Safety and Security Processes for Medical Device Software

Dr Fergal Mc Caffery

Director of the Regulated Software Research Centre in Dundalk Institute of Technology

Ceara Treacy

Doctoral Researcher in the Regulated Software Research Group at Dundalk Institute of Technology

Given the complexity of modern day medical devices, it is important to ensure the safety and security of such devices. Failure of a medical device could result in potential harm to people. It is therefore important that medical device software is developed in line with regulatory standards and guidelines. The integration of medical devices, mobile medical apps and the prevalence of the IoT in the healthcare industry means sensitive health data flows across various applications, technologies and networks including public and open networks. This change in data flow exposes health data to greater attack surfaces and cyber-attacks are becoming a much larger threat as this is a vulnerability that cybercriminals identify and are actively exploiting. There is limited guidance for developers in the medical device, mobile medical app and IoT health domain on how to apply information security through implementing regulatory driven security controls into the development process, that address the security requirement to keep health data in flow secure.

This presentation discusses a safety and security framework that could be implemented when developing software for the safety critical medical device domain.

About Dr Fergal Mc Caffery

Dr Fergal Mc Caffery is a Senior Lecturer in the Department of Computing and Mathematics, at Dundalk Institute of Technology (DkIT). He is Director of the Regulated Software Research Centre and the Medical Device Software Engineering competency area leader in Lero. He has been awarded over €13 million in funding including SFI funding through the Stokes Lectureship, Principal Investigator, CSET and Centres Programmes to research the area of medical device software. Additionally, he has received H2020, EU FP7 research funding to improve the effectiveness of software development environments for the medical device industry. He also has received Enterprise Ireland Commercialisation funding for a number of different medical device projects. He is Chief R&D Officer for STATSports and Co-founder of Nova Leah. He has published over 200 peer-reviewed conference and journal papers and is on the editorial board/programme committee for a number of leading software engineering conferences and journals. He has also been appointed to an advisory committee for medical devices by the Minister for the Department of Health until the end of 2020. Winner of the DkIT Established Researcher of the Year Award in 2017.

About Ceara Treacy

Ceara received her BSc (Hons) and her M.Ed. at Ulster University and a HDip in Computing at Dundalk Institute of Technology. She is now studying for a PhD in computing by researching the area of Mobile Medical Apps and Data Security under the guidance of Dr Fergal Mc Caffery and Dr John Loane.