LEGAL ASPECTS OF THE TRANSFER AND USE OF PERSONAL DATA IN THE CROSS-BORDER CIRCULATION OF MEDICAL SOFTWARE

Abstract

The article considers the principal legal grounds and safeguards applicable to the processing and cross- border transfer of health data, including consent, protection of vital interests, public interest, contractual safeguards and privacy by design. Particular attention is given to the differences between the US, European and the Russian regulatory framework concerning international data transfers, including adequacy requirements, transfer impact assessments, notifi - cation obligations. The author identifies key legal risks arising from divergent regulatory requirements across jurisdictions and formulates recommendations for medical software developers concerning data minimization, pseudonymization, separation of ordinary and special categories of personal data, and the incorpo- ration of privacy and security requirements at the technology design stage.