Informed Consent in the Digital Era: Telemedicine and Data Protection

Abstract

In the context of digital transformation, telemedicine has emerged as a significant instrument within the healthcare system, ensuring accessibility, continuity, and efficiency of medical services. However, the development of remote healthcare services raises substantial legal challenges, particularly in relation to informed consent and personal data protection.

The present study aims to assess the legal framework of telemedicine in the context of informed consent and data protection, based on a comparative analysis of international standards and Georgian practice. The research is grounded in doctrinal, historical, and comparative legal methods and encompasses international instruments such as the GDPR, HIPAA, and ISO 13131:2021, alongside an analysis of national legislation.

The findings demonstrate that, although the Georgian legal framework generally incorporates the fundamental principles of patient rights protection and data security, several telemedicine-specific issues remain only fragmentarily and insufficiently regulated. These include the absence of a clearly defined legal framework governing the form and legal validity of remote informed consent, patient identification procedures, and detailed rules for data processing.

The paper develops recommendations aimed at establishing a mandatory legal standard for remote informed consent, strengthening data protection mechanisms, and clarifying the scope of professional liability in telemedicine. These measures are essential for ensuring the effective protection of patient rights and supporting the sustainable development of digital healthcare in Georgia.