EVALUATION OF TELEMEDICINE SOFTWARE AS A MEDICAL DEVICE: CURRENT CHALLENGES AND FUTURE DIRECTIONS

The innovative development of telemedicine has changed the process of providing medical services by applying digital technologies in diagnostic, monitoring, and therapeutic procedures, and Software as a Medical Device (SaMD) has become a key enabler in managing healthcare Telemedicine SaMD can support remote consultations, management of chronic illnesses, and real-time monitoring of patients, but it may open up special regulatory, technical, and clinical considerations when it comes to evaluation The paper critically analyzes the existing methods of how telemedicine SaMD can be evaluated, considering performance verification, interoperability, cybersecurity, and adherence to international regulations and guidelines, such as the Total Product Lifecycle model developed by the FDA and IMDRF requirements. The review of the existing literature includes pieces of evidence based on peer-reviewed articles and latest regulatory reports to determine the sufficiency of the currently available assessment models regarding safety, efficacy, and post-market surveillance. The risks that remain prevalent are the lack of regulatory harmonization, the insufficient lifecycle risk management, and the inability to integrate decision support systems, mostly based on AI. The implications are the necessity of internationally consensual evaluation, adaptive risk assessment methods, and clinical confirmation of a secure patient, and the reliability of technology in the future. The results add to the discussion about creating standard, scalable, and future-proof evaluation frameworks of SaMD in telemedicine and offer practical implications to policymakers, vendors, and clinicians.