Open Access

Fatemeh Stodt, Philipp Ruf, Christoph Reich

• Modern healthcare relies heavily on the Internet of Medical Things (IoMT) and other medical devices that provide real-time monitoring, diagnostics, and treatment support. However, because these devices constantly gather and transmit sensitive health data, making them robust against cyberattacks, managing their lifecycle and guaranteeing their security are substantial challenges. The vital need for improved healthcare device security, including accountability and lifecycle management, is addressed in this study. Our proposal is a Digital Product Passports (DPP) framework that is enabled by blockchain and aims to improve the security, traceability, and management of medical devices over their entire life cycle. Our method demonstrates how much device security and regulatory compliance can be improved by utilizing blockchain technology to provide immutable, traceable records of device data, including manufacturing information, maintenance records, software updates, and usage history. The useful applications and advantages of the framework are demonstrated by comprehensive use-case, such as surgical instrument traceability and medical device lifecycle management. This approach provides a strong solution for the safe deployment and management of medical devices in medical ecosystems by integrating blockchain-enabled DPPs, ultimately improving patient safety and trust.