Data Security and Privacy Risk Management Framework for Medical Device Software Artificial Intelligence Model Lifecycle

This project is being undertaken by Buddhika Gayashani Jayanethi.

Buddhika's research addresses a growing challenge in modern healthcare, ensuring that sensitive patient data remains secure and private throughout the entire lifecycle of an AI model embedded in medical device software. To address this, she has developed a practical and comprehensive risk management framework that helps manufacturers and developers identify, assess, and manage data security and privacy risks at every stage of the AI model lifecycle from initial data collection, through development, deployment, and maintenance. A key motivation for this research is the recognised absence of comprehensive, practical guidance in this space. Existing standards and regulations offer only high-level guidance, leaving medical device developers without a clear, unified approach. Buddhika's framework addresses this gap directly by delivering a comprehensive set of processes designed specifically for the medical device software AI model lifecycle.

Buddhika is supervised by Dr Gilbert Regan and Prof. Fergal McCaffery

This project is funded through the Technological University Transfer Fund (TUTF) and DkIT.