Methods for Universal Authentication of Medical Devices

Abstract

The need for effective means of authentication of medical devices has increased with the growing number of falsified in vitro diagnostics and devices being introduced across world markets. Such substandard products result in negative consequences ranging from harm to patients and/or failure to impart the desired clinical outcomes to a loss of public trust in healthcare providers and regulatory agencies. Herein, we discuss the growing specter of medical device falsification, related cybersecurity threats and selected novel approaches suggested for authentication.