Proposals are formulated: to supplement Part 1 of Article 20 of Federal Law No. 323FZ with an indication of the mandatory disclosure of the use of AI algorithms and the right to refuse; to approve a special IVC form for telemedicine; to introduce a mechanism of dynamic consent for neurodata; to establish linguistic requirements for forms; to clarify Article 41 of the Criminal Code of the Russian Federation regarding IVC as a criterion of justified risk.
Ekaterina Dmitrievna Sungurova (Fri,) studied this question.